chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Cough, Pyrexia
Clinical narrative: tremors; cold sweat; cough; high fever; chills; This is a spontaneous report from a contactable pharmacist. A 64-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 02Oct2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Oct2021 (9 days after vaccination), the patient experienced high fever, chills, tremors, cough and cold sweat. The patient's body temperature was high when tested on 11Oct2021. Patient wanted to know if these side effects were reported 9 days after they got the vaccine. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremors; cold sweat; cough; high fever; chills; This is a spontaneous report from a contactable pharmacist. A 64-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 02Oct2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Oct2021 (9 days after vaccination), the patient experienced high fever, chills, tremors, cough and cold sweat. The patient's body temperature was high when tested on 11Oct2021. Patient wanted to know if these side effects were reported 9 days after they got the vaccine. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anxiety, Asthenia, COVID-19, Drug ineffective, Frustration tolerance decreased
Clinical narrative: Rheumatoid arthritis flare up; Intentional misuse; Frustration; Anxiety; COVID-19; COVID-19; Night sweats; Weight loss; Loss of energy/no energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie (Mfr. Control No.#: 21K-163-4110316-00). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), intramuscular on an unspecified date as single dose for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from 2016 (Batch/Lot number was not reported) to 23Jun2021, at 40 mg (40 mg, 1 in 2 wk) for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced frustrated, possible misuse, anxiety and rheumatoid arthritis flare-up. In 2021, the patient experienced weight loss, no energy, night sweats and covid 19. The patient was treated with Prednisone. The patient underwent lab tests and procedures which included covid test: positive on 05Aug2021. The action taken in response to the event(s) for adalimumab was permanently withdrawn on 23Jun2021. Outcome of event weight loss, rheumatoid arthritis flare-up was not recovered; other events was unknown.  The reporter's causality for the event(s) weight loss, no energy, frustrated, possible misuse, night sweats, anxiety, covid 19 and rheumatoid arthritis flare-up was not provided for suspect Humira and was reported as possible for suspect BNT162b2.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Intentional product misuse, Night sweats, Rheumatoid arthritis, Weight decreased
Clinical narrative: Rheumatoid arthritis flare up; Intentional misuse; Frustration; Anxiety; COVID-19; COVID-19; Night sweats; Weight loss; Loss of energy/no energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie (Mfr. Control No.#: 21K-163-4110316-00). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), intramuscular on an unspecified date as single dose for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from 2016 (Batch/Lot number was not reported) to 23Jun2021, at 40 mg (40 mg, 1 in 2 wk) for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced frustrated, possible misuse, anxiety and rheumatoid arthritis flare-up. In 2021, the patient experienced weight loss, no energy, night sweats and covid 19. The patient was treated with Prednisone. The patient underwent lab tests and procedures which included covid test: positive on 05Aug2021. The action taken in response to the event(s) for adalimumab was permanently withdrawn on 23Jun2021. Outcome of event weight loss, rheumatoid arthritis flare-up was not recovered; other events was unknown.  The reporter's causality for the event(s) weight loss, no energy, frustrated, possible misuse, night sweats, anxiety, covid 19 and rheumatoid arthritis flare-up was not provided for suspect Humira and was reported as possible for suspect BNT162b2.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Nausea, Pain, Pyrexia
Clinical narrative: Nausea; Body aches; Fever, it is at 104 and it kind of went down but it is going back up; Lower back pain; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (parent) reported that a 16-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 11Oct2021 as DOSE 1, SINGLE for covid-19 immunisation at the age of 16 years old.  The patient medical history and concomitant medications were not reported.  The patient experienced nausea on 11Oct2021 with outcome of unknown and fever, it is at 104 and it kind of went down but it is going back up, lower back pain and body aches, above on Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 104 on Oct2021.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Palpitations, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FF2589), via an unspecified route of administration, on Oct 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported.  