chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Eating disorder, Headache, Migraine, Nausea
Clinical narrative: Hasn't eaten much; Really bad headache; Migraine; nausea; vomiting; This is a spontaneous report from a contactable consumer reported for herself. This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 09:35 Arm Left at single dose (Lot: EW0151) for COVID-19 immunisation. Family medical history included Migraines. No other products. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at age of 61-year-old Left Upper Arm at single dose (Lot: ER8727) for COVID-19 immunisation. She had only a sore arm after the first dose of the vaccine. Says it started the day of the vaccine and lasted for a couple of days then it was gone. She got her second dose of the vaccine on Saturday 10Apr2021. States right after that she started having a really bad headache on 10Ap2021, not long after the vaccine, that turned into a migraine, Continues but has gotten better. She was nauseous and vomiting on 10Apr2021. States she stayed in bed most of the weekend. Nausea and Vomiting began on 10Apr2021. States she had eaten that day. Hasn't eaten much since then besides crackers. States the nausea and vomiting started before the headache got really bad. States the nausea and vomiting have improved and then again mentions she hasn't eaten anything besides some crackers. States she has also taken some nausea medication. Lab data included a CT Scan of her sinuses and throat; about a week or so ago; has not received any results. Outcome of the event headache, Migraine, nausea, vomiting was recovering. Outcome of other events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Blood test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive again for Covid 19 during pre-op labs/asymptomatic; tested positive again for Covid 19 during pre-op labs/asymptomatic; This is a spontaneous report from contactable consumers. A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) at a single dose and dose 1 via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: EL9262; Expiration Date: May2021) at a single dose, for COVID-19 immunization. Medical history included kidney disease, high blood pressure, and also had Covid in Dec2020. Concomitant medications included unspecified blood thinner, high blood pressure pills and a heart medication. The patient is a 67-year-old female who had Covid 19 in Dec2020, was vaccinated with both doses of the Pfizer Covid 19 vaccine, and just tested positive again for Covid 19 during pre-op labs. She was asymptomatic and doesn't know where she would have gotten it. It was also reported that, now, the patient caught Covid again which she doesn't know how. She was getting ready for open-heart surgery that week and they did pre-op and they said she was Covid positive again. She was also calling about her son and grandson who received the first doses of the Pfizer Covid 19 vaccine last week and have been exposed to her. She is afraid they might have Covid 19 now too and they are being tested for it. The patient also asked how it would affect their second dose that is scheduled for 27April2021. The patient underwent lab tests and procedures which included blood work with unknown results. She said her COVID-19 Virus RPR (rapid) test was also negative when she had it done on an unspecified date in 2021, and a Covid 19 positive test result on an unspecified date in 2021. She had 3 or 4 then on 9th on Saturday, the 9th that's when she found she was Covid positive. The event outcome was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has worsened.; She believed she was injected improperly.; pain and felt that her arm has been "rendered useless".; she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back; difficulty sleeping due to the pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Lot Number: ER2613) (at the age of 64-year-old) as single dose for COVID-19 immunisation.  Medical history included ongoing obesity. The patient's concomitant medications were not reported.  The patient experienced soreness in her left arm for 2 to 3 days (on 20Mar2021) that she thought was going to get better but stated it has worsened. Caller stated that she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back. She reported difficulty sleeping due to the pain and felt that her arm has been "rendered useless". She stated that this has been ongoing for 3 weeks after her first injection. She stated that because of this, she felt like she may need physical therapy in the future. She believed she was injected improperly. She thought that happens more with people overweight, like her, because it is not quite so easy to see the muscle. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and TYLENOL, the patient stopped taking NORCO (she did not like taking it). Despite treatment, it just didn't get any better/did not work and finally she couldn't take it and she ended up going to her doctor, she was told it hasn't been verified it was an injury. The patient outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site pain, Pain in extremity, Physiotherapy
