chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Pyrexia
Clinical narrative: Fever for 4 weeks; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced fever for four weeks. On an unspecified date, the patient underwent lab tests included blood test revealed antibodies was at maximum level, which was more than 2500, too many antibodies. The clinical course of the event as follows: the patient was having fever for 4 weeks and was wondering would that have any relationship with high antibody because after the patient had the Pfizer vaccination. The blood test was saying antibody was at maximum level which was more than 2500. The patient was asking would that like too many antibodies, would that be a cause for patient being like, patient was running high to low fever for 4 weeks. The outcome of event was recovered.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I have not got my period since this first dose of my vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that, she was wondering if this was normal that she had not got her period since this first dose of her vaccine. It was been like 2 or 3 months. The seriousness for event was unspecified. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Suspected COVID-19
Clinical narrative: Chills; Sweaty; I was thinking it tonight thinks that it might be Covid 19(Further clarification unknown) related Covid 19 shot?; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 10May2021, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 17May2021, Patient started getting the chills and sweaty and then got the chills and it is been going on since 17May2021 and patient was thinking it tonight thinks that it might be Covid-19 (Further clarification unknown) related Covid-19 shot. Further reported, it is the shot that patient got on 10May might be giving the chills and sweatiness. The patient was curious to know if, that is one of the side effects. The outcome of the event chills was not recovered, and the events sweaty and Suspected COVID-19 was unknown at the time of report.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More tired than usual; This is a spontaneous report received from a contactable. This consumer (Patients Mother) reported for a female patient (Reporters Daughter).  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as single dose for covid-19 immunisation Pharmacy. The patient medical history and concomitant medications were not reported. Patient's historical vaccine includes first dose of BNT162B2 via an unspecified route of administration on unspecified date for COVID-19 Immunization and experienced no reaction. Patients Mother states, her daughter got the second one, the Pfizer, her daughter was more tired than usual on unspecified date in 2021, but she okay now, her daughter got the second shot at the same time as the caller got her first one on 15Jun2021. The outcome of the event was reported as resolved on unspecified date in 2021.  Information on batch/lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I have had four nose bleed.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on an unspecified date (Lot Number: ER8736) as a single dose at the age of 60-year-old  for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan taken for blood pressure, start and stop date were not reported; estradiol taken for an unspecified indication, start and stop date were not reported. The patient was on different medication along with blood pressure medication. The patient takes the first dose two weeks before and have had four nose bleed. The patient never had any nose bleed since before the vaccination. The patient wanted to know if the nosebleed would be part of the symptom and should she got the second one. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: The little finger in the left hand was paralyzed with a tingling sensation and difficulty to move it.; The little finger in the left hand was paralyzed with a tingling sensation and difficulty to move it.; The little finger in the left hand was paralyzed with a tingling sensation and difficulty to move it.; Joint pain was a little bit stronger/joint pain in knees and a little bit in elbows; This is a spontaneous report from a contactable consumer. A female patient reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EE0175, Expiry Date and NDC number: not provided), via an unspecified route of administration on 01May2021 as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737,), via an unspecified route of administration on 03Apr2021 as 1ST DOSE, SINGLE for covid-19 immunization. The consumer stated that after the first dose she experienced chills and little bit of a runny nose. Later she experienced joint pain in knees and little bit in elbows. Consumer reported that, after second dose, she had stronger joint pain and left pinky finger paralyzed, with tingling sensation and difficulty moving it. The outcome of all events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Fear, Insomnia, Pain, Peripheral swelling
Clinical narrative: Then the swelling got worse and worse; Itchy; Swelling under my armpit; It was very painful; Couldn't 'sleep; I was scared; This is a spontaneous report from a contactable consumer (patient, self-reported). A 48-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0167 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left, on 14Jun2021 (age at vaccination: 48 year), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Deltoid Left, on 24May2021 (age at vaccination: 48 year), as a single dose for COVID-19 immunization and no reaction. The patient reported that the patient was calling to report that the patient had an adverse reaction to the Pfizer Vaccine for COVID-19 virus. The patient got the second shot on Monday. On an unspecified date in Jun2021, it felt itchy and that was okay but when the patient got home, the patient started having some swelling under my