chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A vial punctured for 20 times , but for the 20th dose, only drew 0.20 ml. Withdrawn another 0.05ml from another vial. The dose was administered to a patient that contained contents from two different Moderna COVID19 Vaccine vials. No concomitant medication were given. No treatment information were given.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Severe muscle aches; Headaches; fatigue; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Severe muscle aches), HEADACHE (Headaches) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (allergy to PCN), Sulfonamide allergy (sulfa allergy), Depression and Impaired fasting glucose. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METFORMIN for Impaired fasting glucose, INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for Vaccination, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    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 MYALGIA (Severe muscle aches), HEADACHE (Headaches) and FATIGUE (fatigue). At the time of the report, MYALGIA (Severe muscle aches), HEADACHE (Headaches) and FATIGUE (fatigue) had resolved.        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.   No treatment information provided. The symptoms cleared after 48 hours. The patient's height was 60 and weight was 182 (unit : not specified).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache, Myalgia, Underdose
Clinical narrative: Body ache; Chills; Headache; Received booster from expired vial; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache), EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA (Batch.no UT383JA,IM andleft arm on) on 12-Oct-2021. Concurrent medical conditions included Asthma, Hypertension, GERD, Anxiety, Allergy to animal dander, Environmental allergy, Sulfonamide allergy, Drug allergy and Allergy to molds. Concomitant products included AZELASTINE HYDROCHLORIDE (AZELASTIN COMOD) from 17-Jan-2020 to an unknown date for Allergy, CLONAZEPAM (KLONOPIN) from 19-Oct-2021 to an unknown date and BUPROPION from 02-May-2018 to an unknown date for Anxiety, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from 20-Oct-2021 to an unknown date for GERD, MAGNESIUM from 23-Jan-2020 to an unknown date for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients). On 30-Oct-2021, the patient experienced MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) and UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) had resolved. On 31-Oct-2021, MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Accidental underdose, Chills, Expired product administered, Headache, Pain
Clinical narrative: On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; Received booster from expired vial; Aches; Fever; chills; Headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Aches), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE injection for an unknown indication.    Concurrent medical conditions included High cholesterol since 04-Jan-2017.   On 29-Oct-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (Intramuscular) 1 dose. On 29-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache). On 29-Oct-2021, ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) had resolved. At the time of the report, PAIN (Aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) had resolved.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 43.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pyrexia
Clinical narrative: On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; Received booster from expired vial; Aches; Fever; chills; Headache; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Aches), PYREXIA (Fever), CHILLS (chills), HEADACHE (Headache) and ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE injection for an unknown indication.    Concurrent medical conditions included High cholesterol since 04-Jan-2017.   On 29-Oct-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (Intramuscular) 1 dose. On 29-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache). On 29-Oct-2021, ACCIDENTAL UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) had resolved. At the time of the report, PAIN (Aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (Headache) had resolved.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Date the vial was initially stored in the refrigerator: 26-Oct-2021 The pharmacist administered some vaccinations on 05-nov-2021 morning from a Moderna COVID-19 vial that had been punctured on 04-Nov-2021 at 9:40 am and was now past the 12 hour beyond use date. 10 patients received vaccine from this vial.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported. On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna Covid-19 vial that had been punctured on 04-NOV-2021 and is past the 12 hour beyond use date at time of administration. No concomitant medication were given. No treatment information were given.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash in the arm that was really itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash in the arm that was really itchy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NICOTINE POLACRILEX (HABITROL [NICOTINE POLACRILEX]) transdermal patch for Smoking cessation therapy.    The patient's past medical history included Stroke. Concomitant products included HYDROCODONE and GABAPENTIN (NEURONTIN) for an unknown indication.   On 20-Sep-2021, the patient started NICOTINE POLACRILEX (HABITROL [NICOTINE POLACRILEX]) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced RASH PRURITIC (rash in the arm that was really itchy). