chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema
Clinical narrative: Pain in left shoulder and upper back muscle; Red circle area at the shot area about the size of a nickel; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 Immunisation. The patient medical history included Osteopenia, Osteoarthritis, Nerve pain in legs and occasional bouts of Trigeminal neuralgia, drug allergy (Ibuprofen), allergy to contrast media, food allergy (spicy food). The patient past drug history included Ibuprofen, Iodinated Contrast. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient concomitant medications were not reported. On 04Mar2021 at 13:15 the patient experienced Pain in left shoulder and upper back muscle and red circle area at the shot area about the size of a nickel. It was reported that pain shoulder had never gone away continues still today 18Mar2021.  Around 08Mar2021 patient noticed a red circle area at the shot area about the size of a nickel.  By 16Mar2021 it was 2X2 and oblong.  Patient took photos of it. By 18Mar2021 it was even larger but the middle of the circle was starting to fade and only the edges were dark pink. The patient was not treated for the adverse events. The clinical outcome of the events pain in left shoulder and upper back muscle and red circle area at the shot area about the size of a nickel was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chronic fatigue syndrome, Headache, Pyrexia, Somnolence
Clinical narrative: fever; chills; head soreness; extreme sleepiness / falling asleep constantly; chronic fatigue syndrome; ache her my arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 11Mar2021 as 1st dose, single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, head soreness, extreme sleepiness / falling asleep constantly, chronic fatigue syndrome and ache her my arm at the injection site. Therapeutic measure was taken as a result of the event ache her my arm at the injection site included TYLENOL. It was reported that the patient was asking if the vaccine can cause a false-positive or false-negative for Cologuard. The patient was also asking if it is okay to take an antibiotic between the 2 doses of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fever; chills; head soreness; extreme sleepiness / falling asleep constantly; chronic fatigue syndrome; ache her my arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 11Mar2021 as 1st dose, single dose for COVID-19 immunisation. Medical history included diabetes from an unknown date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, head soreness, extreme sleepiness / falling asleep constantly, chronic fatigue syndrome and ache her my arm at the injection site. Therapeutic measure was taken as a result of the event ache her my arm at the injection site included TYLENOL. It was reported that the patient was asking if the vaccine can cause a false-positive or false-negative for Cologuard. The patient was also asking if it is okay to take an antibiotic between the 2 doses of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Renal failure, Urinary retention, Urinary tract infection
Clinical narrative: couldn't pee; shut his kidneys down; UTI; got very sick; This is a spontaneous report from a contactable Consumer (patient friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced couldn't pee, shut his kidneys down, UTI and got very sick on an unspecified date. The reported stated that I heard people are getting observed for 15 minute after getting it. A friend of mine got the vaccine and got very sick. It shut his kidneys down and couldn't pee and got an UTI. He is a lot younger than me and on TV news hearing that the vaccine developed by Astra Zeneca reporting cases of 30 different people with blood clots not sure if it's connected to the vaccine and will investigate that. I'm 81 and I'm scared to get it. I do have allergies. I have high blood pressure and beginnings of emphysema. Years ago when I got the flu vaccine (it was a live vaccine) and I got the flu from the vaccine. Now they use dead virus and since then I didn't have a problem. Reporter also stated, Pfizer used to carry a body and hand cream which they discontinued. It is not made anymore and when I asked before they said I could get it on (E-commerce Company) and/or (Pharmacy) both selling old remaining stock if it's not being produced. It was called pacquin plus cream. It was so nice and worked well and smelled nice. It's hard to believe they discontinued it. I don't know why they did. It worked so well. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea 30 minutes following; Sore arm; This is a spontaneous report from a contactable consumer, patient. A 51-year-old non-pregnant female received first dose of BNT16B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), solution for injection, via an unspecified route of administration in the left arm on 18Mar2021at 14:15 (at the age 51-year-old) as single dose for COVID-19 vaccination. Medical history included Autoimmune hepatitis. The patient did not have allergies to any medications, food or other product. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were numerous. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 15:00, the patient experienced diarrhea, sore arm. The patient did not receive any treatment for the adverse events.  