chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: My first shot kicked me out of menopause. I had a full cycle after 3 years of no period; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program A female patient of 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 single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "My first shot kicked me out of menopause". I had a full cycle after 3 years of no period". The adverse event onset date was on 22Apr2021 (12:32). The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Seizure
Clinical narrative: worst seizure; First Pfizer Covid Shot on 17Mar2021# Second Pfizer Covid Shot on 31Mar2021; This is a spontaneous report from a non-contactable consumer (parent of patient). This report is for the second dose. A 16-year-old non-pregnant female patient received BNT162B2(PFIZER BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 31Mar2021 (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. Relevant medical history includes catamenial epilepsy and attention deficit hyperactivity disorder (ADHD). Patient had no other vaccines in 4 weeks. Patient had no known allergies. Patient had not had COVID prior to vaccination. Concomitant medications included levetiracetam (KEPPRA) taken at 1000 mg twice daily to help control seizures, start and stop date were not reported and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient historically took first dose of Pfizer BNT162B2 (Lot number EN6206) on the left arm at age 16 years on 17Mar2021 at 10:30AM for COVID-19 immunisation and experienced worst seizures. Reporter's daughter has been diagnosed with catamenial epilepsy, and has been taking 1000 mg KEPPRA twice daily to help control seizures. The shortest duration between seizures was approximately 1 month, and that was before her epilepsy diagnosis and starting on the KEPPRA. She has recently suffered a cluster of seizures which is atypical for her. Last night, reporter read an article about some women starting their periods after years of not having it soon after receiving the COVID vaccine, so reporter looked back at her daughter's seizure record and noticed a potential link.Patient had her first Pfizer COVID Shot on 17Mar2021, and she experienced her worst seizure ever on 27Mar2021 (10 days after COVID vaccine). On 31Mar2021, patient had her second Pfizer COVID Shot and she experienced her second worst seizure ever on 10Apr2021 (again 10 days after the second COVID vaccine. Again, her daughter has never had seizures occur in such a short duration, with the minimum time between seizures being one month. The adverse reaction resulted in doctor or other healthcare professional office/clinic visit. Patient was treated for the event which is increase in KEPPRA dose to 1250 mg. Patient had not been tested with COVID-19 post vaccination. Vaccination facility was at a public health department. The outcome was unknown.   No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I had a seizure and I am not common to having seizure; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 33-year-old, dose 2 via an unspecified route of administration, administered in left arm on 21Apr2021 (Lot Number: ER8735) as single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included bisoprolol 10 mg. The patient was previously vaccinated with the first dose of BNT162B2 on 31Mar2021 at the age of 33-year-old for COVID-19 immunisation. The patient stated that he had a seizure on 21Apr2021, and he was not common to having seizure. No treatment was received for the event. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Thyroid cancer
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st DOSE SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported she recently had thyroid cancer and got pregnant a few months ago. She received the vaccine. The patient was not enrolled in a clinical trial. Clinical outcome of the events thyroid cancer and got pregnant a few months ago, received the vaccine was unknown.   Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Autoscopy, Hallucination, Lack of spontaneous speech
Clinical narrative: Hallucinations; Wanting to speak but couldn't speak; out of body experience; This is a spontaneous report from a contactable consumer, reporting for herself.  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 08:45 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included thalassaemia from an unknown date, drug allergy (unspecified) from an unknown date, food allergy (unspecified) from an unknown date. The patient's concomitant medications were not reported.  Past vaccination history included first dose of BNT162B2 on 02Apr2021 at 07:45 in the left arm for covid-19 immunization. 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 experienced hallucinations on 23Apr2021 at 23:00 with outcome of recovering, wanting to speak but couldn't speak on 23Apr2021 at 23:00 with outcome of recovering, and out of body experience on 23Apr2021 at 23:00 with outcome of recovering. The patient did not receive treatment for the events.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Congenital anomaly, Maternal exposure timing unspecified
