chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: bloody stools; This is a spontaneous report from a contactable consumer (parent). A 13-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 21Jul2021 at 10:00 (Lot Number: FA7485) at the age of 13-year-old as single dose for COVID-19 immunization. Medical history was none. No other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergies none. Concomitant medications included  multi vitamins, vitamin c [ascorbic acid] and vitamin d [vitamin d nos]. On 22Jul2021 at 21:45, the patient had bloody stools a total of four times on different days after she received her first shot of the Covid-19 Pfizer shot. First bloody stool was Thursday 22Jul2021.  After that day she had bloody stool with less blood each time on Saturday 24Jul2021, Sunday 25Jul2021, Monday 26Jul2021, and Tuesday 27Jul2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient used suppositories for three days as treatment. The outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Her husband is currently in the intensive care unit on a ventilator with Covid 19; Her husband is currently in the intensive care unit on a ventilator with Covid 19; This is a spontaneous report from a contactable consumer or other non hcp (patient wife). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in Jan2021 as dose 1 and dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunization. Patient medical history and concomitant medications were not reported.   On an unspecified date reporter husband was in the intensive care unit on a ventilator with covid 19 (covid-19). Patient received first dose of Pfizer Covid 19 vaccine in Jan2021 and second dose in Feb2021 and he was currently in the intensive care unit on a ventilator with Covid 19. Patient's wife was very concerned and thought they were both protected. She knew there was a chance you could get it but everyone said it would be a mild case and not something you would have to go on a ventilator for. Reporter stated further that if she would have known this, we would have kept our masks on. The patient underwent lab tests and procedures which included sars-cov-2 test: with covid 19 on an unspecified date, currently in the intensive care unit on a ventilator with Covid 19. The outcome of the event covid-19 was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: arm pain; body aches; This is a spontaneous report from a contactable consumer (patient) via Pfizer- sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 06Aug2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient explains that she got her first dose and patient experiencing body aches and arm pain on an unspecified date in Aug2021. She took Tylenol but mentions that it does not work for her. She would like to take ibuprofen and wants to know if it would be ok or is Tylenol the only thing recommended. Therapeutic measures were taken as a result of arm pain and body aches. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: My breathing pattern has change where I have moments that I can't breathe well; Headaches; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 29Jul2021 at 14:00 at the age of 29-year-old as single dose for COVID-19 immunization. Medical history was not reported. No COVID prior vaccination. No COVID tested post vaccination. No known allergy. No other vaccine in four weeks. No other medications in two weeks. On 31Jul2021 at 12:00 PM, the patient experienced breathing pattern had change where he had moments that he can't breathe well and headaches occur. No treatment was received. The outcome of events was not recovered.  Information about the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID  Test; positive COVID  Test; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number, unknown, single for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive COVID test on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date.  The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in the hand and arm of the same side of injection (left); Tingling and numbness in the hand and arm of the same side of injection (left); This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an intramuscular route of administration in the left arm on 05Aug2021 at 15:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 05Aug2021 at 20:00, the patient experienced tingling and numbness in the hand and arm of the same side of the injection (left). The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events tingling and numbness in the hand and arm of the same side of injection (left) were not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received full vaccination several months ago but tested positive for Covid-19 this week. Experiencing loss of smell and mild cold symptoms.; Patient received full vaccination several months ago but tested positive for Covid-19 this week. Experiencing loss of smell and mild cold symptoms.; This is a spontaneous report from a contactable consumer (Pfizer employee). A 42-year-old male patient received the first and second doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot numbers: unknown) via unspecified routes as single doses on unspecified dates for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. It was unknown if patient received other vaccines within four weeks of the COVID-19 vaccine. It was reported that patient received full vaccination several months ago but tested positive for COVID-19 this week on 04Aug2021. Patient was experiencing loss of smell and mild cold symptoms. Adverse event start date was reported as 02Aug2021. Patient received a PCR COVID-test post vaccination via nasal swab on 04Aug2021 with result Positive. There was no treatment received for the events. The outcome of the events was recovering.   The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash macular
Clinical narrative: Red blotches all over body; Very tired all of the time; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 51-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient previously received codeine and experienced drug allergy. The patient did not receive any concomitant medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced red blotches all over body - still 4 months later. The patient was very tired all of the time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red blotches all over body and very tired all of the time were not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia, Paraesthesia
