chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hypoaesthesia, Nausea
Clinical narrative: wrung out; nauseous; strange headache; I noticed my leg felt strange. When I touched it I found my left thigh felt numb; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, on 12Feb2021, 13:15PM (age at vaccination: 62), in left arm as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as high cholestrol, acid reflux, & high blood pressure. Patient reported other medicines in two weeks includes Other medications in two weeks: Omeprazole, Atorvastatin, Lisinopril, Calcium and other vaccine in four weeks reported as no. Patient known allergies reported as unknown. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via an unspecified route of administration, on 12Jan2021, 10:30 AM (age at vaccination: 62), in left arm as dose 1, single for COVID-19 immunization. Patient reported that COVID prior vaccine and post vaccination was no. On 12Feb2021, 14:30PM patient had strange headache, about 4 hours patient noticed that leg felt strange When touched it found my left thigh felt numb, feeling nauseous and on 15Feb2021 patient experienced feel wrung out but no headache, nausea, or numbness. Treatment was not taken. The outcome of all events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Vision blurred
Clinical narrative: Dizziness; Blurred vision; Chills; Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 84-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), via an unspecified route of administration administered on left arm on 11Feb2021 (84-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were reported as none. On 12Feb2021, the patient experienced dizziness, blurred vision, chills and nausea. The patient got a COVID shot morning on 11Feb2021, and on 12Feb2021, he started getting symptoms. The patient experienced dizziness especially when moving his head. The patient was wondering if it was normal to still have these things. The patient still had it when he moved his head from side to side or quickly. The patient still had dizziness as of this morning. The patient's vision is okay most of the time. The last couple of days, when the patient looked at the TV he would experience some blurriness from the dizziness. The patient does not have a prescribing doctor. The patient was ready to go to the ER Friday but did not. It all has let up a little. The patient's blurred vision has improved a lot. The blurred vision does occur at the same time as the dizziness. The patient has not received treatment for it. The patient did not want to go to the doctor because these days it is hard to get to the doctor. The patient decided to wait a couple of days to see how he felt. The patient got the vaccine because of the covid virus going around. The patient was wondering if these are possible side effects and how long would they last.No treatment received for event blurred vision. The outcome of blurred vision was recovering and the other events were not recovered.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: headache; nausea; tired; arm hurt little; This is a spontaneous report from a contactable consumer. This female consumer reported that  A female patient of an unspecified age received (BNT162B2, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. Patient reported side effects after receiving the first dose of the vaccine. On an unspecified date, patient had headache that last a all day, nausea, tired and arm hurt little. Patient took Tylenol 4-5 hours post vaccination and she heard it is not recommended to take it before receiving the vaccine. Patient wanted to confirm if you Cannot take Tylenol before taking the vaccine. Also wanted to know how long do you have to wait before taking tylenol. Patient mentioned that she took Tylenol after the first dose due to headache. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain hardly noticeable; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for herself (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch no: not reported/ Lot Number: EN5318; expiration date: unknown) via unknown route administered in left arm on 13Feb2021 01:30 PM (at the age of 30-year-old) as dose 2, single and patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283, expiration date: unknown) administered via unknown route in left arm on 23Jan2021 01:00 PM as dose 1, single both for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not take other vaccinations within 4 weeks prior to vaccination. Patient had no COVID-19 prior to vaccination was not tested post vaccination. On an unknown date in 2021, the patient reported injection site pain hardly noticeable. Other than that patient experienced zero symptoms from either injection. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: lymphadenopathy of central axillary nodes; headache; fatigue; diarrhea; injection site pain; neck stiffness; This is a spontaneous report from a contactable nurse (patient, self-reported). A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Left leg, on 13Feb2021 11:30 AM (age at vaccination: 33 years), as a single dose for COVID-19 immunization. Facility type vaccine was doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Left, on 22Jan2021 at 12:30 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not have any known allergies. On 13Feb2021, the patient experienced lymphadenopathy of central axillary nodes, headache, fatigue, diarrhea, injection site pain, and neck stiffness. The patient received 1000mg Acetaminophen PO q6h x6 doses as treatment for the events. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: lymphadenopathy of central axillary nodes; headache; fatigue; diarrhea; injection site pain; neck stiffness; This is a spontaneous report from a contactable nurse (patient, self-reported). A 34-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Left leg, on 13Feb2021 11:30 AM (age at vaccination: 33 years), as a single dose for COVID-19 immunization. Facility type vaccine was doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Left, on 22Jan2021 at 12:30 PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not have any known allergies. On 13Feb2021, the patient experienced lymphadenopathy of central axillary nodes, headache, fatigue, diarrhea, injection site pain, and neck stiffness. The patient received 1000mg Acetaminophen PO q6h x6 doses as treatment for the events. Outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache; Dizziness; Body ache; Tiredness; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12Feb2021 at 14:45 pm (age at vaccination was 36 years) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 22Jan2021 at 14:45 pm (age at vaccination was 36 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Feb2021, the patient experienced headache, dizziness, body ache and tiredness. No treatment was received for the adverse events. The outcome of the events was resolved on an unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Vaccination site pain
Clinical narrative: Chills; Soreness at injection site; Headache (migraine like); This is a spontaneous report from a contactable consumer (Patient).  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3247), via an unspecified route of administration on 11Feb2021 10:30 AM (at the age of 48-year-old) as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient did not receive any other vaccines within four weeks. Patient does not have COVID prior vaccination and was not tested to COVID post vaccination. Patient had no known allergies. On 12Feb2021 12:00 AM the patient experienced chills, Soreness at injection site, Headache (migraine like). Patient had not received any treatment for the events reported. The outcome of the events was recovered on unspecified date in 2021. Follow-up attempts completed. No further information expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: her blood pressure has been slowly going up; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 (at the age of 90-years-old) (Batch/Lot Number: EL9263; Expiration Date: 31May2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included macular degeneration from 2005 and ongoing. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) administered in left arm on 20Jan2021 for covid-19 immunisation. The caller reported that her blood pressure had been slowly going up a little bit on 14Feb2021. It was reported that her blood pressure was 141/85 yesterday on 14Feb2021. On 15Feb2021 in morning, her blood pressure was fluctuating and it was 179/105. Patient did not receive additional vaccines on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) was reported as Covid-19 vaccine. Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea, Mucous stools
Clinical narrative: He described his reaction as something that was more or less like diarrhea, except that the only thing coming out was mucus.; He described his reaction as something that was more or less like diarrhea, except that the only thing coming out was mucus./he started having discharge through his rectum, like a mucous, no color to it; It did not stop until Sunday afternoon when his bowel movement returned to normal.; This is a spontaneous report from a contactable Consumer. An 81-years-old male patient reported himself that he received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: Solution for injection, batch/lot number: EL9267) via an unspecified route of administration on 11Feb2021, Thursday at around 09:00 AM (at the age of 81-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient did not have medical history. The concomitant medications were not reported. The patient did not experience a reaction until Friday noon. On 12Feb2021, Friday around noon, the patient started having discharge through his rectum, like a mucous, no color to it. He described his reaction as something that was more or less like diarrhea, except that the only thing coming out was mucus. It did not stop until Sunday afternoon when his bowel movement returned to normal. On, Saturday morning the patient called a nurse through his insurance and she basically said if it does not don't go away call doctor Monday morning and made an appointment. On Saturday afternoon the patient had one little movement that was a little brown in color then it went right back to liquid, he could not stop it anytime gas came out or anything he couldn't stop it and that went on until noon Sunday and at noon on Sunday he had a movement, a little movement again which was brown and now it seems like it is back to normal. The patient did not know whether or not go see a doctor, he wanted to see if anyone has reported this before with the vaccine. He did not really know what he was trying it say but he wanted to try to find out if it was a reaction so he would know whether or not he can expect it the second time. At the time of this reported the discharge had resolved. The outcome of the events was recovered on an unspecified date in Feb2021.  Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: This is a spontaneous report from contactable consumer (patient). A male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported, expiry date: unknown), via an unspecified route of administration on an unspecified date, in Feb 2021, single dose, for COVID-19 immunization. Patient's medical history included inflammation from tumors in his neck (receiving chemotherapy and often gets congestion that interferes with breathing). Concomitant medications not reported. The patient reported, he had both shots. The last was 13 days ago. He wants to take an antibiotic but wanted to make sure it won't hamper with the vaccine. He reports these symptoms as normal for him but reports his only side effects from the vaccine was "it felt like someone took a baseball bat to my arm afterwards," on an unspecified date. Outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt a little bit of soreness.; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 13Feb2021 (at the age of 73-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. In Feb2021, he felt "a little bit of soreness" within 12 from receiving the Pfizer-BioNTech COVID-19 Vaccine. He is currently fine. He is scheduled on 26Feb2021 for a dental appointment to remove a temporary crown. He mentioned that he would be given a local anesthesia, and asked if this would have any interaction with the vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Headaches still to this day; nausea; vomiting; chills; injection site pain for over a week; not feeling good; tired; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 04Feb2021 12:00 (at the age of 70 years-old) as dose 1, single for covid-19 immunisation. Medical history included HBP from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not experience any known allergies. Concomitant medications included amlodipine, zinc, vitamin d3, vitamins taken for an unspecified indication, start and stop date were not reported. On 04Feb2021 14:00, the patient experienced headaches still to this day, nausea, vomiting, chills, not feeling good, tired, injection site pain for over a week and the patient reported just don't feel good. The patient did not receive any treatment for the events. The outcome of the event injection site pain for over a week was recovered on 12Feb2021 while other events were not recovered.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Headaches still to this day; nausea; vomiting; chills; injection site pain for over a week; not feeling good; tired; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 04Feb2021 12:00 (at the age of 70 years-old) as dose 1, single for covid-19 immunisation. Medical history included HBP from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not experience any known allergies. Concomitant medications included amlodipine, zinc, vitamin d3, vitamins taken for an unspecified indication, start and stop date were not reported. On 04Feb2021 14:00, the patient experienced headaches still to this day, nausea, vomiting, chills, not feeling good, tired, injection site pain for over a week and the patient reported just don't feel good. The patient did not receive any treatment for the events. The outcome of the event injection site pain for over a week was recovered on 12Feb2021 while other events were not recovered.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: Wounds on her legs; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 61-years-old female patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-Not reported), via an unspecified route of administration on an unspecified date as DOSE 1,SINGLE for covid-19 immunisation .Medical history included rheumatoid arthritis, immunosuppression, toe operation , diabetes mellitus , neoplasm , wound infection staphylococcal from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported. On an unspecified date, patient was a 61 year old female who go the first dose of the Pfizer Covid 19 vaccine. She has a home health nurse that comes in 3 times per week due to wounds on her legs that are trying to heal. She also has RA, so her immune system is already compromised. If someone is on antibiotics will it effect the vaccine? She's not taking an antibiotic now, but sometimes she does because of prior MRSA. Will the vaccine effect my wound healing. She is not in a immunosuppressive medication now but previously took a medication for RA and she lost toes due to diabetes and has tumors in her neck because of it. She did not give the name of the medication. The outcome of event was recovering.