The patient got the booster shot yesterday and felt absolutely terrible (Oct 2021). The patient was a little worried, because it didn't feel like this after the 2nd shot (unspecified date). The patient's heart was racing, had a fever and was just hurting all over. The patient knew this was some of the side effect, and asked if this is normal. "So what does a person do that is having an adverse reaction?" The patient didn't think they needed a hospital but needed to know if this was normal. Patient further added, "Can you tell me because I am having reaction with this (further not clarified hence event captured as per verbatim), is this something that's gonna go away? Is this normal, is all I am asking, is it normal?" The outcome of the events: unknown.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chills, Decreased appetite, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FF2589), via an unspecified route of administration, on Oct 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported.  The patient got the booster shot yesterday and felt absolutely terrible (Oct 2021). The patient was a little worried, because it didn't feel like this after the 2nd shot (unspecified date). The patient's heart was racing, had a fever and was just hurting all over. The patient knew this was some of the side effect, and asked if this is normal. "So what does a person do that is having an adverse reaction?" The patient didn't think they needed a hospital but needed to know if this was normal. Patient further added, "Can you tell me because I am having reaction with this (further not clarified hence event captured as per verbatim), is this something that's gonna go away? Is this normal, is all I am asking, is it normal?" The outcome of the events: unknown.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Headache, Pain, Palpitations, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FF2589), via an unspecified route of administration, on Oct 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported.  The patient got the booster shot yesterday and felt absolutely terrible (Oct 2021). The patient was a little worried, because it didn't feel like this after the 2nd shot (unspecified date). The patient's heart was racing, had a fever and was just hurting all over. The patient knew this was some of the side effect, and asked if this is normal. "So what does a person do that is having an adverse reaction?" The patient didn't think they needed a hospital but needed to know if this was normal. Patient further added, "Can you tell me because I am having reaction with this (further not clarified hence event captured as per verbatim), is this something that's gonna go away? Is this normal, is all I am asking, is it normal?" The outcome of the events: unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain, Palpitations, Pyrexia
Clinical narrative: Woke up around midnight to following symptoms:  Fever of 102, Extreme Chills, Headache, Headache lingering behind eyeballs since vaccine, Extreme Body Ache, RACING heart rate, Lack of appetite  At around 8:15PM, when symptoms were not subsiding, I finally called advise nurse at Pfizer and my Insurance and was advised to go to the Emergency Room. I arrived at ER at 8:30PM
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chills, Decreased appetite, Electrocardiogram
Clinical narrative: Woke up around midnight to following symptoms:  Fever of 102, Extreme Chills, Headache, Headache lingering behind eyeballs since vaccine, Extreme Body Ache, RACING heart rate, Lack of appetite  At around 8:15PM, when symptoms were not subsiding, I finally called advise nurse at Pfizer and my Insurance and was advised to go to the Emergency Room. I arrived at ER at 8:30PM
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Headache, Pain, Palpitations, Pyrexia
Clinical narrative: Woke up around midnight to following symptoms:  Fever of 102, Extreme Chills, Headache, Headache lingering behind eyeballs since vaccine, Extreme Body Ache, RACING heart rate, Lack of appetite  At around 8:15PM, when symptoms were not subsiding, I finally called advise nurse at Pfizer and my Insurance and was advised to go to the Emergency Room. I arrived at ER at 8:30PM
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Coordination abnormal, Diplopia, SARS-CoV-2 test
Clinical narrative: I came down with bells palsy which runs in the family; i started getting uncoordinated; double vision; This is a spontaneous report from a contactable consumer (patient). This 38-year-old male patient received dose 2 of BNT162B2 via an unspecified route of administration on 17Feb2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included family history of Bell's palsy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on 26Jan2021 as a single dose for COVID-19 immunization. On 01Mar2021 the patient came down with Bell's palsy which runs in the family so he ignored that. That went away and he started getting uncoordinated which turned into double vision. The patient visited an emergency room/department of urgent care for the events. The patient was hospitalized for 5 days for the events. The patient received treatment with steroids for the events. The outcomes of Bell's palsy, uncoordinated, and double vision were recovered with lasting effects. It was also reported that since the vaccination the patient was tested with a nasal swab for COVID-19 on 11May2021 with result of negative.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: miscarriages; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's friend) reporting same event under the same suspect product for four patients. This is one of four reports. A female patient of unspecified age received bnt162b2 (Pfizer covid vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, Caller unwilling to complete the report) as dose number unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was pregnant. The patient blamed her miscarriage on the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101343886 same report/drug/AE, different patients
