chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain
Clinical narrative: feeling unwell; nausea; redness; injection site swelling; little fever; joint pain; chills; muscle ache; headache; body ache; tiredness; couldn't hardly stand; This is a spontaneous report from a contactable consumer or other non hcp.  A 55-years-old male patient received bnt162b2 (BNT162B2solution for injection), dose 2 via an unspecified route of administration on 19Apr2021 12:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included blood pressure measurement and concomitant medications were not reported. On Tuesday,feeling unwell, nausea, redness, injection site swelling right where they gave me the shot, a little fever, joint pain, chills, muscle ache, headache, body ache, tiredness and rated his pain as 10/10. The patient had taken Acetaminophen, drank sprite, ate crackers, and laid down for about 2 hours. He also reported that back pain is still existent a couple of inches above his waist line and on one side, all the way across. Caller states he rates his back pain as a 4 or 3/10, is nauseous rating it 2/10, has pressure in his hands and swelling in his fingers. He was taking Acetaminophen for every 6 hours. The outcome of the vents was unknown.   No follow up attempts required as no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: feeling unwell; nausea; redness; injection site swelling; little fever; joint pain; chills; muscle ache; headache; body ache; tiredness; couldn't hardly stand; This is a spontaneous report from a contactable consumer or other non hcp.  A 55-years-old male patient received bnt162b2 (BNT162B2solution for injection), dose 2 via an unspecified route of administration on 19Apr2021 12:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included blood pressure measurement and concomitant medications were not reported. On Tuesday,feeling unwell, nausea, redness, injection site swelling right where they gave me the shot, a little fever, joint pain, chills, muscle ache, headache, body ache, tiredness and rated his pain as 10/10. The patient had taken Acetaminophen, drank sprite, ate crackers, and laid down for about 2 hours. He also reported that back pain is still existent a couple of inches above his waist line and on one side, all the way across. Caller states he rates his back pain as a 4 or 3/10, is nauseous rating it 2/10, has pressure in his hands and swelling in his fingers. He was taking Acetaminophen for every 6 hours. The outcome of the vents was unknown.   No follow up attempts required as no further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear infection viral, Vertigo
Clinical narrative: The caller stated she has vertigo and the doctor says it is a viral ear infection; The caller stated she has vertigo and the doctor says it is a viral ear infection; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on an unspecified date in 2021. The medical history and concomitant medications were not reported. On an unknown date, the patient stated that she had vertigo and the doctor told it as a viral ear infection. He prescribed an antiviral and anti-inflammatory medications that she was picking up. The doctor said she cannot get the second dose when it is scheduled on 27th because she will be taking these medications. She asked if these symptoms are from the vaccine. She stated she asked the doctor and he said no one knows. She stated she has never had vertigo or an ear infection but 12 days after the vaccine this happened but it could be a coincidence.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness transitory, Hypoacusis, Tinnitus, Vertigo
Clinical narrative: The caller stated she has vertigo and the doctor says it is a viral ear infection; The caller stated she has vertigo and the doctor says it is a viral ear infection; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on an unspecified date in 2021. The medical history and concomitant medications were not reported. On an unknown date, the patient stated that she had vertigo and the doctor told it as a viral ear infection. He prescribed an antiviral and anti-inflammatory medications that she was picking up. The doctor said she cannot get the second dose when it is scheduled on 27th because she will be taking these medications. She asked if these symptoms are from the vaccine. She stated she asked the doctor and he said no one knows. She stated she has never had vertigo or an ear infection but 12 days after the vaccine this happened but it could be a coincidence.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a non-contactable consumer (Patient) via Medical Information Team. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 15Apr2021 (at the age of 60-years), as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient took 1st dose of COVID-19 VACCINE. On 16Apr2021 (one day after vaccination), patient had rash. Patient wanted to know if she can take Benadryl for the rash. Patient stated that she received documentation that this normally happened within an hour, and now this reaction occurred one day later and was asking about any information on side effects. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Then 10 days later got Covid; This is a spontaneous report from Pfizer sponsored program from a contactable consumer (patient). A female patient of an unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date in Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that the patient received her 1st dose on an unspecified date in Jan2021 and then 10 days later got Covid. She was told to wait until 01May2021 to get her 2nd dose. She wants to know if this then would be her 2nd dose or if she would have to start the process over again. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :PFIZER INC-2021443522 same drug and patient, different event and drug dose
