chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Dysphonia, Insomnia, Lung disorder
Clinical narrative: COVID-19; COVID-19; TROUBLE SLEEPING; Right Lung Weak; Voice was different and felt like were going to die; Impending doom; This is a solicited report based on information received by Pfizer (manufacturer control number: 21K-163-4084076-00) from a contactable consumer(patient)   A 69-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 01Mar2021 at single dose intramuscular for COVID-19 immunization and adalimumab (HUMIRA) for moderate to severe rheumatoid arthritis. Relevant medical history included Moderate to Severe Rheumatoid Arthritis. Concomitant medications were not reported.  The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02May2021 at single dose intramuscular for COVID-19 immunization. On an unspecified date the patient experienced vaccination failure, COVID- 19, trouble sleeping, right lung weak, voice was different and felt like were going to die and impending doom. At the time of the reporting event outcome was unknown.   The reporter's causality for all the reported events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  was provided as possible.  The reporter's causality for the event of covid-19 with Humira(adalimumab) was provided as no reasonable possibility. The Reporter's causality for the events of trouble sleeping, right lung weak, Voice was different and felt like were going to die with Humira(adalimumab) was not provided.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19, insomnia (non-serious) , lung disorder (non-serious), dysphonia (non-serious) and anxiety (non-serious) and BNT162B2.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID-19; COVID-19; TROUBLE SLEEPING; Right Lung Weak; Voice was different and felt like were going to die; Impending doom; This is a solicited report based on information received by Pfizer (manufacturer control number: 21K-163-4084076-00) from a contactable consumer(patient)   A 69-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 01Mar2021 at single dose intramuscular for COVID-19 immunization and adalimumab (HUMIRA) for moderate to severe rheumatoid arthritis. Relevant medical history included Moderate to Severe Rheumatoid Arthritis. Concomitant medications were not reported.  The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02May2021 at single dose intramuscular for COVID-19 immunization. On an unspecified date the patient experienced vaccination failure, COVID- 19, trouble sleeping, right lung weak, voice was different and felt like were going to die and impending doom. At the time of the reporting event outcome was unknown.   The reporter's causality for all the reported events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  was provided as possible.  The reporter's causality for the event of covid-19 with Humira(adalimumab) was provided as no reasonable possibility. The Reporter's causality for the events of trouble sleeping, right lung weak, Voice was different and felt like were going to die with Humira(adalimumab) was not provided.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, covid-19, insomnia (non-serious) , lung disorder (non-serious), dysphonia (non-serious) and anxiety (non-serious) and BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive of COVID-19; Tested positive of COVID-19; This is a spontaneous report from a non-contactable consumer (patient) via the Pfizer sponsored program.  A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 27Aug2021, as 1st single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Sep2021, the patient was sick and tested positive for COVID-19. The patient was asking if they could get the 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: I have been bleeding from my finger nail; This is a spontaneous report from a contactable nurse (patient herself).  A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 22Sep2021 at single dose (dose number unknown) for COVID-19 immunization. No relevant medical history and concomitant medications were provided. On 22Sep2021, the patient has been bleeding from her finger nail. The outcome of the event wass unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Hemorrhage cannot be completely 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from contactable consumer (patient's parent). A 34-years-old male patient of received at the age of 33-years-old second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm on 20Jan2021 (Batch/Lot number was not reported) as dose 2, single, and first dose via an unspecified route of administration, administered in arm three weeks before the second on Dec2020 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient received the doses probably in the morning, but can't guarantee. The route was reported as arm, but unknown which arm. First dose was the side he sleeps on, second dose was the opposite arm. Medical history included arm soreness from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient tested positive for COVID-19. Had the Pfizer COVID-19 Vaccines. He was an Athletic Trainer. Patient started feeling bad on 10Sep2021-11Sep2021. Didn't do a rapid COVID test, did the extensive test. Test was done by his work. Is employed with Health System. Employer had patient come in on Monday for a COVID test and was confirmed he was positive.  Went for the COVID-19 test on Monday, 13Sep2021, results came back positive on Wednesday, 15Sep2021. Went back to work on 22Sep2021. Patient is feeling fine. COVID-19 Vaccine saved him from being in the hospital. The patient received his COVID-19 test at a hospital facility, but it was done outside. Did not have to see a doctor. The patient had heavy contact with unvaccinated people because of his job. Before he got COVID-19 tested, patient thought he had a cold. Patient used an antihistamine and Tylenol. Then patient lost smell and taste. At the time of reporting the patient was good and back and to work. Only felt bad for a day or two. The outcome of event was resolved on an unspecified date in Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Extra dose administered, Fatigue, Headache