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Laboratory test
Clinical narrative: more joint pain than before.; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL9266) via an unspecified route of administration in arm left on 11Feb2021 (age at vaccination 87 year) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (age at vaccination 87 year) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced more joint pain than before. The patient underwent lab tests and procedures which included laboratory test, result was unknown (labs done on 3 month diabetic check). The outcome of the event more joint pain was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dermatitis, Laboratory test, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9267, Expiry date: not reported) via an unspecified route of administration on 19Feb2021 (at the age of 88 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9263, Expiry date: not reported) via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization. Calling about the COVID vaccine. Was fortunate to get the first shot after much anguish and with time, and was scheduled for the second shot, she understood it was recommended be given three weeks after the first shot, her appointment was for 4 weeks after. Calling to find out, would it be just as effective as the recommended three weeks. On an unspecified date in 2021, Shortly often receiving the second dose of the Covid vaccine the patient developed a rash. Her dermatologist thought it might be Shingles. The rash had little blisters and itched. Lab test showed it wasn't Shingles. They identified it as a dermatitis. She had not had negative reaction to other vaccines. The rash had gone away. The patient underwent lab tests and procedures which included laboratory test: Lab test showed it wasn't Shingles. They identified it as a dermatitis in 2021, weight: 132 lbs. in 2021. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9267, Expiry date: not reported) via an unspecified route of administration on 19Feb2021 (at the age of 88 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9263, Expiry date: not reported) via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization. Calling about the COVID vaccine. Was fortunate to get the first shot after much anguish and with time, and was scheduled for the second shot, she understood it was recommended be given three weeks after the first shot, her appointment was for 4 weeks after. Calling to find out, would it be just as effective as the recommended three weeks. On an unspecified date in 2021, Shortly often receiving the second dose of the Covid vaccine the patient developed a rash. Her dermatologist thought it might be Shingles. The rash had little blisters and itched. Lab test showed it wasn't Shingles. They identified it as a dermatitis. She had not had negative reaction to other vaccines. The rash had gone away. The patient underwent lab tests and procedures which included laboratory test: Lab test showed it wasn't Shingles. They identified it as a dermatitis in 2021, weight: 132 lbs. in 2021. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: High heart rate
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Headache, Injection site inflammation, Injection site pain
Clinical narrative: Fever, aching joints, headache, sensitivity to light (eyes), loss of appetite, inflammation of injection site in LEFT arm from prior Covid Vaccination (September 3, 2021 - Moderna Lot 939901), Hyperinflammation - pain and swelling - continuing in LEFT knee, hyperinflammation in RIGHT knee started several days later and persists in both knees; Hyperinflammation - pain, some swelling - at site of 1st vaccination (LEFT arm) persists.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Photophobia, Pyrexia
Clinical narrative: Fever, aching joints, headache, sensitivity to light (eyes), loss of appetite, inflammation of injection site in LEFT arm from prior Covid Vaccination (September 3, 2021 - Moderna Lot 939901), Hyperinflammation - pain and swelling - continuing in LEFT knee, hyperinflammation in RIGHT knee started several days later and persists in both knees; Hyperinflammation - pain, some swelling - at site of 1st vaccination (LEFT arm) persists.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac monitoring, Chest pain, Computerised tomogram, Computerised tomogram head
Clinical narrative: HEADACHE, ELEVATED BLOOD PRESSURE, ELEVATED HEART RATE, CHEST PAIN, PALPITATIONS
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Heart rate increased, Laboratory test, Palpitations