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for Covid after getting the first Covid shot; testing positive for Covid after getting the first Covid shot; This is a spontaneous report from a non-contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose 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's medical history and concomitant medications were not reported. The reporter wanted to know if his child should get the vaccine after testing positive for Covid after getting the first Covid shot on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid19; tested positive for Covid19; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (reported as "recently") (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he is scheduled to receive the second BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine shot within days, yet he has recently been tested positive for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatments for the event. The event outcome was unknown at the time of the report.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Flushing, Gastrooesophageal reflux disease, Nervousness
Clinical narrative: she got a little flushed; had a weird taste in her mouth; then a burning sensation on her tongue.; Caller stated it triggered her panic attacks.; anxiety really bad.; had acid reflux and stated she was afraid to go to bed; the shot made her nervous; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left arm on 20Apr2021 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder. The patient has allergic to amoxicillin, penicillin, cefdinir, codeine, phenergan and contrast dye with iodine. Concomitant medications were not reported. On unknown date Caller stated she got the Pfizer covid 19 vaccine yesterday, 20Apr2021, patient experienced right after the shot she got a little flushed, anxious and had a weird taste in her mouth then a burning sensation on her tongue. Caller stated the nurse said it was not an anaphylactic reaction. Patient waited 20 to 25 minutes after the vaccine at the facility and stated it triggered her panic attacks, had anxiety really bad. She came home and worried all night and had acid reflux and stated she was afraid to go to bed last night because she did not know what was going to happen. Caller stated her PCP told her she had heard of others that have the burning tongue and she had the burning only slightly today. Caller reported no swelling and stated the shot made her nervous and she did get anxious and could be due to panic. Caller asked should she get the second dose and stated she was autoimmune. Caller stated she took contrast dye with iodine and it made her feel super drugged and she took guiafenesin with codeine and had to go to the ER because her throat and mouth were on fire. Caller had an appointment at 1:00 and did not have time to be transferred. The patient visited emergency room (ER) because her throat and mouth were on fire on unknown date. The patient received treatment for the events with contrast dye with iodine and guiafenesin with codeine. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Taste disorder
Clinical narrative: she got a little flushed; had a weird taste in her mouth; then a burning sensation on her tongue.; Caller stated it triggered her panic attacks.; anxiety really bad.; had acid reflux and stated she was afraid to go to bed; the shot made her nervous; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered in left arm on 20Apr2021 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder. The patient has allergic to amoxicillin, penicillin, cefdinir, codeine, phenergan and contrast dye with iodine. Concomitant medications were not reported. On unknown date Caller stated she got the Pfizer covid 19 vaccine yesterday, 20Apr2021, patient experienced right after the shot she got a little flushed, anxious and had a weird taste in her mouth then a burning sensation on her tongue. Caller stated the nurse said it was not an anaphylactic reaction. Patient waited 20 to 25 minutes after the vaccine at the facility and stated it triggered her panic attacks, had anxiety really bad. She came home and worried all night and had acid reflux and stated she was afraid to go to bed last night because she did not know what was going to happen. Caller stated her PCP told her she had heard of others that have the burning tongue and she had the burning only slightly today. Caller reported no swelling and stated the shot made her nervous and she did get anxious and could be due to panic. Caller asked should she get the second dose and stated she was autoimmune. Caller stated she took contrast dye with iodine and it made her feel super drugged and she took guiafenesin with codeine and had to go to the ER because her throat and mouth were on fire. Caller had an appointment at 1:00 and did not have time to be transferred. The patient visited emergency room (ER) because her throat and mouth were on fire on unknown date. The patient received treatment for the events with contrast dye with iodine and guiafenesin with codeine. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Herpes zoster, SARS-CoV-2 test
