chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-1 test, SARS-CoV-2 test positive
Clinical narrative: he got positive with Covid-19; dizziness; woke up sweating; chills; muscle spasms; can not eat; Coughing; This is a spontaneous case is received from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced he got positive with covid-19 (sars-cov-2 test positive), dizziness on 06Apr2021, chills on 04Apr2021, muscle spasms on 04Apr2021, coughing (cough) on 01Apr2021, woke up sweating (hyperhidrosis) on 06Apr2021, cannot eat (feeding disorder)on 03Apr2021. The patient underwent lab tests and procedures which included sars-cov-1 test: positive. Therapeutic measures were taken as a result of, woke up sweating (hyperhidrosis). The outcome of the events sars-cov-2 test positive was unknown, chills, cough, feeding disorder were recovering, dizziness, hyperhidrosis were recovered on 06Apr2021, muscle spasms were recovered on 04Apr2021.  Follow-up activities have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual period; This is a spontaneous report from a contactable consumer (patient). This 38-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. With the first dose of the vaccine she started experiencing an irregular menstrual period. The outcome of event was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377753 the same patient and product, different doses and partial similar adverse events
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer. The reporter reported the same events for three patients. This is the third of the report.   A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E10140, expiration date: 31Mar2021) via unspecified route single dose for COVID-19 immunization, first dose on 23Dec2020, second dose on 13Jan2021, at 90-year-old. Medical history included: chronic kidney disease; anemia; a fib; heart disease. Concomitant medication was not reported. The facility discovered that the patient at the facility tested positive for COVID after receiving both doses of the vaccine. Lab data included: positive COVID-19 PCR test on 23Mar2021. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021376654 same reporter, product and adverse event, different patients;US-PFIZER INC-2021376693 same reporter, product and adverse event, different patients
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report received from a contactable nurse. A 66-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), 1st dose via intramuscular route of administration, on 02Apr2021 09:30 AM (at the age of 66-years-old) as single dose for COVID-19 immunisation. Patient's medical history included asthma, GERD. Concomitant medications were not reported. The patient previously took keflex, peanut, fentanyl, pcn ms and experienced known allergies. On 02Apr2021 09:30 AM, the patient experienced anaphylaxix chest/throat tightness, which resulted in emergency room visit. Treatment received for the adverse events included epi, albuterol, and Benadryl. It was unknown that the patient was diagnosed with COVID-19, prior to vaccination and whether the patient had been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylaxis and the suspect drug BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: "covid arm" huge red itchy at injection site; "covid arm" huge red itchy at injection site; This is a spontaneous report from a non-contactable consumer. This consumer reported two reports for herself. This is the first of two reports. An adult female patient received the first dose bnt162b2 (Pfizer, Batch/Lot number was unknown) administered in arm on 11Mar2021 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications; and unknown if was diagnosed with COVID-19 prior to vaccination or has been tested for COVID-19 since the vaccination. The patient experienced "covid arm" huge red itchy at injection site in 2021 with outcome of recovered in 2021. The treatment was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 antibody test positive, Sinusitis
Clinical narrative: occasional cough; sinuses; congestion; Caller mentions that she got the first dose of the Pfizer covid vaccine on March 27th but was diagnosed with covid yesterday; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored Covax . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), via an unspecified route of administration on 27Mar2021 as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient reported that, she got the first dose of the vaccine on 27Mar2021, but was diagnosed with COVID-19 yesterday (05Apr2021). She also reported occasional cough, sinuses and congestion on an unspecified date. Patient had an appointment to get on 17Apr2021, the second dose of vaccine and wanted to know if she can still receive the second dose of covid-19 vaccine after testing positive for covid-19 virus after first dose. All the events were considered as non-serious as reported. Outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Diagnosed with Covid/tested positive for Covid on 30Mar2021 after receiving first dose of the Covid vaccine on 10Mar2021; Diagnosed with Covid/tested positive for Covid on 30Mar2021 after receiving first dose of the Covid vaccine on 10Mar2021; This is a spontaneous report received from a Pfizer Sponsored Program from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 10:00 (Lot Number: ER2613) as SINGLE DOSE (at the age of 55-years-old) for covid-19 immunization.  