chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid. Fully vaccinated; Tested Positive for Covid. Fully vaccinated; This is a spontaneous report from a contactable consumer (Pfizer employee) via COVID-19 Vaccine Adverse Event Self-Reporting portal. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single, for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior vaccination. On 04Aug2021, the patient tested positive for Covid (post vaccination). The patient was fully vaccinated. Treatment for the adverse event (AE) was unknown. The patient was recovering from the event.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Lymphadenopathy, Peripheral swelling
Clinical narrative: "golf ball" size swollen gland under her arm; swollen arm; headache; fatigue; injection site pain and swelling; injection site pain and swelling; 1st dose 14May2021 & 2nd dose received 07Aug2021; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Aug2021 17:00 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included had a child with COVID on top of her for 2 days and she didn't catch it on an unspecified date. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks other than bnt162b2. No relevant tests. The patient previously received the first dose of bnt162b2 on 14May2021 at 50 years old in the Arm Left for COVID-19 immunization. On 09Aug2021, the patient experienced a "golf ball" size swollen gland under her arm and was asking if this something that is normal or that she should be concerned about. The patient also experienced other "typical" reactions which include swollen arm, headache, fatigue, injection site pain and swelling on 08Aug2021. The events were treated with Advil and the patient will be consulting with her physician on the phone. The patient received the 1st dose 14May2021 and 2nd dose on 07Aug2021. The outcome of the event "golf ball" size swollen gland was not recovered, for the events headache and fatigue were recovered on an unspecified date in Aug2021 while for the other events was unknown.     The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: "golf ball" size swollen gland under her arm; swollen arm; headache; fatigue; injection site pain and swelling; injection site pain and swelling; 1st dose 14May2021 & 2nd dose received 07Aug2021; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Aug2021 17:00 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included had a child with COVID on top of her for 2 days and she didn't catch it on an unspecified date. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks other than bnt162b2. No relevant tests. The patient previously received the first dose of bnt162b2 on 14May2021 at 50 years old in the Arm Left for COVID-19 immunization. On 09Aug2021, the patient experienced a "golf ball" size swollen gland under her arm and was asking if this something that is normal or that she should be concerned about. The patient also experienced other "typical" reactions which include swollen arm, headache, fatigue, injection site pain and swelling on 08Aug2021. The events were treated with Advil and the patient will be consulting with her physician on the phone. The patient received the 1st dose 14May2021 and 2nd dose on 07Aug2021. The outcome of the event "golf ball" size swollen gland was not recovered, for the events headache and fatigue were recovered on an unspecified date in Aug2021 while for the other events was unknown.     The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Joint swelling, Overdose
Clinical narrative: Swelling of all joints, very painful; Swelling of all joints, very painful; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Mar2021 17:00 (Batch/Lot Number: EN6201) as dose 1, single; on 06Mar2021 (Batch/Lot Number: EN6208) as dose 2, single for covid-19 immunisation; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 17:00 at 60-years-old (Batch/Lot Number: EN6201) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 06Mar2021 (Batch/Lot Number: EN6208) as dose 2, single for COVID-19 immunization. Medical history included ankylosing spondylitis (AS) and osteoarthritis. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA); tramadol. The patient previously took statins and experienced drug allergy. The patient experienced swelling of all joints, very painful (disability) on 29Mar2021 with outcome of not recovered. The patient was given Injections in knees, back and 3xs pretizone. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Events reported as serious due to disability.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on Aug 2.; tested positive on Aug 2.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727) via an unspecified route of administration on 27Mar2021 as dose 1 single and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration on 17Apr2021 as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient presented with sore throat, headache and coughing on 31Jul2021 and tested positive on 02Aug2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Hospitalization prolonged was no. Traveling companion was tested positive 30Jul2021. Since the vaccination, the patient had been tested for COVID-19 (sars-cov-2 test) via Nasal Swab which revealed negative on 28Jul2021 and positive 02Aug2021. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear swelling, Hypoaesthesia, Pain in extremity, Rash
