chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Musculoskeletal discomfort, Vasculitis
Clinical narrative: she came down with an autoimmune disease; had a lot of joint discomfort; ended up being a form of vasculitis; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she called on the suggestion of her rheumatologist to see if we can help whether or not she should get a second Pfizer shot. The patient stated she received the first Pfizer vaccine on 02Feb2021, and then on 04Feb2021 she came down with an autoimmune disease that had a lot of joint discomfort and ended up being a form of vasculitis. The patient stated she was on steroids and immune suppressing drugs to deal with the damage the disease causes. The patient stated she has been seeing two of the top Rheumatologists and they said Pfizer would be the best to find information about getting the second shot because the Rheumatologists don't have enough information. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Drug ineffective, Headache, Illness
Clinical narrative: patient is currently pregnant; sick; Covid; Covid; headaches; sinus infection; most of taste and smell for 4 days; most of taste and smell for 4 days; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old pregnant female patient. A 26-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: EL9269) via intramuscularly in left arm on 13Feb2021 at 10:30 AM (at the age of 26 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: EL9269) via intramuscularly in left arm on 13Feb2021 at 10:30 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was currently pregnant (4 months) at the time of vaccination. Patient did not have covid prior vaccination. On 19Sep2021 at 9:00 AM, the patient experienced Mild headaches, most of taste and smell for 4 days, sinus infection like symptoms, on 20Sep2021 she had been sick with Covid week of 20Sep2021 and 27Sep2021 with covid. Patient visited clinic due to event. The patient did not received treatment. The lab data included Nasal Swab (Bionex) result was positive on 21Sep2021. The outcome of the events were recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure timing unspecified, SARS-CoV-2 test, Sinusitis, Taste disorder
Clinical narrative: patient is currently pregnant; sick; Covid; Covid; headaches; sinus infection; most of taste and smell for 4 days; most of taste and smell for 4 days; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old pregnant female patient. A 26-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: EL9269) via intramuscularly in left arm on 13Feb2021 at 10:30 AM (at the age of 26 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number: EL9269) via intramuscularly in left arm on 13Feb2021 at 10:30 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive other vaccine in four weeks. The patient was currently pregnant (4 months) at the time of vaccination. Patient did not have covid prior vaccination. On 19Sep2021 at 9:00 AM, the patient experienced Mild headaches, most of taste and smell for 4 days, sinus infection like symptoms, on 20Sep2021 she had been sick with Covid week of 20Sep2021 and 27Sep2021 with covid. Patient visited clinic due to event. The patient did not received treatment. The lab data included Nasal Swab (Bionex) result was positive on 21Sep2021. The outcome of the events were recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Immunisation, Off label use
Clinical narrative: Strong Headache; Non-stop shivers; Fever; Body aches (muscular); diarrhea; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 29Sep2021 12:15 (at the age of 30 years) (Batch/Lot Number: EW0217) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient had no medical history. Concomitant medication included influenza vaccine inact sag 3v (FLUCELVAX) taken for immunisation from 28Sep2021 to 28Sep2021. The patient previously took BNT162B2 DOSE 1 on 20Jan2021 (lot: EL3247) and DOSE 2 on 08Feb2021 (lot: EL3247); (at the age of 29 years) via intramuscular route for COVID-19 Immunization. The patient experienced strong headache, non-stop shivers, fever, body aches (muscular) and diarrhea on 29Sep2021 21:00. Therapeutic measures were taken as a result of the events (Tylenol, Advil and Dexamethasone). The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Strong Headache; Non-stop shivers; Fever; Body aches (muscular); diarrhea; dose number=3; dose number=3; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 29Sep2021 12:15 (at the age of 30 years) (Batch/Lot Number: EW0217) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient had no medical history. Concomitant medication included influenza vaccine inact sag 3v (FLUCELVAX) taken for immunisation from 28Sep2021 to 28Sep2021. The patient previously took BNT162B2 DOSE 1 on 20Jan2021 (lot: EL3247) and DOSE 2 on 08Feb2021 (lot: EL3247); (at the age of 29 years) via intramuscular route for COVID-19 Immunization. The patient experienced strong headache, non-stop shivers, fever, body aches (muscular) and diarrhea on 29Sep2021 21:00. Therapeutic measures were taken as a result of the events (Tylenol, Advil and Dexamethasone). The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Rash, Swelling face, Urticaria
