chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: dizzy; numbness on face and neck; This is a spontaneous report received from a Pfizer sponsored program Covax US Support. A contactable consumer (patient) reported for himself that the male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced dizzy on an unspecified date with outcome of unknown, numbness on face and neck on an unspecified date with outcome of unknown. The clinical course was reported as follows: caller had first dose a few days ago, sees vaccine is not FDA approved, states he is dizzy, numbness on face and neck.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Anaphylactic reaction
Clinical narrative: had an anaphylactic reaction to Prevnar13; This is a spontaneous report from Pfizer sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The relevant medical history and concomitant medications were not reported. The patient had an anaphylactic reaction to Prevnar 13 on an unspecified date. The patient was skeptical about getting the Covid vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Renal disorder
Clinical narrative: Kidney disorder; Kidney disorder; missed his 2nd dose; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. Medical history included renal transplant in 2013, ongoing renal disorder. Concomitant medications were not reported. The patient experienced kidney disorder on an unspecified date with outcome of unknown. The event caused patient's hospitalization. Due to this, the patient missed his 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: Tired/fatigue; unable to sleep throughout the night; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on 01Apr2021 at 10:15 (at 52-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunization. On 01Apr2021 in the evening, the patient became very tired and laid down for about a half an hour which seem to help around 5 PM. When she did go to bed at nine, she slept for only a few hours and then she was unable to sleep throughout the night. She was experiencing a headache, dizziness and it has continued through 01Apr2021 along with the fatigue. The time currently was 12:36. She had been drinking a lot of water this morning and that seemed to have helped a little. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid after both doses; tested positive for covid after both doses; This is a spontaneous report from a contactable consumer. This consumer reported for himself. This is 1 of the 3 report.  This is a spontaneous report from a contactable consumer. The report is from a facility regarding 3 residents at the facility who tested positive for COVID after receiving both doses of the vaccine. This is 1 of three reports. A 86-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: E10140 and Expiry date: 31Mar2021), via ) via intramuscular route on 13Jan2021 as a SINGLE DOSE for COVID-19 immunization. Medical history includes diabetes, heart disease, hypertension and Alzheimer's disease from unspecified-to-unspecified date. The historical vaccine patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, lot number: E10140 and Expiry date: 31Mar2021) 0.3ml via intramuscular route in the right upper arm on 23Dec2020 as a COVID-19 immunization. There were no concomitant medications reported. On 30Mar2021 the patient tested positive for COVID after both doses. The patient underwent lab tests and procedures which included COVID-19 PCR test which was positive on 30Mar2021. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sponsored Program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced back pain on an unspecified date with outcome of unknown. The patient received vaccine on 31Mar2021 and wanted to know if he could take Mortrin or Tyleonol for back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid after both doses; tested positive for covid after both doses; This is a spontaneous report from a contactable consumer. The report is from a facility regarding 3 residents at the facility who tested positive for COVID after receiving both doses of the vaccine. This is two of three reports. A 91-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: E10140 and Expiry date: 31Mar2021), via an unspecified route of administration on 13Jan2021 as single dose for COVID-19 immunization. Medical history included, cardiomegaly, acute kidney injury, atrial fibrillation, diabetes mellitus, hypertension, hyperlipidaemia and anaemia, all from an unknown date and unknown if ongoing. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: E10140 and Expiry date: 31Mar2021), via an unspecified route of administration on 23Dec2020 as single dose for COVID-19 immunization. There were no concomitant medications reported. On 30Mar2021 the patient tested positive for COVID after both doses. The patient underwent lab tests and procedures which included COVID-19 PCR test which was positive on 30Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: pain and swollen hands; pain and swollen hands; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose (dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing arthritis. The patient's concomitant medications were not reported. The patient was calling because she wanted to reschedule her 2nd dose shot scheduled tomorrow (on 02Apr2021) because she would be going to her doctor today (on 01Apr2021) because of her arthritis and would have a steroid shot. According to the caller, she's experiencing pain and swollen hands on an unspecified date. She took her first shot on 12Mar2021. The patient wanted to know if it was possible reschedule her 2nd dose. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he is experiencing pain in the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient got his 1st dose on 31Mar2021 and now he is experiencing pain in the arm on 01Apr2021. Patient also asked if he could walk around to the park to do exercise under the sun. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on her COVID test; tested positive on her COVID test; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient got the first dose of the Pfizer COVID-19 Vaccine last March 18 and she just got back from a trip and she was tested positive on her COVID test. She was asking if that could be the vaccine being detected or something else. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Mar2021.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test, COVID-19, SARS-CoV-2 test
Clinical narrative: testing positive for covid; 24 hour amnesia; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 68-year-old female patient (reporter's mother) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported the patient had an accidental finding of COVID positive on 19Mar2021. She had blood work when she had an overnight stay at the hospital but everything was fine. The patient was completely asymptomatic other than that. It was also reported that the patient ended up having 24 hour amnesia (as reported) on an unspecified date in Mar2021. During the day of the report, 01Apr2021, the patient was due for her second shot but was not allowed to get her second shot that day and that she needed to wait at least a month. The reporter wanted to know if this was correct. The patient did not receive treatment for the events. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on the timing of finding a Covid positive test relative to day of vaccination, event 'Covid-19' was an intercurrent medical condition assessed not related to vaccination with BNT162B2.  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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: felt symptoms similar to pneumonia; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, Lot number was not reported), intramuscularly on 04Apr2021 at age of 48-year-old at single dose for covid-19 immunisation. The patient previously received first dose of BNT162B2 at single dose for covid-19 immunisation and felt itchy and experienced a skin rash. The patient's concomitant medications were not reported. On an unspecified date, after the second dose, the patient felt symptoms similar to pneumonia for one day. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377012
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic disorder
Clinical narrative: Pancreas issues; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was in the hospital with pancreas issues. The patient's wife said that it was not because of vaccine that the patient was hospitalized after first dose. The patient missed the second vaccine dated 19Mar2021 and the patient's wife wanted to know if this will be at a certain location again. The outcome of the event was unknown. The event was assessed as unrelated to the suspect vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Reported event pancreatic issues is considered intercurrent and unrelated to BNT182B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive with Covid Virus; she tested positive with Covid Virus; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. Patient had historical vaccine BNT162B2, first dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Mar2021, she tested positive with Covid virus. She got Covid-19 virus after receiving both doses. The patient underwent lab test and procedures included covid-19 test positive on 31Mar2021. The outcome of event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Hypoaesthesia, Ultrasound Doppler
Clinical narrative: right sided  jaw, facial, neck numbness; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899) via an unspecified route of administration at 2:00 on 28Dec2020 at single dose in left upper arm for COVID-19 immunization, and experienced neck was swollen with rash bilateral, neck palpitations and bounding pulse on 04Jan2021 at 9:00 (referred to AER#2021025542). CTA (computed tomography angiography) neck contrast showed no pulmonary embolism, no aneurysm or dissection, no pneumonia. Bilateral cartoid ultrasound on 11Jan2021 showed no mass or adenopathy or fluid detection. Post 2 weeks the patient experienced right sided jaw, facial, neck numbness and E.R visited on 05Feb2021. The outcomes of the events were unknown.  Information on Lot/ Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021025542 same patient/drug, different dose/AE
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: I got rash on my arm where the vaccine is on my left arm they did the vaccine and it looks like a red little; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) at single dose at arm left for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. "Today" all of sudden the patient got rash on patient's arm where the vaccine was on patient's left arm they did the vaccine and it looked like a red little. The action taken in response to the event for BNT162B2 was not applicable. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Palpitations
