chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: CHILLS, FEELING UNWELL, FEVER, HEADACHE, INJECTION SITE PAIN, INJECTION SITE REDNESS, INJECTION SITE SWELLING, JOINT PAIN, MUSCLE PAIN, NAUSEA, VOMITING, DIARRHEA, SWOLLEN LYMPH NODES AND TIREDNESS. HAVE RECOVED FROM MOST OF THESE SYMPTOMS BUT THE SWOLLEN LYMPH  NODES AS OF 1/12/20.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: Has soreness today with triceps injection; It was given subcutaneously in his triceps, when it should be given intramuscularly in the deltoid; He received 2nd dose of Covid vaccine today and received it subcutaneously on his triceps which he thinks is an incorrect site of administration; This is a spontaneous report from a contactable physician (patient). A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), subcutaneously in the triceps on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician called about the COVID-19 vaccine and stated that he was given his second dose that morning after the three weeks, and he was pretty sure it was given subcutaneously in his triceps, when it should be given intramuscularly in the deltoid. He says that he would like to inquire about recommendations for his next step, since it was given not per recommendations, and see if there is anything in Pfizer's recommendations such as check for antibodies in a couple weeks or to get another injection. He says that this injection was done a lot lower than his first dose, and he was reading Pfizer vaccine recommendations to be the deltoid, and he is guessing they gave it to him in the triceps subcutaneously. He says after the first shot, he had mild arm soreness with no other symptoms, he so far has soreness that day with triceps injection. He would like to know what recommendations are to do next, or if there is a higher risk of side effects since it was given into soft tissue, if there is any information or studies with data about subcutaneous administration of this vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness
Clinical narrative: very bad headache; feels terrible/feeling bad; she was sick; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL4238, Expiration date: 30Apr2021), via an unspecified route of administration at site of right arm at 14:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high cholesterol for several years. Concomitant medication included rosuvastatin calcium (CRESTOR) for cholesterol (had taken it for several years). The patient had a bad headache and feels terrible at 6 am on 07Jan2021, she wanted to know if she could take something for the headache. She got up at 6 am and feeling bad on 07Jan2021, she left for work and came home, and she was sick. Her feeling terrible started sometime during the night. She was feeling fine on 06Jan2021. These events were identified as non-serious by reporter. Vaccination Facility Type was in public health department. Vaccine was not administered at military facility. No history of all previous immunization with the Pfizer vaccine considered as suspect. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. No adverse events required a visit to emergency room. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. The outcome of events 'headache' was not recovered; of rest events was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: Extreme Chills, Muscle Aches, Tiredness, Joint pain throughout the body. Rest and Motrin used. Length: 48hrs
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Severe diarrhea, followed by severe muscle cramps; Severe diarrhea, followed by severe muscle cramps; This is a spontaneous report from a contactable nurse reported for himself.  A 64-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number EL1283), intramuscular in right arm on 05Jan2021 11:00 at single dose for COVID-19 immunization.  Medical history included ankylosing spondylitis, ulcerative colitis, prediabetes, previous hypertension, hypothyroidism, partial heart block and known allergies: Sulfa.  Concomitant medication included mesalazine (LIALDA), indometacin (INDOMETHACIN), levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), zolpidem tartrate (AMBIEN), metformin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced severe diarrhea, followed by severe muscle cramps on 05Jan2021 16:00 with outcome of recovered in Jan2021. The events were reported as non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Injection site is very sore; arm swelling; fatigue; This is a spontaneous report from a contactable Physician (patient). A 34-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9321), via an unspecified route of administration on 06Jan2021 at 08:00 at single dose in left arm for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced injection site was very sore, arm swelling, and fatigue on 06Jan2021 at 08:00. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient had not been tested for COVID-19 since vaccination. The outcome of the events was resolving.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site cellulitis, Product administered at inappropriate site
Clinical narrative: Developed cellulitis at injection site. It should be noted that injection was to be given intramuscularly but the RN who administered it gave to the back of the arm which was likely subcutaneous rather than  intramuscular.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: 5 minutes post vaccine experienced tingling lips and dry mouth; 5 minutes post vaccine experienced tingling lips and dry mouth; 6 hours followed by lip numbness still occurring (23 hours post vaccine so far); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO142), via an unspecified route of administration on 06Jan2021 16:45 at single dose at right arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. The patient experienced 5 minutes post vaccine experienced tingling lips and dry mouth x 6 hours followed by lip numbness still occurring (23 hours post vaccine so far) with outcome of recovered with lasting effects in Jan2021. Patient received Benadryl 37.5mg x 1 dose for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report is considered non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Nephrolithiasis, Oropharyngeal pain