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash over arms, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash in the arm that was really itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had developed the rash on the opposite arm to the site of application of nicotine patch.; Sender's Comments: This case concerns a 59-year-old male patient with no relevant medical history, who experienced the unexpected event of Rash Pruritic. The event occurred on an unknown date after receiving an unknown dose of mRNA-1273 (Moderna COVID-19 Vaccine) and Co-suspect drug NICOTINE POLACRILEX (HABITROL [NICOTINE POLACRILEX]). The rechallenge was unknown since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was administered to 2 patients from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 2 patients from an expired vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 2 patients from an expired vial). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was administered to 2 patients from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient received booster dose from an expired vial. No side effects were reported.  This is a case of Expired Product Administered concerning a female patient of unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a female patient of unknown age with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   product removed from freezer 8AM No treatment information was provided. No concomitant medication was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Fear, Influenza like illness
Clinical narrative: Appendicitis; fearful of getting the booster shot; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 17-Aug-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEAR (fearful of getting the booster shot). The patient was hospitalized from 17-Aug-2021 to 21-Aug-2021 due to APPENDICITIS. The patient was treated with Surgery (Had surgery on 19-Aug-2021 to have appendix removed) for Appendicitis. On 25-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, APPENDICITIS (Appendicitis) had resolved and FEAR (fearful of getting the booster shot) outcome was unknown.            No Concomitant medication provided. No treatment medication reported.  Company Comment: This case concerns a 75-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of appendicitis. The event occurred 4 months and 25 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-374276 (Patient Link).; Sender's Comments: This case concerns a 75-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of appendicitis. The event occurred 4 months and 25 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Heavy menstrual bleeding, Palpitations, Urticaria
Clinical narrative: Heart palpitations/fluttering; hives on feet/ankles; onset of bleeding, Heaviest bleeding of my life and NOT at the expected time of the month; shortness of breath; This is spontaneous report from non-contactable consumer (patient). A 48-year-old non-pregnant female patient received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and Expiry date: not provided), via an unknown route administered in Arm Left on 26Jul2021 (at eth age of 48 years) as dose 1, single for Covid-19 immunization. The patient's medical history included hypersensitivity from an unknown date and unknown if ongoing (allergies), and covid-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). The patient's concomitant medication was not reported. She was diagnosed with COVID prior vaccination and patient not tested Covid-19, post vaccination. On 06Aug2021, the patient had shortness of breath. On 07Aug2021, the patient had hives on feet/ankles, heaviest bleeding of her life and not at the expected time of the month. No usual cramps, bloating, irritability, just heavy bleeding. On 12Aug2021, the patient had heart palpitations/fluttering. The patient underwent lab tests and procedures which included covid-19: diagnosed with COVID prior vaccination on an unknown date. The outcome of the event shortness of breath and heart palpitations/fluttering was not resolved on 21Aug2021, outcome of the event hives on feet/ankles was unknown and outcome of the event onset of bleeding, Heaviest bleeding of my life and NOT at the expected time of the month was resolved on 14Aug2021.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: Chest pain; Fast fluttering Heartbeat; I also have shortness of breath because I have Asthma; Asthma; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 21-year-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: FC3182 and expiration date was not reported) via an unspecified route of administration, administered in arm left on 25Aug2021 (age at vaccination 21-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for COVID-19 immunization and had no events reported. No prior vaccination within 4 weeks. On an unspecified date in Aug2021, the patient experienced chest pain, asthma, fast fluttering heartbeat, I also have shortness of breath because I have asthma. When probed for the concern, consumer stated, he was taking about the second dose, he had second dose and he was experiencing chest pain and he was having like fast fluttering heartbeat that was all today he thought 24 hours and he also had shortness of breath because he had asthma (event conservatively captured). When paraphrased the concern, consumer stated, he concerned was that everyone was telling him to go to the ER (Emergency Room) near Hospital. He was asking whether he needed to go. But he did not have money for that, did Pfizer pay for that. Consumer stated, he did take both the shots (1st and 2nd dose), that's what he meant to say 2 vaccines (both doses) in a month. When probed if having any prior medical history, consumer stated, he did not put on hold. As consumer abruptly hung up the call. Product details (Expiration date, NDC and UPC), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Atrial flutter, Blood pressure increased, Blood pressure measurement, Blood test