Clinical narrative: My face has rash then my arm; My ears swelled and coming to bother; my right ear can't hear anything and today my other ear start to swell; My ears swelled and coming to bother; my right ear can't hear anything and today my other ear start to swell; My right face was numb; I had arm sore; This is a spontaneous report from a contactable consumer (patient). A 35-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Aug2021 (Batch/Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin allergy (allergy to Penicillin) and allergic to ants and cockroach; all from an unknown date and unknown if ongoing. There was no prior vaccination (within 4 weeks). The patient's concomitant medications were not reported. It was reported that "On 04Aug2021, I just had the Pfizer Covid Vaccine first dose and then the first day I had arm sore and on 06Aug2021 my ear start to swell and coming to bother, my right face was numb and on 07Aug2021 I went to the Emergency Room and while my right ear can't hear anything and now today my other ear start to swell." The patient also stated, "I got vaccine, before I told them about my allergy to Penicillin and allergic to ants and cockroach, still they gave me the shot (vaccine). I don't know why my right ear can't hear anything and my right face is numb." For the treatment the patient stated "No, I didn't." It was added, "I don't know what should I do for my ear, I was going in Emergency Room to see ENT Doctor, I don't know if they can fix my problem or not. My face has rash then my arm, my right ear is swelled and now my left ear start to swell." And, "Can you get me call back or something like that how to resolve my problem of my ears swelling." The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Upon landing took rapid test at airport on Jul 30 and tested postiive ; Upon landing took rapid test at airport on Jul 30 and tested postiive ; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single and on an unspecified date (Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient been tested for COVID-19 since the vaccination. The patient took polymerase chain reaction (PCR) test nasal swab on 28Jul2021 prior to boarding flight  and received the result as positive upon landing on 30Jul2021. Upon landing took rapid test (nasal swab) at airport on 30Jul2021 and tested positive was quarantined. The patient was not hospitalized and did not receive any treatment. The outcome of the events was recovered on an unspecified date in 2021.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: shortness of breath; chest pain and tightening; chest pain and tightening; This is a spontaneous report from a contactable nurse (patient's spouse). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in deltoid left on 10Aug2021 09:00 (Batch/Lot Number: FC3180) (at age 52-year-old) as dose 1, single for covid-19 immunisation. Medical history included high cholesterol from Jun2021 to an unknown date and gastrooesophageal reflux disease from Jun2021 to an unknown date. Concomitant medication(s) included omeprazole (PRILOSEC); pravastatin sodium; paracetamol (TYLENOL); ibuprofen and multivitamins. There were no other vaccines administered on the same date. The patient had his 1st dose of the vaccine the morning of 10Aug2021 and within a minute, he experienced shortness of breath, chest pain and tightening but went away after 3 minutes. Reporter was asking if patient need to get the 2nd dose of the vaccine. Events did not require a visit to the emergency room nor physician's office. Outcome of the events was recovering. The reporter considered the events medically significant.; Sender's Comments: A contributory role of BNT162B2 to events shortness of breath, chest pain and tightening cannot be excluded based on temporal association and available information. 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in arm left on 23Jul2021 at 18:45 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hyperthyroidism (over 20 years). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hyperthyroidism from an unspecified start date and ongoing. The patient experienced facial numbness on 23Jul2021 (reported as 20-30 mins after). The clinical course was as follows: The patient experienced the facial numbness with no other symptoms 20-30 mins after she received the dose. Stated numbness lasted 4 hours; she took 2 diphenhydramine (BENADRYL) and facial numbness (including across cheekbone and nose) started improving an hour after she took BENADRYL dose. The patient explained she is scheduled for her second shot on Friday, 13Aug2021. After the first dose, she experienced numbness in her face. She wanted to know if this is a normal side effect, she hasn't seen it listed anywhere. The first shot was given on 23Jul2021 at around 6:45pm in the left upper arm. The facial numbness was noticed about a half hour later, after getting the shot. She took a couple Benadryl and about 4 hours later after waking from a nap, it improved. By the next morning it was gone. She hasn't received a lot of vaccines, just childhood vaccine and one as an adult that she doesn't remember what it was, but she had no reaction. She doesn't normally get vaccines. Therapeutic measures were taken as a result of facial numbness. The outcome of the event was recovered on 24Jul2021.