chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure went high for 223/106; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 01Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Apr2021, it was reported that the patient was rushed to the emergency room, her blood pressure went high for 223/106 after receiving the 1st dose. The patient was reported as hospitalized. The patient wanted to know what's with the Covid19 vaccine that can cause her to have this reaction. The patient underwent lab tests and procedures which included blood pressure measurement: 223/106 (high) on 01Apr2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Headache, Vision blurred
Clinical narrative: I was working at and, around 5:30 am when I felt some strong pain both side of my chest.  Sonner I felt a slight headache and from time to time it intensified to become unsupportable. At that time though about a lack of oxygenation, because I wore mask for the whole time I was working. About 9:am when I drove to home, I saw everything foggy in front of me.  When I get home I took  some paracetamol and another painkiller, because at that time my entire body was so warm, and the headache was very bad. I slept for 5 hours, when I woke up I went to the mechanic to fix my car.  While I got back during the time I saw the same foggy vision.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Slight fatigue after 8 hours, minor body aches after about 10 hours, chills and low grade temp after about 12 hours. Woke up with loud ringing ears at about 15 hours after vaccination. The following morning (21 hours after vaccination) ringing ears were less intense, no body aches or chills. Still low energy. 45 hours after vaccine noticed slight fever again. 60 hours after vaccine all symptoms gone except light ringing ears.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Slight fatigue after 8 hours, minor body aches after about 10 hours, chills and low grade temp after about 12 hours. Woke up with loud ringing ears at about 15 hours after vaccination. The following morning (21 hours after vaccination) ringing ears were less intense, no body aches or chills. Still low energy. 45 hours after vaccine noticed slight fever again. 60 hours after vaccine all symptoms gone except light ringing ears.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Lethargy, Lymph node pain
Clinical narrative: April 9, lethargic in afternoon, seeing flashing light in left eyesight. Lasted 2-3 days. Lymph node in rt groin swollen and sore. Persisting still. April 17, feverish, 101.5 F, chills, no appetite. Still persists. Difficulty breathing, slight, comes and goes.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Photopsia, Pyrexia
Clinical narrative: April 9, lethargic in afternoon, seeing flashing light in left eyesight. Lasted 2-3 days. Lymph node in rt groin swollen and sore. Persisting still. April 17, feverish, 101.5 F, chills, no appetite. Still persists. Difficulty breathing, slight, comes and goes.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Feeling cold, Feeling hot
Clinical narrative: sore arm, could hardly lift it by the end of the night of the vaccine, hot and chilled all night, left arm pain, right neck pain, next day slight headache, very tired, weak, winded easily, improved by the end of the next day
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: sore arm, could hardly lift it by the end of the night of the vaccine, hot and chilled all night, left arm pain, right neck pain, next day slight headache, very tired, weak, winded easily, improved by the end of the next day
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Loss of consciousness
Clinical narrative: In the middle of the night after second innoculation  found myself on the floor next to my bed. I have no idea how I got there and was not aware of who I has or how I got there.  I don't remember how I got to the floor and didn't remember falling out of  bed.  The next morning my right hip was very sore, so I concluded I had been unconcious ancd fell out of bed I'm reporting this on the hope  that cases ofothers who had similar cases can help me understand.  I believe my case is unusual and severe,  I live alone and I could have been fatally injured
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Hours after the second dose I became dizzy, nauseous, had a racing heartbeat, had severe body aches and headache, and ran a fever of 101. I began throwing up, even water, and this continued for 3 days.  As of today, I have a very red and swollen arm, sore and itchy, and am still experiencing nausea, chills, vertigo, and intermittent body aches in my back, hips, knees, shoulders. I also developed diarrhea.  My fever ended yesterday. I have also noticed loss of taste and tinnitus.  I was so ill on Thursday and Friday that my partner was prepared to take me to the ER if I didn't improve by Saturday.  Fortunately, I did begin to feel a bit better on Saturday, but as of this evening I am still far from recovered. I have taken photos of my injected arm daily.  Based on my experience with this 2nd dose of Moderna, I will never voluntarily take another COVID-19 vaccine, no matter the manufacturer.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Hours after the second dose I became dizzy, nauseous, had a racing heartbeat, had severe body aches and headache, and ran a fever of 101. I began throwing up, even water, and this continued for 3 days.  As of today, I have a very red and swollen arm, sore and itchy, and am still experiencing nausea, chills, vertigo, and intermittent body aches in my back, hips, knees, shoulders. I also developed diarrhea.  My fever ended yesterday. I have also noticed loss of taste and tinnitus.  I was so ill on Thursday and Friday that my partner was prepared to take me to the ER if I didn't improve by Saturday.  Fortunately, I did begin to feel a bit better on Saturday, but as of this evening I am still far from recovered. I have taken photos of my injected arm daily.  Based on my experience with this 2nd dose of Moderna, I will never voluntarily take another COVID-19 vaccine, no matter the manufacturer.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Tinnitus, Vertigo, Vomiting