Clinical narrative: My heart was racing; Felt really weird in my body; Right leg got kind of numb and my body was so weird after that; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received first single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration on 14Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After taking the vaccine, patient's heart was racing and patient felt really weird in body and right leg when patient was driving in the evening on the highway, patient's right leg got kind of numb and body was weird after that. So, the patient was resisting taking the second shot. Patient asked what if he/she take the second shot after this time as it is more than two months. The patient had not decided yet and he/she want to know what is the maximum period after the first one and if so, what is the is the effect. The outcome of the reactions was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021377639 same drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: She was worried maybe they were scheduled to get the Moderna vaccine; This is a spontaneous report from manufacturer support received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled more than 21 days for their second appointment 29Apr2021. Patient knew that it should be 21 days apart to get the second dose of the vaccine. She was worried maybe they were scheduled to get the Moderna vaccine instead of Pfizer vaccine. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot no. EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration on 19Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had first shot of vaccine on 19Mar2021 and on 29Mar2021 tested positive for Covid. Patient asked, is she need to take the second shot or is it safe to take the second shot if she had the Covid. Patient did not have any trouble with the shot, came up with the Covid after the first shot but she do not think that it was the shot. The outcome of the was unknown.  Information on lot/ batch number has been requested.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Incorrect route of product administration, Skin burning sensation, Swelling
Clinical narrative: short red line and but it didn't feel like nothing it was just a red line there and then the patient woke up yesterday morning and it was burning; swelled up; Subcutaneous; red line going down collarbone; This is a spontaneous report from a contactable consumer (patient). A 63-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), subcutaneous in right arm on 29Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had first Pfizer COVID-19 shot (COVID-19 Vaccine), the 29Mar2021 two days ago (reported on 31Mar2021). The patient had nothing on collarbone when the patient went there and got the shot, the patient got the shot on right arm and when the patient got home the patient just had this red line going down collarbone, the short red line and but it didn't feel like nothing it was just a red line there and then the patient woke up yesterday morning and it was burning and yesterday afternoon it turn around and it swelled up and it like had a 'gas down' (not clarified) as it was seen where the red line was and it looked like it's coming down affected, so the patient put on (not clear nor clarified). It's still swollen on right side, they did right arm where the vaccine was and then it's right collarbone. It was on collarbone and now it looks like it's just an infected area, it was all puffed up and everything else (not clarified further). Outcome of the event swollen was not recovered, of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest discomfort, Chest pain
Clinical narrative: Odd Joint Aches; Stomach pain; Felt like an elephant was sitting on her chest, she thought she was having a heart attack.; chest pain is not as bad but it is still ongoing off and on for the past 7 weeks/generally at night but sometimes during the day; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6200), dose 2 via an unspecified route of administration, administered in left arm on 17Feb2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history included tennis elbow (20 years ago). The patient previously received first dose of bnt162b2 (Lot/Batch number: EL3247) on 27Jan2021 for COVID-19 immunization and old shingles shot for shingles and experienced arm swelled up like a baseball and got really hot (it was a long time ago probably 7-10 years). The patient's concomitant medications were not reported. The patient neither had any history nor took any other products. No additional vaccines administered on same date of the pfizer suspect. The patient felt like an elephant was sitting on her chest, she thought she was having a heart attack and chest pain is not as bad but it is still ongoing off and on for the past 7 weeks/generally at night but sometimes during the day on 18Feb2021 at 02:00, stomach pain on 28Feb2021 and odd joint aches on 01Mar2021. She further clarified that her chest pain isn't as bad, it doesn't feel like she is having a heart attack. The tennis elbow is back sometimes and then she will work out and then her knee hurts and she doesn't have knee problems. States it comes and goes. The patient states it is odd because she knows 4 other people that are having same thing. States 1 had the Moderna and 2 are Pfizer, and 1 had the Johnson and Johnson. They all felt like they were having heart attacks in the middle of the night. The patient was treated with Nexium and states she can only eat oatmeal, bananas, chicken and rice. She neither visit the emergency room nor the physician office due to the events. She is very healthy and in good shape. She called her physician's office and they said to go to the ER or a cardiologist office. There was no family medical history relevant to the adverse events. The outcome of the event felt like an elephant was sitting on her chest, she thought she was having a heart attack was unknown and was not recovered for the rest of the events.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Peripheral swelling, Rash
