chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: his fingers started having a tingling sensation; This is a spontaneous report received from a contactable consumer (patient). A male patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and lot number: UNKNOWN) via an unspecified route of administration on 15Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection and lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On 15Apr2021, half hour after the vaccine patient fingers started having a tingling sensation that had continued. The outcome of the event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Somnolence
Clinical narrative: 1st day I was a bit drowsy and heavy in my head; 1st day I was a bit drowsy and heavy in my head; Headache; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 08Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that 1st day patient was a bit drowsy and heavy in his head, then on the 2nd day he had a headache and took Tylenol. Then the next day there was heaviness again on his head. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Limb discomfort, Pain
Clinical narrative: Pain in her body, more so on the left side where she had the injection; Nerves running down the side on left and right hand; Bad headache; every night her entire left side of body feels like all bones are cracking, like she has two different bodies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported) on 06Jan2021 and second dose on 27Jan2021 both via an unspecified route of administration, both as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started experiencing pain in her body, more so on the left side where she had the injection, nerves running down the side on left and right hand, bad headache and entire left side of body feels like all bones are cracking, like she has two different bodies. The bad headache went away. The outcome of the bad headache was recovered and was unknown for the rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: she developed diarrhea and has had this symptom continue since then; She also reports a small headache in the middle night on most nights; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 12Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient received her first Pfizer Covid vaccine dose on 12Mar2021. A week or two after that dose, she developed diarrhea and has had this symptom continue since then. Her second dose was on 02Apr2021. She wants to know if this was normal and if Pfizer has anymore information about this side effect. The patient stated that she was going to start taking probiotics. She also reports a small headache in the middle night on most nights. The outcome of the event diarrhea was not recovered/not resolved. The outcome of the event headache was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: However, her mother currently has Covid-19; However, her mother currently has Covid-19; This is a spontaneous report from a non-contactable consumer. An 82-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection) on an unknown date as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Consumer said her 82-year-old mother already received the 1st dose of the Pfizer-BioNTech Covid-19 vaccine and was scheduled to receive the 2nd dose on Thursday. However, her mother currently had Covid-19 and wanted to know if she should receive the 2nd dose beyond the 3-week recommended interval. She also wanted to know how long her mother should isolate herself. And how she could schedule a new appointment for her mother's 2nd dose. No PQC was present. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Ringing in ears/Tinnitus; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left Arm on 23Mar2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history included did had surgery a month before and did had a bunch of lab work to get to that. Concomitant medication(s) included rosuvastatin calcium (CRESTOR), zolpidem. The patient experienced Ringing in ears, Nausea, Tinnitus, all on 13Apr2021. First dose was 23Mar2021; second dose scheduled for 14Apr2021. May delay or not get second dose. Caller states he got his first shot on 23Mar2021 (three weeks before) and is scheduled for his second shot today (14Apr2021). Says that yesterday (13Apr2021) he began experiencing ringing in his ears and nausea. States he looked online and saw that other people were also experiencing tinnitus and that it got worse after the second shot. Says some of them had said it got so bad they could not sleep or hear. He is worried about getting his second shot today and is asking if he should possibly delay it, or not get it? Patient took first vaccine 3 weeks before today and patient was due for the second vaccine today and patient started developing some ringing in ear a couple days before and patient didn't really think about much of it and so patient heard of few other people mentioned the same thing so patient was reading about it and hear that it is you know a side effect that people are experiencing. Patient just want to know if patient should not take the second dose that is scheduled for today or not, people like online people are saying the second dose made it much worse and people had severe ringing to the point where it affected their hearing and they couldn't sleep and it got along after their second dose, and that's what patient was about to go get today so patient want to know if patient should not take the second dose?". The outcome of the events was unknown. No Treatment in response to events.
