chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia, Suspected COVID-19
Clinical narrative: feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: sick; tested positive for Covid after first dose of vaccine; This is a spontaneous report from a contactable Nurse. This 49-year-old female nurse reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685) on 21Dec2020 at left arm for Covid vaccine. Medical history included hypertension diagnosed 20 years ago and asthma diagnosed all her life. Concomitant products were not provided. She was scheduled to get the second dose but she tested positive for COVID on 28Dec2020. She got sick with the first dose so she was scared about getting the second dose.  She was still positive for Covid as of 21Jan2021 and still symptomatic with a cough, no smell or taste. She did not know when she can get the second vaccine. The outcome of Covid was not resolved, of other event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: my fever has been worst than it's been; This is a spontaneous report from a contactable consumer reported for himself. This 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient received the first dose of the Pfizer vaccine. He wanted to know when he would have normalcy. He stated it had been going on for 9 days and it's not getting better. Today had been worse, his fever had been worst than it's been. When he showed up for his second dose because he had a high fever the night before, they pushed it back, 7 days from when he was supposed to receive the 2nd shot. It (fever) didn't start until his 3rd week. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Vaccination site pain
Clinical narrative: Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 31Jan2021 at 08:43 (at the age of 47-years-old) at single dose for COVID-19 vaccination. Medical history included seafood allergy (also happens when she gets seafood from, company name, it makes her lips puffy). Concomitant medications were not reported. The patient stated everything was fine except for some injection site soreness on 31Jan2021 that lasted about two hours then completely resolved. On 01Feb2021, the patient stated this morning her upper lip is a little swollen (puffy). The puffiness as if a 2 year were to head butt you and it left your lip puffy. The patient stated last night for dinner she ate ham which was a different brand than usual and was wondering if it may have had some preservatives in it that could have caused the lip swelling and did not have any lip swelling before she went to bed at 10 pm last night. The outcome of the event lip swelling was unknown. The outcome of the event injection site soreness was recovered on 31Jan2021 after 2 hours.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: neurological adverse event; This is a spontaneous report from a non-contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 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. It was reported that the patient got the COVID vaccine on an unspecified date and had neurological adverse event to it on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; pains in knee and muscle above knee; pains in knee and muscle above knee; Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EN5318 expiration date: 31Jan2021, via an unspecified route of administration on 31Jan2021 12:20 at a single dose in the right arm for COVID-19 immunization. The patient had no family medical history and no concomitant medications. The patient had her first dose yesterday (31Jan2021), and she had some reactions to it last night 31Jan2021, had fever, headache and pains in knee and muscle above knee. She knows some of the side effect was normal. She was wondering more so, when is it ok to take a pain reliever for it, like aspirin or Ibuprofen. She went online and it said not to take anything, so she did not. She imagined her fever went away sometime during the night, she took it (unspecified) twice last night. This morning when she woke up, she had the headache, and it's gone now. Her pain in the knee started 4 hours after the injection, it was still sore but much better. The events did not require a visit to the emergency room. The patient had no prior vaccinations within four weeks. The outcome of the event fever was recovered on 31Jan2021, headache recovered on 01Feb2021 and for events pains in knee and muscle above knee was recovering.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Influenza like illness, Musculoskeletal chest pain, Neck pain, Vaccination site erythema
Clinical narrative: felt like she had the flu; muscle to her left arm is sore; stated that left arm below the shot is red with splatters going down to elbow; neck was hurting left side radiating to shoulders; stated when she takes breath in hurts under arms down to ribs on left side; she has arthritis and stated both knees hurt and stiff; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9261) solution for injection, via an unspecified route of administration in left arm on 29Jan2021 at a single dose for Covid-19 immunization. Medical history included arthritis. Concomitant medications included paracetamol (TYLENOL) and other medications. The patient reported she had the second shot on 29Jan2021 and the muscle to her left arm was sore on 30Jan2021(for clarification). On 30Jan2021, she felt like she had the flu, stated that her left arm below the shot was red with splatters going down to elbow, neck was hurting left side radiating to shoulders and stated when she takes breath in it hurts under arms down to ribs on left side. She also mentioned she has arthritis and stated both knees hurt and stiff on 30Jan2021. Treatment: patient stated that she rubbed her knees with Bengay on Saturday. Patient stated that all these are for second shot. She did not have any problems with the first shot which she had on 07Jan2021. She stated that she will let her doctor know when she sees him. Outcome of the event felt like she had the flu was recovered on 31Jan2021; she has arthritis and stated both knees hurt and stiff was recovered on 30Jan2021; left arm below the shot is red with splatters going down to elbow was recovering; while the rest of the events was not recovered.  