Clinical narrative: HEADACHE, ELEVATED BLOOD PRESSURE, ELEVATED HEART RATE, CHEST PAIN, PALPITATIONS
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling abnormal
Clinical narrative: afib, brain fog
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Back pain, Exposure during pregnancy, Haemorrhage
Clinical narrative: Bleeding lower back pain, miscarriage of my baby in 3 days of shot.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Gastrointestinal sounds abnormal, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Got the flu vaccine, around 11 pm I woke up with severe stomach cramps that feel as if I had been kicked multiple times. Difficulty moving because of pain. Gurgling stomach. I took gas-x and nexium for pain and pain has not subsided as of 8 am the next day. Still in extreme pain.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, COVID-19 pneumonia, Fatigue, Malaise
Clinical narrative: sore arm; tired; Didn't feel good; run a 103 fever; This case has been considered invalid initially upon follow up information case was processed as valid file  This is a spontaneous report from a contactable other health care professional (patient herself) via medical information team.  A 77-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3249), via intramuscularly, administered in Left arm on 20Jan2021 02:15 PM (at the age of 77-year-old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 09Dec2020 to Jan2021. The patient's concomitant medications were not reported. On 21Jan2021, the patient experienced sore arm, tired, didn't feel good, run a 103 fever. The patient underwent lab tests and procedures which included covid-19 resulted as positive on 09Dec2020, covid-19 pneumonia resulted as positive on 21Dec2020, covid-19 pneumonia resulted as positive on 24Dec2020. It went away in a couple of hours on its own. Clinical outcome of the event was reported as recovered on unspecified date Jan2021 events went away in a couple of hours on its own.  No follow-up attempts are needed. No further information is expected
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; tired; Didn't feel good; run a 103 fever; This case has been considered invalid initially upon follow up information case was processed as valid file  This is a spontaneous report from a contactable other health care professional (patient herself) via medical information team.  A 77-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3249), via intramuscularly, administered in Left arm on 20Jan2021 02:15 PM (at the age of 77-year-old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 09Dec2020 to Jan2021. The patient's concomitant medications were not reported. On 21Jan2021, the patient experienced sore arm, tired, didn't feel good, run a 103 fever. The patient underwent lab tests and procedures which included covid-19 resulted as positive on 09Dec2020, covid-19 pneumonia resulted as positive on 21Dec2020, covid-19 pneumonia resulted as positive on 24Dec2020. It went away in a couple of hours on its own. Clinical outcome of the event was reported as recovered on unspecified date Jan2021 events went away in a couple of hours on its own.  No follow-up attempts are needed. No further information is expected
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program via contactable consumer. This consumer reported for both himself and his wife. This is for the reporter.  A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in right arm on 11Feb2021 at 12:30 (at the age of 74-years) as dose 2, single for covid-19 immunization. The patient medical history included none. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in right arm on 21Jan2021 at 11:15 (at the age of 74-years) as dose 1, single for covid-19 immunization. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. After second vaccination, on an unspecified date in Feb2021, the patient had experienced a little bit soreness on their right arm where the vaccine was administered. Therapeutic measures were taken as a result of arm soreness and included treatment with Advil and Tylenol. The outcome of the event was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue; Slight temperature; In initial report (PRD 11Feb2021), this case was considered as invalid as there was no indication that the patient experienced an event under BNT162b2. Upon follow-up #2 on (PRD 15Apr2021) the case becomes valid due to new event reported. This is a spontaneous report from a contactable consumer or non-healthcare professional (patient) via Pfizer sponsored program Support.