Clinical narrative: muscle pain; twitching in all extremities; ice pick like sensation in all muscle groups, pin pricking like sensation all over the body; This is a spontaneous report from a non-contactable consumer. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included hypothyroid. Concomitant medications included unspecified Thyroid medication. The patient experienced muscle pain, twitching in all extremities and ice pick like sensation in all muscle groups, pin pricking like sensation all over the body on Mar2021. The events resulted in emergency room visit and physician office visit and were assessed as disability by the reporter. The patient did not received any treatment for the events. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal, Headache, Pruritus
Clinical narrative: Feels like crap; Body itches in different places; blood pressure 170/110; Headaches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included high blood pressure; he has had high blood pressure before, but his medication keeps it under control. The patient's concomitant medications were not reported. The patient developed headaches. This morning at 2am, he had a really bad headache and checked his blood pressure and it was 170/110. He did not specify what blood pressure medication he was taking. He stated he felt like crap. The patient further stated that he had the itch, clarified that his body itches in different places. He has had high blood pressure before, but his medication keeps it under control. He got a Covid shot on Wednesday morning. Yesterday morning he got a headache (05Aug2021), and he woke up at 2am this morning (06Aug2021) with a really bad headache so he thought he better check his blood pressure, and it was 170/110. He asked could the Covid vaccine make it to where the blood pressure medicine can not do the job it needs to do. He stated that he felt like crap. Stated that this may all be normal, he just wanted to be sure that high blood pressure could be a side effect of the shot. Stated that his doctor's office was closed on Fridays, or he would call them. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes under my arm that became large and painful. They had to be surgically removed.; swollen lymph nodes under my arm that became large and painful. They had to be surgically removed.; shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 2, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 in Jan2021 for COVID-19 Immunization and became ill. The patient works at a local hospital as an MLT and received the first shot in January. Afterwards, patient became ill, and got better and therefore received the second shot. On unspecified date, after the second shot, patient ended up with swollen lymph nodes under the arm that became large and painful and had to be surgically removed. A month after, patient ended up with shingles. Prior to the vaccine patient had no underlying health issues. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Menstruation delayed, Thrombosis, Vaccination site rash
Clinical narrative: when I had it, it was very blood clotty and short; My period went late by 3 weeks; also have had a few minor rashes since the vaccine on my arm around the injection site; battling diaharrea for a few weeks; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jun2021 11:00 (Batch/Lot Number: EW0161) as dose 2, single (at the age of 39 years) for covid-19 immunisation. The patient's medical history included nut allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EP7533) via unspecified route in the right arm on 11Jun2021 at 15:45PM (at the age of 39 years) for Covid-19 immunisation. On 06Jul2021, the patient experienced when she had it, it was very blood clotty and short, her period went late by 3 weeks, also have had a few minor rashes since the vaccine on my arm around the injection site, and battling diarrhea for a few weeks. It was further reported that patient typically have regular periods. Her period went late by 3 weeks, when she had it, it was very blood clotty and short. She never had late periods, nor a period like that before. Patient also had few minor rashes since the vaccine on my arm around the injection site and was battling diarrhea for a few weeks after the second shot.  Nothing was major, but felt that any additional information for the vaccine would be helpful for you all- thank you for all your hard work. The outcome of the events was recovered on unknown date.   No follow-up attempts are possible; information about batch number already obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Pyrexia, Vaccination failure
Clinical narrative: Patient got positive results of COVID-19 on 08-06-2021; Patient got positive results of COVID-19 on 08-06-2021; OTCs for fever; This is a spontaneous report from a contactable consumer or other non hcp. A 27-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EP6955) via an intramuscular route of administration, administered in arm left on 23Mar2021 at 13:00 (age at the time of vaccination 27-years-old) as DOSE 1, SINGLE and dose 2 (Lot Number: EP6955) via an intramuscular route of administration, administered in arm left on 12Apr2021 at 13:00 (Age at the time of vaccination: 27-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient had no known allergies. The patient medical history not reported. There were no concomitant medications reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. On 03Aug2021 at 08:00 AM, The patient got positive results of covid-19 on 08-06-2021 and OTCs for fever. The patient underwent lab tests and procedures which included polymerase chain reaction was positive on 05Aug2021. Therapeutic measures were taken as a result of OTCs for fever. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The event OTCs for fever outcome was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: developed blood clots; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on an unspecified date in Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on an unspecified date in Jul2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after the first dose of vaccination, the patient experienced developed blood clots. Reporter reported that, the patient developed blood clots after getting both doses of the vaccine. Reporter wanted to know what studies and reports was available of others experiencing the same effect. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available limited information, a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event thrombosis cannot be fully assessed/exclude. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test result Positive / throat, cough, nasal congestion; COVID test result Positive / throat, cough, nasal congestion; This is a spontaneous report from a contactable consumer (patient).    A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 10Jun2021 (Lot Number: EW0191) and dose 1 via an unspecified route of administration, administered in Arm Right on 20May2021 (Lot Number: EW0187), both at single dose (at the age of 15 years old) for COVID-19 immunisation.  Medical history included known allergies: Penicillin. There were no concomitant medications.  The vaccines were administered at Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Jul2021, the patient experienced sore throat, cough, nasal congestion. COVID test result was positive on 01Aug2021. Post vaccination patient was diagnosed with COVID-19. Patient did not receive any treatment for the reported events. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: my husband now has Covid; my husband now has Covid; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (husband). A male patient of an unspecified age was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown) as a dose 2, via an unspecified route of administration in Jan2021 as dose 2, single, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in Jan2021 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date on 2021,  my husband now has Covid. The reporter reported that, after receiving two doses of the Pfizer vaccine in Jan my husband now has Covid. I probably do also. I just did not get tested. The lab data included tested Covid on an unspecified date on 2021.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Gait disturbance, Pain in extremity, Paralysis
Clinical narrative: Felt like she had no breath; couldn't walk; felt paralyzed; the pain moved from the arm to her back; Pain in left arm; This is a spontaneous report from a contactable consumer.   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     There were no concomitant medications.  The patient experienced the pain moved from the arm to her back (back pain) (non-serious) on 31Jul2021 with outcome of not recovered , couldn't walk (gait disturbance) (non-serious) on 04Aug2021 12:00 with outcome of not recovered , felt paralyzed (paralysis) (non-serious) on 04Aug2021 with outcome of recovered , pain in left arm (pain in extremity) (non-serious) on 29Jul2021 16:00 with outcome of unknown , felt like she had no breath (dyspnoea) (non-serious) on 04Aug2021 12:30 with outcome of recovered.  The patient underwent lab tests and procedures which included x-ray: unknown results   on 2021  .  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of the pain moved from the arm to her back (back pain), felt like she had no breath (dyspnoea).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Felt like she had no breath; couldn't walk; felt paralyzed; the pain moved from the arm to her back; Pain in left arm; This is a spontaneous report from a contactable consumer.   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     There were no concomitant medications.  The patient experienced the pain moved from the arm to her back (back pain) (non-serious) on 31Jul2021 with outcome of not recovered , couldn't walk (gait disturbance) (non-serious) on 04Aug2021 12:00 with outcome of not recovered , felt paralyzed (paralysis) (non-serious) on 04Aug2021 with outcome of recovered , pain in left arm (pain in extremity) (non-serious) on 29Jul2021 16:00 with outcome of unknown , felt like she had no breath (dyspnoea) (non-serious) on 04Aug2021 12:30 with outcome of recovered.  The patient underwent lab tests and procedures which included x-ray: unknown results   on 2021  .  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of the pain moved from the arm to her back (back pain), felt like she had no breath (dyspnoea).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Aug2021 at 16:00, after 4 hours of receiving the vaccine, the patient experienced shingles. The events result in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported event which included prescription medication. The clinical outcome of the event shingles was not recovered at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hyperhidrosis, Hypertension, Paraesthesia
Clinical narrative: High blood pressure; Sweating; Lump in throat; Started seeing stars; Tingling in both hands; This is a spontaneous report from a contactable HCP (Pharmacy intern). An unspecified age male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced high blood pressure, sweating, lump in throat, started seeing stars and tingling in both hands. The report was no related to a study or programme. The reporter's Pharmacist wanted to know if these have been reported and if there was any information on incidents of blood pressure increasing. Post-authorization safety reports: As of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal mass
Clinical narrative: High blood pressure; Sweating; Lump in throat; Started seeing stars; Tingling in both hands; This is a spontaneous report from a contactable HCP (Pharmacy intern). An unspecified age male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, the patient experienced high blood pressure, sweating, lump in throat, started seeing stars and tingling in both hands. The report was no related to a study or programme. The reporter's Pharmacist wanted to know if these have been reported and if there was any information on incidents of blood pressure increasing. Post-authorization safety reports: As of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: developed COVID-19 infection; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced developed covid-19 infection. Reporter would like to know what patient should do about his second dose of the Pfizer COVID-19 vaccine that was scheduled on 13Aug2021 and by when he will be out of isolation. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The outcome of the event was unknown.