Clinical narrative: Lip, chin, face swelling; Lip, chin, face swelling; Rash and hives all over entire body; Rash and hives all over entire body; This is a spontaneous report from a contactable consumer (patient). A 12-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 03Sep2021 (15:00) as dose 1, single, with route of administration unspecified, for COVID-19 immunization at the physician's office. Medical history included sulfa meds allergy. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient previously took amoxicillin, and had drug allergy. The patient did not receive other vaccines in four weeks. On 06Sep2021 (20:00), the patient had lip, chin, and face swelling, rash, and hives all over entire body. The events were reported to be serious (medically significant); and had resulted into a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had received steroids, allergy medications and asthma medications as treatment for the events. The outcome of the events was not recovered. The patient did not have COVID-19 prior to vaccination, and has not been tested post-vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Herpes zoster, Malaise
Clinical narrative: she got the shingles; condition was bad; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in 2021, as dose 2, single for COVID-19 immunization. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in 2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the shingles on an unspecified date in Jul2021 and her condition was bad. The patient had lingering effects of shingles. With that, consumer wanted to know if his friend should wait until she recovered before getting the booster dose. Consumer also wants to know if there is any way to test the levels of antibody after receiving the vaccine. His friend discussed her condition with the doctor, she had her antibody levels tested. The patient underwent lab tests and procedures which included antibody test: lower. She found out that she only had 5 or 6 which was lower than expected. The outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, CSF test, Computerised tomogram, Delusion, Dementia
Clinical narrative: the patient was much more out of it/she not feeling well/ her mother began not feeling good; Her mental capacity is 10% of what she was; she in a dementia, delusional state; she in a dementia, delusional state; Extensive abdominal pain; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm on 24Sep2021 (Batch/Lot Number: 301358A) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included dementia delusional state (patient is in a dementia delusional state and does not know who they are or where she is and thinks it is 1985). There were no concomitant medications. On an unknown date, the patient experienced the patient was much more out of it, her mental capacity is 10% of what she was, she not feeling well/ her mother began not feeling good, she in a dementia, delusional state, she in a dementia, delusional state, extensive abdominal pain. It was further reported that the patient began not feeling good after receiving the vaccine on 24Sep2021 and on Wednesday the patient was much more out of it and on Thursday her mother was admitted to the ICU at 4:00am and has been there since; states the only thing that her mother has had done is the Pfizer COVID Vaccine. They ran every test on her and she was completely fine mentally and physically prior to getting the shot and they have done every test on her and nothing is showing. The patient had another MRI and a lumbar spine fluid test today and the patient is in a dementia delusional state and does not know who they are or where she is and thinks it is 1985 and has no idea what is going on with her; states the patient talks about having extensive abdominal pain but there is nothing in her abdomen and they checked her abdomen four times and her mental capacity is down to like 10 percent. The patient went into the hospital on Thursday 30Sep2021 by ambulance and does not normally get vaccines; states on Thursday she was admitted to the hospital and on Friday they did a cat scan and MRI at the first hospital and those tests came back inconclusive and the patient would not sit still and she was moved to the hospital on Saturday 02Oct2021. She was requesting any information or some report where older people after getting the vaccine become totally deteriorated afterwards. The patient was hospitalized for the patient was much more out of it from 30Sep2021 to an unknown date. Relevant laboratory analysis included CAT scan and MRI which was inconclusive (on Friday they did a cat scan and MRI at the first hospital and those tests came back inconclusive), on 04Oct2021, lumbar spine fluid test and MRI which has unknown results, and on an unknown date, every test nothing was showing (done every test on her and nothing was showing). The outcome of the events was unknown.  No follow-up attempts are possible; Information about batch number already obtained.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging, Malaise, Mental impairment
Clinical narrative: the patient was much more out of it/she not feeling well/ her mother began not feeling good; Her mental capacity is 10% of what she was; she in a dementia, delusional state; she in a dementia, delusional state; Extensive abdominal pain; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm on 24Sep2021 (Batch/Lot Number: 301358A) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included dementia delusional state (patient is in a dementia delusional state and does not know who they are or where she is and thinks it is 1985). There were no concomitant medications. On an unknown date, the patient experienced the patient was much more out of it, her mental capacity is 10% of what she was, she not feeling well/ her mother began not feeling good, she in a dementia, delusional state, she in a dementia, delusional state, extensive abdominal pain. It was further reported that the patient began not feeling good after receiving the vaccine on 24Sep2021 and on Wednesday the patient was much more out of it and on Thursday her mother was admitted to the ICU at 4:00am and has been there since; states the only thing that her mother has had done is the Pfizer COVID Vaccine. They ran every test on her and she was completely fine mentally and physically prior