chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Loss of consciousness, Vertigo
Clinical narrative: Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Approximately 3 hours after injection, I became very dizzy, lightheaded, and passed out for a few minutes.I experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time; Was unable to sleep for longer than an hour at a time for 5 days; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm at school or student health clinic on 15Mar2021 16:45 (at the age of 57-year-old) as SINGLE DOSE 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 has not been tested for COVID-19 since the vaccination. The patient had no medical history. The patient had no allergies to medication, food, or products. Concomitant medications included finasteride and morniflumate (FLOMAX [MORNIFLUMATE]). On 15Mar2021 at 19:15, approximately 3 hours after injection, the patient became very dizzy, lightheaded, and passed out for a few minutes. The patient also experienced vertigo for 24 hours, and was unable to sleep for longer than an hour at a time. There was no treatment for the events. On an unspecified date, the patient recovered from all events.  Information about batch/lot number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Insomnia
Clinical narrative: exhausted / Fatigue; she could hardly sleep; Mild sore throat; Headache; No energy; Myalgia; Arthralgia; This is a spontaneous report from a contactable physician. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 18:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing asthma, attention deficit disorder, and depression. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) for attention deficit hyperactivity disorder and ongoing bupropion for depression. Family history included brother had Covid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Apr2021, the patient developed headache (important medical event - IME), no energy (disability), myalgia (disability), arthralgia (IME), and mild sore throat. On 18Apr2021, she could hardly sleep and exhausted/fatigue (disability). The patient had no shortness of breath, even though she has asthma and it was not an anaphylactic reaction. The patient took TYLENOL for the events which helped somewhat but didn't relieve it fully. It resolved as time passed. The outcome of the events headache, no energy, myalgia, arthralgia, mild sore throat was recovered on 18Apr2021. The outcome of the events could hardly sleep and exhausted/fatigue was recovered in Apr2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: exhausted / Fatigue; she could hardly sleep; Mild sore throat; Headache; No energy; Myalgia; Arthralgia; This is a spontaneous report from a contactable physician. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 18:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing asthma, attention deficit disorder, and depression. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) for attention deficit hyperactivity disorder and ongoing bupropion for depression. Family history included brother had Covid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Apr2021, the patient developed headache (important medical event - IME), no energy (disability), myalgia (disability), arthralgia (IME), and mild sore throat. On 18Apr2021, she could hardly sleep and exhausted/fatigue (disability). The patient had no shortness of breath, even though she has asthma and it was not an anaphylactic reaction. The patient took TYLENOL for the events which helped somewhat but didn't relieve it fully. It resolved as time passed. The outcome of the events headache, no energy, myalgia, arthralgia, mild sore throat was recovered on 18Apr2021. The outcome of the events could hardly sleep and exhausted/fatigue was recovered in Apr2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dysmenorrhoea, Pyrexia, Uterine haemorrhage
Clinical narrative: having period pain and bleeding discharge; having period pain and bleeding discharge today; have a low fever (less than 100.3); This is a spontaneous report from a contactable consumer (the patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 16Apr2021 at 11:00 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included: COVID-19 and known allergies: penicillin, sulfa drugs, and shellfish. The patient was not pregnant at the time of vaccination. Concomitant medications included: creatine, glutamine, and beta-alanine, all taken for an unspecified indication, start and stop date were not reported; and levonorgestrel (KYLEENA) for an unspecified indication from an unspecified date and ongoing. The patient previously took and had allergies to amoxicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated she had a KYLEENA IUD (intrauterine device) and had not had a menstrual cycle in 3 years. On 20Apr2021 08:00, the patient started having period pain and bleeding discharge, 4 days after the first dose. She continued to have a low fever (less than 100.3) for the fourth day. No treatment was received. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information about lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Lip blister, Rash pustular, Skin disorder, Vaccination site mass
