chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Took first dose vaccine, by 10 days after that experienced Covid (SARS-CoV-2 infection); This is a spontaneous report received from a contactable consumer (patient) who reported for himself. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown, via unspecified route, on 17Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On 26Apr2021 (10 days after the first dose vaccine, the patient tested positive with Covid-19. The patient's wife, she took the 1st dose on 17Apr2021. As per the caller, they both were tested positive with Covid-19, 10 days after taking the 1st dose. The 2nd dose was on (09May2021) which was more than 21 days. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Intracranial hypotension, Magnetic resonance imaging, Tinnitus
Clinical narrative: Lost a little hearing in my left ear; Intracranial hypotension; got humming in my right ear/Started with a swish in my left ear and then it started humming right after that; swish noise in my ear and the humming started; This is a spontaneous report from a contactable consumer (patient)   A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266) on 15Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Atrial fibrillation, Hypertension, Blood cholesterol abnormal. The patient received first dose of BNT162B2 (Lot number-EL9269) on 22Feb2021 and experienced feeling abnormal. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) for blood pressure abnormal, losartan potassium, apixaban (ELIQUIS), calcium and rosuvastatin. From an unspecified date the patient started to get weird sensation on the top of her head and lost a little hearing in my left ear. On about 04Mar2021 she also started to get humming in her left ear; She got humming in her right ear; swish noise in her ear and the humming started. Patient reported that the left ear was the high pitch, the right ear that started later after the second vaccine with the low pitch, so now there are times when it is the whole head. When she got that swish noise in my ear and the humming started.  It was informed that patient was seen by a neurologist. On 02Ap2021 patient underwent MRIs of my brain with and without contrast and 09Apr2021 underwent MRI of spine that showed intracranial hypotension. Patient informed that 'the neurologist wanted to put blood patch in cervical part of the spine but he was not sure; neurosurgeon believed that patient don't need that and commented that  the humming was from the Pfizer, numerous patients that received vaccination have humming in the ears' (as such). At the time of the reporting events outcome was unknown.                                                                                              Follow-up attempts are needed. Further information is expected
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Zoster ocular disease; This is a spontaneous report received from a contactable (reporting on himself). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0151 and Expiration Date was not reported) via an unspecified route of administration in Arm Left on 04Apr2021, as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination.  The patient was not tested for COVID-19 since the vaccination. Patient received Protein shakes - green powder within 2 weeks of vaccination. On 16Apr2021, patient experienced zoster ocular disease. The outcome of the event was re-covering.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The patient reported that his arm was tender in May2021. The patient was wondering if this was normal and asked was it normal for the pain in his arm to last this long. The patient also asked whether it was a problem if he was on blood thinners. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021530614 same reporter/drug, different patient/event
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Neck pain, Pain in extremity, Thrombosis
Clinical narrative: blood clot; Also have had neck pain since the first vaccine that will not go away; extreme pain in my left leg; unable to walk; This is a spontaneous report from a contactable consumer (patient) who reported events after first and second dose of the vaccine. This case is for events after the second dose.  A 33-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in Arm Left on 31Mar2021 at 13:00 (at 33 years) for covid-19 immunization.  Medical history included asthma. Concomitant medication included methylphenidate taken for an unspecified indication, start and stop date were not reported.  The patient previously took the first dose of the vaccine on 03Mar2021 at 13:00 in Left arm for covid-19 immunization and had neck pain. On 19Apr2021 at 12:00 (also reported as 3 weeks after the final vaccination) the patient experienced suddenly extreme pain in her left leg and was unable to walk on it. Doctors found a superficial blood clot. Also had neck pain since the first vaccine that will not go away. Events required Doctor or other healthcare professional office/clinic visit and treatment (unspecified) was given. The final outcome of all the events was reported as recovering. Information on the batch number has been requested; Sender's Comments: Linked Report(s) : -PFIZER INC-2021523861 same patient/drug, different dose/event
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica, Ultrasound Doppler
