chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pyrexia, Tension, Tremor
Clinical narrative: fever; chills/severe shivering; hot sweats, cold sweats; hot sweats, cold sweats; severe nausea; body tense from head to toes; extreme headache near back; waves of shaking that started at head and slowly went down my body; couldnt focus on anything; just felt absolutely terrible; This is a spontaneous report from a contactable consumer. This 50-Year-Old female consumer (patient) reported for herself.  A 50-years-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0191, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 26May2021 at 17:00 (50-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included had foot/ankle surgery from 21May2021 (thus the pain meds). Concomitant medication(s) included norethindrone [norethisterone] (NORETHINDRONE [NORETHISTERONE]) taken for an unspecified indication, ketorolac (KETOROLAC) taken for an unspecified indication and acetaminophen; hydrocodone (ACETAMINOPHEN; HYDROCODONE) taken for an unspecified indication. The patient had no known allergies. Patient did not receive other vaccine in four weeks. Patient has no covid prior vaccination, not tested covid post vaccination. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0173, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 05May2021 at 18:00 (50-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. On 26May2021 at 23:00, 06 hrs after vaccination, the patient experienced fever, chills/severe shivering, hot and cold sweats, severe nausea, body tense from head to toes, extreme headache near back, waves of shaking that started at head and slowly went down my body, couldn't focus on anything and just felt absolutely terrible. It was reported that patient experienced fever, chills, hot sweats, cold sweats, severe shivering for hours on end, severe nausea, body tense from head to toes, extreme headache near back of head, waves of shaking that started at head and slowly went down my body, couldnt focus on anything and just felt absolutely terrible. Patient did not receive any treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Computerised tomogram thorax, Dyspnoea
Clinical narrative: Stronger dyspnea/have difficulties to deep breath; chest pain/discomfort; chest pain/discomfort; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:00 as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 60 Years). Medical history and concomitant medications were not reported. No known allergies and other medical history. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 60 Years) and it was reported that strong dysnea for 3 days after 1st dose starting first night, disappeared. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Then the patient experienced on 05Mar2021 stronger dysnea & chest pain/discomfort after 2/3 hours of 2nd application and never left (slowly improving, but never left). It was reported, can perform sports and regular activities, however, have difficulties to deep breath (at times patient can't deep breath) and chest discomfort yet today. Doctors diagnosed by discard emotional stress. They ruled out and did not further investigated for myocarditis and heart issues. Would like her case to be reviewed by Pfizer as the coincidence with the shots are too direct. The patient underwent lab tests and procedures which included blood test: ok in 2021, Contrast chest CT scan (computerized tomogram thorax): negative in 2021, electrocardiogram: negative in 2021, oxygen saturation: ok % in 2021, Covid 19 rapid diagnostic test (sars-cov-2 test): negative on 13Apr2021 Nasal Swab, spirometry: normal in 2021, x-ray: negative in 2021. The patient did not receive any treatments. The patient visited Urgent Care, Primary doctors, Pulmonologist. The clinical outcome of the events was recovering and chest discomfort was not recovered.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Oxygen saturation, SARS-CoV-2 test, Spirometry, X-ray
Clinical narrative: Stronger dyspnea/have difficulties to deep breath; chest pain/discomfort; chest pain/discomfort; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 16:00 as DOSE 2, SINGLE for covid-19 immunisation (Age at vaccination 60 Years). Medical history and concomitant medications were not reported. No known allergies and other medical history. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 17:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 60 Years) and it was reported that strong dysnea for 3 days after 1st dose starting first night, disappeared. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Then the patient experienced on 05Mar2021 stronger dysnea & chest pain/discomfort after 2/3 hours of 2nd application and never left (slowly improving, but never left). It was reported, can perform sports and regular activities, however, have difficulties to deep breath (at times patient can't deep breath) and chest discomfort yet today. Doctors diagnosed by discard emotional stress. They ruled out and did not further investigated for myocarditis and heart issues. Would like her case to be reviewed by Pfizer as the coincidence with the shots are too direct. The patient underwent lab tests and procedures which included blood test: ok in 2021, Contrast chest CT scan (computerized tomogram thorax): negative in 2021, electrocardiogram: negative in 2021, oxygen saturation: ok % in 2021, Covid 19 rapid diagnostic test (sars-cov-2 test): negative on 13Apr2021 Nasal Swab, spirometry: normal in 2021, x-ray: negative in 2021. The patient did not receive any treatments. The patient visited Urgent Care, Primary doctors, Pulmonologist. The clinical outcome of the events was recovering and chest discomfort was not recovered.  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Body temperature, Burning sensation