Clinical narrative: Caller stated he went to the ED with a "large red bump on my arm" and "they numbed it and lanced it and blood and pus came out.; the same thing happened on my face, around my mouth; got bumps on my left arm shoulder where I got the shot; Also got bumps on my arms, hands, back, left side of my chest and my left shoulder where I got the shot; the same thing happened on my face, around my mouth; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via unspecified route of administration, 31Mar2021 (Batch/Lot number not reported) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 on 10Mar2021 for COVID-19 immunisation and had after my 1st dose, my mouth and lips developed cold blisters outside and inside my mouth. I had bumps on the inside of my mouth, and it took 7-10 days for the cold blisters to go away. Bumps inside my mouth are still there and the size of kidney beans. On an unspecified date in 2021, the patient stated, when I got my 2nd vaccine dose the same thing happened on my face, around my mouth and I also got bumps on my arms, hands, back, left side of my chest and my left shoulder where I got the shot. The patient stated he went to the ED with a large red bump on my arm and they numbed it and lanced it and blood and pus came out. They gave me antibiotics but that did not help with the bumps on my body. The patient stated his HCP said that was what you get for getting vaccinated. The patient stated his HCP does not wear a mask or believe we need the vaccinations. Can you tell me what these bumps are and is it a normal reaction to the vaccine? The outcome of the events was not recovered.  No follow up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gastrointestinal infection, Haematochezia, Illness
Clinical narrative: she has been diagnosed with a GI infection and is currently experiencing bloody stools.; she has been diagnosed with a GI infection and is currently experiencing bloody stools.; she got sick; I have been having joint pain ever since I got the first dose and don't feel like maybe should take it today.; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program and also via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration, on 31Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she had her first dose of Pfizer Covid-19 vaccine on 31Mar2021 and was scheduled to take her second dose on 26Apr2021. On an unspecified date in 2021, she got sick and was admitted at the ER and was told that she has an inflammation and infection in her intestine/colon. She was diagnosed with GI infection and experiencing bloody stools at the time of the report. She also reported that she was having joint pain ever since she got the first dose and did not feel like taking the vaccine. The outcome of the events was unknown.   Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: minor blood clot on his leg; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 03Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient had the first dose on 03Apr2021 and he was scheduled on Saturday 24Apr2021 to get the second dose of the vaccine. However, the patient had a minor blood clot on his leg, and he was taking blood thinners. Patient asked if it was okay to get the vaccine while talking to the blood thinners (as reported). The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My son took the first dose of the Pfizer Vaccine. About 4 days later contracted Covid; My son took the first dose of the Pfizer Vaccine. About 4 days later contracted Covid; This is a spontaneous report from a non-contactable consumer. A male patient (reporter's son) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, NDC number: Unknown, Expiration date: 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. Reporter stated, "My son took the first dose of the Pfizer vaccine. About 4 days later contracted COVID. My question was should he get his follow up shot, this Friday." The outcome of the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: a week later she tested with COVID positive; This is a spontaneous report from a Pfizer sponsored program. This consumer (patient) reported that a female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route on 03Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. One week later on 09Apr2021, she was tested with COVID positive, she currently was in quarantine. The patient's second dose was scheduled on 24Apr2021 and also she would be out of quarantine on that day. She wanted to know if she could get the vaccine or she needs to see doctor first. She was trying to see if she needed to rescheduled the second shot or go ahead and take it. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Disorientation, Dizziness, Dysphonia
Clinical narrative: Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat and chest; tightness in throat and chest; dizziness; disorientation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 as single dose for covid-19 immunization in an hospital. Medical history included reaction to preservatives in foods, products, and medications from an unknown date. The patient's concomitant medications were not reported. The patient previously took sodium metabisulfite and experienced anaphylaxis. No other vaccines taken in four weeks. No COVID-19 prior to vaccination. On 08Mar2021 18:00 the patient experienced anaphylaxis reaction immediately post-vaccine, difficulty speaking, hoarseness, tightness in throat and chest, dizziness, and disorientation. The events required emergency room and physicians office visit and were considered life threatening by the reporter. The patient was treated with Epinephrine, Benadryl, Prednisone, and Pepcid. The patient was tested for COVID-19 via nasal swab post vaccination on 08Mar2021 with a negative result. The outcome of the events were recovered with sequel.   Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Speech disorder, Throat tightness
