chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, Somnolence, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: could hardly move; all she wants to do is sleep / more sleepy than she already is experiencing; ached from head to toe; arm was red; arm itching; This spontaneous case was reported by a nurse and describes the occurrence of HYPOKINESIA (could hardly move), SOMNOLENCE (all she wants to do is sleep / more sleepy than she already is experiencing), PAIN (ached from head to toe), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE PRURITUS (arm itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Diabetes.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced HYPOKINESIA (could hardly move), SOMNOLENCE (all she wants to do is sleep / more sleepy than she already is experiencing), PAIN (ached from head to toe), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE PRURITUS (arm itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) for Itching, at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (could hardly move), SOMNOLENCE (all she wants to do is sleep / more sleepy than she already is experiencing), PAIN (ached from head to toe), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE PRURITUS (arm itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   List of concomitant medication were not given. She received the Moderna Booster shot on 29oct2021 (more than 6 months after her first 2 shots).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: Still weak; Felt strange for an hour; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Still weak) and FEELING ABNORMAL (Felt strange for an hour) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 011A21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Eczema and Lupus erythematosus (Skin lupus). Concomitant products included DUPILUMAB (DUPIXENT) for Eczema, HYDROXYCHLOROQUINE for Lupus erythematosus, METFORMIN and EMPAGLIFLOZIN (JARDIANCE) for Type 2 diabetes mellitus, ALLOPURINOL and ATORVASTATIN for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 12:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced ASTHENIA (Still weak) and FEELING ABNORMAL (Felt strange for an hour). On 01-Nov-2021, FEELING ABNORMAL (Felt strange for an hour) had resolved. At the time of the report, ASTHENIA (Still weak) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Company Comment: This case concerns a 75  AGE year-old male patient with a history of systemic lupus erythematosus and type 2 diabetes mellitus who experienced the unexpected non-serious events of asthenia and feeling abnormal. The event occurred approximately  1 day after the third dose of Moderna COVID-19 Vaccine. The medical history of systemic lupus erythematosus and type 2 diabetes mellitus remain confounders for asthenia and feeling abnormal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-374977 (Patient Link).; Sender's Comments: This case concerns a 75  AGE year-old male patient with a history of systemic lupus erythematosus and type 2 diabetes mellitus who experienced the unexpected non-serious events of asthenia and feeling abnormal. The event occurred approximately  1 day after the third dose of Moderna COVID-19 Vaccine. The medical history of systemic lupus erythematosus and type 2 diabetes mellitus remain confounders for asthenia and feeling abnormal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Seven patients were administered expired doses of the Moderna COVID-19 vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Seven patients were administered expired doses of the Moderna COVID-19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Seven patients were administered expired doses of the Moderna COVID-19 vaccine.). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Seven patients were administered expired doses of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel ill) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VALSARTAN (DIOVAN) for Blood pressure, LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROXYCHLOROQUINE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feel ill). At the time of the report, MALAISE (feel ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was not provided.   This case was linked to MOD-2021-371878 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Fatigue
Clinical narrative: received booster from expired vial; Chiils; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chiils), FATIGUE (Fatigue) and EXPIRED PRODUCT ADMINISTERED (received booster from expired vial) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Bacitracin allergy), Drug allergy (Lidocaine allergy), Allergy to antibiotic (polysporin allergy), GERD, High cholesterol and Hyperlipidemia. Concomitant products included SIMVASTATIN for Hyperlipidemia, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Reflux esophagitis.    On 29-Oct-2021 at 1:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In 2021, the patient experienced CHILLS (Chiils) and FATIGUE (Fatigue). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster from expired vial). In 2021, CHILLS (Chiils) and FATIGUE (Fatigue) had resolved. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received booster from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   The adverse events lasted for 24 hours.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: follow up received contains updated reporter type, patient demographic details, medical history, added concomitant medications and added events
