chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac ventricular thrombosis, Cerebrovascular accident
Clinical narrative: Stroke; Left ventricular thrombus in his heart; This is a spontaneous report from a contactable physician. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: EW0153) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included coronary artery disease (several years ago) and had a bypass (several years ago; not ongoing). The patient's concomitant medications were not reported. It was reported that the patient had a stroke on 17Apr2021 after he formed a left ventricular thrombus in his heart in Apr2021. The patient was hospitalized for the events from 17Apr2021 to 23Apr2021 and was treated with Coumadin. The outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely for BNT162B2 vaccine  since there is no plausible mechanism implicating the subject drug to the events. The reported events may be regarded as natural progression of patient's pre-existing conditions. The impact of this report on the benefit/risk profile of the Pfizer drug 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, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose on 20Apr2021 and had positive COVID-19 test on 27Apr2021; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A male patient of unspecified age received BNT162VB2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received his first dose on 20Apr2021 and had positive COVID-19 test on 27Apr2021.  The patient will be off quarantine on 07May2021. The patient was scheduled to receive his second dose on 11May2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Swelling face
Clinical narrative: Swelling of feet, legs, hands, arms and face; Swelling of feet, legs, hands, arms and face; itching in face and neck; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 17:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old.  Medical history included severe back issues and "I have had 6 back surgeries", allergy to all Nsaids. The patient previously received bnt162b2, dose 1 administered in Arm Left on 16Mar2021 08:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old. Concomitant medications included hydrocodone, cefixime (FLEXERIL [CEFIXIME]), buprenorphine hydrochloride (BELBUCA), atorvastatin, clarithromycin, omeprazole, tinidazole (OTC-HP) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling of feet, legs, hands, arms and face, itching in face and neck on 07Apr2021 02:00 with outcome of recovered in 2021. Therapeutic measures taken to all events included Benadryl and prescribed EpiPen. The events were assessed as medically significant. The events resulted in Emergency room/department or urgent care visit.  It was reported as: Swelling of feet, legs, hands, arms and face as well as itching in face and neck after about 8 hours of receiving 2nd dose. 1st dose was unremarkable.   The lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the Covid virus after the first vaccine; tested positive for the Covid virus after the first vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized, when she tested positive for the Covid virus after the first vaccine on an unspecified date. She stated she would have been getting her second dose on 05May2021. She was not in the hospital anymore at the time of report, but still can't go outside. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021507654 similar report from same reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Flatulence, Muscle spasms, Myocardial infarction, Nausea
Clinical narrative: I thought I was having heart attack.; At midnight I woke up with severe chest pains.; Nausea; It was severe gas & cramping.; It was severe gas & cramping.; This is a spontaneous report from a non-contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Mar2021 19:30 (Batch/Lot Number: 1621146-00) (at the age of 68 years old) as 1st dose, single for COVID-19 immunization. The patient had no other medical history and concomitant medications were not reported. The patient previously took polyethylene glycol and had known allergies to the medication. No other vaccine in four weeks. The shot given was at 19:30. At midnight (16Mar2021 12:00 AM), the patient woke up with severe chest pains. She thought she was having heart attack. It was severe gas (Gas in chest) and cramping. The patient had this almost daily for 2 weeks. She had nausea for one week. The patient reported that she never experienced this in her life and still happens at least once a week. There has been no change in her diet before or after the vaccination. Events usually will be relieved within 2 hours after taking GasX. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Amphetamines, Amphetamines positive
Clinical narrative: testing positive for amphetamine; This is a spontaneous report from a contactable consumer reported for himself. A 27-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 16:50 at the age of 27-years-old (Batch/Lot Number: ER8733) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included stomach pain from an unknown date and colons (as reported).  The patient's concomitant medications were not reported.  