Clinical narrative: A few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it.; Stomach pain; Back pain; Most joints in extreme pain; most muscles in extreme pain; extreme migraine, (could not brush hair on head due to causing extreme migraine pain); shortness of breath; fever; chills; chest pain; Urinated with extreme Frequency; unable to move left arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736), dose 2 via an unspecified route of administration, administered in the left arm on 28May2021 17:30 (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The facility in which the vaccination was administered was other. Medical history included asthma only from pollen, deathly allergic to Pollen, known allergies: Onions, raw carrots. The patient concomitant medication was not reported. The patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in the left arm on 07May2021 17:30 (at the age of 48 years old) as dose 1, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28May2021 17:30 the patient experienced a few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it, stomach pain, back pain, relived pain from some athletic injuries that were healed up in the past, but 10 times worse, most joints in extreme pain, most muscles in extreme pain, extreme migraine, (could not brush hair on head due to causing extreme migraine pain), shortness of breath, fever, chills, chest pain, the pain was the worst I have ever felt, urinated with extreme frequency, unable to move left arm. The patient underwent lab tests and procedures which included body temperature resulted 101.7 on May2021, oxygen saturation resulted 92 on May2021 O2 level at 92. The clinical outcome of the events was reported as recovered on an unspecified date in May 2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Migraine, Mobility decreased
Clinical narrative: A few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it.; Stomach pain; Back pain; Most joints in extreme pain; most muscles in extreme pain; extreme migraine, (could not brush hair on head due to causing extreme migraine pain); shortness of breath; fever; chills; chest pain; Urinated with extreme Frequency; unable to move left arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736), dose 2 via an unspecified route of administration, administered in the left arm on 28May2021 17:30 (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The facility in which the vaccination was administered was other. Medical history included asthma only from pollen, deathly allergic to Pollen, known allergies: Onions, raw carrots. The patient concomitant medication was not reported. The patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in the left arm on 07May2021 17:30 (at the age of 48 years old) as dose 1, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28May2021 17:30 the patient experienced a few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it, stomach pain, back pain, relived pain from some athletic injuries that were healed up in the past, but 10 times worse, most joints in extreme pain, most muscles in extreme pain, extreme migraine, (could not brush hair on head due to causing extreme migraine pain), shortness of breath, fever, chills, chest pain, the pain was the worst I have ever felt, urinated with extreme frequency, unable to move left arm. The patient underwent lab tests and procedures which included body temperature resulted 101.7 on May2021, oxygen saturation resulted 92 on May2021 O2 level at 92. The clinical outcome of the events was reported as recovered on an unspecified date in May 2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oxygen saturation, Pollakiuria, Pyrexia
Clinical narrative: A few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it.; Stomach pain; Back pain; Most joints in extreme pain; most muscles in extreme pain; extreme migraine, (could not brush hair on head due to causing extreme migraine pain); shortness of breath; fever; chills; chest pain; Urinated with extreme Frequency; unable to move left arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8736), dose 2 via an unspecified route of administration, administered in the left arm on 28May2021 17:30 (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The facility in which the vaccination was administered was other. Medical history included asthma only from pollen, deathly allergic to Pollen, known allergies: Onions, raw carrots. The patient concomitant medication was not reported. The patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in the left arm on 07May2021 17:30 (at the age of 48 years old) as dose 1, single for COVID-19 immunisation. No other vaccines were given within 4 weeks. No other medications were given within 2 weeks. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28May2021 17:30 the patient experienced a few minutes after I received the 2nd shot the left arm started to burn like Ben Gay or Icy Hot cream was on it, stomach pain, back pain, relived pain from some athletic injuries that were healed up in the past, but 10 times worse, most joints in extreme pain, most muscles in extreme pain, extreme migraine, (could not brush hair on head due to causing extreme migraine pain), shortness of breath, fever, chills, chest pain, the pain was the worst I have ever felt, urinated with extreme frequency, unable to move left arm. The patient underwent lab tests and procedures which included body temperature resulted 101.7 on May2021, oxygen saturation resulted 92 on May2021 O2 level at 92. The clinical outcome of the events was reported as recovered on an unspecified date in May 2021.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dermal cyst, Illness, Pyrexia, Rhinitis