Clinical narrative: Sciatica with pain going down the back of her leg; This is a spontaneous report from a contactable Nurse (patient).   A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8731), an unspecified route of administration, in right arm on 09Apr2021 (at 67 years) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis (diagnosed about a year ago; an overlap with rheumatoid arthritis a year ago; she has been in remission from her rheumatoid arthritis and off medication since Aug2020), ongoing hypothyroidism (diagnosed 2 years before in 2019), ongoing osteoarthritis (for years) and ongoing Sjogren's disease (for years). Previously patient took methylprednisolone (MEDROL) that worked before. The patient's concomitant medications were not reported.  The patient developed sciatica with pain going down the back of her leg in Apr2021, serious as medically significant and described as follows: patient had the first dose of the vaccine on 09Apr2021 and her symptoms started two weeks later in Apr2021; she went to her internist on 22Apr2021 because she was in such pain. Internist doctor said she had developed sciatica. Patient reported the pain was going down the back of her leg and knee was hurting, it was very painful, her foot was tingling, like when the foot was waking up from being asleep, has had this feeling before when she first got rheumatoid arthritis, stated behind her knee hurt so bad. Patient had a doppler done on an unknown date in 2021, that was negative for blood clots. Patient was put on a methylprednisolone (MEDROL) dose pack but it did not help at all, did nothing and made no difference whatsoever. Final outcome of the event was not recovered.Patient asked if there was any report of the first dose of the covid 19 vaccine that caused a flare or bring a person out of remission for persons with autoimmune disorders. Patient stated she was not sure if this sciatica was due to the vaccine revving up her autoimmune issues or if it was unrelated. Patient delayed the second dose by one week per the doctor's recommendation and second dose was administered on  07May2021 (at 68 years, lot ER8736) in right arm.; Sender's Comments: Based on available information, the contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8731), to the reported event sciatica cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Groin pain, Headache
Clinical narrative: hurts to go up the steps and can be difficult getting out of bed; pain in the right hip extends from the groin; developed a headache; feverish; Achy; slept 18 hours a day for two to two and half days; She's still a little more fatigued than usual and taking more naps.; left-sided hip inflammation and pain; left-sided hip inflammation and pain; right hip was so painful it felt like it could be a bone cancer; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVD-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 27Apr2021 (at the age of 57-years-old) as first dose, single for COVID-19 immunization. Medical history included degenerative back issue on her right side and COVID-19 on an unspecified date (reported as "this winter") for five and half weeks, she was not sure if it was so severe because of her blood type B positive. The patient's concomitant medications were not reported. Two hours after the vaccine, on 27Apr2021, the patient developed a headache, was feverish, achy, and slept 18 hours a day for two to two and half days. She still had a little more fatigue than usual and was taking more naps since 27Apr2021. She also developed hips pain on both sides and never had prior hip problems. She did have a degenerative back issue but it was on the right side and her physical therapist said that the hip pain was not due to her back issue. The left-sided hip inflammation and pain resided, but the right hip was so painful it felt like it could be a bone cancer and she felt like she could cry. It hurt to go up the steps and can be difficult getting out of bed. The pain in the right hip extends from the groin around and to the far side of the hip. The patient wanted to know if she can delay receiving the second dose of vaccine. The outcome of the event "slept 18 hours a day" was recovered in Apr2021 (for two to two and half days), left hip inflammation and pain was recovered on an unspecified date in 2021, right hip pain and fatigue was not recovered, and outcome of the other events was unknown at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Mobility decreased, Pain, Pyrexia
Clinical narrative: hurts to go up the steps and can be difficult getting out of bed; pain in the right hip extends from the groin; developed a headache; feverish; Achy; slept 18 hours a day for two to two and half days; She's still a little more fatigued than usual and taking more naps.; left-sided hip inflammation and pain; left-sided hip inflammation and pain; right hip was so painful it felt like it could be a bone cancer; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVD-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 27Apr2021 (at the age of 57-years-old) as first dose, single for COVID-19 immunization. Medical history included degenerative back issue on her right side and COVID-19 on an unspecified date (reported as "this winter") for five and half weeks, she was not sure if it was so severe because of her blood type B positive. The patient's concomitant medications were not reported. Two hours after the vaccine, on 27Apr2021, the patient developed a headache, was feverish, achy, and slept 18 hours a day for two to two and half days. She still had a little more fatigue than usual and was taking more naps since 27Apr2021. She also developed hips pain on both sides and never had prior hip problems. She did have a degenerative back issue but it was on the right side and her physical therapist said that the hip pain was not due to her back issue. The left-sided hip inflammation and pain resided, but the right hip was so painful it felt like it could be a bone cancer and she felt like she could cry. It hurt to go up the steps and can be difficult getting out of bed. The pain in the right hip extends from the groin around and to the far side of the hip. The patient wanted to know if she can delay receiving the second dose of vaccine. The outcome of the event "slept 18 hours a day" was recovered in Apr2021 (for two to two and half days), left hip inflammation and pain was recovered on an unspecified date in 2021, right hip pain and fatigue was not recovered, and outcome of the other events was unknown at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling hot, Headache