Clinical narrative: sore shoulder; my foots swell; I got all in groin area kind of sore; rash and skinfold in groin; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got bnt162b2 yesterday (reported on 31Mar2021) and had sore shoulder little, foots swell and today the patient was driving car for an hour got all in groin area kind of sore and the patient had a rash and skinfold in groin. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Chills, Choking, Discouragement
Clinical narrative: This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in.  On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club.  Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Irritability, Nasopharyngitis, Pain, Productive cough
Clinical narrative: This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in.  On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club.  Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing
Clinical narrative: This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in.  On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club.  Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Malaise, Nausea, Pain
Clinical narrative: fever; body ache; headache; little nausea; loss of appetite; malaise and did not feel well; This is a spontaneous report from a contactable consumer. This Consumer reported for her son (Patient). A 28-years-old male patient 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 29Mar2021 as single dose for COVID-19 immunization. Medical history included covid-19 and nephrocalcinosis. The patient concomitant medications were not reported. Caller reported that her son developed symptoms early Monday morning, 7-8 days later, the patient experienced fever, body ache, headache, little nausea, loss of appetite, feeling unwell and malaise. Caller stated that her son wanted to get tested for covid and asked if the test would not come back negative because of the shot. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; body ache; headache; little nausea; loss of appetite; malaise and did not feel well; This is a spontaneous report from a contactable consumer. This Consumer reported for her son (Patient). A 28-years-old male patient 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 29Mar2021 as single dose for COVID-19 immunization. Medical history included covid-19 and nephrocalcinosis. The patient concomitant medications were not reported. Caller reported that her son developed symptoms early Monday morning, 7-8 days later, the patient experienced fever, body ache, headache, little nausea, loss of appetite, feeling unwell and malaise. Caller stated that her son wanted to get tested for covid and asked if the test would not come back negative because of the shot. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: the patient experienced took vaccine already and tested positive for covid vaccine; COVID-19 virus test positive; This is spontaneous report received via Social Media report from by a consumer. A patient of unspecified age and gender was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via intramuscular route of administration as a single dose for COVID-19 immunization. Patient was also administered with Creon (Pancreatin, Formulation and Lot number: were not provided) via an Intramuscular route of administration (with unknown daily dosage and Therapy dates) for Exocrine Pancreatic insufficiency(EPI) not associated with cystic fibrosis. Medical history and concomitant medication was not reported. Patient took vaccine already and tested positive for covid vaccine did not protect from getting covid with creon (pancreatin). On an unknown date, the patient experienced took vaccine already and tested positive for covid vaccine did not protect from getting covid on 21Mar2021, the patient experienced took vaccine already and tested positive for covid vaccine did not protect from getting covid. Outcome of the events was unknown.  Causality for Creon (pancreotin): The reporter's causality for the event(s) of Took vaccine already and tested positive for covid vaccine did not protect from getting covid unknown onset and took vaccine already and tested positive for covid vaccine did not protect from getting covid onset 21Mar2021 was not provided.  Information about lot/batch has been request.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report, received by a contactable consumer (patient).  A male patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, on 17Mar2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Second dose was scheduled on 07Apr2021. After first shot, the patient had bad symptoms so he got a test for COVID-19 which resulted negative. He continued to have bad symptoms, so he had a test again on 30Mar2021 which resulted positive. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program . A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left deltoid on 08Feb2021 at single dose for covid-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FL8982), via an unspecified route of administration on 05Jan2021. at single dose for covid-19 immunization. Medical history included anxiety, allergy, iron deficiency and bone locked. Concomitant medications included escitalopram oxalate (LEXAPRO) at a dose 20 mg one a day for anxiety, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg for allergy, ethinylestradiol, norgestimate (SPRINTEC) one a day for birth control, iron tablet at a dose of 325 mg one a day for iron deficiency and calcium carbonate, colecalciferol (CALTRATE + D [CALCIUM CARBONATE; COLECALCIFEROL]) at 2 tablets a day for bone locked. The patient stated, she got both doses of the Pfizer Covid vaccine and she just tested positive for Covid today. The patient reported that she cannot find the date that she got. She was not sure. It will be January. No treatment was received. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Death, Dehydration, Guillain-Barre syndrome, Laboratory test