Sex: F
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: sustained injury; This is a spontaneous report received from Pfizer sponsored program.  A contactable consumer (patient) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced sustained injury after first dose for unknown reason and seeking to reschedule appointment for second dose of vaccine on 14apr2021due to injury on an unspecified date. 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: Abdominal pain upper, Nausea
Clinical narrative: nausea; pain in her stomach she describes as 'stomach cramps; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On an unspecified date, on the 1st day of 2nd dose, patient experienced nausea and 3 days later had a pain in her stomach she described it as 'stomach cramps, terrible'. Outcome for the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea
Clinical narrative: Joint pain; Her skin felt like it was on fire; Dizziness; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown, Expiry date: unknown) via an unspecified route of administration on 17Apr2021 12:55 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On 18Apr2021, the patient experienced nausea, chills, headache, dizziness, joint pain and her skin felt like it was on fire. Patient would like to know if she should receive the second dose of the Pfizer COVID vaccine. She received the first dose this past Saturday at 12:55 pm and would also like to know if people experienced side effects with the first dose will they experience side effects with the second dose. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Joint pain; Her skin felt like it was on fire; Dizziness; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown, Expiry date: unknown) via an unspecified route of administration on 17Apr2021 12:55 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On 18Apr2021, the patient experienced nausea, chills, headache, dizziness, joint pain and her skin felt like it was on fire. Patient would like to know if she should receive the second dose of the Pfizer COVID vaccine. She received the first dose this past Saturday at 12:55 pm and would also like to know if people experienced side effects with the first dose will they experience side effects with the second dose. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back injury, Pain in extremity, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Lot Number: ER8737) via an unspecified route of administration in Arm Left on 05Apr2021 as single dose for covid-19 immunisation. Medical history included blood cholesterol increased, back pain. The concomitant medication was not reported. On unknown date, The patient experienced my pain went away and so did is his. how did that happen therapeutic response unexpected, wrenched his back , soreness in his arm. Patient went through a screening process earlier. Her husband and she had first dose on 05Apr2021 within 5 min of each other. He didn't get much of a reaction but patient got nauseated, chills, and felt really lowsy for Thursday, Friday, Saturday and Sunday. But, here's the weird thing that happened to both. He threw his back out and was in acute pain, he was on muscle relaxers and all this other stuff. He could hardly move. In July 2017  she had a bad spell, and had a lot of chromic pain. Patient had to have surgery on shoulder, hit my left side pretty hard, stepped in a pothole. It happened around over the weekend. she noticed her husband was moving around a lot better. Not Tylenol or anything. Now his back went completely out the week before we went to get our shot. It's like you waved a wand and they are both pain free.  The outcome of the events soreness in arm and therapeutic response unexpected was unknown and the outcome of the event Back pain was recovered.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from Pfizer-sponsored. A Non-contactable consumer reported that a female patient (Grandmother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 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 very sick and can't make it to second dose appointment.  The outcome of event was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test positive for the virus; test positive for the virus; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date in 2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of the COVID-19 vaccine a couple of weeks ago and tested positive for the virus on an unspecified date in 2021. She was asking what she should do about the second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Seizure
Clinical narrative: multiple seizures; sick; pain in his legs; This is a spontaneous report from a contactable consumer.   A male patient (reporter's husband) of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. The patient received the two shots of the COVID-19 vaccine and has been sick ever since the second dose was administered on an unspecified date. The patient also experienced multiple seizures in the evening on an unspecified date. He has also been suffering from pain in his legs which he did not encounter before the contact with the second dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: had them really being tired; her husband had a headache; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for her husband.  A male patient of unspecified age had received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 13APR2021 as a single dose for COVID-19 immunisation. Past medication included Tylenol. The patient medical history included knee pain. Caller stated she was reading what to expect and she read not to take tylenol before the vaccine and she took tylenol 600 mg before the vaccine for knee pain. Caller stated she is having knee surgery but HCP said to wait until she had the vaccines and wanted to know if she should protected even though she took the tylenol before the vaccine and asked are they doing research on how tylenol affects the vaccine. Caller stated she is overly tired and everything so the vaccine must be protecting her immune system and had to go back to bed after she got up and was up a couple of times during the night and patient had a headache. At the time of reporting, the outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is one of four reports. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced Pain and tenderness at injection site on 12Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: extremely weak; tired; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced extremely weak and tired after vaccine. The outcome of the events was recovered.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433228 Same reporter/ drug, different patients/ events