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she had diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient wanted to report the side effects she had after receiving the first and second dose of Pfizer COVID-19 vaccine. She read the prescribing information sheet but the side effect she had was not listed. Patient did not have any questions she was just calling to report the side effect. She said 2 days after receiving the first dose she had diarrhea for a day and the same thing happened after the second dose. The outcome of the event was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: Caller is reporting tiredness; I've not been able to do anything.; Caller reports that her brain was in a fog and she was not able to process anything.; she is a little anxious about it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Caller reported that she was perfectly fine after receiving the first dose of the vaccine. Caller was reporting tiredness that started on Thursday around noon (11Feb2021). On an unspecified date in Feb2021, caller stated that she was not been able to do anything. She had been in bed since then and very distressed about it. Caller reported that her brain was in a fog and she was not able to process anything. As of 14Feb2021 night and this morning 15Feb2021, caller reported that her brain to be much less foggy, but her fatigue was overwhelming both mentally and physically. Caller stated that she became physically tired out within 5 minutes and she was a little anxious about it. The clinical outcome of the event tiredness was not recovered and brain was in a fog was recovering whereas outcome of the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced a headache on an unspecified date. The patient reported she received a dose of Pfizer-BioNTech COVID-19 vaccine on Saturday and has had a headache since then. She wanted to know if this was normal, and if she can take anything to treat the headache (that seems to be a result of the Pfizer-BioNTech COVID-19 vaccine). She inquired whether any there were any contraindications with the fentanyl patch she uses. She wanted to know if she could use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 28-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), via an unspecified route of administration in arm left on 23Jan2021 15:45 (age at vaccination was 28 Years) as dose 1, single for covid-19 immunisation at school or student health clinic. Medical history included bipolar disorder and bell's palsy (twice). Known allergies were unknown. Concomitant medication(s) received in two weeks included lamotrigine (LAMICTAL), vitamin D NOS, biotin, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and birth control; all were taken for an unspecified indication, start and stop date were not reported. No other vaccine was received in four weeks prior to the COVID vaccine. On an unspecified date, the patient experienced sore arm. No covid prior vaccination and no covid tested post vaccination. Outcome of the event was unknown.    Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Epstein-Barr viraemia
Clinical narrative: Epstein Barr Virus; This is a spontaneous report from a contactable other hcp. A 40 (unit not provided) female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 07Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced Epstein Barr Virus. She was not able to get scheduled initially as Epstein Barr Virus and possibility of antivirals. The patient underwent lab tests and tested negative for antibody procedure. Patient concerned about administration and efficacy. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unknown date (at the age of 72 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband had the Pfizer 2nd covid 19 vaccine, other than a sore arm on an unspecified date, didn't have any other side effects. Wants to know if it was effective. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: he started experiencing some swelling and pain in the arm.; he started experiencing some swelling and pain in the arm.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number was not provided) via an unknown route of administration, administered on 11Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 as DOSE 1, SINGLE for covid-19 immunisation. It was reported that after received the second dose of the Pfizer vaccine patient was told that it was okay to take pain relievers after vaccination. However, they also heard reports contradicting this saying that it might affect antibody production of the vaccine. Patient took some Aleve since he started experiencing some swelling and pain in the arm. Therapeutic measures were taken as a result of he started experiencing some swelling and pain in the arm. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Severe headache on left side of head; Injection site a little sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (age reported as 83; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (INFLUENZA VACCIN) taken for antiviral prophylaxis from Feb2021. It was reported by the patient that she got the first dose of the covid vaccine on 12Feb2021 (Friday) and got a little sore because she also got a flu shot. Since Saturday she got headache in the left side of her head (the side of the body where she got the vaccine) and she would like to know how long it would last and when that would be expected to get better. She said that she took Tylenol last night for this since it is a severe side effect. She does not have an email and did not wish to complete report. No further details provided. The outcome was unknown for the event of vaccination site pain and patient was not recovered from the event of headache.   Information on the lot/batch number has been requested.   Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Gait inability, Headache