to getting the shot and they have done every test on her and nothing is showing. The patient had another MRI and a lumbar spine fluid test today and the patient is in a dementia delusional state and does not know who they are or where she is and thinks it is 1985 and has no idea what is going on with her; states the patient talks about having extensive abdominal pain but there is nothing in her abdomen and they checked her abdomen four times and her mental capacity is down to like 10 percent. The patient went into the hospital on Thursday 30Sep2021 by ambulance and does not normally get vaccines; states on Thursday she was admitted to the hospital and on Friday they did a cat scan and MRI at the first hospital and those tests came back inconclusive and the patient would not sit still and she was moved to the hospital on Saturday 02Oct2021. She was requesting any information or some report where older people after getting the vaccine become totally deteriorated afterwards. The patient was hospitalized for the patient was much more out of it from 30Sep2021 to an unknown date. Relevant laboratory analysis included CAT scan and MRI which was inconclusive (on Friday they did a cat scan and MRI at the first hospital and those tests came back inconclusive), on 04Oct2021, lumbar spine fluid test and MRI which has unknown results, and on an unknown date, every test nothing was showing (done every test on her and nothing was showing). The outcome of the events was unknown.  No follow-up attempts are possible; Information about batch number already obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Headache, Pain, Ulcerative keratitis
Clinical narrative: developed Cranial nerve VI palsy double vision right side ( eye ).; Headaches; pain; Coroneal ulcer in her left eye; This is a spontaneous report from a contactable pharmacist.     A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported. The patient had received the first dose of the same vaccine on Feb2021. On 26May2021, the patient developed Cranial nerve VI palsy double vision right side (eye). Headaches and pain. She was hospitalized. She got treated for this with medication and issue got cleared up after two months. Now at the end of Sep2021, she has developed a Coroneal ulcer in her left eye. The outcome of the events was recovered except for the event coroneal ulcer in her left eye n Sep2021 with outcome of unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her sister contracted COVID; her sister contracted COVID; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single dose and dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller mentioned that patient contracted COVID in 2021, she took her first dose of the Pfizer Covid-19 vaccine in February and second dose in March. Caller stated that they are all scared and concerned on how long they will be protected. Caller has also completed her vaccination series and received her second dose in Apr2021. Caller was asking if the booster dose was safe? Caller clarified if they can receive the booster dose. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness; This is a spontaneous report received from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FF8839 and expiry were reported) via an intramuscular, at the age of 39-year-old, on 16Sep2021 10:30, at the left arm, at dose 2, single for covid-19 immunisation in a Pharmacy/drug store. The patient didn't have any medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers: FA6780 and expiry dates: 30Sep2021) via an intramuscular on 07Aug2021 11:00 at age of 39 years old dose 1, single for covid-19 immunisation and experienced nerve Pain on 08Aug2021 and swollen lymph nodes on 09Aug2021. The patient tested COVID-19 on 02Sep2021 and 13Sep2021 and had negative results. On 16Sep2021 17:00, the patient experienced facial numbness. The outcome of the event was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Atelectasis, Blood pressure increased, Blood test normal, Chest X-ray abnormal
Clinical narrative: Facial numbness; This is a spontaneous report received from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FF8839 and expiry were reported) via an intramuscular, at the age of 39-year-old, on 16Sep2021 10:30, at the left arm, at dose 2, single for covid-19 immunisation in a Pharmacy/drug store. The patient didn't have any medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers: FA6780 and expiry dates: 30Sep2021) via an intramuscular on 07Aug2021 11:00 at age of 39 years old dose 1, single for covid-19 immunisation and experienced nerve Pain on 08Aug2021 and swollen lymph nodes on 09Aug2021. The patient tested COVID-19 on 02Sep2021 and 13Sep2021 and had negative results. On 16Sep2021 17:00, the patient experienced facial numbness. The outcome of the event was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Contusion, Ear pain, Electrocardiogram, Inflammation
Clinical narrative: Facial numbness; This is a spontaneous report received from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FF8839 and expiry were reported) via an intramuscular, at the age of 39-year-old, on 16Sep2021 10:30, at the left arm, at dose 2, single for covid-19 immunisation in a Pharmacy/drug store. The patient didn't have any medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers: FA6780 and expiry dates: 30Sep2021) via an intramuscular on 07Aug2021 11:00 at age of 39 years old dose 1, single for covid-19 immunisation and experienced nerve Pain on 08Aug2021 and swollen lymph nodes on 09Aug2021. The patient tested COVID-19 on 02Sep2021 and 13Sep2021 and had negative results. On 16Sep2021 17:00, the patient experienced facial numbness. The outcome of the event was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Pleural effusion