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: slight fever; chills; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on unknown date at single dose for COVID-19 immunisation. Medical history and Concomitant medication were not reported. It was reported that the patient suffered from slight fever and chills on unknown date. The outcome of the events was recovered on unknown date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433228 Same reporter/ drug, different patients/ events
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Presyncope
Clinical narrative: felt like was going to pass out; very cold; This is a spontaneous report from a contactable consumer. This consumer reported different events under the same suspect product for four patients. This is the fourth of the four reports. A female patient of an unspecified age (reported as 20 something) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first vaccine that day at a mass vaccination event. The reporter learned this one from a friend who was at the same event. The patient became very cold and felt like she was going to pass out. She had to lay down after 10 minutes and EMT's were called, not sure of the end result or any other information except she didn't eat that day. The outcome of the events was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433228 Same reporter/drug; different patients/events
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Diarrhoea
Clinical narrative: Chills; Significant back pain; Sore and swollen arm at injection site; Sore and swollen arm at injection site; Diffuse arthralgias; Explosive diarrhea; Fever of 102; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0153), via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing chronic allergic rhinitis. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955) administered via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunization. The patient previously received fexofenadine hydrochloride (ALLEGRA) 180mg, once daily (QD) and azelastine hydrochloride, fluticasone propionate (DYMISTA) nasal spray at one spray, twice daily (BID) for allergic rhinitis. On early evening of 15Apr2021, the patient experienced fever of 102, chills, significant back pain, sore and swollen arm at injection site, diffuse arthralgias, and explosive diarrhea. The patient took 1000 mg acetaminophen and went to bed. Awoke in the morning of 16Apr2021 as much improved and afebrile. The patient recovered from the event fever on 16Apr2021 and was recovering from other events.  No follow-up attempts are possible; No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; Significant back pain; Sore and swollen arm at injection site; Sore and swollen arm at injection site; Diffuse arthralgias; Explosive diarrhea; Fever of 102; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0153), via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing chronic allergic rhinitis. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955) administered via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunization. The patient previously received fexofenadine hydrochloride (ALLEGRA) 180mg, once daily (QD) and azelastine hydrochloride, fluticasone propionate (DYMISTA) nasal spray at one spray, twice daily (BID) for allergic rhinitis. On early evening of 15Apr2021, the patient experienced fever of 102, chills, significant back pain, sore and swollen arm at injection site, diffuse arthralgias, and explosive diarrhea. The patient took 1000 mg acetaminophen and went to bed. Awoke in the morning of 16Apr2021 as much improved and afebrile. The patient recovered from the event fever on 16Apr2021 and was recovering from other events.  No follow-up attempts are possible; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Poor quality product administered, Product storage error
Clinical narrative: Second dose was invalid; There were storage issues; Second dose was invalid; There were storage issues; Headache; Nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for her boyfriend (Patient) that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunisation. Patient received the first dose on 19Mar2021. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received a notification stating that the second dose was invalid and told that it was a storage issue, that is basically the concern that the second dose was invalid. Also, patient did have side effects from the invalid dose just like kind of typical side effects like headache, nausea and so, I was just wondering if there is a risk of getting like a third dose or if there was some sort of efficacy in the invalid dose. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411228 same reporter, different patient and event
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: now he experienced mild headache and soreness in the arm; now he experienced mild headache and soreness in the arm; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONETCH COVID-19 VACCINE; lot number and expiration ate were not reported), via an unspecified route of administration on 16Apr2021 (yesterday) at single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced mild headache and soreness in the arm now on 17Apr2021. The patient wanted to know that if he could take aspirin for the headache and asked if it's true that if you had the vaccine you should not take ibuprofen, tylenol or aspirin. The patient was provided with the Pfizer medical information team's (PMI's) contact number. The outcome of both the events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Illness, SARS-CoV-2 test positive
