chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022; No adverse event; Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Unspecified COVID-19 Vaccine, Dose 1), COVID-19 VACCINE (Unspecified COVID-19 Vaccine, Booster Dose 1), COVID-19 VACCINE (Unspecified COVID-19 Vaccine and Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 06-Sep-2022 at 3:18 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 3:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022).    No concomitant medication was reported. On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: chills / same as before but no period; fever / same as before but no period; Sore arm / same as before but no period; Achy joint / same as before but no period; Nausea / same as before but no period; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills / same as before but no period), PYREXIA (fever / same as before but no period), PAIN IN EXTREMITY (Sore arm / same as before but no period), ARTHRALGIA (Achy joint / same as before but no period) and NAUSEA (Nausea / same as before but no period) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 016B22A, 007B21A and 040A21A) for COVID-19 prophylaxis.     The patient had not been diagnosed or tested positive for COVID-19.  The patient's past medical history included Stomach cancer (ongoing checkups) in 2020 and Tumour excision (Stomach cancer, tumor removed, ongoing checkups) in 2020. Concurrent medical conditions included Eczema since 10-Jun-1958, Blood pressure high, Acid reflux (esophageal), Restless leg syndrome (RLS), Drug allergy (Oxycodone), Allergy to moulds and Food allergy. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, LOSARTAN and AMLODIPINE for Blood pressure high.   On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 8:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced CHILLS (chills / same as before but no period), PYREXIA (fever / same as before but no period), PAIN IN EXTREMITY (Sore arm / same as before but no period), ARTHRALGIA (Achy joint / same as before but no period) and NAUSEA (Nausea / same as before but no period). At the time of the report, CHILLS (chills / same as before but no period), PYREXIA (fever / same as before but no period), PAIN IN EXTREMITY (Sore arm / same as before but no period), ARTHRALGIA (Achy joint / same as before but no period) and NAUSEA (Nausea / same as before but no period) had resolved.            Dose 4 was given at 01:00pm. Patient was taking an unknown concomitant medication for RLS. Treatment information was not provided. The event had not caused patient t seek medical care.   This case was linked to MOD-2021-074747, MOD-2021-074721 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Administration error: dose administered after 30-day use by date; Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022) and NO ADVERSE EVENT (No adverse event) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052B22A and 051B22A) for COVID-19 vaccination.     Patient had no allergies. Patient had no history relating to adverse event and both acute and chronic illnesses at the time of vaccination.    On 19-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administration error: dose administered after 30-day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 19Jul2022 and 2nd dose on 15Sep2022).    Patient did not received other vaccines within one month prior to Moderna. No concomitant medications were reported. Vial of Moderna COVID-19 vaccine was stored in the fridge since 15-Aug-2022 and was inadvertently administered on 15-Sep-2022. Patient did not report any adverse event after the vaccine was given. No treatment medications were reported.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: dose involved in excursion administered to 2 year old; The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (dose involved in excursion administered to 2 year old) and PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge  and administered on 15 Sep 22).    No concomitant medications was reported.  The nurse had a temperature excursion for 7 hours. They wanted to make sure that the vaccines were still viable. Nurse used the temperature excursion tool online, but was not sure if she done that right. One dose was administered on 15 Sep 2022. The product was monovalent with dose of 0.25 ml. at the time of temperature excursion the vial was stored in the fridge. Maximum or minimum temperatures reached, as applicable were min 33.2 F, max 35.9 F with excursion duration of 7 hours. The vial was moved from freezer to refrigerator on 14 Sep 22 and stored in fridge at the time of reporting. There was no change in the visual inspection and no any vaccine stage change noted. The number of vials or doses impacted were unknown with no previous excursions.  