Clinical narrative: Hours after the second dose I became dizzy, nauseous, had a racing heartbeat, had severe body aches and headache, and ran a fever of 101. I began throwing up, even water, and this continued for 3 days.  As of today, I have a very red and swollen arm, sore and itchy, and am still experiencing nausea, chills, vertigo, and intermittent body aches in my back, hips, knees, shoulders. I also developed diarrhea.  My fever ended yesterday. I have also noticed loss of taste and tinnitus.  I was so ill on Thursday and Friday that my partner was prepared to take me to the ER if I didn't improve by Saturday.  Fortunately, I did begin to feel a bit better on Saturday, but as of this evening I am still far from recovered. I have taken photos of my injected arm daily.  Based on my experience with this 2nd dose of Moderna, I will never voluntarily take another COVID-19 vaccine, no matter the manufacturer.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling drunk, Headache, Nausea, Pain in extremity
Clinical narrative: I am not able to move my left arm without feeling strong pain.  I felt nauseated, dizzy, and a headache. As if I was drunk.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Covid arm - red, hot, itchy circle around injection site
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Muscle spasms, Myocardial infarction, Paraesthesia
Clinical narrative: the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps  in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown.  Information on the Lot/Batch number has been requested
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site coldness
Clinical narrative: the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms); the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms; in the left arm it was cold and tingling; in the left arm it was cold and tingling; experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours; diarrhea on the weekend; strong cramps  in her stomach (stomach flu-like symptoms); This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 23Mar2021 (Lot number and Expiry date was not reported) as single dose for covid-19 immunisation. Medical history included ischemic colitis in the past and she thinks that maybe the cramping started triggering it again. The patient's concomitant medications were not reported. On 02Apr2021 strong cramps in her stomach (stomach flu-like symptoms) and on an unspecified date, the patient experienced the contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms), in the left arm it was cold and tingling (vaccination site coldness), (paraesthesia), experiencing contractions and cramping in her arm and the left side of her torso in the ribcage area that continued for 24 hours (muscle spasms) and diarrhoea on the weekend. Her second dose is scheduled on 13Apr2021, she would like to know if there are recommendations for her second dose because she heard that with the second dose the side effects are worse, she would like to know if someone else has reported these symptoms. She would like to know if she should possibly receive the vaccine in her thigh instead of her arm and if that would be helpful. The outcome of the events diarrhoea was recovered on 05Apr2020 and outcome of contractions and cramping sensation went trough out her entire chest region and her back (like heart attack symptoms) was not recovered and rest of the events was unknown.  Information on the Lot/Batch number has been requested
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram neck, Myocardial infarction, Pain in extremity, X-ray
Clinical narrative: possible heart attack; High pain in left arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in left arm on 08Feb2021 13:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation from 2010 to an unknown date, hypertension from 1971 to an unknown date, both knees replace from May2011 to an unknown date, left shoulder replaced from Nov2011 to an unknown date, left eye cataract removal from Jun2013 to an unknown date, right eye cataract removal from Oct2013 to an unknown date, L4 & L5 disc repair from Aug2014 to an unknown date, Gall bladder removed from Sep2014 to an unknown date, Right shoulder, Kidney disorder, cramps, Virus fighter, Heart disorder, eye disorder, General Health, Blood thinner, R. shoulder pain, sleep disorder, constipation, Clear vessels. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. The patient experienced possible heart attack on 08Feb2021 with outcome of not recovered, high pain in left arm on 08Feb2021 with outcome of not recovered. High pain in left arm-possible heart attack on 08Feb2021. Reported it was not caused by shot, but result is possible pitched nerve- X-ray and CT scan Being done. AE required Scheduled X-Ray and then CT scan on neck. Treatment included the event did require the initiation of new medication/other treatment/procedure. Seriousness criteria reported as not serious. COVID-19 testing had not been conducted.; Sender's Comments: A contributory role of the vaccine BNT162B2 to the event possible heart attack cannot be fully excluded based on the temporal relationship. Patient's advanced age, underlying hypertension, atrial fibrillation, kidney disorder and other comorbidities provide alternate explanation for the event. Case will be  reassessed if additional information is received.   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) : US-PFIZER INC-2021277193 same patient, same product (second dose), similar events.