Clinical narrative: Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat and chest; tightness in throat and chest; dizziness; disorientation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 as single dose for covid-19 immunization in an hospital. Medical history included reaction to preservatives in foods, products, and medications from an unknown date. The patient's concomitant medications were not reported. The patient previously took sodium metabisulfite and experienced anaphylaxis. No other vaccines taken in four weeks. No COVID-19 prior to vaccination. On 08Mar2021 18:00 the patient experienced anaphylaxis reaction immediately post-vaccine, difficulty speaking, hoarseness, tightness in throat and chest, dizziness, and disorientation. The events required emergency room and physicians office visit and were considered life threatening by the reporter. The patient was treated with Epinephrine, Benadryl, Prednisone, and Pepcid. The patient was tested for COVID-19 via nasal swab post vaccination on 08Mar2021 with a negative result. The outcome of the events were recovered with sequel.   Information about lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for coronavirus first of this month after completing both vaccines in Feb2021; testing positive for coronavirus first of this month after completing both vaccines in Feb2021; This is a spontaneous report from a contactable consumer (patient) and a contactable other health care professional. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), via an unspecified route of administration on unknown date in Feb2021 at single dose (at age of 59-year-old) for COVID-19 immunisation, Lot number: unknown. Medical history included Psoriatic Arthritis. Concomitant medication included tofacitinib citrate (XELJANZ) taken for psoriatic arthritis from 22Feb2021 and ongoing. The patient received the first dose of bnt162b2 (BNT162B2) vaccine on an unknown date in Feb2021 (at age of 59-year-old) for Covid-19 immunization. Patient stated that she was testing positive for coronavirus on 01Apr2021 (first of this month) after completing both vaccines in Feb2021. Symptoms of cough/fever/chills/nausea, symptoms resolved after one and half days. Md unaware. Encouraged to notify MD. no additional information/details provided. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got covid after getting the first dose of the vaccine; got covid after getting the first dose of the vaccine; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that she was getting off quarantine was scheduled to get her second dose thursday April29th, she got COVID after getting the first dose of the vaccine, wanted to know if it is safe for her to go ahead and get the second dose of the vaccine. Patient took down medical number for future references and she knows that there are a few ahead of her in Que. No unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknow.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: received first dose of Covid Vaccine on 3/22 . Husband and daughter came down with Covid; received first dose of Covid Vaccine on 3/22 . Husband and daughter came down with Covid; This is spontaneous case received from a contactable consumer husband (patient).   A male patient of unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot no. unknown; Expiration date: unknown) via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunization. patient medical history and concomitant medication were not reported. Reporter and his family received first dose of COVID Vaccine on 22Mar2021. On an unknown date in 2021, husband and daughter came down with Covid she is in quarantine and will miss her second dose date. she will be on day 46 past window. the outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Off label use, Product use issue, SARS-CoV-2 test
Clinical narrative: Tested covid after having received the first dose/tested positive; Tested covid after having received the first dose/tested positive; other vaccine same date vaccine date: 07Apr2021; other vaccine same date vaccine date: 07Apr2021; This is a spontaneous report received from a contactable consumer (who is also the patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ew0151), via an unspecified route of administration in the left arm, on 07Apr2021 14:00, as single dose, for COVID-19 immunisation. There was no medical history. The patient had no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included an unspecified vaccine administered on 07Apr2021 (reported as "other vaccine same date vaccine date: 07Apr2021"). There were no other medications in two weeks. The patient tested COVID after having received the first dose on 26Apr2021 10:00 (also reported as "exactly 22 days after having received the first dose"). The patient tested positive for COVID-19 thru COVID oral swab test on 26Apr2021 (also reported as 27Apr2021). No treatment was received for the event. The patient assessed the event as life-threatening. The outcome of the event was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Fatigue, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: Feeling Tired; Headaches; Passed away; found dead in her bed; Was not feeling well; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 11Apr2021 (lot number: ER8729) at the age of 49 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included naproxen sodium (NAPROSYN) taken for an unspecified indication from 05Apr2021 to an unspecified stop date; and benzonatate taken for an unspecified indication from 05Apr2021 to an unspecified stop date. The patient previously received first dose of BNT162b2 on 21Mar2021 (lot number: EP6955) at the age of 49 years old, for COVID-19 immunization and experienced fatigue, legs were hurting, dry cough, and really bad headaches. No other vaccines received in four weeks. The caller's friend (patient) got her second dose on a Sunday (11Apr2021). Monday, (12Apr2021), the patient went to work, but left because she wasn't feeling well. The reporter stated that the reporter did not speak to her friend (patient) directly on this day but was told that her friend (the patient) was feeling tired and having headaches. The reporter stated that her friend died early Tuesday morning 13Apr2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 05Apr2021. The patient died on 13Apr2021. An autopsy was performed, and results were not provided. Outcome of events 'was not feeling well', 'feeling tired', and 'headaches' was unknown.; Reported Cause(s) of Death: Passed away; found dead in her bed