No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Non significant follow up- reporter email address updated.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: she has gotten the Moderna shot each time even though she got a horrible rash each time; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (she has gotten the Moderna shot each time even though she got a horrible rash each time) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (she has gotten the Moderna shot each time even though she got a horrible rash each time). At the time of the report, RASH (she has gotten the Moderna shot each time even though she got a horrible rash each time) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment dug information was provided.  Reporter did not know the name of the patient.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Overdose, Product preparation error
Clinical narrative: Received 0.3mL undiluted dose; The patient received 0.3mL undiluted for his dose; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A 12-year-old male patient received BNT162b2 (BNT162B2), on 26Jul2022 as dose 3 (booster), 0.3ml single (Lot number: FL8094, Expiration Date: 05Aug2022) at the age of 12 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 (Primary immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 26Jul2022, outcome "unknown", described as "Received 0.3mL undiluted dose"; OVERDOSE (non-serious) with onset 26Jul2022, outcome "unknown", described as "The patient received 0.3mL undiluted for his dose"; FATIGUE (non-serious), outcome "recovered", described as "severe fatigue".  Additional information: The patient did not administer any additional vaccines on Same Date of the Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's relevant tests were none. The Pfizer product had a causal effect to the adverse event. Vaccination Facility Type was a Pharmacy or Drug store. No prior vaccinations (within 4 weeks). No tests for thromboembolic events with thrombocytopenia. Patient was administered 0.3ml of undiluted Pfizer vac covid-19 5-11 y injection. The Pfizer vac covid-19 5-11 y injection vial was used to draw the vaccination dose. The error was discovered where vials were inspected after the vaccination. The patient's mother was called to report of the doses discrepancy. Patient's other reported the patient was laying on the couch. On 01Sep2022, its parent were called to question any issue after the immunization father reported that the patient experienced covid vaccine syndrome. Patient experienced severe fatigue for 48hours. After 48 hours period, was back to normal without showing side effects.  Follow-Up (22Aug2022): Follow-up attempts are completed. No further information is expected.  Follow-up (13Sep2022): This is a spontaneous follow-up report received from a contactable Pharmacist . This Pharmacist reported in response to HCP letter sent which included that: Updated information included: new event Fatigue was captured. Vaccination anatomical Location (left arm) was captured.
Age: 24.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Vaccination error
Clinical narrative: Failed to make wheal x2, given subQ in same arm
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Rash, Urticaria, Vomiting
Clinical narrative: Systemic: Allergic: Rash Generalized-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient had hives all over body a day after administration of shot. She went to the ER and they gave her benadryl and steroids which only made her hives worse. She states she has had flu shots in the past with no issues. However the patient does have numerous other allergies - none of which were identified as being in the high dose flu shot.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Pain
Clinical narrative: Full body aches starting 11 hours after vaccine and lasting a total of 36 hours. Chills starting at 11 hour and lasting for about 24 hours
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site inflammation
Clinical narrative: PATIENT HAD INFLAMMATION ABOUT THE SIZE OF AN ORANGE JUST BELOW THE INJECTION SITE.
