chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k218, 013m208 and 0276208) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm soreness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 19-Jan-2022 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.            No concomitant medications were provided.   This case was linked to MOD-2022-455764, MOD-2022-455763 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Wiped out after the injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Wiped out after the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Wiped out after the injection). At the time of the report, FATIGUE (Wiped out after the injection) had resolved.            Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Patient experienced event for one and a half day.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: felt a little sick; Little bit of the chills; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (felt a little sick) and CHILLS (Little bit of the chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     Concomitant products included DULAGLUTIDE (TRULICITY) and LOSARTAN for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt a little sick) and CHILLS (Little bit of the chills). At the time of the report, ILLNESS (felt a little sick) and CHILLS (Little bit of the chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Treatment medications were not provided.   This case was linked to MOD-2022-455789 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: seeing cloudy images; This spontaneous case was reported by a health care professional and describes the occurrence of VISION BLURRED (seeing cloudy images) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (seeing cloudy images). At the time of the report, VISION BLURRED (seeing cloudy images) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient recently received Moderna booster vaccine.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Cardiac flutter, Heart rate, Hypertension
Clinical narrative: Heart is fluttering; High Blood Pressure 191/115 mmHg; Palpitation; Insomnia; Not sure if he is having Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), HYPERTENSION (High Blood Pressure 191/115 mmHg), PALPITATIONS (Palpitation), INSOMNIA (Insomnia) and ANXIETY (Not sure if he is having Anxiety). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), HYPERTENSION (High Blood Pressure 191/115 mmHg), PALPITATIONS (Palpitation), INSOMNIA (Insomnia) and ANXIETY (Not sure if he is having Anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, Blood pressure measurement: high (High) 191/115 mmHg. On 11-Jan-2022, Heart rate: high (High) 95 BPM.         Reporter stated that patient did not have side effects after the first 2 doses.  Patient medical history totally healthy, Never had heart or blood pressure Issues. He never had COVID-Disease and he never had a positive PCR test.   No concomitant medications were reported.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 20 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of cardiac flutter. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 20 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of cardiac flutter. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Palpitations
Clinical narrative: Heart is fluttering; High Blood Pressure 191/115 mmHg; Palpitation; Insomnia; Not sure if he is having Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), HYPERTENSION (High Blood Pressure 191/115 mmHg), PALPITATIONS (Palpitation), INSOMNIA (Insomnia) and ANXIETY (Not sure if he is having Anxiety). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), HYPERTENSION (High Blood Pressure 191/115 mmHg), PALPITATIONS (Palpitation), INSOMNIA (Insomnia) and ANXIETY (Not sure if he is having Anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, Blood pressure measurement: high (High) 191/115 mmHg. On 11-Jan-2022, Heart rate: high (High) 95 BPM.         Reporter stated that patient did not have side effects after the first 2 doses.  Patient medical history totally healthy, Never had heart or blood pressure Issues. He never had COVID-Disease and he never had a positive PCR test.   No concomitant medications were reported.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 20 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of cardiac flutter. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 20 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, AESI of cardiac flutter. The event occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the event was not reported. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Investigation, Urinary tract infection
Clinical narrative: she has a urinary tract infection; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79 year-old female patient received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "she has a urinary tract infection"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urinary tract infection.  Additional information: His wife takes warfarin and he is wondering if it's a contraindication with the vaccine. He also mentions that his wife became sick a few days ago, she has a urinary tract infection. She takes Cephalexin 250mg every 6 hours, 4 times a day. She has E.coli bacterial infection in her urinary tract. She started taking it yesterday, 17nov. She will stop taking the medication on 22nov which is the day before the booster shot. He is wondering if that will be a problem with the vaccine (drug interaction). He had called back in March. He explains that both his wife and himself took both doses of the Pfizer BioNTech COVID19 vaccine "under the emergency usage authority". He is calling because he has follow up questions because they are scheduled to take the booster. The appointment for the booster shot is for 23Nov.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: Started getting a slight headache/ he has the same symptoms as me; pressure headache/he has the same symptoms as me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Started getting a slight headache/ he has the same symptoms as me"; HEAD DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "pressure headache/he has the same symptoms as me".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had a little soreness of the arm with first  dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "he had a little soreness of the arm with first  dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Immunisation, Investigation, Thyroid hormones test
