chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Pain
Clinical narrative: Body aches; chills; SOB; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 20-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in left arm on 22Jan2021 17:00 (reported as 05:00 PM) at SINGLE DOSE for COVID-19 immunisation. The patient was administered COVID-19 vaccine at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Medical history included endometriosis, interstitial cystitis, depression, anxiety, post-traumatic stress disorder (PTSD), pelvic pain, migraines, and diagnosis of COVID-19 prior to vaccination. Concomitant medications included etonogestrel (NEXPLANON), duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR), pantoprazole, and others (unspecified). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported) on 31Dec2020 at 11:45 AM at the right arm for COVID-19 immunization and patient was 20-year-old at the time of the vaccination. On 22Jan2021 at 20:30 (reported as 08:30 PM), the patient experienced body aches, chills, shortness of breath (SOB), and fatigue. The reporter considered the events as non-serious. There was no treatment received for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events body aches, chills, SOB, and fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Vaccination site pain
Clinical narrative: Supraclavicular and axillary lymphadema; tenderness only in side where shot was given; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 21Jan2021 10:15 for COVID-19 immunization. Age at vaccination: 31-year-old. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications within 2 weeks of vaccination. On 23Jan2021 07:00, the patient experienced supraclavicular and axillary lymphedema; and tenderness only in side where shot was given. No treatment was given for the events. The events were considered non-serious by the reporter. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events at the time of reporting.  Information on the lot/batch number has been requested
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Nausea, Ocular discomfort, Urinary tract infection, Urine analysis
Clinical narrative: extremely nauseated; my eyes kind of crossed; Well after the shot I could barely even walk from the first tent to the second tent; UTI; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reported stated she receive the first dose of the COVID-19 vaccine on Wednesday 20Jan2021 and she had a "strange" reaction on 20Jan2021. Specifically, she states, "as soon as she pushed it in, I became extremely nauseated, my eyes kind of crossed and I had to sit in my car for 4 hours afterwards because I couldn't drive. They had 2 tents set up. Tent 2 was for people who had previous reactions or allergies and tent 1 was for people who had no reactions. Well after the shot I could barely even walk from the first tent to the second tent I stayed there for 45 minutes and then I could barely even walk to my car." Caller wants to know if she should get the second dose of the vaccine. She was started on the antibiotic sulfamethoxazole;trimethoprim (BACTRIM) on 22Jan2021 for a UTI which started after receiving first dose of COVID-19 vaccine in Jan2021. She would like to know if it is okay to use this medication since she just received the vaccine. She reported that she submitted her urinalysis the same day that she received the vaccine on 20Jan2021. The patient underwent lab tests and procedures which included urinalysis: with unknown results on 20Jan2021. Therapeutic measures were taken as a result of UTI. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Insomnia, Pain in extremity, SARS-CoV-2 test, X-ray
Clinical narrative: Sore arm first evening then it went away, it did wake me up that night; Sore arm first evening then it went away, it did wake me up that night; The caller's friend then tested positive for Covid 19 on 24Jan2021./The caller has had a rapid Covid test and xray in the ER and both were neg for Covid 19; This is a spontaneous report from a contactable consumer.  A 78-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 07Jan2021 for COVID-19 immunization. She is due for her 2nd dose 30Jan2021. Medical history and concomitant drugs were unknown.  Following the 1st vaccine dose she had a sore arm first evening then it went away, it did wake her up that night.  In addition she reported that has friend she took to the ER with rectal bleeding on 23Jan2021. and the caller spent the whole day with ''in a couple feet" of her friend. The caller's friend then tested positive for Covid 19 on 24Jan2021.  The caller has had a rapid Covid test and xray in the ER and both were neg for Covid 19. She is wondering if this can effect her getting her 2nd shot. Further the caller is "suppose to take someone in for a hip replacement tomorrow am and then pick up 1-3 days and she was supposed to stay at her house following surgery. She wondered if it is safe to take care of her. The friend  having surgery received her first vaccine shot 07Jan2021.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pain, Pain in extremity
Clinical narrative: a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer.  A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at  08:00 a single dose for covid-19 immunization.  Medical history included breast cancer stage one  from Oct2019.  There were no allergies to medications, food, or other products.  Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN).  The patient experienced the following event on 21Jan2021, at  03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea.  The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a few hours after injection my arm was unusually sore past; my elbow chills that lasted for about 6 hrs; temp of 100.6; body aches; nausea; This is a spontaneous report from a contactable consumer.  A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3302), via an unspecified route of administration in the left arm on 21Jan2021, at  08:00 a single dose for covid-19 immunization.  Medical history included breast cancer stage one  from Oct2019.  There were no allergies to medications, food, or other products.  Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), benazepril (MANUFACTURER UNKNOWN).  The patient experienced the following event on 21Jan2021, at  03:00: a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea.  The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit on 21Jan2021. Details were as follows: a few hours after injection, the patient noted that her arm was unusually sore past elbow chills that lasted for about six hours. Temp of 100.6 body aches nausea. It was reported that treatment was not received for the events; however she used a heating pad to relieve the pain. The events were non-serious. No diagnosis of COVID-19 prior to vaccination was noted. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of events, a few hours after injection my arm was unusually sore past, my elbow chills that lasted for about 6 hrs, temp of 100.6, body aches and nausea was recovered in Jan2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Lip disorder, Rash