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route of administration on 04Feb2021 as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267) via an unspecified route of administration on 25Feb2021 as dose 2, single both for COVID-19 immunization. Medical history included cold sore. Concomitant medication(s) included acyclovir (ACYCLOVIR) 400 mg taken for cold Sores. On an unspecified date in 2021, the patient experienced fatigue and slight temperature for a day or two. It was reported that, the patient got her first dose of the Pfizer COVID Vaccine on 04Feb2021. Everything was fine. She was reading online, and it said, if you are taking an antiviral when getting the vaccination, it may reduce the effectiveness of vaccine. Well, she had a cold sore and thinks was taking Acyclovir at the time she had the vaccine. Now she was panicking and hoping the shot was still good. She enquired should she be concerned about having taken the Acyclovir the same time she got the shot. She was unsure when she started the Acyclovir but it was before the vaccine. She might have been still taking it when she got the vaccine, she could not remember. She was unsure, but there was a good chance she was still taking it when she got the vaccine. She called Pfizer because she heard it was maybe a problem to take anti-viral that it would cause shot to be in affective. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: for a cold he was experiencing both before and after the second dose; This is a spontaneous report from a contactable consumer or other non-health professional. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. It was reported that on unspecified date patient states he received his second dose of the Pfizer Covid vaccine but was given prednisone to take for a cold he was experiencing both before and after the second dose. Patient clarified that had a cold prior to receiving the second COVID-19 Vaccine. Patient enquired got a little bit of a cold. Patient enquired to know if it hurts anything to take Prednisone. He wants to know if this lessened the effectiveness. The Outcome of the event was unknown.  No follow-up attempts are possible; informationabout lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphonia, Nausea
Clinical narrative: his voice is a little raspy; diarrhea; nausea; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 18Feb2021 at 10:30 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. It was reported that the patient would be off the blood thinner (unspecified) very soon. On 18Feb2021, same day of vaccination at 23:30, the patient experienced diarrhoea, nausea, and on 19Feb2021, his voice was a little raspy. The patient reported that his voice is a little raspy on the day of reporting. He got his 1st dose of the vaccine about 10:30 am yesterday (18Feb2021), and after getting the shot they gave him a packet of information. States that they really should have given him the information before giving the injection because he discovered that the packet says to tell someone if you are on blood thinners. States that no one asked him if he was on a blood thinner, and he didn't know that was something he should have told them. Will that make a difference since he already had the shot. States that he will be off the blood thinner very soon. Also states that about 11:30 pm that night, 13 hours post vaccination, he started having diarrhea and was nauseous. It might have been something he ate but could those be side effects from the vaccine and if so, can anyone else catch his side effects. Patient wants to know if these side effects are related to the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: flu like symptoms; body aches and pains; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-year-old male patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL9267 and expiration date was not reported), dose 1 intramuscular, administered in left arm on 12Feb2021 at 07:30 AM (Age at vaccination was 73 years) as dose 1, single for covid-19 immunisation. Medical history included arthritis also stated that, which was pretty normal for his age, cancer caller states he does have a compromised immune system from previous cancer treatment from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (TYLENOL)  taken for arthritis, start and stop date were not reported. On an unspecified date in Feb2021 the patient experienced body aches and pains and on an unspecified date patient also experienced flu like symptoms. It was also explained that patient says, body aches and pains, flu-like symptoms and things like that, which he know are all normal. Patient was asking if he can take Tylenol to treat symptoms because he read you should not take it before the vaccine. Patient was asking if he needs to stop taking Tylenol before the next dose. Patient stated he was still getting body and aches and pains. Patient wanted to know is it pretty much normal to still be experiencing this. The patient stated he started to get body aches and pains a couple of days after the shot. The relevant test was none. The outcome of event body aches and pains was not recovered and outcome of flu like symptoms was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: headache; Bad fatigue/a lot of fatigue; sore arm/little soreness in the arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EM9809, Expiration date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 10Feb2021 (age at vaccination 38-year-old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EL324, Expiration date: 31May2021), on 20Jan2021 (age at vaccination 38-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced sore arm/little soreness in the arm. On 14Feb2021 the patient experienced headache and bad fatigue/a lot of fatigue. Caller stated she had a question, stated she got the second dose of the Pfizer vaccine on 10Feb2021, did not feel anything but a little soreness in the arm when she got the vaccine, stated this past Monday, she started to feel like she had a headache and a lot of fatigue that lasted through Wednesday, stated it was a little better on Thursday, and today, Friday, felt a lot better. Caller wanted to know if it was possible to have a delayed reaction to the vaccine. Outcome of the events headache and bad fatigue/a lot of fatigue was recovering and for sore arm/little soreness in the arm outcome was unknown.