The clinical outcome of diarrhea, sore arm was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Body aches; Sore throat; Fever; Headache; Nausea; Cough; chills; Swollen lymph nodes; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via unspecified route of administration in left arm on 10Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Medical history included gastroparesis. The patient was allergic to penicillin, Bactrim and Cipro. Concomitant medications included Estradial (MANUFACTURE UNKNOWN), Topamax (MANUFACTURE UNKNOWN), Imitrex ( MANUFACTURE UNKNOWN) and Wellbutrin (MANUFACTURE UNKNOWN), from an unknown date. On 12Mar2021 at 18:45 patient experienced body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired. The patient did not receive treatment for the reported events. The clinical outcome of the body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body aches; Sore throat; Fever; Headache; Nausea; Cough; chills; Swollen lymph nodes; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via unspecified route of administration in left arm on 10Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Medical history included gastroparesis. The patient was allergic to penicillin, Bactrim and Cipro. Concomitant medications included Estradial (MANUFACTURE UNKNOWN), Topamax (MANUFACTURE UNKNOWN), Imitrex ( MANUFACTURE UNKNOWN) and Wellbutrin (MANUFACTURE UNKNOWN), from an unknown date. On 12Mar2021 at 18:45 patient experienced body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired. The patient did not receive treatment for the reported events. The clinical outcome of the body aches, sore throat, fever, headache, nausea, cough, chills, swollen lymph nodes and feeling tired was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Vaccination site swelling
Clinical narrative: I woke up in severe pain in my left armpit; Swelling and pain in armpit of the arm of injection; I felt a large lump in that armpit; This is a spontaneous report from a contactable consumer or non-health care professional, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route and administrated in the left arm on 12Mar2021 at 17:00 hours (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 14March2021, patient experienced severe pain in her left armpit after woke up, swelling and pain in armpit of the arm of injection, she felt large lump on that armpit it was for 5 days, and then pain was better but the swelling was not gone down. Patient did not receive any treatment for the reported events. On 14March2021, the patient was recovered from the events armpit pain, not recovered from the swelling armpit of the arm of injection, large lump. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea
Clinical narrative: Loss of smell; lost her taste; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in left arm on 15Mar2021 at 10:00 hours as 1st dose, single dose (at the age of 61-year-old) for COVID-19 immunisation. Patient had no medical history (including any illness at time of vaccination). Patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 15Mar2021 at night, patient lost her taste and smell and had diarrhea. Patient stated that diarrhea stopped at night only and got her taste and smell back today (16Mar2021). Patient declined any treatment for the events. Patient did not get any blood work or diagnostic testing done. Patient had no emergency room and physician office visit. Patient asked if a person was supposed to had side effects after receiving the COVID-19 Vaccine and stated she was scheduled for her second COVID-19 vaccine on 05Apr2021. The outcome of diarrhea was recovered on 15Mar2021 and recovered for rest both the events on 16Mar2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: she started to manifest Shingles yesterday afternoon.; This is a spontaneous report from a contactable female consumer via Pfizer-sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Feb2021 as 1st dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient said that she received the 1st dose on 20Feb2021 and scheduled to get the 2nd dose today 15Mar2021. However, she started to manifest Shingles yesterday (14Mar2021) afternoon. She did have the names of the medicines she is taking for Shingles. She is also not sure if she can take the 2nd dose today. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: he and his wife were around people tested positive, for covid; he and his wife were around people tested positive, for covid; This is a spontaneous report from a non-contactable consumer reported similar event for 02 patients. This is 1st of 02 reports.   This non-contactable Consumer reported that a 62-Year-old female patient (Wife) received bnt162b2 (BNT162B2), Batch/Lot number: unknown), dose1 via an unspecified route of administration on 12Mar2021 (at the age of 62-years-old), as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient and his wife were around people tested positive, for covid on unspecified date. The patient stated that His wife (age 62) received 1st dose of the  vaccine 12Mar2021, scheduled 02Apr2021 for second dose, he and his wife were around people tested positive, for covid. Caller states: He received both doses of the Pfizer covid vaccine last month, in February, and his wife is due to get the second dose in April. he enquired if she could go and get the vaccine? Response: Spoke from attached documents CONS - post-vaccination