Clinical narrative: Oral Shingles Outbreak; This is a spontaneous report from a contactable consumer (patient).    A 43-years-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:00; at the age of 43-year-old, (Batch/Lot Number: EP 6955) as SINGLE DOSE for covid-19 immunisation. Historical vaccination included first dose of BNT162B2 (Lot number: EN 5318) on 02Mar2021 02:00 PM.  Medical history included, lyme disease from an unknown date and unknown if ongoing.      The patient's concomitant medications were not reported.  The patient previously took hydroquinone and experienced drug hypersensitivity.  The patient experienced oral shingles outbreak (herpes zoster) (disability) on 10Apr2021 09:00 with outcome of not recovered.  The patient was seen at Physician Office.  The patient underwent lab tests and procedures on 16Apr2021 which included blood immunoglobulin G: pending results, blood immunoglobulin M: pending result, Sars-cov-2 test: pending the same day (16Apr2021). Therapeutic measures were taken as a result of oral shingles outbreak includes Valacyclovir HCL 1 gram.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: The caller stated they have a patient who got a shot from another Walgreens and thinks she got half the dose when the pharmacist administered it; The caller stated they have a patient who got a shot from another pharmacy and thinks she got half the dose when the pharmacist administered it; This is a spontaneous report from a contactable pharmacist. A 28-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that they had a patient who got a shot from another pharmacy and thought she got half the dose when the pharmacist administered it. The reporter wondered if the patient needed another dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Circumstance or information capable of leading to medication error, Fatigue, Pregnancy test negative, SARS-CoV-2 test negative
Clinical narrative: having no energy; fatigued/extreme tiredness; Not sure if she will get second dose of the vaccine; Sleeping 13-14 hours a day; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EW0151), dose 1 via an unspecified route of administration on 07Apr2021 17:30 (at the age of 30-years-old) as single dose for covid-19 immunisation . Medical history included breast cancer and urinary bladder haemorrhage. The patients concomitant medications were not reported. On 08Apr2021 the patient experienced fatigued/extreme tiredness. On an unspecified date in Apr2021 the patient was not sure if she will get second dose of the vaccine, sleeping 13-14 hours a day and having no energy. She was sleeping 13-14 hours a day and that was not normal for her. She was not sure if she would take the second dose because she was tired all of the time. For extreme tiredness patient visited physician office. Patient did not receive any other vaccine prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included pregnancy test negative: negative, sars-cov-2 test negative: negative. The outcome of event experienced fatigued/extreme tiredness was not recovered and outcome of rest of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: having no energy; fatigued/extreme tiredness; Not sure if she will get second dose of the vaccine; Sleeping 13-14 hours a day; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EW0151), dose 1 via an unspecified route of administration on 07Apr2021 17:30 (at the age of 30-years-old) as single dose for covid-19 immunisation . Medical history included breast cancer and urinary bladder haemorrhage. The patients concomitant medications were not reported. On 08Apr2021 the patient experienced fatigued/extreme tiredness. On an unspecified date in Apr2021 the patient was not sure if she will get second dose of the vaccine, sleeping 13-14 hours a day and having no energy. She was sleeping 13-14 hours a day and that was not normal for her. She was not sure if she would take the second dose because she was tired all of the time. For extreme tiredness patient visited physician office. Patient did not receive any other vaccine prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included pregnancy test negative: negative, sars-cov-2 test negative: negative. The outcome of event experienced fatigued/extreme tiredness was not recovered and outcome of rest of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Menstruation irregular
Clinical narrative: having no energy; fatigued/extreme tiredness; Not sure if she will get second dose of the vaccine; Sleeping 13-14 hours a day; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EW0151), dose 1 via an unspecified route of administration on 07Apr2021 17:30 (at the age of 30-years-old) as single dose for covid-19 immunisation . Medical history included breast cancer and urinary bladder haemorrhage. The patients concomitant medications were not reported. On 08Apr2021 the patient experienced fatigued/extreme tiredness. On an unspecified date in Apr2021 the patient was not sure if she will get second dose of the vaccine, sleeping 13-14 hours a day and having no energy. She was sleeping 13-14 hours a day and that was not normal for her. She was not sure if she would take the second dose because she was tired all of the time. For extreme tiredness patient visited physician office. Patient did not receive any other vaccine prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included pregnancy test negative: negative, sars-cov-2 test negative: negative. The outcome of event experienced fatigued/extreme tiredness was not recovered and outcome of rest of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: he fell in the bathroom and passed out; he fell in the bathroom and passed out; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's son). This consumer reported similar event for two patients (father and mother). This is the first (father) of the two reports.  