Clinical narrative: soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has worsened.; She believed she was injected improperly.; pain and felt that her arm has been "rendered useless".; she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back; difficulty sleeping due to the pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Lot Number: ER2613) (at the age of 64-year-old) as single dose for COVID-19 immunisation.  Medical history included ongoing obesity. The patient's concomitant medications were not reported.  The patient experienced soreness in her left arm for 2 to 3 days (on 20Mar2021) that she thought was going to get better but stated it has worsened. Caller stated that she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back. She reported difficulty sleeping due to the pain and felt that her arm has been "rendered useless". She stated that this has been ongoing for 3 weeks after her first injection. She stated that because of this, she felt like she may need physical therapy in the future. She believed she was injected improperly. She thought that happens more with people overweight, like her, because it is not quite so easy to see the muscle. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and TYLENOL, the patient stopped taking NORCO (she did not like taking it). Despite treatment, it just didn't get any better/did not work and finally she couldn't take it and she ended up going to her doctor, she was told it hasn't been verified it was an injury. The patient outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration, Insomnia, Joint range of motion decreased, Pain in extremity, Vaccination site pain
Clinical narrative: soreness in her left arm for 2 to 3 days that she thought was going to get better but stated it has worsened.; She believed she was injected improperly.; pain and felt that her arm has been "rendered useless".; she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back; difficulty sleeping due to the pain; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.   A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Mar2021 (Lot Number: ER2613) (at the age of 64-year-old) as single dose for COVID-19 immunisation.  Medical history included ongoing obesity. The patient's concomitant medications were not reported.  The patient experienced soreness in her left arm for 2 to 3 days (on 20Mar2021) that she thought was going to get better but stated it has worsened. Caller stated that she had a limited range of motion above her head and wrapping her arm around, she cannot put her arm over her head, she can't put her arm around her back. She reported difficulty sleeping due to the pain and felt that her arm has been "rendered useless". She stated that this has been ongoing for 3 weeks after her first injection. She stated that because of this, she felt like she may need physical therapy in the future. She believed she was injected improperly. She thought that happens more with people overweight, like her, because it is not quite so easy to see the muscle. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen and TYLENOL, the patient stopped taking NORCO (she did not like taking it). Despite treatment, it just didn't get any better/did not work and finally she couldn't take it and she ended up going to her doctor, she was told it hasn't been verified it was an injury. The patient outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Glycosylated haemoglobin normal, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. The patient was not pregnant at the time of event and the patient has twins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-APR-2021, the patient experienced stroke. The patients husband figured out that it was a stroke and drove her to hospital the ambulance. The patient had experienced left sided paralysis before she was taken in to the hospital. The patient was administered with anticoagulant medication. The patient was hospitalized for 3 days and was not discharged at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralyzed left side and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210451687-Covid-19 vaccine ad26.cov2.s-STROKE. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. The patient was not pregnant at the time of event and the patient has twins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-APR-2021, the patient experienced stroke. The patients husband figured out that it was a stroke and drove her to hospital the ambulance. The patient had experienced left sided paralysis before she was taken in to the hospital. The patient was administered with anticoagulant medication. The patient was hospitalized for 3 days and was not discharged at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralyzed left side and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210451687-Covid-19 vaccine ad26.cov2.s-STROKE. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. The patient was not pregnant at the time of event and the patient has twins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-APR-2021, the patient experienced stroke. The patients husband figured out that it was a stroke and drove her to hospital the ambulance. The patient had experienced left sided paralysis before she was taken in to the hospital. The patient was administered with anticoagulant medication. The patient was hospitalized for 3 days and was not discharged at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralyzed left side and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210451687-Covid-19 vaccine ad26.cov2.s-STROKE. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: 3 days after 2nd vaccine shot I started experiencing sporadic chest pain and a feeling of being light headed.  The next day I still had the same symptoms so I described them to my doctor.  She recommended going to a  urgent care facility.  I was diagnosed with 2 small blood clots - one in each lung.  I'm on anti-coagulants for the next 6 months.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram thorax, Dizziness