Clinical narrative: Facial numbness; This is a spontaneous report received from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FF8839 and expiry were reported) via an intramuscular, at the age of 39-year-old, on 16Sep2021 10:30, at the left arm, at dose 2, single for covid-19 immunisation in a Pharmacy/drug store. The patient didn't have any medical history. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers: FA6780 and expiry dates: 30Sep2021) via an intramuscular on 07Aug2021 11:00 at age of 39 years old dose 1, single for covid-19 immunisation and experienced nerve Pain on 08Aug2021 and swollen lymph nodes on 09Aug2021. The patient tested COVID-19 on 02Sep2021 and 13Sep2021 and had negative results. On 16Sep2021 17:00, the patient experienced facial numbness. The outcome of the event was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got her third booster a week go friday 24Sep2021 but tested positive for covid after.; got her third booster a week go Friday 24Sep2021 but tested positive for covid after.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration on 24Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her third booster a week ago, on Friday 24Sep2021, but she tested positive for covid after. She took Regeneron on Tuesday 28Sep2021. She asked if she should be getting another booster shot. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got her third booster a week go friday 24Sep2021 but tested positive for covid after.; got her third booster a week go Friday 24Sep2021 but tested positive for covid after.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration on 24Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE; and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got her third booster a week ago, on Friday 24Sep2021, but she tested positive for covid after. She took Regeneron on Tuesday 28Sep2021. She asked if she should be getting another booster shot. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID 19 on 27SEP2021; she tested positive for COVID 19 on 27SEP2021; This is a spontaneous report from a Program from a contactable (patient).  A 62-year-old female patient received BNT162B2 third dose (booster dose) on 24Sep2021 at single dose, second dose on unspecified date at single dose and first dose on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got a booster dose of the Pfizer COVID vaccine on 24Sep2021 and she tested positive for COVID 19 on 27Sep2021. Caller would like to know if she has to repeat the booster dose because she had the Regeneron infusion 1200 mg IV on 28 Sep2021. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she tested positive for COVID 19 on 27SEP2021; she tested positive for COVID 19 on 27SEP2021; This is a spontaneous report from a Program from a contactable (patient).  A 62-year-old female patient received BNT162B2 third dose (booster dose) on 24Sep2021 at single dose, second dose on unspecified date at single dose and first dose on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got a booster dose of the Pfizer COVID vaccine on 24Sep2021 and she tested positive for COVID 19 on 27Sep2021. Caller would like to know if she has to repeat the booster dose because she had the Regeneron infusion 1200 mg IV on 28 Sep2021. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Chest X-ray, Electrocardiogram
Clinical narrative: Pfizer booster, 3rd shot; Pfizer booster, 3rd shot; a blood pressure of above 200/it was from 150 to 180 to 190; heart palpitation; This is a spontaneous report from contactable consumer (patient). A 76-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 02Oct2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation at age of 76-year-old. The patient's medical history and concomitant medications were not reported. The patient had her first dose of bnt162b2 and experienced sore arm and had second dose of bnt162b2 and was fine. The patient had COVID 19 vaccine on 02Oct2021 (Saturday) and on Sunday (03Oct2021), she needed to go to the Emergency Room (ER) for heart palpitation and a blood pressure of above 200. Her 1st and 2nd were fine so she assumed her 3rd would be. Patient stated that yesterday (03Oct2021) when she got up, she was laying there and got up for decaf coffee and went back to bed. Patient stated she had a little thumping, palpitations and what not and she said this was very strange and she had a blood pressure machine they gave her husband and she checked her blood pressure. Patient stated her blood pressure was high and higher and she called the nurse line on the card and they advised her to go to the ER as it was from 150 to 180 to 190 whatever. Patient relayed at the hospital it was 200 and she was getting palpitations and they did all kinds of tests. Patient stated she knows it's the vaccine and she doesn't take medication for blood pressure and her blood pressure is fine until the shot and now it's not. Patient stated they couldn't confirm it was or wasn't and they checked her with EKG, chest x-ray, bloodwork and blood pressure. Patient stated that today (04Oct2021) it was 129 which was a normal blood pressure. Patient stated she knew it was the vaccine she just knew it; she had had nothing like that in her entire life. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Palpitations