The patient's medical history and concomitant medication were not reported. The patient did not receive prior vaccinations within 4 weeks.. The patient was diagnosed with Covid on 30March2021. She tested positive for Covid on 30Mar2021 after receiving first dose of the Covid vaccine on 10Mar2021. She was scheduled to receive her second Pfizer Covid 19 vaccine on 10April2021. She honestly thought it was allergies but she just wanted to be certain because she was supposed to go out of town for the weekend. She has not had another test. She was told not to come back for a repeat test. She has no symptoms and she is beyond her quarantine. She wants to make sure it is okay to get the second dose. The events did not require a visit to the emergency room. She went to the urgent care center. Treatment included she took over the counter medication; ibuprofen (ADVIL), guaifenesin (MUCINEX) and NetiPot. The patient underwent lab tests and procedures which included covid-19: positive on 30Mar2021.  Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is spontaneous report received from the non-contactable female consumer (Patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient experienced pain. The patient scheduled for the second dose on 21Apr2021. She supposed to receive injection shots for pain on 20Apr2021 Fl fluoro injection. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Malaise
Clinical narrative: deep phlegmy cough/ the phlegm is now green; deep phlegmy cough/ the phlegm is now green; sore throat; a fever ranging from 100-102; Severe chills; headache; tired; feeling lousy; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 30Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 31Mar2021, the patient experienced a fever ranging from 100-102 F (fever lasting more than a week), severe chills, and headache. In Mar2021, the patient was tired and feeling lousy. On 02Apr2021, the patient developed deep phlegmy cough/ the phlegm was now green, and sore throat. There was no emergency room or physician office visit. Treatment for the events fever, headache, sore throat, tired and feeling lousy included acetaminophen (TYLENOL). There was no treatment for the events chills and phlegmy cough/phlegm was now green. The outcome of the events fever, chills, deep phlegmy cough/phlegm was now green, and sore throat was not recovered. The outcome of the event headache was recovered on 03Apr2021. The outcome of the events tired and feeling lousy was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia, Sputum discoloured
Clinical narrative: deep phlegmy cough/ the phlegm is now green; deep phlegmy cough/ the phlegm is now green; sore throat; a fever ranging from 100-102; Severe chills; headache; tired; feeling lousy; This is a spontaneous report from a contactable consumer. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 30Mar2021 at 16:45 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 31Mar2021, the patient experienced a fever ranging from 100-102 F (fever lasting more than a week), severe chills, and headache. In Mar2021, the patient was tired and feeling lousy. On 02Apr2021, the patient developed deep phlegmy cough/ the phlegm was now green, and sore throat. There was no emergency room or physician office visit. Treatment for the events fever, headache, sore throat, tired and feeling lousy included acetaminophen (TYLENOL). There was no treatment for the events chills and phlegmy cough/phlegm was now green. The outcome of the events fever, chills, deep phlegmy cough/phlegm was now green, and sore throat was not recovered. The outcome of the event headache was recovered on 03Apr2021. The outcome of the events tired and feeling lousy 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: Seizure
Clinical narrative: seizure; This is a spontaneous report received from a contactable pharmacist (patient) via medical information team. Follow-up (06Apr2021) was received from same reporter and processed together with initial information.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729; Expiration Date: 20Jul2021), via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. Other suspect medications included: saline [sodium chloride], via an unspecified route of administration from an unspecified date (Lot Number: 6023228), at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient reported that after administering the Covid 19 vaccine on 06Apr2021, within about 20 minutes there were 4 patients with reactions. One patient had a seizure and 3 patients passed out. These patients had just received the Covid 19 vaccine and were still being watched within the 15-minute post vaccination time. All 4 patients received the Covid 19 vaccine from the same lot number but not from the same vial. Seriousness of event was medically significant. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and strong temporal relationship, A possible causal relationship between event Seizure and suspect drug  bnt162b2  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, SARS-CoV-2 test, Smear test