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 pharmacist. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist called for patient who received first dose of Pfizer COVID-19 vaccine on an unspecified date and then after receiving tested positive for COVID on an unspecified date. The pharmacist was wondering when can the patient get second dose, what would be recommended. The outcome of the events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: B-lymphocyte count, B-lymphocyte count decreased, Haemolysis, SARS-CoV-2 antibody test
Clinical narrative: her b-cells are 1% of normal now; increase in hemolysis; This is a spontaneous report from a contactable consumer (patient's parent). A 15-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0185) via an unspecified route of administration on 16May2021 (15-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included autoimmune hemolytic anemia. Concomitant medications were not reported. The patient previously received Rituximab in 2018 to ablate her B cells (for autoimmune hemolytic anemia). The patient experienced an increase in hemolysis for a period of 3 weeks after the shot, from 19May2021. The event resulted in Doctor or other healthcare professional office/clinic visit. Patient's parent reported, "My 15-year-old daughter has autoimmune hemolytic anemia. She received Rituximab that ablated her B cells in 2018. She experienced an increase in hemolysis. Hospital test showed that she did not develop any antibody. Please advise how we can check if she has any protection against COVID-19...Should she try to get the 2nd shot. Her hematologist is unsure if there will be any benefits." Her b-cells are 1% of normal now. The patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination (as reported). No therapeutic measures were taken as a result of the events. The outcome of the event increase in hemolysis was recovered; outcome of other event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac flutter, Dysgeusia, Dyspnoea
Clinical narrative: heart racing; metal taste; blood pressure though the roof; Couldn't breathe; Thought having panic attack; a tiny bit of heart fluttering; tingling in her back; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included sjogren's syndrome from an unknown date and unknown if ongoing (does not take medication to treat it). The patient's concomitant medications were not reported. On 26Jun2021 00:35, 35 minutes after she experienced a metal taste and heart racing, blood pressure though the roof, couldn't breathe. Patient  stated she's not sure if it was a panic attack and did require paramedic help for an hour. Later in the day, she felt tingling in her back and it continues every once in a while and occasionally a tiny bit of heart fluttering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the events dyspnea, panick attack and cardiac flutter with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic attack, Paraesthesia
Clinical narrative: heart racing; metal taste; blood pressure though the roof; Couldn't breathe; Thought having panic attack; a tiny bit of heart fluttering; tingling in her back; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included sjogren's syndrome from an unknown date and unknown if ongoing (does not take medication to treat it). The patient's concomitant medications were not reported. On 26Jun2021 00:35, 35 minutes after she experienced a metal taste and heart racing, blood pressure though the roof, couldn't breathe. Patient  stated she's not sure if it was a panic attack and did require paramedic help for an hour. Later in the day, she felt tingling in her back and it continues every once in a while and occasionally a tiny bit of heart fluttering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the events dyspnea, panick attack and cardiac flutter with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was a mother who was calling regarding her child. On an unspecified date, she stated regarding herself that she had an anaphylactic reaction with the first dose of the Pfizer COVID19 vaccine and so we would not be getting the second dose. She would like to know if any data on how likely her child was to have the same type of reaction. She stated that she would like to know a certain percentage of people who have had an anaphylactic reaction. She had spoken to 3 doctors and they did not know how likely it would be for her child to have the same reaction. The clinical outcome of the event was unknown at the time of report.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hemiplegia, Loss of consciousness, Seizure, Speech disorder, Transient ischaemic attack
Clinical narrative: TIA MINI STROKE; went into a seizure; My whole right side lost everything; lost everything; whole side started shaking; lost everything my speech everything; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received the second dose of bnt162b2 on 26Apr2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient got a reaction to the vaccine. The whole right side lost everything the speech everything. The last second vaccine of Pfizer was 26Apr2021 whole side started shaking and lost everything and went into a seizure. Patient went into a TIA MINI STROKE. Make sure no one went through what patient did. This was so hard on patient life and the daughters. The life was not the same. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TIA MINI STROKE; went into a seizure; My whole right side lost everything; lost everything; whole side started shaking; lost everything my speech everything; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received the second dose of bnt162b2 on 26Apr2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient got a reaction to the vaccine. The whole right side lost everything the speech everything. The last second vaccine of Pfizer was 26Apr2021 whole side started shaking and lost everything and went into a seizure. Patient went into a TIA MINI STROKE. Make sure no one went through what patient did. This was so hard on patient life and the daughters. The life was not the same. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Visual impairment