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dry mouth, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: 25 minutes after the shot was administered I felt nauseas; almost passed out; was covered in sweat and became short of breath; was covered in sweat and became short of breath; my jaw hurt; back of my throat hurt; head hurt; cotton mouth; lips turned blue; I immediately had arm pain; foggy head; forgetful; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient (Age at time of vaccination 27-years) received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 11:45 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced lips turned blue on 09Aug2021 at 12:10, I immediately had arm pain on 09Aug2021 at 11:45 and 25 minutes after the shot was administered I felt nauseas, almost passed out, was covered in sweat and became short of breath, my jaw hurt, back of my throat hurt, head hurt and cotton mouth all on 09Aug2021 at 12:10 and foggy head and forgetful on 09Aug2021. Patient reported, I immediately had arm pain and then 25 minutes after the shot was administered I felt nauseas and almost passed out, was covered in sweat and became short of breath, lips turned blue, then my jaw hurt and the back of my throat hurt and my head hurt. Then it faded and I had cotton mouth. The rest of the day I was nauseated, foggy head and forgetful, with really intense arm pain. The event Lips turned blue was reported as serious-medically significant. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Memory impairment, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: 25 minutes after the shot was administered I felt nauseas; almost passed out; was covered in sweat and became short of breath; was covered in sweat and became short of breath; my jaw hurt; back of my throat hurt; head hurt; cotton mouth; lips turned blue; I immediately had arm pain; foggy head; forgetful; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient (Age at time of vaccination 27-years) received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 11:45 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced lips turned blue on 09Aug2021 at 12:10, I immediately had arm pain on 09Aug2021 at 11:45 and 25 minutes after the shot was administered I felt nauseas, almost passed out, was covered in sweat and became short of breath, my jaw hurt, back of my throat hurt, head hurt and cotton mouth all on 09Aug2021 at 12:10 and foggy head and forgetful on 09Aug2021. Patient reported, I immediately had arm pain and then 25 minutes after the shot was administered I felt nauseas and almost passed out, was covered in sweat and became short of breath, lips turned blue, then my jaw hurt and the back of my throat hurt and my head hurt. Then it faded and I had cotton mouth. The rest of the day I was nauseated, foggy head and forgetful, with really intense arm pain. The event Lips turned blue was reported as serious-medically significant. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Presyncope
Clinical narrative: 25 minutes after the shot was administered I felt nauseas; almost passed out; was covered in sweat and became short of breath; was covered in sweat and became short of breath; my jaw hurt; back of my throat hurt; head hurt; cotton mouth; lips turned blue; I immediately had arm pain; foggy head; forgetful; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient (Age at time of vaccination 27-years) received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 11:45 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced lips turned blue on 09Aug2021 at 12:10, I immediately had arm pain on 09Aug2021 at 11:45 and 25 minutes after the shot was administered I felt nauseas, almost passed out, was covered in sweat and became short of breath, my jaw hurt, back of my throat hurt, head hurt and cotton mouth all on 09Aug2021 at 12:10 and foggy head and forgetful on 09Aug2021. Patient reported, I immediately had arm pain and then 25 minutes after the shot was administered I felt nauseas and almost passed out, was covered in sweat and became short of breath, lips turned blue, then my jaw hurt and the back of my throat hurt and my head hurt. Then it faded and I had cotton mouth. The rest of the day I was nauseated, foggy head and forgetful, with really intense arm pain. The event Lips turned blue was reported as serious-medically significant. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: hair loss; extreme dizziness; tingling and swollen lips; tingling and swollen lips; decreased left ear hearing; joint pain/extreme joint pain; brain fog; fatigue; This is a spontaneous report from a non-contactable healthcare professional (patient). A non-pregnant 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 13Jan2021 (Lot Number: ek4176, unknown expiration; at the age of 46 years old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D); biotin; and unspecified multivitamin.  The patient previously took Percocet, amoxicillin, and doxycycline, and has known allergies to it. On 13Jan2021, few hours after the vaccination, the patient experienced extreme dizziness, tingling and swollen lips, decreased left ear hearing, joint pain, brain fog, and fatigue. Now (on 10Aug2021), the patient experienced hair loss and extreme joint pain, and dizziness on and off 8 months later. No COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient had not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events dizziness, paraesthesia oral, lip swelling, hypoacusis, Arthralgia, feeling abnormal, fatigue and alopecia cannot be excluded. 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Lip swelling, Paraesthesia oral