Clinical narrative: 3 days after 2nd vaccine shot I started experiencing sporadic chest pain and a feeling of being light headed.  The next day I still had the same symptoms so I described them to my doctor.  She recommended going to a  urgent care facility.  I was diagnosed with 2 small blood clots - one in each lung.  I'm on anti-coagulants for the next 6 months.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Pulmonary thrombosis, Ultrasound Doppler
Clinical narrative: 3 days after 2nd vaccine shot I started experiencing sporadic chest pain and a feeling of being light headed.  The next day I still had the same symptoms so I described them to my doctor.  She recommended going to a  urgent care facility.  I was diagnosed with 2 small blood clots - one in each lung.  I'm on anti-coagulants for the next 6 months.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness the morning after 2nd vaccination; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 16Feb2021 at 11:15 AM (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, nasal polyps, chronic rhinitis and allergy to NSAID. Concomitant medication included 20mg olmesartan daily. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (Lot Number: EL3247) on 26Jan2021 at 11:15 AM, as single dose in left arm for COVID-19 immunisation. On 16Feb2021, morning after second vaccination, the patient experienced tiredness. There was no treatment received for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The outcome of the event was recovered.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin
Clinical narrative: Patient had fever one day after his vaccine. Two days after his vaccine, he had acute onset chest pain that was described as 10/10.  He was admitted to hospital on 4/25 due to EKG showing diffuse ST elevations and troponin T being elevated up to 1700. During the hospitalization, he was found to have a run of ventricular tachycardia and occasional pre ventricular contractions. He was found to have myocarditis after cardiac MRI was performed on 4/26. After confirmation of the myocarditis, he was treated with 2/kg of IVIG and two days of Solumedrol followed by outpatient steroid taper.  He was discharged on 4/29/21.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Cardiac imaging procedure abnormal, Chest pain, Echocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Patient had fever one day after his vaccine. Two days after his vaccine, he had acute onset chest pain that was described as 10/10.  He was admitted to hospital on 4/25 due to EKG showing diffuse ST elevations and troponin T being elevated up to 1700. During the hospitalization, he was found to have a run of ventricular tachycardia and occasional pre ventricular contractions. He was found to have myocarditis after cardiac MRI was performed on 4/26. After confirmation of the myocarditis, he was treated with 2/kg of IVIG and two days of Solumedrol followed by outpatient steroid taper.  He was discharged on 4/29/21.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Myocarditis, Pyrexia, Troponin T increased, Ventricular extrasystoles
Clinical narrative: Patient had fever one day after his vaccine. Two days after his vaccine, he had acute onset chest pain that was described as 10/10.  He was admitted to hospital on 4/25 due to EKG showing diffuse ST elevations and troponin T being elevated up to 1700. During the hospitalization, he was found to have a run of ventricular tachycardia and occasional pre ventricular contractions. He was found to have myocarditis after cardiac MRI was performed on 4/26. After confirmation of the myocarditis, he was treated with 2/kg of IVIG and two days of Solumedrol followed by outpatient steroid taper.  He was discharged on 4/29/21.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Patient had fever one day after his vaccine. Two days after his vaccine, he had acute onset chest pain that was described as 10/10.  He was admitted to hospital on 4/25 due to EKG showing diffuse ST elevations and troponin T being elevated up to 1700. During the hospitalization, he was found to have a run of ventricular tachycardia and occasional pre ventricular contractions. He was found to have myocarditis after cardiac MRI was performed on 4/26. After confirmation of the myocarditis, he was treated with 2/kg of IVIG and two days of Solumedrol followed by outpatient steroid taper.  He was discharged on 4/29/21.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Mechanical ventilation
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 57 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's past medical history included previous back injury, and concurrent conditions included alcohol intake 2-3 beers a day, and smoking 1-2 cigarettes per month, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and vaccination site not reported, batch number: 1808607 or 1808609, expiry: UNKNOWN) administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, patient experienced pain and tingling sensation on his back but he still went to work. On 16-APR-2021, he did not go to work, tingling sensation started going on his hands. On 17-APR-2021, patient went to the emergency clinic, and was told the symptoms might be cause by herniated disc. On 19-APR- 2021, he went to fill out worker's compensation and was seen by his worker's comp doctor. X-ray was taken and showed some abnormality in the neck area. On 20-APR-2021, symptoms worsened and patient was paralyzed from the shoulder down. On 21-APR-2021, patient went to the hospital and was admitted. Magnetic resonance imaging (MRI) found nothing on patient's neck and showed old back injury, but per patient's doctor it should not cause the paralysis. Unspecified additional tests were done, and Guillain-Barre Syndrome was diagnosed. On 25-APR-2021, hospital physician ruled out other causes and confirmed that Guillain-Barre Syndrome (GBS) was caused by Janssen COVID vaccine. At the time of report, the patient was intubated at the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Life Threatening).; Sender's Comments: V0: 20210456333-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Laboratory test, Magnetic resonance imaging, X-ray