Clinical narrative: pulse rate high; go to bed with a racing heart and wake up with a racing heart; anxiety; heart went from fluttering to fast beating out of chest; heart started fluttering like butterfly fluttering; heart beating fast; blood pressure higher than normal; arm sore; felt a little tired; This is a spontaneous report from a contactable consumer (patient) reported that:  A 47-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH Covid 19 vaccine, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in left upper arm on 06Aug2021 11:30 (Age at vaccination- 47years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No, Prior Vaccinations (within 4 weeks). Hasn't had any vaccines since 2014, the tetanus, T-Dap booster. That is every 10 years. On an unspecified date, the patient had experienced arm sore, felt a little tired, go to bed with a racing heart and wake up with a racing heart and pulse rate high. On 08Aug2021, the patient had experienced heart started fluttering like butterfly fluttering, heart beating fast, heart went from fluttering to fast beating out of chest and blood pressure higher than normal. Her friend said that maybe it was an allergic reaction and to take Benadryl. She took Benadryl and it did not help. They said allergic reactions would happen immediately, not 2 days after. That is why the Benadryl really didn't do anything. Physician was ticked yes. The patient underwent lab tests and procedures which included blood pressure measurement: 130/87 and 150/97, blood test with unknown results. On 26Jul2021, the lab test of electrocardiogram with results as normal was reported. The heart rate was reported as 70, 114 and 130 was reported. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: pulse rate high; go to bed with a racing heart and wake up with a racing heart; anxiety; heart went from fluttering to fast beating out of chest; heart started fluttering like butterfly fluttering; heart beating fast; blood pressure higher than normal; arm sore; felt a little tired; This is a spontaneous report from a contactable consumer (patient) reported that:  A 47-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH Covid 19 vaccine, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in left upper arm on 06Aug2021 11:30 (Age at vaccination- 47years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No, Prior Vaccinations (within 4 weeks). Hasn't had any vaccines since 2014, the tetanus, T-Dap booster. That is every 10 years. On an unspecified date, the patient had experienced arm sore, felt a little tired, go to bed with a racing heart and wake up with a racing heart and pulse rate high. On 08Aug2021, the patient had experienced heart started fluttering like butterfly fluttering, heart beating fast, heart went from fluttering to fast beating out of chest and blood pressure higher than normal. Her friend said that maybe it was an allergic reaction and to take Benadryl. She took Benadryl and it did not help. They said allergic reactions would happen immediately, not 2 days after. That is why the Benadryl really didn't do anything. Physician was ticked yes. The patient underwent lab tests and procedures which included blood pressure measurement: 130/87 and 150/97, blood test with unknown results. On 26Jul2021, the lab test of electrocardiogram with results as normal was reported. The heart rate was reported as 70, 114 and 130 was reported. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: pulse rate high; go to bed with a racing heart and wake up with a racing heart; anxiety; heart went from fluttering to fast beating out of chest; heart started fluttering like butterfly fluttering; heart beating fast; blood pressure higher than normal; arm sore; felt a little tired; This is a spontaneous report from a contactable consumer (patient) reported that:  A 47-year-old female patient received first dose of bnt162b2 (PFIZER BIONTECH Covid 19 vaccine, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in left upper arm on 06Aug2021 11:30 (Age at vaccination- 47years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No, Prior Vaccinations (within 4 weeks). Hasn't had any vaccines since 2014, the tetanus, T-Dap booster. That is every 10 years. On an unspecified date, the patient had experienced arm sore, felt a little tired, go to bed with a racing heart and wake up with a racing heart and pulse rate high. On 08Aug2021, the patient had experienced heart started fluttering like butterfly fluttering, heart beating fast, heart went from fluttering to fast beating out of chest and blood pressure higher than normal. Her friend said that maybe it was an allergic reaction and to take Benadryl. She took Benadryl and it did not help. They said allergic reactions would happen immediately, not 2 days after. That is why the Benadryl really didn't do anything. Physician was ticked yes. The patient underwent lab tests and procedures which included blood pressure measurement: 130/87 and 150/97, blood test with unknown results. On 26Jul2021, the lab test of electrocardiogram with results as normal was reported. The heart rate was reported as 70, 114 and 130 was reported. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersomnia, Immunisation, Off label use, Vaccination site pain
Clinical narrative: arm was sore; slept the entire day; Off-label use; Booster; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient), forwarded as an Adverse Event by the Escalation team  A 65-years-old patient of an unspecified gender received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunisation. The patient medical history included immuno-compromised, rheumatoid arthritis (RA). Concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as dose 1 single and dose 2 single for COVID-19 immunization. It was reported that patient was mildly immuno-compromised (RA) the day after patient slept the entire day and patient arm was sore. The outcome of the events slept the entire day, arm was sore was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Limb discomfort, Pain in extremity
