chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Ischemic stroke from occlusion of Right middle cerebral artery stroke.Ischemic stroke from occlusion of the distal right A2 segment near origin of the callosomarginal artery; This is a spontaneous report from a contactable consumer (patient) received via Regulatory authority. A non-pregnant 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Jul2021 at 12:15 (Lot Number: EW0191) (at the age of 76-year-old) as single dose for COVID-19 immunisation.  Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19; since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  The patient previously took aspirin and experienced upset stomach.  The patient experienced ischemic stroke from occlusion of right middle cerebral artery stroke. Ischemic stroke from occlusion of the distal right A2 segment near origin of the callosomarginal artery on 11Jul2021 11:00. The event was serious, medically significant and caused hospitalization for 14 days.  Unspecified therapeutic measures were taken as a result of the event. The patient outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Headache; Pain in arms; Vomiting; Nausea; This is a spontaneous report from a Pfizer-sponsored Program. A non-contactable female consumer (patient) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation and experienced hypersensitivity and pain arm. The patient experienced side effect after getting the second dose. The side effect that she experiences was headache, pain in arms, vomiting and nausea on unspecified date in Jul2021. The patient just wants to know something that something she need to ask. The patient's concern was if she needs to go to the doctors about it or if she needs to like go to the hospital. Patient was informed about the role of Pfizer drug safety department and was also informed about the role of Medical information department. As per patient's request, call was transferred to MI department however it was unsuccessful. The outcome of clinical events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102.9, when I took her temperature again it went up to a 100; She still has fever; Fever of 102.9 was the highest and then this last one I took was 103.1, so it's probably 102; Little sore in her arm; This is a spontaneous report from a contactable consumer (patient mother). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 22Jul2021 15:45 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter concern was her daughter had the Pfizer at 3:45 yesterday afternoon and she was doing fine and then she has a little sore in her arm Jul2021, but the time she woke up with a fever of 102.9, and this afternoon when I took her temperature again it went up to a 100 and, we had two different thermometers so, for her fever, so she still has a fever. Patient has a Fever of 102.9 was the highest and then this last one I took was 103.1, so it is probably 102 on 23Jul2021. Reporter was informed about the roles of Pfizer Drug Safety and also informed about the role of Pfizer Medical Information and offered the number. The outcome of the event Pain in arm was unknown and not recovered for another event.  Information on Lot/Batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Pain in extremity, Somnolence
Clinical narrative: Headache; I feel like I am tired and want to sleep a lot.; I feel like I am tired and want to sleep a lot.; Have a pain in my arm; I do not feel good; This is a spontaneous report received from a contactable consumer (patient). A 37-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191, NDC number, UPC number, Expiry Date were unknown) via unspecified route on administration on 22Jul2021 at 13:16 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included vitamins nos (reported as patient receives sometime some vitamins) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (Lot Number: EW0191) as dose 1, single via unspecified route on administration on 01Jul2021 (at the age of 37-years-old) for COVID-19 immunization. The patient did not take any other vaccine during the COVID vaccine time period. On 23Jul2021, Patient had a headache, and was requesting the day off on work because, he did not feel good. Patient felt like tired and want to sleep a lot too and also feel like pain in arm, and on the right side of of head (headache). The patient did not undergo lab test. No investigation assessment. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle discomfort
Clinical narrative: tiredness/exhaustion; chills; muscles feeling funny; exhaustion; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on unspecified date in Jul2021 as single dose for covid-19 immunisation. Medical history included covid-19 from Dec2020 to an unknown date covid virus back in Dec. The patient's concomitant medications were not reported. The patient experienced tiredness/exhaustion, chills, muscles feeling funny on unspecified date in Jul2021. Reporter is a 55-year-old female who received her first dose of the Pfizer BioNTech covid 19 vaccine on Wednesday. Her 58-year-old husband also received his first dose this same day. The reporter reports they both experienced side effects such as tiredness, exhaustion, chills, and muscles feeling funny. Both she and her husband had the covid virus back in December. The clinical outcome of the events was unknown.  Information on batch/ lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100942010 Same reporter/drug/AE, different patient