Clinical narrative: anomaly or birth defect; anomaly or birth defect; This is a spontaneous report from a contactable other HCP, the parent for mother/baby. This is the baby case. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) transplacental, in the left arm on 09Apr2021 at 10:00 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced unspecified anomaly or birth defect on an unspecified date.  The outcome of the event was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of anomaly or birth defect  due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : -PFIZER INC-2021456443 mother/baby
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Gait disturbance, Pain, Peripheral swelling, Skin burning sensation
Clinical narrative: skin its burning like there was fire in her leg; Right leg was so swollen; can't walk; pain was excruciating; Knee problem; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 01Mar2021 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The first dose was received on 08Feb2021 at age 65 years old. Medical history included diabetes and heart condition; both from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the vaccination, patient was in the hospital. They can't find nothing wrong with her, patient's right leg was so swollen and the skin its burning like there was fire in her leg and she believe that this was.. (statement incomplete). Patient had been in bed can't walk, her skin burns and the pain was excruciating. It was reported that three weeks ago, like 01April, she started getting the symptoms. Patient started having knee problem like a week, it got out worse and worse and then on 01Apr2021, it started really highly worse that she had to go back to the doctor and then can do X-ray. The things were worse and worse that she ended up in the hospital (reason not clarified) that she couldn't work,  couldn't walk and it was burning achy and unbearable. Patient was still on bed, still can't work and was still have the burning feeling in her leg. She was hospitalized on 01Apr2021 but had problems prior to it but got worse on 01Apr2021. Date of discharge was reported was 18Apr2021. Outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: skin its burning like there was fire in her leg; Right leg was so swollen; can't walk; pain was excruciating; Knee problem; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 01Mar2021 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The first dose was received on 08Feb2021 at age 65 years old. Medical history included diabetes and heart condition; both from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the vaccination, patient was in the hospital. They can't find nothing wrong with her, patient's right leg was so swollen and the skin its burning like there was fire in her leg and she believe that this was.. (statement incomplete). Patient had been in bed can't walk, her skin burns and the pain was excruciating. It was reported that three weeks ago, like 01April, she started getting the symptoms. Patient started having knee problem like a week, it got out worse and worse and then on 01Apr2021, it started really highly worse that she had to go back to the doctor and then can do X-ray. The things were worse and worse that she ended up in the hospital (reason not clarified) that she couldn't work,  couldn't walk and it was burning achy and unbearable. Patient was still on bed, still can't work and was still have the burning feeling in her leg. She was hospitalized on 01Apr2021 but had problems prior to it but got worse on 01Apr2021. Date of discharge was reported was 18Apr2021. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia, Weight
Clinical narrative: arm was very tender; fever or 103 degrees went up to 105-106 degrees; Chills; This is a spontaneous report received from a contactable consumer (patient friend). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number: Unknown) via an unspecified route of administration on 20Apr2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021, the patient experienced fever or 103 degrees (reported as last night) stated it went up to 105-106 degrees fever, she was also very chilly with two or three blankets now the fever was 102 and her arm was very tender. Patient received Tylenol and it has improved. The outcome for the events fever or 103 degrees went up to 105-106 degrees and chills was recovering and for arm was very tender was not recovered. Reporter enquired whether her friend is going to be okay or if she needs to go to the emergency room.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immobile, Migraine, Nervousness, Pain
Clinical narrative: She could even barely make it to give herself to go pee, she was completely immobilized.; Migraine/light sensitive/nausea/headache; Extremely dizzy; Painful and scary; scary; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the 1st of 2 reports.  A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) (at the age of 42-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that she woke up at 6:00 in the morning (on 17Apr2021), there were on migraine, light sensitive, extremely nauseous and extremely dizzy. She could even barely make it to give herself to go pee, she was completely immobilized. She was that nauseous and that dizzy, she was staying in the bed she could not do anything else; she could not get in the kitchen or get something to drink. She took a MOTRIN (as a treatment) around 3 after, she was still felling the symptoms, migraine got disappeared, she was able to move around but eventually got better headache. She was painful and scary. The patient outcome of migraine was recovered and the outcome of the other events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021479302 same reporter, drug, different patient and event