Clinical narrative: nasty infection in my nose; horrible cyst on my back; sick with fever for 5 days; sick with fever for 5 days; This is a spontaneous report from a contactable consumer (patient himself). A 60-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP7533; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 14May2021 (at the age of 60-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not any known allergies. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EP6955; Expiration date: unknown) via an intramuscular route of administration, administered in Arm Left on 07Apr2021 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced horrible infection in thumb. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, after the 2nd shot on 17May2021 patient got nasty infection in nose and as soon as that went away 5 days later got a horrible cyst on back and have been sick with fever for 5 days. The infections were outrageously fast after shots even shocked to the Doctor. The second was a cyst on back and while patient have had cysts before never anything like this one. AEs resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of AEs as patient was prescribed with sulfamethoxazole (Drain infection prescribed sulfamethoxazole). Since the vaccination, patient has not been tested for COVID-19. Relevant tests were reported as none. The outcome of all events was resolved on an unspecified date in 2021.  Follow up attempts are completed. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Off label use
Clinical narrative: sore throat; upset stomach; achy; Fever; fatigue; headache; chills; Age at vaccination: 9 years; Age at vaccination: 9 years; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 9-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182; Expiration date: not provided) via an unspecified route of administration on 12May2021 (age at vaccination 09-year-old) in right arm as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date, the patient experienced fever, fatigue, headache, sore throat, upset stomach, achy and chills. The patient received treatment of tylenol for true events. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Product use issue, Pyrexia
Clinical narrative: sore throat; upset stomach; achy; Fever; fatigue; headache; chills; Age at vaccination: 9 years; Age at vaccination: 9 years; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 9-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0182; Expiration date: not provided) via an unspecified route of administration on 12May2021 (age at vaccination 09-year-old) in right arm as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On an unspecified date, the patient experienced fever, fatigue, headache, sore throat, upset stomach, achy and chills. The patient received treatment of tylenol for true events. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Lip swelling, SARS-CoV-2 test
Clinical narrative: Upper lip swelling; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0170), via an unspecified route, administered in arm right on an unspecified date in May2021 at 06:30 PM (age at vaccination was 54 years) as DOSE 1, SINGLE for COVID-19 immunization . Medical history included high blood pressure from an unknown date and unknown if ongoing. No known allergies were reported. No other vaccines were received within four weeks prior to the administration of bnt162b2. No other medications the patient received within 2 weeks of vaccination. Concomitant medications were not reported. On 26May2021 at 03:00 PM, the patient experienced upper lip swelling. The adverse event resulted in visit to doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of upper lip swelling included methylprednisolone. The patient underwent lab tests and procedures which included blood test: negative on 26May2021, COVID-19 Antibody IgG/IgM Rapid POC Test: negative on 26May2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Outcome of the event was recovered with sequelae on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: swelling spread to half of right breast and down to middle of rib cage; swelling in underarm area; right shoulder & half of right breast is red and itches; pain and redness in right arm; pain and redness in right arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot Number: lot ER8736) via an unspecified route of administration, administered in right arm (upper right arm) on 25May2021 11:15 AM (at the age of 68-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol and had known allergies from an unknown date and unknown if ongoing. The patient's concomitant medications included estrogens conjugated (PREMARIN), ezetimibe (ZETIA), both taken for an unspecified indication, start and stop date were not reported. Patient was non pregnant at the time of vaccination. Patient took no other vaccine within four weeks of covid vaccine. Patient did not have COVID prior to vaccination. Patient did not tested for covid post vaccination. On 25May2021 11:45 AM the patient experienced pain and redness right arm, and right shoulder & half of right breast is red and itches, on 26May2021 on Wednesday or next morning experienced swelling in underarm area, on 27May2021 on thursday patient experienced swelling spread to half of right breast and down to middle of rib cage and on friday or every is still swollen today. No treatment received for the events. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore joints for over a month; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient (age at vaccination: 22 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0150 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08Apr2021 at 08:30 AM, as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8731 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 29Apr2021 at 08:30 AM, as dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Covid 19. The patient did not have any known allergies. Concomitant medication included birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 09Apr2021 at 08:00 AM, the patient experienced sore joints for over a month. The patient did not receive any treatment for the event. Outcome of the event was not recovered. Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Day 3 it also turned red and itchy; Injection spot felt like a bruise for 2 days.; Day 3 it also turned red and itchy; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0168) via an unspecified route of administration, administered in right arm on 20May2021 18:00 (at the age of 49-year-old) as dose 1, single for covid-19 immunization. Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 24) taken for contraception (reported as birth control), start and stop date were not reported, valacyclovir hydrochloride (VALACYCLOVIR HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. On 21May2021 07:00 the patient experienced day 3 it also turned red and itchy,this lasted 5 more days, injection spot felt like a bruise for 2 days. No treatment received for the events. Outcome of the events resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Mild fever; Arm was sore; Dull ache; Hurts at the injection site; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer(patient) reported. A 51-year-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/lot number: EN6201) via unknown route of administration in right arm on 12Feb2021 at 10:30AM (at the age of 51 years old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history included she had been taking Tamoxifen but have stopped it and it had had no impact on the pain. Patient did not have the allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications the patient received within 2 weeks of vaccination. On 26Feb2021, the patient had mild fever after a day but when she resumed going to the gym realized the arm was sore and the arm was sore to this day. It was very unusual because she had major surgeries in the past and there was never this kind of soreness. When she sleep on the side there was a dull ache and when she change clothes, stretch to pull a t-shirt over her head, it was hurts at the injection site. The patient did not diagnose with COVID-19, Prior to vaccination and not tested for COVID-19, Since the vaccination. Patient did not receive treatment for events. At the time of this report the outcome of the events were not recovered.  Follow-Up (30Jun2021): Follow-up attempts were completed. No further information was expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe itching and hives/welts over my body; Severe itching and hives/welts over my body; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0175) via an unspecified route of administration, administered in Arm Left on 29May2021 (at the age of 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history not reported. Concomitant medication(s) included metronidazole (METRONIDAZOLE). No known allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine/ No other vaccine in four weeks. The patient experienced severe itching and hives/welts over my body on 29May2021. Patient did not receive any treatment for the event. No covid prior vaccination. No covid tested post vaccination. Reporter assessed case as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Breast pain, Chills, Inappropriate schedule of product administration
Clinical narrative: fever; chills; the pain went through the underarm; she got the first dose of the Pfizer Covid-19 Vaccine on 16Apr2021/getting her 2nd dose of the vaccine on 03May2021; very serious pain in right breast; This is a spontaneous report received from a contactable consumer or other non-health professional (patient).  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch no: not reported/Lot Number: EW0172) via an unspecified route, administered in left arm on 03May2021 (Age at vaccination 75 years) as dose 2, single for covid-19 immunization. Medical history included ongoing diabetes mellitus since unspecified start date and concomitant medications reported as none. Historical vaccine included patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158) via an unspecified route of administration, administered in left arm on 16Apr2021 (Age at vaccination 75 years) as dose 1, single for covid-19 immunization with no adverse events. The patient got the first dose of the Pfizer covid-19 vaccine on 16Apr2021, and 2nd dose on 03may2021 with inappropriate schedule of product administration. After the second shot, on 03May2021 patient experienced with very serious pain in right breast that she had not had before which was started that evening. Reported as her breast pain was severe and that the pain went through the underarm. She got the shot on the left side but was having the problems in her right side. On an unspecified date she experienced fever and chills a day after the 2nd dose but went away a day after when her daughter gave her tea. Her daughter had her mammogram and was telling her doctor about it. Her doctor asked if the pain started from her back. Doctor told her daughter that it was from the Covid shot. Patient wanted to know how long it last or will it wear itself out. On 01Mar2021, the patient underwent lab tests and procedures which included blood work with unknown results done before got Covid shot. Treatment was reported as none. Outcome of the events chills and pyrexia was recovered on an unknown date in 2021, Breast pain and pain went through the underarm was recovering.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; the pain went through the underarm; she got the first dose of the Pfizer Covid-19 Vaccine on 16Apr2021/getting her 2nd dose of the vaccine on 03May2021; very serious pain in right breast; This is a spontaneous report received from a contactable consumer or other non-health professional (patient).  