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Intrauterine growth restriction of fetus without other risk factors; Pregnant Yes; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 08:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient experienced intrauterine growth restriction of fetus without other risk factors on 22Jul2021 (reported also as 4 weeks of gestation but per LMP, should be 31 weeks, for clarification). Patient's last menstrual period date was 17Dec2020. Pregnancy Due Date is 23Sep2021. No Hospitalization Prolonged. Treatment Received. The outcome of the event was unknown. Facility where the most recent COVID-19 vaccine was administered:Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event were weekly ultrasounds, possibly early delivery. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 23Jul2021.  Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported event intrauterine growth restriction  as the fetus was exposed to the drug. However, information available in this report is limited and does not allow a medically meaningful assessment.   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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test
Clinical narrative: I contracted a community grade pneumonia and had to be hospitalized the next day after taking the first vaccine; This is a spontaneous report from a contactable consumer (patient).    A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jun2021 15:00 (Lot Number: EWO181) as single dose (at 41 years old) for COVID-19 immunisation.  Medical history included hernia repair. Concomitant medications included ibuprofen  and multivitamins, both taken for an unspecified indication, start and stop date were not reported.  The patient stated that "on 19Jun2021 15:00 I contracted a community grade pneumonia and had to be hospitalized the next day after taking the first vaccine (hospitalization) with outcome of recovering.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 19Jun2021. Therapeutic measures were taken as a result of the event included antibiotics and painkillers. She received the second dose of BNT162B2 (Lot number FA6780), in the left arm on 18Jun2021 (as reported).
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea
Clinical narrative: Experiencing like runny bowel movement; diarrhea; This is a spontaneous report from a contactable consumer (parent). A male patient (reporter's son) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 13Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Caller wanted to know about side effect from the second dose of Pfizer vaccine and wondering if this was happening because of the vaccine. On an unspecified date in Jul2021, the patient experienced experiencing like runny bowel movement, diarrhea. The outcomes of events were unknown.  Information on lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Slight headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration in left arm on 22Jul2021 at 12:15 (at the age of 60-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included arthritis and pain. The concomitant medications of the patient included ibuprofen (IBUPROFEN) taken for pain. No prior vaccinations within 4 weeks. The AE(s) following prior vaccinations was reported as none. No family medical history Relevant to AE. The relevant tests were reported as none. On 22Jul2021, the patient experienced slight headache and experienced fever on 23Jul2021. The patient stated she got the vaccine the previous day and they said there might be side effects. The previous night, she had a slight headache but no other side effects. Then 24 hours later, she had a fever, and she asked was that normal that it would take that long to develop. Was noticed just that afternoon and had stayed the same. She stated slight headache it went away. No investigation assessment. Treatment included: she took Ibuprofen. She also takes Ibuprofen as needed for her arthritis pain. The outcome of the event fever was reported as not resolved and the patient recovered from slight headache on an unspecified date in Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Malaise
Clinical narrative: I just have allergy; I do not feel good; I am feeling bad ever since I got that shot; Feeling horrible; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0198, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jul2021 (at the age of 69-years-old) as a DOSE 1, SINGLE for covid-19 immunization at Pharmacy. The patient's medical history and concomitant medications were not reported. The patient reported that, I just have allergy and I do not feel good; I am feeling bad ever since I got that shot; feeling horrible, both on Jul2021. Reporter stated, I took the Pfizer shot last Saturday on the 17th and I don't have any face (Incomplete information), have any swell, do not have a fever and my body have been (Incomplete information) so far. So, I am just wondering, how long I am going to be like this? Further stated, No, I don't have a fever, I just have allergy. She stated, I do not feel good. Do I have Covid? and My first dose was 17Jul2021. Patient stated, No, no treatment I just got that vaccination shot, the first shot on 17Jul and I am feeling bad ever since I got that shot and I just want to know do I have Covid or not and how long I am going to be feeling horrible like this? Reporter seriousness for the events were unspecified. Outcome of the events was unknown.  Comment: Due to connectivity issue, consumer's voice was breaking over the call.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Abdominal pain, Blood pressure measurement, Dehydration, Fatigue