armpit. So, each day since Monday it got worse. Today, the patient had to go to the doctor so that they could see, you know patient was scared. The patient did not know if it was breast cancer or a tumor or what. The patient would like to know if it was just a reaction to the vaccination. The patient stated, Monday, 14Jun2021, that was when it started and then it accelerated and then the swelling got worse and worse. The patient went to see the doctor because patient couldn't 'sleep' and it was very painful. The doctor prescribed some pain medicines like Ibuprofen, 800 mg, one every 8 hours. The doctor told the patient to put a warm comfort on it. Outcome of the event I was scared was reported as unknown and for all other events, it was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Then the swelling got worse and worse; Itchy; Swelling under my armpit; It was very painful; Couldn't 'sleep; I was scared; This is a spontaneous report from a contactable consumer (patient, self-reported). A 48-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0167 and expiry date was not reported), via an unspecified route of administration, in Deltoid Left, on 14Jun2021 (age at vaccination: 48 year), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Deltoid Left, on 24May2021 (age at vaccination: 48 year), as a single dose for COVID-19 immunization and no reaction. The patient reported that the patient was calling to report that the patient had an adverse reaction to the Pfizer Vaccine for COVID-19 virus. The patient got the second shot on Monday. On an unspecified date in Jun2021, it felt itchy and that was okay but when the patient got home, the patient started having some swelling under my armpit. So, each day since Monday it got worse. Today, the patient had to go to the doctor so that they could see, you know patient was scared. The patient did not know if it was breast cancer or a tumor or what. The patient would like to know if it was just a reaction to the vaccination. The patient stated, Monday, 14Jun2021, that was when it started and then it accelerated and then the swelling got worse and worse. The patient went to see the doctor because patient couldn't 'sleep' and it was very painful. The doctor prescribed some pain medicines like Ibuprofen, 800 mg, one every 8 hours. The doctor told the patient to put a warm comfort on it. Outcome of the event I was scared was reported as unknown and for all other events, it was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Condition aggravated, Injury, Scratch
Clinical narrative: The second dose resulted in ten scratches developing; Hurt; The second dose resulted in ten scratches developing; Lost my sense of taste and smell; Lost my sense of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date were unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 on an unspecified date which resulted in two scratches and they hurt. On an unspecified date, the patient resulted in ten scratches developing, hurt, lost my sense of taste and smell. After each dose patient had developed scratches on arm which look like a cat scratched and they hurt. Patient had picture of the arm. The outcome of all the events was unknown.  Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Having cold; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER -BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jun2021 (Lot Number: D21JBED; Expiration date: Unknown) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported as thinking of getting a cold on an unknown date in Jun2021. The patient wanted to know about getting second dose when having cold. The outcome of the event was unknown. The patient was scheduled to receive second dose of vaccine on 23Jun2021 13:00.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; This is a spontaneous report received from a contactable consumer or other non hcp (patient).   A 38-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0187) via an unspecified route of administration on 17Jun2021 at 16:00 (age at vaccination 38years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not take any other medical condition. The patient did not take any other vaccine after covid vaccine. The patient previously received BNT162B2 dose 1 on 27May2021 16:00 AM (at 38 years of age) (Batch/Lot number: EW0185) via unspecified route of administration for COVID-19 immunisation. The patient experienced arm was hard, swollen, and tender and it was not getting any better on 18Jun2021. The patient did not receive any treatment for the events. The clinical outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test
Clinical narrative: Right arm feel kind of numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on an unspecified date reported as 'on the 16' (Lot Number: EP7534; Expiration Date: Jul2021) at the age of 54-year-old as dose 1, single for covid-19 immunization. The vaccine was administered at doctor's office. Medical history included diabetes from an unknown date and unknown if ongoing. The patient received unspecified concomitant medications. The patient did not receive any prior vaccination. The patient had unspecified lab test on an unspecified date. The patient experienced in right arm feel kind of numb on an unspecified date. The outcome of the event was unknown. The patient did not receive any treatment for the event.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: they both woke up at 4:00 in the morning vomiting and its been 6 hours of non stop throwing up; extremely ill; This is a spontaneous report from a contactable consumer or other non-health care professional (Parent to patient). A patient of unspecified age and gender 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 18Jun2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 19Jun2021 04:00 the patient woke up at 4:00 in the morning vomiting and had 6 hours of non stop throwing up and are extremely ill. Primary reporter (parent) just don't know whom else to call what to do other than going to the emergency room. The outcome of the events was unknown.  