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 26Mar2021 (batch/lot number: ER8727) at 79 years old as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing AFib (atrial fibrillation) diagnosed between 1 and 2 years ago. Patient also has a pacemaker from an unknown date. Patient was exposed to COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS) oral from an unspecified start date and ongoing at 5 mg twice a day taken for AFib (atrial fibrillation). On 07Apr2021, the patient was admitted to the hospital due to a fall; he fell in the bathroom and passed out. The patient is on Eliquis, so they were worried about bleeding. He tested positive for COVID on 07Apr2021, this was the same day he was admitted to the hospital. He was discharged on 10Apr2021 and was improving. It was reported that the reporter (patient's son) tested positive for COVID on 27Mar2021, so it was likely his parents were exposed or infected prior to their first dose of the vaccine. The reporter confirmed he has not been vaccinated. The patient was due to get the second shot today, but the reporter cancelled the appointment since his dad was still in quarantine. The reporter heard different things about when to get the second dose, everyone says to wait 90 days, they're getting mixed information, then he has heard 3 weeks is long enough to wait. The reporter wanted to know when his dad can get the second dose of the vaccine after having the COVID-19 infection. The patient is recovering from "he fell in the bathroom and passed out." Outcome of the event "tested positive for Covid" was unknown.   This case involves a Product Complaint: Consumer reported that his father and mother tested positive for Covid infection on 07Apr2021 after receiving the first dose of the Pfizer COVID vaccine on 26Mar2021. It was not provided if a sample of the product was available to be returned, if requested and if packaging was sealed and intact.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443810 same reporter, same drug, same event, different patient
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: was sent to the hospital due to a stroke; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced stroke and was sent to the hospital. The patient was not able to get the second dose tomorrow (as reported). His 2nd dose will be on 17Apr2021. Outcome of event was unknown.  Information about lot/batch has been requested.
Age: 99.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: being dizzy; he "can't stand straight, I almost fell backwards; This is a spontaneous report from a contactable consumer (patient).   A 99-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on 15Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date around three days after the vaccination the patient felt dizzy, and he could not stand straight he almost fell backwards. It was reported that dizziness become worse. Patient asked about how long would side effects last and wanted to know treatment recommendations. Outcome of events was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Impaired driving ability, Malaise
Clinical narrative: I'm not doing too well; can't drive; This is a spontaneous report from a Pfizer sponsored program, Pfizer Patient Assistance and Savings Program. A contactable 52-year old male consumer (patient) reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) on an unspecified date via unspecified route as a single dose for COVID-19 immunization and pregabalin (LYRICA) from an unspecified date, route, dose, frequency, and indication unspecified. Medical history and concomitant medications were not reported. The patient reported that he just had the COVID shot and can't drive (unspecified date). He was not doing too well from the second vaccine. The action taken in response to the events for pregabalin was unknown. The clinical outcome of the events can't drive and not doing too well was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested COVID positive with mild symptoms over next days; This is a spontaneous report from contactable consumer or other non healthcare professional via Pfizer sponsored program. A 99-years-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Jan2021 as single dose for COVID-19 immunization. Medical history included kidney and breast cancer survived after surgeries. The patient's concomitant medications were not reported. On 25Jan2021, patient tested COVID positive with mild symptoms over next days. On 25Jan2021, patient underwent lab tests and procedures which included covid-19: positive. On 29Jan2021, patient received infusion monoclonal antibodies followed by much worsening of symptoms. Gradual improvement within a month had strength and stamina back decided against getting second dose scheduled on 07Feb2021. Reporter wanted to know if patient should she get her second vaccination and when. Reporter also wanted to know if had any information about how long to wait to get the Pfizer vaccine after receiving monoclonal antibodies. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: small widely scattered rash on all parts of the body which consists of small pinpoint lesion bumps which were extremely itchy; small widely scattered rash on all parts of the body which consists of small pinpoint lesion bumps which were extremely itchy; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After 46 days of receiving the Pfizer COVID-19 vaccine, the patient developed a small widely scattered rash on all parts of the body which consists of small pinpoint lesion bumps which were extremely itchy on an unspecified date. The outcome of these events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Dry eye, Ear pain, Oropharyngeal pain