Clinical narrative: STOMACH ISSUES; VOMITING; HEADACHE; DEHYDRATION; ABDOMINAL PAIN; FATIGUE/FEELS WIPED OUT; This is a solicited report from a non-Pfizer sponsored program (PSP-CVSLEN-US-01) from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-095398).  A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 30Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral at 20 mg, 1x/day, from 28Jun2021 to 2021, then from Jul2021 to an unspecified date, for kidney cancer. Medical history was none. Concomitant medications included pembrolizumab (KEYTRUDA) and amlodipine. The patient experienced stomach issues, vomiting, headache, dehydration, and abdominal pain on 30Jun2021, fatigue/feels wiped out on 29Jun2021. The events were serious per hospitalization. The patient underwent lab tests and procedures which included blood pressure: 130/65, 105/60 on 21Jun2021 (taking amlodipine), 128/78 on 29Jun2021. The action taken in response to the events for lenvatinib mesilate was permanently withdrawn on an unspecified date. The outcome of events abdominal pain and fatigue was unknown, outcome of other events was resolved on 04Jul2021. The reporter's causality for lenvatinib mesilate with all events was unrelated. The reporter's causality for bnt162b2 with events stomach issues, vomiting, headache, dehydration, and abdominal pain was related, reporter's causality for bnt162b2 with event fatigue/feels wiped out was not provided.  The reporter's assessment of the causal relationship of the event, fatigue/feels wiped out, with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the  information in the case report and a plausible temporal relationship, a possible causal relationship between the event Abdominal discomfort, Vomiting, Headache, Dehydration, Abdominal pain and suspect drug BNT162B2 cannot be excluded"  Event Fatigue unrelated to suspect drug BNT162B2  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Vomiting
Clinical narrative: STOMACH ISSUES; VOMITING; HEADACHE; DEHYDRATION; ABDOMINAL PAIN; FATIGUE/FEELS WIPED OUT; This is a solicited report from a non-Pfizer sponsored program (PSP-CVSLEN-US-01) from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-095398).  A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 30Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral at 20 mg, 1x/day, from 28Jun2021 to 2021, then from Jul2021 to an unspecified date, for kidney cancer. Medical history was none. Concomitant medications included pembrolizumab (KEYTRUDA) and amlodipine. The patient experienced stomach issues, vomiting, headache, dehydration, and abdominal pain on 30Jun2021, fatigue/feels wiped out on 29Jun2021. The events were serious per hospitalization. The patient underwent lab tests and procedures which included blood pressure: 130/65, 105/60 on 21Jun2021 (taking amlodipine), 128/78 on 29Jun2021. The action taken in response to the events for lenvatinib mesilate was permanently withdrawn on an unspecified date. The outcome of events abdominal pain and fatigue was unknown, outcome of other events was resolved on 04Jul2021. The reporter's causality for lenvatinib mesilate with all events was unrelated. The reporter's causality for bnt162b2 with events stomach issues, vomiting, headache, dehydration, and abdominal pain was related, reporter's causality for bnt162b2 with event fatigue/feels wiped out was not provided.  The reporter's assessment of the causal relationship of the event, fatigue/feels wiped out, with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the  information in the case report and a plausible temporal relationship, a possible causal relationship between the event Abdominal discomfort, Vomiting, Headache, Dehydration, Abdominal pain and suspect drug BNT162B2 cannot be excluded"  Event Fatigue unrelated to suspect drug BNT162B2  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Rapid heart rate/ he still feel a somewhat of rapid heartbeat; Shortness of breath; Chest pain; He felt nauseous; This is a spontaneous report from a contactable consumer (patient's mother reported for her son). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jul2021 10:35 (age at vaccination 13 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No investigation assessment. On Jul2021 the patient experienced rapid heart rate/ he still feel a somewhat of rapid heartbeat, shortness of breath, chest pain, he felt nauseous. Reporter stated, Patient had to go to the emergency room 23Jul2021 (yesterday) with rapid heart rate and shortness of breath and chest pain. So, she feels need to report this side effect or a reaction. And it was reported, it is important for young ones right and he still feel a somewhat of rapid heartbeat that's why it is important that anything he need to do, the doctors in the hospital said that if he continues, go back to the hospital but he has also an appointment with his doctor on Tuesday its just comes and go. Patient was not hospitalized; he was there in emergency room. Patient received treatment after the vaccine as Yes, Emergency room for rapid heart rate and shortness of breath. Motrin 400mg and Zofran for nausea because he felt nauseous. Regarding dose of, Zofran he don't know how much, he was looking for in papers but it does not say here. The outcome of event Rapid heart rate/ he still feel a somewhat of rapid heartbeat was not recovered, rest of all events outcome was unknown.  Follow-up attempts are completed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Malaise