No follow-up activities are needed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt like she had the flu; muscle to her left arm is sore; stated that left arm below the shot is red with splatters going down to elbow; neck was hurting left side radiating to shoulders; stated when she takes breath in hurts under arms down to ribs on left side; she has arthritis and stated both knees hurt and stiff; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9261) solution for injection, via an unspecified route of administration in left arm on 29Jan2021 at a single dose for Covid-19 immunization. Medical history included arthritis. Concomitant medications included paracetamol (TYLENOL) and other medications. The patient reported she had the second shot on 29Jan2021 and the muscle to her left arm was sore on 30Jan2021(for clarification). On 30Jan2021, she felt like she had the flu, stated that her left arm below the shot was red with splatters going down to elbow, neck was hurting left side radiating to shoulders and stated when she takes breath in it hurts under arms down to ribs on left side. She also mentioned she has arthritis and stated both knees hurt and stiff on 30Jan2021. Treatment: patient stated that she rubbed her knees with Bengay on Saturday. Patient stated that all these are for second shot. She did not have any problems with the first shot which she had on 07Jan2021. She stated that she will let her doctor know when she sees him. Outcome of the event felt like she had the flu was recovered on 31Jan2021; she has arthritis and stated both knees hurt and stiff was recovered on 30Jan2021; left arm below the shot is red with splatters going down to elbow was recovering; while the rest of the events was not recovered.  No follow-up activities are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Hot flush, Pain in extremity
Clinical narrative: She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility.   Information regarding batch/lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: She is having a hot flash; she gets warm; left arm started hurting really bad, it was throbbing; Headache; Tiredness; Sleepy like/She had the sleepiness last night; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), on the left arm, intramuscularly, on 30Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. No vaccine administered on the same day as BNT162B2 and no other vaccines administered within 4 weeks prior to administration. On 30Jan2021, it was reported that after the patient got the shot she felt the tiredness, sleepy-like. She had the sleepiness last night, she slept really good. The patient added that she had the first dose and she was fine. Then at night on 31Jan2021 around 1am or 130am her left arm started hurting really bad, it was throbbing. She could not put her hand over her arm, it was so painful. She called her work and was told to put ice on it and take ibuprofen. Patient also experienced headache on 31Jan2021 and took Tylenol which took away the headache, however, the patient reports headache at the time of reporting. Patient reports that on an unspecified date, she is having a hot flash, states she gets warm and then it goes away. The patient did not visit an emergency room but will see her doctor to report what is going on with her. Patient reports she is not going to take the second dose. She took off work Sunday since it was so bad and could not work like that. She is asking what happens if she does not take the second dose and how long does it take for the first dose to wear off. The outcome of the events tiredness and sleepy-like was unknown, for the event headache was not recovered, for the event left arm started hurting really bad, it was throbbing was recovering, while for the events having a hot flash, states she gets warm was recovered. The patient was vaccinated at an assisted living facility for 65+ and not in a military facility.   Information regarding batch/lot number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Extreme tiredness; nausea; feeling like I was run over by a truck; chills; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received first dose BNT162B2 (Solution for injection, Lot number: EL9264) via an unspecified route of administration on 31Jan2021 16:00 at single dose in right arm for covid-19 immunisation. Medical history included breast cancer and hodgkin Lymphoma. Concomitant medication included simvastatin, vitamin d nos. The patient had extreme tiredness, nausea, feeling like I was run over by a truck, chills, headache, weakness on 01Feb2021 at 13:00 pm. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. The outcome of the events was recovering.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: vertigo; light headedness; nausea; This is a spontaneous report received from a contactable other health professional (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on left arm on 19Jan2021 12:15 at single dose for COVID-19 immunisation at hospital. Medical history included depression and anxiety. The patient had no allergies to medications, food, or other products. Concomitant medication included trazodone at 100 mg and sertraline at 150 mg; both are received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, two weeks after vaccine (on 01Feb2021 22:00) the patient had onset of vertigo, light headedness, and nausea. Patient still experiencing vertigo 12 hours later. Did not imbibe alcohol or substances. Did not do strenuous activity. The adverse events result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 27Jan2021 at a  single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very tiny soreness in the arm in Jan2021 and its already gone. The patient recovered from the event in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Sinus disorder