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: Patient received the incorrect dosage of Jynneos. He received 0.1ml subcutaneously, instead of 0.5ml.  Patient denies any adverse effects or feeling unwell. He was scheduled to return for the corrected injection, but was a no-show for the appointment. Administering RN was retrained and demonstrated back the correct techniuqe and dosage per route.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Death, Dementia, Gait disturbance, Laboratory test abnormal
Clinical narrative: I am writing this report for my mother who is now dead due to these shots.  Prior to these shots she was in good health.  Right after her first shot she started showing signs of dementia.  Not long after she had some tests done which showed she had multiple small strokes.  She was having trouble walking and needed a wheelchair. She had more tests done and it was found she was full of blood clots.  We had a procedure done to stop one of the big clots in her leg but she died two days later.  I looked up her batch numbers on a website and found that all of her lot numbers were a part of bad batches with multiple deaths and injuries.  I believe Pfizer murdered my mother.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Thrombosis, Wheelchair user
Clinical narrative: I am writing this report for my mother who is now dead due to these shots.  Prior to these shots she was in good health.  Right after her first shot she started showing signs of dementia.  Not long after she had some tests done which showed she had multiple small strokes.  She was having trouble walking and needed a wheelchair. She had more tests done and it was found she was full of blood clots.  We had a procedure done to stop one of the big clots in her leg but she died two days later.  I looked up her batch numbers on a website and found that all of her lot numbers were a part of bad batches with multiple deaths and injuries.  I believe Pfizer murdered my mother.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Patient administered partial dose of Moderna 2.5mL to RVL. Prior to noticing, patient was poked with partial dose. Noticed dose on patient's leg. Patient made aware. Full dose of vaccine given via LVL.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anticoagulant therapy, Asthenia, Cardiac stress test, Chest pain
Clinical narrative: Please see my prior report for the first dose. I was given Pfizer covid 19 vaccine at 7:45 AM. After few minutes I was itching all over my body.  A few rashes and itching more inside my body. Hitting myself helped the itchiness. I was given 25 mg of Benadryl by mouth and 1 capsule to take home. Perhaps around 9AM I felt tingling and numbing in my face, arms and legs and overall shakiness. I was feeling very confused and not understanding my feelings. I had 2-3 times diarrhea, fast heart beats, swollen lower lip and my throat is feeling tight/swollen, I gave myself epi injection and went to the ER. From the ER, I was given prednisone, Benadryl injection, dextrose and prescriptions for Epipen, Prednisone and Benadryl. It?s been 5 months since my second dose and I still have my confusing symptoms, sometimes worst ? weakness, tingling and numbing in my face, legs, and arms. There are times I can?t sit or stand after few minutes, having lower body discomfort related to bowel movements, uncontrolled urination, brain fog, cognitive issues, bubbling feelings in my arms, legs and thighs, choking even not eating. New symptoms of heart bubbling that makes me cough and pee.  I can?t cope up/remember all my symptoms I don?t really know how to describe them. Had fast heart beats and chest pain that were gone after taking Eliquis. I am now back taking Eliquis due to vein insufficiency. Currently seeing a neurologist and cardiologist.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cognitive disorder, Confusional state, Cough, Diarrhoea
Clinical narrative: Please see my prior report for the first dose. I was given Pfizer covid 19 vaccine at 7:45 AM. After few minutes I was itching all over my body.  A few rashes and itching more inside my body. Hitting myself helped the itchiness. I was given 25 mg of Benadryl by mouth and 1 capsule to take home. Perhaps around 9AM I felt tingling and numbing in my face, arms and legs and overall shakiness. I was feeling very confused and not understanding my feelings. I had 2-3 times diarrhea, fast heart beats, swollen lower lip and my throat is feeling tight/swollen, I gave myself epi injection and went to the ER. From the ER, I was given prednisone, Benadryl injection, dextrose and prescriptions for Epipen, Prednisone and Benadryl. It?s been 5 months since my second dose and I still have my confusing symptoms, sometimes worst ? weakness, tingling and numbing in my face, legs, and arms. There are times I can?t sit or stand after few minutes, having lower body discomfort related to bowel movements, uncontrolled urination, brain fog, cognitive issues, bubbling feelings in my arms, legs and thighs, choking even not eating. New symptoms of heart bubbling that makes me cough and pee.  I can?t cope up/remember all my symptoms I don?t really know how to describe them. Had fast heart beats and chest pain that were gone after taking Eliquis. I am now back taking Eliquis due to vein insufficiency. Currently seeing a neurologist and cardiologist.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Electromyogram, Feeling abnormal, Heart rate increased, Hypoaesthesia