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Head ache; Chills; This is a spontaneous report from a contactable other-HCP (patient). A 57-year-old female patient received and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EN6205) via an unspecified route of administration on 24Feb2021 14:20 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EL3247) via an unspecified route of administration on 27Jan2021 14:15 as dose 1, single for covid-19 immunization. It was reported, patient missed her appointment for the second dose on 17Feb2021. On 24Feb2021, the patient experienced fever, headache and chills. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EN5318, expiry date: 31May2021), via an unspecified route of administration in left arm on 12Feb2021 (at the age of 77-years) as dose 1, single for COVID-19 immunization. Medical history includes bad fall, operation and broke her left collarbone (she fell 4 years ago, broke her left collarbone, and had a titanium rod placed). About 4 years ago, she had a bad fall taking care of an old gentleman. The patient had a titanium plate placed because her collar bone was pretty bad off and had no trouble or pain with the titanium plate since it was placed; the only thing was that one of the screws in the plate stuck out a little bit, it did not hurt, just almost felt like something stuck upward. Concomitant medications were not reported. It was reported that on Feb2021 (starting 16Feb2021 or 17Feb2021), the titanium plate the patient had placed about 4 years ago was visible and hurts. It was almost like the flesh was being sucked underneath the titanium plate, there was like no blood or anything but there was a hole and it was kind of scary. The patient did not know if that was coincidental or related to Pfizer COVID-19 Vaccine but wanted to ask if it was possible it could be related to the Pfizer COVID-19 Vaccine. The patient said her 86 y/o (year-old) sister received the vaccine and her arm was very sore 5 days after receiving it. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Peripheral swelling
Clinical narrative: foot so swollen can barely walk; foot so swollen can barely walk; This is a spontaneous report from a contactable consumer (Patient) report from a Pfizer-sponsored program COVAX US SUPPORT. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included autoimmune disorder and arthritis: from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient's foot was so swollen that can barely walk. The patient is scheduled to receive the second dose of the Pfizer COVID-19 vaccine on an unspecified date. She reported that she is also scheduled to receive a cortisone injection in her foot because it was so swollen that she can barely walk at this time. When the patient spoke with the doctor, doctor advised that it would be okay to receive the second dose of the Pfizer COVID-19 vaccine as scheduled along with the cortisone injection in her foot. The patient wanted to know if Pfizer has any information on whether this cortisone injection would interact with the vaccine. The patient reported that she has an autoimmune disorder and takes a biologic medication and understands that the vaccine may not work as well for her due to having an autoimmune disorder and taking immunosuppressants. It was reported that the reporter is not a Healthcare Professional (HCP). The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Fatigue, Feeling abnormal, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.   A 35-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9267; Expiration Date: 31May2021) via an unspecified route of administration, administered in Arm Right on 13Feb2021, at 15:45 (at the age of 35 years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypoxia from an unknown date and unknown if ongoing. There were no concomitant medications reported. patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medication within 2 weeks. On 13Feb2021, 23:30 patient experienced symptoms of vertigo, blurry vision, tinnitus, anxiety. on 14Feb2021 patient experienced tired, dizzy, drowsy, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know how long it will take for his body to feel normal again, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know if he reschedules his second dose instead of 3 weeks after the first dose to 4 or 6 weeks will side effects be less severe once he takes the second dose. He would like to know if he decides not to receive the second dose of the vaccine if one dose will be enough for him to be protected against Covid-19, and if he takes both doses how long he will be protected (6 months, 1 year, 2 years). Patient did not received treatment for the events. The events vertigo, blurry vision, tinnitus, anxiety resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome for the events experiencing tired, dizzy and drowsy and he feels like if his brain is not 100% like a person who takes a lot of drugs was unknown. The outcome for events vertigo, blurry vision, tinnitus, anxiety was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Vision blurred