Clinical narrative: 3rd dose; significant hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE-1, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE- 2, Unknown manufacturer), for Covid-19 immunization, reaction(s): "hair loss". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "3rd dose"; ALOPECIA (non-serious), outcome "unknown", described as "significant hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101863625 same drug and patient, different event and drug dose
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Peripheral swelling
Clinical narrative: Booster; feet swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: Date of administration/Lot/NDC/Expiry: Not provided), for COVID-19 Immunization; Bnt162b2 (Second dose: Date of administration/Lot/NDC/Expiry: Not provided), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (non-serious) with onset Dec2021, outcome "recovering", described as "feet swelling".  Additional information: The report is not related to a study or programme. The caller wanted to know if feet swelling was a known side effect of the vaccine. Response: Spoke from the attached CONS-what are the risks of the vaccine (v10.0), cant find the exact term/description "feet swelling", swelling of lymph nodes or lymphadenopathy has been reported as common side effects of the vaccine. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. For any specific questions regarding the risks of the vaccine based on your medical condition, please speak with your healthcare provider. Lot/NDC/Expiry of third dose was not provided. He explained that usually when he eats food with lots of salt his feet swell up. Because of that for the last 2-3 weeks he hasn't eaten anything with salt. After he was administered this booster shot on 18Dec2021 he did not have any side effects. His wife did of fatigue; but when he looked at his feet, both feet swelled quite a bit, considerably. He couldn't think of anything he had with salt, but everyday he looked at his feet and they wouldn't go down. When he looked online to see if side effect was swelling it did indicate swelling is side effect. The feet swelling has gone down somewhat at this point; compared to when he first looked when they were considerably swollen, they looked like grapefruit and now look like oranges. When reading he became concerned. He is thinking because he has had no salt intake that the feet swelling is from the booster shot of Pfizer Covid Vaccine. He did not call his physician yet and wanted to know if he should see his physician, or if he was ok.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Immunisation, Menstrual disorder
Clinical narrative: Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown: False, Previous dose lot unknown: True, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion, Previous dose administration date: 14Apr2021, Previous dose administration time: 03:00 PM, Previous dose number: 2, Previous dose Vaccine location: Left arm), administration date: 14Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Menstrual cycle - increased cramping", "heavier than normal bleeding"; Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose lot unknown reason=Not available/provided to reporter at the time of report completion,, Previous dose administration date: 31Mar2021, Previous dose administration time: 03:00 PM, Previous dose number: 1, Previous dose Vaccine location: Left arm), administration date: 31Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Menstrual cycle - increased cramping", "heavier than normal bleeding". The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster"; MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "recovering" and all described as "Menstrual cycle - increased cramping, heavier than normal bleeding". Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, heavy menstrual bleeding.  Additional information: It was reported that, the patient had no Known allergies. No other vaccine in four weeks. No other mediation in two weeks. No covid prior vaccination. No covid tested post vaccination. Facility type vaccine: Hospital. The patient did not receive any treatment for the adverse event.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product label confusion, Wrong product administered