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Expired product administered, Headache, Hot flush
Clinical narrative: received booster from expired vial; Hot flashes to chills; Headaches; Achy joints; Hot flashes to chills; This spontaneous case was reported by a physician and describes the occurrence of HOT FLUSH (Hot flashes to chills), HEADACHE (Headaches), ARTHRALGIA (Achy joints), CHILLS (Hot flashes to chills) and EXPIRED PRODUCT ADMINISTERED (received booster from expired vial) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (PCN (Penicillin)) and ADHD. Concomitant products included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for Vaccination.    On 29-Oct-2021 at 11:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In October 2021, the patient experienced HOT FLUSH (Hot flashes to chills), HEADACHE (Headaches), ARTHRALGIA (Achy joints) and CHILLS (Hot flashes to chills). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster from expired vial). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) (oral) ongoing since an unknown date for ADHD, at a dose of 25 mg once a day. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received booster from expired vial) had resolved. At the time of the report, HOT FLUSH (Hot flashes to chills), HEADACHE (Headaches), ARTHRALGIA (Achy joints) and CHILLS (Hot flashes to chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. The adverse events occurred after 24-48 hours of receiving the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: follow up received contains updated reporter type, patient demographic details, medical history, added concomitant medications and added events
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had a breakthrough case of Covid-19 on 23AUG2021; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had a breakthrough case of Covid-19 on 23AUG2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 01120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced COVID-19 (Had a breakthrough case of Covid-19 on 23AUG2021) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Had a breakthrough case of Covid-19 on 23AUG2021) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. Company comment:This case concerns a 70-year-old, female patient with medical history of immunocompromise, who experienced the unexpected serious adverse event of special interest of COVID-19. Drug ineffective was considered an additional event. The events occurred approximately 159 days after the second dose of Moderna COVID-19 vaccine. The medical history of immunocompromise remain a confounder for drug ineffective. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-378929 (Patient Link).; Sender's Comments: This case concerns a 70-year-old, female patient with medical history of immunocompromise, who experienced the unexpected serious adverse event of special interest of COVID-19. Drug ineffective was considered an additional event. The events occurred approximately 159 days after the second dose of Moderna COVID-19 vaccine. The medical history of immunocompromise remain a confounder for drug ineffective. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Chest pain, Dizziness
Clinical narrative: continuing lethargy after 5 days; Injection site pain; Sharp chest pains when exhaling; Sternum pain when bending over; dizziness; Shortness of breath; Tremors in left pointer finger; Left side lymph node swelling along collar bone very painful; Left side lymph node swelling along collar bone very painful; lower back pain between S5 and L1 and right hip; lower back pain between S5 and L1 and right hip; Extreme dry mouth; This is a spontaneous report from a contactable consumer (patient himself). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route of administration in left arm on 18Jul2021 at 15:30 as dose 1, single (at the age of 42-years-old) for COVID-19 immunization. The patient was diagnosed with COVID-19 prior vaccination. The patient was not tested COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's medical history was none. The patient's concomitant medication included pramipexol taken in two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 19Jul2021 at 07:00, the patient experienced injection site pain, sharp chest pains when exhaling, sternum pain when bending over, dizziness, shortness of breath, tremors in left pointer finger, left side lymph node swelling along collar bone very painful, lower back pain between S5 and L1 and right hip and extreme dry mouth. On 24Jul2021, after 5 days, the patient experienced continuing lethargy. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Lethargy, Ligament sprain, Lymphadenopathy
Clinical narrative: continuing lethargy after 5 days; Injection site pain; Sharp chest pains when exhaling; Sternum pain when bending over; dizziness; Shortness of breath; Tremors in left pointer finger; Left side lymph node swelling along collar bone very painful; Left side lymph node swelling along collar bone very painful; lower back pain between S5 and L1 and right hip; lower back pain between S5 and L1 and right hip; Extreme dry mouth; This is a spontaneous report from a contactable consumer (patient himself). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route of administration in left arm on 18Jul2021 at 15:30 as dose 1, single (at the age of 42-years-old) for COVID-19 immunization. The patient was diagnosed with COVID-19 prior vaccination. The patient was not tested COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's medical history was none. The patient's concomitant medication included pramipexol taken in two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 19Jul2021 at 07:00, the patient experienced injection site pain, sharp chest pains when exhaling, sternum pain when bending over, dizziness, shortness of breath, tremors in left pointer finger, left side lymph node swelling along collar bone very painful, lower back pain between S5 and L1 and right hip and extreme dry mouth. On 24Jul2021, after 5 days, the patient experienced continuing lethargy. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: continuing lethargy after 5 days; Injection site pain; Sharp chest pains when exhaling; Sternum pain when bending over; dizziness; Shortness of breath; Tremors in left pointer finger; Left side lymph node swelling along collar bone very painful; Left side lymph node swelling along collar bone very painful; lower back pain between S5 and L1 and right hip; lower back pain between S5 and L1 and right hip; Extreme dry mouth; This is a spontaneous report from a contactable consumer (patient himself). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196, Expiration date: Unknown), via an unspecified route of administration in left arm on 18Jul2021 at 15:30 as dose 1, single (at the age of 42-years-old) for COVID-19 immunization. The patient was diagnosed with COVID-19 prior vaccination. The patient was not tested COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient's medical history was none. The patient's concomitant medication included pramipexol taken in two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 19Jul2021 at 07:00, the patient experienced injection site pain, sharp chest pains when exhaling, sternum pain when bending over, dizziness, shortness of breath, tremors in left pointer finger, left side lymph node swelling along collar bone very painful, lower back pain between S5 and L1 and right hip and extreme dry mouth. On 24Jul2021, after 5 days, the patient experienced continuing lethargy. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; Minimal arm pain for both doses; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot number: EL9264) via an unspecified route of administration, administered in right arm on 09Feb2021 08:30 AM (at the age of 48 years old) as dose 2, single for COVID-19 immunization. Patient was non-pregnant at the time of vaccination. No other vaccine in 4 weeks and no covid prior vaccination. The patient's medical history included known allergies to shellfish. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot number: EL8982) via an unspecified route of administration, administered in right arm on 19Jan2021 08:30 AM (at the age of 48 years old) as dose 1, single dose for COVID-19 immunization and experienced headache, insomnia and minimal arm pain. On 09Feb2021, at 16:45 (04:45PM), after 2nd dose vaccination patient had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day and minimal arm pain for both doses. Not tested for COVID post vaccination. No treatment received for the events. The outcome of the events was resolved on fourth day, unspecified date in Feb 2021, for event minimal arm pain for both doses was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; 2nd dose had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day. Minimal arm pain for both doses.; Minimal arm pain for both doses; This is a spontaneous report from a non-contactable consumer (patient). A 48-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot number: EL9264) via an unspecified route of administration, administered in right arm on 09Feb2021 08:30 AM (at the age of 48 years old) as dose 2, single for COVID-19 immunization. Patient was non-pregnant at the time of vaccination. No other vaccine in 4 weeks and no covid prior vaccination. The patient's medical history included known allergies to shellfish. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection; batch or lot number: EL8982) via an unspecified route of administration, administered in right arm on 19Jan2021 08:30 AM (at the age of 48 years old) as dose 1, single dose for COVID-19 immunization and experienced headache, insomnia and minimal arm pain. On 09Feb2021, at 16:45 (04:45PM), after 2nd dose vaccination patient had fever, body ache, chills, fatigue, diarrhea which all subsided by the 4th day and minimal arm pain for both doses. Not tested for COVID post vaccination. No treatment received for the events. The outcome of the events was resolved on fourth day, unspecified date in Feb 2021, for event minimal arm pain for both doses was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hot flush, Migraine, Night sweats, Weight increased
Clinical narrative: migraine headache; Hot flashes/Hot flush; night sweats; joint aches/Joint pain; weight gain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8737, Expiration date: 31Dec2069) on 02Apr2021 via an unspecified route of administration in left arm as DOSE 1, SINGLE for covid-19 immunization and received second dose of BNT162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8733, Expiration date: 31Dec2069) on 23Apr2021 via an unspecified route of administration in arm as DOSE 2, SINGLE for covid-19 immunization (age at vaccination: 62-years-old).Patient medical history included Ongoing Hypothyroidism, approx. from 2000. The patient continued taking Levithyroxine (88 mg) from an unspecified date for Hypothyroidism within 2 weeks of covid-19 vaccine and was still ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was not administered at facility. Patient did not