chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first shot of the vaccine couple month ago and then about a week ago was supposed to get second shot. Patient was tested positive for Covid. Patient just didn't know when to go get test if see test negative and now if test negative what was the procedure going forward because patient would like to get second shot or do patient had to start all over again? The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Postmenopausal haemorrhage, Pyrexia
Clinical narrative: second period two weeks after the second dose; headache; sore arm; slight temperature; tiredness; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received second dose of BNT162B2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 03:45 (Batch/Lot Number: ER8734) as 2ND DOSE SINGLE for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, The patient has not been tested for COVID-19 since the vaccination. The patient experienced second period two weeks after the second dose, headache, sore arm, slight temperature and tiredness all on Apr2021. No treatment was received for all the events. The outcome of second period two weeks after the second dose was unknown. Outcome of all the other events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Glomerular filtration rate decreased, Vomiting
Clinical narrative: dry vomiting; GFR had been 18 but drop to 7; This is a spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent via follow-up letter. A 67-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in arm on 11Mar2021 (Batch/Lot Number: EN6208) as 2nd dose, single for covid-19 immunisation. Medical history included polycystic kidney disease genetic from mother, stage 4 kidney failure. Family medical history included mother had polycystic kidney disorder. Concomitant drug was none. Prior vaccination (within 4 weeks) was none. Patient previously received first dose of BNT162B2 on 18Feb2021 16:00 (Batch/Lot no: EN6201) via intramuscular in arm for covid-19 immunisation and experienced sick for basically 2 weeks. The patient experienced dry vomiting and GFR had been 18 but drop to 7 (both seriousness criteria: hospitalization) on 12Mar2021 02:00. Adverse events required visit to emergency room. Duration of stay in hospital was 11 days. Treatment received including haemodialysis. Patient stated had a very difficult reaction to the first shot, sick for basically 2 weeks. Hesitated to take the second shot. Could find no information on people with kidney disease. All doctors said get the shot. Patient did and 10 hours later. Patient was dry vomiting uncontrollably went to the emergency room. Patient's kidney GFR had been 18 but dropped to 7 after the shot. Patient was put on emergency now permanent haemodialysis was in hospital for 11 days. Dialysis was in patient's future but not so soon. As an aside last night. Patient was talking to neighbour her sister worked in a nursing home. After 2 period of no COVID deaths 6 patients died of kidney failure after taking vaccine. Relevant tests was none (as reported). Vaccine was not administered at Military Facility. Conclusion stated more research needed on people with advanced kidney disease. The event outcome for events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: reaction of fainting and was taken to the hospital; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (parent) reported that a female patient (daughter) of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller calling about her daughter who received her first covax in a mall on 15Apr2021 and had reaction of fainting and was taken to the hospital. She was asking what they should do about the second covax. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, visual, Pain
Clinical narrative: Multiple visual hallucinations; Body aches; This is a spontaneous report from a contactable other Health Professional.  A 43-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at age of 43-years, on 22Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hyperlipidaemia (HLD) and post-traumatic stress disorder (PTSD). There were other medications in two weeks but unspecified. The patient previously took morphine and experienced allergy. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 01Apr2021 (Lot number was not reported) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced multiple visual hallucinations and usual body aches occurring evening of vaccine on 22Apr2021, resolved by next day. There was no treatment received for the above events. The patient did not diagnose with COVID-19 prior to vaccination and not test for COVID-19 since the vaccination. Events outcome was recovered on 23Apr2021.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported multiple visual hallucinations  and the administration of the suspect, COVID19 vaccine, based on the reasonable temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: the patient was tested positive with Covid-19 after his first dose; the patient was tested positive with Covid-19 after his first dose; This is a spontaneous report from Pfizer-sponsored program. A contactable other HCP reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient the patient was tested positive with Covid-19 on unknown date after his first dose. Outcome of event was unknown.   Information on the lot/batch number has been requested; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity as full immunity is expected 7 days after 2nd dose.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: "knocked out" by the second dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was "knocked out" by the second dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 09Mar2021 at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported after 2 days on 11Mar2021 patient was tested positive for COVID. She was in ICU for 3 weeks then in a rehabilitation for another 3 weeks. Patient wanted to know what to do on her 2nd dose. She was asking whether she needs to start over again on the 1st dose or was there enough antibody since she tested positive. The outcome of the event was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Platelet count, Thrombocytopenia