Clinical narrative: can tell me if this label is actually mislabeled and it actually wasn't adult dose that got a child label sticker on; He was supposed to receive the adult formulation but believes he got the pediatric formulation; Received the Pfizer COVID-19 Vaccine, it should be an adult dose but on the label of the vaccination card where it's written like the pediatric dose was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 (Lot number: FL0007, Expiration Date: Mar2022) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing), notes: Medical Condition and Concomitant Medication: Consumer stated, "Yes, I have heart condition. The patient took concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 21Dec2021, outcome "unknown", described as "He was supposed to receive the adult formulation but believes he got the pediatric formulation"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Dec2021, outcome "unknown", described as "Received the Pfizer COVID-19 Vaccine, it should be an adult dose but on the label of the vaccination card where it's written like the pediatric dose was administered"; PRODUCT LABEL CONFUSION (non-serious), outcome "unknown", described as "can tell me if this label is actually mislabeled and it actually wasn't adult dose that got a child label sticker on".  Additional addition: Vaccination card which was typically had to be peeled off the vaccination vial indicates it's a pediatric Pfizer 5 to 11 its a 0.2ml, Pfizer age 12 plus 0.3. The patient received the Pfizer COVID-19 Vaccine, it should be an adult dose but on the label of the vaccination card where its written like, the pediatric dose was administered or the sticker on the vaccination card that has been given to him apparently was a Pediatric Pfizer vaccine 5 to 11 years old. The patient had no recent lab work. The reporter related to a study or programme.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Headache, Hypersensitivity
Clinical narrative: rash, shortness of breathe, sever trouble breathing, high fever, vomiting, Diarrhea, body chills , headache, numbness in hands and feet. went to e.r. was treated for allergic reaction and pain. discharged with fever and continued vomiting for next 12 hours. rash continued for 5 days. when rash went away pain in the arm causing loss of use and unable to work still current as of day 9 after vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: rash, shortness of breathe, sever trouble breathing, high fever, vomiting, Diarrhea, body chills , headache, numbness in hands and feet. went to e.r. was treated for allergic reaction and pain. discharged with fever and continued vomiting for next 12 hours. rash continued for 5 days. when rash went away pain in the arm causing loss of use and unable to work still current as of day 9 after vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: rash, shortness of breathe, sever trouble breathing, high fever, vomiting, Diarrhea, body chills , headache, numbness in hands and feet. went to e.r. was treated for allergic reaction and pain. discharged with fever and continued vomiting for next 12 hours. rash continued for 5 days. when rash went away pain in the arm causing loss of use and unable to work still current as of day 9 after vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria to whole body, moderate relief with antihistamines. Started on 01/17/2022 and is still occurring as of now, 01/21/2022
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: sleepy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Somnolence, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: sleepy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Weakness-Severe
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Insomnia, Keratosis pilaris, Pain in extremity, Peripheral swelling
Clinical narrative: I received the J&J vaccine back in March of 2021 and actually went to the ER due to an extremely high fever. A few days ago, I received the Moderna booster and once again had an extremely high fever of 101+, accompanied by excruciating pain in my right arm upon waking up the day after. At the end of that day, the 19th, my fever had felt like it was mostly gone however I was still left with extreme pain in my arm. Now, at 5 AM on the 21st, unable to sleep due to the pain in my arm that is now particularly swollen with a large red area on it along with "chicken skin", I am not having the greatest time. I plan on going and getting it looked at later today.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I received the J&J vaccine back in March of 2021 and actually went to the ER due to an extremely high fever. A few days ago, I received the Moderna booster and once again had an extremely high fever of 101+, accompanied by excruciating pain in my right arm upon waking up the day after. At the end of that day, the 19th, my fever had felt like it was mostly gone however I was still left with extreme pain in my arm. Now, at 5 AM on the 21st, unable to sleep due to the pain in my arm that is now particularly swollen with a large red area on it along with "chicken skin", I am not having the greatest time. I plan on going and getting it looked at later today.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Mild, Additional Details: Seizure monitored by husband and lasted approx 30 minutes. The seizure subsided before EMS arrived and patient sent them away without receiving additional evaluation. I advised the patient to seek additional medical evaluation from their PCP to determine if there may have been another cause for this event.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dizziness, Flushing
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Tremor
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: numbness and tingling in the arm-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient was experiencing arm pain, hot to touch, swollen and red (about 6 inches), and itch. Patient left message with MD on 01/20/2022.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient was experiencing arm pain, hot to touch, swollen and red (about 6 inches), and itch. Patient left message with MD on 01/20/2022.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eyelid function disorder, Facial paralysis, Movement disorder