precautions - wearing a mask and social distancing after receiving the vaccine (v5.0). the patient was asked to still take steps to protect himself and others in many situations, like wearing a mask, staying at least 6 feet apart from others, and avoiding crowds and poorly ventilated spaces. Take these precautions whenever they are: In public, gathering with unvaccinated people from more than one other household, visiting with an unvaccinated person who was at increased risk of severe illness or death from COVID-19 or who lives with a person at increased risk. We're still learning how long COVID-19 vaccines can protect people. As we know more, CDC will continue to update our recommendations for both vaccinated and unvaccinated people. CONS-Can they Receive the Vaccine with a Prior or Current COVID-19 Diagnosis (US) (v2.0): These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms, and completed any required isolation. Please be sure to discuss any questions about receiving the vaccine and if you have COVID-19 or develop COVID-19 after receiving the first dose with your vaccination provider, doctor, or other health care professional. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314110 same reporter/product/events, different patient.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes outbreak 4 days after injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: unknown), dose 2 via an unspecified route of administration on 06Apr2021 at 13:30 (at the age of 47-years) and dose 1 via an unspecified route of administration on 16Mar2021 at 10:30 (at the age of 47-years), both as single dose in left arm for COVID-19 immunization. The patient's medical history included Herpes, systemic scleroderma, hypothyroidism and allergic to seafood, mango, other various intolerances (start date and ongoing status was unknown). The patient did not receive any other vaccine in four weeks. The patient received other medications in two weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 20Mar2021 at 16:00, four days after first injection, the patient experienced herpes outbreak. The patient has not had an outbreak in over 5 years. It was unknown if patient received any treatment for herpes and outcome reported as not resolved. On 12Apr2021 at 18:00, six days after second injection, she again had a herpes outbreak and received treatment with Valacyclovir. Since the vaccination the patient had not been tested for COVID-19. The outcome of event was resolving.  No follow-up attempts were Possible. Information on lot/batch could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash on neck. Left side; This is a spontaneous report from a non-contactable consumer (patient). An adult male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6206) via an unspecified route of administration in the left arm on 18Mar2021 at 09:30 as 1st dose, single dose for COVID-19 immunization. The patient did not had any medical history. Concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021, about 5 hours after the shot, the patient experienced red rash (reported as red rush) on the left side of the neck. The patient did not receive any treatment for the event. The clinical outcome of the event red rash on the left side of the neck was unknown.   No follow-up attempts are possible. No further information is expected since reporter is non-contactable.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's initial should be captured separately as first name and last name in general tab.  2. patient's initial added in first name field in patient tab. 3."Relevant medical history-None" was added in other relevant history tab since Relevant medical history and concurrent conditions is provided as No. 4.Treatment Received ticked as No. 5. final sentence should be No follow-up attempts are possible. No further information is expected since reporter is non-contactable. 6.Concomitant therapy leave blank since no information provided about the concomitant drug. 7. adverse_event_start_time: 03:00 AM provided in source document.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable patient. A 49-years old no pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm on 19Feb2021 at 02:00 PM as a single dose for COVID-19 immunisation. Medical history included Dysfibrinogenemia. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received any other medications within 2 weeks of vaccination. The patient experienced sore arm on 19Feb2021 at 09:00 PM. Sore arm got worst on 2nd and 3rd day of vaccination. The patient experienced sore arm for about a week. The patient experienced soreness in arm similar to any other vaccine received as a child. Treatment was not received for event. The clinical outcome of sore arm recovered at time of reporting. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 08Mar2021 as first dose, single for COVID-19 immunisation. Medical history included diabetes from an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced chills and feeling really bad. The patient tested positive for COVID-19 on an unspecified date in Mar2021. The patient underwent lab tests included SARS-CoV-2 test with a positive result on Mar2021. Outcome of the event was not recovered. The reporter would like to know if the patient, her husband, will have to start the COVID-19 vaccination series all over again once no longer in isolation from his current diagnosis of a COVID-19 infection. Also, the reporter would like to know whether she will have to take a COVID-19 test before receiving her second dose of the COVID-19 vaccine since she was in contact with her husband.