Follow up needed, further information was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021741983 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: They both woke up at 4:00 in the morning vomiting and its been 6 hours of non stop throwing up; Extremely ill; This is a spontaneous report from a contactable consumer (patient's parent) reporting same event(s) under the same suspect product(s) for 2 patients (reporter's children). This is one of two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: unknown) via an unspecified route of administration on 18Jan2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Jun2021, the caller stated that both woke up at 4:00 in the morning and were vomiting. The patient stated that it has been 6 hours of nonstop throwing up. The caller stated that her children were extremely ill. The caller stated that she just doesn't know who else to call, what to do about the events other than going to the emergency room. The caller stated that she took the same dose along with them at the same time and felt just fine. Caller was asking whether this was like a normal occurrence happening to all the people. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021741920 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; sore in the part of the injection; arm it is like very painful and my armpit, I feel like I am, I don't know, it's very painful; arm it is like very painful and my armpit, I feel like I am, I don't know, it's very painful; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, administered in arm (unspecified) on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization and No patient not had reaction on previous exposure. On 17Jun2021 (reported as yesterday), the patient experienced light symptoms like fever, chills, sore in the part of the injection, arm it is like very painful and my armpit, feels like it's very painful. So, the patient doesn't know if it's normal or like should do something. It's on left side and was afraid. The outcome of all the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling of despair
Clinical narrative: They are getting desperate; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, expiry date was not reported) first dose on 09Mar2021 (Lot number: EN6205) and second dose (Lot number: EP1533) on 30Mar2021 via an unspecified route of administration in left arm as both as single dose for covid-19 immunisation. The Patient  Medical history and concomitant medications were not reported. The patient experienced they are getting desperate on an unspecified date. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Epistaxis, Headache, Rhinalgia
Clinical narrative: Nosebleed; pain in nose and forehead; pain in nose and forehead; Dizzy; having problems with breathing; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Reporter's coworker). A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an un-specified route of administration on 17Jun2021 (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation and experienced no reaction. On 18Jun2021 patient experienced nosebleed, pain in nose and forehead, dizzy and having problems with breathing. The reporter stated that had the second shot yesterday, after that he drank 3 beers and now today is having a nosebleed, pain in his nose and in his forehead and is also dizzy and having problems with breathing. Caller states that he wanted to ask something and that he is more worried about his partner because he is in the worst condition. Caller says that his own symptoms are very minor and very slight. Caller requests that his partner go first and needs to know if his partner needs to go to the clinic. At the time of report, event outcome was not resolved.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: This is normal pain in the inoculation site, shot after shot/ I am now having phantom like you know the feeling I did have like the day I got the shot was kind of feeling like that and the right arm where the second inoculation took place; Pain; This is a spontaneous report from a contactable consumer or other non health care professional. A patient of unspecified age and gender received BNT162b2 (Pfizer Covid-19 mRNA Vaccine, Solution for injection, Lot No: ER8737), via an unspecified route of administration, administered in Arm Right on 07May2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine was BNT162B2 (Lot number- EP7533), via Arm left for Ist dose, single COVID-19 immunization. On an unspecified date the patient experienced pain and inoculation site pain. Patient had no side effects at all. None other than normal pain in the inoculation site, shot after shot. But now, originally, first inoculation was in the left arm and was having phantom like feeling like the day got the shot was kind of feeling like that and the right arm where the second inoculation took place. Is it an anomaly or maybe he pulled a muscle in sleep and then phantom that pops up within like months or afterwards. Treatment included a little bit of Aspirin like known earlier and that helped him a little bit that is why he thought it is a pulled muscle in sleep. Therapeutic measures were taken as a result of this is normal pain in the inoculation site, shot after shot/ i am now having phantom like you know the feeling i did have like the day i got the shot was kind of feeling like that and the right arm where the second inoculation took place. Outcome of the events were unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches/gotten worse today; This is a spontaneous report from a contactable consumer. A 24-year-old female patient (reporter's daughter in law) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), via an unspecified route of administration, administered in Arm Left on 18Jun2021 (at the age of 24-year-old) (Batch/Lot Number: EW0151) as single for covid-19 immunization. Medical history included headache from an unknown date  was ongoing, depression from an unknown date and unknown if ongoing and pregnancy from an unknown date and unknown if ongoing. The reporter stated she (patient) has been having some headaches because she was on some medication for depression after having a baby and she stopped the medication and she thinks it is possible that could have caused that. Concomitant medication included escitalopram oxalate (LEXAPRO) at 10 mg every night at bedtime taken for depression (antidepressant) from Jun2021 to Jun2021 (additional Information was provided as she quit taking it 2 days before the vaccine and was only taking for a week and a half) and some unspecified sleeping pill (additional Information was mentioned as they gave her some type of sleeping pill, she only took it once, they only gave her one pill, does not remember the name of the medication). History of all previous immunization with the Pfizer vaccine considered as suspect was none and additional vaccines administered on same date of the Pfizer suspect was none. Family Medical History Relevant to AE(s) was not provided. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was not provided. Reporter mentioned her daughter-in-law received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and reported having some headaches on 18Jun2021 and asked if they can take Tylenol or Ibuprofen because reporter wanted to verify because she has been told that some medications might "lessen the effect of the vaccine". Caller had reported that the patient had been experiencing headaches before the Covid 19 vaccine but they had gotten worse. States that she was taking an antidepressant (Lexapro) and then stopped taking it. When asked when the headaches began, caller states her daughter in law, has been having headaches but they have gotten worse today and they wanted to take something for them and did not know what to they could take. AE did not result in Emergency Room or Physician Office visit. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021734937 same reporter/ product/ event, different patient
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nauseous; Dizzy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 17Jun2021 (at the age of 57-year-old), as DOSE 2, SINGLE for covid-19 immunization. The patient's medical and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), DOSE 1, SINGLE for covid-19 immunization (no reaction experienced). The patient had his second shot of the Pfizer COVID 19 vaccine yesterday and is nauseous and dizzy. It was further reported as: patient got the vaccine on 17Jun2021 and symptoms like dizziness started at 4:00pm and onwards; and on 18Jun2021, he has a little bit of dizziness as well as nauseous. Patient also reported that, symptoms are very minor and very slight. The outcome of events was not recovered at the time of the report.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Lingering tinnitus; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced lingering tinnitus. Consumer stated that the patient mentioned that almost 2000 people who had a similar reaction from the Moderna COVID-19 vaccine and Pfizer. The outcome of the event was unknown.  Follow-up attempts are needed. Information on Lot/Batch number can be requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Legs starting hurting me and my feet felt a little like tingling and I still kind of feel that; Legs starting hurting me and my feet felt a little like tingling and I still kind of feel that; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jun2021 (the patient stated Batch/Lot number was EVZ0171 or it was EW0171 maybe or EVZ0171, did not know and expiration date was not reported; pending clarification) 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 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date was not reported) as dose 1, single for covid-19 immunization. The patient reported that legs started hurting and feet felt a little like tingling and patient still kind of feels that. The patient reported the event onset as about 12 days ago but like few hours after the patient got vaccine (in Jun2021). The outcome of the event legs started hurting was unknown, while outcome of felt a little like tingling was not recovered.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from contactable other Health Care Professional and contactable consumer. A other Health Care Professional and 50-year-old female consumer reported that, A 50-years-old female patient received vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE and second dose (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "I don't feel good right now." Post vaccination of her first dose patient experienced worsening symptoms of rheumatoid arthritis flare-ups. MD was unaware. after receiving the covid-19 vaccine last month (date unspecified), noted "mild flare-ups#" however, the 2nd dose of the covid-19 vaccine caused "strong flare-ups' of rheumatoid arthritis. no missed doses while receiving the vaccine. MD was aware. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rheumatoid arthritis flare-ups. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: he experienced fatigue a day after the first dose was given to him; This is a spontaneous report from a Pfizer. A non-contactable male patient of an unspecified age reported that he received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on 09Jun2021 as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient reported that the first dose of the Pfizer Covid-19 vaccine was on 09Jun2021 and the second dose was scheduled on 30Jun2021. His employer was going to have a bus come to their workplace to vaccinate them on 22Jun2021 and 24Jun2021 so he wondered whether he could take the second dose on either of those dates instead. He also mentioned that he experienced fatigue a day after the first dose was given to him. The outcome of event was unknown.  