Clinical narrative: Guillain-Barre Syndrome; urinary incontinence; confusion; lethargy; dehydration; expired; This is a spontaneous report from a contactable physician. A 76-year-old male 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 on an unspecified date as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received his second Pfizer vaccine dose and 2 weeks after receiving the vaccine he presented to her office with urinary incontinence, confusion and lethargy. He was admitted to the hospital and within a few days later, day 5, he was diagnosed with Guillain-Barre Syndrome. Following tests and a lumbar puncture. He was hospitalized x2 weeks, received IVIG x 5days. He was then transferred to a Nursing Home. He was readmitted to the hospital with dehydration and expired 2 days later (last night). The physician asked, "have you seen this type of thing before, with GBS?" The physician considered the case as non-serious. The outcome of the events was unknown except for expired. The patient died on 06Apr2021 as he expired. There was no autopsy done.  Information on the lot/batch number has been requested.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case.  Based on the current available information, a possible contributory role of the suspect product to the development of events cannot be totally excluded. Additional information including relevant medical history, detailed clinical course, and specified concomitant medications is required to better assess the case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: expired
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Lumbar puncture, Urinary incontinence
Clinical narrative: Guillain-Barre Syndrome; urinary incontinence; confusion; lethargy; dehydration; expired; This is a spontaneous report from a contactable physician. A 76-year-old male 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 on an unspecified date as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received his second Pfizer vaccine dose and 2 weeks after receiving the vaccine he presented to her office with urinary incontinence, confusion and lethargy. He was admitted to the hospital and within a few days later, day 5, he was diagnosed with Guillain-Barre Syndrome. Following tests and a lumbar puncture. He was hospitalized x2 weeks, received IVIG x 5days. He was then transferred to a Nursing Home. He was readmitted to the hospital with dehydration and expired 2 days later (last night). The physician asked, "have you seen this type of thing before, with GBS?" The physician considered the case as non-serious. The outcome of the events was unknown except for expired. The patient died on 06Apr2021 as he expired. There was no autopsy done.  Information on the lot/batch number has been requested.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case.  Based on the current available information, a possible contributory role of the suspect product to the development of events cannot be totally excluded. Additional information including relevant medical history, detailed clinical course, and specified concomitant medications is required to better assess the case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: expired
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cardiac arrest, Death, Dysphagia, Gait inability
Clinical narrative: Guillain-Barre Syndrome; urinary incontinence; confusion; lethargy; dehydration; expired; This is a spontaneous report from a contactable physician. A 76-year-old male 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 on an unspecified date as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received his second Pfizer vaccine dose and 2 weeks after receiving the vaccine he presented to her office with urinary incontinence, confusion and lethargy. He was admitted to the hospital and within a few days later, day 5, he was diagnosed with Guillain-Barre Syndrome. Following tests and a lumbar puncture. He was hospitalized x2 weeks, received IVIG x 5days. He was then transferred to a Nursing Home. He was readmitted to the hospital with dehydration and expired 2 days later (last night). The physician asked, "have you seen this type of thing before, with GBS?" The physician considered the case as non-serious. The outcome of the events was unknown except for expired. The patient died on 06Apr2021 as he expired. There was no autopsy done.  Information on the lot/batch number has been requested.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case.  Based on the current available information, a possible contributory role of the suspect product to the development of events cannot be totally excluded. Additional information including relevant medical history, detailed clinical course, and specified concomitant medications is required to better assess the case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: expired