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch no: not reported/Lot Number: EW0172) via an unspecified route, administered in left arm on 03May2021 (Age at vaccination 75 years) as dose 2, single for covid-19 immunization. Medical history included ongoing diabetes mellitus since unspecified start date and concomitant medications reported as none. Historical vaccine included patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0158) via an unspecified route of administration, administered in left arm on 16Apr2021 (Age at vaccination 75 years) as dose 1, single for covid-19 immunization with no adverse events. The patient got the first dose of the Pfizer covid-19 vaccine on 16Apr2021, and 2nd dose on 03may2021 with inappropriate schedule of product administration. After the second shot, on 03May2021 patient experienced with very serious pain in right breast that she had not had before which was started that evening. Reported as her breast pain was severe and that the pain went through the underarm. She got the shot on the left side but was having the problems in her right side. On an unspecified date she experienced fever and chills a day after the 2nd dose but went away a day after when her daughter gave her tea. Her daughter had her mammogram and was telling her doctor about it. Her doctor asked if the pain started from her back. Doctor told her daughter that it was from the Covid shot. Patient wanted to know how long it last or will it wear itself out. On 01Mar2021, the patient underwent lab tests and procedures which included blood work with unknown results done before got Covid shot. Treatment was reported as none. Outcome of the events chills and pyrexia was recovered on an unknown date in 2021, Breast pain and pain went through the underarm was recovering.  Follow-up attempts completed. No further information expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nasopharyngitis, Pain
Clinical narrative: Low grade fever; Aches/achy feet; Chills; Headache; Cold; Tired; This is a spontaneous report received from a non-contactable consumer (patients parent) reported for a (reporters son) that. A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0179) via intramuscular, administered in Arm Left on 31May2021 (Age at Vaccination 12-years-old) as DOSE 2, SINGLE for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0165) via intramuscular, administered in Arm Left on 13May2021 (Age at Vaccination 12-years-old) as DOSE 1, SINGLE for COVID-19 Immunization. On 01Jun2021 the patient experienced Low grade fever, Aches/achy feet, Chills, Headache, Cold and Tired. Patient did not received treatment for adverse events. The outcome of the events was unknown.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; Aches/achy feet; Chills; Headache; Cold; Tired; This is a spontaneous report received from a non-contactable consumer (patients parent) reported for a (reporters son) that. A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0179) via intramuscular, administered in Arm Left on 31May2021 (Age at Vaccination 12-years-old) as DOSE 2, SINGLE for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0165) via intramuscular, administered in Arm Left on 13May2021 (Age at Vaccination 12-years-old) as DOSE 1, SINGLE for COVID-19 Immunization. On 01Jun2021 the patient experienced Low grade fever, Aches/achy feet, Chills, Headache, Cold and Tired. Patient did not received treatment for adverse events. The outcome of the events was unknown.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: 7 days after 1st dose patient experienced 2 days of blood in urine.2 days after 2nd dose experienced 2 days of blood in urine; This is a spontaneous report from a contactable consumer (Patient) via COVID-19 reporting through Regulatory Authority.  A 32-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0179), dose 1 via an unspecified route of administration, administered in Arm Left on 05May2021 13:00 as (At the age of 32-years) dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 27May2021 13:30 (Batch/Lot Number: Ew0191) as dose 2, single at Doctor's office/urgent care, both doses for COVID-19 immunization. The patient medical history included depression, anxiety, herpes simplex, obesity, seasonal allergies and gastrooesophageal reflux disease. The patient previously took ceclor and experienced drug hypersensitivity. The patient concomitant medication(s) included paracetamol (TYLENOL) and ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19. On May2021, 7 days after 1st dose patient experienced 2 days of blood in urine and 2 days after 2nd dose experienced, 2 days of blood in urine. Adverse event resulted into emergency room visit to the patient. Treatment not received for the event. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Musculoskeletal stiffness