Clinical narrative: hurts to go up the steps and can be difficult getting out of bed; pain in the right hip extends from the groin; developed a headache; feverish; Achy; slept 18 hours a day for two to two and half days; She's still a little more fatigued than usual and taking more naps.; left-sided hip inflammation and pain; left-sided hip inflammation and pain; right hip was so painful it felt like it could be a bone cancer; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVD-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 27Apr2021 (at the age of 57-years-old) as first dose, single for COVID-19 immunization. Medical history included degenerative back issue on her right side and COVID-19 on an unspecified date (reported as "this winter") for five and half weeks, she was not sure if it was so severe because of her blood type B positive. The patient's concomitant medications were not reported. Two hours after the vaccine, on 27Apr2021, the patient developed a headache, was feverish, achy, and slept 18 hours a day for two to two and half days. She still had a little more fatigue than usual and was taking more naps since 27Apr2021. She also developed hips pain on both sides and never had prior hip problems. She did have a degenerative back issue but it was on the right side and her physical therapist said that the hip pain was not due to her back issue. The left-sided hip inflammation and pain resided, but the right hip was so painful it felt like it could be a bone cancer and she felt like she could cry. It hurt to go up the steps and can be difficult getting out of bed. The pain in the right hip extends from the groin around and to the far side of the hip. The patient wanted to know if she can delay receiving the second dose of vaccine. The outcome of the event "slept 18 hours a day" was recovered in Apr2021 (for two to two and half days), left hip inflammation and pain was recovered on an unspecified date in 2021, right hip pain and fatigue was not recovered, and outcome of the other events was unknown at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Illness, Myalgia, Pain, Pyrexia
Clinical narrative: hurts to go up the steps and can be difficult getting out of bed; pain in the right hip extends from the groin; developed a headache; feverish; Achy; slept 18 hours a day for two to two and half days; She's still a little more fatigued than usual and taking more naps.; left-sided hip inflammation and pain; left-sided hip inflammation and pain; right hip was so painful it felt like it could be a bone cancer; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVD-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 27Apr2021 (at the age of 57-years-old) as first dose, single for COVID-19 immunization. Medical history included degenerative back issue on her right side and COVID-19 on an unspecified date (reported as "this winter") for five and half weeks, she was not sure if it was so severe because of her blood type B positive. The patient's concomitant medications were not reported. Two hours after the vaccine, on 27Apr2021, the patient developed a headache, was feverish, achy, and slept 18 hours a day for two to two and half days. She still had a little more fatigue than usual and was taking more naps since 27Apr2021. She also developed hips pain on both sides and never had prior hip problems. She did have a degenerative back issue but it was on the right side and her physical therapist said that the hip pain was not due to her back issue. The left-sided hip inflammation and pain resided, but the right hip was so painful it felt like it could be a bone cancer and she felt like she could cry. It hurt to go up the steps and can be difficult getting out of bed. The pain in the right hip extends from the groin around and to the far side of the hip. The patient wanted to know if she can delay receiving the second dose of vaccine. The outcome of the event "slept 18 hours a day" was recovered in Apr2021 (for two to two and half days), left hip inflammation and pain was recovered on an unspecified date in 2021, right hip pain and fatigue was not recovered, and outcome of the other events was unknown at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, International normalised ratio
Clinical narrative: Cellulitis from his right leg to the bottom; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 04May2021 the case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional (patient). This other health professional reported 2 cases for different patients. This is one of the 2 reports. A 64-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 14Apr2021, as single dose, for COVID-19 immunisation. Medical history included dizziness (subsided) from Oct2020. Concomitant medications were not reported. The patient previously took warfarin for blood clotting disorder; rabies vaccine in Jul2020 for immunisation and experienced arms and legs were weak (subsided), hypersensitivity with eczema psoriasis, allergic reaction, stroke and brain bleeding and the patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on an unspecified date for COVID-19 immunisation.  The patient underwent lab tests and procedures which included international normalized ratio: 3.5 on an unspecified date still threw a clot. The patient was in the emergency room in May2021 in the night because of cellulitis from his right leg to the bottom. Therapeutic measures were taken as a result of the event and included treatment with antibiotics.  The information on the lot/batch number has been requested.; Sender's Comments: Due to implausible temporal association, the event of Cellulitis is assessed as unrelated to the Vaccine BNT162B2.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551733 same drug/AE, different patient;US-PFIZER INC-2021553013 same drug/AE, different patient;US-PFIZER INC-2021553014 same drug/AE, different patient;US-PFIZER INC-2021553015 same drug/AE, different patient;US-PFIZER INC-2021553016 same drug/AE, different patient;US-PFIZER INC-2021553017 same drug/AE, different patient;US-PFIZER INC-2021553018 same drug/AE, different patient;US-PFIZER INC-2021553019 same drug/AE, different patient;US-PFIZER INC-2021553020 same drug/AE, different patient