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: found dead/ sudden death; This is a spontaneous report from a contactable physician. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was found dead with her dog by her side on Thursday night just days after she took the second dose of the Pfizer COVID-19 vaccine. The reporter noted, "Covid-19 has turned all of our lives upside down in a way that we never imagined, and now it's safe to say that we won't even be able to say goodbye to our daughter." The (Name) mother also blamed the vaccine for the sudden death of her "healthy" daughter. While a post-mortem was expected to be held to learn more about her death, some of the family members believed she simply suffered a heart attack, while her mother was connecting her sudden death to the vaccine. The patient died in Apr2021. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information in this report precludes a full assessment of the case; therefore a possible contributory role of the Pfizer suspect product BNT162B2 to the reported Death cannot be completely excluded. Information on relevant medical history, concomitant medications, and post-mortem result would be needed for a thorough medical evaluation of the patient's sudden death.  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.; Reported Cause(s) of Death: found dead/ sudden death
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Immune system disorder, Rash
Clinical narrative: The immune system was going crazy with this reaction; Allergic reaction (massive); Rash all over (severe); This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 23Apr2021 (Lot# EW0172), as single dose, for COVID-19 immunisation. Medical history included seasonal allergy, rubber sensitivity, drug hypersensitivity. Concomitant medication included multivitamins. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EW0150) at 51 years for COVID-19 immunisation. The patient experienced a massive allergic reaction with rash all over (severe) on 26Apr2021. The immune system was going crazy with this reaction. Rash was described as rash on her whole body which started around her thigh area, the rash was really severe and all blow-up. The events required physician office visit. Therapeutic measures were taken as a result of the events and included treatment with Prednisone. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Pulmonary embolism
Clinical narrative: 1 pulmonary embolism in the left lung, 2 pulmonary embolisms in my right lung; a slight pleural effusion in the right lower lung; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 13Mar2021 14:00 at 22 years-old, as a single dose for COVID-19 immunisation. Medical history included Known Allergies: Penicillin and COVID-19, both on an unknown date. Concomitant medications included ethinylestradiol, levonorgestrel (CAMRESE LO) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin, diphenhydramine (BENADRYL), xylometazoline hydrochloride (SUDAFED), guaifenesin and all experienced allergies. The patient previously received first dose of BNT162B2 (Lot Number: EM9809), via an unspecified route of administration, administered in the left arm on 20Feb2021 14:00 at 22 years old as single dose for COVID-19 immunisation. On 05Apr2021 18:00, the patient experienced 1 pulmonary embolism in the left lung, 2 pulmonary embolisms in the right lung and a slight pleural effusion in the right lower lung. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and considered as a Life threatening illness. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all the events which included Xarelto and Hydrocodone. The outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced seizure on 10Apr2021. The patient had no other vaccine in four weeks. The patient was tested for COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative. Therapeutic measures (medication and follow-up treatment) were taken as a result of seizure. The outcome of the event was not recovered. The event was reported as serious-hospitalized, disability, life-threatening.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for Covid-19; testing positive for Covid-19; This is a spontaneous report from a contactable consumer (patient's wife) reported. A  62-year-old male patient received initial dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on 07 Apr2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. He started to experience fever, chills, and a cough after receiving the vaccine and she thought these were normal side effects but he ended up testing positive for Covid-19. He is due for his second dose of the vaccine on 05May2021. Outcome of the events is unknown.  Follow-up attempts are possible; information about lot/batch number requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Headache, Nausea