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Kidney infection, Night sweats, Pyrexia
Clinical narrative: headaches; severe kidney infection; drenching night sweats; Fever; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 as single dose for COVID-19 immunization in an hospital. Medical history included irritable bowel syndrome-constipation (IBS-C) from an unknown date. No known allergies. Unknown if with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication and unspecified generic birth control both start and stop date were not reported. On 31Mar2021, the patient experienced fever and drenching night sweats. On 01Apr2021 the patient developed headaches. On an unspecified date on Apr2021, 4-5 days post vaccination of the first dose, the patient developed severe kidney infection treated with ciprofloxacin. The events required doctor or office/clinic and emergency room visit. The outcome of the events was recovered. The patient received the second dose on bnt162b2 (lot number: EW0164) on 19Apr2021 left arm for COVID-19 immunization.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive after all; Tested positive after all; This is a spontaneous report received from a contactable consumer (patient) reported that a male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches and cough and tested positive after all in 2021. He stated that it's been 3 months he never got the 2nd dose of the vaccine. Right now, he wanted to know if he can get the 2nd dose and is it safe after all. The outcome of the events were unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021480462 Same patient and product, different dose
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Influenza, Malaise, SARS-CoV-2 test positive
Clinical narrative: Tested positive after all; Tested positive after all; This is a spontaneous report received from a contactable consumer (patient) reported that a male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches and cough and tested positive after all in 2021. He stated that it's been 3 months he never got the 2nd dose of the vaccine. Right now, he wanted to know if he can get the 2nd dose and is it safe after all. The outcome of the events were unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021480462 Same patient and product, different dose
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: he had a minor stroke; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's sister) reported that a male patient (reporter's brother) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date in Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter's brother was scheduled to take the 2nd dose of the Pfizer Covid-19 vaccine on 01May2021 (Saturday) however on 19Apr2021 (Monday) he had a minor stroke. Reporter would like to know if her brother can still proceed with the 2nd dose. First dose was given 3 weeks ago. The outcome of the event was unknown.  Information about lot/batch number could not obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid infection >14 days after first eligible dose of vaccination; Covid infection >14 days after first eligible dose of vaccination; This is a literature report. This literature report from a physician reporting same event under the same suspect product for 9 patients. This is one of 9 reports.  Many pregnant persons are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. Method: From 14Dec2020, to 28Feb2021, authors used data from the Vaccine Adverse Event Reporting System (VAERS), and other data to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons. Result: A total of 35,691 participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases). Conclusions: Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.  An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced COVID infection more than 14 days after first eligible dose of vaccination on an unspecified date. The mother reported she became pregnant while taking bnt162b2.  The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 7 days after the second dose.,Linked Report(s) : US-PFIZER INC-2021513072 Pfizer;US-PFIZER INC-2021513093 Pfizer;US-PFIZER INC-2021513094 Pfizer;US-PFIZER INC-2021513095 Pfizer;US-PFIZER INC-2021513097 Pfizer;US-PFIZER INC-2021513098 Pfizer;US-PFIZER INC-2021513099 Pfizer;US-PFIZER INC-2021513096 Pfizer
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID after first vaccine; COVID after first vaccine; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient's son) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Solution for injection, via an unspecified route of administration (dose: 01) on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the reporter mentioned that after the vaccination the patient had COVID-19. The outcome of the event was unknown.  No other new information reported. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage
Clinical narrative: Arm started bleeding; it was too fast to have the vaccine administered; This is a spontaneous report from a contactable nurse, the patient (retired registered nurse). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for COVID-19 immunization and had no adverse event. On 27Apr2021, patient stated that when she received the second dose of the Pfizer BNT162B2, she believes that the vaccine was no administered as the person who did just "jabbed" the syringe in a second, her arm started bleeding and placed a band aid and stated that it was too fast to have the vaccine administered. She found suspicious that the vaccine provider did not write down his initials on the vaccination card as the lady who administered the first dose did. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; 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 vaccination site bleeding. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Heart rate increased, Lethargy, Nausea, Pain
Clinical narrative: Fever running around 102 it spikes to 104.5; Nausea; Bodyache; Vomiting; soreness in my arm where shot was given; rapid heartbeat; Lethargic; This is a spontaneous report received from a contactable consumer (reporting himself). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via intramuscular in left arm (left upper arm) on 22Apr2021 at 23:30 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medication included diltiazem hydrochloride tablet; once a day by mouth for High Blood Pressure, Irbesartan/ Hydrochlorot tablet; 300-12.5 mg; frequency as once in a day and route of administration as orally, daily for High Blood Pressure. Patient stated, I trying to report, I have severe reaction to the Pfizer 2nd Covid shot. On 22Apr2021, the patient experienced fever, running around 102 it spikes to 104.5, nausea, bodyache, vomiting, soreness in my arm where shot was given, rapid heartbeat and lethargic. The patient received Advil 200 mg, took two pills for total 400mg as treatment medication for events. Patient confirmed about taking the shot from the nurse. The outcome was not recovered.   No follow-up attempts are needed. No further information was expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Fever running around 102 it spikes to 104.5; Nausea; Bodyache; Vomiting; soreness in my arm where shot was given; rapid heartbeat; Lethargic; This is a spontaneous report received from a contactable consumer (reporting himself). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8735), via intramuscular in left arm (left upper arm) on 22Apr2021 at 23:30 as a single dose for COVID-19 immunization. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient's concomitant medication included diltiazem hydrochloride tablet; once a day by mouth for High Blood Pressure, Irbesartan/ Hydrochlorot tablet; 300-12.5 mg; frequency as once in a day and route of administration as orally, daily for High Blood Pressure. Patient stated, I trying to report, I have severe reaction to the Pfizer 2nd Covid shot. On 22Apr2021, the patient experienced fever, running around 102 it spikes to 104.5, nausea, bodyache, vomiting, soreness in my arm where shot was given, rapid heartbeat and lethargic. The patient received Advil 200 mg, took two pills for total 400mg as treatment medication for events. Patient confirmed about taking the shot from the nurse. The outcome was not recovered.   No follow-up attempts are needed. No further information was expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Illness, Nausea, Syncope
Clinical narrative: I almost fainted; Nausea; Feeling sick and throw up; Feeling sick and throw up; felt very light headed/dizzy; Ear pain (right); This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at 18:00 (Lot Number: EW0162), as single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included unspecified nasal spray. The patient experienced almost fainted (medically significant) on an unspecified date with outcome of unknown, nausea (non-serious) on an unspecified date with outcome of unknown, feeling sick and throw up (non-serious) on an unspecified date with outcome of unknown, felt very light headed/dizzy (non-serious) on an unspecified date with outcome of unknown, ear pain (right) (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I almost fainted; Nausea; Feeling sick and throw up; Feeling sick and throw up; felt very light headed/dizzy; Ear pain (right); This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 21Apr2021 at 18:00 (Lot Number: EW0162), as single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medication included unspecified nasal spray. The patient experienced almost fainted (medically significant) on an unspecified date with outcome of unknown, nausea (non-serious) on an unspecified date with outcome of unknown, feeling sick and throw up (non-serious) on an unspecified date with outcome of unknown, felt very light headed/dizzy (non-serious) on an unspecified date with outcome of unknown, ear pain (right) (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; This is a spontaneous report received from patient. A female patient of an unspecified age received at second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient experienced and got the second dose of the Pfizer COVID vaccine after 5 days later, tested positive for COVID-19 and tested positive for COVID-19 on an unspecified date. The report was received as, caller was calling on behalf of her daughter who has been exposed to COVID-19 after receiving the first dose. "My husband and I got the second dose of the Pfizer COVID vaccine and a 5 days later, tested positive for COVID-19. My daughter has tested negative, but she lives in the house with us. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The events were assessed as medically significant. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; This is a spontaneous report received from patient. A female patient of an unspecified age received at second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient experienced and got the second dose of the Pfizer COVID vaccine after 5 days later, tested positive for COVID-19 and tested positive for COVID-19 on an unspecified date. The report was received as, caller was calling on behalf of her daughter who has been exposed to COVID-19 after receiving the first dose. "My husband and I got the second dose of the Pfizer COVID vaccine and a 5 days later, tested positive for COVID-19. My daughter has tested negative, but she lives in the house with us. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The events were assessed as medically significant. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus congestion
Clinical narrative: got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; got the second dose of  the Pfizer covid vaccine and a 5 days later, tested positive for covid 19; This is a spontaneous report received from patient. A female patient of an unspecified age received at second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient experienced and got the second dose of the Pfizer COVID vaccine after 5 days later, tested positive for COVID-19 and tested positive for COVID-19 on an unspecified date. The report was received as, caller was calling on behalf of her daughter who has been exposed to COVID-19 after receiving the first dose. "My husband and I got the second dose of the Pfizer COVID vaccine and a 5 days later, tested positive for COVID-19. My daughter has tested negative, but she lives in the house with us. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The events were assessed as medically significant. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Initial insomnia, Pain, Seizure
Clinical narrative: seizure; Body soreness; Inability to sleep/stay asleep; Loss of memory/confusion; Loss of memory/confusion; This is a spontaneous report from a contactable consumer. A 26-yearsold male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Apr2021 13:00 (Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right as single dose for covid-19 immunization (Age at vaccination: 26 years). Medical history included High blood pressure. Concomitant medication included marijuana. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm (lot number: EW0150) on 08Apr2021, 10:00AM for covid-19 immunization (Age at vaccination: 25 years). The patient experienced seizure, body soreness, inability to sleep/stay asleep (initial insomnia), loss of memory/confusion on 30Apr2021 07:00. The events were assessed as life-threatening by the reporter. The patient was not diagnosed with COVID-19 prior vaccination and the patient has not been tested with COVID-19 since the vaccination. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Illness
Clinical narrative: Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Secretion discharge, Vomiting
Clinical narrative: Dizzy; Weak; Non-stop vomiting for 8 hours; Nausea; Loose stools; Body Aches; Chills, no fever; Too sick to call Pfizer yesterday about symptoms; Has a ton of mucous discharge; This is a spontaneous report from a contactable Nurse. A 62-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: JR8729), via an unspecified route of administration, administered in Deltoid Left on 21Apr2021 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 62 years). The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6207) on 31Mar2021 for covid-19 immunisation and experienced Sore Arm after first vaccine (Age at vaccination: 62 years). The patient also had a historical vaccine of Flu vaccine on 16Oct2020 for immunisation and experienced Local Reaction; Redness at injection site (Age at vaccination: 61 years). The patient experienced non-stop vomiting for 8 hours on 22Apr2021 02:30, nausea, loose stools, body aches, chills, no fever and too sick to call Pfizer yesterday about symptoms on 22Apr2021, dizzy and weak on 23Apr2021. The patient also stated that she has a ton of mucous discharge on Apr2021. The events were considered as medically significant by the reporter. Outcome of the event vomiting was recovered on 22Apr2021, outcome of the events body aches and chills was recovering while outcome of the events mucous discharge and sickness was unknown. Outcome of the remaining events was not recovered.; Sender's Comments: There is a reasonable possibility that the events vomiting, nausea, diarrhea, and chills were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events 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, Chills, Dizziness, Erythema, Feeling abnormal