Clinical narrative: Thrombocytopenia; Blood blisters; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable Other-HCP reported for a 81-year-old female patient that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Left on 19Apr2021 (Lot Number: ER8737; Expiration Date: Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation  .  Medical history included deep vein thrombosis. Concomitant medication included apixaban (ELIQUIS) taken for deep vein thrombosis from 29Apr2021 to 30Apr2021.  The patient experienced thrombocytopenia and blood blisters on 29Apr2021.  The patient was hospitalized for thrombocytopenia from 29Apr2021 to 02May2021.  The patient visited emergency room and physician office due to thrombocytopenia. The patient underwent lab tests and procedures which included platelet count: 3,000/dropped on 29Apr2021, platelet count: 348,000 on 04May2021.  Therapeutic measures were taken as a result of thrombocytopenia included platelets. The outcome of events was recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombocytopenia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness neurosensory, Fatigue, SARS-CoV-2 test, Tinnitus
Clinical narrative: hearing loss/Unilateral sensorineural hearing loss; ringing in his ear; Tired; This is a spontaneous report from a contactable consumer (patient's wife). A 46-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE2), via an unspecified route of administration on 04May2021 09:00 (Batch/Lot Number: EW0179) as 2nd dose, single for covid-19 immunisation. The first dose was received on 13Apr2021 15:00 (lot number: ER8731) and patient experienced tired, slight fever and back pains similar to what he experienced with covid. Medical history included sinus surgery on Dec2014 and covid-19 positive on from 11Jan2021 to an unknown date. Concomitant medications included rosuvastatin for cholesterol; propranolol for blood pressure; finasteride for hair loss; and multivitamin. Patient felt tired on 04May2021. On 08May2021 07:30, patient woke with ringing in ear and hearing loss/ significant reduced hearing. Tinnitus was reported as ongoing, reported as medically significant, and resulted to physician's office visit. Prednisone 2-pac was given as treatment. ENT (Otorhinolaryngologist) performed hearing test and exam, no obvious reason for issues. Hearing test on 10May2021, High frequency SNHL Right greater than Left (Unilateral sensorineural hearing loss) muffled hearing. Patient had experienced improvement but still has tinnitus (17May2021). Outcome of the event of tired was unknown and for the remaining events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Mental disorder
Clinical narrative: Two weeks later developed mental health issues and has never been sick a day in her life; This is a spontaneous report from a Pfizer group. A contactable consumer (patient was reporter's sister in law) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Two weeks after 1st vaccine in Mar2021, patient developed mental health issues and has never been sick a day in her life with outcome of unknown. All tests are normal. She has now been in the hospital 5 weeks and reporter was having to look for memory care living for patient. The outcome of event was unknown.  lot/batch number has been requested in follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I received 2 doses of the Covid 19 Vaccine. 4 weeks later I had a confirmed breakthrough infection of Covid 19; I received 2 doses of the Covid 19 Vaccine. 4 weeks later I had a confirmed breakthrough infection of Covid 19; This is spontaneous report received from Pfizer RXPathways. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 2 doses of the covid 19 vaccine. 4 weeks later who had a confirmed breakthrough infection of covid 19 on an unspecified date with outcome of unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out without warning; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729; Expiration date was not reported) on the left arm on 13Apr2021 (09:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the public health department. Medical history included lower back pain; allergy to latex; and allergies with bananas and avocados. The patient was not pregnant at the time of vaccination. The patient's concomitant medication included an unspecified pain medication. The patient previously took ketorolac (TORADOL), and had allergies with this medication. On 13Apr2021 (10:00), the patient had passed out without warning; assessed as serious (medically significant). The patient did not receive any treatment for the event. The outcome of the event was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: mild to moderate anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had a mild to moderate anaphylactic reaction. He just wonders if there is provisions. Reporter asked if Pfizer was helping with clinic and EMT (Emergency Medical Technicians) bills. It was protocol, they had to take her. Now they have a 1800 fee from the hospital, and 800 for the ambulance. That is a lot of money. