chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Pain in extremity, Prostatic specific antigen, Urticaria
Clinical narrative: pain in hands and feet; hives; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EWU196) via intramuscularly administered in upper Arm on 18Jun2021 11:30 as dose 2, single for covid-19 immunisation at Pharmacy or Drug store. Medical history included hypothyroid from 1996 and ongoing, psoriatic arthritis from 2016 and ongoing, UTDs from 1978 to Apr2021 Pertinent Details with on /off recurring and family medical history relevant to AE was Psoriasis, Hypothyroidism. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for thyroid disorder and liothyronine sodium (CYTOMEL) taken for thyroid disorder both from unknown start date and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Batch/Lot number: EW01ET) via an intramuscular administration on 28May2021 at 11:30 in upper arm as dose 1, single for covid-19 immunisation and experienced hives and pain in joints and visited Physician Office with treatment Aspirin and natural meds and acupuncture for pain along with Apis 200C (Homeopathic). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Jun2021 11:30 am, the patient experienced hives and on an unknown date, pain in hands and feet. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone: 2.10 on 04Jun2021 results as normal and prostatic specific antigen results positive swelly on unspecified date in Jan2019, prostatic specific antigen (X-ray) positive NA on Jan2019. Patient was received Apis 200C (Homeopathic) as treatment for event hives. It was reported that On18Jun2021, 2nd dose, hives took onset away homeopathic TX fw hives fine in 2 hours, still having pains in hands and feet. The clinical outcome of event hives was recovered on 18Jun2021, while event pain in hands and feet was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: Losing his eyesight; After the second dose, he is like gradually he is losing it; Started seeing a floater in his eyes, then he was like seeing all the blank, black things; This is a spontaneous report from a contactable consumer reporting for her husband. A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot/batch number: EW0173) via unspecified route in the left arm on 06May2021 (at the age of 67-years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported but reporter stated that patient was on several medications like hypertension, but reporter did not want to give full medical history here. Patient previously received first dose of BNT162B2 for COVID-19 Immunization. Patient did have underlying conditions (history). Reporter concern was, something had to be done with the vaccine because after few weeks, patient started seeing a floater in his eyes, then he was like seeing all the blank, black things. Within couple of weeks (second or third week) (in May2021), patient started losing his eyesight. Reporter meant it was pretty gradually. Patient went to optometrist and ophthalmologist right away, they went to 'retinopathy' and they were trying to figure it out why all of sudden patient experienced it and then they realized that it just happened after couple of weeks, after the vaccine. The clinical outcome for the events was unknown. Patient had a lab test like a month ago or something.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arterial catheterisation, Arteriosclerosis, COVID-19, Drug ineffective, Dyspnoea
Clinical narrative: Patient got COVID few days after she got the shot; Patient got COVID few days after she got the shot; Patient end up having well from the very beginning; Not being able to breathe; One of Patient artery is blocked 90% which was not blocked at all a year and half ago; This is a spontaneous report from a non-contactable consumer (reported for herself). A female patient of an unspecified age received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer stated that, "The reason the patient was calling is because quite a while back I wrote Pfizer and fill whole bunch of forms because she got COVID few days after she got the shot so with my husband and with few other people that were in my doctors office (Further not clarified, split not made). And now, what happened is the patient had to be in home because of COVID and had ended up having well from the very beginning not being able to breathe or whatever and her doctor gave her catheterization and found out one of her artery was blocked 90% which was not blocked at all a year and half ago very unusual for not reclogged that quickly that much and in less than a year and half, so, the patient wanted to know whether it was possible that the shot had caused the clogged artery". The events COVID-19 and drug ineffective was assessed as serious (medically significant). The patient underwent lab tests and procedures which included arterial catheterisation: found out one of the artery was blocked 90% and sars-cov-2 test: positive on an unspecified date (Patient got COVID few days after she got the shot). The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: Patient got COVID few days after she got the shot; Patient got COVID few days after she got the shot; Patient end up having well from the very beginning; Not being able to breathe; One of Patient artery is blocked 90% which was not blocked at all a year and half ago; This is a spontaneous report from a non-contactable consumer (reported for herself). A female patient of an unspecified age received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer stated that, "The reason the patient was calling is because quite a while back I wrote Pfizer and fill whole bunch of forms because she got COVID few days after she got the shot so with my husband and with few other people that were in my doctors office (Further not clarified, split not made). And now, what happened is the patient had to be in home because of COVID and had ended up having well from the very beginning not being able to breathe or whatever and her doctor gave her catheterization and found out one of her artery was blocked 90% which was not blocked at all a year and half ago very unusual for not reclogged that quickly that much and in less than a year and half, so, the patient wanted to know whether it was possible that the shot had caused the clogged artery". The events COVID-19 and drug ineffective was assessed as serious (medically significant). The patient underwent lab tests and procedures which included arterial catheterisation: found out one of the artery was blocked 90% and sars-cov-2 test: positive on an unspecified date (Patient got COVID few days after she got the shot). The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Currently showing symptoms of Covid; Currently showing symptoms of Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced currently showing symptoms of COVID. It was reported that patient traveled to the country to get vaccinated, she already received the first dose of the Pfizer Covid-19 vaccine. She was currently showing symptoms of Covid, but she had not been tested yet. Her second dose was scheduled for July 19th. She asked If I tested positive, can I get vaccinated or how long should I wait. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Headache; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 9269), via unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that later patient received the second dose of BNT162B2 (Lot number: EN6200) via unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization. On or around 18Feb2021, the patient experienced headache and tinnitus. It was reported that the headache came and went about a week and tinnitus has remained 24/7. Patient visited ENT specialist. Patient was recovered from headache on an unknown date and outcome of tinnitus was not recovered at the time of report.  Information about lot /Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Paraesthesia, Rash
Clinical narrative: she proceeds to break out in hives almost every week.; her left hand is numb and she can't use it; rash on her hand; her hands broke out and were so sore and red and she has no feeling in her left hand.; her hands broke out and were so sore and red and she has no feeling in her left hand.; her hands broke out and were so sore and red and she has no feeling in her left hand.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received an unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. vaccine that she got in Feb and Mar. Consumer states she phoned about 3 weeks ago and she got an answer back and they said they would send papers to fill out, but she hasn't received them. On unspecified date consumer states she took a very severe reaction, and she is still suffering, and it has been 4 months, and she proceeds to break out in hives almost every week. In Feb2021, her hands broke out and were so sore and red and she has no feeling in her left hand. Consumer states in Mar2021, she doesn't know why she got another one so quick with the rash on her hand, but they said it was the sanitizer but it wasnt sanitizer and they are still red and sore. Her left hand is numb, and she can't use it. Consumer states she doesnt know what the matter with it is, it was never like that before the vaccine. Consumer states she is 86 years old, and she needs a bit of help and she is not getting it here. Consumer states she don't want any more fooling around, she wants something done about it. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she proceeds to break out in hives almost every week.; her left hand is numb and she can't use it; rash on her hand; her hands broke out and were so sore and red and she has no feeling in her left hand.; her hands broke out and were so sore and red and she has no feeling in her left hand.; her hands broke out and were so sore and red and she has no feeling in her left hand.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received an unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. vaccine that she got in Feb and Mar. Consumer states she phoned about 3 weeks ago and she got an answer back and they said they would send papers to fill out, but she hasn't received them. On unspecified date consumer states she took a very severe reaction, and she is still suffering, and it has been 4 months, and she proceeds to break out in hives almost every week. In Feb2021, her hands broke out and were so sore and red and she has no feeling in her left hand. Consumer states in Mar2021, she doesn't know why she got another one so quick with the rash on her hand, but they said it was the sanitizer but it wasnt sanitizer and they are still red and sore. Her left hand is numb, and she can't use it. Consumer states she doesnt know what the matter with it is, it was never like that before the vaccine. Consumer states she is 86 years old, and she needs a bit of help and she is not getting it here. Consumer states she don't want any more fooling around, she wants something done about it. The outcome of events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Pain in extremity, Pharyngeal swelling
Clinical narrative: on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; headache; on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; patient had increased heart rate; swelling of the throat; a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021; This is a spontaneous report from a contactable consumer (the patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FA6780, expiration date was not reported) via an unspecified route of administration, in the left arm, on an 10Jul2021 at 12:45 (at the age of 27-year-old), as single dose, for COVID-19 immunization. The patient's medical history included allergies to Metal. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. On 10Jul2021 at 16:00, a few minutes after the first dose, patient had increased heart rate, swelling of the throat and had a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021. On 13Jul2021 at 16:00, on the fourth day, patient had a headache, increased heart rate, and on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back (injected arm). Outcome of the events was not recovered.   Follow-up actions are needed. Further information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; headache; on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back; patient had increased heart rate; swelling of the throat; a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021; This is a spontaneous report from a contactable consumer (the patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FA6780, expiration date was not reported) via an unspecified route of administration, in the left arm, on an 10Jul2021 at 12:45 (at the age of 27-year-old), as single dose, for COVID-19 immunization. The patient's medical history included allergies to Metal. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. On 10Jul2021 at 16:00, a few minutes after the first dose, patient had increased heart rate, swelling of the throat and had a very sore arm; sore arm proceeded the next day and the following day arms soreness was very minimal on 11Jul2021. On 13Jul2021 at 16:00, on the fourth day, patient had a headache, increased heart rate, and on and off numbness in my left arm along with a blood clot on my left hand, and the left side of my back (injected arm). Outcome of the events was not recovered.   Follow-up actions are needed. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Infected with COVID-19; Infected with COVID-19; This is a spontaneous report from a contactable other healthcare professional. This other HCP reported for a patient.  A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced infected with covid-19 on an unspecified date. The reporter mentioned that, reporter had a friend that had received full Pfizer vaccine for COVID 19 and recently was confirmed that patient infected with COVID 19. Reporter did not know any additional information, although it sounds like the disease was not severe and there was no hospitalization yet. While not an adverse event relating to the vaccine itself, reporter thought this would be information the team would want to know. The patient lab test included sars-cov-2 test was positive on unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got COVID-19 after my vaccine; I got COVID-19 after my vaccine; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that:  A patient of an unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On an unspecified date patient experienced COVID-19 after vaccination (drug ineffective). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine; Four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was 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 In the last few days, reporter have had four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine. Also, reporter aware of two other cases in vaccinated patients who are being seen by colleagues. This may be sampling issue, but it was running contrary to the conventional wisdom that most of the cases are in unvaccinated people. Last patient out of four was a 68-year-old man who had a syncopal episode. His only symptoms were severe muscle aches and a headache. He also appears to have spread it to his wife and adult daughter who are also all fully vaccinated. They had the same symptoms. The entire family had their Pfizer vaccinations in March, and all three are positive. Are others seeing this. Are we missing more of these vaccinated cases because we no longer routinely test vaccinated people who are not having typical presentation.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relation, the association between the events of drug ineffective and COVID-19 and the suspect product of BNT162B2 cannot be completely ruled out.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: mild URI symptoms; fever; confirmed COVID-19; confirmed COVID-19; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date 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 and co-suspect moderna covid-19 vaccine (COVID-19 VACCINE MRNA (MRNA 1273)), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at dose 1, single for immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that "three patients, all since 01Jul2021, with PCR-confirmed COVID-19. Isolates sent for genotypic profiling - probably get results next winter. 2 with relatively mild URI symptoms but fever 100 (+). All received mRNA vaccine (Pfizer x 2, Moderna x 1) between Feb2021 and Apr2021. None with classic immunocompromising conditions but 1 was a robust 76". The events vaccination failure and Covid-19 were assessed as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Jul2021 and pyrexia: 100 (+) fahrenheit on an unspecified date. Therapeutic measures were taken as a result of events include TLC (tender loving care) with every other day follow-up. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID patients after weeks of none; COVID patients after weeks of none; This is a spontaneous report from a non-contactable physician. A 58-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date not reported), via an unspecified route of administration on an unknown date in Jan2021 (age at vaccination: 58-years-old) as dose 2, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing she was also on a biological for rheumatoid arthritis. The patient concomitant medications were not reported. Previously, patient received first dose of BNT162B2 (Lot number not reported) on an unknown date in Jan 2021 for covid-19 immunization. The patient underwent lab tests and procedures which included sars-cov-2 test: positive an unknown date. The patient was fully vaccinated in Jan 2021 and presented with a cough and severe headache. The patient had covid-19. The physician had seen covid patient after weeks of none. Her case makes more sense because she was also on a biological for rheumatoid arthritis and her presentation was more classic. The physician reported that they had stopped covid testing on fully vaccinated asymptomatic people a couple of weeks ago, so should they go back doing that. And response was provided to developing a testing approach that not only looks at vaccination status, but also takes into consideration your community prevalence (either test positivity or of new cases/100K, for example) and host factors (immunocompromised patients, those that live in congregate settings, persons with known close contact/household exposure, etc. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Unresponsive to stimuli, Vision blurred
Clinical narrative: Pt received  vaccine at 1600 today, pt returned home with mother without incident. At approx 2330 later that night pt mother removed bandage from vaccination site, pt then reported to mother that "he had blurred vision and so I had him sit down. Once he was sitting down he got really pale and his eyes closed. He stopped responding for a few seconds and then he came to."