Clinical narrative: Cellulitis; This is a spontaneous report received from a contactable Other Health Professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 26Feb2021 15:15 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included asthma, GERD (gastrooesophageal reflux disease) and HTN (hypertension). Patient was allergy to Sulfa, mometasone furoate (NASONEX) and ciclesonide (OMNARIS). Concomitant medications included pantoprazole, prednisone, phentermine and more.  The patient experienced cellulitis "10 days" on 10Mar2021 with outcome of recovered. Patient received treatment included cefalexin (KEFLEX) then doxycycline. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Lab test on 27Mar2021 included RT-PCR of SARS-CoV-2 test and nasal swab were both negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event of cellulitis and the suspect vaccine BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: chest pains; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the second dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9263), via an unspecified route of administration in the left arm on 14Feb2021 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included piroxicam (PAXIL). The patient was not pregnant at the time of vaccination. The patient had not had COVID-19 prior to vaccination. The patient had no known allergies. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 24Jan2021 11:00 (at the age of 67-years-old) as a single dose for COVID-19 immunization. On 14Feb2021 22:00, after the second vaccine, the patient began having chest pains, which she had never experienced before. The pain has lasted, and she was now being checked by a cardiologist. Treatment was received for the event. The patient had a chest X-ray and EKG on an unspecified date. The outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information about lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a contactable consumer. This contactable female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 imuunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced fatigue after getting the 1st dose of the vaccine. The patient stated her husband completed the 2 doses of PFIZER-BIONTECH COVID-19 VACCINE and did not have any side effects. She asked if she could take Tylenol after I received the 1st dose. Outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 3 days after the first dose I developed a blood clot in my right calf, never had one before, no trauma, i am very active; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first received first dose of bnt162b2 (Pfizer, Formulation: Solution for injection, Lot Number: EP 7534b) via an unspecified route of administration, administered in left arm on 13Mar2021 11:00 at a single dose for covid-19 immunization. Medical history and known allergies were none. Concomitant medication included rivaroxaban (XARELTO). The patient developed a blood clot in his right calf 3 days after the first dose, never had one before, no trauma, he was very active on 16Mar2021 07:00. No covid vaccination was taken prior. No covid tested post vaccination. Blood thinner for the clot was given as the treatment. The outcome of the event was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: then got positive for covid on 22Mar2021; positive COVID-19 test (22Mar2021) with symptoms; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer reported for herself that the patient has received the first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route of administration in left arm on 04Mar2021 as single dose for COVID-19 immunization, Protection, preventing the spread (Age at the time of vaccination:51-year-old). The patient's medical history included occasional hypertension and high cholesterol and concomitant medication included Lipitor 10mg by mouth for high cholesterol. On 21Mar2021 the patient had dry cough. On 22Mar2021 she tested positive for Covid. She is getting mixed information from the CDC and her doctor as to when it is safe or necessary to get the second dose of the vaccine. She confirms this as the Covid vaccine. Her symptoms started on 21Mar2021.On 22Mar2021 the patient had very low-grade fever and the event resolved on 23Mar2021, on 24Mar2021, the patient had congestion, had loss of taste and loss of smell. The patient reported that she had a dry cough, a very low-grade fever for one day, congestion, and loss of taste and smell. She had lasting effects because she had Covid last Mar also. She had a mild cough, that had not changed. She was just a little congested and her taste and smell are muted. She has mild congestion when she wakes up in the morning. It started a couple of days after she tested positive. She lost her sense of taste and smell Thursday or Friday, 25Mar2021 or 26Mar2021. Some things she can taste and some things she cannot. The patient was not received any treatment for the events. The outcome of the events were reported as unknown.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Eye swelling, Lip swelling, Urticaria