Clinical narrative: Please see my prior report for the first dose. I was given Pfizer covid 19 vaccine at 7:45 AM. After few minutes I was itching all over my body.  A few rashes and itching more inside my body. Hitting myself helped the itchiness. I was given 25 mg of Benadryl by mouth and 1 capsule to take home. Perhaps around 9AM I felt tingling and numbing in my face, arms and legs and overall shakiness. I was feeling very confused and not understanding my feelings. I had 2-3 times diarrhea, fast heart beats, swollen lower lip and my throat is feeling tight/swollen, I gave myself epi injection and went to the ER. From the ER, I was given prednisone, Benadryl injection, dextrose and prescriptions for Epipen, Prednisone and Benadryl. It?s been 5 months since my second dose and I still have my confusing symptoms, sometimes worst ? weakness, tingling and numbing in my face, legs, and arms. There are times I can?t sit or stand after few minutes, having lower body discomfort related to bowel movements, uncontrolled urination, brain fog, cognitive issues, bubbling feelings in my arms, legs and thighs, choking even not eating. New symptoms of heart bubbling that makes me cough and pee.  I can?t cope up/remember all my symptoms I don?t really know how to describe them. Had fast heart beats and chest pain that were gone after taking Eliquis. I am now back taking Eliquis due to vein insufficiency. Currently seeing a neurologist and cardiologist.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure, Laboratory test normal, Lip swelling, Paraesthesia, Peripheral venous disease
Clinical narrative: Please see my prior report for the first dose. I was given Pfizer covid 19 vaccine at 7:45 AM. After few minutes I was itching all over my body.  A few rashes and itching more inside my body. Hitting myself helped the itchiness. I was given 25 mg of Benadryl by mouth and 1 capsule to take home. Perhaps around 9AM I felt tingling and numbing in my face, arms and legs and overall shakiness. I was feeling very confused and not understanding my feelings. I had 2-3 times diarrhea, fast heart beats, swollen lower lip and my throat is feeling tight/swollen, I gave myself epi injection and went to the ER. From the ER, I was given prednisone, Benadryl injection, dextrose and prescriptions for Epipen, Prednisone and Benadryl. It?s been 5 months since my second dose and I still have my confusing symptoms, sometimes worst ? weakness, tingling and numbing in my face, legs, and arms. There are times I can?t sit or stand after few minutes, having lower body discomfort related to bowel movements, uncontrolled urination, brain fog, cognitive issues, bubbling feelings in my arms, legs and thighs, choking even not eating. New symptoms of heart bubbling that makes me cough and pee.  I can?t cope up/remember all my symptoms I don?t really know how to describe them. Had fast heart beats and chest pain that were gone after taking Eliquis. I am now back taking Eliquis due to vein insufficiency. Currently seeing a neurologist and cardiologist.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash, Sensory disturbance, Throat tightness
Clinical narrative: Please see my prior report for the first dose. I was given Pfizer covid 19 vaccine at 7:45 AM. After few minutes I was itching all over my body.  A few rashes and itching more inside my body. Hitting myself helped the itchiness. I was given 25 mg of Benadryl by mouth and 1 capsule to take home. Perhaps around 9AM I felt tingling and numbing in my face, arms and legs and overall shakiness. I was feeling very confused and not understanding my feelings. I had 2-3 times diarrhea, fast heart beats, swollen lower lip and my throat is feeling tight/swollen, I gave myself epi injection and went to the ER. From the ER, I was given prednisone, Benadryl injection, dextrose and prescriptions for Epipen, Prednisone and Benadryl. It?s been 5 months since my second dose and I still have my confusing symptoms, sometimes worst ? weakness, tingling and numbing in my face, legs, and arms. There are times I can?t sit or stand after few minutes, having lower body discomfort related to bowel movements, uncontrolled urination, brain fog, cognitive issues, bubbling feelings in my arms, legs and thighs, choking even not eating. New symptoms of heart bubbling that makes me cough and pee.  I can?t cope up/remember all my symptoms I don?t really know how to describe them. Had fast heart beats and chest pain that were gone after taking Eliquis. I am now back taking Eliquis due to vein insufficiency. Currently seeing a neurologist and cardiologist.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Ultrasound Doppler abnormal, Urinary incontinence