Clinical narrative: Severe Nausea, Headache, Fatigue, Body aches. kidney stones and sore throat.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe Nausea, Headache, Fatigue, Body aches. kidney stones and sore throat.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Hives all over her body; Shortness of breath; This is a spontaneous report from a contactable nurse reported for patient (coworker). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Dec2020 at occupational health department at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had a worse reaction than reporter did. The patient's worse reaction included hives all over her body and shortness of breath. Caller cannot believe the patient was still working like this. The outcome of events was unknown. Caller declined to provide any further information for this report.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Body itchiness
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea exertional, Fatigue, Investigation
Clinical narrative: Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that continues on; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular on 21Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included neuropathy. Concomitant medication included gabapentin. Past drug history included known allergies: TOPAMAX. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020, the patient experienced fatigue, chills, tingling sensation of extremities that continues on. Treatment for the events fatigue, chills, tingling sensation of extremities included ibuprofen (MOTRIN) and acetaminophen (TYLENOL) taken with minimal or short temporary relief. On 30Dec2020, the patient experienced shortness of breath on exertion and weakness and tried to go to Urgent care clinic for Covid test but no available test so the doctor prescribed ZITHROMAX in case it was Covid. On 30Dec2020, MRI, XRAY, LABS were taken and all came back negative and normal except having all these symptoms. On 02Jan2021, Covid test done and result was negative, tested for antibody and it was positive. The outcome of the event fatigue was unknown. The outcome of the events chills and tingling sensation of extremities was recovered in Jan2021. The outcome of the events shortness of breath on exertion and weakness was not recovered. The events fatigue, chills, tingling sensation of extremities that continues on, shortness of breath on exertion and weakness required a physician office visit.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, SARS-CoV-2 antibody test, SARS-CoV-2 test, X-ray
Clinical narrative: Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that continues on; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular on 21Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included neuropathy. Concomitant medication included gabapentin. Past drug history included known allergies: TOPAMAX. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020, the patient experienced fatigue, chills, tingling sensation of extremities that continues on. Treatment for the events fatigue, chills, tingling sensation of extremities included ibuprofen (MOTRIN) and acetaminophen (TYLENOL) taken with minimal or short temporary relief. On 30Dec2020, the patient experienced shortness of breath on exertion and weakness and tried to go to Urgent care clinic for Covid test but no available test so the doctor prescribed ZITHROMAX in case it was Covid. On 30Dec2020, MRI, XRAY, LABS were taken and all came back negative and normal except having all these symptoms. On 02Jan2021, Covid test done and result was negative, tested for antibody and it was positive. The outcome of the event fatigue was unknown. The outcome of the events chills and tingling sensation of extremities was recovered in Jan2021. The outcome of the events shortness of breath on exertion and weakness was not recovered. The events fatigue, chills, tingling sensation of extremities that continues on, shortness of breath on exertion and weakness required a physician office visit.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema
Clinical narrative: injection site was really red. It was the size of a 50 cent piece if not bigger; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# 037K20A, expiration date: Jul2021), via an unspecified route of administration in left arm on 05Jan2021 at single dose for Covid-19 immunisation. Medical history was none.  Concomitant medication included escitalopram oxalate (LEXAPRO), warfarin and another medication. The patient worked in health care. She received the Covid-19 injection. The injection site was really red on 06Jan2021. It was the size of a 50 cent piece if not bigger. She wasn't sure if she should be worried. The outcome of event was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Rigors; Feverish (yet afebrile); Myalgias; Fatigue; This is a spontaneous report from a non-contactable consumer (patient herself).  This 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 at single dose, for COVID-19 immunisation. Vaccine location was right arm. The patient did not have a relevant medical history. No known allergies. No relevant concomitant medications were provided.  No other vaccine was received in four weeks. On unknown date, the patient developed rigors, feverish (yet afebrile), myalgias, and fatigue. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the events. She recovered from the events on unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia, Sleep disorder