Clinical narrative: arm is a little sore; headache; sinus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot and expiry were not reported), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her 1st dose last Friday and no reactions but arm was a little sore. The patient asked if she could take over the counter drug for headache and sinus. The patient said that it was normal for her to experience these. The patient also asked if she could take some over the counter drugs and how many days not to take any over the counter drug. The patient further asked if she could take acetylsalicylic acid (ASPIRIN) or pseudoephedrine hydrochloride (SUDAFED) for her normal headache and sinus. The patient said that it was not the side effect from the Covid-19 Vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported headache, sinus, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive 5 days after his first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 17Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, 5 days after his first dose, the patient tested positive (SARS-CoV-2 PCR test positive). The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: just a shoulder pain; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (31Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history included back pain. The patient's concomitant medication included tramadol for back pain and unspecified Blood thinner.   It was reported that patient already took the vaccine and was taking Blood thinner and tramadol for his back pain, wanted to know if that was okay. The patient wanted to know if the vaccine was contraindicated to be administered with people taking blood thinners and tramadol. The patient stated that he had no other side effects but just a shoulder pain around the injection site. The said it was normal for him and will go away with time. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pyrexia, Suspected COVID-19
Clinical narrative: All of the other symptoms that I had when I had COVID returned for about four days; All of the other symptoms that I had when I had COVID returned for about four days; I had a high fever; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 31Jan2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiry date was not reported), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included COVID and a COVID infection which the patient recovered maybe for two weeks when she received the first dose of the vaccine. The patient's concomitant medications were not reported. The patient mentioned that she had fever for four days after receiving  vaccine, and had covid and received 1st dose of vaccine only a few weeks later, wanted to know if she should receive the 2nd dose of the vaccine. The patient received first dose of the vaccine and mentioned that she was reluctant to receive the second dose based on the reaction that she had. She mentioned that she had recovered from COVID and a COVID infection. She recovered maybe for two weeks when she received the first dose of the vaccine. She mean, then she had a high fever, all of the other symptoms that she had when she had COVID returned for about four days. The high fever was what concerned her because it wasn't that high when she was ill. So, she wasn't sure whether it was advisable to get the second dose and if she should, she queried, how long should she wait before she get it. The onset dates for the events was unknown. The outcome of "All of the other symptoms that I had when I had COVID returned for about four days" and 'I had a high fever' was recovered on an unknown date (duration of 4 days).; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills
Clinical narrative: he started feeling weak and chills; he started feeling weak and chills; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration on 30Jan2021 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband got his first COVID-19 vaccine yesterday and now, 31Jan2021, he started feeling weak and chills. Outcome of the events was unknown.    Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rashes after the 1st vaccine; This is a spontaneous report from a non-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) solution for injection, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced skin rashes after the first dose of the vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: swollen tongue after the 1st vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that 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 an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swollen tongue after the 1st vaccine. The outcome of the 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
Clinical narrative: After receiving her 1st dose of vaccine she got Covid virus; After receiving her 1st dose of vaccine she got Covid virus; This is a spontaneous report from a Pfizer sponsored program from a contactable female consumer (patient). er First  A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving 1st dose of vaccine, the patient got Covid virus now, she wanted to know if she still needed to take the 2nd dose of vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: wife tested positive; wife tested positive; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter and his wife received the first dose 3 weeks ago (Jan2021) and the 2nd dose is scheduled tomorrow, 01Feb2021. He said they were 3 in the house and there was an adult handicapped child living with them. His wife and child both took the swab test last weekend (Jan2021). His child tested negative, but his wife tested positive. He was asking if his wife tested positive after the 1st dose and if they can continue the 2nd dose tomorrow. Outcome of the events was unknown.   Information on about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: experienced chills after the 2nd shot; This is a spontaneous report from a contactable consumer.  A female patient (wife) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient experienced chills (Jan2021) after the 2nd shot yesterday on 30Jan2021. The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Malaise
Clinical narrative: Headache; she really isn't feeling well; BP has been going up; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the 2nd dose on 28Jan2021 and woke up with a headache since and BP has been going up on an unspecified date in 2021. They tried transferring the patient, but the patient reported she really wasn't feeling well and didn't want to wait long so they tried disconnecting due to long hold times and transfer the patient but accidently disconnected on the patient. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the site of injection for 2 days duration; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. After receiving second vaccination, the patient experienced pain at the site of injection for 2 days duration. No other symptoms. Event took place after use of product. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Insomnia