Clinical narrative: 'problems with her legs'; Legs were hurting; feet were burning; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on 10Sep2021 as DOSE 2, SINGLE (age at vaccination 61-year-old) for covid-19 immunisation. The patient medical history was not reported as none. The patient's had no concomitant medications. The patient historical vaccine includes BNT162B2 (BNT162B2, Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on 10Sep2021 as DOSE 1, SINGLE (age at vaccination 61-year-old) for covid-19 immunisation and had pain. It was reported that On her 2nd dose, she experienced leg pain within 24 hours - Legs were hurting, feet were burning and really had bad pain, she had to massage to ease the pain, it is hard to sleep and never had this before She did not take any pain medication or any other drugs in the past, Asking if has anybody reported like leg pain after getting the shot of the Pfizer COVID 19 vaccine. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: his arm was sore; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE (age at vaccination 64-year-old) for COVID-19 IMMUNISATION. The patient medical history included covid-19 from 2020 to 2020 (mentioned that he tested positive for COVID last year, it was mild and resolved after 2-3 weeks), pneumonia from he has a history of pneumonia. The patient's concomitant medications were not reported. The patient previously took flu and pneumonia shot and hasn't been getting sick every year. It was reported that patient had experienced sore arm after receiving the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 2020 Caller mentioned that he tested positive for COVID last year, it was mild and resolved after 2-3 weeks. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Feeling abnormal, Headache, Immunisation
Clinical narrative: That was really a bad experience; I am still having some heart issue from it; raising heart; Light-headed; pain; headache; I just got the booster on September 4th; I just got the booster on September 4th; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number), dose 3 via an unspecified route of administration, administered in Arm Left on 04Sep2021 (Batch/Lot Number: 30130HA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included thyroid cancer Stage II from an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (T3) taken for an unspecified indication, start and stop date were not reported. She stated that she is having side effect from the COVID-19 Vaccine. The patient reported first vaccine just felt like the regular shot and the second one was really sick and just got the booster on 04Sep2021, that was the really a bad experience and the patient was still having some heart issue from it. Patient mentioned she has some medical conditions that made her to get the booster and have many things that she take for Thyroid cancer, she take 2 stage thyroid cancer. On 04Sep2021 right after the shot the patient experienced that was really a bad experience (feeling abnormal), still having some heart issue from it; raising heart (cardiac disorder), light-headed (dizziness), pain, headache, immunization and just got the booster on september 4th (off label use). Therapeutic measures were taken as a result of still having some heart issue from it; raising heart (cardiac disorder), light-headed (dizziness), pain , headache. The patient underwent lab test for raising heart on an unspecified date. The patient reported that she took number of things, she thought she may have some bones out that was her limb nodes to be backed up (Further Clarifications unknown). She took medicine for pain, used her inhaler, she used her heart medicine because the raising heart, the patient was getting very light headed. The patient reported that she possibly took Tylenol for headache, lorazepam, apparently heart medicine and then took loprazolam. For the other medication she called to her cardiologist and she got her a heart manager to try catch what's going on. At that time she was not sure that it was related to a vaccine cause she do have heart conditions (Further Clarifications Unknown). Patient just wanted to make sure to understand what's going on so its getting better over time. And just wanted to make sure you have the data she truly appropriate the opportunity to got the vaccine. The outcome of cardiac disorder was not recovered.The outcome of all the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: That was really a bad experience; I am still having some heart issue from it; raising heart; Light-headed; pain; headache; I just got the booster on September 4th; I just got the booster on September 4th; This is a spontaneous report from a contactable consumer or other non hcp.   A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number), dose 3 via an unspecified route of administration, administered in Arm Left on 04Sep2021 (Batch/Lot Number: 30130HA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included thyroid cancer Stage II from an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (T3) taken for an unspecified indication, start and stop date were not reported. She stated that she is having side effect from the COVID-19 Vaccine. The patient reported first vaccine just felt like the regular shot and the second one was really sick and just got the booster on 04Sep2021, that was the really a bad experience and the patient was still having some heart issue from it. Patient mentioned she has some medical conditions that made her to get the booster and have many things that she take for Thyroid cancer, she take 2 stage thyroid cancer. On 04Sep2021 right after the shot the patient experienced that was really a bad experience (feeling abnormal), still having some heart issue from it; raising heart (cardiac disorder), light-headed (dizziness), pain, headache, immunization and just got the booster on september 4th (off label use). Therapeutic measures were taken as a result of still having some heart issue from it; raising heart (cardiac disorder), light-headed (dizziness), pain , headache. The patient underwent lab test for raising heart on an unspecified date. The patient reported that she took number of things, she thought she may have some bones out