Clinical narrative: Please see my prior report for the first dose. I was given Pfizer covid 19 vaccine at 7:45 AM. After few minutes I was itching all over my body.  A few rashes and itching more inside my body. Hitting myself helped the itchiness. I was given 25 mg of Benadryl by mouth and 1 capsule to take home. Perhaps around 9AM I felt tingling and numbing in my face, arms and legs and overall shakiness. I was feeling very confused and not understanding my feelings. I had 2-3 times diarrhea, fast heart beats, swollen lower lip and my throat is feeling tight/swollen, I gave myself epi injection and went to the ER. From the ER, I was given prednisone, Benadryl injection, dextrose and prescriptions for Epipen, Prednisone and Benadryl. It?s been 5 months since my second dose and I still have my confusing symptoms, sometimes worst ? weakness, tingling and numbing in my face, legs, and arms. There are times I can?t sit or stand after few minutes, having lower body discomfort related to bowel movements, uncontrolled urination, brain fog, cognitive issues, bubbling feelings in my arms, legs and thighs, choking even not eating. New symptoms of heart bubbling that makes me cough and pee.  I can?t cope up/remember all my symptoms I don?t really know how to describe them. Had fast heart beats and chest pain that were gone after taking Eliquis. I am now back taking Eliquis due to vein insufficiency. Currently seeing a neurologist and cardiologist.
Sex: M
Vaccine: PNC13
Symptoms: Device leakage, Underdose
Clinical narrative: Leakage and the patient couldn't get the full dose/ there was a leakage and not all of the expected dose was administered; Leakage and the patient couldn't get the full dose/ there was a leakage and not all of the expected dose was administered; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team.  A 17-month-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), UNDERDOSE (non-serious) and all described as "Leakage and the patient couldn't get the full dose/ there was a leakage and not all of the expected dose was administered".  Additional information: Caller stated that a patient (male, 17 months) was supposed to get a dose of the Prevnar 13 vaccine. However, there was a leakage, and the patient couldn't get the full dose. It exploded and the patient didn't get all the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Sep2022): This is a spontaneous follow-up report received in response to query. Updated information includes: updated reporter information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Vaccination site pain
Clinical narrative: my arm is still sore from that shot and cannot even sleep on that side it hurts; it is bothersome because sometimes I can't even raise my arm. I can't even sleep on that side, it hurts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "my arm is still sore from that shot and cannot even sleep on that side it hurts"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "it is bothersome because sometimes I can't even raise my arm. I can't even sleep on that side, it hurts.".  Additional Information: The patient reported that she had some issues with the adverse reaction to the booster shot. The patient stated that she had the booster dose in February later corrected to October of last year (2021) and experienced arm sore from that shot and she don't know if anybody else had the same reaction or what. The patient just wanted to know because it was bothersome because sometimes she cannot even raise arm. The patient cannot even sleep on that side as it hurts. The patient still have the arm sore.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac murmur, Heart rate, Hyperhidrosis, Mitral valve prolapse
Clinical narrative: pulse is typically in the 60s-low 70 and it was racing to 100/bad reaction of her heart racing; mitral valve prolapse; heart murmur; aches; bad muscle aches; joint muscle pain; Aches and muscle pains and joint muscle pain was that bad she could not move; chronic sweating; 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 female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "muscle aches"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "pulse is typically in the 60s-low 70 and it was racing to 100", "chronic sweating"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "chronic sweating", "muscle aches"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "pulse is typically in the 60s-low 70 and it was racing to 100". The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "chronic sweating"; PALPITATIONS (non-serious), outcome "recovering", described as "pulse is typically in the 60s-low 70 and it was racing to 100/bad reaction of her heart racing"; MITRAL VALVE PROLAPSE (non-serious), outcome "unknown"; CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur"; PAIN (non-serious), outcome "recovering", described as "aches"; MYALGIA (non-serious), outcome "recovering", described as "bad muscle aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joint muscle pain"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Aches and muscle pains and joint muscle pain was that bad she could not move". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, she had a bad reaction of her heart racing, really bad muscle aches and chronic sweating for a few days, resting pulse was typically in the 60s-low 70 and it was racing to 100. Aches and muscle pains and joint muscle pain was that bad she could not move. 3 days the achiness started to go away and heart rate started to come down. The sweating took one month to go away. Patient had mitral valve prolapse and heart murmur and are several medications including any medications that have phedra or phedrine at the end of the medication name, or any cough medications with a D or DM on the end of the medication name. No specific products mentioned and no additional information provided.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201139221 similar report from same reporter;US-PFIZER INC-202201139222 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain, Palpitations