The patient reported that he tested positive for amphetamine after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there were reported cases of testing positive for amphetamine after getting vaccinated for COVID 19. He mentioned that he never used any prohibited drugs. He stated he got his first vaccine on 08Apr2021 and like he took around the mid-day then the second day suddenly he went to a sample, a urine sample and somehow it showed there was he tested positive in case, he didn't use drugs and he did not do drugs and anything that it showed he tested positive, he had a word with doctors they said it might be a positive reaction or something but you got to call Pfizer and just tell them about that. He got the vaccine at mid-day like it was around his appointment was 16:50 and he got it that on 08Apr2021 and he did the drug test on 09Apr2021 when he woke up on the next day. The outcome of the event was unknown.  Information on lot/batch number was available. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: temporary facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 30Apr2021 14:00 (Batch/Lot number was not reported) (at the age of 41 years old) as unknown (dose number), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 02May2021, the patient experienced temporary facial paralysis. There was no treatment for the event. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the event was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Cutaneous T-cell lymphoma, Mass
Clinical narrative: diagnosed with cutaneous T-Cell lymphoma; A pimple- like mushroom lump; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 (Batch/Lot Number: EN6208) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included high blood pressure. On 30Mar2021 (reported as 10 days after the last vaccine), the patient had a pimple-like mushroom lump. On 01Apr2021, the patient was diagnosed with cutaneous t-cell lymphoma. The patient underwent lab tests and procedures which included biopsy: unknown result on 22Apr2021. The patient received an unspecified treatment for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested post vaccination.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Disorientation, Dizziness, Ear discomfort, Flatulence
Clinical narrative: Fainted; Dizziness; Sweaty palms; Heart rate dropped; Weird burning sensation in the back of his neck with tension; Weird burning sensation in the back of his neck with tension; Disorientated; Lost his color; Weird sensation in throat; Headache; Had pressure in his ears; Gassy; This is a spontaneous report from a contactable consumer (mother of the patient). A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731; Expiration date was not reported) on 15Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). The patient had no relevant medical history and concomitant medications. On 15Apr2021, after the first dose of vaccination, the patient had fainted; dizziness; sweaty palms; heart rate has dropped; had weird burning sensation at the back of the neck with tension; was disorientated; and had lost his color. In Apr2021, the patient had weird sensation in the throat; headache; had pressure in his ears; and was gassy. The outcome of the events was unknown for 'lost his color'; was not recovered for 'headache'; and was recovered on an unspecified date in 2021 for all the other events.  Information on lot/batch number was available. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate decreased, Hyperhidrosis, Muscle tightness
Clinical narrative: Fainted; Dizziness; Sweaty palms; Heart rate dropped; Weird burning sensation in the back of his neck with tension; Weird burning sensation in the back of his neck with tension; Disorientated; Lost his color; Weird sensation in throat; Headache; Had pressure in his ears; Gassy; This is a spontaneous report from a contactable consumer (mother of the patient). A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731; Expiration date was not reported) on 15Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). The patient had no relevant medical history and concomitant medications. On 15Apr2021, after the first dose of vaccination, the patient had fainted; dizziness; sweaty palms; heart rate has dropped; had weird burning sensation at the back of the neck with tension; was disorientated; and had lost his color. In Apr2021, the patient had weird sensation in the throat; headache; had pressure in his ears; and was gassy. The outcome of the events was unknown for 'lost his color'; was not recovered for 'headache'; and was recovered on an unspecified date in 2021 for all the other events.  Information on lot/batch number was available. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pallor, Syncope
Clinical narrative: Fainted; Dizziness; Sweaty palms; Heart rate dropped; Weird burning sensation in the back of his neck with tension; Weird burning sensation in the back of his neck with tension; Disorientated; Lost his color; Weird sensation in throat; Headache; Had pressure in his ears; Gassy; This is a spontaneous report from a contactable consumer (mother of the patient). A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731; Expiration date was not reported) on 15Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). The patient had no relevant medical history and concomitant medications. On 15Apr2021, after the first dose of vaccination, the patient had fainted; dizziness; sweaty palms; heart rate has dropped; had weird burning sensation at the back of the neck with tension; was disorientated; and had lost his color. In Apr2021, the patient had weird sensation in the throat; headache; had pressure in his ears; and was gassy. The outcome of the events was unknown for 'lost his color'; was not recovered for 'headache'; and was recovered on an unspecified date in 2021 for all the other events.  Information on lot/batch number was available. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient received her 1st Pfizer vaccine on 1/4/21. She then tested positive for COVID-19 on 1/18/21; The patient received her 1st Pfizer vaccine on 1/4/21. She then tested positive for COVID-19 on 1/18/21; This is a Spontaneous report from Pfizer sponsored program from a contactable pharmacist.  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jan2021 at the age of 40-years-old (Batch/Lot Number: EL0142) as 1ST DOSE,SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient received her 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021. The patient was hospitalized for the event. She then received a "plasma transfusion" on 28Jan2021. She was now returning for her 2nd vaccine dose today 06May2021. The reporter asked if  this was ok since it had been 90 days and if her first dose need to be repeated. The outcome of the events was resolved on an unspecified date in 2021. The reporter considered Pfizer Covid-19 Vaccine with event tested positive for Covid-19 after first dose was unrelated.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia
Clinical narrative: he's had high blood sugar readings for no reason; This is a spontaneous report received from contactable consumer, the wife of the patient. A 49-year-old adult male received the first dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 22Apr2021 (at 49-years-old) for COVID-19 immunization. Relevant medical history included diabetes. There were no concomitant medications reported. The consumer reported that ever since her husband got his first dose of the COVID-19 vaccine on 22Apr2021, he has had high blood sugar reading for no reason. The consumer explained that the patient has only had a black coffee today and his blood sugar is greater than 200 (no unit reported). The consumer reported that his blood sugars have event been as high as 400 (no unit provided). The outcome of the event had high blood sugar reading for no reason was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Chills, Loss of consciousness
Clinical narrative: She stated that a few seconds after receiving the first dose of the vaccine, the patient blacked out; chills; This is a spontaneous report from a Pfizer sponsored program, via a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She stated that a few seconds after receiving the first dose of the vaccine, the patient blacked out and when they went home, she experienced chills. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event loss of consciousness and the suspect drug 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.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic pain, Hepatomegaly
Clinical narrative: Enlarged liver; Pain in liver; This is spontaneous report received from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 30Apr2021 at age of 18-year-old at single dose, unknown dose number for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at time of vaccination and events onset. It was unknown if there was other vaccine in four weeks. It was unknown if patient had COVID-19 prior to vaccination. And it was unknown if COVID-19 was tested post vaccination. Patient experienced enlarged liver and pain in liver, both on 01May2021 with outcome of unknown. Events were serious as hospitalization. It was unknown if patient received treatment for the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Rash, Swelling, Weight decreased
Clinical narrative: Rash on arms, hands, legs, feet, and a little bit on chest.; The worst part was that his groin swelled up to about the size of a Cantaloupe.; lost about 60-70 pounds in water weight.; fisrt dose on 20Jan2021/second dose on 06Feb2021; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer(patient). A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Feb2021 15:00 (Lot Number: EL9261) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, Obese. Concomitant medication included 17 medcations (unspecifed). The patient previously took first dose of bnt162b2 (lot number: EL3249) on 20Jan2021 at age of 61 years old, administered in Left arm, for covid-19 immunisation. The patient previously took lithium. The patient reported rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. He was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The adverse events occurred on 07Feb2021. The adverse event resulted in emergency room/department or urgent care. Catheterization and Furosemide were received as treatment for the adverse events. The outcome of events was recovered with sequelae.  Follow attempts are needed. Further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Rash, Swelling
Clinical narrative: Rash on arms, hands, legs, feet, and a little bit on chest.; The worst part was that his groin swelled up to about the size of a Cantaloupe.; lost about 60-70 pounds in water weight.; fisrt dose on 20Jan2021/second dose on 06Feb2021; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer(patient). A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Feb2021 15:00 (Lot Number: EL9261) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, Obese. Concomitant medication included 17 medcations (unspecifed). The patient previously took first dose of bnt162b2 (lot number: EL3249) on 20Jan2021 at age of 61 years old, administered in Left arm, for covid-19 immunisation. The patient previously took lithium. The patient reported rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. He was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The adverse events occurred on 07Feb2021. The adverse event resulted in emergency room/department or urgent care. Catheterization and Furosemide were received as treatment for the adverse events. The outcome of events was recovered with sequelae.  Follow attempts are needed. Further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness neurosensory, Tinnitus