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable pharmacist.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot number: Unknown), via an unspecified route of administration on 02Mar2021 as 1st dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient subsequently got shingles. Treatment medication included valaciclovir. The clinical outcome of the event was unknown.   No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: covid-like symptoms; Stiff sore arm; Stiff sore arm/ tired sore legs; extreme fatigue; loss of appetite; Feverish; This is a spontaneous report from a contactable consumer or other non hcp.  A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration on 20Mar2021 as unknown, single dose for covid-19 immunization. Medical history included covid-19 and allergies to Latex, shellfish and fruit. The patient's concomitant medications were not reported. On 21Mar2021, the patient experienced Covid-like symptoms, stiff sore arm, stiff sore arm/ tired sore legs, extreme fatigue, loss of appetite and feverish. Events were not treated. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test was unknown. The outcome for all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: covid-like symptoms; Stiff sore arm; Stiff sore arm/ tired sore legs; extreme fatigue; loss of appetite; Feverish; This is a spontaneous report from a contactable consumer or other non hcp.  A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP6955), via an unspecified route of administration on 20Mar2021 as unknown, single dose for covid-19 immunization. Medical history included covid-19 and allergies to Latex, shellfish and fruit. The patient's concomitant medications were not reported. On 21Mar2021, the patient experienced Covid-like symptoms, stiff sore arm, stiff sore arm/ tired sore legs, extreme fatigue, loss of appetite and feverish. Events were not treated. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test was unknown. The outcome for all events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sars-COV-2 positive following receipt of first dose; Sars-COV-2 positive following receipt of first dose; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported Sars-COV-2 positive following receipt of first dose. Patient has administered a second dose a couple of hours ago before reporting this event. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; sick as heck; This is a spontaneous report from a contactable consumer (patient, self-reported). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1686), dose 1 via an unknown route of administration on 25Jan2021 at 11:30 as single dose for covid-19 immunisation. The patient's medical history included COPD (takes 3 inhalers for that), AFib, blood sugar and type 2 diabetes from an unknown date. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) started taking about a year ago, tiotropium bromide (SPIRIVA) started taking about 7 months ago and salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) started taking about 7months ago for chronic obstructive pulmonary disease; apixaban (ELIQUIS) started taking 6 months ago and diltiazem hydrochloride (DILTIAZEM [DILTIAZEM HYDROCHLORIDE]) started taking 6 months ago for atrial fibrillation; metformin started taking 7 years ago for type 2 diabetes mellitus and saxagliptin started taking 7 years ago for blood glucose abnormal. On 27Jan2021, 2 days after the vaccination, the patient had sick as heck. On 29Jan2021, the patient tested positive for COVID-19 and the patient went to ER and had a bad symptom, tested positive. The patient goes to the clinic and once every 3-4 months they change doctors and contacted by the health department and got all his information. Patient had symptoms for 2 days and just kept getting worse so went to the ER. He was not admitted to the hospital. The patient state that about 4-5 days later his wife got COVID-19 and must have got from him he guesses, and he got the shot and there must have been someone in there that had it and he must have got in contact with them but he's not sure how because everyone was wearing masks. Also stated that it just happened, and he was still heavy in the COVID-19 then and he missed the dose. He enquired that he had 1 dose and missed the 2nd dose, the patient had COVID-19 and probably have antibodies, what does he need to do, and does he need to start over or does he need to get the second dose at all. The patient was supposed to take second shot on 15Feb2021. The patient had probably beginning, pretty rough no need for the hospital, but stayed home with medication, some rally offensive antibiotics, that stayed in my system for 15 days. I got better. but it was in the middle of the series. I think maybe I got it in line for the vaccine. All events are non-serious. The patient underwent lab tests and procedures which includedCOVID-19 SARS-Cov-2 test was positive on 29Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: Sore arm; tired; feels a little weak; This is a spontaneous report received from a non-contactable consumer (patient) via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm, tired and he/she felt a little weak. The events took place after the use of the product. 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: Asthenia, Chills, Pyrexia