Sex: M
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby, Respiratory disorder neonatal
Clinical narrative: in the NICU for respiratory support; preterm delivery after 2nd covid vaccine; first dose on 19Dec2020; This is a spontaneous report from a contactable physician (parent). This physician reported information for both mother and baby. This is the baby report.  A fetal male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 19Dec2020 (lot number: EL0140) and second dose on 08Jan2021; both transplacental as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The mother had a preterm delivery after second COVID vaccine. The patient (2-day old at the time of the report) was in the NICU for respiratory support; no infection and was breastfeeding well. The patient had no malformation/anomalies diagnosed. The reporter considered the events to be non-serious. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded based on temporal association. Case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-2021015910 same drug, different event and patient
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Might have Guillain-Barre Syndrome; her mother's legs "went numb and weak"; her mother's legs "went numb and weak"; her speech started to slur; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received BNT162B2 (Solution for injection) via an unspecified route of administration on 30Mar2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was reported that upon returning home after the vaccination, her mother was unable to get out of the car under her own power, with the caller reporting her mother's legs "went numb and weak". Later on that day, her speech started to slur. They had contacted their family physician who thinks her mother Might have Guillain-Barre Syndrome. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hip fracture
Clinical narrative: broke his hips; This is a spontaneous report from a contactable consumer (reported from himself) from a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 15Mar2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitantly, the patient was taking unspecified blood thinners. The patient called in because he was scheduled to get his 2nd dose on Monday, 05Apr2021 He got his 1st dose on 15Mar2021 and 10 days ago from the time of the report (Mar2021) he said he broke his hips and had surgery. He said he was on blood thinners and asking if it is ok for him to take the 2nd dose on the scheduled date. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Pain in extremity, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome; Pain in arm; Joint pain; This is a solicited report from a contactable consumer (patient), via a non-Pfizer marketing program.  A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on an unspecified date as single dose for COVID-19 immunization and adalimumab (HUMIRA), subcutaneously from an unspecified date at unspecified dose for moderate to severe adult crohn's disease. Medical history included hemorrhage of colon from 2018 and moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. On an unspecified date, patient experienced postural orthostatic tachycardia syndrome, pain in arm and joint pain. The events were reported as serious, medically significant. The action taken in response to the events for adalimumab was unknown. Outcome of event pain in arm was unknown while for all other events was recovered on an unspecified date. Causality assessment for the drug Humira and the events Postural orthostatic tachycardia syndrome and Joint pain was reported as No reasonable possibility by the reporter and manufacturer while for the event Pain in arm was not reported by the reporter and No reasonable possibility by the manufacturer. Causality assessment for the drug BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the events postural orthostatic tachycardia syndrome, pain in arm and joint pain was not reported by the reporter.  The reporter's assessment of the causal relationship of the events with the suspect product 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. No further information is expected.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be fully excluded based on the presumed temporal relationship and since it is part of the product safety profile. Underlying hemorrhage of colon and moderate to severe adult Crohn's disease may be contributory to the event orthostatic tachycardia syndrome. Case will be  reassessed if additional information is received  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