Clinical narrative: AS sensorineural hearing loss; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:00 (Lot Number: EN8737) as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included bupropion hydrochloride (BUPROPION HCL XL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of  bnt162b2  (Lot number: EN6208) on 13Mar2021 15:30, administered in Left arm for covid-19 immunisation. The patient experienced Sudden AS sensorineural hearing loss likely causing tinnitus possibly related to Covid vaccination response on 04Apr2021 08:00. Event seriousness criteria was disability. The patient presented with hearing loss for 1 month, onset after COVID vaccine which was on 03Apr2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included two separate transtympanic steroid injections, and prednisone medication (60mg then taper). Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: My sugar level used to be between 100 to 129 before the shot. after taking covid 19 vaccine when i got my blood test it came around 266.; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in left arm on 29Mar2021 13:30 (Batch/Lot Number: EP7534) (age at vaccination: 48 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had previously received the first dose of  BNT162b2 on 10Mar2021 07:30 (Batch/Lot Number: EN6206) for COVID-19 immunisation. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported. The patient's sugar level used to be between 100 to 129 before the shot. After taking the COVID-19 vaccine, he got blood test it came around 266, on 04May2021 07:45. No treatment was received for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Ocular icterus, Pyrexia, Rash
Clinical narrative: fever; headache; lot of general malaise; yellow coloration in my eyes; skin rash; This is a Spontaneous report from a contactable consumer. A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 at 16:28 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 20Apr201, the patient presented fever, headache and a lot of general malaise, currently presenting yellow coloration in eyes and skin rash. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Hypersensitivity, Illness, Malaise
Clinical narrative: felt unwell; took his oxygen level and it was at 80%; he had swelling; difficulty breathing; tachycardia; allergic reaction; tested Covid-19 positive; blood clots; he got very sick; This is a spontaneous report from a contactable consumer(patient's daughter). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) at the age of 71-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fine and nothing happened until after the vaccine. The patient took the 1st dose on 24Apr2021 and the next day he got very sick, they thought it was just a reaction from the vaccine, then he was swelling said he was not feeling well. The day after the vaccine, the patient was rushed to the emergency room and confined to the ICU. He felt unwell and it got worse and worse, we took his oxygen level and it was at 80%, he had swelling, difficulty breathing and tachycardia. The reporter thought it was an allergic reaction but this morning the patient tested positive for covid, he didn't go out the only time he went out was to get the vaccine. The reporter asked If he didn't know he had covid and got the vaccine, will he get more sick. In the report they found blood clots and the doctors thought it was from the vaccine. He was diagnosed with blood clots and difficulty breathing and he tested Covid-19 positive. Events seriousness criteria reported as hospitalization. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Swelling, Tachycardia, Thrombosis
Clinical narrative: felt unwell; took his oxygen level and it was at 80%; he had swelling; difficulty breathing; tachycardia; allergic reaction; tested Covid-19 positive; blood clots; he got very sick; This is a spontaneous report from a contactable consumer(patient's daughter). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) at the age of 71-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fine and nothing happened until after the vaccine. The patient took the 1st dose on 24Apr2021 and the next day he got very sick, they thought it was just a reaction from the vaccine, then he was swelling said he was not feeling well. The day after the vaccine, the patient was rushed to the emergency room and confined to the ICU. He felt unwell and it got worse and worse, we took his oxygen level and it was at 80%, he had swelling, difficulty breathing and tachycardia. The reporter thought it was an allergic reaction but this morning the patient tested positive for covid, he didn't go out the only time he went out was to get the vaccine. The reporter asked If he didn't know he had covid and got the vaccine, will he get more sick. In the report they found blood clots and the doctors thought it was from the vaccine. He was diagnosed with blood clots and difficulty breathing and he tested Covid-19 positive. Events seriousness criteria reported as hospitalization. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from contactable Pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 06May2021 10:15 am (Lot Number: EW0171) at the age of 17-year-old as single dose for covid-19 immunisation. Medical history reported as none. No known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. Vaccine was given, patient was sitting with her mother. Approximately 10 minutes after vaccine, she slumped to the side and passed out. When the reporter got to her she was just waking up. She still felt dizzy, skin was sweaty and pale. Paramedics arrived within 5-10 minutes to evaluate. They said they had seen this vasovagal reaction with the covid vaccine. Patient left on gurney with the paramedics. Adverse events start date was 06May2021. Events resulted in Emergency room/department or urgent care. The outcome of the events was unknown. The patient had no covid prior vaccination, no Covid tested post vaccination.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Loss of consciousness. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder
Clinical narrative: She is curious because she was just diagnosed with an immune disease; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at 61-year-old) at second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at first dose, single for COVID-19 immunisation. The patient was curious because she was just diagnosed with an immune disease recently. She asked if side effects can start 4 weeks after receiving the second dose of the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Illness
Clinical narrative: She is curious because she was just diagnosed with an immune disease; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at 61-year-old) at second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at first dose, single for COVID-19 immunisation. The patient was curious because she was just diagnosed with an immune disease recently. She asked if side effects can start 4 weeks after receiving the second dose of the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: She is curious because she was just diagnosed with an immune disease; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at 61-year-old) at second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at first dose, single for COVID-19 immunisation. The patient was curious because she was just diagnosed with an immune disease recently. She asked if side effects can start 4 weeks after receiving the second dose of the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: She is curious because she was just diagnosed with an immune disease; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at 61-year-old) at second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at first dose, single for COVID-19 immunisation. The patient was curious because she was just diagnosed with an immune disease recently. She asked if side effects can start 4 weeks after receiving the second dose of the vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anal haemorrhage, Blood urine present, Haematochezia, Rectal haemorrhage
Clinical narrative: anal bleeding/when she pooped and there was blood/it was only on her rectum; blood in her stool; anal bleeding/when she pooped and there was blood/it was only on her rectum; she peed and the water was red like she was on her period/ went to pee and there was blood; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 05May2021 10:00 at single dose for COVID-19 immunisation at the age of 50-year old. Medical history reporter as none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) in the Arm Left on 05Apr2021 at the age of 50-year old for COVID-19 immunization. The patient was not received additional other vaccines on same day of the BNT162B2 vaccination. The caller received her second dose of the vaccine yesterday 05May2021 at 10:00 am. Stated caller woke up today 06May2021 at 05:00 a.m. and noticed she was bleeding. Stated she first noticed it when she pooped and there was blood, she didn't specify if the blood was in the water or in the stool.  A few minutes later, she peed and the water was red like she was on her period. Caller said anal bleeding but didn't specify more. Caller clarified, at 5:00 a.m. in the morning,  when she went to the bathroom and evacuated she realized there was blood in her stool and a moment ago she went to pee and there was blood, like she was on her period. Caller stated when she peed she didn't have any blood coming out of her vagina, it was from her rectum because when she was cleaning the vagina, there was no blood, it was only on her rectum. Treatment: None. Caller stated this had never happened to her before, and the only thing that was different was the vaccine. Stated she thought it was due to that because she hasn't ingested anything. Stated she wanted to make an appointment with her doctor but he doesn't open until 1:00 p.m. The events were not resulted in Emergency Room or Physician Office visit. Family Medical History Relevant to adverse events reported as none. Relevant Tests reported as none. Event onset date reported as 06May2021 05:00. No treatment received for the events. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myelitis transverse