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: patient caught Covid in Apr2021 and was sick for 2 weeks; patient caught Covid in Apr2021 and was sick for 2 weeks; This is a spontaneous report received from a non-contactable physician reporting for himself via sales representative. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in late Dec2020 and second dose in Jan2021 both at single dose for COVID-19 immunization. Medical history included extremely over weight. Concomitant medications were not reported. The patient was a physician who works in a hospital as a psychiatrist. He recieved his first vaccine in late Dec2020 and had his second vaccine 3 weeks later in Jan2021. The patient caught Covid in Apr2021 and was sick for 2 weeks. He believed he caught Covid from a patient. The outcome of the event was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid 19. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Inappropriate schedule of product administration
Clinical narrative: Strong sharp pains in her heart; Took one shot already and it was about 6 weeks ago and has not got the second one; This is a spontaneous report received from a non-contactable consumer (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated she was calling about the COVID 19 vaccine. Caller stated she took one shot already and it was about 6 weeks ago and had not got the second one. Caller stated the reason she did not take the second one was because she was afraid since after the first one she experienced strong sharp pains in her heart and was still in the process of checking this out before she got the second vaccine. Caller stated what she wanted to know was if she can get the second vaccine more than 6 weeks apart. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Investigation, Pain, Pulmonary pain, Thrombosis
Clinical narrative: she feels pain in the lungs, in the body,in her head there is blood clot; she feels pain in the lungs, in the body,in her head there is blood clot; she feels pain in the lungs, in the body,in her head there is blood clot; every day she feels different; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  This female patient of an unspecified age received received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. In Apr2021, the patient experienced that she feels pain in the lungs, in the body, in her head there is blood clot, every day she feels different with outcome of unknown.  The clinical course was reported as follows: The patient had the 2nd dose of the vaccine 3 or 4 weeks ago, since then she had the symptoms, she feels something's changed, and she feels pain in the lungs, in the body, in her head there is blood clot, every day she feels different. In the hospital they do tests and X-ray but results turn out normal and nothing is wrong. She had never felt this strange in her life, she didn't feel well.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: she feels pain in the lungs, in the body,in her head there is blood clot; she feels pain in the lungs, in the body,in her head there is blood clot; she feels pain in the lungs, in the body,in her head there is blood clot; every day she feels different; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  This female patient of an unspecified age received received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. In Apr2021, the patient experienced that she feels pain in the lungs, in the body, in her head there is blood clot, every day she feels different with outcome of unknown.  The clinical course was reported as follows: The patient had the 2nd dose of the vaccine 3 or 4 weeks ago, since then she had the symptoms, she feels something's changed, and she feels pain in the lungs, in the body, in her head there is blood clot, every day she feels different. In the hospital they do tests and X-ray but results turn out normal and nothing is wrong. She had never felt this strange in her life, she didn't feel well.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: unusual menstrual cycle that has lasted more than 2 weeks thus far with extremely heavy bleeding/hemorrhaging; unusual menstrual cycle that has lasted more than 2 weeks thus far with extremely heavy bleeding/hemorrhaging; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 12:00 (Batch/Lot Number: ER 8729) as the 1st dose, single for COVID-19 immunization. The patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8735) on an unspecified date in the left arm. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient's medical history were not reported. The patient had no allergies to medications, food, or other products. There were no concomitant medications; the patient had not received any other medications 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. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient experienced unusual menstrual cycle that had lasted more than 2 weeks thus far with extremely heavy bleeding/hemorrhaging. The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event. The outcome of the event was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in her right foot and hand; numbness and tingling in her right food and hand; This is a spontaneous report from a contactable Nurse (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 31Mar2021 13:00 (Lot Number: ER8732; Expiration Date: 31Jul2021) as 2ND DOSE, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.  Concomitant medications were not provided. The patient previously took the first dose bnt162b2 on 04Mar2021 for covid-19 immunization at 39-years-old, and Flu shot.  