Clinical narrative: ear pain; eye dry; sore throat; Bell's palsy on the left side of my face; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old patient of an unspecified gender received first dose of BNT162B2), via an unspecified route of administration on 27Mar2021 16:00 (Batch/Lot Number: ER8733) as single dose in left arm for covid-19 immunisation.  Medical history included hypertension and blood cholesterol increased from an unknown date. Concomitant medications included evolocumab (REPATHA) 420mg monthly intramuscular for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported.  At 8:30 pm, four days after the COVID vaccine (on 31Mar2021), patient started to have dried left eye, pain behind my left ear and real deep sore throat and took 1 tablet of Ibuprofen 200mg orally (treatment),  and went to bed and then the next morning, woke up with total paralysis on the left side of face, lip was dripping, eye wouldn't close and was diagnosed with Bell's palsy by the doctor. Outcome of events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got his 1st dose last Wednesday and now has Covid; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 14Apr2021 (last Wednesday, as reported) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got his 1st dose last Wednesday and had Covid at the time of the report, in Apr2021. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose bnt162b2 on 02Apr2021/ tested positive for COVID virus on 06Apr2021; This is a spontaneous report from a Pfizer sponsored program. A female patient reported for herself, received the first dose bnt162b2 (Batch/Lot number was not reported) on 02Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for COVID virus on 06Apr2021, wondering if she was able to get the second dose. The outcome of the event is unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Skin exfoliation
Clinical narrative: rash; "scaly" on his abdomen & legs; it could be shingles; This is a spontaneous report from a contactable consumer (reported for himself).  A 60-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot number: not reported) via an unknown route of administration on 11Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection, Lot number: not reported) via an unknown route of administration on 18Feb2021 as SINGLE DOSE for covid-19 immunization On an unknown date, the patient experienced rash, scaly on his abdomen and legs and it could be shingles. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: Missed second dose of Covid-19 vaccine on 17Apr2021; one week later I was positive for Coronavirus; Fever; This is a spontaneous report from a contactable consumer. A 47-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302) via an unspecified route of administration, administered in left arm on 27Mar2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy (allergies 5 years ago). He reported that he was supposed to be getting the allergy injections for 3 years to be immune because allergy season was really bad for him, especially with pollen. He reported that he gets allergy injections every week in his arms. Concomitant products allergy injections: he began getting weekly allergy injections about 18 months ago. No Additional Administered Vaccines. No adverse event following prior vaccinations. On 07Apr2021, the patient experienced fever. On 08Apr2021, one week later he tested SARS-CoV-2 test: positive. He had a phone consultation with his physician after testing positive for Covid-19. He was supposed to be going for his second dose on 17Apr2021. Patient missed second dose of Covid-19 vaccine. He asked my doctor and she said she didn't know when he could get his second dose. They told me him had to call Pfizer. He missed second dose of Covid-19 vaccine. The events assessed as non-serious. On 10Apr2021, the event fever was resolved. On Monday, 19Apr2021, he went to get checked again for Covid-19 and he tested negative. He reported that he just recovered from the coronavirus last week. The outcome of the event tested positive for coronavirus is recovered on an unspecified date in Apr2021 and fever was recovered on 10Apr2021, missed dose was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Insomnia, Rash, Rash pruritic
