chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pharyngeal swelling, Swelling face
Clinical narrative: Sore arm; Felt light headed; left side of my face becoming numb; restricted breathing threw my nose; pain forming in the left side of my neck; left cheek on my face began to swell; top left part of my throat began to swell; tingling feeling on the left side of my face.; This is a spontaneous report from a contactable consumer, the patient.   A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534), via an unspecified route of administration in the left arm on 16Mar2021 at 03:15 PM as a single dose for COVID-19 immunisation. The patient's medical history included asthma. Concomitant medications included ZYRTEC D for unknown indication from an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 03:30 PM the patient experienced pain in arm, light headed (waited the recommended 15 minutes and left), numbness in face, breathing difficulty, neck pain (immediately went back to the facility that administrated the shot, was put under observation), cheek swelling, throat swelling and tingling. Treatment received for the events included diphenhydramine and Tylenol. The clinical outcome of the events pain in arm, light headed, numbness in face, breathing difficulty, neck pain, cheek swelling, throat swelling and tingling was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Vaccination site pain
Clinical narrative: sore muscle at injection site; exhaustion; lethargy; general ache; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 17:00, as a single dose for COVID-19 immunisation. Medical history included genital herpes and depression. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included LEXAPRO and VALTREX, all for an unspecified indication. The patient was allergic to neomycin and bacitracin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021 at 06:00, the patient experienced very sore muscles at injection site "Cant lift arm past my shoulders", generalized aches, lethargy and exhausted. The patient did not receive any treatment for the reported events. The clinical outcome of the events generalized aches, lethargy, exhausted, injection site pain was not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Burning pain at area; I can't lift my arm above chest level; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Cp6955), via an unspecified route of administration in left arm on 17Mar2021 at 17:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, patient had not tested positive for COVID-19. Concomitant medications reported as not applicable. On 17Mar2021 at 18:30 PM, the patient experienced burning pain at area and unable to lift her arm above chest level. No therapeutic measures were taken for the adverse events. The clinical outcome of the events burning pain at area and unable to lift arm above chest level was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood group O, Fatigue, Lymphadenopathy, Malaise
Clinical narrative: Feeling unwell; Injection site swelling; Joint pain; Nausea; Swollen lymph nodes; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:45 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to medications, food or other products. The patient had blood type o-negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included vitamin B-complex (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), beta carotene (MANUFACTURER UNKNOWN), St. John's wort (MANUFACTURER UNKNOWN), CLARITIN-D for unknown indications, FLOMAX for benign prostatic hyperplasia and unspecified medication for high blood pressure, all from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021 at 13:45, the patient experienced injection site swelling, nausea wave on inject date, swollen lymph nodes, joint pain, tiredness and was feeling unwell through most of the day. The patient had no temperature issues and had not received any flu injection for past 15 to 20 years. The patient did not receive any treatment for the adverse events. The clinical outcome of the events injection site swelling, nausea, swollen lymph nodes, joint pain, tiredness and feeling unwell was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site swelling
Clinical narrative: Feeling unwell; Injection site swelling; Joint pain; Nausea; Swollen lymph nodes; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 12Mar2021 at 13:45 (at the age of 75-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient did not have any allergies to medications, food or other products. The patient had blood type o-negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included vitamin B-complex (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), vitamin E (MANUFACTURER UNKNOWN), beta carotene (MANUFACTURER UNKNOWN), St. John's wort (MANUFACTURER UNKNOWN), CLARITIN-D for unknown indications, FLOMAX for benign prostatic hyperplasia and unspecified medication for high blood pressure, all from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021 at 13:45, the patient experienced injection site swelling, nausea wave on inject date, swollen lymph nodes, joint pain, tiredness and was feeling unwell through most of the day. The patient had no temperature issues and had not received any flu injection for past 15 to 20 years. The patient did not receive any treatment for the adverse events. The clinical outcome of the events injection site swelling, nausea, swollen lymph nodes, joint pain, tiredness and feeling unwell