Clinical narrative: hair loss; extreme dizziness; tingling and swollen lips; tingling and swollen lips; decreased left ear hearing; joint pain/extreme joint pain; brain fog; fatigue; This is a spontaneous report from a non-contactable healthcare professional (patient). A non-pregnant 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 13Jan2021 (Lot Number: ek4176, unknown expiration; at the age of 46 years old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D); biotin; and unspecified multivitamin.  The patient previously took Percocet, amoxicillin, and doxycycline, and has known allergies to it. On 13Jan2021, few hours after the vaccination, the patient experienced extreme dizziness, tingling and swollen lips, decreased left ear hearing, joint pain, brain fog, and fatigue. Now (on 10Aug2021), the patient experienced hair loss and extreme joint pain, and dizziness on and off 8 months later. No COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient had not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events dizziness, paraesthesia oral, lip swelling, hypoacusis, Arthralgia, feeling abnormal, fatigue and alopecia cannot be excluded. 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID; positive for covid; This is a spontaneous report from a contactable other healthcare professional. An adult male patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot numbers were not reported), via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunization. Medical history included leukemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient who was fully vaccinated got exposed to his wife who was not vaccinated, and he came up positive for COVID which resulted in hospitalization. The patient underwent lab tests and procedures which included COVID-19 test: positive on 09Aug2021. The events resulted in emergency room/department or urgent care visit. It was unknown if treatment was received for the events. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive for COVID  based on the known safety profile.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient loss her sense of taste and tested positive for COVID; Patient loss her sense of taste and tested positive for COVID; This is a spontaneous report from a contactable other hcp. A 30-Years-old female patient (pregnant: unknown) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EN5318), via intramuscular route of administration, administered in Arm Left on 04Mar2021 as (at the age of 29-Years-old) unknown dose number, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. The patient medical history and concomitant medications were not reported. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, the patient been tested for COVID-19. The patient loss her sense of taste and tested positive for COVID on 05Aug2021. No hospitalization was prolonged. The adverse event was resulted in doctor or other healthcare professional office/clinic visit. Prior The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Aug2021. No treatment was received for the reported events. The outcome of the event was reported as not recovered.  Product Quality Complaint: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. 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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Gastrooesophageal reflux disease, Incomplete course of vaccination, Myocardial infarction
Clinical narrative: It felt like a heart attack type of thing; Pins and needles through his chest, arm pits, and arms; Electric shock waves...feelings / felt like he was poisoned; acidic reflux feelings; really weak; felt nauseous; he did not go back to receive his second shot; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he received the first shot of the vaccine on April and he did not go back to receive his second shot due to a serious reaction that was a lot worse than others. He also mentioned needles, electric shock waves, and acidic reflux feelings. He reported that he felt like he had electric shock waves, he felt really weak and nauseous, felt like he was being poisoned. He said that it lasted for weeks and months and sometimes he still feels it. He said that he also had the pins and needles through his chest, arm pits, and arms. He said that it felt like a heart attack type of thing although he has never had a heart attack. There was no way he was the only person that had bad side effects  He said that he has never had a problem with any other vaccines that he has taken in the past, but he did have a problem with this vaccine. He said that he feels better, but said that he does not know the long term implications of the vaccine. He also asked if he was the only person to ever report a serious adverse reaction with the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: It felt like a heart attack type of thing; Pins and needles through his chest, arm pits, and arms; Electric shock waves...feelings / felt like he was poisoned; acidic reflux feelings; really weak; felt nauseous; he did not go back to receive his second shot; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he