chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: After receiving the second dose it was more painful than his first dose; This is a spontaneous report received from a contactable male consumer (patient) from a Pfizer sponsored Program COVAX US Support. A male patient of an unknown age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation and experienced after receiving the second dose it was more painful than his first dose. On an unknown date, the patient experienced after receiving the second dose it was more painful than his first dose. The patient reported that after receiving the second dose it was more painful than his first dose. He was calling about the Pfizer covid 19 vaccine. The patient wants to know if he still needs to take the booster shot. The patient stated he was concerned about the delta virus because it was running rampant. The side effects were negligible for him. He has been getting vaccines since he was a child. He has to hang up his nephew was calling him. No further details provided. The outcome of the event was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow up attempts completed, No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough covid infection 30Aug2021; breakthrough covid infection 30Aug2021; This is a spontaneous report from an other health care professional (patient). This 61-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose 03Mar2021 13:00, 2nd dose on 24Mar2021 13:00, both at single dose via an unknown route in left arm at 60-year-old for Covid-19 immunization. Medial history included known allergies with PCN, aspirin, ibuprofen. Patient had no Covid prior vaccination. No other medical history. Concomitant drug was not provided.  No other vaccine in four weeks. No other medications in two weeks. Patient experienced adverse event of breakthrough covid infection on 30Aug2021. The adverse event start on 29Aug2021. Nasal Swab PCR Covid test post vaccination on 30Aug2021 was positive. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the event. Outcome of the event was not resolved.    The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: after receiving the second dose it was more painful than his first dose; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) received from Pfizer Sponsored Program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after receiving the second dose it was more painful than his first dose. Side effects were negligible for him. Caller said after receiving the second dose it was more painful than his first dose. He was calling about the Pfizer COVID 19 vaccine. He wants to know if he still needs to take the booster shot. Caller stated he was concerned about the delta virus because it is running rampant in country. The side effects were negligible for him. He has been getting vaccines since he was a child. He has to hang up his nephew was calling him. The clinical outcome of the events was reported as unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Bone pain, Guillain-Barre syndrome, Insomnia
Clinical narrative: Guillain barre syndrome; bones and joints hurt.; bones and joints hurt.; Now can't sleep due to pain and throbbing and tingling of bones, joints, and muscles;; tingling of bones, joints, and muscles;; Now can't sleep due to pain and throbbing and tingling of bones, joints, and muscles;; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Aug2021 at 09:15 (Batch/Lot Number: FC3810) as single dose for COVID-19 immunisation. Patient age at vaccination was 37-year-old. Medical history included COVID prior vaccination. Concomitant medications included cyanocobalamin (B12 [CYANOCOBALAMIN]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), both taken for an unspecified indication, start and stop date were not reported.  Other concomitant medication included Super B12 Complex. During the first couple of weeks, patient experienced bones and joints hurt. Patient can't sleep due to pain and throbbing and tingling of bones, joints, and muscles. Patient finally went to get blood work yesterday (30Aug2021) and won't know results for a few days. Patient called Primary Care doctor and was going to ER later to be evaluated and rule out that Guillain barre syndrome and anything else. Adverse events start date was 09Aug2021 at 18:00. No treatment was received for the events. Outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Guillain barre syndrome; bones and joints hurt.; bones and joints hurt.; Now can't sleep due to pain and throbbing and tingling of bones, joints, and muscles;; tingling of bones, joints, and muscles;; Now can't sleep due to pain and throbbing and tingling of bones, joints, and muscles;; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 09Aug2021 at 09:15 (Batch/Lot Number: FC3810) as single dose for COVID-19 immunisation. Patient age at vaccination was 37-year-old. Medical history included COVID prior vaccination. Concomitant medications included cyanocobalamin (B12 [CYANOCOBALAMIN]) and colecalciferol (VITAMIN D [COLECALCIFEROL]), both taken for an unspecified indication, start and stop date were not reported.  Other concomitant medication included Super B12 Complex. During the first couple of weeks, patient experienced bones and joints hurt. Patient can't sleep due to pain and throbbing and tingling of bones, joints, and muscles. Patient finally went to get blood work yesterday (30Aug2021) and won't know results for a few days. Patient called Primary Care doctor and was going to ER later to be evaluated and rule out that Guillain barre syndrome and anything else. Adverse events start date was 09Aug2021 at 18:00. No treatment was received for the events. Outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Headache, Illness, Pain