Clinical narrative: her symptoms started as a couple of dots at the injection site; The rash started growing all over her body; Rash growing all over body was worsened; It is still burning and itching; It is still burning and itching; Neither of them can sleep; This is a spontaneous report from a contactable consumer (Patient husband) via Medical Information Team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 01Apr2021 (at the age of 49-years) as single dose for COVID-19 immunisation. It was reported that the patient received vaccine 22 days ago. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient experienced symptoms that started as a couple of dots at the injection site that got worsen and started growing all over her body, it is still burning and itching, neither of them can sleep. There is no relief for her rash even after ten days. Patient visited the emergency room four times and has been to her primary doctor and her pain management doctor where she received six different prescriptions, of which three are from a hospital which prescribed over-the-counter medicine and asked to come back after seven days. But nothing helped and the rash is still growing like poison ivy. Reporter described that patient back looks like the surface of Mars as seen on a television channel. Nothing else was different in her diet or medications outside of the vaccine. Later, patient visited another hospital where she was prescribed with another medication. Patient received treatment with an unspecified intravenous (IV) medication which helped her to sleep. Reporter stated that none of the medication helped except the IV medication, considered so because it helped her sleep. Reporter was upset and thought that Pfizer vaccine gave the patient that rash. The outcome of the event insomnia was recovered and the outcome of the event condition aggravated was unknown while for all the other events, it was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: her symptoms started as a couple of dots at the injection site; The rash started growing all over her body; Rash growing all over body was worsened; It is still burning and itching; It is still burning and itching; Neither of them can sleep; This is a spontaneous report from a contactable consumer (Patient husband) via Medical Information Team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 01Apr2021 (at the age of 49-years) as single dose for COVID-19 immunisation. It was reported that the patient received vaccine 22 days ago. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient experienced symptoms that started as a couple of dots at the injection site that got worsen and started growing all over her body, it is still burning and itching, neither of them can sleep. There is no relief for her rash even after ten days. Patient visited the emergency room four times and has been to her primary doctor and her pain management doctor where she received six different prescriptions, of which three are from a hospital which prescribed over-the-counter medicine and asked to come back after seven days. But nothing helped and the rash is still growing like poison ivy. Reporter described that patient back looks like the surface of Mars as seen on a television channel. Nothing else was different in her diet or medications outside of the vaccine. Later, patient visited another hospital where she was prescribed with another medication. Patient received treatment with an unspecified intravenous (IV) medication which helped her to sleep. Reporter stated that none of the medication helped except the IV medication, considered so because it helped her sleep. Reporter was upset and thought that Pfizer vaccine gave the patient that rash. The outcome of the event insomnia was recovered and the outcome of the event condition aggravated was unknown while for all the other events, it was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash papular, Swelling face, Urticaria
Clinical narrative: hives; swollen face; red bumps on her face; eyes were swollen; This is a spontaneous report from a contactable consumer ( Patients Grandmother). A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration was not reported), via an intramuscular route of administration as a single dose for COVID-19 immunization. The patient's medical history included allergy to pencillin. Concomitant medications were not reported. It was reported that consumer calling on behalf of her granddaughter who received the first dose of the Pfizer vaccine on Friday, after 24 hours by Saturday night she had hives, swollen face, red bumps on her face, her eyes were swollen, (all reactions on her face) it was severe for like 2 days and next three days was not so severe and began to cool down after 3 days. She had appointment on 30Apr2021 for next vaccine, is there anything she can do or take prior to the vaccine to prevent it. She had allergy to penicillin she would get hives. last time she had penicillin was about 5 or 7 years ago. Is there any information about getting the second vaccine after side effects after the first dose, A lot of people have a problem after the second dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pyrexia, Vaccination site pain
Clinical narrative: headaches ever since vaccine; fever; Could not sleep; hurt like hell; This is a spontaneous report from a Pfizer sponsored program . A contactable female consumer (patient) reported for herself. Follow-up information received on 19Apr2021 from same reporter was processed together with initial information. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via intramuscular route in left arm on 13Feb2021 (at 62-years age) as single dose for covid-19 immunisation. Medical history included high cholesterol. Patient States her whole family was dead, and all died of cancer. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has never been sick or had a headache in her whole life until after receiving 2nd dose of Covid19 Vaccine. Said has headaches ever since vaccine. Wants to speak to someone about this. She later clarified and stated she wanted to report that the headaches are happening daily. If she would have known, she would have not taken the vaccine, even if it was to be with her mother-in-law. A friend of hers works for a research company states she would not recommend that anyone get the vaccine. Then she states she was provaccine. When providing details about the first dose she states the vaccine hurt like hell. The pain started 20 minutes after the vaccine was given on 13Feb2021. It hurt all night and went away the next day. The second vaccine was given on 06Mar2021. Provides lot number as EL330. The vaccine was given in the upper left arm. The second one did not hurt. There is no expiration date or NDC number on the vaccine card for either vaccine. She had a headache the first night her and her husband had the shot on 0, and they could not sleep on 13Feb2021. They felt like they did a whole bunch of cocaine. Tossing and turning could not sleep. Her husband did not have headaches. She also had a fever and the headaches have been going on daily. The headaches come and go but gets it at least once a day and now she's getting them in the morning. After the first shot they could not sleep, but she does have insomnia. However, the issue of could not sleep that occurred with this occurrence has. Patient states today was the worst headache. She might call her doctor. Caller also mentioned she was sore as well. She just feels like the headaches are form the vaccine. She doesn't like to take Advil or any medication. Taking Tylenol really affects her. States she doesn't take any medication, and hopes no none else has headaches and needs to take Tylenol and Ibuprofen every day. It was awful. She will call her doctor if this keeps happening. She thinks it was crazy that all her life she has not had headaches, and now she gets them every day. The outcome of the events was not recovered for headache and resolved for other events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea, Vomiting
Clinical narrative: can't walk straight; developed dizziness/ so dizzy; nauseous; thrown up; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported), dose 1 via an unspecified route of administration on 17Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, patient can't walk straight, developed dizziness/ so dizzy, nauseous and thrown up on 21Apr2021. When she woke up today, after she was up for a while she developed dizziness. She told that she was so dizzy that she was nauseous. She had even thrown up.  She stated that she could not stop spinning and was sure what was going on, was that normal. She told that every time she moved her head, she started spinning again and she could not walk straight. By the time she walked to her bathroom and back, she was on the verge of throwing up again. She wants to know if this was normal. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Hypoaesthesia, Pain
Clinical narrative: Her left arm was starting to get numb; pain, Two days in a row she's been sore; swelling/red swelling, not a bump, just swelling at her injection site; chills; her left arm hurts because of the injection, had pain all in her legs and everywhere; swelling; swelling/red swelling, not a bump, just swelling at her injection site; breathes real hard she can feel it in her chest; her test was positive; This is a spontaneous report from a contactable consumer (patient). A 65-year-old Female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Apr2021 at 14:15 at single dose in left arm for COVID-19 immunisation at the age of 65-year-old. Lot number was ER8731. Medical history included high blood pressure, enlarged heart, diabetes and concomitant medications included ongoing metformin hydrochloride (METFORMIN N), carvedilol (CARVEDILOLO). On unknown date, left arm was starting to get numb, and the patient experienced pain, Two days in a row she's been sore, swelling/ red swelling, not a bump, just swelling at her injection site, chills, her left arm hurts because of the injection, had pain all in her legs and everywhere, swelling. On 20Apr2021, the patient underwent sars-cov-2 test and it resulted positive, patient breathed real hard she could feel it in her chest. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Her left arm was starting to get numb; pain, Two days in a row she's been sore; swelling/red swelling, not a bump, just swelling at her injection site; chills; her left arm hurts because of the injection, had pain all in her legs and everywhere; swelling; swelling/red swelling, not a bump, just swelling at her injection site; breathes real hard she can feel it in her chest; her test was positive; This is a spontaneous report from a contactable consumer (patient). A 65-year-old Female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Apr2021 at 14:15 at single dose in left arm for COVID-19 immunisation at the age of 65-year-old. Lot number was ER8731. Medical history included high blood pressure, enlarged heart, diabetes and concomitant medications included ongoing metformin hydrochloride (METFORMIN N), carvedilol (CARVEDILOLO). On unknown date, left arm was starting to get numb, and the patient experienced pain, Two days in a row she's been sore, swelling/ red swelling, not a bump, just swelling at her injection site, chills, her left arm hurts because of the injection, had pain all in her legs and everywhere, swelling. On 20Apr2021, the patient underwent sars-cov-2 test and it resulted positive, patient breathed real hard she could feel it in her chest. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.