Clinical narrative: Soreness at injection site started at 1600 Body aches, headache, and low grade fever woke me up around 0100
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient with Covid between their first and second doses of the Covid vaccine; Patient with Covid between their first and second doses of the Covid vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable Pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A patient of an unspecified age and gender received the first dose of BNT162B2 (Pfizer/BioNTech Covid-19 vaccine) on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got Covid between first and second doses of the Covid vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (got COVID between first and second doses) with BNT162b2 can not be fully excluded.,Linked Report(s) : US-PFIZER INC-2021011515 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Tenderness, Ultrasound scan
Clinical narrative: some axillary tenderness; some localized site tenderness; swollen lymph nodes; This is a spontaneous report from two contactable Other HCPs. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced some localized site tenderness, some axillary tenderness in the days after the vaccine and then symptoms went away. The past couple of days she was experiencing extremely swollen lymph nodes and an ultrasound confirmed this. No other symptoms at this time. The outcome of events some axillary tenderness and some localized site tenderness was recovered; of event swollen lymph nodes was unknown.  Information on lot number/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient with covid between their first and second doses of the covid vaccine; patient with covid between their first and second doses of the covid vaccine; This is a spontaneous report from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported similar events for two patients. This is the first case out of 2 cases. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Apr2021, NDC#59267-1000-1), 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 with Covid between the first and second doses of the Covid vaccine on an unspecified date. The reporting pharmacist wanted to know if the patients with covid between their first and second doses of the covid vaccine what their risk would be, Reportedly 2 different patient. The outcome of the events was unknown.; Sender's Comments: The association between the event lack of effect (COVID between first and second dose) with BNT162b2 can not be fully 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.,Linked Report(s) : US-PFIZER INC-2021011471 same reporter/drug/event, different patient..
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Moderna COVID-19 Vaccine EUA. Large bump (1/2 inch raised from the rest of my arm)  on injection site appeared roughly a week after vaccine. Roughly 2.5 inches in diameter and firm to the touch. Mildly itchy and red with a few small bumps.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Inappropriate schedule of product administration, Malaise, Migraine
Clinical narrative: Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications.  The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be.  Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test
Clinical narrative: Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications.  The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be.  Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive and also received the vaccine from COVID-19; tested positive and also received the vaccine from COVID-19; This is a spontaneous report from a Pfizer sponsored program. This contactable physician reported similar events for the physician herself and a patient. This is the second report, the patient report of 2 reports.  A patient of unspecified age and gender received 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 physician reported there was another person in her clinic that tested positive and also received the COVID vaccine on an unspecified date with outcome of unknown.    The information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection needed for meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021000799 Same reporter, same drug, different patients
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Injection site swelling, Lethargy, Pain
Clinical narrative: Mild to moderate muscular pain around injection site.  Pain present upon any kind of movement (7/10), even when resting if arm was not in a fully relaxed and supported position, and upon palpation.  Mild swelling present, but no visible bruising, redness, rash, or bleeding.   General body weakness and slight body aches.  Mild fever (typical temperature mid-97, highest temperature that day of 99.3).  Lethargy all day.  Treatment consisted of increased fluid/electrolyte intake and rest.  No medications taken.  Approximately 22-23 hours after the first symptoms occurred, they went away.  After waking up the next day, none of the symptoms were present with the exception of very mild pain (1-2/10) around the injection site on palpation only.  No other symptoms present.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild to moderate muscular pain around injection site.  Pain present upon any kind of movement (7/10), even when resting if arm was not in a fully relaxed and supported position, and upon palpation.  Mild swelling present, but no visible bruising, redness, rash, or bleeding.   