Clinical narrative: Pure water diarrhea, and it's bad; Short stomach pain; I am not feeling well; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B, (Lot number was not reported) via an unspecified route of administration on 24Jul2021 as dose number unknown, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced pure water diarrhea, where it was bad and had some short stomach pain, also she was not feeling well on 25Jul2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Muscular weakness, Pain in extremity
Clinical narrative: Dizziness; Weak muscles; Arm paining; Not feeling good; This is a spontaneous report from a contactable consumer. This 60-year-old consumer (female patient) reported for herself that.  A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jul2021 as (At the age of 60-years) DOSE 1, SINGLE for covid-19 immunisation. Medical history included high pressure from an unknown date and unknown if ongoing Verbatim: patient on high pressure and got high blood pressure pills. Concomitant medications were not reported. The patient experienced dizziness on 24Jul2021 and weak muscles, arm paining and not feeling good on Jul2021. It was reported that patient had question, she took the shot, and she had lot of side effects from the shot (COVID 19 Vaccine), so what should she do. Consumer was informed about the role of Pfizer Drug Safety. Consumer stated, "the side effects that they said you'll have I have; you know I took the shot yesterday and I am having dizziness and weak muscles you know I am just not feeling good and my arm paining too. Yeah, so this is the 'mid-day' so how many days it will take to stop bothering me" Consumer was informed about the role of Pfizer Medical Information department and offered the number. Consumer further stated, "I didn't think I will have side effects this bad; I just took the shot yesterday and it is still happening today." Later Consumer stated, "This is the First one. I don't know if I will take the second one." It was reported that Date of administration for first shot: Consumer stated, "23Jul2021 which is yesterday." Start date of event (Dizziness): Consumer stated, "Today, it nearly started at 12 midnight and it is still bothering today (24Jul2021)." and Treatment: Consumer stated, "No I haven't. No treatment was given. Reporter seriousness for events: Unspecified. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Hypoaesthesia, Vaccination site swelling
Clinical narrative: Numb around I got the shot, got particularly swelling just like a little wound; Numb around I got the shot, got particularly swelling just like a little wound; Feeling uncomfortable; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 23Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced numb around i got the shot, got particularly swelling just like a little wound and feeling uncomfortable on an unknown date in Jul2021. No treatment was given for the events. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Malaise, Product administered at inappropriate site
Clinical narrative: I am not feeling good/not feeling well; I am not still not good, I am vomiting; Diarrhoea; I can not breathe; In right hand get the vaccine; Itchy; Feel really bad/Feel very bad/ I am still terrible; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 23Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jul2021, the patient experienced I am not feeling good/not feeling well; I am not still not good, I am vomiting; Diarrhoea; I can not breathe; In right hand get the vaccine; Itchy; and Feel really bad/Feel very bad/ I am still terrible. Patient stated, my doctor told me do not do that for second one, I cannot go for the second one. The outcome for all the events was not recovered.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Vomiting
Clinical narrative: I am not feeling good/not feeling well; I am not still not good, I am vomiting; Diarrhoea; I can not breathe; In right hand get the vaccine; Itchy; Feel really bad/Feel very bad/ I am still terrible; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 23Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Jul2021, the patient experienced I am not feeling good/not feeling well; I am not still not good, I am vomiting; Diarrhoea; I can not breathe; In right hand get the vaccine; Itchy; and Feel really bad/Feel very bad/ I am still terrible. Patient stated, my doctor told me do not do that for second one, I cannot go for the second one. The outcome for all the events was not recovered.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis
Clinical narrative: My heartbeat fast; Sweaty; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 22Jul2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Asking about lot number patient reported that my immunization card, 8733. (Further not clarified hence not captured tab). On an unspecified date in Jul2021, the patient experienced my heartbeat fast, sweaty. Reported that patient think this could be the side effects on people and want to know how long does it last. The outcomes of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: hands developed a rash and blisters; hands developed a rash and blisters; This is a spontaneous report from a contactable consumer (patient). A 15-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 09Jul2021 (Lot Number: EW0172) (at age of 15-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported, and patient had no known allergies. The patient's concomitant medications were not reported. The patient had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number unknown), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and she had not been tested for COVID-19 since the vaccination. The patient reported that her hands developed a rash and blisters on 10Jul2021 07:00 am. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The outcome of the events was recovering.  Follow-Up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Flushing, Headache, Pain, Vaccination site pain