The patient experienced numbness and tingling in her right foot and hand in Apr2021, especially the fingers. No emergency room and physician office due to events. The outcome of events was not recovered.  Seriousness criteria reported as medical significant. The nurse reported that events related to bnt162b2. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: Based on limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Hypoasthesia and Paraesthesia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: developed "Bell Palsy" between 48-72 hours after his second shot; This is a spontaneous report from a contactable consumer (patient). A 39-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 01May2021 10:00 (at age of 39-year-old) (lot number: EW0167) as single dose for covid-19 immunisation. Medical history included high cholesterol. No known allergies. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on an unknown date in Apr2021 10:00 (lot number: EW0153) for covid-19 immunization. The patient developed "Bell Palsy" between 48-72 hours after his second shot. The event start date was on 03May2021 14:00. The event resulted in doctor or other healthcare professional office/clinic visit. The event resulted in Emergency room/department or urgent care. No covid prior vaccination, no covid tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event included prednisone and valacyclovir. Event outcome was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: I lost my smell for several days like I did when I had covid 19 several months back. However when I had Covid, I regained my sense of smell. I have yet to fully regain my sense of smell from the Covid; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on the left arm, on 05Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included allergy to shellfish from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZIRTEC) and spironolactone (SPIRONOLACTONE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalosporin nos and experienced drug hypersensitivity. On 06Apr2021, the patient stated, "I lost my smell for several days like I did when I had covid 19 several months back. However when I had Covid, I regained my sense of smell. I have yet to fully regain my sense of smell from the Covid 19 vaccine. I can smell most things now, but stronger smells just smell like bleach still after 2 months". The event resulted in disability or permanent damage. The outcome of the event was recovered with sequelae.  Information about lot and batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: clarification if one experiences a severe allergic reaction with 1st dose as one of their family members has experienced a severe reaction; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced a severe allergic to the 1st dose. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Disease recurrence
Clinical narrative: Relapsing of CIDP; Relapsing of CIDP; This is a spontaneous report from a contactable consumer (reported for himself). A 57-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EP7534) administered in left arm via an unknown route of administration on 06Apr2021 at 10:00am as SINGLE DOSE for covid-19 immunization. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208) administered in left arm via an unknown route of administration, on 18Mar2021 at 10:00am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Concomitant medications received within 2 weeks of vaccination included Atorvastatin (LIPITOR), Levothyroxine sodium (LEVOTHYROXINE SODIUM), Cetirizine hydrochloride (ZYRTEC ALLERGY). On 15Apr2021, the patient experienced relapsing of CIDP (chronic inflammatory demyelinating polyradiculoneuropathy) and Disease recurrence. The patient received treatment for the event as  IVIG. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination, the patient was not diagnosed with covid-19 and not tested for covid post vaccination. Patient had no allergy. Device Date was 12May2021. The outcome of the event was not recovered.  Information about batch number/lot number was available. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Seizure
Clinical narrative: His son having back to back seizure; His son having back to back seizure; This is a spontaneous report from a contactable consumer (patient's father).   A male patient of an unspecified age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included seizure (son already had a history of seizure). The patient's concomitant medications were not reported. On an unspecified date patient received 1st dose of BNT162B2 for covid-19 immunisation. On an unspecified date reporter son having back to back seizure after getting the second shot of Pfizer Covid Vaccine. Patient got VNS prior to getting shot. Son already had a history of seizure. The caller is asking does this medicine cause more seizure. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pulmonary thrombosis
Clinical narrative: blood clot in her lungs; bronchial asthma; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient historically received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient received second dose of COVID vaccine and has since had a blood clot in her lung and bronchial asthma from unspecified dates. The outcome of the events was unknown. Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Headache, Hypoacusis, Sleep disorder, Tinnitus