Clinical narrative: fever; chills; headache; feels sick all the time; opposite arm from where she received the vaccine is swollen; it like it was a burn and like beaten; it like it was a burn and like beaten; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 19Aug2021 as dose number unknown, single for covid-19 immunization. The patient medical history included breast cancer (she had breast cancer before where they took 14 lymph nodes in the right side), took 14 lymph nodes in the right side (she had breast cancer before where they took 14 lymph nodes in the right side). Concomitant medications were not reported. It was reported that, Patient is a consumer calling about her severe reaction with the vaccine. She said that she received the Pfizer Biontech COVID19 vaccine on 19Aug2021. She experienced fever, chills, headache, and that she feels sick all the time. She also said that the opposite arm from where she received the vaccine is swollen and that was the side she had breast cancer before where they took 14 lymph nodes in the right side. She stated that the shot was given to her left arm. She described it like it was a burn and like beaten. She also mentioned about a rumor going around in the pharmacy where the opposite arm from where they receive the shot is swollen. She wants to know how long would these last. The reporter assessed the seriousness as non-serious. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: fever; chills; headache; feels sick all the time; opposite arm from where she received the vaccine is swollen; it like it was a burn and like beaten; it like it was a burn and like beaten; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 19Aug2021 as dose number unknown, single for covid-19 immunization. The patient medical history included breast cancer (she had breast cancer before where they took 14 lymph nodes in the right side), took 14 lymph nodes in the right side (she had breast cancer before where they took 14 lymph nodes in the right side). Concomitant medications were not reported. It was reported that, Patient is a consumer calling about her severe reaction with the vaccine. She said that she received the Pfizer Biontech COVID19 vaccine on 19Aug2021. She experienced fever, chills, headache, and that she feels sick all the time. She also said that the opposite arm from where she received the vaccine is swollen and that was the side she had breast cancer before where they took 14 lymph nodes in the right side. She stated that the shot was given to her left arm. She described it like it was a burn and like beaten. She also mentioned about a rumor going around in the pharmacy where the opposite arm from where they receive the shot is swollen. She wants to know how long would these last. The reporter assessed the seriousness as non-serious. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Alanine aminotransferase, Aspartate aminotransferase, Hepatitis acute, Investigation
Clinical narrative: acute hepatitis; transaminitis; Nausea; Vomiting; Belly pain; This is a spontaneous report from a contactable physician. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. 3 days after the Pfizer covid 19 vaccine, patient developed acute hepatitis with transaminitis. She was symptomatic, but was improving. She had profound transaminitis with nausea, vomiting, and belly pain. She had a surgical workup and emergency room workup and everything was negative and physician was calling to see if this had been described previously. What physician was seeing was elevated AST and ALT as seen following drug induced injury. Emergency room visited for the events. The outcome of events acute hepatitis and transaminitis was recovering. The outcome of rest events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; 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 Hepatitis acute, Transaminases increased, nausea, vomiting and abdominal pain 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: F
Vaccine: COVID19
Symptoms: Nausea, Transaminases increased, Vomiting