Clinical narrative: dehydration; Chills; low fever; nausea; body ache; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, second dose) solution for injection intramuscular in the right arm on 19Feb2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and overweight. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EN5318) for COVID-19 immunisation on 26Jan2021 and experienced dehydration, fatigue, chills, headache, fever, nausea, body ache, and cough. On 19Feb2021 at 18:00, the patient experienced dehydration, chills, low fever, nausea, body ache, fatigue, and headache which resulted in an Emergency Room visit. The patient was treated for dehydration. The outcome of the events dehydration, chills, low fever, nausea, body ache, fatigue, and headache was recovered in Feb2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: dehydration; Chills; low fever; nausea; body ache; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, second dose) solution for injection intramuscular in the right arm on 19Feb2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and overweight. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EN5318) for COVID-19 immunisation on 26Jan2021 and experienced dehydration, fatigue, chills, headache, fever, nausea, body ache, and cough. On 19Feb2021 at 18:00, the patient experienced dehydration, chills, low fever, nausea, body ache, fatigue, and headache which resulted in an Emergency Room visit. The patient was treated for dehydration. The outcome of the events dehydration, chills, low fever, nausea, body ache, fatigue, and headache was recovered in Feb2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: DTAP
Symptoms: Amniotic cavity infection
Clinical narrative: chorioamnionitis; Initial information was received on 22-Apr-2014 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves a 33 year-old female patient who experienced chorioamnionitis (amniotic cavity infection), after she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported   On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious chorioamnionitis (amniotic cavity infection) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At time of reporting, outcome of the event was unknown.  Information on batch number was requested.; Sender's Comments: This case involves a 33 year-old female patient who experienced amniotic cavity infection after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (unknown manufacturer). The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Patient received a dose of expired Menactra with no adverse event.; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00561594) and transmitted to Sanofi on 14-Apr-2021.  This case involves a patient with unknown demography who received an expired 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6585AA and expiry date: 11-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 13-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know what side effects are associated with giving an expired Mentactra to a patient. The reporter also reported that she did not have any additional information available at her location at the time of the call, therefore the AE template was not completed.  At the time of reporting, the patient experienced 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 the guidelines. 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: 0.5
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Extra dose administered, Incorrect dose administered, Medication error
Clinical narrative: A patient received Adacel instead of Daptacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00577378).  This case involves a six-month-old male patient who received a third dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5689AA and expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination on 14-Apr-2021 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for prophylactic vaccination.  This was a case of actual medication error due to extra dose administered (latency same day).  At the time of reporting, 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 holders compliance with the requirements. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Eye swelling, Hypoaesthesia oral, Pruritus, Swelling face
Clinical narrative: Patient states she received 1st dose of Pfizer vaccine oon 3/29; had an allergic reaction with whole body itching,  numbness  on mouth and lips, facial swelling (left eye).  She was given Benadryl and observed for 1.5 hours and sent home.  (at vaccine clinic 3/29/21) Patient reports she is still having some mild  itching, throat is a bit hoarse.  She is using allergy eye drops.  Patient was advised to see her PCP. and not to receive her second dose of vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Nodule
Clinical narrative: "  Patient's left arm had been sore with a red circle around the injection site for a couple of days since her second Moderna vaccine on 2/26/21.  After the initial pain and redness went away, a second episode of redness the size of two quarters appeared and lasted for a couple of days.  That redness it subsided for a day. Then the  redness returned is about the size of the palm of patient's  hand. It is not a bright red or itchy and doesn't look like a rash. In addition, patient reports developing a nodule at the collarbone on her left side two days after the vaccine. Patient reports no fever or other symptoms. At Clinic visit, provider notes that all of the patient's symptoms are resolving.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Lymph node pain, Lymphadenopathy
Clinical narrative: 6 days after 1st dose lymph nodes in left arm became enlarged and painful. Lasted 3 days and responded to NSAID treatment. On day 10 red rash with itchiness appeared at injection site.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood lactate dehydrogenase, Blood pressure increased, Chest pain, Heart rate increased