Clinical narrative: headache; muscle pain; tender at the injection site; nausea; chills; dizzy; weak; couldn't walk; sore throat; This is a spontaneous report from a contactable Consumer. This (Age:65; Unit: Unknown) female Consumer reported for herself.  A 65-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FL9269, Expiration date: unknown), via unspecified route, administered in left arm on 08Feb2021 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Hypertension from unspecified date to unknown ongoing and thyroid disorder from unspecified date to unknown ongoing and concomitant medications were not reported but mentioned as taking for thyroid and hypertension. On an unspecified date, after the vaccination, the patient experienced headache, sore throat, the muscle pain. The patient tried to get up off the couch to walk and the patient was so dizzy, the patient was going to fall over. Then the patient got nausea and chills. the patient had the chills so bad; it was that bad that her whole body shook. Now the patient due to get the second shot. She is terrified because most people who got the first shot said all they had pain in the injection area and maybe a slight headache, but they did not have any symptoms like she had. So, if she had those symptoms like that, they say the second shot is worse than the first. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (01Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: headache; muscle pain; tender at the injection site; nausea; chills; dizzy; weak; couldn't walk; sore throat; This is a spontaneous report from a contactable Consumer. This (Age:65; Unit: Unknown) female Consumer reported for herself.  A 65-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FL9269, Expiration date: unknown), via unspecified route, administered in left arm on 08Feb2021 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Hypertension from unspecified date to unknown ongoing and thyroid disorder from unspecified date to unknown ongoing and concomitant medications were not reported but mentioned as taking for thyroid and hypertension. On an unspecified date, after the vaccination, the patient experienced headache, sore throat, the muscle pain. The patient tried to get up off the couch to walk and the patient was so dizzy, the patient was going to fall over. Then the patient got nausea and chills. the patient had the chills so bad; it was that bad that her whole body shook. Now the patient due to get the second shot. She is terrified because most people who got the first shot said all they had pain in the injection area and maybe a slight headache, but they did not have any symptoms like she had. So, if she had those symptoms like that, they say the second shot is worse than the first. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (01Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: fatigue/super fatigued; chills; sweats; nausea/nauseous; injection site pain; Fatigue worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 13Feb2021 (age at vaccination 62years old) as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fatigue/super fatigued, chills, sweats, nausea/nauseous, injection site pain, fatigue worsened. The patient has a Report reference number. She is upset as she has been waiting to 50+ minutes to speak with a Nurse or someone with Medical Experience. She has already gone through a report, she has reference number. She got covid shot. She was positive for covid previously in early Nov2020. She just got the first dose on Saturday 13Feb2021. She experienced injection site pain, was super fatigued, chills, sweats, was nauseous, the fatigue got worse. It was not quite as bad as when she had the actual covid virus in Nov2020. Today she is better. she is supposed to babysit her 2-year-old triplets, she wants to know if having these symptoms after the first dose means that she is contagious. If she goes there and gets her kiddos sick, her daughter will shoot her. The Kid's Mom and Dad had covid. They think 2 of 3 triplets had covid but the paediatrician refuses to test them, the kids have not been tested. She clarifies that she went through the safety report just this morning. She was upset when informed that for her question she would have to be transferred. She spoke to a gentleman prior to this that gave the number and she even spoke to a last prior to this that asked her so many questions when all she wanted was her questions address, she gave the same number. She is upset she was not informed about selecting option 3, She has been going in circles on the phone line. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: fatigue/super fatigued; chills; sweats; nausea/nauseous; injection site pain; Fatigue worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 13Feb2021 (age at vaccination 62years old) as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fatigue/super fatigued, chills, sweats, nausea/nauseous, injection site pain, fatigue worsened. The patient has a Report reference number. She is upset as she has been waiting to 50+ minutes to speak with a Nurse or someone with Medical Experience. She has already gone through a report, she has reference number. She got covid shot. She was positive for covid previously in early Nov2020. She just got the first dose on Saturday 13Feb2021. She experienced injection site pain, was super fatigued, chills, sweats, was nauseous, the fatigue got worse. It was not quite as bad as when she had the actual covid virus in Nov2020. Today she is better. she is supposed to babysit her 2-year-old triplets, she wants to know if having these symptoms after the first dose means that she is contagious. If she goes there and gets her kiddos sick, her daughter will shoot her. The Kid's Mom and Dad had covid. They think 2 of 3 triplets had covid but the paediatrician refuses to test them, the kids have not been tested. She clarifies that she went through the safety report just this morning. She was upset when informed that for her question she would have to be transferred. She spoke to a gentleman prior to this that gave the number and she even spoke to a last prior to this that asked her so many questions when all she wanted was her questions address, she gave the same number. She is upset she was not informed about selecting option 3, She has been going in circles on the phone line. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: fatigue/super fatigued; chills; sweats; nausea/nauseous; injection site pain; Fatigue worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 13Feb2021 (age at vaccination 62years old) as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fatigue/super fatigued, chills, sweats, nausea/nauseous, injection site pain, fatigue worsened. The patient has a Report reference number. She is upset as she has been waiting to 50+ minutes to speak with a Nurse or someone with Medical Experience. She has already gone through a report, she has reference number. She got covid shot. She was positive for covid previously in early Nov2020. She just got the first dose on Saturday 13Feb2021. She experienced injection site pain, was super fatigued, chills, sweats, was nauseous, the fatigue got worse. It was not quite as bad as when she had the actual covid virus in Nov2020. Today she is better. she is supposed to babysit her 2-year-old triplets, she wants to know if having these symptoms after the first dose means that she is contagious. If she goes there and gets her kiddos sick, her daughter will shoot her. The Kid's Mom and Dad had covid. They think 2 of 3 triplets had covid but the paediatrician refuses to test them, the kids have not been tested. She clarifies that she went through the safety report just this morning. She was upset when informed that for her question she would have to be transferred. She spoke to a gentleman prior to this that gave the number and she even spoke to a last prior to this that asked her so many questions when all she wanted was her questions address, she gave the same number. She is upset she was not informed about selecting option 3, She has been going in circles on the phone line. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pain
Clinical narrative: fatigue/super fatigued; chills; sweats; nausea/nauseous; injection site pain; Fatigue worsened; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 13Feb2021 (age at vaccination 62years old) as single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced fatigue/super fatigued, chills, sweats, nausea/nauseous, injection site pain, fatigue worsened. The patient has a Report reference number. She is upset as she has been waiting to 50+ minutes to speak with a Nurse or someone with Medical Experience. She has already gone through a report, she has reference number. She got covid shot. She was positive for covid previously in early Nov2020. She just got the first dose on Saturday 13Feb2021. She experienced injection site pain, was super fatigued, chills, sweats, was nauseous, the fatigue got worse. It was not quite as bad as when she had the actual covid virus in Nov2020. Today she is better. she is supposed to babysit her 2-year-old triplets, she wants to know if having these symptoms after the first dose means that she is contagious. If she goes there and gets her kiddos sick, her daughter will shoot her. The Kid's Mom and Dad had covid. They think 2 of 3 triplets had covid but the paediatrician refuses to test them, the kids have not been tested. She clarifies that she went through the safety report just this morning. She was upset when informed that for her question she would have to be transferred. She spoke to a gentleman prior to this that gave the number and she even spoke to a last prior to this that asked her so many questions when all she wanted was her questions address, she gave the same number. She is upset she was not informed about selecting option 3, She has been going in circles on the phone line. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Fatigue/Tiredness; Body chills/ Chills; Body ache; Headache; Sweat a little bit through the night; Nauseous; Just kind of feel all around not good; This is a spontaneous report via a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EN6200) via an unspecified route of administration on 13Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included Asthma ongoing and patient had suffered from COVID-19 in early November. Patient concomitant medications were reported as unspecified. Patient stated that she received her vaccine on Saturday since then experienced body chills and fatigue on 13Feb2021 and It seems to be better today and on an unspecified date in 2021 patient experienced with body ache and today she had headache, chills, sweat a little bit through the night. She don't think she had a fever, a little nauseous but not terrible just kind of feel all around not good. The fatigue will be the worst part of it." Patient did not received the treatment for all events. Outcome of events (Chills and Fatigue) was recovering and unknown for all other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.