Clinical narrative: Sagging left lip; rash under arms; This is a spontaneous report from a contactable other hcp (patient).  A 68-years-old male patient received bnt162b2 (BNT162B2, brand: Pfizer) first dose, via an unspecified route of administration at arm left on 20Jan2021 10:30 AM at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had no allergies to medications, food, or other products. Concomitant medication included atorvastatin, vitamin d3, alpha lipoic acid received within 2 weeks of vaccination.  The patient experienced sagging left lip on an unspecified date with outcome of unknown, rash under arms on an unspecified date with outcome of unknown. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the possible contribution of suspect vaccine BNT162B2 to the event facial droop 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test normal, Cardiovascular evaluation, Chest pain, Fatigue, Injection site pain
Clinical narrative: chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Pulmonary function test normal
Clinical narrative: chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". 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: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for COVID; patient tested positive for COVID; Had the 1st dose of COVID 19 vaccine last 26Dec20 - Due for 2nd dose on 27Jan21; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID and quarantined on an unspecified date. The patient had the 1st dose of COVID 19 vaccine last 26Dec2020, will be due for 2nd dose on 27Jan2021. The patient asked if it is safe to have the 2nd dose of the vaccine. The patient underwent lab tests and procedures which included COVID test: positive on an unspecified date. The outcome of events was unknown.    Information about lot/batch has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Vitreous floaters
Clinical narrative: received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; received the first dose of the vaccine/have pre-existing conditions having floaters and headaches. but there's an increase in frequency.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 67; Unit: Unknown) received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 (on the 07 or 08 of this month) at single dose for covid-19 immunisation.  Medical history included she had pre-existing conditions having floaters and headaches.  The patient's concomitant medications were not reported.  The patient received the first dose of the vaccine on the 07 or 08 of this month. She stated she had pre-existing conditions having floaters and headaches. This could be coincidental, but there was an increase in frequency. She asked if it was ok to get the second vaccine. She asked if there was any information on floater or blindness. She wanted to know if it was okay to take Benadryl. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Haematochezia, Hyperhidrosis
Clinical narrative: Following day, bloody stool-diarrhea.; Nausea wanting to vomit; Nausea wanting to vomit; massive diarrhea; severe fatigue; chills; diaphoresis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3248), via Intramuscular on left arm on 28Dec2020 at 10:00 AM at single dose for COVID-19 immunization. The relevant medical history included hypertension. Concomitant medications included acetaminophen. The patient experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis. Following day, bloody stool-diarrhea. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on bloody stool-diarrhea reported 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Following day, bloody stool-diarrhea.; Nausea wanting to vomit; Nausea wanting to vomit; massive diarrhea; severe fatigue; chills; diaphoresis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3248), via Intramuscular on left arm on 28Dec2020 at 10:00 AM at single dose for COVID-19 immunization. The relevant medical history included hypertension. Concomitant medications included acetaminophen. The patient experienced nausea wanting to vomit, massive diarrhea, severe fatigue, with chills and diaphoresis. Following day, bloody stool-diarrhea. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2  on bloody stool-diarrhea reported 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: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; This is a spontaneous report from a contactable physician via a sales representative. An adult female patient (cardiac nurse) received the 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. The patient received her first COVID vaccine and had tachycardia for several hours immediately following the injection on an unspecified date. Patient planned to get second injection. Outcome of event was unknown.   No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haematoma
Clinical narrative: his left arm entire bicep there's giant hematoma, a bruised yellowish green blue; his left arm entire bicep there's giant hematoma, a bruised yellowish green blue; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for himself. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient said that in his left arm entire bicep there's giant hematoma, a bruised yellowish green blue in Jan2021. It was around 2 inches wide by 5 inches long and didn't know if it was from the COVID-19 Vaccine since he didn't do anything last week after taking the vaccine. The outcome of events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Pain
Clinical narrative: had little bit sore; This is a spontaneous report from a contactable female consumer via Pfizer-sponsored program. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on unknown date at single dose for covid-19 immunisation. Medical history included high level of potassium. Concomitant medication was not provided. The patient stated that she received her first dose of the Covid-19 vaccine last Tuesday and had little sore and had no other reactions. The patient inquired what ingredients were in the injection as she was concern if there was potassium content in the vaccine. The outcome of event "had little sore" was unknown.  The lot number/expiration date for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Chills, Headache, Nausea