Clinical narrative: acute hepatitis; transaminitis; Nausea; Vomiting; Belly pain; This is a spontaneous report from a contactable physician. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. 3 days after the Pfizer covid 19 vaccine, patient developed acute hepatitis with transaminitis. She was symptomatic, but was improving. She had profound transaminitis with nausea, vomiting, and belly pain. She had a surgical workup and emergency room workup and everything was negative and physician was calling to see if this had been described previously. What physician was seeing was elevated AST and ALT as seen following drug induced injury. Emergency room visited for the events. The outcome of events acute hepatitis and transaminitis was recovering. The outcome of rest events was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.; 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 Hepatitis acute, Transaminases increased, nausea, vomiting and abdominal pain 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: didn't feel great; three days he got nauseous; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 41-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the Pfizer shot, he had a few underlying conditions, when he got his first shot, he didn't feel great. For three days he got nauseous, he did not know if it was a coincidence. Later he got his second shot. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: it occurred with four different patients, they received 0.3ML of the vaccine undiluted; it occurred with four different patients, they received 0.3ML of the vaccine undiluted; This is a spontaneous report received from a contactable other hcp or pharmacist reporting same event(s) under the same suspect product(s) for 4 patients. A 88-years-old patient of an unspecified gender received 1st dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Aug2021 (at the age of 88 years old) as Dose 1, 0.3 ML Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced it occurred with four different patients, they received 0.3ml of the vaccine undiluted on 27Aug2021. Reporter wanted to call to get information on whether the patient needs to be re-vaccinated or not.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101136408 same reporter/ vaccine/ AE, different patients;US-PFIZER INC-202101136407 Same reporter/ vaccine/ AE, different patients;US-PFIZER INC-202101136409 same reporter/ vaccine/ AE, different patients;US-PFIZER INC-202101169375 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, Condition aggravated, Urinary tract infection
Clinical narrative: Reactive arthritis got a lot worse after receiving the second dose; Reactive arthritis got a lot worse after receiving the second dose; UTI; This is a spontaneous report from a contactable healthcare professional. An 80 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, as the second single dose, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on an unknown date experiencing reactive arthritis. Other medical history and concomitant medication were not reported. The patient came in the emergency room with severe arthritis and joint pain and was diagnosed with reactive arthritis due to BNT162B2 vaccine. It started with first dose and got a lot worse 2 days after receiving the second dose. Patient was given prednisone and was treated for UTI. The case was reported as non-serious. Reactive arthritis worsened had not yet resolved. The outcome of UTI was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; 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 event reactive arthritis, condition aggravated and UTI 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.,Linked Report(s) : US-PFIZER INC-202101127267 Same reporter/patient/vaccine, different dose/events
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia, Pain in extremity
Clinical narrative: I had blood in my stool; I was experiencing pain in my arm.; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration, administered in the right arm on 20Aug2021 at 10:15 (at the age of 59-years-old) as dose number unknown, single for COVID-19 immunization at Hospital. Patient was not pregnant at time of vaccination. Medical history included focal segmental glomerulosclerosis from an unknown date and unknown if ongoing. And patient had known allergies to shellfish, contrast, amoxicillin clavulanic. No other vaccine in four weeks. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included lisinopril 20 mg (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); both taken for an unspecified indications, start and stop dates were not reported. It was reported that 4 hours apart of vaccination, patient took one Tylenol around 12:30 with food, and took another Tylenol around 17:00 with food. On 20Aug2021 at 23:00, after vaccination, the patient had blood in stool and pain in arm. Treatment was not received for events. Outcome of the events was unknown.  The lot number for [BNT162B2] was not requested and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Nausea