Clinical narrative: Fever 102.7; Chills; Sweats; Fatigue; Nausea; Headache; Body aches; from the booster- 3rd shot; from the booster- 3rd shot; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Right on 24Sep2021 11:00 (At the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. No relevant past drug history, known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 and dose 2 via an unspecified route of administration (At the age of 39-year-old) as single dose for COVID-19 immunisation and the patient previously received FLU vaccine via an unspecified route of administration, administered in Arm Left on 23Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Sep2021 23:00 the patient experienced fever 102.7, chills, sweats, fatigue, nausea, headache, body aches, from the booster- 3rd shot. The patient underwent lab tests and procedures which included body temperature: 102.7 on 24Sep2021. The outcome of the event from the booster- 3rd shot was unknown and outcome of other events was not recovered,  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Off label use, Pain, Pyrexia
Clinical narrative: Fever 102.7; Chills; Sweats; Fatigue; Nausea; Headache; Body aches; from the booster- 3rd shot; from the booster- 3rd shot; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Right on 24Sep2021 11:00 (At the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. No relevant past drug history, known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 and dose 2 via an unspecified route of administration (At the age of 39-year-old) as single dose for COVID-19 immunisation and the patient previously received FLU vaccine via an unspecified route of administration, administered in Arm Left on 23Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Sep2021 23:00 the patient experienced fever 102.7, chills, sweats, fatigue, nausea, headache, body aches, from the booster- 3rd shot. The patient underwent lab tests and procedures which included body temperature: 102.7 on 24Sep2021. The outcome of the event from the booster- 3rd shot was unknown and outcome of other events was not recovered,  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: having reaction to the vaccine./I really don't feel good; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 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. Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete. The patient medical and concomitant medication history were reported. Patient stated, really did not feel good and really can not understand. Patient had reaction to the vaccine. Patient went to the emergency room and nobody can help patient. Patient was unwilling to share further information, hence, product details (LOT#, expiration date, NDC#, UPC#) and other details were unknown. The outcome of event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Erythema, Nausea, Pyrexia
Clinical narrative: Throat felt enclosed; redness on neck; difficulty breathing; hives on chest, arm, and head; nausea; diarrhea; fever; This is a spontaneous report from a contactable consumer reported for herself. A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3182; Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 17Sep2021 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC); vitamin c [ascorbic acid] (VITAMIN C); fish oil (FISH OIL); folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced throat felt enclosed, redness on neck, difficulty breathing, hives on chest, arm, and head, nausea, diarrhea, fever on 18Sep2021 10:30. Therapeutic measures were taken as a result of the events. AE (adverse event) resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for AE. AE treatment included nausea medication. There was no prolonged hospitalization. The events were not serious and seriousness criteria included none. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: Throat felt enclosed; redness on neck; difficulty breathing; hives on chest, arm, and head; nausea; diarrhea; fever; This is a spontaneous report from a contactable consumer reported for herself. A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3182; Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 17Sep2021 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC); vitamin c [ascorbic acid] (VITAMIN C); fish oil (FISH OIL); folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced throat felt enclosed, redness on neck, difficulty breathing, hives on chest, arm, and head, nausea, diarrhea, fever on 18Sep2021 10:30. Therapeutic measures were taken as a result of the events. AE (adverse event) resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for AE. AE treatment included nausea medication. There was no prolonged hospitalization. The events were not serious and seriousness criteria included none. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle rupture, Muscle spasms, Seizure