Clinical narrative: Chills; Lack of energy; Fever; This is a spontaneous report received from contactable health care professional (patient) works in hospital setting via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number not reported), on unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills, lack of energy and fever. It was reported that the events took place after the use of the product. 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got positive after getting the vaccine; got positive after getting the vaccine; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is a 1st (wife's report) of 2 reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient got positive after getting the vaccine. The patient was scheduled for her second dose on 05Apr2021 (more than 21 days). She wanted to know if she can still get the second dose vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test result: positive in Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021328802 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got positive after getting the vaccine; got positive after getting the vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for herself and for her husband. This report for her husband. This consumer reported for a male patient (reporter's husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer mentioned that she and her husband had the first dose of the vaccine on 11Mar2021 and got positive after getting the vaccine. The patient tested positive on an unspecified date in Mar2021. The consumer would like to know if they can still get the second dose of vaccine on 05Apr2021 (more than 21 days). At the time of reporting outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021328790 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I lost my sense of smell and my sense of taste; I lost my sense of smell and my sense of taste; This is a spontaneous report received from a contactable nurse (consumer). A 68-year-old patient (same age at vaccination) female received second dose of bnt162b2 (BNT162B2, Solution for injection, lot: ER2613) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history reported was high blood pressure, osteoporosis , chronic UTI and high cholesterol . Concomitant medications reported was Omeprazole 40 mg (once daily), Losartan as 100 mg once daily, Atenolol as 25 mg one daily, Oxybutynin as 5 mg daily, Rosuvastatin as 10 mg daily, acetylsalicylic acid (ASPIRIN) as 81 mg daily, estradiol (ESTRACE, cream) as 2 times a week, alendronate sodium (ALENDRONATE SODIUM) as 70 mg weekly , vaccinium macrocarpon (CRANBERRY) as once daily, Multivitamin daily and Calcium as 600 mg twice a day. The patient previously took first dose of BNT162B2 (lot number EN6198) on 02Mar2021. Patient reported lost of her sense of smell and my sense of taste. Retired nurse stated she believed that it was caused by the vaccine. Retired Nurse stated Let me get my card right now, you want both doses okay my first dose was lot number EN6198 and the second one the lot number was ER2613. It was reported. Patient was still experiencing the events. No treatment was received by patient in response to the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hyposmia
Clinical narrative: Diminished/loss of sense of smell; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: ER8732), via an unspecified route of administration on 27Mar2021 at 12:15 pm (Age at vaccination: 24 Years), as first dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not experienced COVID prior to vaccination. Caller state that after receiving the first dose of vaccine, on an unspecified date the patient experienced diminished/loss of sense of smell. Patient had not received the treatment for the event. Since the vaccination, patient was not tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site reaction
Clinical narrative: Also tingling comes and goes in arm; I noticed the night of  injection that I had an indention in my arm at shot site.  If any change at all it has becime even more pronounced and deepened.  Also  tingling comes abd goes in arm.; This is a spontaneous report from a contactable other hcp (patient). A 64-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Dec2020 12:30 (Batch/Lot Number: EK5730) as single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination. On 22Dec2020, 18.00, the night of injection, the patient noticed that she had an indention in her arm at shot site. If any change at all it had become even more pronounced and deepened. Also tingling comes and goes in arm. AE resulted in Disability or permanent damage and Doctor or other healthcare professional office/clinic visit. The patient received treatment and had healthcare provider look at. The patient had not tested Covid post vaccination. Outcome of the events was not recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2 ,a temporal association between the events and administration of BNT162B2 cannot be excluded. Due to limited information, a complete medical assessment cannot be made. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Presyncope, Tachycardia, Vaccination site pain