Clinical narrative: headaches; nausea; He received the third dose of the vaccine; This is a spontaneous report from a contactable other hcp (Nurse). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 3, single for covid-19 immunization (at the age of 74-years-old). Medical history included leukaemia (moderately immunocompromised with a history of leukemia) and moderately immunocompromised from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported that to the patient who was moderately immunocompromised with a history of leukemia, his haematologist recommended he receive the third dose of the Pfizer Covid-19 vaccine and he received the third dose last Wednesday on 25Aug2021 and on 26Aug2021 he started experiencing side effects of headaches and nausea and been having them ever since. Caller reports treating the patient with Tylenol. Caller asked were there any other treatment recommendations. Caller states "he was basically asking me if I had any medical advice, so I'll have him call his doctor and keep treating with Tylenol." The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Heart rate, Heavy menstrual bleeding
Clinical narrative: Heavy mensural bleeding for over 28 days; low BP; tachycardia; nausea; migraines; Fatigue; Chills; hot flashes; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 02Aug2021 at 16:00 (Lot Number: Ew0196) at the age of 39-year-old as single dose for COVID-19 immunization. Medical history included Na. The patient didn't receive other vaccine in four weeks. COVID prior vaccination was none. COVID tested was performed post vaccination. On 13Aug2021, the patient performed COVID test (Nasal Swab) post vaccination and result was negative. Known Allergy was none. Concomitant medication was not reported. On 02Aug2021 at 18:00, the patient experienced heavy mensural bleeding for over 28 days, low BP, tachycardia, nausea, migraines and excessive fatigue chills hot flashes. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for events included Zofran. The outcome of events was not recovered.  No Follow-up attempts are possible. No Further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Heavy menstrual bleeding" and suspected vaccine BNT162B2 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypotension, Migraine, Nausea, SARS-CoV-2 test
Clinical narrative: Heavy mensural bleeding for over 28 days; low BP; tachycardia; nausea; migraines; Fatigue; Chills; hot flashes; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 02Aug2021 at 16:00 (Lot Number: Ew0196) at the age of 39-year-old as single dose for COVID-19 immunization. Medical history included Na. The patient didn't receive other vaccine in four weeks. COVID prior vaccination was none. COVID tested was performed post vaccination. On 13Aug2021, the patient performed COVID test (Nasal Swab) post vaccination and result was negative. Known Allergy was none. Concomitant medication was not reported. On 02Aug2021 at 18:00, the patient experienced heavy mensural bleeding for over 28 days, low BP, tachycardia, nausea, migraines and excessive fatigue chills hot flashes. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for events included Zofran. The outcome of events was not recovered.  No Follow-up attempts are possible. No Further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Heavy menstrual bleeding" and suspected vaccine BNT162B2 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Heavy mensural bleeding for over 28 days; low BP; tachycardia; nausea; migraines; Fatigue; Chills; hot flashes; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 02Aug2021 at 16:00 (Lot Number: Ew0196) at the age of 39-year-old as single dose for COVID-19 immunization. Medical history included Na. The patient didn't receive other vaccine in four weeks. COVID prior vaccination was none. COVID tested was performed post vaccination. On 13Aug2021, the patient performed COVID test (Nasal Swab) post vaccination and result was negative. Known Allergy was none. Concomitant medication was not reported. On 02Aug2021 at 18:00, the patient experienced heavy mensural bleeding for over 28 days, low BP, tachycardia, nausea, migraines and excessive fatigue chills hot flashes. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for events included Zofran. The outcome of events was not recovered.  No Follow-up attempts are possible. No Further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Heavy menstrual bleeding" and suspected vaccine BNT162B2 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.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received both doses of the Pfizer covid vaccine early on and they all got covid 19; Received both doses of the Pfizer covid vaccine early on and they all got covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is the first of five reports.   An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer covid vaccine early on and the patient got covid 19 on an unspecified date. The outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101145699 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101145698 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101145696 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101145697 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101145699 Same Reporter/Drug/AE, Different Patient;US-PFIZER INC-202101145698 Same Reporter/Drug/AE, Different Patient