Clinical narrative: body convulsions; torn muscle; subsequent muscle spasms; This is a spontaneous report from a contactable consumer (patient)  A patient of unspecified age and gender received COVID-19 VACCINE  MANUFACTURER UNKNOWN via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced body convulsions (hospitalization) on an unspecified date with outcome of unknown , torn (hospitalization) on an unspecified date with outcome of unknown , subsequent muscle spasms (hospitalization) on an unspecified date with outcome of not recovered.  The clinical course was reported as follows:When I received my Pfizer J&J COVID-19 vaccination in April, I had extremely severe reactions that included full body convulsions, which resulted in a torn muscle and subsequent muscle spasms that eventually led to my hospitalization. I'm still having muscle spasms from the injury due to the convulsions caused by the vaccine.  The lot number for the vaccine, [COVID-19 VACCINE], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: for my face to go numb/my arm to go numb on the side of the injection site?"; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, and Expiry Date are unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that is it normal to loose, for her face to go numb and her arm to go numb on the side of the injection site? on an unspecified date. The outcome of event was unknown.  Follow-up attempts have been completed. Batch/lot number is not available for [BNT162B2]. No further Information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Impaired driving ability
Clinical narrative: he had a stroke; her husband can't drive; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not reported, expiration date: not reported, NDC number: not reported) via an unspecified route of administration on 02Sep2021 as Dose 1, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received their second dose was unspecified. on an unspecified date,  patient experienced he had a stroke and her husband can't drive. The outcome of all the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: She did start getting menstrual bleeding again; I'm going through the menopause since right after 50; I'm having menstrual cycle and it's going on 3 days now; I hadn't had a period from 4 years; This is a spontaneous report from a Pfizer sponsored program reported by contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date in Apr2021 as single dose, and first dose via an unspecified route of administration on an unspecified date in Apr2021 as single dose for COVID-19 immunization. The medical history included menopause (I'm going through the menopause since right after 50). Concomitant medication included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) ongoing. The patient reported that, she had to got to take Prempro. "I'm 54 years old, I'm taking Prempro (as she was going through the menopause and had not had a period from 4 years) 45mg whatever menopausal anyway Prempro is giving me period". On an unspecified date in Sep2021, the patient experienced "she did start getting menstrual bleeding again; I'm going through the menopause since right after 50; I'm having menstrual cycle and it's going on 3 days now; I hadn't had a period from 4 years (now 54 years now)". The patient was asking "will you think that it ends or otherwise I continue to bleed." The patient was asking if she was eligible for the third dose of COVID-19 vaccine, but she also did mention that she was on Prempro. She did start getting menstrual bleeding again but she was having better sex life so that was great, but she wanted to report those AEs and then medical information regarding the third dose. The patient was told by pharmacy that she is not eligible for any third shot. Consumer hung up the call abruptly, further probing could not be done. Hence, limited information available over the call. The outcome of the event was reported as not resolved.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Pain in extremity
Clinical narrative: Patient had the 1st dose of the Pfizer COVID 19 vaccine on 02Apr2021, She only got her 2nd dose on 24Sep2021; headache; sore arm; a little bit of nausea; This is a spontaneous report from a contactable consumer (Patient, reported for self). A 64-year-old female patient received second dose of bnt162b2 ((COMIRNATY), COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 24Sep2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had earlier received first dose of Pfizer COVID-19 vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Apr2021 (at the age of 64-year-old) and experienced miserable headache, stomach ache, nausea (mentioned that she was so sick). Patient only got her 2nd dose on 24Sep2021. On an unspecified date in Sep 2021, patient experienced headache, sore arm and a little bit of nausea. Patient reported that she thought she had to restart the series of vaccination since it had been months since she had her first dose. Vaccinator told her (not sure if pharmacist or nurse) that she is already fully vaccinated and no need to repeat the series - She was also advised to come back after 6 months for the booster, and she wanted to confirm if that was true. The clinical outcome of events was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: I had the strange side effect; lips tingling; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 25Sep2021 at single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 25Sep2021, the patient had the strange side effect, lips tingling. The patient