No follow-up attempts was possible; information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: swollen vein on his nick; high fever; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer.  A male patient of an unspecified age received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single, dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was calling on behalf of someone who received both doses of the vaccine and caller wanted to know if he should be worried about a swollen vein on his nick and a high fever. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: She has pain under her arm and in the area close to her breast; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on left arm, in 18Jun2021 (reported as Friday) (at the age of 53-year-old), as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain under her arm and in the area close to her breast on 21Jun2021. It was reported that it did not hurt on 18 Jun2021, 19Jun2021 or 20Jun2021 (reported as Friday, Saturday, or Sunday) and the patient was feeling weird a thing at the time of report. The outcome for the event was unknown.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 antibody test
Clinical narrative: Fatigue; This is a spontaneous report from a Pfizer sponsored program regulatory authority support via contactable consumer (patient) and contactable physician A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Apr2021 as a single dose (at the age of 76-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Apr2021 as a single dose at the age of 76-year-old for covid-19 immunisation. Medical history included ongoing breast cancer. Concomitant medication included tamoxifen taken for breast cancer from an unspecified start date and ongoing. The patient states that both of her vaccines went very smoothly, and she only had some minor side effects, which includes fatigue. The patients antibodies test is negative and wanted to know if she can do another test to check the antibodies. Also wanted to know what she can or cant do there after the vaccination. The outcome of the event was unknown.    Information about batch/Lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: DNA test for fragile X, Drug effect less than expected, Drug ineffective, Immune system disorder, Lymphocyte count
Clinical narrative: She was told by her hcp office that because she is taking methotrexate, the covid vaccine not effective; Immune compromised; Has taken two Pfizer vaccine shots and from the antigen test, it appears as if it didn't help; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 19Jan2021 (at the age of 63-years-old) as a single dose for covid-19 immunization and the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 10Feb2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. Medical history included ongoing psoriatic arthropathy she was diagnosed almost 18 years ago when she was 49 years old. It is an auto-immune disease, autoimmune disorder, immunodeficiency. Concomitant medication(s) included methotrexate. Caller states her rheumatologist gave her an antigen test before the one on 10Jun2021 but she doesn't think was as clear as the more recent test. Her internist gave her the second test and her rheumatologist gave her the first test. First test was preformed: 02Jun2021. She was told by her hcp office that because she is taking methotrexate, the covid vaccine not effective. She had antigen test done and it showed no immunity. The patient reported that they are immune compromised and take methotrexate. They got a notice from the local hospital. The notice said that the vaccine is not effective for people who take Methotrexate and that they would need to take an antigen test, which she did. Her antigen test was very very low and it's as if she never took the vaccine. Caller would like to know about taking a 3rd dose. They want to know what they can do, because of right now, she has taken two Pfizer vaccine shots and from the antigen test, it appears as if it didn't help. They heard from the news that one person took a third shot and that worked like a charm. The patient underwent lab tests and procedures which included on 10Jun2021- dna test for fragile x: 6.5, lymphocyte count: 49.9 %, mean cell volume: 100, neutrophil count: 1.44, neutrophil count: 39 %, red blood cell count: 3.80, red cell distribution width increased: 17.8, sars-cov-2 test: unknown on 02Jun2021 she doesn't think was as clear as the more recent test. She had antigen test done and it showed no immunity, sars-cov-2 test: very low on 10Jun2021. She had antigen test done and it showed no immunity. Outcome of the event was unknown. No follow-up attempts are needed. No further Information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell volume, Neutrophil count, Red blood cell count, Red cell distribution width increased, SARS-CoV-2 test
Clinical narrative: She was told by her hcp office that because she is taking methotrexate, the covid vaccine not effective; Immune compromised; Has taken two Pfizer vaccine shots and from the antigen test, it appears as if it didn't help; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 19Jan2021 (at the age of 63-years-old) as a single dose for covid-19 immunization and the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 10Feb2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. Medical history included ongoing psoriatic arthropathy she was diagnosed almost 18 years ago when she was 49 years old. It is an auto-immune disease, autoimmune disorder, immunodeficiency. Concomitant medication(s) included methotrexate. Caller states her rheumatologist gave her an antigen test before the one on 10Jun2021 but she doesn't think was as clear as the more recent test. Her internist gave her the second test and her rheumatologist