Clinical narrative: Tiredness; headache; muscle pain; joint pain; not feeling well; nausea; Stiffness in neck, shoulders and upper back. Having a hard time turning neck; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0778, Expiry Date: Not Reported), via an unspecified route, administered in Left Arm on 27May2021 (at the age of 64-year-old) at 12:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccine within four weeks. The patient medical history included breast cancer, diabetes mellitus. The patient's concomitant medications were not reported. The patient was allergic to codeine and contrast dye. On 29May2021 (Saturday) at 2.30, the patient experienced tiredness, headache, muscle pain, joint pain, not feeling well, nausea, stiffness in neck, shoulders, and upper back, having a hard time turning neck and patient still having these symptoms 5 days later. Patient  don't feel any relief in my neck or back. The patient did not receive any treatment for the reported event. The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. Outcome of the events was Not Recovered.  No follow-up attempts are needed. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Tiredness; headache; muscle pain; joint pain; not feeling well; nausea; Stiffness in neck, shoulders and upper back. Having a hard time turning neck; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0778, Expiry Date: Not Reported), via an unspecified route, administered in Left Arm on 27May2021 (at the age of 64-year-old) at 12:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccine within four weeks. The patient medical history included breast cancer, diabetes mellitus. The patient's concomitant medications were not reported. The patient was allergic to codeine and contrast dye. On 29May2021 (Saturday) at 2.30, the patient experienced tiredness, headache, muscle pain, joint pain, not feeling well, nausea, stiffness in neck, shoulders, and upper back, having a hard time turning neck and patient still having these symptoms 5 days later. Patient  don't feel any relief in my neck or back. The patient did not receive any treatment for the reported event. The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid post vaccination. Outcome of the events was Not Recovered.  No follow-up attempts are needed. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Swelling
Clinical narrative: Pain and numbness in shoulder, arm, elbow and hand; Pain and numbness in shoulder, arm, elbow and hand; Swelling in hands, face and feet; This is a spontaneous report from a contactable consumer (patient). A 58-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 10:00 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at time of vaccination. Patient denied for any medical history. Patient concomitant medication(s) received within 2 weeks of vaccination included iron, multivitamins [vitamins NOS] (MULTIVITAMINS [VITAMINS NOS]), calcium, biotin, cyanocobalamin (B12 [CYANOCOBALAMIN]), all were taken for an unspecified indication, from an unknown start and stop date were not reported for any. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27May2021 at 07:30, the patient experienced pain and numbness in shoulder, arm, elbow and hand (could not use or feel her hand at all) and had swelling in hands, face and feet. It was reported that AE resulted in doctor or other healthcare professional office/clinic visit. The reporter considered the event as non-serious. The patient did not receive any treatment for the events. The outcome of events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Lethargy, Nausea
Clinical narrative: 12 hours after injection I had a fever at 105 for one night, the next 24 hours I had a fever at 102, the next 24 hours I had a fever at 99; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0191, Expiry date: unknown) (age at the time of vaccination was 43 years), via unspecified route of administration, administered in Arm Left on 27May2021 at 12:15 as dose 2, single for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medication was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 06May2021 at 12:15 as dose 1, single for COVID-19 immunization. On 27May2021 at 00:15, the patient had typical symptoms of fever, overall soreness, dizziness, nausea, loss of appetite and lethargic. No treatment received. The patient underwent lab tests and procedures, which included Fever: 105 on 27May2021, 102 0n 28May2021, 99 on 29May2021. The outcome of the events was resolving.  Follow-up attempts were completed. No further information was expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 12 hours after injection I had a fever at 105 for one night, the next 24 hours I had a fever at 102, the next 24 hours I had a fever at 99; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0191, Expiry date: unknown) (age at the time of vaccination was 43 years), via unspecified route of administration, administered in Arm Left on 27May2021 at 12:15 as dose 2, single for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medication was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 06May2021 at 12:15 as dose 1, single for COVID-19 immunization. On 27May2021 at 00:15, the patient had typical symptoms of fever, overall soreness, dizziness, nausea, loss of appetite and lethargic. No treatment received. The patient underwent lab tests and procedures, which included Fever: 105 on 27May2021, 102 0n 28May2021, 99 on 29May2021. The outcome of the events was resolving.  Follow-up attempts were completed. No further information was expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Stiff neck left side that lasted 10 days and soreness left side check joint that lasted 3 weeks.; Stiff neck left side that lasted 10 days and soreness left side check joint that lasted 3 weeks.; This is a spontaneous report form a contactable consumer. This patient (reported for himself):  A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN0185), via unspecified route of administration, in left arm on 13May2021 12:45 (at the age of 65-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included allergies and high blood pressure. The concomitant medication of the patient included nifedipine (NIFEDIPINE), terazosin (TERAZOSIN), labetalol (LABETALOL), potassium (POTASSIUM) and valsartan (VALSARTAN). Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 15May2021 04:00 the patient experienced stiff neck left side that lasted 10 days and soreness left side check joint that lasted 3 weeks. Outcome for all the reported events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.