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: prolonged arm pain after second COVID shot; lack of mobility; This is a spontaneous report received from a contactable consumer (patient). A 74-year old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN16202, pending clarification) intramuscularly on 01Mar2021 at 13:00 as a single dose in the right arm for COVID-19 immunisation. Medical history included heart disease from 31Jan2007 and ongoing, double bypass and aortic valve replacement on an unspecified date, 2-stents on 07Nov2007 and ongoing, 1-stent in Jan2009 and ongoing, 1-stent on 10Jun2009 and ongoing and 1 stent on 02Dec2013 and ongoing. Family medical history relevant to the adverse events was reported as diabetes type 2, high blood pressure and heart disease. Concomitant medications were not reported. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL9264) intramuscularly on 08Feb2021 at 16:30 as a single dose in the right arm for COVID-19 immunisation. On unspecified dates the patient experienced prolonged arm pain after second COVID shot and lack of mobility. The clinical course was reported as follows: "I waited 3 weeks after 2nd shot to see doctor at a Hospital. He had assured me that my arm's pain and lack of mobility was not one to vaccine. I have pain if arm is raised above my shoulder and when moved side to side. (Example) it is difficult to move right arm to position to put on or take off a shirt. MD said the shot may have with a vein in my shoulder and had recommended physical therapy." The clinical outcomes of the events prolonged arm pain after second COVID shot and lack of mobility were both unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Lower limb fracture
Clinical narrative: Fell several days ago and fractured her leg; Fell several days ago and fractured her leg; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 13Mar2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient received the first Pfizer vaccine on 13Mar2021 and was scheduled to receive second vaccine today (03Apr2021). The patient fell several days ago and fractured her leg in Mar2021, would like to reschedule. The outcome of the event fractured her leg and fell was unknown.  Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: he is bleeding a little; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). This male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was bleeding a little on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Eating disorder, Lip swelling, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: entire face was swollen; entire face was swollen (his lips, throat, tongue); entire face was swollen (his lips, throat, tongue); entire face was swollen (his lips, throat, tongue); he could not eat anything; This is a spontaneous report received from a contactable consumer reporting on behalf of her husband. A male patient of unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 (lot ER8727), for COVID-19 immunization. The first dose of the vaccine was given on an unspecified date in 2021. Medical history and concomitant medications were not reported. On 01Apr2021 morning the patient woke up and his entire face was swollen (meaning his lips, throat, tongue) and he could not eat anything. The reporter gave him diphenhydramine (BENADRYL) last night. Reporter added they got a nurse, she told them to go to urgent care. Reporter also stated she will rather for him to answer, he was gone to the urgent care and she was just calling to see if that was a normal thing. Events outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Movement disorder
Clinical narrative: actually passed out slightly; Really dizzy; can't move and stand by; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration on 27Mar2021 (batch/lot number: ER8730) at 55 years old at a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Type II diabetes, Thyroid inactive, and blood pressure management, all from an unknown date. Concomitant therapy included unspecified blood pressure medication. On 27Mar2021, the patient actually passed out slightly (loss of consciousness), got really dizzy (dizziness), and can't move and stand by (movement disorder). It was reported that about 5 minutes after vaccination, patient got really dizzy and actually passed out slightly and was dizzy for about that day; he was dizzy all day, he can't move and stand by. Patient stated that he actually got better but took five days. Patient further stated, "I just determine, because of the reaction, people say, second is worse and I don't know if its allergic reaction or is that normal. If they consider." Outcome of the events was recovering.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in jaw
Clinical narrative: dizziness; Fatigue; Jaw pain; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 08Apr2021 12:15 (Batch/Lot number was not reported) as single dose (at the age of 33-year-old) for COVID-19 immunsation, at workplace clinic.   The patient medical history was not reported. No known allergies. The patient had not experienced Covid-19 prior vaccination. No known allergies. There were no concomitant medications in two weeks. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 09:30 AM (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced dizziness, fatigue and jaw pain on 09Apr2021 12:00. Events resulted in: hospitalization, hospitalization prolongation, life threatening illness (immediate risk of death from the event), disability or permanent damage, congenital anomaly or birth defect (as reported). The patient received treatment for the events: Tylenol. COVID was not tested post vaccination. The with outcome of events was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Malaise, SARS-CoV-2 test