Clinical narrative: Pfizer booster, 3rd shot; Pfizer booster, 3rd shot; a blood pressure of above 200/it was from 150 to 180 to 190; heart palpitation; This is a spontaneous report from contactable consumer (patient). A 76-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 02Oct2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation at age of 76-year-old. The patient's medical history and concomitant medications were not reported. The patient had her first dose of bnt162b2 and experienced sore arm and had second dose of bnt162b2 and was fine. The patient had COVID 19 vaccine on 02Oct2021 (Saturday) and on Sunday (03Oct2021), she needed to go to the Emergency Room (ER) for heart palpitation and a blood pressure of above 200. Her 1st and 2nd were fine so she assumed her 3rd would be. Patient stated that yesterday (03Oct2021) when she got up, she was laying there and got up for decaf coffee and went back to bed. Patient stated she had a little thumping, palpitations and what not and she said this was very strange and she had a blood pressure machine they gave her husband and she checked her blood pressure. Patient stated her blood pressure was high and higher and she called the nurse line on the card and they advised her to go to the ER as it was from 150 to 180 to 190 whatever. Patient relayed at the hospital it was 200 and she was getting palpitations and they did all kinds of tests. Patient stated she knows it's the vaccine and she doesn't take medication for blood pressure and her blood pressure is fine until the shot and now it's not. Patient stated they couldn't confirm it was or wasn't and they checked her with EKG, chest x-ray, bloodwork and blood pressure. Patient stated that today (04Oct2021) it was 129 which was a normal blood pressure. Patient stated she knew it was the vaccine she just knew it; she had had nothing like that in her entire life. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak on both arms and some on legs; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection, Lot Number: not reported), via an unspecified route of administration, administered in Arm Left on 23Sep2021 08:30 AM (at the age of 68 years) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included colon cancer, yeast allergy and mycotic allergy. No covid prior vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced shingles outbreak on both arms and some on legs on 01Oct2021 06:30 AM. Not covid tested post vaccination. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The clinical outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Stress
Clinical narrative: stressed me out; My pressure was up when I was dating this man who stressed me out/ I stopped dating him and my blood pressure has been just fine; This is a spontaneous report from a contactable consumer.   This 72-year-old female consumer (patient) reported for herself that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, the patient experienced her pressure was up when she was dating that man who stressed her out. She stopped dating him and her blood pressure has been just fine. She got both doses of the Pfizer covid vaccine. Then in June, on 06Jun2021, she was in a car crash, her jeep got onto fire and her vaccination card burned up in the crash, need to get a replacement card. Will be 73 years old next month and was very healthy for her age. She takes 2 pills. One of them is a 1/2 of a blood pressure pill. Her pressure was up when she was dating that man who stressed her out. Stopped dating him and blood pressure has been just fine with that 1/2 pill. Do not even take the potassium pill and when her blood was checked, her potassium was just fine. Not getting that booster shot. Have 2 girlfriends who got that booster shot. One of them died 2 days after getting that booster and the other one was in the hospital right now. To be honest, their health was terrible. Hated to talk to them because it was depressing. They had blindness and serious cancers, like breast and liver cancer. Just did not even want to hear about it. Outcome was unknown for stressed me out and was resolving for the other event.  Follow-up (03Oct2021): This is a follow-up spontaneous report from a contactable consumer. This 72-year-old female consumer (patient) reported for herself.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable nurse (patient). A 89-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection; Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 24Mar2021 (at the age of 89-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection; Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on unspecific date as dose 1, single for COVID-19 immunization and also received Flu shot on unspecific date and never had a problem with the Flu shot before. On 02Apr2021, 9 days later after second COVID vaccination, the patient experienced shingles. Patient came down with a really bad case of the shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Patient reports her doctor told her to wait at least a year to see if a booster dose was offered. She was asking whether she have to wait for a year to get the booster dose. Patient wants to know how long should she wait to get the Flu shot. Wants to know how close in between can the Flu shot be given and COVID shot taken and asks is there a time between the second COVID shot and the booster shot because she had shingles. The outcome of the event is unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Suicidal ideation