Clinical narrative: Tested Positive for COVID-19; I got sick; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 08:30 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient stated that she got her Pfizer shot on 31Mar2021. She got sick (unknown date in 2021) after she got the shot and tested (Covid) positive on 06Apr2021. On 06Apr2021 the patient underwent lab tests and procedures which included chest x-ray: normal, covid-19: positive, sars-cov-2 test: positive. Therapeutic measures were taken as a result of tested positive for covid-19 (covid-19). No treatment received for the event sick. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: a slight fever; chills; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via an unspecified route of administration, on 07Apr2021 (last Wednesday), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunization. Patient reported that a few hours after receiving his 2nd dose of the vaccine, experienced a slight fever and chills on 07Apr2021. Outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Thrombosis
Clinical narrative: Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 19Mar2021 04:15 (at 51 years old, not pregnant), single dose for covid-19 immunisation. Medical history included stroke, high blood pressure, diabetes mellitus, all from an unknown date and unknown if ongoing. The patient's concomitant medications was unspecified (mentioned other medications in two weeks: yes but prescribed). The patient had her first dose of BNT162B2 vaccine on 26Feb2021 04:15 at 51 years old, for COVID-19 immunisation on left arm. The patient experienced large blood Clotting after each dose during menstral cycle. Bled for more than 2 weeks. All on 27Mar2021 12:00. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No treatment for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Constipation, Dry throat
Clinical narrative: Abdominal pain; Tiredness; Joint pain; Muscle ache; Chills; Nauseated; Constipation; Sometimes it feels kind of like stuffy for me to breath; I drink all this water but I do not know where it is going like, I am not passing it like I used to; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 07Apr2021 (Batch/Lot number was not reported) (at age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported.  The patient's concomitant drug included unspecified drug (some pills). It was reported the patient having some side effects (in Apr2021) from the shot that took few weeks ago, the Pfizer shot. Consumer stated, "Abdominal pain in the stomach, tiredness, joint pain, muscle ache, chills and nauseated, this is like I have to deal with it since the shot, just going with it seems like it's getting worse. I drink a lot of water and I was not done with passing my water and then have constipation. The strange thing is I drink all this water but I do not know where it is going like, I am not passing it like I used to and I take fluid pills (Clarification unknown)." When paraphrased the above concern consumer stated, "Yes and sometimes it feels kind of like stuffy for me to breath." Therapeutic measures were taken included Baking soda for nausea. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nasal congestion, Nausea
Clinical narrative: Abdominal pain; Tiredness; Joint pain; Muscle ache; Chills; Nauseated; Constipation; Sometimes it feels kind of like stuffy for me to breath; I drink all this water but I do not know where it is going like, I am not passing it like I used to; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 07Apr2021 (Batch/Lot number was not reported) (at age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported.  The patient's concomitant drug included unspecified drug (some pills). It was reported the patient having some side effects (in Apr2021) from the shot that took few weeks ago, the Pfizer shot. Consumer stated, "Abdominal pain in the stomach, tiredness, joint pain, muscle ache, chills and nauseated, this is like I have to deal with it since the shot, just going with it seems like it's getting worse. I drink a lot of water and I was not done with passing my water and then have constipation. The strange thing is I drink all this water but I do not know where it is going like, I am not passing it like I used to and I take fluid pills (Clarification unknown)." When paraphrased the above concern consumer stated, "Yes and sometimes it feels kind of like stuffy for me to breath." Therapeutic measures were taken included Baking soda for nausea. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: with only mild GI symptoms as a reaction; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient of  received BNT162B2 (Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration Date: Unknown) via an unspecified route of administration on 15APR2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unspecified date the patient experienced only mild GI symptoms as a reaction. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433455 same reporter/drug/event, different patient.;US-PFIZER INC-2021433454 same reporter/drug/event, different patient.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal tract irritation
Clinical narrative: with only mild GI symptoms as a reaction; This is a spontaneous report from a contactable consumer or other non-HCP. A 46-years-old male patient received 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 were not reported. On an unspecified date the patient experienced with only mild GI symptoms as a reaction. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) same reporter/drug/event, different patient.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable Other Health care professional (patient) reported herself. A 54-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was unknown), via an unspecified route of administration on 13Apr2021 09:00 left arm as single dose for covid-19 immunisation. Medical history included covid-19 (prior to the vaccination). Allergies to medications, food, or other products: no. Concomitant medication included melatonin. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID. The patient experienced fever, Chills, headache, Nausea, Diarrhea and Fatigue on 14Apr2021 10:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021. Patient did not receive any treatment for the events. The outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable Other Health care professional (patient) reported herself. A 54-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6207, Expiration date was unknown), via an unspecified route of administration on 13Apr2021 09:00 left arm as single dose for covid-19 immunisation. Medical history included covid-19 (prior to the vaccination). Allergies to medications, food, or other products: no. Concomitant medication included melatonin. Patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID. The patient experienced fever, Chills, headache, Nausea, Diarrhea and Fatigue on 14Apr2021 10:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021. Patient did not receive any treatment for the events. The outcome of the events were not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient received the Pfizer COVID-19 vaccine (both doses) and had just recently tested positive for COVID-19; Patient received the Pfizer COVID-19 vaccine (both doses) and had just recently tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient who is a healthcare worker). A patient of unspecified age and gender received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via unspecified routes of administration, on unspecified dates, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Pfizer COVID-19 vaccine (both doses) and had just recently tested positive for COVID-19 this past weekend (Apr2021). Although the patient was very aware that breakthrough does occur, from what the patient understands, it is still a fairly rare phenomenon. The patient was reaching out to see if there is any way he/she could be of assistance for research purposes to better understand why he/she was a breakthrough. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID-19 based on the known safety profile.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Limb discomfort, Neuropathy peripheral, Pain in extremity, Swelling
Clinical narrative: slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, there was pain; arthritis; it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there; nerve problems; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in left arm on 01Apr2021 11:30 (Batch/Lot number was not reported) at the age of 74 years old as single dose for covid-19 immunisation. Medical history included pain from back and neck surgery she had predating treatment with the vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 11Mar2021 11:30 am in her left arm at the age of 74 years old for covid-19 immunisation and didn't feel anything different. The patient received the second dose on 01Apr2021 at 11:30 am in her left arm. Reported the first dose she didn't feel anything different. This time she didn't feel anything different until this morning. Added her arm was feeling heavy (Apr2021), she thought maybe she needed to exercise it, and she slept on that side mostly. She reported she was having a slight pain in her arm. Mentioned she also had arthritis and nerve problems (Apr2021). Added it was not swollen, but right where she got the vaccine, just a little, there was pain (Apr2021). She was asking should she just exercise it. Added it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there (Apr2021). Added it was young and it had not scattered out yet. She thought the slight pain in her arm started a few days after the second dose of the vaccine, about 05Apr2021, and now it was better than when she first noticed it. Mentioned she was concerned about getting the vaccine because of her other problems but her doctor told her to go ahead and get it. The outcome of the event slight pain in her arm was recovering, of the other events was unknown.  Information about lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, there was pain; arthritis; it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there; nerve problems; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in left arm on 01Apr2021 11:30 (Batch/Lot number was not reported) at the age of 74 years old as single dose for covid-19 immunisation. Medical history included pain from back and neck surgery she had predating treatment with the vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 11Mar2021 11:30 am in her left arm at the age of 74 years old for covid-19 immunisation and didn't feel anything different. The patient received the second dose on 01Apr2021 at 11:30 am in her left arm. Reported the first dose she didn't feel anything different. This time she didn't feel anything different until this morning. Added her arm was feeling heavy (Apr2021), she thought maybe she needed to exercise it, and she slept on that side mostly. She reported she was having a slight pain in her arm. Mentioned she also had arthritis and nerve problems (Apr2021). Added it was not swollen, but right where she got the vaccine, just a little, there was pain (Apr2021). She was asking should she just exercise it. Added it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there (Apr2021). Added it was young and it had not scattered out yet. She thought the slight pain in her arm started a few days after the second dose of the vaccine, about 05Apr2021, and now it was better than when she first noticed it. Mentioned she was concerned about getting the vaccine because of her other problems but her doctor told her to go ahead and get it. The outcome of the event slight pain in her arm was recovering, of the other events was unknown.  Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Methylenetetrahydrofolate reductase gene mutation, Pain in extremity
Clinical narrative: real tired; legs felt heavy and aching; legs felt heavy and aching; I have a MTHFR mutation; This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198 and expiration date not provided), via an unspecified route of administration, in right arm, in Mar2021 15:45  (at the age of 60-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included MDD (major depressive disorder), allergies to IV contrast dye. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included sertraline. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and ketorolac tromethamine (TORADOL), both had allergies. The patient stated the first dose made her real tired, and after 2 weeks her legs felt heavy and aching (but no redness or swelling). Patient had a MTHFR mutation (Methylenetetrahydrofolate reductase gene mutation) so she was scared about clots. After the 2nd shot on 04Apr2021 patient feel better. Patient thought COVID is in our bodies already and the shot just stimulates antibodies which somehow create the clotting. No treatment received for events. No COVID tested post vaccination. The outcome of the events was recovered.   Information on the lot/batch number has been requested.