Clinical narrative: full body blistering hives; full body blistering hives; eyes swollen shut; lips started to swell; This is a spontaneous report from a contactable consumer reported for herself.  A 18-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm on 26Mar2021 12:00, at the age of 18 years old (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation, at the hospital. The patient had received the first dose of BNT162B2 on  05Mar2021 02:00 PM from lot # EN6200 in the left arm. Medical history included hypersensitivity. The patient's concomitant medications were not reported.  The patient was not pregnant. Patient had not Covid prior vaccination, patient has not tested positive for COVID-19 since having the vaccine. No Covid tested post vaccination. The patient experienced full body blistering hives, eyes swollen shut, lips started to swell on 27Mar2021 12:00 AM with outcome of recovering.  The patient was treated for the events with an injection of steroids and Benadryl at ER.   No follow up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: started bleeding, period symptoms, and it has progressed much worse; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 29Mar2021 15:00 as single dose for covid-19 immunisation. Medical history included birth control. Patient is not pregnant. Concomitant medication included medroxyprogesterone acetate (DEPO-PROVERA shot) taken for birth control. Within an hour of receiving, patient started bleeding, period symptoms at 04:00 PM on 29Mar2021, and it has progressed much worse. This makes patient question the integrity of her birth control, a depo shot once every 3 months. Patient visited doctor or other healthcare professional office for the event. No treatment received. It was unknown if patient had covid prior vaccination. No other vaccine in four weeks. Patient did not test covid post vaccination. Outcome of the event was recovering.    Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: because I vomited after getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization.  Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient vomited after getting the vaccine on 03Apr2021, and it may have been the food the patient ate because the patient still can't eat it. The patient wanted to say thanks for the vaccine, she cried when she got the shot, she had COPD and this virus was deadly to someone like her. The outcome of the event was unknown.   No follow up attempts are needed; No further information is expected. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy
Clinical narrative: bruise on left arm where he got the first shot; lymph node swelling/ swollen lymph nodes; This is a spontaneous report received from Pfizer-sponsored program from a contactable consumer (patient). This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  He was having almost every side effect stated on Pfizer BioNtech covid-19 vaccine after his first dose of the vaccine on 18Mar2021 including lymph node swelling and still having bruise on the left arm where the site of injection was. He got the first shot on 18 Mar2021 and was scheduled to get his second shot on 08Apr2021. Stated he still had a bruise on his left arm where he got the first shot. Every symptoms listed in the flyer they gave him he had, including the swollen lymph nodes. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Feeling abnormal, Hyperpyrexia
Clinical narrative: high fever; Arm was sore where she got the shot for a few days after the Vaccine; chills; body aches and pains/pain; migraine headache; severe sinus issues; diarrhea; nausea; stayed in bed all day/has not had energy; not feeling good; flu like symptoms; sick; fogginess; vomiting; forgetfulness; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for three patients. This is the second of three reports.   A 67-years-old female patient received the second dose of  bnt162b2 (BNT162B2),  via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: were not reported) ) as SINGLE DOSE for covid-19 immunisation. The patient received first dose of bnt162b2 (lot and expiry were not reported) on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced high fever (medically significant), arm was sore where she got the shot for a few days after the vaccine,  chills, , body aches and pains/pain, migraine headache, severe sinus issues,  diarrhea,  nausea,  stayed in bed all day/has not had energy,  not feeling good, flu like symptoms, sick, fogginess, vomiting, forgetfulness. The clinical course was as follows the reporter referred to her friend .This patient (name redacted) had the same symptoms as the reporter but did not have the burning lungs, but did have a high fever. Caller believes the patient is 67. Caller believes the patient received her vaccine while in Pennsylvania because that is where she lives. Caller does not have further information about the patient. No NDC, Lot or Expiration for the Pfizer COVID Vaccine, caller doesn't have the information. [Redacted] hers only last 24hrs after the 2nd shot. It was reported No Treatment was given. The clinical outcome of the events was unknown.    Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372305 same reporter/drug, different patient/AE;US-PFIZER INC-2021377357 same reporter/drug, different patient/AE;US-PFIZER INC-2021380809 same reporter, different patients/events