General body weakness and slight body aches.  Mild fever (typical temperature mid-97, highest temperature that day of 99.3).  Lethargy all day.  Treatment consisted of increased fluid/electrolyte intake and rest.  No medications taken.  Approximately 22-23 hours after the first symptoms occurred, they went away.  After waking up the next day, none of the symptoms were present with the exception of very mild pain (1-2/10) around the injection site on palpation only.  No other symptoms present.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Myalgia; This is a spontaneous report from a non-contactable physician (the patient).  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on 16Dec2020 (lot EK5730) and second dose on 06Jan2021 at 18:00 (lot EL3246), both in left arm at single dose for covid-19 immunisation. The vaccine was administered at Hospital Facility. The patient did not receive other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced myalgia on 07Jan2021 08:00. The patient underwent lab tests and procedures which included Nasopharyngeal Nasal Swab/sars-cov-2 test: negative on 21Dec2020. No treatment was given for the event. The event was non-serious with outcome of recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Bladder discomfort, Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: dizziness/light headedness; increased blood pressure; anxiety; a rash that developed down to the elbow; cramping; bladder pressure; received the menstrual period earlier than expected; This is a spontaneous report from a contactable other healthcare professional (patient) via Pfizer sales representative.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history included kidney stones. Concomitant medications were not reported. Patient experience dizziness, light headedness after receiving the vaccine. Additionally, the patient had increased blood pressure and anxiety, as well as a rash that developed down to the elbow. The rash resolved the following day. The day after receiving the vaccine, the patient reported cramping, bladder pressure and received the menstrual period earlier than expected. Events took place after use of product. The outcome of events cramping and bladder pressure is not recovered. The outcome of event rash was recovered. The outcome of other events was unknown.  Information on the lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Muscle spasms, Rash
Clinical narrative: dizziness/light headedness; increased blood pressure; anxiety; a rash that developed down to the elbow; cramping; bladder pressure; received the menstrual period earlier than expected; This is a spontaneous report from a contactable other healthcare professional (patient) via Pfizer sales representative.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history included kidney stones. Concomitant medications were not reported. Patient experience dizziness, light headedness after receiving the vaccine. Additionally, the patient had increased blood pressure and anxiety, as well as a rash that developed down to the elbow. The rash resolved the following day. The day after receiving the vaccine, the patient reported cramping, bladder pressure and received the menstrual period earlier than expected. Events took place after use of product. The outcome of events cramping and bladder pressure is not recovered. The outcome of event rash was recovered. The outcome of other events was unknown.  Information on the lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Rash
Clinical narrative: notice a rash on her left hand; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via unspecified route of administration on left arm on 05Jan2021 at single dose for Covid. The relevant medical history and concomitant medications were reported as none. The patient stated that she just got the first shot of COVID vaccine and noticed a rash on her left hand. She stated that it was the same arm that she got the shot. She wanted to know if there was anything that she needed to do. She stated that she got it through the state as a healthcare worker. She stated that she noticed the rash 20 minutes prior to the report. The patient had no treatment for the event. The patient was tested for COVID the week prior the report in Dec2020 and it was negative. She was going in at the time of the report to get another COVID test. The outcome of the event was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: 4 cm area of redness, slightly warm to the touch
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: consumed alcohol yesterday and was woozy afterwards; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included consume alcohol. Concomitant medications were not reported. Patient took the vaccine at work yesterday (05Jan2021), she works in the healthcare industry, and wants to know if after getting the vaccine can a person consume alcohol. The patient remarked that she did consume alcohol yesterday and was woozy afterwards. She read somewhere that a person should not consume alcohol for 2 months as the vaccine will not work as well. She wanted to know if this was true. Outcome of the event was unknown.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received BNT162B2 (batch/lot number: EH9899) first dose on 15Dec2020 13:00 Intramuscular Deltoid Left at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Prior Vaccinations (within 4 weeks) None. AE(s) following prior vaccinations None. Family Medical History Relevant to AE(s) None. He said that he had no side effects with the first dose except for injection site pain. Vaccination Facility Type was Hospital. Vaccine not Administered at Facility. No events require a visit to: Emergency Room or Physician Office. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dehydration, Diarrhoea, Headache, Migraine