after receiving the first dose of vaccine left the vaccination center, but they said to stay for 50 minutes. The pateint's whole family received the COVID Vaccination but only the patient had the strange side effect and was not sure if it was real or not and if anyone had complained about lips tingling right after the COVID Vaccination. The patient was not interested in filing any report, but just called to ask if it was a common side effect. The outcome of events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: He had an adverse reaction; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported; Expiration Date: Apr2021) via an unspecified route of administration on 04Jan2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient had received the Pfizer COVID vaccine back in Jan2021 and he had an adverse reaction (Allergic reaction-hypersensitivity) on an unspecified date in 2021 and he believed that he had documented this with Pfizer on an incident report back then and he was wondering if it was possible to get any documentation on that or not. Later he confirmed that he has had no new events since his original report, he said he was pretty well within about 4 to 5 days. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Oxygen saturation, Pulse abnormal
Clinical narrative: tested positive for Covid; tested positive for Covid; pulse ox in to high 80's-low 90's; sick; This is a spontaneous report from a contactable pharmacist (patient's wife) via the Medical Information Team. This pharmacist reported similar events for 5 patients. This is the 5th of 5 reports. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 26Apr2021 (age at the time of vaccination was 46 years) as DOSE 1, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration on 17May2021 (age at the time of vaccination was 46 years) as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive for covid, pulse ox in to high 80's-low 90's and sick. The reporter, her husband, and her other two daughters also tested positive for Covid. She and her husband had received both doses already but her other two daughters have not. She says this was the sickest she has been in twenty years. Reportedly, the patient was also very sick with a pulse ox in to high 80's-low 90's and still has not returned to normal. He was a marathon runner and now has a pulse ox in the mid 90's. The reporter enquired what was the optimal interval post COVID infection, to administer the second dose (ex. wait until clinical symptoms resolve vs. wait 3 more weeks vs don't exceed 6w from first dose vs do not complete series vs give ASAP regardless). On an unspecified date, the patient underwent lab tests and procedures which included Pulse Ox: high 80's-low 90's, Pulse Ox: mid 90's and COVID: positive. The outcome of the event tested positive for covid was unknown. The outcome of the event pulse ox in to high 80's-low 90's and sick was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Amendment: This Amendment report is being submitted to amend previously reported information (To update narrative leadline): This is a spontaneous report from a contactable pharmacist (patient's wife) via the Medical Information Team.  This pharmacist reported similar events for 5 patients. This is the 5th of 5 reports.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event s Drug Ineffective and COVID-19 and the suspect drug bnt162b2
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: all of the vaccinated I know ALL are getting covid-19; all of the vaccinated I know ALL are getting covid-19; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's 1st daughter).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that all the vaccinated people the reporter knows were getting covid-19 including reporter's two daughters and two granddaughters. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. the outcome of events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101281144 same reporter, different patient
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: two flutter episodes in eight months; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history included COVID in Dec after which she had rate and rhythm heart issues for approximately 3 months. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. After being first Pfizer COVID vaccine, frequently and intensity of cardiovascular issues decreased. After second Pfizer vaccination the CV symptoms essentially stopped. On an unspecified date, the patient had two flutter episodes in eight months since being fully vaccinated. Event took place after use of product. The outcome of the event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Malaise, Pain
Clinical narrative: COVID; COVID; Felt achy; Not feeling well; This is a solicited report (FACILITATED COLLECT) from a contactable consumer (patient), based on the information received by Pfizer from Regulatory Authority (Mfr. Control No. 21K-163-4084993-00).   A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 1, single, and second dose intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for rheumatoid arthritis.  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced COVID on Aug2021, not feeling well on 2021 and felt achy on 2021.It was reported that in 2021, the patient experienced might be not feeling well and felt achy after covid-19 vaccine. In Aug2021, the patient experienced covid. In 2021, the might be not feeling well and felt achy after covid-19 vaccine resolved.  