Clinical narrative: Sore arm at injection site; fatigue; Tachycardia; near syncope; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 15Apr2021 12:00 (at the age of 43-year-old) as 1st dose, single for COVID-19 immunisation . The patient's medical history was not reported. Patient was not pregnant. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (IBUPROFEN); both taken for an unspecified indication. The patient experienced sore arm at injection site, fatigue, tachycardia and near syncope on 22Apr2021 12:30. The events required emergency room and physician office visit. Patient received METOPROLOL as treatment for the reported events. Outcome of events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of Vaccination site pain, Fatigue, Tachycardia and Presyncope and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Herpes virus infection, Infection, Infection reactivation, Pain in extremity
Clinical narrative: Herpes infection; Sore arm; General joint pain; The day after he received his first dose of the covid vaccine, he got a herpes re infection; herpes infection flared up again big; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that whenever he received the first dose of the COVID vaccine, he had a herpes infection at the time. The herpes infection was healing up. The day after he received his first dose of the COVID vaccine, he got a herpes re infection. The patient had other COVID vaccine symptoms. He had a sore arm and general joint pain. His herpes infection flared up again big. He asked if that was a documented side effect and if he could take his herpes medication. He also asked if his herpes medication was contraindicated with the COVID vaccine. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine that started about 2 hours after receiving the vaccine; This is a spontaneous report from a non-contactable health care professional. An adult female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 30Mar2021 as an unknown dose number at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had an amoxicillin-only drug allergy and may have other allergies (as reported). The patient had a migraine that started about 2 hours after receiving the vaccine on 30Mar2021. The migraine has persisted for 3.5 weeks.The event resulted in a visit to the emergency room/department or urgent care and to a doctor or other healthcare professional office/clinic visit. The patient received Toradol injection for pain, with Benadryl and Promethazine and a prescription for Sumatriptan. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of migraine  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Herpes zoster, Presyncope
Clinical narrative: Shingles after second dose; Dizziness; confusion; Near syncope; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age of 58-years) as single dose for COVID-19 immunization. Medical history included hyperthyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); levothyroxine sodium (SYNTHROID). The patient was not pregnant at the time of vaccination. Patient previously took sulfur, epinephrine, morphine and experienced known allergies. The patient previously received first dose of BNT162B2 on 12Mar2021 at 14:15 (Lot number: EN6199) in Left leg for COVID-19 immunization and experienced rash on face after first dose; still have the rash and it comes and goes now. Prior to vaccination it was unknown, if the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 13Mar2021 at 11:30, the patient experienced shingles after second dose, dizziness for 2 weeks, confusion, near syncope. The patient had near syncope after 24 hours and 4 days later. Therapeutic measures were taken as a result of events. Patient received treatment with antiviral medication and bed rest. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Shingles after second dose; Dizziness; confusion; Near syncope; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age of 58-years) as single dose for COVID-19 immunization. Medical history included hyperthyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); levothyroxine sodium (SYNTHROID). The patient was not pregnant at the time of vaccination. Patient previously took sulfur, epinephrine, morphine and experienced known allergies. The patient previously received first dose of BNT162B2 on 12Mar2021 at 14:15 (Lot number: EN6199) in Left leg for COVID-19 immunization and experienced rash on face after first dose; still have the rash and it comes and goes now. Prior to vaccination it was unknown, if the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 13Mar2021 at 11:30, the patient experienced shingles after second dose, dizziness for 2 weeks, confusion, near syncope. The patient had near syncope after 24 hours and 4 days later. Therapeutic measures were taken as a result of events. Patient received treatment with antiviral medication and bed rest. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for covid; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program.   A 43-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 17Apr2021, as 1st dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22APR2021, after receiving first dose of COVID vaccine, the patient was positive for COVID. Reporter enquired whether it was fine to received second dose or to change the appointment. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unknown date in Apr2021. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.