Clinical narrative: suffering from a stroke; not being well; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 21Mar2021 (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 previously had first dose of BNT162B2 for COVID-19 immunization. The patient had symptoms of an illness (perhaps covid like symptoms) starting on 19Mar2020 (between his first and second dose of Pfizer BioNtech). The patient went ahead and got his second dose on 21Mar2021. He then went to see his DR in the last week (week of 05Apr2021) because of not being well. The primary care DR thought the patient had perhaps been exposed to COVID between the 1st & 2nd doses (due to symptoms that the DR thought seemed like body's over-reaction to COVID) but a COVID test was done and it was negative. Then the patient has been admitted to the hospital since suffering from a stroke on 08Apr2021. He still has not tested positive for COVID again but he is in ICU with stroke symptoms. The stroke resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was a life threatening illness (immediate risk of death from the event). The patient was in the hospital for four days. The facility where the COVID-19 vaccine was administered was in the Public Health Clinic/facility. It was unknown if the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or other medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was not recovered. Treatment for the event stroke was given. The patient underwent lab tests and procedures which included COVID test: both negative on 18Mar2021 and 08Apr2021.  Information on the Lot/Batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure, SARS-CoV-2 test
Clinical narrative: Kidney Failure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 at 14:30 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient has no medical history and no known allergies. The patient's concomitant medications were not reported. Facility type vaccine was other. No other vaccine in four weeks. The patient experienced kidney failure on 25Mar2021 at 06:30. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for kidney failure for 7 days. Treatment was received for the adverse event. The patient underwent lab tests and procedures which included Covid test nasal swab: negative on 25Mar2021 and negative on 07Apr2021. The outcome of the event was recovered with lasting effects.  Information about lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: heart attack; stroke; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 24Jan2021 13:00 (at the age of 67-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypothyroid, sleep apnea, known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); clarithromycin (CLARITIN [CLARITHROMYCIN]). In Feb2021, Exactly 3 weeks after the first dose, the patient had a heart attack and stroke. The events were assessed as serious (hospitalized, life-threatening, disability). The event resulted in emergency room and physician visit.The patient was hospitalized for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Respiratory arrest, SARS-CoV-2 test
Clinical narrative: heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021.  An autopsy was not performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a non-contactable pharmacist.  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at the age of 71-years, at single dose in right arm on 02Apr2021 09:00 (Lot number: EP7533) for COVID-19 immunisation. The patient medical history was not reported and there were no known allergies. Concomitant medications included rivaroxaban (XARELTO); empagliflozin (JARDIANCE); lisinopril all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly at the age of 71-years, at single dose in right arm on 05Mar2021 09:00 (Lot number: EN6199) for COVID-19 immunisation. The patient experienced stroke on 11Apr2021 (Stroke 7 days after injection (as reported)), it resulted in "Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) and Disability or permanent damage". The patient was hospitalized for stroke for 2 days. The patient was not diagnosed with COVID prior to vaccination and he had not been tested for COVID since the vaccination. Event outcome was not recovered.  No follow up attempts are possible. No further information is expected.; Sender's Comments: The reported stroke is likely due to an underlying medical condition and unrelated to BNT162B2. Although temporally related, there is no sufficient evidence that the reported stroke is related to BNT162B2. Note that the patient's medical history was not reported, however, patient is taking rivaroxaban and lisinopril for unspecified indication. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I know a physician in died afterwards; This is a spontaneous report from a Pfizer-sponsored programs from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient knows a physician and died afterwards on an unspecified date. It was unknown if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: I know a physician in (name) died afterwards
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: Maternal exposure during pregnancy; The newborn is in the NICU; This is a spontaneous report from a contactable consumer (parent) via a Pfizer sales representative. This consumer reported information for both mother and fetus/baby. Thi is the fetus/baby rpeort. Only this case is serious. A fetus of an unspecified gender received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via transplacental route of administration on unspecified dates as single dose for COVID-19 immunisation. The patient experienced maternal exposure during pregnancy and premaure birht at 25 weeks (the newborn is in the NICU) on an unspecified date. The events were considered serious as life-threatening. Birthweight was 1.96 pounds. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513513 Same reporter/ drug, different patients/ events;US-PFIZER INC-2021412709 Same reporter/ drug, different patients/ events