The action taken in response to the events for adalimumab was unknown. The outcome of event COVID was recovering, the other events were resolved.    The reporter's assessment of the causal relationship of the reported events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  Causality for humira(adalimumab): the reporter's causality for the event(s) of might be not feeling well and felt achy after covid-19 vaccine was not provided. The reporter's causality for the event(s) of covid with humira(adalimumab) was a reasonable possibility.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective, COVID-19, pain and malaise  cannot be totally excluded. The case will be reassessed if additional information becomes available.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Headache, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient contracted and tested positive; patient contracted and tested positive; had a headache for a day; This is a Non-Interventional report from Facilitated Collect based on the information received by Pfizer from Regulatory Authority (MFR Control No. 21K-163-4090044-00) from a contactable consumer (patient).   A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Jan2021 (Batch/Lot number was not reported), intramuscular, and the second dose in Feb2021 (Batch/Lot number was not reported) intramuscular as single dose for covid-19 immunisation (both doses at the age of 55); upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced patient contracted and tested positive (covid-19) on 02Sep2021, had a headache for a day on Feb2021. The patient was hospitalized for patient contracted and tested positive (covid-19) for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Sep2021. The action taken in response to the event(s) for upadacitinib was unknown. Headache recovered in Feb2021. The outcome of the other events was recovering.  The reporter's causality for the events COVID-19 and headache of Rinvoq (Upadacitinib): no reasonable possibility.  The reporter's causality for the events COVID-19 and headache of Pfizer Biontech COVID-19 vaccine: No reasonable possibility.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination failure, Covid-19 and Headache (non-serious) and BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: He also mentioned that he had a family member who had vaccines and had covid.; He also mentioned that he had a family member who had vaccines and had covid.; This is a spontaneous report from a Pfizer-sponsored program  Support from a non-contactable consumer (Family member)  A patient of unspecified age and gender received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) , both on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was informed that patient experienced drug ineffective and COVID-19 infection as it was mentioned that patient had vaccines and had covid'. At the time of the reporting event outcome was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough covid case after being fully vaccinated with Pfizer vaccine  resulting in death from COVID; Breakthrough covid case after being fully vaccinated with Pfizer vaccine  resulting in death from COVID; This is a spontaneous report from a contactable consumer (Pfizer colleague). An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at age of 45 years (as reported) and not pregnant on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. In Sep2021, patient experienced breakthrough covid case after being fully vaccinated with Pfizer vaccine resulting in death from COVID. Covid was treated at medical center. Seriousness criteria was reported as results in death, no life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect involved. Therapeutic measures were taken as a result of the events. The patient died on 27Sep2021. Death cause was Covid. It was unknown if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: covid; covid
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Dysstasia, Feeling abnormal, Gait disturbance
Clinical narrative: I had an attack of angina; Pain in all muscles; Pain in all muscles and joints; could not stand or walk; could not stand or walk; Severe pain in arms and legs; Severe pain in arms and legs with swelling; body felt like patient was retaining water; This is a spontaneous report from a contactable consumer (patient). A 78-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Sep2021 09:00 (at age of 78 years old) as single dose for COVID-19 immunization. Medical history included Heart capillary deficiency, Known allergies: Yes. No COVID prior vaccination. No COVID tested post vaccination. Patient had other medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592) on 01Sep2021 10:00 AM (at age of 78 years old) at left arm as single dose for COVID-19 immunisation. On 23Sep2021 06:00 PM, the patient had pain in all muscles and joints so severe patient could not stand or walk. Severe pain in arms and legs with swelling; body felt like patient was retaining water. Patient had an attack of angina (severe), which was under treatment for. Patient had similar, but less severe problems with the first shot. Patient will not take any more COVID shots as feel symptoms will get worse and life will be in danger. AE resulted in: Life threatening illness immediate risk of death from the event. No treatment received for all other events (except attack of angina). The outcome of the events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: I had an attack of angina; Pain in all muscles; Pain in all muscles and joints; could not stand or