that was her limb nodes to be backed up (Further Clarifications unknown). She took medicine for pain, used her inhaler, she used her heart medicine because the raising heart, the patient was getting very light headed. The patient reported that she possibly took Tylenol for headache, lorazepam, apparently heart medicine and then took loprazolam. For the other medication she called to her cardiologist and she got her a heart manager to try catch what's going on. At that time she was not sure that it was related to a vaccine cause she do have heart conditions (Further Clarifications Unknown). Patient just wanted to make sure to understand what's going on so its getting better over time. And just wanted to make sure you have the data she truly appropriate the opportunity to got the vaccine. The outcome of cardiac disorder was not recovered.The outcome of all the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastroenteritis viral, Immunisation, Malaise, Nasopharyngitis
Clinical narrative: She has the stomach flu, she has never had cramping like this before/pains in her stomach; Arm was killing her; Cold; Nausea; She has the stomach flu, she has never had cramping like this before.; Was not feeling well; She is calling about the Pfizer Covid booster vaccine and got the booster; she is calling about the Pfizer Covid booster vaccine and got the booster; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in arm on Sep2021 (Monday) (at the age of 81 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single and received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 2, single for COVID-19 immunisation. On Sep2021 (on Monday night), patient was not feeling well, her arm was killing her, she was cold and had the usual things and does not remember what else she had. On Sep2021 (the next day), patient had pains in her stomach and feels nausea at times and yesterday (28Sep2021), she was really nauseous, and patient stated that she can feel stomach pains/ stomach hurt and asked was that a reaction to the booster vaccine. Patient thought it went away but today (29Sep2021) it was the same way. Patient had side effects from the second dose, but never this, and the side effects did not say anything about stomach hurting. Patient thought maybe she had the stomach flu and she never had cramping like this before. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pain in extremity
Clinical narrative: She has the stomach flu, she has never had cramping like this before/pains in her stomach; Arm was killing her; Cold; Nausea; She has the stomach flu, she has never had cramping like this before.; Was not feeling well; She is calling about the Pfizer Covid booster vaccine and got the booster; she is calling about the Pfizer Covid booster vaccine and got the booster; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in arm on Sep2021 (Monday) (at the age of 81 years old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single and received BNT162b2 (Comirnaty, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered on an unspecified date as dose 2, single for COVID-19 immunisation. On Sep2021 (on Monday night), patient was not feeling well, her arm was killing her, she was cold and had the usual things and does not remember what else she had. On Sep2021 (the next day), patient had pains in her stomach and feels nausea at times and yesterday (28Sep2021), she was really nauseous, and patient stated that she can feel stomach pains/ stomach hurt and asked was that a reaction to the booster vaccine. Patient thought it went away but today (29Sep2021) it was the same way. Patient had side effects from the second dose, but never this, and the side effects did not say anything about stomach hurting. Patient thought maybe she had the stomach flu and she never had cramping like this before. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Muscle twitching
Clinical narrative: Currently Bilateral feeling of numbness along jawline from upper jaw to chin began 3 days post booster vaccination.; Booster vaccination.; Started as twitching on left side of chin 2days post booster vaccination; This is a spontaneous report from a contactable consumer (patient) reported for himself that:  A 44-year-old male patient received bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191), intramuscularly, administered in left arm on 26Sep2021 08:15 AM (Age at vaccination: 44 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history was not reported. No known allergies. The patient had received Flu shot on 15Sep2021, left arm vaccines within 4 weeks prior to the COVID vaccine. The patient received Valsartan within 2 weeks of vaccination. The patient previously received first and second dose of bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown) via an unspecified route of administration at an unknown dose for COVID-19 immunisation. On 28Sep2021, the patient had experienced twitching on left side of chin 2 days post booster vaccination / Currently Bilateral feeling of numbness along jawline from upper jaw to chin began 3 days post booster vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Off label use
Clinical narrative: received a Covid-19 Booster vaccine; received a Covid-19 Booster vaccine; nausea; This is a spontaneous report from a contactable consumer (patient sister) reported for a consumer(patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 24Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccines included COVID-19 VACCINE (MANUFACTURER UNKNOWN) dose 1 and dose 2 (Primary Immunization series complete but unknown manufacturer) both doses taken for COVID-19 Immunization. The reporter stated that her sister (patient) received a Covid-19 Booster vaccine last Friday and that she also experienced nausea after that vaccine (on an unspecified date in Sep2021). Outcome of event nausea was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (06Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.