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 57 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's past medical history included previous back injury, and concurrent conditions included alcohol intake 2-3 beers a day, and smoking 1-2 cigarettes per month, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, dose and vaccination site not reported, batch number: 1808607 or 1808609, expiry: UNKNOWN) administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, patient experienced pain and tingling sensation on his back but he still went to work. On 16-APR-2021, he did not go to work, tingling sensation started going on his hands. On 17-APR-2021, patient went to the emergency clinic, and was told the symptoms might be cause by herniated disc. On 19-APR- 2021, he went to fill out worker's compensation and was seen by his worker's comp doctor. X-ray was taken and showed some abnormality in the neck area. On 20-APR-2021, symptoms worsened and patient was paralyzed from the shoulder down. On 21-APR-2021, patient went to the hospital and was admitted. Magnetic resonance imaging (MRI) found nothing on patient's neck and showed old back injury, but per patient's doctor it should not cause the paralysis. Unspecified additional tests were done, and Guillain-Barre Syndrome was diagnosed. On 25-APR-2021, hospital physician ruled out other causes and confirmed that Guillain-Barre Syndrome (GBS) was caused by Janssen COVID vaccine. At the time of report, the patient was intubated at the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Guillain-Barre Syndrome. This report was serious (Life Threatening).; Sender's Comments: V0: 20210456333-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Eyelid function disorder, Fatigue, Hypersomnia, Migraine
Clinical narrative: BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital swelling, Somnolence
Clinical narrative: BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Entropion, Eye pain, Eyelid irritation, Feeling abnormal, Migraine
Clinical narrative: BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ocular hyperaemia, Photophobia
Clinical narrative: BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematuria
Clinical narrative: BLOOD IN URINE; This spontaneous report received from a health care professional concerned an 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine. This report was non-serious.; Sender's Comments: V0:As per standard protocol ,comment is not required for non-serious case.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood urine present
Clinical narrative: BLOOD IN URINE; This spontaneous report received from a health care professional concerned an 84 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine. This report was non-serious.; Sender's Comments: V0:As per standard protocol ,comment is not required for non-serious case.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extraocular muscle paresis, Vision blurred, Visual impairment
Clinical narrative: She is having an adverse reaction with her vision (did not elaborate)./The caller's reaction is the vaccine made her eyes blurry, she is having a problem with her right eye vision.; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 13Apr2021 as single dose for covid-19 immunisation. Medical history included Arrhythmia from 2018. Concomitant medication included apixaban (ELIQUIS) 5mg two times a day. On 13Apr2021, the patient had adverse reaction with her vision, the vaccine made her eyes blurry and was having a problem with her right eye vision. The blurry eyes were in both eyes, but the right eye is more so than the left. She would like to know if she should get her second dose of the vaccine because of this. She is concerned about whether or not she needs to see a doctor like an optometrist or an ophthalmologist. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: She is having an adverse reaction with her vision (did not elaborate)./The caller's reaction is the vaccine made her eyes blurry, she is having a problem with her right eye vision.; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 13Apr2021 as single dose for covid-19 immunisation. Medical history included Arrhythmia from 2018. Concomitant medication included apixaban (ELIQUIS) 5mg two times a day. On 13Apr2021, the patient had adverse reaction with her vision, the vaccine made her eyes blurry and was having a problem with her right eye vision. The blurry eyes were in both eyes, but the right eye is more so than the left. She would like to know if she should get her second dose of the vaccine because of this. She is concerned about whether or not she needs to see a doctor like an optometrist or an ophthalmologist. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he contracted covid-19 virus; he contracted covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had his first dose of the Pfizer Covid-19 vaccine on 28Jan2021 and shortly after that day (in 2021), he contracted covid-19 virus and was hospitalized for several days which was the reason why he was not able to get his second dose. The patient called to ask how he could proceed with the second dose after testing positive (in 2021). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: he contracted covid-19 virus; he contracted covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had his first dose of the Pfizer Covid-19 vaccine on 28Jan2021 and shortly after that day (in 2021), he contracted covid-19 virus and was hospitalized for several days which was the reason why he was not able to get his second dose. The patient called to ask how he could proceed with the second dose after testing positive (in 2021). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: he contracted covid-19 virus; he contracted covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had his first dose of the Pfizer Covid-19 vaccine on 28Jan2021 and shortly after that day (in 2021), he contracted covid-19 virus and was hospitalized for several days which was the reason why he was not able to get his second dose. The patient called to ask how he could proceed with the second dose after testing positive (in 2021). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he contracted covid-19 virus; he contracted covid-19 virus; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 28Jan2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Shortly after that day, he contracted covid-19 virus and was hospitalized for several days which is the reason why he was not able to get his 2nd dose. The outcome of the events was unknown. The patient tested positive for covid-19 on an unspecified date.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: he contracted covid-19 virus; he contracted covid-19 virus; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 28Jan2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Shortly after that day, he contracted covid-19 virus and was hospitalized for several days which is the reason why he was not able to get his 2nd dose. The outcome of the events was unknown. The patient tested positive for covid-19 on an unspecified date.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: he contracted covid-19 virus; he contracted covid-19 virus; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 28Jan2021, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Shortly after that day, he contracted covid-19 virus and was hospitalized for several days which is the reason why he was not able to get his 2nd dose. The outcome of the events was unknown. The patient tested positive for covid-19 on an unspecified date.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: VACCINE ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced vaccine administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administration error was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administration error
Clinical narrative: VACCINE ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced vaccine administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administration error was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Aphasia, Bradyphrenia, Chest discomfort, Chills
Clinical narrative: neck ache; headache with intermittent nausea; headache with intermittent nausea; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; the muscle twitches have become worse and are "more intense" and "more often."; her eyeballs feel like "they're shaking in my head"; she has fatigue in her quads; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter states she received the first dose of vaccine on 05Apr2021 and reports afterwards approximately on an unknown date in Apr2021, the patient experiencing neck ache and headache with intermittent nausea and muscle spasms and muscle twitches that did not start until after she got home a few hours later. She reported that the muscle twitches had become worse and were more intense and more often. Her eyeballs felt like they were shaking in head and had fatigue in her quads. She wanted to know what to do to make these side effects go away. She was curious if Pfizer has any products that could be used to treat her symptoms and what were the reported side effects there are with the Pfizer BioNTech COVID-19 vaccine. She asked if you were in a situation where you were worried about side effects, what questions would you ask. She reported that she was scheduled to receive her second dose of the Pfizer BioNTech COVID-19 vaccine on 26APR2021 but does not know if she should get it or wait on it due to her lingering side effects. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: neck ache; headache with intermittent nausea; headache with intermittent nausea; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; the muscle twitches have become worse and are "more intense" and "more often."; her eyeballs feel like "they're shaking in my head"; she has fatigue in her quads; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter states she received the first dose of vaccine on 05Apr2021 and reports afterwards approximately on an unknown date in Apr2021, the patient experiencing neck ache and headache with intermittent nausea and muscle spasms and muscle twitches that did not start until after she got home a few hours later. She reported that the muscle twitches had become worse and were more intense and more often. Her eyeballs felt like they were shaking in head and had fatigue in her quads. She wanted to know what to do to make these side effects go away. She was curious if Pfizer has any products that could be used to treat her symptoms and what were the reported side effects there are with the Pfizer BioNTech COVID-19 vaccine. She asked if you were in a situation where you were worried about side effects, what questions would you ask. She reported that she was scheduled to receive her second dose of the Pfizer BioNTech COVID-19 vaccine on 26APR2021 but does not know if she should get it or wait on it due to her lingering side effects. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.