Clinical narrative: tested positive for Covid19; tested positive for Covid19; chills; nausea; headache; Loss of smell; This is a spontaneous report from a Pfizer Sponsored Program Pfizer. A contactable female consumer of an unspecified age reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid-19 on unspecified date, chills, nausea, headache, loss of smell on 13Jan2021 with outcome of unknown. Patient second dose of Covid will be on 02Feb2021.   Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid19; tested positive for Covid19; chills; nausea; headache; Loss of smell; This is a spontaneous report from a Pfizer Sponsored Program Pfizer. A contactable female consumer of an unspecified age reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for covid-19 on unspecified date, chills, nausea, headache, loss of smell on 13Jan2021 with outcome of unknown. Patient second dose of Covid will be on 02Feb2021.   Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the patient, reported a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), first dose, via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a headache. The clinical outcome of the headache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, Hypersensitivity, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive (swab test); COVID-19 virus test positive (swab test); bad allergies; feeling not so good; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15Jan2021/16Jan2021 the patient started feeling not so good, she had bad allergies. She went to an urgent care and they did a COVID-19 virus test (swab test) and she tested positive.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive (swab test); COVID-19 virus test positive (swab test); bad allergies; feeling not so good; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15Jan2021/16Jan2021 the patient started feeling not so good, she had bad allergies. She went to an urgent care and they did a COVID-19 virus test (swab test) and she tested positive.  The information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, Hypersensitivity, SARS-CoV-2 test positive
Clinical narrative: she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jan2021 at single dose for Covid-19 immunization. Medical history included high blood pressure, acid reflux, allergy. Concomitant medication included lisinopril for high blood pressure, oxymetazoline hydrochloride (CLARITIN ALLERGIC) for allergy, cetirizine hydrochloride (ZYRTEC ALLERGY) for allergy, omeprazole magnesium (PRILOSEC) (reported as it's like Prilosec) for acid reflux. Patient received the first vaccination on the 15Jan2021 and she did not have any symptoms until Tuesday (19Jan2021), she started feeling kind of bad, she was very prone to allergies, she just thought it was back, this was her season to get sick if she had to get allergies, this was when it happened like January early February, so she went to Urgent care and she wanted a cortisone shot and she didn't think she should get a cortisone shot because it would effect the effectiveness of vaccine, so they said no and they would like to swab her nose to rule out that she didn't have COVID, and he did and it came out positive, so she wanted to get our opinion that if we thought it was a true positive or false positive. She thought she couldn't get COVID after she got the part of vaccine, and the second question she had was her second dose would be on 05Feb2021 by that she would be out of quarantine so should she plan and take the second one. Patient guess the lot number was EL0142. Th outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test positive
Clinical narrative: she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; she did not have any symptoms until Tuesday (19Jan2021)/swab her nose/it came out positive; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Jan2021 at single dose for Covid-19 immunization. Medical history included high blood pressure, acid reflux, allergy. Concomitant medication included lisinopril for high blood pressure, oxymetazoline hydrochloride (CLARITIN ALLERGIC) for allergy, cetirizine hydrochloride (ZYRTEC ALLERGY) for allergy, omeprazole magnesium (PRILOSEC) (reported as it's like Prilosec) for acid reflux. Patient received the first vaccination on the 15Jan2021 and she did not have any symptoms until Tuesday (19Jan2021), she started feeling kind of bad, she was very prone to allergies, she just thought it was back, this was her season to get sick if she had to get allergies, this was when it happened like January early February, so she went to Urgent care and she wanted a cortisone shot and she didn't think she should get a cortisone shot because it would effect the effectiveness of vaccine, so they said no and they would like to swab her nose to rule out that she didn't have COVID, and he did and it came out positive, so she wanted to get our opinion that if we thought it was a true positive or false positive. She thought she couldn't get COVID after she got the part of vaccine, and the second question she had was her second dose would be on 05Feb2021 by that she would be out of quarantine so should she plan and take the second one. Patient guess the lot number was EL0142. Th outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: running fever; tiredness, and fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced running fever, tiredness, and fatigue after taking the vaccine on 19Jan2021. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: sore throat; body aches; This is a spontaneous report from a contactable nurse received from a Pfizer-sponsored program.  A female patient of an unspecified age received 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 medical history and concomitant medications were not reported.  The patient experienced a sore throat and body aches. The patient outcome of the events was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives from neck to bottom of feet/ Hives or nettle rash, also urticaria from the neck to the foot; This is a spontaneous report from a contactable Other health care professional (HCP) (patient). A female patient not pregnant of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on unknown date as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. Patient stated that four days after first dose had hives from neck to bottom of feet. Resolved after diphenhydramine hydrochloride (BENADRYL) 100 mg per day for 3 days. It was also reported hives or nettle rash, also urticaria from the neck to the foot, patient wanted to know whether she could take the second dose. Patient recovered from the event on unknown date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: small joint pain; This is a spontaneous report from a contactable consumer reporting for a patient. A 42-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 31Dec2020 at SINGLE DOSE for covid-19 immunisation.  Medical history included was reported as none. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was reported that patient experienced small joint pain on 31Dec2020. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Intercepted medication error, Malaise