Clinical narrative: stroke; brain bleed; vision was affected; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer reported that a male patient (reporter's brother-in-law) of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 2021 (lot number and expiry date was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that within 12 days of the patient's second shot, he had a brain bleed and a stroke on an unknown date in 2021. The patient was slowly getting better and there are things that are more of a struggle like his vision was affected. Retraining his brain has also been a bit of a challenge. The reporter states that they understand numerous factors could have caused this stroke and brain bleed, but, it was also a side effect of the vaccine and that they needed to report this. The outcome of the events stroke and brain bleed was recovering while the outcome of the event vision was affected was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive 16 days after dose 2, requiring admission; tested positive 16 days after dose 2, requiring admission; This is a literature report. The full publication has been requested.  A patient of unspecified age and gender received first and second dose of BNT162B2, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing cancer.  The patient's concomitant medications were not reported.  The patient was tested positive 16 days after dose 2, requiring admission. The patient underwent lab tests and procedures which included COVID-19 (C19) test: positive.  The action taken in response to the event for bnt162b2 was not applicable. 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.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of the lack of efficacy of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Consumer was fully vaccinated with Pfizer vaccine. Contracted COVID Tested positive; Contracted COVID Tested positive; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported, Consumer was fully vaccinated with Pfizer vaccine. Contracted COVID while Tested positive ill with symptoms for one week. On an unspecified date the outcome of the event was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient developed Covid-19 infection with a positive test on 05Aug2021. Symptoms included fever (up to 103 F), chills, congestion, and cough.; Patient developed Covid-19 infection with a positive test on 05Aug2021. Symptoms included fever (up to 103 F), chills, congestion, and cough.; This is a spontaneous report from a contactable consumer (Pfizer employee). A 39-year-old male patient (Pharmacist) received bnt162b2, dose 2 intramuscularly on 22Jan2021 (Lot Number: EL3246) as dose 2, single, dose 1 intramuscularly on 30Dec2020 (Lot Number: EH9899) as dose 1, single, both at the age of 39-year-old for covid-19 immunisation. No relevant medical history. No known allergies. No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. Patient developed Covid-19 infection with a positive test on 05Aug2021 03:00. Symptoms included fever (up to 103F), chills, congestion, and cough. No treatment received for COVID-19. No Covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab: positive on 05Aug2021. The outcome of COVID-19 was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glossodynia, Migraine, Pain, Pyrexia
Clinical narrative: Sores on the back of tongue; High fever; Migraine; Fatigued beyond comprehension; Body aches so bad nothing helps.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jul2021 at 15:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had known allergies to azithromycin (ZITHROMAX). Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jul2021 at 06:00, the patient experienced every symptom severely over a week. The patient experienced sores on the back of tongue, high fever and migraine that won't let up. The patient stated she would not be getting the second dose as she was fatigued beyond comprehension and her body ached so bad nothing helped. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sores on the back of tongue, high fever, migraine, fatigued beyond comprehension and body ached so bad nothing helped was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Full body rash; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 29May2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 08May2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 02Jun2021, the patient experienced full body rash. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 03Jun2021, the patient underwent SARS-COV-2 Test (Nasal Swab) and the result was Negative. The clinical outcome of the event full body rash was recovered with sequelae at the time of this report.   No follow-up attempts are possible. No further information is expected.