Clinical narrative: Diarrhea continue for a couple days, resolved for a couple days, and then returned for a couple more days before resolving; Dehydrated from the diarrhea; Stomach cramps; Headache; Migraine; This is a spontaneous report from a contactable other HCP (patient) via Pfizer sales representative. This other HCP reported information for two patients. This is the first of the two reports. A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose via unknown route of administration for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported diarrhea that began about 1 hour after receiving the vaccine. Diarrhea continued for a couple days, resolved for a couple days, and then returned for a couple more days before resolving. The patient was dehydrated from the diarrhea and also had stomach cramps the days that she had the diarrhea. Patient also reported headache/migraine since she received the vaccine. The outcome of the event Diarrhea was recovering. The outcome of other events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity
Clinical narrative: sore arm; The patient got the flu and pneumococcal 13-valent conjugate vaccines at the same appointment; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 30Sep2020 at single dose for immunization; and influenza vaccine (FLU), via an unspecified route of administration on 30Sep2020 at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient got the flu and pneumococcal 13-valent conjugate vaccines at the same appointment. The patient had a very sore arm for 48 hours. While it was sore, the patient was able to fully use it. The shots were administered on 30Sep. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Malaise, Off label use
Clinical narrative: first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021; her fever went up to 101.4/ her fever is down to 99.6; still does not feel good/ felt sick/ felt terrible; wanted throw up; shaking chills; extreme weakness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via unspecified route of administration on 21Dec2020 at single dose, and second dose (lot number: EL3246), via unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that she got it in the evening and had a fever and felt sick like she wanted throw up. She stated that her fever went up to 101.4, that she felt terrible, had shaking chills and extreme weakness. She tried to drink a lot of liquids thinking that would help. Stated that it was a really bad experience. She clarified that all of these side effects were with the second dose. She had no side effects with the first dose. She reported all of this previously. She stated that she called in fever down 99.6 and did not feel good. She stated that the Tylenol brought fever down a little bit. She was still not able to go to work. The outcome of the event "her fever went up to 101.4/ her fever is down to 99.6" was recovering, the event "still does not feel good/ felt sick/ felt terrible" was not recovered, while other events were unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia, Vomiting
Clinical narrative: first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021; her fever went up to 101.4/ her fever is down to 99.6; still does not feel good/ felt sick/ felt terrible; wanted throw up; shaking chills; extreme weakness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via unspecified route of administration on 21Dec2020 at single dose, and second dose (lot number: EL3246), via unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that she got it in the evening and had a fever and felt sick like she wanted throw up. She stated that her fever went up to 101.4, that she felt terrible, had shaking chills and extreme weakness. She tried to drink a lot of liquids thinking that would help. Stated that it was a really bad experience. She clarified that all of these side effects were with the second dose. She had no side effects with the first dose. She reported all of this previously. She stated that she called in fever down 99.6 and did not feel good. She stated that the Tylenol brought fever down a little bit. She was still not able to go to work. The outcome of the event "her fever went up to 101.4/ her fever is down to 99.6" was recovering, the event "still does not feel good/ felt sick/ felt terrible" was not recovered, while other events were unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Gait disturbance
Clinical narrative: The morning after the injection when I woke up my entire body was sore to even walk.  That lasted 1 day.  Since then I have experienced chills, lightheadedness, confusion and an overall feeling of exhaustion.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: The morning after the injection when I woke up my entire body was sore to even walk.  That lasted 1 day.  Since then I have experienced chills, lightheadedness, confusion and an overall feeling of exhaustion.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is spontaneous report from a contactable nurse (patient, an oncology nurse navigator) via a company representative. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient received Pfizer COVID-19 vaccine and got a headache. Patient is a female and. The nurse was excited to share that they received the vaccine. Event took place after use of product. Outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: experiencing fever of 101 degrees F; muscle aches; chills; This is a spontaneous report from a Pfizer-sponsored program, received via a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was experiencing fever of 101 degrees F, muscle aches, and chills on 05Jan2021. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; Headache; body aches; This is a Spontaneous report from a contactable physician (patient) via a Pfizer Sponsored Program Corporate (Pfizer) Social Media Platforms. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported "Hang in there immune response kicked my butt at about 12 hr point (chills, headache, body aches)". The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: did develop COVID that week probably symptoms in general by 25Dec/probably infected whenever got the vaccine; did develop COVID that week probably symptoms in general by 25Dec/probably infected whenever got the vaccine/I don't feel very well right now; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st vaccine on 21Dec2020. The patient did develop COVID that week probably symptoms in general by 25Dec2020. She was probably infected whenever she got the vaccine and the patient was scheduled to have second vaccine on 11Jan2021 which was next Monday and the patient was still sick, should the patient delayed that. The patient also did not feel very well on an unknown date ("right now"). The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Pain, Spinal pain
Clinical narrative: Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of weird headache; body aching; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. Medical history included depression, had hip surgery last year (from 2020) and anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety and depression. esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), on regular basis naproxen sodium (ALEVE) and paracetamol (TYLENOL) because of her hip. Patient was calling because she was vaccinated yesterday, 03Jan2021. Patient was a nurse and she got the COVID Vaccine yesterday. she wanted to go into the symptom checker or whatever because she was having, she woke, she wasn't (incomplete sentence). she had a difficult time sleeping last night. She woke up like with all her joints start just achy and she did not have a great time. she wanted to report her symptoms. patient have other things. No really big co-morbidities, like, she had depression. she had some body issues like she had a "torn labor" and stuff like that but that needs to be repaired but not like blood pressure, diabetes, none of those things. she had hip surgery last year. she took two Aleve in the morning and two 500 Tylenol. And she took one more Aleve in the evening and two more Tylenol. As of causality, patient stated she believe so. It's much more intense than it was, than she was feeling yesterday. she definitely could feel it after she had the vaccination. she got like this aching all up her spine and sort of the weird headache for about (incomplete sentence). it was for the rest of the day about an hour after she got the vaccination. She was a little too un-tuned with her body aching. Consumer stated, "Is there, I mean, more I was calling to register with that CDC thing or whatever to report, you know just what's happening. I figured it was probably, kind of part of the research study or whatever for symptoms and tracking and all that. Is that what I am doing as well too by doing this or is that something separate?" When probed if reported through CDC questionnaire, consumer stated, "No, I went onto the website and it said that on CDC website the worst thing and it said that you needed a code or something a key code to get into the program and I don't. Is this where the reporting is going or how do I register with the (app Name) or whatever? Is that what I did by telling you what's going on?" When informed about the role of Pfizer Drug Safety, consumer stated, "I did not understand that safety report or I figured that we were like also assisting in some kind of research trial type thing too. Are they going to call me or no? Is this the last time I'm hearing from anyone?" No investigation assessment. No Lab Work. No Treatment. Outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Disturbance in attention, Fatigue, Nausea
Clinical narrative: Nausea, vomiting, diarrhea starting at 2230 until 0100. Body aches, chills, fatigue, difficulty concentrating until 12/25 afternoon
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea starting at 2230 until 0100. Body aches, chills, fatigue, difficulty concentrating until 12/25 afternoon
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Nurse had the same symptoms but her symptoms were even worse. She had some numbness in the face and the extremities and her symptoms lasted longer and then subsided next day according to the nurse; This is a spontaneous report from a contactable physician. A patient (ICU nurse) of unspecified age and gender received 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 reporter reported that the nurse had some numbness in the face and the extremities and her symptoms lasted longer and then subsided next day according to the nurse who administered the vaccine to the reporter but again, the reporter didn't know if even those guys were reporting this or not. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache
Clinical narrative: had covid after his first dose; had covid after his first dose; headaches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable Physician. A male patient of an unspecified age received his first single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on an unspecified date in Dec2020 for Covid-19 immunization. The patient previously had Covid in Apr2020. Concomitant medications were not reported. After his first dose of vaccine, in Dec2020, the patient had Covid and headaches. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The reported "had Covid" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.