Clinical narrative: Nausea; Chills; Blurry brain; When the needle got in, she felt warmth in her body; Felt pressure in her head; Left side of the face got numb; Felt lightheadedness/dizziness; Her nervous system started tingling; Redness at the hand; Headaches; severe allergic reactions, including anaphylaxis; Severe allergic reaction; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included diabetes type 2. Concomitant medications were not reported. It was reported that, "severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials." She received the first dose of the vaccine on 19Apr2021. She was due for the second dose on 10May2021. She says she had a severe allergic reaction after the first dose on an unspecified date in 2021. When the needle got in, she felt warmth in her body on 19Apr2021. After the shot, she felt pressure in her head, her left side of the face got numb, she felt lightheadedness/dizziness, her nervous system started tingling on 19Apr2021. She stayed at the vaccination site 1 hour until they told her it was ok to go. She added that she had redness at the hand on 19Apr2021. The next day (20Apr2021), she had nausea, chills, blurry brain. She says she's still getting headaches/dizziness on an unspecified date in 2021. Enquired what was the efficacy after one dose. Referred to her healthcare professional. Enquired how many severe allergic reactions were reported. Response: No specific numbers found. Enquired should she get the second dose or not. The outcome of the events headache, dizziness was not recovered and unknown for the other events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, Headache, Hypersensitivity, Hypoaesthesia
Clinical narrative: Nausea; Chills; Blurry brain; When the needle got in, she felt warmth in her body; Felt pressure in her head; Left side of the face got numb; Felt lightheadedness/dizziness; Her nervous system started tingling; Redness at the hand; Headaches; severe allergic reactions, including anaphylaxis; Severe allergic reaction; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included diabetes type 2. Concomitant medications were not reported. It was reported that, "severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials." She received the first dose of the vaccine on 19Apr2021. She was due for the second dose on 10May2021. She says she had a severe allergic reaction after the first dose on an unspecified date in 2021. When the needle got in, she felt warmth in her body on 19Apr2021. After the shot, she felt pressure in her head, her left side of the face got numb, she felt lightheadedness/dizziness, her nervous system started tingling on 19Apr2021. She stayed at the vaccination site 1 hour until they told her it was ok to go. She added that she had redness at the hand on 19Apr2021. The next day (20Apr2021), she had nausea, chills, blurry brain. She says she's still getting headaches/dizziness on an unspecified date in 2021. Enquired what was the efficacy after one dose. Referred to her healthcare professional. Enquired how many severe allergic reactions were reported. Response: No specific numbers found. Enquired should she get the second dose or not. The outcome of the events headache, dizziness was not recovered and unknown for the other events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: Nausea; Chills; Blurry brain; When the needle got in, she felt warmth in her body; Felt pressure in her head; Left side of the face got numb; Felt lightheadedness/dizziness; Her nervous system started tingling; Redness at the hand; Headaches; severe allergic reactions, including anaphylaxis; Severe allergic reaction; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included diabetes type 2. Concomitant medications were not reported. It was reported that, "severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials." She received the first dose of the vaccine on 19Apr2021. She was due for the second dose on 10May2021. She says she had a severe allergic reaction after the first dose on an unspecified date in 2021. When the needle got in, she felt warmth in her body on 19Apr2021. After the shot, she felt pressure in her head, her left side of the face got numb, she felt lightheadedness/dizziness, her nervous system started tingling on 19Apr2021. She stayed at the vaccination site 1 hour until they told her it was ok to go. She added that she had redness at the hand on 19Apr2021. The next day (20Apr2021), she had nausea, chills, blurry brain. She says she's still getting headaches/dizziness on an unspecified date in 2021. Enquired what was the efficacy after one dose. Referred to her healthcare professional. Enquired how many severe allergic reactions were reported. Response: No specific numbers found. Enquired should she get the second dose or not. The outcome of the events headache, dizziness was not recovered and unknown for the other events.  Information on the lot/batch number has been requested.