Clinical narrative: she reports chills; feeling achy all over; cannot sleep; exhausted; slight temperature to 99.9; splotchy rash on her trunk; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date. On an unspecified date, reported as after the second dose, the patient experienced chills, feeling achy all over, cannot sleep, exhausted, slight temperature to 99.9, and splotchy rash on her trunk. Outcome of the events was unknown.  No follow-up attempts are possible, information about the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: she reports chills; feeling achy all over; cannot sleep; exhausted; slight temperature to 99.9; splotchy rash on her trunk; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date. On an unspecified date, reported as after the second dose, the patient experienced chills, feeling achy all over, cannot sleep, exhausted, slight temperature to 99.9, and splotchy rash on her trunk. Outcome of the events was unknown.  No follow-up attempts are possible, information about the lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: pain in the arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient (approximately 170 pounds, 5'11) received bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration in arm on 28Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced pain in the arm where he received the injection. The outcome of event was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I have been diagnosed COVID Positive as of 29Jan2021; I have been diagnosed COVID Positive as of 29Jan2021; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose and the first dose, via an unspecified route of administration on an unspecified date at single dose for vaccination for COVID-19. The patient medical history and medications were not reported. It was reported that the patient was a Registered Nurse in the state of (state name withheld) and had received both doses of the Pfizer vaccination for COVID-19. The patient received second dose was 3 weeks before 01Feb2021 (in Jan2021) and the patient had been diagnosed COVID Positive as of 29Jan2021. The patient was not sure if we are keeping this type of data or not, but she/he believe it is useful for her/him to reach out and make this known. The patient had no fear that she/he would contract the virus after receiving his/her vaccination but she/he find herself/himself to be a part of the 5%. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: On Friday, the patient showed symptoms of Covid. (name) felt exposure from a student; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. This consumer reported similar events for two patients. This is 1st of two reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The concomitant medications were not reported. The patient was vaccinated with Pfizer Covid 19 vaccine on Tuesday 26Jan2021 and had no reaction. On Friday 29Jan2021, the patient showed symptoms of Covid. "(name)" felt exposure from a student. On Saturday night 30Jan2021, patient was administered with immunotherapy due to their comorbid medical conditions. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112464 same reporter, event/different patient
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Suspected COVID-19
Clinical narrative: patient showed symptoms of Covid/ felt exposure from a student; patient showed symptoms of Covid/ felt exposure from a student; This is a spontaneous report from a non-contactable consumer via a sales representative. This consumer reported similar events for two patients. This is the second of two reports.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date, via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history were unspecified. The patient's concomitant medications was not reported. The patient was vaccinated on Tuesday 26Jan2021 with no reaction. On Friday (29Jan2021), the patient showed symptoms of Covid. Patient felt exposure from a student. On Saturday night, the patient was administered with immunotherapy due to comorbid medical conditions. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112463 same reporter, product, events, different patients
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: flu-like symptom; aches; chills; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received 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 medical history and concomitant medications were not reported. The patient reported that he felt like he had flu-like symptoms, aches and chills on an unspecified date (Event took place after use of product). The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced arm pain with first injection. The outcome of the event is unknown  No follow-up attempts are possible;Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Arm pain; Fatigue; Body aches; This is a spontaneous report from a contactable physician (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration second dose on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization first dose from unknown date and experienced arm pain. It was reported that patient experienced on second dose of injection of arm pain. Additionally, the patient experienced body aches and fatigue but able to work with Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Paranasal sinus discomfort, Respiratory symptom
Clinical narrative: little bit of upper respiratory symptoms; feel like I've been hit by a truck; headache; sinus pressure; vomiting; fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history of patient's body attacking itself during immune responses.The patient's concomitant medications were not reported. On an unspecified date, the patient experienced a little bit of upper respiratory symptoms yesterday. She felt like she had been hit by a truck, had headache, sinus pressure, vomiting and fatigue. The outcome of the event was unknown.  Information on the batch/lot number has been requested.