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease
Clinical narrative: Crohn's aggravated; This is a solicited report from a non-Pfizer sponsored marketing program, based on the information received by Pfizer. A contactable consumer (patient) and physician reported that a 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose (Citrate Free) for moderate to severe adult Crohn's disease. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a covid-19 vaccine trial. In 2021, the patient received 1st dose covid-19 vaccine manufactured by Pfizer intramuscularly for covid-19 immunization at age of 66 years old. The patient experienced crohn's aggravated in Mar2021. The action taken in response to the event for adalimumab was unknown. The outcome of the event was unknown.   The reporter's assessment of the causal relationship of the event 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.  Information on the lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Crohn' disease aggravated and the suspect drug.  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: Bell's palsy
Clinical narrative: Bell's palsy in left side of face; This is a spontaneous report from a contactable consumer (patient).   A 26-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 16Mar2021 09:00 (Lot Number: ZP7534) single dose for covid-19 immunisation. First dose was administered on 18Feb2021 3:00PM left arm, lot# ZL9267.   The patient medical history was not reported. No concomitant therapy received within 2 weeks of vaccination. 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 has not been tested for COVID-19. The patient experienced Bell's palsy in left side of face on 26Mar2021. Treatment received for the adverse event included anti inflammatory drugs. The outcome was recovered.    No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: fever, arthralgias and fatigue/Covid-like symptoms; fever, arthralgias and fatigue/Covid-like symptoms; This is a spontaneous report from a contactable consumer (Patient). This report was received via a sales representative.     A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included covid-19 in Nov2020. Historical vaccine included First dose of bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose single for covid-19 immunisation. Patient had Covid-19 infection in November of 2020 which hit her hard and she was ill but at home for over two weeks. The patient's concomitant medications were not reported. On an unspecified date, the patient experience Covid-like symptoms after the second shot of the Pfizer Covid-19 vaccine. Patient mentioned the symptoms as fever, arthralgias and fatigue. At the time of this report event outcome was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: show symptoms of COVID-19/positive for COVID-19; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old male patient received BNT162B2(BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 20Apr2021 13:30 (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient family medical history relevant to event was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, patient developed symptoms of Covid and on 23Apr2021, he tested positive for the Covid infection. The caller states that she was wondering if he should get the second vaccine. The events not resulted in emergency room/physician office. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 07May2021, sars-cov-2 test positive: positive on 23Apr2021. Therapeutic measures included: None, he stayed home, and after 14 days, he got a negative result test for Covid on 07May2021. Reporter seriousness for Tested positive for Covid 19 on 23Apr2021, after receiving the first dose of the Covid vaccine on 20Apr2021, with symptoms starting on 22Apr2021: Unspecified. The outcome of the event was recovered on 07May2021.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: his big toe on right foot swelled; This is a spontaneous report from a contactable consumer or other non health care professional (Patient) from a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Lot number was not reported ), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included limb injury wound in his leg from shrapnel, pieces of rock. The patient's concomitant medications were not reported.  The patient never had gout. On an unspecified date 3 to 4 days after vaccination, the patient experienced his big toe on right foot swelled. his feet was swollen and very painful, like needles.he never had gout.The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s)
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: After 2nd shot, right foot swelled up and toe of right foot is swollen and very painful, like needles.; After 2nd shot, right foot swelled up and toe of right foot is swollen and very painful, like needles.; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient himself) of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration on an unspecified date as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller was a, with a wound in his leg, pieces of rock etc. He received the 1st Pfizer vaccine BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 3-4 days later his big toe on right foot swelled. On an unspecified date after 2nd shot, patient experienced right foot swelled up and toe of right foot is swollen and very painful, like needles. Never had gout. Was verifying his personal information when the call disconnected. The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She had more energy; This is a spontaneous report received from a contactable consumer. This report is a response to mail trail sent regarding the confirmation of query: Pfizer COVID vaccine can do more than being seen. A 91-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The reporter reported that the patient (mom of reporter) had problems getting going in the morning but when she had her second Pfizer COVID shot she felt great. She had more energy, she felt younger and was more active for about 6 weeks. Then she lost that energy, and she was back to feeling 91 again. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for covid a few days later; positive for covid a few days later; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that:  A female patient of unspecified age received first dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: Unknown; Expiration Date: Unknown) via an unspecified route of administration on 17Apr2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The Patient Experienced Covid-19 after few days of vaccination. She wants to know if she should get her 2nd dose that is scheduled today or if she should wait cold transferred. No medical questions addressed by this program forwarded/referred to Medical Information. Customer and/or medical inquiry was NOT forwarded or referred. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other health professional. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (vaccination age was 41-year-old), first dose intramuscularly, administered in arm left on 28Jan2021 (Batch/Lot number was not reported) as single dose and second dose intramuscularly, administered in arm left on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes, HTN (hypertension) and high cholesterol. Concomitant medications received within 2 weeks of vaccination included atorvastatin; insulin; lisinopril and linagliptin (TRADJENTA), all with unknown dose, date and indication. On 06May2021, the patient was diagnosed with covid. The event resulted in doctor or other healthcare professional office/clinic visit. Lab test included rapid PCR (Nasal swab) with result was positive on 06May2021. The patient received OTC medications for the event. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of the event was recovering.   Information about lot/batch number has been requested.; 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 and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: He had bad side effects of the vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got the first dose of the Pfizer vaccine a month ago (Apr2021), and he mentioned that he had bad side effects of the vaccine. The patient was not able to specify what the side effects were. The outcome of the event was unknown.  Medical Information: No customer and/or medical inquiry was not forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: myocarditis; Chest pain; This is a spontaneous report from two contactable consumers (one is patient himself and the other one is patient's wife). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 15:30 (Batch/Lot Number: EW 0171; Expiration Date: Aug2021) as 2nd dose, single for covid-19 immunisation, at a public Health Department. The vaccine was not administered at Military Facility. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient's medical history included known allergies: Sulfa. No family Medical History Relevant to events. There were no concomitant medications. There was no other products. The patient did not receive any other medications within 2 weeks of vaccination. For historical vaccine, there was no prior vaccinations within 4 weeks aside from first dose: bnt162b2, dose 1 intramuscular administered in Arm Left on 16Apr2021 15:30 (Batch/Lot Number: ER 8737; Expiration Date: Aug2021) (at the age of 35-year-old) as 1st dose, single for covid-19 immunisation. The facility of vaccination was Other no AE. On 08May2021 02:00, the patient experienced chest pain. The event chest pain resulted in Emergency room/department or urgent care, hospitalization, and was life threatening illness (immediate risk of death from the event). On 13May2021, the patient's wife reported that her husband was in the hospital with myocarditis onset from 11May2021(also reported as three days after receiving his second dose of the vaccine). The patient was admitted to the hospital at 02:00 on Tuesday 11May2021, he was still in the hospital by the time of reporting. Also reported that the event myocarditis required Emergency Room visit. A lot of testing were done such as cardiac ultrasounds, several electrocardiogram (EKG)s and electrocardiogram (ECG)s, nuclear cardiac wall motion test or some kind of nuclear test she is unsure of the name, chest x-rays three times, several blood works, his troponin levels (heart enzyme) was critical. The patient did not have COVID prior to vaccination. The patient had been tested post vaccination, COVID test type post vaccination was Nasal Swab on 11May2021, result was Negative. The patient had full work up less than a year ago and everything came back completely normal (In 2020). Therapeutic measures were taken as a result of events chest pain and myocarditis. The patient was treated with medication and he had to get a wearable defibrillator called Life Vest. They have him on a blood thinner, carvedilol, and entresto. The outcome of the events was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Investigation, Myocarditis, SARS-CoV-2 test, Troponin