Clinical narrative: Soreness injection site; Headache; Loss of appetite; Feeling flush; Achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, in left arm, on 24Jul2021 15:15, at the age of 46-year-old, at dose 1, single for covid-19 immunization. Medical history included anxiety, depression and arthritis. Concomitant medication included citalopram. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced soreness at injection site, headache, loss of appetite, feeling flush and achy on 25Jul2021 03:00. The reporter assessed the case as non-serious. No treatment was administered for the events. The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Mental disability, Tinnitus
Clinical narrative: I have worsening tinnitus in both ears; mental health; depression worse; This is a spontaneous report from a contactable consumer (patient).  A 53-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18May2021 11:00 (Lot Number: ewc177) as single dose for covid-19 immunisation at Pharmacy or Drug Store.  Medical history included Major depressive disorder (ongoing), tinnitus (ongoing) insomnia, arthritis and menopause. Concomitant medication included venlafaxine (VENLAFAXINE 75 mg) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took nickel sulfate, morphine and benzoyl peroxide and experienced drug hypersensitivity. The patient previous received the first dose of bnt162b2 for covid-19 immunisation on 27Apr2021 14:00, in left arm (lot number EWO171) when 53 years old. The patient experienced worsening tinnitus in both ears (tinnitus) (medically significant), mental health (mental disability) (non-serious), depression worse (depression) (non-serious) on 30May2021 with outcome of not recovered. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not treated due to the events. Prior to vaccination, the patient was not diagnosed was not with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported she had worsening tinnitus in both ears.  What was once a low hum for several years, was now a remarkedly high pitched hiss in both ears since getting the 2nd dose of the vaccine. Loud enough to be heard over normal conversation and her television set. It was negatively impacting her mental health and making her depression worse.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: I have a really bad cough right now; 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), dose 2 via an unspecified route of administration on Jul2021 as dose 2, single for covid-19 immunisation .The patient medical and concomitant medications was not reported. It was Reported that, the patient experienced had a really bad cough right now on 24Jul2021 with outcome of not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Erythema, Rash, Swelling
Clinical narrative: Doctor prescribed Loratadine for rash all over body but it is not working; body is getting worse and really bad; getting red, and swollen; getting red, and swollen; This is a spontaneous report received from a contactable consumer or other non-HCP. A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0173), via an unspecified route of administration on 11May2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Hernia. The patient's concomitant medications included Loratadine 10mg, and Pantoprazole. The patient previously took first dose of BNT162B2 vaccine, (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization. No prior vaccinations. On an unspecified date, the patient experienced Doctor prescribed Loratadine for rash all over body but it is not working; body is getting worse and really bad, getting red, and swollen. On 05Jul2021, the patient underwent lab tests and procedures which included blood test: everything was fine, she needs to go to the Dermatology (for rash treatment). Reporter stated, patient went to the Doctor to the Hospital, 3 times and it's been like 2 months and Doctor prescribed her a medication Loratadine as treatment, but that is not working. The outcome of all the events was not recovered.  Follow-up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: very stabbing pains in to her ears; very stabbing pains down in to like her little finger and next to little finger on both the hands and the same on her feet and heels; started feels like stuff has been flushed off through her body and it feels very weird; Ache/ Pain; This is a spontaneous report from contactable consumer (Patient's friend) reported for female patient. A female patient of unspecified age received second dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Lot number: EWO168, Expiration date: Unknown), via an unspecified route on an unknown date, as a single dose of covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection) on an unknown date as a single dose for covid-19 immunization. On an unknown date in the morning 05:00 or 07:00, patient experienced typical aches and pains that you read about, but she is also very stabbing pains in to her ears and very stabbing pains down in to like her little finger and next to little finger on both the hands and the same on her feet and heels and she started feels like stuff has been flushed off through her body and it feels very weird. Is this something which is normal. or is this something she should be concerned about. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site in my arm; This is a spontaneous report from contactable consumer(patient) via Pfizer sponsored program. A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0202; Expiration Date: 30Sep2021), via an Intramuscular route of administration on 23Jul2021 in the arm left (at the age of 63-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jul2021, the patient experienced pain at injection site in my arm. She received the 1st dose of Pfizer Covid-19 Vaccine yesterday on 23Jul2021 and then right now she is experiencing pain in her (left) arm. Patient stated that I just had a question like I said I had pain at injection site in my arm and I took one Tylenol 500 mg (treatment) and it was quite consoling for 24 hours since I had the injection (vaccine). I just wanted to know how long to put warm or cold compress on that area. Therapeutic measures were taken as a result of i had pain at injection site in my arm (vaccination site pain). The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Cough, Hypertension
Clinical narrative: Hypertension; chest pain; Dry cough; 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, lot and expiry were not reported), via an unspecified route of administration, administered in deltoid left on 28Apr2021 as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had chest pain and was found to have hypertension in 2021. Linsopril started. Switch to losartan due to side effect of dry cough in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Renal pain
Clinical narrative: Heart pain; Kidney pain; This is a spontaneous report from a contactable consumer or other non hcp.    A 33-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jul2021 19:00 (Batch/Lot Number: EWOI98) as single dose for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient experienced heart pain  and  , kidney pain  on an unspecified date with outcome of unknown.  Therapeutic measures were taken as a result of heart pain and  kidney pain and included Tylenol.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Dysphagia, Fatigue
Clinical narrative: Thyroiditis subacute; arthralgia; asthenia; bone pain; dysphagia; fatigue; headache; myalgia; neck pain; pyrexia; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thyroiditis subacute, arthralgia, asthenia, bone pain, dysphagia, fatigue, headache, myalgia, neck pain and pyrexia. The events were reported as non-serious by reporter. Outcome of the event was unknown. There is no product complaint associated with this case No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Neck pain, Pyrexia, Thyroiditis subacute
Clinical narrative: Thyroiditis subacute; arthralgia; asthenia; bone pain; dysphagia; fatigue; headache; myalgia; neck pain; pyrexia; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thyroiditis subacute, arthralgia, asthenia, bone pain, dysphagia, fatigue, headache, myalgia, neck pain and pyrexia. The events were reported as non-serious by reporter. Outcome of the event was unknown. There is no product complaint associated with this case No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Caller wants to know if she can get the dose tomorrow when she still have colds.; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch Number/Lot Number were not reported) via unspecified route of administration on 07Jul2021 at DOSE 1, SINGLE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient experienced on 21Jul2021 and it was reported, recently this Friday, she caught a cold and the symptoms started on Wednesday and Thursday. The patient wants to know if she can get the dose tomorrow when she still have colds. Consumer who received the first dose of the Pfizer Biontech COVID19 vaccine on 07Jul2021 and is scheduled to receive the second dose on 27Jul2021 (tomorrow). The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Gait disturbance, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient of an unspecified age received BNT162B2, via an unspecified route of administration on 20Feb2021, at the age of 73-years-old, (Batch/Lot Number: EN6201) as DOSE 2, SINGLE for COVID-19 immunization.  The patient's medical history includes sciatica and cataracts. Concomitant medications were not reported. Historical vaccine include dose 1 of BNT162B2 received on 30Jan2021 (Lot Number: EL9269). The patient stated after her first dose she had no problems, then after her second dose, 6 days later when she got out of her car she can hardly walk which gets worse after that. She says she went to see her daughter because they were gonna leave for the city and she wanted to see her, and it was a 2.5 hour car ride, after which she could hardly walk, which her husband said will go away. She says she has been relying on Tylenol and Advil to get by. She says it is a long story. She says she decided she can't take anymore and went to the emergency room on 12Apr2021, and waited all day to be seen in the ER, and when they finally saw her the doctor took a CAT scan and sent her to physical therapy, which she had 4 visits. She says that she did her therapy, and she had to do Tylenol before her PT visits or she would have been in pain when she does the stuff. She says she has been doing therapy religiously, but she can't do it every day because if she does it, that day she is shot. She says she has to take Tylenol, and sometimes when she bends over cooking she gets a terrible pain in her back. She says everyone says oh it's a coincidence, but she doesn't think so, she thinks that is the story of her life now. She says she was in pretty good physical shape before all this. The outcome of the events was not recovered. Treatment was received for the events.  No follow-up attempts are needed. No further information is expected.