received the first shot of the vaccine on April and he did not go back to receive his second shot due to a serious reaction that was a lot worse than others. He also mentioned needles, electric shock waves, and acidic reflux feelings. He reported that he felt like he had electric shock waves, he felt really weak and nauseous, felt like he was being poisoned. He said that it lasted for weeks and months and sometimes he still feels it. He said that he also had the pins and needles through his chest, arm pits, and arms. He said that it felt like a heart attack type of thing although he has never had a heart attack. There was no way he was the only person that had bad side effects  He said that he has never had a problem with any other vaccines that he has taken in the past, but he did have a problem with this vaccine. He said that he feels better, but said that he does not know the long term implications of the vaccine. He also asked if he was the only person to ever report a serious adverse reaction with the vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram, Diarrhoea, Diverticulitis, Dyspnoea
Clinical narrative: severe diverticulitis attack; bloody stool; diarrhea; fever; nausea; severe vertigo; difficulty breathing; profuse sweating; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 28Jul2021 08:15 (batch/lot number EW0187 and expiry date unknown) at 43 years of age as dose 1, single for covid-19 immunization in an urgent care center. Medical history included asthma, hyperlipidemia, hypertension, chronic pain, GERD, diverticulitis. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril, omeprazole, ibuprofen, ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that within 24 hours of vaccine being administered (approximately midnight on 29Jul2021), he had severe diverticulitis attack to include bloody stool and diarrhea, experienced fever, nausea, severe vertigo, difficulty breathing, profuse sweating, and intense abdominal pain. The patient informed that he required ER visit via paramedics. He had CT scan with dye contrast administered and was then admitted to the hospital for four days on high IV antibiotic regimen plus IV narcotic pain meds. The patient informed that the adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported serious as caused hospitalization (hospitalization not prolonged). The patient underwent lab tests and procedures which included covid test (nasal swab): negative on 29Jul2021. The outcome of the events was recovering.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia, Hyperhidrosis, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: severe diverticulitis attack; bloody stool; diarrhea; fever; nausea; severe vertigo; difficulty breathing; profuse sweating; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 28Jul2021 08:15 (batch/lot number EW0187 and expiry date unknown) at 43 years of age as dose 1, single for covid-19 immunization in an urgent care center. Medical history included asthma, hyperlipidemia, hypertension, chronic pain, GERD, diverticulitis. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril, omeprazole, ibuprofen, ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that within 24 hours of vaccine being administered (approximately midnight on 29Jul2021), he had severe diverticulitis attack to include bloody stool and diarrhea, experienced fever, nausea, severe vertigo, difficulty breathing, profuse sweating, and intense abdominal pain. The patient informed that he required ER visit via paramedics. He had CT scan with dye contrast administered and was then admitted to the hospital for four days on high IV antibiotic regimen plus IV narcotic pain meds. The patient informed that the adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported serious as caused hospitalization (hospitalization not prolonged). The patient underwent lab tests and procedures which included covid test (nasal swab): negative on 29Jul2021. The outcome of the events was recovering.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe diverticulitis attack; bloody stool; diarrhea; fever; nausea; severe vertigo; difficulty breathing; profuse sweating; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 28Jul2021 08:15 (batch/lot number EW0187 and expiry date unknown) at 43 years of age as dose 1, single for covid-19 immunization in an urgent care center. Medical history included asthma, hyperlipidemia, hypertension, chronic pain, GERD, diverticulitis. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril, omeprazole, ibuprofen, ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that within 24 hours of vaccine being administered (approximately midnight on 29Jul2021), he had severe diverticulitis attack to include bloody stool and diarrhea, experienced fever, nausea, severe vertigo, difficulty breathing, profuse sweating, and intense abdominal pain. The patient informed that he required ER visit via paramedics. He had CT scan with dye contrast administered and was then admitted to the hospital for four days on high IV antibiotic regimen plus IV narcotic pain meds. The patient informed that the adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported serious as caused hospitalization (hospitalization not prolonged). The patient underwent lab tests and procedures which included covid test (nasal swab): negative on 29Jul2021. The outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable other Healthcare Professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 17Feb2021 (at the age of 53-year-old), as dose 2, single in left arm, and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 27Jan2021 (at the age of 53-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported as unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown if the patient had COVID prior vaccination and the patient was tested COVID post vaccination. On 30Jul2021, 5 months and 13 days after second dose of vaccine, the patient was tested positive for COVID and became ill. The patient visited to Doctor or other healthcare professional office/clinic in response to event. It was reported as unknown if the patient received any treatment for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test nasal swab, positive, on 30Jul2021. The clinical outcome of the events was reported as resolving.  Based on the available information ,a possible contributory role of suspect product BNT162B2 to the development of the event covid 19 cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Colleague was exposed to his sister and ended up testing positive for COVID will symptoms.; Colleague was exposed to his sister and ended up testing positive for COVID will symptoms.; Accidental overdose; dose 1 administered on 28Jan2021 and dose 2 administered on 28Jan2021; This is a spontaneous report from a contactable other HCP. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), intramuscular in left arm on 28Jan2021 (at the age of 35-years-old) as dose 1 single and dose 2 via an unspecified route of administration in left arm on 28Jan2021 (Batch/Lot Number: EN5318) (at the age of 35-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the colleague was exposed to his sister and ended up testing positive for COVID symptoms on 16Jul2021. The patient did not require hospitalization for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab taken for the test which showed positive on 16Jul2021. The outcome of event the colleague was exposed to his sister and ended up testing positive for COVID symptoms was recovered on an unspecified date in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 21-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 (Batch/Lot number and Expiry date was not reported) (at the age of 21-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on an unspecified date for covid-19 immunization. On an unspecified date, the patient experienced myocarditis. The patient was subsequently admitted to the hospital with a diagnosis of Myocarditis. The clinical outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 21-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 (Batch/Lot number and Expiry date was not reported) (at the age of 21-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on an unspecified date for covid-19 immunization. On an unspecified date, the patient experienced myocarditis. The patient was subsequently admitted to the hospital with a diagnosis of Myocarditis. The clinical outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Presyncope
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 21-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 (Batch/Lot number and Expiry date was not reported) (at the age of 21-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on an unspecified date for covid-19 immunization. On an unspecified date, the patient experienced myocarditis. The patient was subsequently admitted to the hospital with a diagnosis of Myocarditis. The clinical outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pain
Clinical narrative: aches and pain; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient). This case is generated for the 2nd dose of reporter self.  A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 19Mar2021 (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included urinary tract infection and exposure to COVID-19 (my daughter-in-law, my son, and one of his sons all got COVID). Concomitant medication(s) included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for urinary tract infection, start and stop date were not reported. The patient previously received the first dose of bnt162b2 in Feb2021 for COVID-19 immunization and experienced sore arm. On an unspecified date, the patient experienced aches and pain, muscle pain and dizziness. The patient reported that on Saturday night, she went out with her son, who just had 1 shot of his vaccine (he did not tell which one he got) and his wife and their 2 children. The patient's daughter-in-law came down this COVID-19 the previous day. The patient don't have to do anything. She live alone. She don't see anyone. Her daughter-in-law, her son, and one of his sons all got COVID. She further reported that she was taking Cipro for a urinary tract infection so she did not know if they were symptoms of the antibiotic or of COVID illness. After the first shot, she had a sore arm. After the 2nd shot maybe for 3 days, she had aches and pain. A day an half of muscle pain and very bad dizziness. She wanted some guidance or what to do since she was exposed to someone with COVID over the weekend. The outcome of the events was unknown.  The lot number for the vaccine, (bnt162b2), was not provided and will be requested during follow up.