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.   A 35-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9267; Expiration Date: 31May2021) via an unspecified route of administration, administered in Arm Right on 13Feb2021, at 15:45 (at the age of 35 years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypoxia from an unknown date and unknown if ongoing. There were no concomitant medications reported. patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medication within 2 weeks. On 13Feb2021, 23:30 patient experienced symptoms of vertigo, blurry vision, tinnitus, anxiety. on 14Feb2021 patient experienced tired, dizzy, drowsy, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know how long it will take for his body to feel normal again, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know if he reschedules his second dose instead of 3 weeks after the first dose to 4 or 6 weeks will side effects be less severe once he takes the second dose. He would like to know if he decides not to receive the second dose of the vaccine if one dose will be enough for him to be protected against Covid-19, and if he takes both doses how long he will be protected (6 months, 1 year, 2 years). Patient did not received treatment for the events. The events vertigo, blurry vision, tinnitus, anxiety resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome for the events experiencing tired, dizzy and drowsy and he feels like if his brain is not 100% like a person who takes a lot of drugs was unknown. The outcome for events vertigo, blurry vision, tinnitus, anxiety was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my left arm at the injection site began to feel slightly sore.; This is a spontaneous report from a contactable consumer (patient).   A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL3247) an unspecified route of administration, administered in left arm on 19Feb2021 11:30 (age at vaccination 48 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma. Other vaccine in four weeks was reported as no. The patient had known allergies: seasonal allergies, pets, various foods and dust. Patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medications included Vitamin D, fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), triamcinolone acetonide (NASACORT) and unspecified multivitamin taken for unspecified indication from an unknown date. The patient reported that on the day of vaccination on 19Feb2021 19:00, towards the evening, her left arm at the injection site began to feel slightly sore. The patient was not received any treatment for event. The outcome of the event was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Fatigue; muscle soreness; swollen lymph nodes under arm 24 hrs after vaccination; This is a spontaneous report from a contactable consumer. An adult male patient of an unspecified age (Age: 58, unit: unknown) received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular route of administration, administered in left upper arm on 08Feb2021 as dose 2, single for COVID-19 immunisation and first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an intramuscular route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. The patients medical history and family medical history was reported as unknown. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Feb2021, the patient experienced fatigue, muscle soreness and swollen lymph nodes under arm 24 hrs after vaccination. The event fatigue, started within 24 hours of vaccination. Facility type vaccine was reported as nursing home or senior living facility. The patient did not receive treatment for the events. These events did not require the initiation of new medication or other treatment or procedure. The clinical outcome of events was reported as recovered on unspecified date.    Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain
Clinical narrative: Migraines; general body achiness; exhaustion 12 hours after receiving the shot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in left arm on 18Feb2021 13:45 (at the age of 27-year-old) as dose 2, single for COVID-19 immunization at clinic. Medical history was reported as none. Patient had no known allergies. Concomitant medications included Escitalopram via an unspecified route of administration from an unknown date and unknown if ongoing for an unspecified indication. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in right arm on 28Jan2021 13:45 (at the age of 27-Year-old) as dose 1, single for COVID-19 immunization at clinic. It was reported that on 19Feb2021 01:00, the patient experienced migraines, general body achiness, and exhaustion 12 hours after receiving the shot. Patient did not receive any treatment for the events. The outcome of all events was resolving.  No follow up attempts are possible. No further information is expected.