Clinical narrative: he is deaf in one ear; hard of hearing in the other/My hearing is not very good; his tinnitus has "sky rocketed" and gotten much worse/ringing in ears; has not even been able to sleep much; after my second shot it even got worse; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 19-MAR-2021 as 2nd dose, single for covid-19 immunization. The patient medical history included Tinnitus (tinnitus -ringing of the ears) for about 25 years. Concomitant medications were not reported.  The patient historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 Immunization taken on 26-FEB-2021. Patient stated that he has had tinnitus (ringing of the ears) for about 25 years, however, since he received both doses his tinnitus has "sky rocketed" and gotten much worse. He stated that he has not even been able to sleep much in the past 4 days because of it. This has been ongoing since March. He had seen his doctor multiple times and tried multiple treatments for his worsening tinnitus but it has not gotten any better. He stated that he does not know what to do and his doctor does not know what to do either at this point. The caller wants to know if there have been any other reports or complaints about this type of side effect after receiving the vaccine. The patient declined to be transferred to a hospital at this time. He did give consent for his information and his experience to be shared with hospital and for them to contact him via phone if necessary for any follow up questions. He stated that he was deaf in one ear and hard of hearing in the other. He also stated he was third person he had spoken with and it was hard for him to hear on the phone.  Patient stated that the reason he was calling because he took his Pfizer first shot on February (26Feb2021) and second shot on March (19Mar2021) and he had taken this they going to be ringing in ears "last 35" (not clarified) and after the first shot he ended up getting headache not thinking too much about it but very highly and after his second shot it even got worse he had already been to the doctor to see if he has found out anybody having any problem with Covid shots concerning the ringing in ears. Are you familiar with this?" Consumer was informed about Pfizer Medical information Department. In response to further probing, consumer stated, "No, it is not. My hearing is not very good, so I am stressing right now." As consumer was not willing to proceed the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Headache, Uterine haemorrhage
Clinical narrative: Shortly after that I began to bleed lightly from my uterus; Once receiving the vaccination, a couple hrs later my uterus felt odd maybe even light burning at one point.; Once receiving the vaccination, a couple hrs later my uterus felt odd maybe even light burning at one point.; I had mild headache as well.; This is a spontaneous report received from a contactable consumer (Patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 06May2021 19:00 (Batch/Lot Number: EW0171) as 1st dose, single for covid-19 immunization. Patient had no medical history, no allergies to medications. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 07May2021 at 02:00, once received the vaccination, a couple hours later her uterus felt odd maybe even light burning at one point. Shortly after that she began to bleed lightly from her uterus. This was 8 days after her last period. Vaccine triggered the bleeding outside of her cycle. she bleeds from her uterus lightly for almost a week. she had mild headache as well. No treatment were received. The outcome for events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: bleeding was getting heavier byTuesday I was already going through 10 large pads/blood was gushing out of me; This is a spontaneous report from a contactable consumer (patient).   A 38-years-old female (non pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0183 and Expiration date: not reported), via an unspecified route of administration on 09May2021 at 10:00 (at the age of 38-years-old), as single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Medical history included patient provided a list of medications that she was allergic to. Patient received unspecified prescribed medicines within 2 weeks of vaccination. Patient provided the nurse, that gave her the shot, the list of prescribed medicines that she was taking. Nurse told her that she was ok to take the vaccine and we proceed. After the vaccine patient waited 30 mins sitting down then she was ok to go home. On 09May2021 at 14:00 hours, patient noticed that towards the evening her bleeding was getting heavier by Tuesday (11May2021) and she was already going through 10 large pads by 10:00 am. Patient was told to laid down with her feet up by her mother as her husband was at work and stated that we were going to go to the hospital on the evening. When her husband came home, she stated that we decided that we were going to go on Wednesday (12May2021) morning to the hospital. Patient's husband woke up that Wednesday morning, she was still asleep and screamed at her "you crazy we need to go to the hospital right now". Patient was cover waist down in blood and stated that they told her to try to get up and she felt that blood was gushing out of her (hospitalization). Ambulance was called. Since the vaccination, patient had not been tested for COVID-19. Patient had emergency room/department or urgent care visit. Patient received tranexamic acid, birth control, medroxyprogesterone as treatment for the adverse event. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dizziness, Inner ear inflammation, Tinnitus, Vertigo