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Several colleagues got the Covid vaccine and tested positive; Several colleagues got the Covid vaccine and tested positive; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot Number: GN6204 and Expiry date were not reported), via an unspecified route of administration, on 08Apr2021 as dose1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736; Expiration Date: 31Jul2021), via an unspecified route of administration, on 29Apr2021 as dose2, single for COVID-19 immunization. The patient medical history was not reported.     The patient's concomitant medications were not reported. Stated that she received the first dose on 08Apr2021.and received the second dose on 29Apr2021. She tested positive after the second dose. Stated that she developed Covid on 06Jul2021. Stated that she has to call colleagues when they get Covid. Stated that in the past several days several colleagues got the Covid vaccine and tested positive. Stated that website will not accept Pfizer her Pfizer email. Stated that she reported two yesterday without a problem. Does not have reference numbers from the website from reports yesterday. Stated that the colleagues call in to report this and she follows up. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Jul2021 got the Covid vaccine and tested positive.  QA Review and Rationale: The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot ER8736 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot ER8736, fill lot EP8688, and the bulk formulated drug product lot EP8585. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8736 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8736, fill lot EP8688, and the formulated drug product lot EP8585. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: The caller's wife mentioned that 2 of her friends got Shingles after the second shot; This is a spontaneous report from a non-contactable consumer via Pfizer-sponsored program . A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date. On an unknown date, the reporter's wife stated that 2 of her friends got shingles after the second shot. Outcome of event was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had the COVID vaccine and has had COVID; had the COVID vaccine and has had COVID; This spontaneous report from a contactable consumer reporting under the same suspect product(s) for 13 patients. This is 9 of 13 reports.   A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that a 20-year-old girl who had the COVID vaccine and has had COVID and the side effects from the COVID vaccine are the same side effects get from COVID. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, Immune thrombocytopenia
Clinical narrative: refractory ITP; hemorrhagic stroke; This is a literature report from the 2021, Patient died after receiving COVID-19 vaccine under investigation. Full Publication has been requested.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced refractory ITP and hemorrhagic stroke, on an unspecified date. The patient died several weeks after receiving the Pfizer-BioNTech vaccine due to refractory ITP and hemorrhagic stroke. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Immune thrombocytopenia, hemorrhagic stroke and the suspect drug BNT162B2  cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.; Reported Cause(s) of Death: refractory ITP; hemorrhagic stroke
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer reporting for the mother. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 14Jul2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient took the vaccine on 14Jul2021 and she was experiencing side effects. It was reported that patient was in like lot of pain and then cleared as she had no pain, just dizziness in Jul2021. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling sensation on her left arm several weeks after getting the vaccine; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer- sponsored program Support. A 61-year-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, several weeks after getting the vaccine, the patient experienced tingling sensation on her left arm, further reported that, it was at first unnoticeable but progressed in time and also mentioned that it is not painful and not stopping her to do her daily activities, that is why she is waiting for 2 weeks until her scheduled doctor's appointment. The patient would like to know if this has been a commonly reported side effect of the vaccine. The outcome of the event was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Apnoea, Loss of consciousness
Clinical narrative: Has been passing out since the first dose of the vaccine in Mar2021; Stops breathing; This is a spontaneous report from a contactable consumer (reporter's wife) and from a Pfizer sponsored program.  An unspecified age male patient received the first dose of BNT162B2 (PFIZER-BIONTECH  COVID-19 VACCINE) via an unspecified route of administration in Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. In Mar2021, the patient had been passing out since the first dose of the vaccine. He was still having issues with passing out and he stops breathing. He was seen and the determined in the ER it was a reaction to the vaccine. But recommended he still receive the second dose. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea; vomit; very weak; Body muscles pain; feeling sick; This is a spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that:  A 73-year-old unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via intramuscular route of administration, on 23Mar2021, 10:00 AM, as dose 2, single for COVID-19 Immunisation. Medical history and concomitant medications were not reported. The Patients familial history included Lupus, Arthritis, Asthma. Historical vaccine included BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Pfizer EN6198), via intramuscular route of administration, on 02Mar2021 at 12:00 Noon, as 1st dose, single for COVID-19 Immunisation. On an unknown date, the patient experienced nausea, vomiting, very weak, body muscles pain and feeling sick for 3 or 4 days. The patient did not received any treatment. Prior vaccinations within 4 weeks was none. The outcome of the events were recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 24-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 02Apr2021 (at the age of 24-year-old) (Batch/Lot Number: EP6955) as dose 2, single for covid-19 immunisation. Medical history included covid-19 (Covid prior vaccination). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 via intramuscular, administered in Arm Left on 11Mar2021 (Batch/Lot Number: EL3247) for covid-19 immunisation. On 11Jul2021, patient tested positive for COVID and experienced Loss of sense of smell and taste, cough, congestion and fatigue symptoms. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was diagnosed with COVID-19. Patient tested positive post vaccination. Patient did not receive any treatment for adverse event. Post vaccination patient underwent Nasal Swab test. On 11Jul2021 Nasal swab result as positive. The outcome of events was Recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Experienced a cold, after the first vaccine.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program Support. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported),   via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included Covid test was negative. On unspecified date the patient experienced a cold, after the first vaccine and she does not think cold, is from the vaccine. Patient was scheduled to get her second dose on 19Jul2021 and she wanted to know if she can take the vaccine if she has a cold, or should reschedule her appointment. The outcome of the event was unknown.                                                                             Information about batch/Lot number has been requested; Sender's Comments: Based on a plausible drug-event temporal relationship, a causal association between the reported 'cold' and the administration of the vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 82.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a dose of TYPHIM VI today (15Jul2021) that had expired on 10May2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via Global Medical Information (Reference number- 00683910) and transmitted to Sanofi on 15-Jul-2021.  This case involved 82 year old male patient received a dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] today (15Jul2021) that had expired on 10May2021 (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On 15-Jul-2021, the patient received 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot R2A264M and expiry date: 10-may-2021) (Frequency = Once) (Strength = Standard) via intramuscular route in unknown administration site for prophylactic vaccination (expired product administered)  It was reported that, "Pharmacy resident states that she is calling to report an adverse drug event. Pharmacy resident asking what the next steps should be and if they should give the vaccine to the patient again".  It was an actual medication error case (Expired vaccine used) (latency same day)  At the time of reporting, no adverse event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: bad reaction; Initial information was received on 16-Jul-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case involves a male patient who experienced bad reaction (adverse event) after receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   In 2014, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UI196AB and expiry date: 30-Jun-2015) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad reaction (adverse reaction) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  It was reported that "reporter would like to know the ingredients in FLULAVAL 2014 MDV? Please see Event Field for additional information. Additional Description of event Adverse events : Caller would like to know the ingredients in FLULAVAL 2014 MDV? Caller would like to know what went into his body. Advised caller to visit website which is a institute of health website."  Laboratory data was not reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
Sex: U
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: fever; Initial information regarding an unsolicited valid serious case was received from the other health care professional via Regulatory Authority (Reference number- 00685816) and transmitted to Sanofi on 16-Jul-2021.  This case involves a patient (unknown demographics) who had fever (pyrexia) after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Information on concomitant medications was not reported.  On an unknown date in Jan-2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5216AA; expiry date: 06-Jun-2019) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) the patient developed a serious fever (pyrexia) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event.  It was reported, "They have been advised to research the ingredients of the Adacel at that time to compare to the ingredients of the COVID 19 (corona virus disease -19) vaccines. Is that something you would be able to assist me with"  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.; Sender's Comments: This case concerns a patient (unknown demographics) who had pyrexia after vaccination with ADACEL. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of ACTHIB was inadvertently administered with no AE; Initial information was received on 19-Jul-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Global Medical Information (Reference number- 00687962).  This case involves a three-month-old female patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), IODINATED GLYCEROL (IPOL [IODINATED GLYCEROL]), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination.  On 19-Jul-2021, the patient received a 0.5 mL of Second dose of suspect HIB (PRP/T) VACCINE (lot number: UJ359AAA and expiry date: 11-Jul-2021) via an intramuscular route in right leg for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that, "nurse reporting an expired dose of ACTHIB was inadvertently administered. Caller with question on whether dose needs repeating."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.