receive any prior vaccination before covid-19 vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. It was reported that the patient was 10 Years post menopause at the time of report. Patient did not have any known allergies. On an unknown date in Apr2021, the patient experienced Hot flashes/hot flush, night sweats, and joint aches/Joint pain. On 01May2021 the patient experienced migraine headache and on an unspecified date of 2021 patient had weight gain. It was reported that the hot flush, night sweats, joint aches/Joint pain, and weight gain was recurring. Relevant tests were reported as none. The patient did not receive any treatment for the events of Hot flashes/hot flush, night sweats, joint aches/Joint pain, and migraine headache. The outcome of the events Hot flashes/hot flush, night sweats, joint aches/Joint pain, and migraine headache was not recovered. The outcome of the event weight gain was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: There is a swelling in certain part of armpit and outside of the arm, there are like 4 fingers, like 4 fingers tentatively swelling on her arms; I have a swelling in my armpit the size of a golf ball; There is a swelling in certain part of armpit and outside of the arm, there are like 4 fingers, like 4 fingers tentatively swelling on her arms; I have a swelling in my armpit the size of a golf ball; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer sponsored program. A contactable 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0176 and Expiration Date was not reported) via an unspecified route of administration, administered in left arm on 22Jul2021 at 12:00 (age at vaccination was 66-Years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and Concomitant medication(s) were not reported. It was reported that there was a swelling in certain part of armpit and outside of the arm, there were like 4 fingers, like 4 fingers tentatively swelling on her arms. So, she wanted to know if its normal and the caller stated that she received the vaccination card but unfortunately she had no appointment for the second dose scheduled. She didn't understand she have a swelling in her armpit the size of a golf ball. Patient did not receive any treatment for the events. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: Face allergy side effect and experiencing face swelling; Face allergy side effect and experiencing face swelling; This is a spontaneous report from a contactable consumer or other non-health care professional(reporting for mother). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484) via an unspecified route of administration, on 25Jul2021 15:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No investigation assessment. No prior vaccination within 4 weeks. On an unspecified date, after the shot the patient had an allergy, she did tell the Pharmacist after the vaccine; but she did not explain like a face allergy side effect one of the allergic symptoms. She was experiencing face swelling. Reporter want to know if she can take Zyrtec for her allergy. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Pyrexia, Sleep disorder
Clinical narrative: She got fever; she started sleeping and jumping all the time through night; she move and hit something up and then after land; she started sleeping and jumping all the time through night; she move and hit something up and then after land; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 12-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0196, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she got fever, she started sleeping and jumping all the time through night, she move and hit something up and then after land. The reporter stated, my daughter (consumer) had her (first dose) Pfizer shot vaccinate last two days and she got some fever for this normal and I gave her some Tylenol as treatment but as she after that started to sleeping and jumping all the time like she keep sleeping through every night, she was even last night. She move and hit something up and then after land then another hour, I don't know what was going on with it. It was not a normal reaction. Reporter stated, She was sleeping with me in my sister house in one bed and we are sleeping together. She got fever in the first I think 24 hours, so I didn't go anywhere but she started to jumping all the time, so I was thinking the first night was normal but we have almost 5 nights in a row this thing came and she never do that before. She just took her vaccinate two days on 23rd and this night it was her fever, so we don't pay attention to then. Then on 22Jul, 23Jul, 24Jul and right now when I recently speak today, so it was specially in the night, in the day she is normal, she started to jumping for no reason. Patient was got fever in the first she thinks 24 hours, so she didn't go anywhere but stated to jumping all the time so was thinking the first night was normal, but we have almost 5 nights in a row this thing came and she never do that before. She just took her vaccinate two days on 23rd and this night it was her fever, so didn't pay attention. Then on 22Jul, 23Jul, 24Jul and right now when consumer recently speak today, it was specially in the night, in the day she is normal, patient starts to jump for no reason. The patient received tylenol as treatment for the adverse event. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Pain, Pyrexia