walk; could not stand or walk; Severe pain in arms and legs; Severe pain in arms and legs with swelling; body felt like patient was retaining water; This is a spontaneous report from a contactable consumer (patient). A 78-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Sep2021 09:00 (at age of 78 years old) as single dose for COVID-19 immunization. Medical history included Heart capillary deficiency, Known allergies: Yes. No COVID prior vaccination. No COVID tested post vaccination. Patient had other medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592) on 01Sep2021 10:00 AM (at age of 78 years old) at left arm as single dose for COVID-19 immunisation. On 23Sep2021 06:00 PM, the patient had pain in all muscles and joints so severe patient could not stand or walk. Severe pain in arms and legs with swelling; body felt like patient was retaining water. Patient had an attack of angina (severe), which was under treatment for. Patient had similar, but less severe problems with the first shot. Patient will not take any more COVID shots as feel symptoms will get worse and life will be in danger. AE resulted in: Life threatening illness immediate risk of death from the event. No treatment received for all other events (except attack of angina). The outcome of the events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising; This is a spontaneous report from a contactable other health care professional (patient).  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EU0168 and expiration date: not reported), via intramuscular, in Left Deltoid, on 10Aug2021 (at the age of 36-year-old) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history and concomitant medications were reported as none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  The patient experienced bruising on 10Aug2021. No treatment was received for the adverse event. The outcome of event was not recovered at time of report.; Sender's Comments: The event of bruising is assessed as possibly related to the suspect vaccine Comirnaty based on strong temporal association "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: Cardiac disorder, Dyspnoea
Clinical narrative: couldn't breathe at all; heart issues; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), has been sick for so many years, pulmonary distress, 100% disabled. The patient's concomitant medications were not reported.  During the call caller stated her husband got his 1st shot and the next day was in the ICU struggling for his life. States he has very bad COPD and he also got the Pfizer Covid-19 vaccine Wednesday morning and by 4am Friday he couldn't breathe at all and they called 911 and he went to the hospital. States they wanted to intubate him but he knew because of his COPD he would not get off the vent so they used CPap and got him back breathing. States that such pulmonary distress has created heart issues and he is now on heart medications, he also had a reaction to the vaccine and he has very bad COPD. Caller states her husband was not going to get his 2nd shot, she is the one that wants to make sure she is somewhat better protected. States he is 100% disabled plus the COPD. Caller states her husband has been sick for so many years and she has dealt with so many health professionals for her husband that when your mind is used to this type of thinking it automatically goes there and that is where it has been since. Therapeutic measures were taken as a result of events. Emergency Room Visit and Physician Office Visit for events. The outcome of events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Fibromyalgia, Myalgia
Clinical narrative: Myocarditis; Fibromyalgia development; Chest pain; palpitations; Joint pain; Fatigue; Muscle aches; This is a spontaneous report from a non-contactable consumer (the patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was unknown due to misplaced/discarded) via an unspecified route of administration on 25Aug2021 08:30 at age of 24-year-old at single dose for COVID-19 immunisation. The patient had no medical history (reported as "None never"). No known allergies. The patient had no COVID prior vaccination. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. On 28Sep2021, the patient experienced myocarditis, fibromyalgia development, chest pain, palpitations, joint pain, fatigue and muscle aches. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No treatment received for the events. COVID-19 test=Nasal Swab was taken on 15Sep2021 with negative result. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Palpitations, SARS-CoV-2 test
Clinical narrative: Myocarditis; Fibromyalgia development; Chest pain; palpitations; Joint pain; Fatigue; Muscle aches; This is a spontaneous report from a non-contactable consumer (the patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was unknown due to misplaced/discarded) via an unspecified route of administration on 25Aug2021 08:30 at age of 24-year-old at single dose for COVID-19 immunisation. The patient had no medical history (reported as "None never"). No known allergies. The patient had no COVID prior vaccination. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. On 28Sep2021, the patient experienced myocarditis, fibromyalgia development, chest pain, palpitations, joint pain, fatigue and muscle aches. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No treatment received for the events. COVID-19 test=Nasal Swab was taken on 15Sep2021 with negative result. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.