Clinical narrative: pulse is typically in the 60s-low 70 and it was racing to 100/bad reaction of her heart racing; mitral valve prolapse; heart murmur; aches; bad muscle aches; joint muscle pain; Aches and muscle pains and joint muscle pain was that bad she could not move; chronic sweating; 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 female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "muscle aches"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "pulse is typically in the 60s-low 70 and it was racing to 100", "chronic sweating"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "chronic sweating", "muscle aches"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "pulse is typically in the 60s-low 70 and it was racing to 100". The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "chronic sweating"; PALPITATIONS (non-serious), outcome "recovering", described as "pulse is typically in the 60s-low 70 and it was racing to 100/bad reaction of her heart racing"; MITRAL VALVE PROLAPSE (non-serious), outcome "unknown"; CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur"; PAIN (non-serious), outcome "recovering", described as "aches"; MYALGIA (non-serious), outcome "recovering", described as "bad muscle aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joint muscle pain"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Aches and muscle pains and joint muscle pain was that bad she could not move". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, she had a bad reaction of her heart racing, really bad muscle aches and chronic sweating for a few days, resting pulse was typically in the 60s-low 70 and it was racing to 100. Aches and muscle pains and joint muscle pain was that bad she could not move. 3 days the achiness started to go away and heart rate started to come down. The sweating took one month to go away. Patient had mitral valve prolapse and heart murmur and are several medications including any medications that have phedra or phedrine at the end of the medication name, or any cough medications with a D or DM on the end of the medication name. No specific products mentioned and no additional information provided.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201139221 similar report from same reporter;US-PFIZER INC-202201139222 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperhidrosis, Musculoskeletal pain, Myalgia
Clinical narrative: muscle aches/ache; chronic sweating; pulse is typically in the 60s-low 70 and it was racing to 100; joint muscle pain; 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 female patient received BNT162b2 (BNT162B2), as dose 1, 30 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mitral valve prolapse" (unspecified if ongoing); "heart murmur" (unspecified if ongoing); "sensitive to medications" (unspecified if ongoing), notes: medication with a phedra or pedrine, cough medications that are labeled with the D/DM, and NSAIDS. The patient took concomitant medications. Past drug history included: Nsaids for make my heart race. The following information was reported: MYALGIA (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "muscle aches/ache"; HYPERHIDROSIS (non-serious), 2 days after the suspect product(s) administration, outcome "recovered", described as "chronic sweating"; HEART RATE INCREASED (non-serious), 2 days after the suspect product(s) administration, outcome "unknown", described as "pulse is typically in the 60s-low 70 and it was racing to 100"; MUSCULOSKELETAL PAIN (non-serious), outcome "unknown", described as "joint muscle pain". The events "muscle aches/ache", "chronic sweating" and "pulse is typically in the 60s-low 70 and it was racing to 100" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This case was assessed as non-serious. It was reported that, after receiving first 2, the patient felt fine. So she didnt think to check her pulse. When she got the booster she got really really bad muscle aches and chronic sweating for a few days. She didnt even know what made her check pulse, resting pulse was typically in the 60s-low 70 and it was racing to 100. The patient had never had this before. She took the vaccine and called cardiologist. She was advised to monitor for a few days, she did this. Aches and muscle pains and joint muscle pain was that bad she could not move. 3 days the achiness started to go away and heart rate started to come down. The sweating took one month to go away. Each week it started to decline but she never had chronic sweating before or after that time frame. Never had a fever. It all seemed to be the side effect from the booster and for all 3 shots she had Pfizer."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201139179 similar report from same reporter;US-PFIZER INC-202201139222 same reporter/patient/drug/events, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased, Neurological symptom