Clinical narrative: Caller mentioned that patient was 6 months pregnant, and had a "transverse myelitis" attack after the vaccine; Caller mentioned that Patient is 6 months pregnant, and had a "transverse myelitis" attack after the vaccine; This is a spontaneous report received from a contactable consumer (patient's caregiver). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller mentioned she was asking on behalf of a patient advocacy organization for a young pregnant woman (Patient).  Caller mentioned that patient was 6 months pregnant, and had a "transverse myelitis" attack after the vaccine. Caller disconnected remotely before being able to offer Safety transfer, ask for other questions, offer survey, and closing. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Easily short of breath, winded; weak; Chest heaviness and mild pain with tightness; Chest heaviness and mild pain with tightness; Lung heaviness and mild pain with tightness; Lung heaviness and mild pain with tightness; breathing heavier; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient (not pregnant) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 03May2021 16:00 (39-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history Lupus, fibromyalgia, Lyme, neuropathy, and allergies to Latex. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 19:00, patient experienced Chest/Lung heaviness and mild pain with tightness; Easily short of breath, winded and weak; unable to perform daily routine, breathing heavier is also making her lightheaded. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Lung disorder, Pulmonary pain
Clinical narrative: Easily short of breath, winded; weak; Chest heaviness and mild pain with tightness; Chest heaviness and mild pain with tightness; Lung heaviness and mild pain with tightness; Lung heaviness and mild pain with tightness; breathing heavier; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient (not pregnant) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on 03May2021 16:00 (39-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history Lupus, fibromyalgia, Lyme, neuropathy, and allergies to Latex. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03May2021 19:00, patient experienced Chest/Lung heaviness and mild pain with tightness; Easily short of breath, winded and weak; unable to perform daily routine, breathing heavier is also making her lightheaded. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, Bronchitis, Chest X-ray, Computerised tomogram thorax, Fibrin D dimer
Clinical narrative: Upper respiratory tract something going on; possible bronchitis; Left lower lobe atelectasis; D Dimer that was positive, reading 1.95; Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 21Jan2021 07:30  (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriatic arthritis from 10 years (he started Cosentyx three or four weeks before reporting) and COVID virus from Nov2020. Concomitant medications included secukinumab (COSENTYX) from three or four weeks before reporting for psoriatic arthritis. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at left arm on 31Dec2020 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. Prior vaccinations within 4 weeks was none. Patient states he just wanted to report; and he didn't know if this is significant. Patient reports now he has bilateral pulmonary embolism (from 04May2021) along with an upper respiratory tract something going on. Adds he never had this before. The doctor for his possible bronchitis has him on Omnicef and started Xarelto. Adds they were lucky to find the pulmonary embolism. Mentions the doctor tried a different antibiotic first, Keflex (NDC 68180 0122 02), and it was not helping. The doctor noticed his pulse oximeter (on 04May2021) reading was 92% and did a chest x ray. The chest x ray (on 04May2021) showed left lower lobe atelectasis. The doctor said that would not account for the low pulse oximeter of 92%. She sent him for a D Dimer (on 04May2021) that was positive, reading 1.95; and then had a chest CT at 1:00PM on Tuesday (04May2021), that showed the bilateral pulmonary embolism. Adverse events required a visit to physician office (received outpatient tests). Therapeutic measures were taken as a result of the event possible bronchitis and included Omnicef and Xarelto. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Oxygen saturation, Pulmonary embolism, Respiratory disorder
Clinical narrative: Upper respiratory tract something going on; possible bronchitis; Left lower lobe atelectasis; D Dimer that was positive, reading 1.95; Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 21Jan2021 07:30  (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included psoriatic arthritis from 10 years (he started Cosentyx three or four weeks before reporting) and COVID virus from Nov2020. Concomitant medications included secukinumab (COSENTYX) from three or four weeks before reporting for psoriatic arthritis. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration at left arm on 31Dec2020 07:30 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. Prior vaccinations within 4 weeks was none. Patient states he just wanted to report; and he didn't know if this is significant. Patient reports now he has bilateral pulmonary embolism (from 04May2021) along with an upper respiratory tract something going on. Adds he never had this before. The doctor for his possible bronchitis has him on Omnicef and started Xarelto. Adds they were lucky to find the pulmonary embolism. Mentions the doctor tried a different antibiotic first, Keflex (NDC 68180 0122 02), and it was not helping. The doctor noticed his pulse oximeter (on 04May2021) reading was 92% and did a chest x ray. The chest x ray (on 04May2021) showed left lower lobe atelectasis. The doctor said that would not account for the low pulse oximeter of 92%. She sent him for a D Dimer (on 04May2021) that was positive, reading 1.95; and then had a chest CT at 1:00PM on Tuesday (04May2021), that showed the bilateral pulmonary embolism. Adverse events required a visit to physician office (received outpatient tests). Therapeutic measures were taken as a result of the event possible bronchitis and included Omnicef and Xarelto. The outcome of the events was unknown.  Information on the lot/batch number has been requested.