Clinical narrative: Chills, Aches & Pain, Fever, Bedridden; Chills, Aches & Pain, Fever, Bedridden; Chills, Aches & Pain, Fever, Bedridden; Chills, Aches & Pain, Fever, Bedridden; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received bnt162b2 (BNT162B2,solution for injection,Lot Number was en6204,expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 as(Age at vaccination was 56 years) DOSE 2, SINGLE for covid 19 immunization, Patient was not pregnant at the time of vaccination. Medical history included pulmonary embolism, lung disorder, back pain, surgery from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin from 04Mar2021 to an unspecified stop date, hydrocortisone, warfarin sodium (COUMADIN),omeprazole, eszopiclone (LUNESTA) taken for an unspecified indication, start and stop date were not reported and the patient previously took respaire and experienced drug hypersensitivity, flexeril [cefixime] and experienced drug hypersensitivity, Neosporin and burn relief and experienced drug hypersensitivity. The patient previously had received bnt162b2 (BNT162B2,solution for injection, lot number was EN9581,expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 as DOSE 1, SINGLE for covid-19 immunisation.On 11Feb2021 the patient experienced chills, aches & pain, fever, bedridden,Patient received no treatment for the event,The patient had not received any other vaccine within 4 weeks.Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the events was recovered with sequels.  Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling hot, Rhinorrhoea
Clinical narrative: Sniffles/Runny nose; Cough; Get the chills and I get hot, and I get chills and I get hot and I get chills, stuff like that; Get the chills and I get hot, and I get chills and I get hot and I get chills, stuff like that; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via intramuscular on 21Jul2021 as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route on unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient experienced sniffles/runny nose, cough, get the chills and i get hot, and i get chills and i get hot and i get chills, stuff like that. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Feeling abnormal, Impaired driving ability
Clinical narrative: About 2 weeks later, I started to feel "off" . Just not right. Brain Fog along with Short term memory impairment; About 2 weeks later, I started to feel "off" . Just not right. Brain Fog along with Short term memory impairment; Blurry vision; Difficulty Driving; light Headed; Ringing in the Right Ear; Shortness of Breath; No attention Span; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 07Jun2021 at 11:00 (at the age of 54-year-old) as dose 1, single for COVID-19 immunization at Public Health Clinic/Veterans Administration facility. Patient had no medical history. Concomitant medication in two weeks included levothyroxine sodium and hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient took first dose of Pfizer on 07Jun2021 at 11:00 am. She did not notice any immediate side effects. About 2 weeks later on 21Jun2021, she started to feel off. Just not right. Brain Fog along with Short term memory impairment. She did not think too much off it then, but the symptoms became gradually worse. Other symptoms started to appear blurry Vision, difficulty driving, light headed, no attention span, ringing in the right ear and shortness of breath. Patient reported that the symptoms did not seem to be going away. She had an appointment with her PCP next day at the time of reporting. No treatment received for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Tinnitus, Vision blurred
Clinical narrative: About 2 weeks later, I started to feel "off" . Just not right. Brain Fog along with Short term memory impairment; About 2 weeks later, I started to feel "off" . Just not right. Brain Fog along with Short term memory impairment; Blurry vision; Difficulty Driving; light Headed; Ringing in the Right Ear; Shortness of Breath; No attention Span; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0196, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 07Jun2021 at 11:00 (at the age of 54-year-old) as dose 1, single for COVID-19 immunization at Public Health Clinic/Veterans Administration facility. Patient had no medical history. Concomitant medication in two weeks included levothyroxine sodium and hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient took first dose of Pfizer on 07Jun2021 at 11:00 am. She did not notice any immediate side effects. About 2 weeks later on 21Jun2021, she started to feel off. Just not right. Brain Fog along with Short term memory impairment. She did not think too much off it then, but the symptoms became gradually worse. Other symptoms started to appear blurry Vision, difficulty driving, light headed, no attention span, ringing in the right ear and shortness of breath. Patient reported that the symptoms did not seem to be going away. She had an appointment with her PCP next day at the time of reporting. No treatment received for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Since the vaccine, I have had very painful and irregular menses; Since the vaccine, I have had very painful and irregular menses; Cramps and break through bleeding have been on and off since the second vaccine.; Cramps and break through bleeding have been on and off since the second vaccine.; This is a spontaneous report from a contactable consumer. This 29-year-old female consumer (Patient) reported that:  A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration, administered in arm left on 23May2021 (at the age of 29 years old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in arm left on 29Mar2021, as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28May2021, the patient experienced since the vaccine, i have had very painful and irregular menses and cramps and break through bleeding have been on and off since the second vaccine. The adverse event resulted in Physician Office Visit. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a non-contactable consumer or other non hcp. A 66-years-old female patient (consumer) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included asthma. Concomitant medication(s) included omalizumab (XOLAIR) taken for asthma, start and stop date were not reported. On an unspecified date patient experienced itching. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Fatigue, Headache, Investigation