Sex: M
Vaccine: COVID19
Symptoms: Imaging procedure, Migraine, Transient ischaemic attack
Clinical narrative: stroke-like symptoms/He was told migraine versus TIA; migraine; This is a spontaneous report from a contactable nurse. An unspecified age male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunizaiton. Medical history included TIA. Concomitant medication was not reported. On an unspecified date, the patient experienced stroke-like symptoms/He was told migraine versus TIA. The reporter stated: "I am a cardiac healthcare provider. I had a patient get the Pfizer COVID-19 vaccine.  He indicates that several hours after getting he had stroke-like symptoms and presented to a local ER.  Imaging unremarkable for stroke.  He was told migraine versus TIA.  He does have a history of TIA previously.  He does want to get his 2nd shot, but is concerned.  Whether should he to get or switch to the Moderna.  I honestly do not know what to tell him.  He is high risk." The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event TIA(transient ischemic attack) and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Fatigue, Palpitations, Pyrexia
Clinical narrative: heart palpitations; chest tightness/chest was a little tight; fever/felt feverish with a temperature of100.4; feeling exhausted and has fatigue; This is a spontaneous report received from a contactable consumer(patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN), dose 1 via an unspecified route of administration, administered in arm left on 08Aug2021 13:30 (Lot Number: FA7485; Expiration Date: 31Oct2021) at the age of 59-year-old as single dose for covid-19 immunisation. Patient had COVID virus 18Feb2021 to 01Mar2021. The fever had gone away before he got the vaccine. Patient had benign heart murmur from 1974 (from 12 years old). His dad had open heart bypass when he was 62 years old and his dad died of a heart attack. The patient's concomitant medications were not reported.  No other drugs were received prior Vaccinations (within 4 weeks). Patient mentioned that he had the side effects that people in general have. He experienced fever, chest tightness, feeling exhausted and has fatigue on 10Aug2021. Patient also had heart palpitations which he described as "unbelievable" on 10Aug2021. These events did not result in emergency room or physician office. Clinical course: patient stated he didn't have any side effects for the first 24 hours. His injection site never hurt. The next day (10Aug2021) he felt feverish with a temperature of 100.4, so he took paracetamol (TYLENOL); he felt like he had COVID again on 10Aug2021; his chest was a little tight; he was exhausted and  fatigued; then he started to experience heart palpitations like skipping beats. During the day they were very pronounced but they seemed to go away at night. During the day he could feel the palpitations. The fever was only that day. He took paracetamol once and the fever didn't come back. Patient stated a little palpitation not a big deal to him; but the palpitations he got after the vaccine were unbelievable although not so bad when laying down. He was scheduled to get the second dose of the vaccine this past Sunday. He isn't going to get it until he see a cardiologist. He had not seen a doctor or had any tests yet. He has an appointment 22Sep2021 with a cardiologist. And he was planning to get an antibody serum test tomorrow or the next day.  His symptoms have subsided now and gone away. Outcome of fever was recovered on 10Aug2021, of other events was recovered on 15Aug2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Muscle contractions involuntary, Muscle twitching, SARS-CoV-2 test
Clinical narrative: Shortly after receiving the vaccine I received muscle twitches/fasciculations in my left arm & left leg. Those eventually traveled to my right arm and right leg. They have continued for 4 months in my; Shortly after receiving the vaccine I received muscle twitches/fasciculations in my left arm & left leg. Those eventually traveled to my right arm and right leg. They have continued for 4 months in my; Shortly after receiving the vaccine I received muscle twitches/fasciculations in my left arm & left leg. Those eventually traveled to my right arm and right leg. They have continued for 4 months in my; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:00 at the age of 32-year-old as single dose for covid-19 immunization. The patient had no medical history. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced shortly after receiving the vaccine, he received muscle twitches/fasciculations in his left arm and left leg, those eventually traveled to his right arm and right leg, they have continued for 4 months in his right leg. I've also experienced joint pain in his hands and feet (arch of my foot) on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on unknown date, Covid RAPID & PCR (Nasal Swab): negative in Jul2021. Therapeutic measures were taken as a result of events. The outcome of events was not resolved. No covid prior vaccination. Not known allergies.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac flutter, Dizziness, Illness, Nausea