Clinical narrative: Patient began with chest pain onset today while sitting in chair at home. Patient called ems and was found to have HR of 193. Patient did 2 vagal maneuvers and hr dropped to 150. Patient reports decreased chest pain, denies cough or n/v. Patient on arrival has an initial HR of 132 and a BP 106/69.  Temp 36.6 degrees Celsius.  HR decreased to 100 with no intervention.  500mL of fluids given.  Diltiazem was not given as HR decreased to 100 and BP was 98/62.  Patient reports that she had her COVID19 vaccine yesterday followed by some arm pain and aches in her legs. Patient does have a history of Afib and is on diltiazem at home.  Dx with Afib with RVR.  Patient will be admitted to the hospital.  Patient converted to NSR on her own.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombocytosis, Transaminases increased
Clinical narrative: Patient began with chest pain onset today while sitting in chair at home. Patient called ems and was found to have HR of 193. Patient did 2 vagal maneuvers and hr dropped to 150. Patient reports decreased chest pain, denies cough or n/v. Patient on arrival has an initial HR of 132 and a BP 106/69.  Temp 36.6 degrees Celsius.  HR decreased to 100 with no intervention.  500mL of fluids given.  Diltiazem was not given as HR decreased to 100 and BP was 98/62.  Patient reports that she had her COVID19 vaccine yesterday followed by some arm pain and aches in her legs. Patient does have a history of Afib and is on diltiazem at home.  Dx with Afib with RVR.  Patient will be admitted to the hospital.  Patient converted to NSR on her own.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: Headache,  a little short of breath. Took a Benadryl, was fine the next day.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Skin burning sensation, Throat tightness, Tremor
Clinical narrative: itching/burning sensation on skin, but not everywhere, lightheadedness, congested feeling in throat, shaking all over-  were worst ~50 minutes - 3 hours after injection systemic allergic reaction  Took 2 benedryl  at pharmacy, where I tried to get an epinephrine shot - I thought I would get faster treatment there than ER- was a mistake  Believe should have gone to ER; friend wanted to take me   I categorized as life threatening below - think I was just really fortunate  Did not have what I would consider significant reaction to first injection-- no allergic reaction; very minimal immune  response side effects -  felt a little like I might get sick
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Asthma, Blood test, Chest pain, Dyspnoea
Clinical narrative: Started to have shortness of breath 4/20/2021, began using albuterol inhaler after primary care visit on 4/23/2021, went to ER 4/26/2021 due to still being short of breath and was given prednisone and breathing treatment then was sent home saying it was an asthma exacerbation. Followed up with primary doctor on 4/28/2021 with continuing and worsening symptoms now including chest pain as well as shortness of breath and was sent back to ER for more testing for pulmonary embolisms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, SARS-CoV-2 test, Scan with contrast, Ultrasound scan
Clinical narrative: Started to have shortness of breath 4/20/2021, began using albuterol inhaler after primary care visit on 4/23/2021, went to ER 4/26/2021 due to still being short of breath and was given prednisone and breathing treatment then was sent home saying it was an asthma exacerbation. Followed up with primary doctor on 4/28/2021 with continuing and worsening symptoms now including chest pain as well as shortness of breath and was sent back to ER for more testing for pulmonary embolisms.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen painful arm pit right arm pain in both arms/joints elbow to wrist
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Neck pain
Clinical narrative: Patient experiencing headaches, neck pain, and back pain.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Sudden hearing loss
Clinical narrative: Adverse event is HEARING LOSS in the left ear. Right now being treated with steroids orally. May have to get steroid injections in ear drum. Hearing is completely gone. No signs, just suddenly came on briefly.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Adverse event is HEARING LOSS in the left ear. Right now being treated with steroids orally. May have to get steroid injections in ear drum. Hearing is completely gone. No signs, just suddenly came on briefly.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Swelling, pain, red rash at injection site
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Continuous Tinnitus
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Neck pain
Clinical narrative: fatigue next day after vaccine, second day  fatigue gone but muscle pain all over and severe neck muscle spasm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Multiple cold sores across upper lip
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Pyrexia, Tinnitus
Clinical narrative: headache,  head spinning,  fever, ringing in ears, strange buzzing sound in head, body aches similar to mild flu. Headaches,  head spinning and flu like body aches lasted a few days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: headache,  head spinning,  fever, ringing in ears, strange buzzing sound in head, body aches similar to mild flu. Headaches,  head spinning and flu like body aches lasted a few days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Neuralgia, Rash papular
Clinical narrative: I have a large raised red rash near the injection site. It is itchy and hot. I have also had nerve pain in that arm.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing or buzzing noise in my head it started on 03/26/2021 when i woke up that morning. Still have ringing or buzzing in my head today date is 05/04/2021. Never had this problem before the shot!