Clinical narrative: Bells Palsey - complete paralyzation of the right side of my face - unable to move face, unable to close eye, unable to sniff, eat or drink out of ride side of mouth.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient felt lightheaded after injection. Nurse checked vitals, all within normal range. Pt reported no other symptoms. Mother refused to call EMS or any further medical treatment. Patient was monitored in store for about 30 minutes, stated she was feeling better. Nurse walked her to car (mother driving). Gave instruction to seek medical care if any more symptoms developed or condition worsened
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm,   closed on 1/17. Vaccines were administered to patients in the morning
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, closed on 1/17. Vaccines were administered to patients in the morning
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, Facility closed on 1/17. Vaccines were administered to patients in the morning
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Antinuclear antibody, Biopsy skin, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: Sweet syndrome with concurrent diarrhea/frequent stools. GI s/s lasted approximately 2-3 weeks. Sweet syndrome was treated with steroid taper.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Borrelia test, Chest X-ray, Clostridium test, Culture wound, Diarrhoea
Clinical narrative: Sweet syndrome with concurrent diarrhea/frequent stools. GI s/s lasted approximately 2-3 weeks. Sweet syndrome was treated with steroid taper.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Electrocardiogram, Epstein-Barr virus antibody, Frequent bowel movements, Full blood count
Clinical narrative: Sweet syndrome with concurrent diarrhea/frequent stools. GI s/s lasted approximately 2-3 weeks. Sweet syndrome was treated with steroid taper.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Gram stain, HIV antibody, HIV antigen, Hepatitis A antibody, Herpes simplex test
Clinical narrative: Sweet syndrome with concurrent diarrhea/frequent stools. GI s/s lasted approximately 2-3 weeks. Sweet syndrome was treated with steroid taper.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Mycoplasma test, Parasitic test, Platelet count, Red blood cell count
Clinical narrative: Sweet syndrome with concurrent diarrhea/frequent stools. GI s/s lasted approximately 2-3 weeks. Sweet syndrome was treated with steroid taper.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Respiratory viral panel, Thyroid function test
Clinical narrative: Sweet syndrome with concurrent diarrhea/frequent stools. GI s/s lasted approximately 2-3 weeks. Sweet syndrome was treated with steroid taper.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, facility closed on 1/17. Vaccines were administered to patients in the morning
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Arm is graduating getting worse with pains and is tingling.  Moving to shoulder and neck.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, DOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, closed on 1/17. Vaccines were administered to patients in the morning
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, clinic closed on 1/17. Vaccines were administered to patients in the morning
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, Agency closed on 1/17. Vaccines were administered to patients in the morning
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Fatigue, Headache, Malaise, Tinnitus
Clinical narrative: Hallucination type drams and headache during the night, sick and fatigued the following days. A few days later noticed tinnitus which I didn?t immediately connect with the vaccine. Unresolved and seems to be increasing. No prior hearing liss
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temperature went out of range by 4 degrees overnight Sunday due to storm, health department closed on 1/17/2022. Vaccines administered to patients in the morning.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, facility closed on 1/17. Vaccines were administered to patients in the morning
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, DOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, RIDOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, closed on 1/17. Vaccines were administered to patients in the morning.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, facility closed on 1/17. Vaccines were administered to patients in the morning
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, DOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: Pain at injection site was within an hour, seven hours later pain is radiating through out left arm, Left side neck stiffness, into left side upper back & down into hips to calf left side only. Off & on,ringing in left ear off & on, low grade fever through out 1st night. Have been taking Aleve & Tylenol....alternating. Fever under control, aches, pain, dizziness & ear ringing continues after 24 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Pain at injection site was within an hour, seven hours later pain is radiating through out left arm, Left side neck stiffness, into left side upper back & down into hips to calf left side only. Off & on,ringing in left ear off & on, low grade fever through out 1st night. Have been taking Aleve & Tylenol....alternating. Fever under control, aches, pain, dizziness & ear ringing continues after 24 hours.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, HPV9, RV5
Symptoms: Unevaluable event
Clinical narrative: no signs, symptoms
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, RIDOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight Sunday due to storm, we were closed on 1/17. Vaccines were administered to patients in the morning.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, RIDOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, DOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, DOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Sleep disorder