Clinical narrative: Atrial fibrillation; Tinnitus in my Right Ear; have a lot of annoying ringing in right ear; inflamed; Tinnitus in my Right Ear; have a lot of annoying ringing in right ear; inflamed; Vertigo; Dizziness; This is a spontaneous report received from a contactable consumer. This consumer (patient) that. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation and methylprednisolone sodium succinate (SOLU-MEDROL), route of administration, start and stop date, batch/lot number and dose were not reported for tinnitus. The patient's medical history and concomitant medications were not reported. On May2021 the patient experienced atrial fibrillation, tinnitus in my right ear; have a lot of annoying ringing in right ear;inflamed, vertigo and dizziness. The patient reported that I got my Pfizer Vaccine first (shot) last Tuesday and I was Hospitalized for one of the problem that left me with is I am having Tinnitus in my Right Ear. I had vertigo, dizziness and then it seemed it has gone away but I still have a lot of ringing in my right ear. I went to see my ENT Doctor and at that time he said he would normally put me on steroid (Solu-Medrol) but because when I was in the hospital I had a problem in my heart with (Atrial fibrillation) but he said even that would be resolved, he was afraid to try that. But I saw my Cardiologist on Monday. He said I should stick with steroid like Solu-Medrol dose pack. It's a low dose steroid (Solu-Medrol) for a short period of time. My question is I have to see my ENT Doctor next Friday for follow up. Since I am still having this really annoying ringing in my right ear, how much of a problem if he wants to try the steroid (Solu-Medrol) to take that ringing away and calm the ears and it is probably inflamed by the (Vaccine). Is that going to interfere getting my second shot with getting the full immunity that I need. When probed for second dose due date, consumer stated, I have to get my second shot on 01June2021 but my Doctor needs to use steroid (Solu-Medrol) for my ear. Is that going to be a problem interfering with the immunity to get from the second shot. Therapeutic measures were taken as a result of atrial fibrillation, tinnitus in my right ear; have a lot of annoying ringing in right ear;inflamed, vertigo and dizziness. The outcome for the events atrial fibrillation, tinnitus in my right ear; have a lot of annoying ringing in right ear;inflamed and vertigo was not recovered. The outcome for the event dizziness was unknown.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test with symptoms; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist stated she had a patient that was there for the second dose of the Pfizer COVID vaccine. The pharmacist stated the patient received the first dose of the vaccine on 31Mar2021 and then she tested positive for COVID-19 on 15Apr2021 and had symptoms. The pharmacist stated the patient tested negative for COVID-19 yesterday (15May2021). Outcome of the events was unknown.   Information on the Batch/lot number has been requested.; 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Appendicitis, Computerised tomogram, SARS-CoV-1 test negative
Clinical narrative: appendicitis/diagnosis was acute appendicitis with prerenal azotemia; appendicitis/diagnosis was acute appendicitis with prerenal azotemia; This is a spontaneous report from a contactable consumer. A 22-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 12:45 (Batch/Lot Number: EW0176) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on 20Apr2021 for covid-19 immunization (lot_number=ER8735,lot_unknown=False, administration_date=20Apr2021,administration_time=12:30 PM, dose_number=1,vaccine_location=Left arm]. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced appendicitis/diagnosis was acute appendicitis with prerenal azotemia on 14May2021 10:00 with outcome of recovering, lower abdominal pain on 14May2021 10:00 with outcome of recovering. The patient was hospitalized for appendicitis/diagnosis was acute appendicitis with prerenal azotemia for 2 days.The patient was hospitalized for lower abdominal pain for 2 days.  The patient underwent lab tests and procedures which included computerised tomogram: acute appendicitis   on 14May2021, sars-cov-1 test negative: negative on 14May2021 Nasal Swab. Three days after receiving his second dose, he noticed lower abdominal pain, which resulted in visit to his primary care physician, who suspected appendicitis. He was immediately sent to the hospital for a CT scan that Friday night, and had surgery to remove my appendix Saturday morning. Official diagnosis was acute appendicitis with prerenal azotemia. He was discharged Sunday afternoon. Therapeutic measures were taken as a result of all events. The all events were reported as seriousness criteria of life-threatening.  Information on lot/batch number was available. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure, Vomiting
Clinical narrative: seizures; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm at the age of 63-year-old on 02May2021 (Lot Number: EWQ0171) as single dose for covid-19 immunisation. Medical history reported as no. There was no known allergies. Concomitant medication included telmisartan (MICARDIS) from 2021 (received within 2 weeks of vaccination). The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Apr2021 (Lot Number: ER8729) as single dose for covid-19 immunisation. The patient experienced vomiting and 3 episodes of severe seizures after 9 hours of last vaccine dose on 02May2021. The patient was taking to the hospital emergency room and ICU for treatment. The patient reported the case as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The was not pregnancy at time of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included covid test(Blood test): negative on 03May2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered in May2021.