gave her the first test. First test was preformed: 02Jun2021. She was told by her hcp office that because she is taking methotrexate, the covid vaccine not effective. She had antigen test done and it showed no immunity. The patient reported that they are immune compromised and take methotrexate. They got a notice from the local hospital. The notice said that the vaccine is not effective for people who take Methotrexate and that they would need to take an antigen test, which she did. Her antigen test was very very low and it's as if she never took the vaccine. Caller would like to know about taking a 3rd dose. They want to know what they can do, because of right now, she has taken two Pfizer vaccine shots and from the antigen test, it appears as if it didn't help. They heard from the news that one person took a third shot and that worked like a charm. The patient underwent lab tests and procedures which included on 10Jun2021- dna test for fragile x: 6.5, lymphocyte count: 49.9 %, mean cell volume: 100, neutrophil count: 1.44, neutrophil count: 39 %, red blood cell count: 3.80, red cell distribution width increased: 17.8, sars-cov-2 test: unknown on 02Jun2021 she doesn't think was as clear as the more recent test. She had antigen test done and it showed no immunity, sars-cov-2 test: very low on 10Jun2021. She had antigen test done and it showed no immunity. Outcome of the event was unknown. No follow-up attempts are needed. No further Information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: nausea; fever; vomiting; chills; headache; This is a spontaneous report from a contactable consumer(parent). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Jun2021 as a single dose at the age of 12-years-old for covid-19 immunisation. Medical history included crohns disease from May2018 to an unknown date and now he is currently in remission and doing well. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unspecified date as a single dose for covid-19 immunisation and had no reaction. Concomitant medications included famotidine (PEPCID), vedolizumab (ENTYVIO), vitamin C and a probiotic all taken for crohns disease from an unspecified start date and ongoing. On 18Jun2021 patient experienced nausea and vomiting in morning and also had a fever, chills, headache. The outcome of the events was unknown.  Information regarding the lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cold sweat, Cough, Decreased appetite
Clinical narrative: did not want to eat; flushed and hot; tested positive for covid; congestion in chest; mucus cough; vomiting and clammy; vomiting and clammy; headache; sore throad; Fever; chills; Chest tightness; coughing profusely; This is a spontaneous report from a contactable consumer or other non hcp.   A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jun2021 13:35(age at vaccination 21 years) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient got her first dose of the Pfizer Covid 19 vaccine on 14Jun2021 and is scheduled to get the second dose on 07Jul2021. On 19Jun2021 on Saturday, after they came home from an event the patient experienced coughing profusely, a lot of congestion in her chest, then she started vomiting, she was turning red and clammy and sweating and developing a fever, states initially she treated symptoms with a cold compress, headache, chills and cold sweats. yesterday afternoon she was clammy again and continued to vomit and complaining of chest tightness as well, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion. States today they decided to go to the ER, and she tested positive for Covid on 21Jun2021. she did not want to eat on an unspecified date. The patient treated with Advil and Ibuprofen/Motrin. The patient underwent lab tests which included sars-cov-2 test: positive on 21Jun2021. She Wants guidance on getting the second dose. The event outcome is Unknown for tested positive for covid, did not want to eat, flushed and hot and coughing profusely, Not recovered for Chest tightness, congestion in chest, mucus cough, sore throat and headache Recovering for vomiting and clammy, Fever and chills.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: did not want to eat; flushed and hot; tested positive for covid; congestion in chest; mucus cough; vomiting and clammy; vomiting and clammy; headache; sore throad; Fever; chills; Chest tightness; coughing profusely; This is a spontaneous report from a contactable consumer or other non hcp.   A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jun2021 13:35(age at vaccination 21 years) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient got her first dose of the Pfizer Covid 19 vaccine on 14Jun2021 and is scheduled to get the second dose on 07Jul2021. On 19Jun2021 on Saturday, after they came home from an event the patient experienced coughing profusely, a lot of congestion in her chest, then she started vomiting, she was turning red and clammy and sweating and developing a fever, states initially she treated symptoms with a cold compress, headache, chills and cold sweats. yesterday afternoon she was clammy again and continued to vomit and complaining of chest tightness as well, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion, the patient was flushed and hot and still complaining about sore throat and still had mucus and congestion. States today they decided to go to the ER, and she tested positive for Covid on 21Jun2021. she did not want to eat on an unspecified date. The patient treated with Advil and Ibuprofen/Motrin. The patient underwent lab tests which included sars-cov-2 test: positive on 21Jun2021. She Wants guidance on getting the second dose. The event outcome is Unknown for tested positive for covid, did not want to eat, flushed and hot and coughing profusely, Not recovered for Chest tightness, congestion in chest, mucus cough, sore throat and headache Recovering for vomiting and clammy, Fever and chills.