Clinical narrative: Fatigue; Nauseousness; Headache; Body ache; Pain in my right armpit; Chest pain; This is a spontaneous report from a contactable consumer (patient, nursing assistant) or other non-health care professional. A 22-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FA6780; Expiration Date: 30Sep2021) via an unspecified route of administration on 24Jul2021, Saturday (at the age of 22-year-old) as dose 1, single for COVID-19 immunization. Medical history included HIV from an unknown date and unknown if ongoing. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV infection, start and stop date were not reported. Patient had no prior vaccination. On 24Jul2021, the patient experienced fatigue, nauseousness, headache, body ache, pain in right armpit, chest pain. It was reported that, this was all new, patient had no issues prior to the vaccine. Consumer stated for laboratory test consumer went every three months, not for two months. The patient underwent lab tests and procedures which included routine labs: unknown result on an unspecified date. No treatment received for the events. Outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Fatigue; Nauseousness; Headache; Body ache; Pain in my right armpit; Chest pain; This is a spontaneous report from a contactable consumer (patient, nursing assistant) or other non-health care professional. A 22-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FA6780; Expiration Date: 30Sep2021) via an unspecified route of administration on 24Jul2021, Saturday (at the age of 22-year-old) as dose 1, single for COVID-19 immunization. Medical history included HIV from an unknown date and unknown if ongoing. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) taken for HIV infection, start and stop date were not reported. Patient had no prior vaccination. On 24Jul2021, the patient experienced fatigue, nauseousness, headache, body ache, pain in right armpit, chest pain. It was reported that, this was all new, patient had no issues prior to the vaccine. Consumer stated for laboratory test consumer went every three months, not for two months. The patient underwent lab tests and procedures which included routine labs: unknown result on an unspecified date. No treatment received for the events. Outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation, Injection site haemorrhage, Poor quality product administered
Clinical narrative: The patient's mother reports that "vaccine appeared to be leaking out of the site"; The patient's mother reports that "vaccine appeared to be leaking out of the site"; The patient's mother reports that "vaccine appeared to be leaking out of the site"; blood coming out of the vaccination site; This is a spontaneous report from a contactable pharmacist reported for a 12-year-old female patient (NCSP: 159558). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, Batch/Lot Number: Not provided, Expiration Date: Not provided) via an unspecified route of administration on 02Aug2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient's mother reports that vaccine appeared to be leaking out of the site, reporter stated that mother saw blood coming out of the vaccination site and she felt that all of the vaccine oozed out of the injection site and hours later brought it to our attention that patient mother was concerned that the patient was not adequately vaccinated. The vaccinator believes the dose to be adequate. Mother had a couple daughters receive their COVID-19 Vaccine. After administration, mother called back regarding one of her daughters stating the vaccine is coming out of the site, it is leaking out. Mother is concerned the daughter may not have received the full dose. Confirmed only one of the daughters experienced the vaccine leaking out of the site. Clarified there is only one patient, a 12-year-old female. Person who administered the vaccine is completely trustworthy. The administrator had the perception that there was a bubble to start with, then it bled. Reporter was thinking the mother is confusing serous fluid at the injection site with the vaccine contents. Mother claims the daughter's injection site did not bleed. Reporter stated they had the tissue from this patient showing there was blood. However, reporter also said, "when you vaccinate 20 people a day, how do you know who the tissue belongs to." Reporter doesn't see this as a safety concern and declines report. The reporter would like to know how to proceed: re-administer the entire series, or continue with the second dose? Response from Pfizer included pfizer cannot make individual treatment recommendations. The clinical outcome of all the events were unknown.  Follow-up attempts are completed. No further information is expected.