Clinical narrative: had her first dose this morning/She received a notification that her second dose was today as well at 4 p.m.. She mentioned that her last name was misspelled/wanted to reschedule the second dose; She doesn't feel good; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had her first dose this morning (21Jan2021). She received a notification that her second dose was today as well at 4 p.m.. She mentioned that her last name was misspelled. She wanted to reschedule the second dose. She asked if she could take a second dose at a later time. She said she didn't have time and she didn't feel good. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: experienced running fever; tired; chills; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 20Jan2021 as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. On unknown date in Jan2021 patient experienced running fever, tired and chills and wanted to know if she could take paracetamol (TYLENOL). Outcome of the events was unknown.  Information on lot number/batch number was requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: developed Covid symptoms/diagnosed positive in Covid19; developed Covid symptoms/diagnosed positive in Covid19; This is a spontaneous report from a contactable nurse (patient's wife). This nurse reported same event for two patients, this is the second of two reports.   A 70-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in arm (reported as deltoid) on 02Jan2021 at single dose for COVID. Medical history included hypertension and bad cholesterol. Concomitant medication included levothyroxine (low dose of it), amlodipine besilate (EMADINE) for hypertension, losartan for hypertension, levothyroxine sodium (SYNTHROID) for bad cholesterol, lovastatin (LOVASTIN) for bad cholesterol. The patient got his first dose on 02Jan2021, and on 08Jan2021 developed Covid symptoms. On 11Jan2021, he tested positive for Covid19/diagnosed positive in Covid19. The reporter nurse think they were exposed sometime at that pharmacy, she mean there was a lot of people in the line. Tomorrow (unspecified) was supposed to be second dose and his family physician didn't know if he should get that second dose. The outcome of events was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-2021061825 Same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt a lot of aching; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. Patient received the first vaccine at 1oclock and did not feel anything, however after an hour she felt a lot of aching and wanted to know if she could take paracetamol (TYLENOL). Patient was experiencing some reactions that they think were normal after taking the vaccine. They just wanted to know if she could take TYLENOL after taking the vaccine. Outcome of the event was unknown.  Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle twitching, Vaccination site mass, Vaccination site swelling
Clinical narrative: Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers  will not help; Continues eye twitching; Exteremly tired; This is a spontaneous report from a non-contactable nurse (patient).    This female patient of an unspecified age received the 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 medical history and concomitant medications were not reported.   On unknown date, the patient experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, and extremely tired. The outcome of the events was unknown.  No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers  will not help; Continues eye twitching; Exteremly tired; This is a spontaneous report from a non-contactable nurse (patient).    This female patient of an unspecified age received the 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 medical history and concomitant medications were not reported.   On unknown date, the patient experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, and extremely tired. The outcome of the events was unknown.  No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Muscle twitching, Pain
Clinical narrative: Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers  will not help; Continues eye twitching; Exteremly tired; 102.5 Fever that doesn't want to come down; Body Aches; This is a spontaneous report from a non-contactable nurse (patient).   This female patient of an unspecified age received second 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 medical history and concomitant medications were not reported. The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired. After second shot, on an unspecified date the patient also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired, 102.5 fever that doesn't want to come down and body aches. 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: Pyrexia, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers  will not help; Continues eye twitching; Exteremly tired; 102.5 Fever that doesn't want to come down; Body Aches; This is a spontaneous report from a non-contactable nurse (patient).   This female patient of an unspecified age received second 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 medical history and concomitant medications were not reported. The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired. After second shot, on an unspecified date the patient also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired, 102.5 fever that doesn't want to come down and body aches. 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: Blepharospasm, Fatigue, Headache, Injection site induration, Injection site swelling
Clinical narrative: was not able to get out of bed or have lights on; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbearable Headache; Continues eye twitching; Extremely tired; had a hard time walk due to the body aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received first dose 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 medical history and concomitant medications were not reported.  The patient experienced Knot, Swollen and heat at the injection site, unbearable Headache that pain relievers would not help, Continues eye twitching, Extremely tired, and was not able to get out of bed or have lights on. She had a hard time walk due to the body aches. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mobility decreased cannot be excluded.  The case will be reassessed if additional information becomes available.  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.