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Malaise, Memory impairment, Migraine
Clinical narrative: high fever; Arm was sore where she got the shot for a few days after the Vaccine; chills; body aches and pains/pain; migraine headache; severe sinus issues; diarrhea; nausea; stayed in bed all day/has not had energy; not feeling good; flu like symptoms; sick; fogginess; vomiting; forgetfulness; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for three patients. This is the second of three reports.   A 67-years-old female patient received the second dose of  bnt162b2 (BNT162B2),  via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: were not reported) ) as SINGLE DOSE for covid-19 immunisation. The patient received first dose of bnt162b2 (lot and expiry were not reported) on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced high fever (medically significant), arm was sore where she got the shot for a few days after the vaccine,  chills, , body aches and pains/pain, migraine headache, severe sinus issues,  diarrhea,  nausea,  stayed in bed all day/has not had energy,  not feeling good, flu like symptoms, sick, fogginess, vomiting, forgetfulness. The clinical course was as follows the reporter referred to her friend .This patient (name redacted) had the same symptoms as the reporter but did not have the burning lungs, but did have a high fever. Caller believes the patient is 67. Caller believes the patient received her vaccine while in Pennsylvania because that is where she lives. Caller does not have further information about the patient. No NDC, Lot or Expiration for the Pfizer COVID Vaccine, caller doesn't have the information. [Redacted] hers only last 24hrs after the 2nd shot. It was reported No Treatment was given. The clinical outcome of the events was unknown.    Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372305 same reporter/drug, different patient/AE;US-PFIZER INC-2021377357 same reporter/drug, different patient/AE;US-PFIZER INC-2021380809 same reporter, different patients/events
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Sinus disorder, Vaccination site pain, Vomiting
Clinical narrative: high fever; Arm was sore where she got the shot for a few days after the Vaccine; chills; body aches and pains/pain; migraine headache; severe sinus issues; diarrhea; nausea; stayed in bed all day/has not had energy; not feeling good; flu like symptoms; sick; fogginess; vomiting; forgetfulness; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for three patients. This is the second of three reports.   A 67-years-old female patient received the second dose of  bnt162b2 (BNT162B2),  via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: were not reported) ) as SINGLE DOSE for covid-19 immunisation. The patient received first dose of bnt162b2 (lot and expiry were not reported) on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced high fever (medically significant), arm was sore where she got the shot for a few days after the vaccine,  chills, , body aches and pains/pain, migraine headache, severe sinus issues,  diarrhea,  nausea,  stayed in bed all day/has not had energy,  not feeling good, flu like symptoms, sick, fogginess, vomiting, forgetfulness. The clinical course was as follows the reporter referred to her friend .This patient (name redacted) had the same symptoms as the reporter but did not have the burning lungs, but did have a high fever. Caller believes the patient is 67. Caller believes the patient received her vaccine while in Pennsylvania because that is where she lives. Caller does not have further information about the patient. No NDC, Lot or Expiration for the Pfizer COVID Vaccine, caller doesn't have the information. [Redacted] hers only last 24hrs after the 2nd shot. It was reported No Treatment was given. The clinical outcome of the events was unknown.    Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372305 same reporter/drug, different patient/AE;US-PFIZER INC-2021377357 same reporter/drug, different patient/AE;US-PFIZER INC-2021380809 same reporter, different patients/events
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Feeling abnormal, Illness