Clinical narrative: Headache.  Not sleeping. Uncontrolled shivering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Fridge temp went out of range by 4 degrees overnight sunday due to storm, DOH closed on 1/17. Vaccines were administered to patients in the morning
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Insomnia, Mobility decreased, Neck pain
Clinical narrative: Severe and debilitating arm, shoulder and neck pain. Constant severe pain. Loss of motion. Loss of arm strenght. Could not sleep.  Severe impacts through 2nd week of January, slowly mitigating. At this time, I still only have less than 50% usage of left arm.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Severe and debilitating arm, shoulder and neck pain. Constant severe pain. Loss of motion. Loss of arm strenght. Could not sleep.  Severe impacts through 2nd week of January, slowly mitigating. At this time, I still only have less than 50% usage of left arm.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Condition aggravated, Disturbance in attention, Fatigue
Clinical narrative: Severe fatigue, groggy/inability to focus, muscle soreness all over body, armpit soreness with lump
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Somnolence
Clinical narrative: Severe fatigue, groggy/inability to focus, muscle soreness all over body, armpit soreness with lump
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric Covid vaccine was given to a 14 year old female. PCP notified.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Diarrhoea, Nausea
Clinical narrative: I had the vaccine, within 14 hours, had liquid diarrhea, then had diarrhea about 5 x day for 2 days, then abdominal discomfort, then severe abdominal pain, nausea, abdominal bloating for 4 days. By 1 week then pain has subsided about 75%, appetite is still only 50%, and slight abdominal discomfort.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives morning after shot, used benadryl and they went away. Hives a second time a couple mornings later (date unknown) benadryl again. Today Jan 21 8:20AM hives for a third time. Benadryl seems to be working less. Eating no new foods during or prior to each event.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/28/21, 4/25/21, 10/22/21. Positive on 1/20/22
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/7/21 and 4/28/21. Positive on 1/10/22
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Feeling hot, Headache, Pain
Clinical narrative: Body aches and headache around 10:00 PM when I tried to go to sleep. Restless the entire night while feeling hot like I had a fever. Tool temperature but no fever. In the morning, felt dehydrated. After washing my hair and face, had a fainting spell but never fully fainted, which left me recovering on the bathroom floor for about 20 minutes. Still very sore and had chills with no fever still. Took Tylenol and Advil at different times to help. Not really any symptoms come 9:00 PM on 01/20/22.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, Syncope
Clinical narrative: Body aches and headache around 10:00 PM when I tried to go to sleep. Restless the entire night while feeling hot like I had a fever. Tool temperature but no fever. In the morning, felt dehydrated. After washing my hair and face, had a fainting spell but never fully fainted, which left me recovering on the bathroom floor for about 20 minutes. Still very sore and had chills with no fever still. Took Tylenol and Advil at different times to help. Not really any symptoms come 9:00 PM on 01/20/22.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/9/21 and 3/11/21. Positive on 1/17/22
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose of Pfizer CoVID vaccine at 15 days after 1st dose
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/13/21 and 5/4/21. Positive on 1/20/22
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Pruritus, Urticaria
Clinical narrative: within 24 hours: 1. bodywide hives 2. extreme pruritis 3. polyarticular arthralgia and arthritis  treated with Benadryl, loratadine and prednisone taper
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Moderna 1/26/21, 2/19/21, and 10/28/21. Positive on 1/20/22
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted. COVID-19 infection breakthrough with inpatient admit.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 5/7/21 and 5/28/21. Positive on 1/17/22
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 6/14/21. Positive on 1/20/22
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 1/5/21, 1/26/21, 10/13/21. Positive on 1/18/22
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted.  COVID infection breakthrough with inpatient patient stay
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, no booster.  COVID infection breakthrough with inpatient hospital stay.
Age: 78.0
Sex: U
Vaccine: UNK
Symptoms: Death
Clinical narrative: REFERENCE E REPORT # 767661  UPDATED INFO BELOW
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Pruritus, Rash pruritic
Clinical narrative: Child developed pruritic rash around the mouth beginning a few hours after the vaccine.  He responded to Zyrtec given at home by the parent.   The next morning he still had some redness and itching around the mouth and complained of itchy eyes as well.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: After receiving 2nd COVID vaccine in March of 2021, experienced irregular menses with menstrual cycle beginning within 48 hours of receipt of vaccine and occurring 9 days early.  By history, no irregular menses for >20 years with cycles occurring q29 days and lasting 7 days.  Cycles returned to normal pattern in April 2021 until booster in Jan 2022. After receipt of booster on Jan 19, 2022 menstrual cycle ended after 3 days instead of standard 7 days which is again completely anomalous based on 20 year history.