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: within two weeks of receiving the vaccine the patient died; This is a spontaneous report based on information received by Pfizer from Merck & Co., Inc.    A contactable Consumer reported for a male patient of an unspecified age that received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported.  The patient died within two weeks of receiving the vaccine on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.; Reported Cause(s) of Death: within two weeks of receiving the vaccine both family members died
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: within two weeks of receiving the vaccine both family members died; This is a spontaneous report based on information received by Pfizer (Case Number: 01903495). A contactable Consumer reported for two family members.  A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and  concomitant medications were not reported.  The patient died on an unspecified date within two weeks of receiving the vaccine .   It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.; Reported Cause(s) of Death: Unknown cause of death
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: 2 expired PENTACEL vaccines used,no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number-00536990) and transmitted to Sanofi on 26-Mar-2021.  This case involves a 4 month old female patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ146AAA, expiry date: 14-Feb-2021) via unknown route in unknown administration site for prophylactic vaccination on unknown date (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  Nurse states that 2 expired PENTACEL vaccines were administered. Patient received an expired Pentacel.  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose of Ipol was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health professional (Reference number- 00541462) and transmitted to Sanofi on 30-Mar-2021.  This case involves a 9-year-old female patient who received expired dose of POLIOMYELITIS VACCINE (INACTIVATED) (ipol)) [lot R1B251N and expiry date:13-Mar-2021] via an unknown route at an unknown administration site for prophylactic vaccination on 30-Mar-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (Latency: on the same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: About an hour after vaccine (1st dose) my left cheek and lips were numb, had headaches. Numbness were on and off and lasted for 2 days. At exactly 72 hours I felt like myself again. Not sure if I should get 2nd dose.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue, Migraine
Clinical narrative: Overnight the night of the vaccine:  severe chills, body aches, next day severe headache/migrane, mild nausea, weakness, winded, fatigue
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Overnight the night of the vaccine:  severe chills, body aches, next day severe headache/migrane, mild nausea, weakness, winded, fatigue
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Hot flush, Pain
Clinical narrative: Pfizer-BioNTech Covid 19 Vaccine EUA: One week post-injection I experienced extreme fatigue, body aches, chills, shivering, hot and cold flashes. At this time the symptoms have persisted for 30 hours, although the shivering subsided after sleeping through the night. The heavy fatigue and body aches continue however.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Between 20-60 minutes of receiving the vaccine in my left arm, my lips and face started tingling and going numb, a sensation very similar to receiving  novocaine when visiting the dentist. The sensation was primarily felt on the left side of my face, and had also affected my left arm, chest and leg by the time I was seen at the urgent care clinic. A MRI was conducted to rule out any kind of stroke event.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Between 20-60 minutes of receiving the vaccine in my left arm, my lips and face started tingling and going numb, a sensation very similar to receiving  novocaine when visiting the dentist. The sensation was primarily felt on the left side of my face, and had also affected my left arm, chest and leg by the time I was seen at the urgent care clinic. A MRI was conducted to rule out any kind of stroke event.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Being observed for 30 min due to allergy history. Pt stated she felt like her throat was tight and closing., right at her 30 min time. EMS responded and took control of scene. No wheezing, moving good air, o2 was 96% on room air. Other VS stable.  Kept an additional 10min, VS remained the same and pt calmed down and stated she felt better.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: I woke up with a red hot face rash on my cheeks and chin. It is itchy and burning.  Very red.