Clinical narrative: Arm was sore where she got the shot for a few days after the Vaccine; body aches and pains/pain; stayed in bed all day/has not had energy; not feeling good; sick; basically flu like symptoms; fogginess; vomiting; forgetfulness; chills; migraine headache; severe sinus issues; diarrhea; nausea; high fever; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for three patients. This is the third of three reports.  A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on an unspecified date as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (lot and expiry were not reported) on an unspecified date for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer (patient's friend) reported that the patient's symptoms only last 24hrs after the second shot the patient had the same symptoms as the consumer (friend), but no burning lungs, high fever, chills, migraine headache, severe sinus issues, diarrhea and nausea, all on 04Apr2021. On an unspecified date, arm was sore where she got the shot for a few days after the vaccine, body aches and pains/pain, stayed in bed all day/has no energy, not feeling good, sick, basically flu like symptoms that were worse than the flu, fogginess, vomiting and forgetfulness. 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-2021377356 same reporter/drug, similar events, different patient.;US-PFIZER INC-2021372305 same reporter/drug, similar events, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Memory impairment, Migraine, Nausea
Clinical narrative: Arm was sore where she got the shot for a few days after the Vaccine; body aches and pains/pain; stayed in bed all day/has not had energy; not feeling good; sick; basically flu like symptoms; fogginess; vomiting; forgetfulness; chills; migraine headache; severe sinus issues; diarrhea; nausea; high fever; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for three patients. This is the third of three reports.  A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on an unspecified date as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (lot and expiry were not reported) on an unspecified date for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer (patient's friend) reported that the patient's symptoms only last 24hrs after the second shot the patient had the same symptoms as the consumer (friend), but no burning lungs, high fever, chills, migraine headache, severe sinus issues, diarrhea and nausea, all on 04Apr2021. On an unspecified date, arm was sore where she got the shot for a few days after the vaccine, body aches and pains/pain, stayed in bed all day/has no energy, not feeling good, sick, basically flu like symptoms that were worse than the flu, fogginess, vomiting and forgetfulness. 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-2021377356 same reporter/drug, similar events, different patient.;US-PFIZER INC-2021372305 same reporter/drug, similar events, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sinus disorder, Vaccination site pain, Vomiting
Clinical narrative: Arm was sore where she got the shot for a few days after the Vaccine; body aches and pains/pain; stayed in bed all day/has not had energy; not feeling good; sick; basically flu like symptoms; fogginess; vomiting; forgetfulness; chills; migraine headache; severe sinus issues; diarrhea; nausea; high fever; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for three patients. This is the third of three reports.  A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on an unspecified date as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (lot and expiry were not reported) on an unspecified date for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer (patient's friend) reported that the patient's symptoms only last 24hrs after the second shot the patient had the same symptoms as the consumer (friend), but no burning lungs, high fever, chills, migraine headache, severe sinus issues, diarrhea and nausea, all on 04Apr2021. On an unspecified date, arm was sore where she got the shot for a few days after the vaccine, body aches and pains/pain, stayed in bed all day/has no energy, not feeling good, sick, basically flu like symptoms that were worse than the flu, fogginess, vomiting and forgetfulness. 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-2021377356 same reporter/drug, similar events, different patient.;US-PFIZER INC-2021372305 same reporter/drug, similar events, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: give it too high and they inject in the Bursa; Has not been able to lift arm for 4 days after getting injection; This is a spontaneous report from a contactable reporter on behalf of his brother. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had the shot. This has nothing to do with Pfizer. The shot may have been done wrong. He had not been able to lift her arm for 4 days after getting the injection. The reporter asked if he got injected in the Bursa, whether he would develop sufficient Antigens. The nurse or whoever gave it, they gave it too high and they injected in the Bursa. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms for 24 hours; This is a spontaneous report from a non-contactable consumer. This consumer reported two reports for herself. This is the second of two reports. An adult female patient received the second dose bnt162b2 (Pfizer, Batch/Lot number was unknown) administered on 02Apr2021 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient received the first dose bnt162b2 (Pfizer, Batch/Lot number was unknown) administered in arm on 11Mar2021 as single dose for COVID-19 immunisation and experienced "covid arm" huge red itchy at injection in 2021 with outcome recovered in 2021 and treatment was unknown. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or any other medications; and unknown if was diagnosed with COVID-19 prior to vaccination or has been tested for COVID-19 since the vaccination. The patient experienced flu like symptoms for 24 hours on 02Apr2021 and recovered on 03Apr2021. The treatment was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: noticed a mild rash (looks like sunburn) near where my armpit/boob meet on the side where I got a shot/I feel good and only noticed the rash when I got out of the shower; This is a spontaneous report received from a non-contactable consumer. A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated after her first dose of vaccine on 03Apr2021, she "noticed a mild rash (looks like sunburn) near where her armpit/boob meet on the side where she got a shot". On 06Apr2021, patient stated she felt good and only noticed the rash when she got out of the shower. No pain or itchiness with it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart racing; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9261) via an unspecified route of administration at left arm on 31Mar2021 at 17:00 (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing atrial fibrillation (afib) and allergies to phenothyazines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On  01Apr2021, the patient experienced heart racing. Patient stated since he has afib, caused a problem for a day. Scared to get second dose. Since the vaccination, the patient has not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: nausea; Vomiting; Stomach pain/stomach problems; This is the spontaneous report received from a contactable consumer (patient). A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Mar2021 12:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing Acid reflux. The patient was not sure if the COVID 19 vaccine flare up her acid reflux or not. It has been off and on for a few years. Prior vaccinations (within 4 weeks) was none. The patient's concomitant medications were not reported. The patient had side effects of nausea and vomiting and she still had stomach problems all on 30Mar2021. Nausea was getting better and after she ate something it helped. The patient still had stomach pains. Vomiting stopped a couple of days ago and she was not completely sure if she had recovered completely because it still comes and go. The patient did not eat anything her stomach hurt really bad. For her stomach problems she was taking Mylanta Kaopectate and it was not helping and also Pepto-Bismol. The expiry date was 20Dec2023, lot Lot: 0D167, (s) did not require a visit to Emergency Room or Physician Office. The outcome of event nausea and vomiting was recovering, and stomach pain/stomach problems was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Neck pain, Nervousness, Pain in extremity
Clinical narrative: left arm sore/ left neck and arm were sore; left side of her neck was very sore/ left neck and arm were sore; left arm, leg and especially left foot were numb; like when you are shaky and hold out your hand and the shaking felt like shaking inside; it was a strange sensation; This is a spontaneous report from a contactable nurse reported for self. This 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EN6206) in her left upper arm on 18Mar2021 10:10 at single dose for COVID-19 immunisation. Medical history included ongoing mild asthma (diagnosed a long time ago and it was allergy or exercise triggered, that it was not debilitating). Concomitant medications included amlodipine from Jul2020 and ongoing. The patient previously got the influenza vaccine (FLU) shot for immunisation, and experienced her arm would be numb and sometimes she felt a little tired and achy for a day. Patient stated she was trying desperately to see if she should get the 2nd shot as she had a strange reaction and no one was able to help her. She stated it was a strange reaction that started the same day she got the vaccine on 18Mar2021 about 6 hours after the vaccine. Stated she did take a nap and the reaction may have started in her sleep but she noticed it when she woke up which was 6 hours after the shot.  She clarified the strange reaction as being her left arm sore and she expected that and the left side of her neck was very sore, her left arm, leg and especially left foot were numb. Stated it felt like, it's hard to describe, like when you are shaky and hold out your hand and the shaking felt like shaking inside and it was a strange sensation. She stated the next day her left neck and arm were sore. The numbness was just her left hand and left foot and resolved to an intermittent, by 24Mar2021 it was intermittent and by 01Apr2021 that had resolved but she still had some numbness in her left foot if she stand a long time like if she was cooking.  She stated these were all new to her and had never happened before and can only thought it was the vaccine by the way it presented. Events did not require a visit to Emergency Room or Physician Office.  The outcome of events was unknown. The events seriousness was not reported, causality assessment from the reporter was related.  No follow-up attempts are needed. No further information is expected.