Clinical narrative: Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; Get weak as well as other neurological symptoms and lack of mobility; This is a spontaneous report received from a contactable reporter   An female patient received BNT162b2  as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROLOGICAL SYMPTOM (non-serious), ASTHENIA (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Get weak as well as other neurological symptoms and lack of mobility".  Additional information: The reporter was reporting about the possible side effects on his mother (the patient) that have continued for 1.5 years. The patient continues to get weak as well as other neurological symptoms and lack of mobility. The reporters has identical symptoms. They thought it was due to the Alzheimer's and everyone has the same symptoms. The reporter does not know which vaccine they received it was just ironic they are having that too. A total of 4 patients that experienced identical symptoms which he had reported. Reporter reported that he does not have any other patient information to provide on any of the patients.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: every time she takes a shot she does the same thing/ start her period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "every time she takes a shot she does the same thing/ start her period".  Additional information: It was reported that other women have the same problem. she knows someone the same age. States it happened last year she thinks she was 56. Caller proceeds to state she talked to another girl every time she takes a shot she does the same thing, she started hers too and she is the same age. She has talked to several other people and they have the same thing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201139735 same reporter/product/event, different patient;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal, Investigation, SARS-CoV-2 test
Clinical narrative: I had a mini stroke; occasional feeling like I was going to fall over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Primary biliary cholangitis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; URSODIOL; VITAMIN D [VITAMIN D NOS]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL9261, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 15Oct2021, outcome "recovered", described as "occasional feeling like I was going to fall over"; CEREBROVASCULAR ACCIDENT (medically significant) with onset Dec2021, outcome "recovered", described as "I had a mini stroke". The events "i had a mini stroke" and "occasional feeling like i was going to fall over" required emergency room visit. The patient underwent the following laboratory tests and procedures: Tests: Unknown Results, notes: Many tests to find the cause; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of cerebrovascular accident, feeling abnormal.  Clinical course: After receiving the 3rd shot, patient started having an occasional feeling like she was going to fall over. This symptom continued and got worse until she had a mini stroke. The shot was 05Oct and she had stroke sometime in the mid Dec. No covid prior vaccination. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 11Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BrCa", start date: 1995, stop date: 1997, notes: BrCa 1995-1997; "mastectomy" (unspecified if ongoing); "early melanoma", start date: 1997 (unspecified if ongoing), notes: early melanoma 1997; "mild high cholesterol" (unspecified if ongoing), notes: mild high cholesterol; "osteopenia" (unspecified if ongoing); "herpes" (unspecified if ongoing), notes: herpes; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust. The patient's concomitant medications were not reported. Past drug history included: Nsaids, reaction(s): "Known allergies: NSAIDS", notes: Known allergies: NSAIDS. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Aug2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive, notes: had gotten positive test 12Aug2022; (18Aug2022) Negative, notes: Tested negative 18Aug2022; (27Aug2022) Negative, notes: Tested negative 27Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Other medication in 2 weeks was Yes. COVID 19 Treatment, brand: Paxlovid. Other medication in 2weeks was alendronate sodium (brand Aurobindo, lot number: UA7022020A), rosuvastatin calcium (brand: Torrent, lot number: BDN7H051) and valacyclovir (brand: Camber, lot number: VAC22004). Adverse event: COVID Rebound First COVID bout: symptoms started 13Aug2022; had gotten positive test 12Aug2022. Fatigue, very sore throat, fever, runny nose. Symptoms ended 17Aug2022. Tested negative 18Aug2022 Rebound bout: symptoms started 20Aug20222, fatigue, sore throat, fever, runny nose. Symptoms ended 26Aug2022. Tested negative 27Aug2022 AE treatment: Rest, fluids, Tylenol, antihistamine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.