Clinical narrative: small heart pains; felt like his heart was fluttering; felt like his heart was fluttering; like it was beating really fast; and had small heart pains; dizziness/light headed/felt like he was going to fall or faint; vertigo; Vomiting; Felt like he was kind of sick; nausea; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 26Aug2021 13:17 (Lot Number: FC3184) at the age of 20 years old, at single dose for covid-19 immunisation. Medical history included ongoing asthma (Diagnosed when he was born). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced dizziness/light headed/felt like he was going to fall or faint on 27Aug2021, vertigo on 27Aug2021, vomiting on 27Aug2021, felt like his heart was fluttering; like it was beating really fast; and had small heart pains on 29Aug2021 02:00, felt like he was kind of sick in Aug2021, nausea in Aug2021. Clinical course: The dizziness was really bad the first day on 27Aug2021; he couldn't get up. The next day was better; he could get up. Stated that the dizziness disappeared around the 29th or 30th, but he still felt like he was kind of sick. Then the dizziness came back today (31Aug2021) a little bit. He also had vertigo; felt like he was going to fall, or faint; vomiting; and was light headed, all these side effects began when he woke up around noon 27Aug2021, and they disappeared on the 28Aug2021; except the dizziness which he previously stated came back today (31Aug2021). He also felt like his heart was fluttering; like it was beating really fast. Stated that happened on Sunday (29Aug2021) around 2am. He also had small heart pains every now and then when his heart was fluttering, but he doesn't know if this was a side effect of the vaccine, or if it could be his history. Clarified that this has happened to him even before he got the vaccine. Treatment: He took something for the nausea, but didn't remember what he took. The outcome of the events dizziness/light headed/felt like he was going to fall or faint was recovered in Aug2021, of the events vertigo, vomiting was recovered on 28Aug2021, of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Vertigo, Vomiting
Clinical narrative: small heart pains; felt like his heart was fluttering; felt like his heart was fluttering; like it was beating really fast; and had small heart pains; dizziness/light headed/felt like he was going to fall or faint; vertigo; Vomiting; Felt like he was kind of sick; nausea; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 26Aug2021 13:17 (Lot Number: FC3184) at the age of 20 years old, at single dose for covid-19 immunisation. Medical history included ongoing asthma (Diagnosed when he was born). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced dizziness/light headed/felt like he was going to fall or faint on 27Aug2021, vertigo on 27Aug2021, vomiting on 27Aug2021, felt like his heart was fluttering; like it was beating really fast; and had small heart pains on 29Aug2021 02:00, felt like he was kind of sick in Aug2021, nausea in Aug2021. Clinical course: The dizziness was really bad the first day on 27Aug2021; he couldn't get up. The next day was better; he could get up. Stated that the dizziness disappeared around the 29th or 30th, but he still felt like he was kind of sick. Then the dizziness came back today (31Aug2021) a little bit. He also had vertigo; felt like he was going to fall, or faint; vomiting; and was light headed, all these side effects began when he woke up around noon 27Aug2021, and they disappeared on the 28Aug2021; except the dizziness which he previously stated came back today (31Aug2021). He also felt like his heart was fluttering; like it was beating really fast. Stated that happened on Sunday (29Aug2021) around 2am. He also had small heart pains every now and then when his heart was fluttering, but he doesn't know if this was a side effect of the vaccine, or if it could be his history. Clarified that this has happened to him even before he got the vaccine. Treatment: He took something for the nausea, but didn't remember what he took. The outcome of the events dizziness/light headed/felt like he was going to fall or faint was recovered in Aug2021, of the events vertigo, vomiting was recovered on 28Aug2021, of the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: diagnosed with Acute Lymphoblastic Leukemia (ALL) in bone marrow; her platelets were almost at 0; UTI; This is a spontaneous report from a contactable consumer. A 66-year-old female patient (reporter's Mother in law) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included parathyroid polyps, 5th cycle of chemotherapy, elevated calcium levels. The patient's concomitant