Clinical narrative: myocarditis; Chest pain; This is a spontaneous report from two contactable consumers (one is patient himself and the other one is patient's wife). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 15:30 (Batch/Lot Number: EW 0171; Expiration Date: Aug2021) as 2nd dose, single for covid-19 immunisation, at a public Health Department. The vaccine was not administered at Military Facility. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient's medical history included known allergies: Sulfa. No family Medical History Relevant to events. There were no concomitant medications. There was no other products. The patient did not receive any other medications within 2 weeks of vaccination. For historical vaccine, there was no prior vaccinations within 4 weeks aside from first dose: bnt162b2, dose 1 intramuscular administered in Arm Left on 16Apr2021 15:30 (Batch/Lot Number: ER 8737; Expiration Date: Aug2021) (at the age of 35-year-old) as 1st dose, single for covid-19 immunisation. The facility of vaccination was Other no AE. On 08May2021 02:00, the patient experienced chest pain. The event chest pain resulted in Emergency room/department or urgent care, hospitalization, and was life threatening illness (immediate risk of death from the event). On 13May2021, the patient's wife reported that her husband was in the hospital with myocarditis onset from 11May2021(also reported as three days after receiving his second dose of the vaccine). The patient was admitted to the hospital at 02:00 on Tuesday 11May2021, he was still in the hospital by the time of reporting. Also reported that the event myocarditis required Emergency Room visit. A lot of testing were done such as cardiac ultrasounds, several electrocardiogram (EKG)s and electrocardiogram (ECG)s, nuclear cardiac wall motion test or some kind of nuclear test she is unsure of the name, chest x-rays three times, several blood works, his troponin levels (heart enzyme) was critical. The patient did not have COVID prior to vaccination. The patient had been tested post vaccination, COVID test type post vaccination was Nasal Swab on 11May2021, result was Negative. The patient had full work up less than a year ago and everything came back completely normal (In 2020). Therapeutic measures were taken as a result of events chest pain and myocarditis. The patient was treated with medication and he had to get a wearable defibrillator called Life Vest. They have him on a blood thinner, carvedilol, and entresto. The outcome of the events was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nightmare
Clinical narrative: Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; This is a spontaneous report received from a contactable consumer. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 08May2021 as single dose in left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included severe ovarian cysts, PTSD, food allergy and past drug event was bactrim. Concomitant medications included benadryl, ibuprofen, naproxen, acetaminophen. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After vaccination the patient experienced extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night on 08May2021. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had two vaccines then this Thursday, went to the hospital and tested COVID positive; had two vaccines then this Thursday, went to the hospital and tested COVID positive; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history included COVID-19 last October 2020. The concomitant medications were not reported. On an unspecified date her mother had COVID last October and recovered and had two vaccines but then this Thursday, her mother went to the hospital and tested COVID positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Herpes zoster, Malaise, Pruritus
Clinical narrative: have an auto-immune disorder; Caller had shingles after the first dose; mild case of shingles on my chest. It itches a lot; not feeling well; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 09Apr2021 as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included fibromyalgia, thyroid issues, Hashimoto's disease and a couple other things and she has not taken any medication for it. The patient's concomitant medications were not reported. Patient reported that after first vaccine, around the end of the month and was supposed to get the second one and was not feeling well and was told to wait. On an unspecified date in Apr2021, the patient experienced an auto-immune disorder, caller had shingles after the first dose, mild case of shingles on my chest, it itches a lot, but it didn't pop up until almost 3 weeks after the vaccine. She do have an auto-immune disorder, Is concerned about getting the second vaccine due on 14May2021 and getting the shingles again and if she gets it again she wonders if they can become worse since she is to get the second vaccine at the end of the week. Outcome of all the events was unknown.  Follow-up(12May2021): This is a follow-up spontaneous report from a contactable consumer (patient). This female consumer (patient) reported for herself included the clinical information.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary emboli and DVT bilateral; Pulmonary emboli and DVT bilateral; This is a spontaneous report from a contactable nurse. A 75-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EN6204) as single dose for covid-19 immunisation. Medical history included prediabetes, hypertension (HTN), gastrooesophageal reflux disease (GERD), atherosclerotic heart disease, opthalmoplegic migraine, vitamin D deficiency. 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 been tested for COVID-19. Concomitant medications included butalbital, paracetamol (BUPAP); atorvastatin; doxepin; esomeprazole sodium (NEXIUM); minocycline; carvedilol; montelukast sodium (SINGULAIR); topiramate (TOPAMAX). The patient previously received first dose of bnt162b2 (lot number: EL9267) via intramuscular on 19Feb2021 for covid-19 immunisation. The patient experienced pulmonary emboli and deep vein thrombosis (DVT) bilateral on 19Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was hospitalized for 1 day. And anticoagulation treatment received for the events. The events were reported as serious, serious criteria included life threatening, caused/prolonged hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 23Apr2021. The outcome of events was recovering.; Sender's Comments: Based on current information available, the events pulmonary emboli and DVT mostly represented intercurrent condition in this patient with advanced age and relevant medical history, unrelated to Bnt162b2.   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 RAs, Ethics Committees, and Investigators, as appropriate.