Clinical narrative: nonstop suicidal thoughts; Extreme anxiety; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 20Aug2021 (Batch/Lot Number: fc3182) as DOSE 2, SINGLE (at the age of 46 years) for covid-19 immunisation. Relevant medical history included crohn's disease from an unknown date and unknown if ongoing, lactose intolerant from an unknown date and unknown if ongoing (known allergies: lactose intolerant). The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 on 30Jul2021 (lot number: ew0198) in the left arm at the age of 46 years for Covid-19 immunisation. In Aug2021, the patient had non-stop suicidal thoughts and extreme anxiety. The patient did not receive treatment for the event. The patient underwent lab tests and procedures which included sars-cov-2 test via nasal swab negative on 23Sep2021. The outcome of the events was not recovered at the time of the report.   Follow-up attempts are completed. No further information is expected. Information about batch/lot number already obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: facial swelling (nose and ears); hives; itching; This is a spontaneous report from non-contactable healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0162), via an unspecified route of administration on 17Sep2021 (at the age of 57-year-old) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included HYDROXYZINE. On an unspecified date on Sep2021 the patient experienced facial swelling (nose and ears), hives, and itching. The reaction started around midnight after the vaccine. The patient had taken Hydroxyzine HCL 25mg before the vaccine and then one after the vaccine, then a third one the morning before reporting to the Urgent Care. At urgent care she received a Benadryl shot and the symptoms started to go down but it took about 3 days to completely stop. The urgent care visit happened the morning of 18Sep2021 the morning after receiving the vaccine. The patient recovered from the adverse events on an unspecified date on Sep2021.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: left eye felt blurry, floater and some distortion; left eye felt blurry, floater and some distortion; left eye felt blurry, floater and some distortion; very frustrated; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 04May2021 at 13:00 (at the age of 46-years-old) at dose 1, single for COVID-19 immunization. Medical history included COVID. The patient has no known allergies. Concomitant medication was reported as none. There were no other vaccines in four weeks. Vaccine facility type was reported as urgent care center. She was not tested for COVID post vaccination. On 10May2021 at 08:00, the patient started to feel some problems with her left eye. Her left eye felt blurry, with a floater, and some distortion. She did not take it seriously because she thought her eye contact lenses needed to be changed or cleaned by then. She does not have any ocular disease history before as well as in her family. She has been very frustrated from May2021 since it happened. The time of vaccination was definitely correlated to the problem on set. She received the second dose of the vaccine on 25May2021 at 13:00. Therapeutic measures were taken as a result of the events and included treatment with unspecified infusion and medication. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit and were reported to have caused disability or permanent damage. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Headache, Pain, Peripheral swelling
Clinical narrative: low appetite; my body hurts; I feel horrible; I had COVID before but I feel like I am getting it back again; my arm is being swollen; headache; I have been all day with fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 58-years-old female patient received third dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30145BA), via an unspecified route of administration, administered in Arm Left on 01Oct2021 (Age at vaccination: 58-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included Blood pressure, asthma, covid-19 (had COVID before) all from an unknown date and unknown if ongoing. concomitant medications included medicine for blood pressure. Prior vaccinations were reported as none. Historical vaccine included first and second dose of BNT162B2 for covid-19 immunization. It was reported that patient received booster shot on yesterday and today she had basically all of the symptoms that on paper, they told that from the Pfizer, you should get all the things, Because her arm was being swollen that what she had done and headache. It was also reported she feel horrible and had fever all the day, low appetite, her body hurts and she had COVID before but she feel like she getting it back again. Basically all this symptoms that are on this list with the exception of swollen arm or anything like that. she have everything else. The outcome for the events was reported as not resolved at the time of this report.  Follow-Up (07Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: low appetite; my body hurts; I feel horrible; I had COVID before but I feel like I am getting it back again; my arm is being swollen; headache; I have been all day with fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 58-years-old female patient received third dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 30145BA), via an unspecified route of administration, administered in Arm Left on 01Oct2021 (Age at vaccination: 58-years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included Blood pressure, asthma, covid-19 (had COVID before) all from an unknown date and unknown if ongoing. concomitant medications included medicine for blood pressure. Prior vaccinations were reported as none. Historical vaccine included first and second dose of BNT162B2 for covid-19 immunization. It was reported that patient received booster shot on yesterday and today she had basically all of the symptoms that on paper, they told that from the Pfizer, you should get all the things, Because her arm was being swollen that what she had done and headache. It was also reported she feel horrible and had fever all the day, low appetite, her body hurts and she had COVID before but she feel like she getting it back again. Basically all this symptoms that are on this list with the exception of swollen arm or anything like that. she have everything else. The outcome for the events was reported as not resolved at the time of this report.  Follow-Up (07Oct2021): Follow-up attempts are completed. No further information is expected.