medications were not reported. Her mother in law's first dose was in the middle Mar2021, maybe 15Mar2021, she was not sure. Caller reported her mother-in-law received the Pfizer covid vaccine (first dose in Mar2021, second dose 26Apr2021) and then a month after second shot, became diagnosed with Acute Lymphoblastic Leukemia (ALL) in bone marrow. Caller know the vaccine doesn't change genetic makeup, but reporter read about T-cells and that's what gets stimulated with the vaccine but there are T-cells in cancer. The reporter thought patient was having an autoimmune response, her platelets were almost at 0 at the hospital, she had a UTI at the same time and that was why we took her to the hospital. The reporter was thankful it happened that way because it got her to go to the hospital. She received platelets while she was there but she wasn't taking to them and they started to suspect something else so a few days after bone marrow biopsy, we found out she ALL. She also had parathyroid polyps in the past about a year ago. 2 weeks prior to the vaccine, she had perfect lab work you know at a normal follow up so we do have a baseline there. Caller stated the patient was in remission, they caught very early, but caller know it will be time for boosters to be discussed at some point. It's strange with the time line but patient had the second dose of the vaccine on 26Apr2021, a couple weeks prior to this she had perfect labs, the reason they were even monitoring her labs was because it was for her parathyroid in which there was a concern in which it had elevated calcium levels due to a polyps they found. A month after second shot, she all the sudden was diagnosed with ALL, leukemia in the bone marrow. Caller asked if there was something in the vaccine that could bring it to her attention or any reports of effecting the immune system or symptoms with white blood cells. If there was anything with the vaccine that lingers in the body, there was anything reported like that. Her mother in law at the moment was doing well, she was on a 5th cycle of chemotherapy, they want her to do 8 in total, but she had perfect bone marrow and lumbar test due to all the intensive treatment for ALL. The patient underwent lab tests and procedures which included biopsy bone marrow: abnormal, blood calcium: elevated calcium levels, laboratory test: perfect labs, platelet count decreased: abnormal (almost at 0). The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got COVID; I got COVID; This is a spontaneous report from a contactable nurse (patient). A 24 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Jan2021 08:00 (Batch/Lot number was not reported) at age of 23 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient had no medical history. There were no concomitant medications. The patient got covid in Aug2021.  The outcome of the event was resolving. No treatment received. There was no COVID prior vaccination or COVID tested post vaccination. No other vaccine received in four weeks. No other medications received in two weeks.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash, Skin exfoliation, Skin warm
Clinical narrative: face also became swollen; skin is breaking out; skin is peeling around her jaw line; skin became itchy; skin around her mouth is hot to the touch; It is dry and patchy; This is a spontaneous report received from a contactable consumer or other non hcp. A 29-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: FC3180), via an unspecified route of administration, administered in Arm Right on 18Aug2021 10:30,at the age of 29 years old, as Dose 1,single for covid-19 immunization. Medical history included none.Concomitant medications included drospirenone, ethinylestradiol taken for an unspecified indication, start and stop date were not reported.The patient experienced face also became swollen, skin is breaking out, skin is peeling around her jaw line, skin became itchy, skin around her mouth is hot to the touch, it is dry and patchy on 30Aug2021.Therapeutic measures were taken as a result of skin is peeling around her jaw line.The outcome of the event was not recovered.When the patient had received her 1st dose, she also took a birth control pills and patient thinks the symptoms were related to the birth control pills.Upon follow up on 31st aug2021,patient stated to medical information team that She got her first dose on 18Aug2021 and She is scheduled for her second one 08Sep2021.She had taken her birth control tablets that week.The itching and breaking out started yesterday on 30Aug2021.The skin around her mouth is hot to the touch. It is dry and patchy even with moisturizer. It is flaking up and itching. She doesn't know if it is an interaction between the vaccine and birth control.  Follow-up(31Aug2021):This is a follow up spontaneous report from a Pfizer sponsored program.The patient had not received any vaccines within 4 weeks prior to covid vaccination.Patient was concerned whether to receive 2nd dose of covid vaccination or not.