was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: RASH ON VARIOUS PARTS OF BODY, BACK, FINGERS, WRISTS ETC; ITCHING ON VARIOUS PARTS OF BODY, BACK, FINGERS, WRISTS ETC; This is a spontaneous report received from a contactable consumer, the patient. A 79-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via unspecified route of administration in the left arm on 08Mar2021 at 14:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included chronic obstructive pulmonary disease, diabetes, asthma, arthritis etc (as reported) from unknown date to unknown date. Concomitant medications include metformin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), unspecified medication "D and B", all from an unknown date for an unknown indication. Prior to vaccination, on an unspecified date, the patient was diagnosed with COVID-19. The patient was not tested positive for COVID-19, since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient had allergy to Penicillin. On 09Mar2021, the patient experienced rash and itching on various parts of body, back, fingers, wrists etc. No therapeutic measures were taken for the reported events. The clinical outcome of the events rash and itching were not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Suspected COVID-19
Clinical narrative: felt like she was getting the virus; Caller stated she had a slight headache before she left the facility but Wednesday night she felt sick and was sick Wednesday night; Caller stated she had a slight headache before she left the facility but Wednesday night she felt sick and was sick Wednesday night; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Mar2021 09:00 as 1st dose, single dose for covid-19 immunisation. Medical history included covid-19 from Nov2020. The patient's concomitant medications were not reported. The patient had a slight headache before she left the facility but Wednesday night, she felt sick and was sick Wednesday night, Thursday and Friday and felt better by Saturday. Caller stated it felt like she was getting the virus. Caller was concerned about getting her second dose. Agent called consumer back to ask if caller had time to be transferred to ED. She was not having trouble breathing and she did not go into the hospital. Patient said it was better for her to stay at home. They were supposed to wait 90 days before getting the vaccine. Patient was wondering if she should get the second dose. She knows she would need second shot, which was scheduled on 08Apr2020. She was wondering if she should get it. She does not want to go through that again though, but she needs it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021301381 Different patient, same drug, different event (split)
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Paralysis, SARS-CoV-2 test
Clinical narrative: Paralyzed can't feel/move my legs; feel tired; Paralyzed can't feel/move my legs; This is a spontaneous report received from a contactable consumer (patient). An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took 1st dose of BNT162B2 for COVID-19 immunization. Patients wife and patient had the second dose, in the middle of the night paralyzed can't feel/move his legs. 03:00 am felt better. 10 days since the shot, feel tired. Mentioned it to the doctor. Rapid COVID Test. Covid have the second dose. Then patient had the five day thing. Feeling very tired. Doctor stated could endure 6 months. Patient and his wife are gonna take another rapid test. Patient saying have your stock. The outcome of the events was unknow.  Information on lot number/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Migraine, Pharyngeal swelling, Pruritus
Clinical narrative: Severe migraine headache; 10 minutes after taking vaccine experienced itching in right ear; Itching in throat; blood pressure was 156; throat was swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 42-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on the right arm on 14Mar2021 at 15:30 pm (at the age of 42-years-old) as single dose for COVID-19 immunisation. Medical history included allergy, asthma and pre diabetes, the patient was allergic to baby aspirin, peanut and pecans. Concomitant medications included ZYRTEC, SYMBICORT and azelastine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Mar2021 at 15:45 pm, 10 minutes after the vaccination, the patient experienced itching in right ear and throat which lasted for 40 minutes. On the same day, patient blood pressure was 156 (unit not specified) and five hours later the patient throat was swollen, which went after sometime. On 15Mar2021 at 3.30 am (12 hours after shot), the patient had severe migraine headache which lasted for 36 hours. No treatment was received for the reported events. The clinical outcome of the event blood pressure abnormal was unknown and for event throat swelling it was reported as recovered on 14Mar2021. The outcome of the event itching in right ear was recovered on 14Mar2021 at 16:25 and for event migraine, it was recovered on 16Mar2021 at 15:30.   Information about lot number cannot be obtained. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Severe migraine headache; 10 minutes after taking vaccine experienced itching in right ear; Itching in throat; blood pressure was 156; throat was swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 42-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on the right arm on 14Mar2021 at 15:30 pm (at the age of 42-years-old) as single dose for COVID-19 immunisation. Medical history included allergy, asthma and pre diabetes, the patient was allergic to baby aspirin, peanut and pecans. Concomitant medications included ZYRTEC, SYMBICORT and azelastine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Mar2021 at 15:45 pm, 10 minutes after the vaccination, the patient experienced itching in right ear and throat which lasted for 40 minutes. On the same day, patient blood pressure was 156 (unit not specified) and five hours later the patient throat was swollen, which went after sometime. On 15Mar2021 at 3.30 am (12 hours after shot), the patient had severe migraine headache which lasted for 36 hours. No treatment was received for the reported events. The clinical outcome of the event blood pressure abnormal was unknown and for event throat swelling it was reported as recovered on 14Mar2021. The outcome of the event itching in right ear was recovered on 14Mar2021 at 16:25 and for event migraine, it was recovered on 16Mar2021 at 15:30.   Information about lot number cannot be obtained. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Mild fatigue; Pain at injection site; Pain in nearby muscles of neck; Dull headache; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on unknown date in Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included gestational diabetes and hyperthyroidism from unknown dates. Concomitant medications included methimazole (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 15:00, the patient experienced mild fatigue, pain at injection site and in nearby muscles of neck and dull headache. The patient reports persisting dull headache into the next week. The patient did not received treatment for reported adverse events. The clinical outcomes of the events fatigue, pain at injection site, pain in nearby muscles of neck and dull headache were recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She had a quick test through finger blood sample resulting positive. She received first dose of Pfizer's COVID-19 vaccine 9 days ago; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via unspecified route of administration on an unknown date in Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received first dose of Pfizer's COVID-19 vaccine 9 days ago (in Mar2021) and yesterday (in Mar2021) she had a quick test through finger blood sample resulting positive. The clinical outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for covid19; I tested positive for covid19, following sore throat and headache; I tested positive for covid19, following sore throat and headache; I tested positive for covid19, following sore throat and headache; This is a spontaneous report from a contactable pharmacist (Patient).  A 45-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EL3302), via an unspecified route of administration in Arm Left on 14Jan2021 16:00 as 2nd dose, single dose for covid-19 immunization.Medical history included drug allergies to sulfa. Concomitant medications included phendimetrazine (PHENDIMETRAZINE). Patient did not had COVID-19 prior to vaccination. Other vaccination, which was given within four weeks included, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EL0140), via an unspecified route of administration in Arm Left on 24DEC2020 1st dose, single dose for covid-19 immunization. On 13Mar2021 at 08:30, the patient experienced vaccination failure, covid-19 following sore throat and headache. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Mar2021.The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with azithromycin, ivermectin. The outcome for the events was resolving.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the onset of events and the administration of vaccine cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a contactable pharmacist (patient, self-reported. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in right upper shoulder muscle, on 01Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID vaccine on 01Mar2021 and tested positive for COVID on an unknown date in Mar2021 (reported as on 04Mar2021 or 05Mar2021). The patient also reported that her father received the first dose of the vaccine on 26Feb2021 and tested positive for covid on 08Mar2021. Her father's 14-day quarantine was up this coming Monday and his second dose was scheduled for next Friday. There was a product complaint. No lot number or expiration date were obtained as the patient declined to file a safety report. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021309428 Different patient, same drug/event
Sex: F
Vaccine: COVID19
Symptoms: Contraindication to medical treatment, Vaccination site swelling
Clinical narrative: The injection site it's swollen, but not real painful; just a little swollen nothing big.; took a ibuprofen 600mg around 8am in the morning then took first dose in the around 2:30 in the afternoon, any effect because of the ibuprofen; This is a spontaneous report from a Pfizer sponsored program (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 20Mar2021 at 14:30 at single dose for covid-19 immunization. Medical history included arthritis. Concomitant medication included ibuprofen 600mg taken for arthritis. On 20Mar2021 at14:30, patient took her first dose but before that she took ibuprofen 600mg around 8:00 on in the morning then took first dose in the around in the afternoon. Patient was wondering if her arm hurts and if she can take anything for it. Patient experienced the injection site was swollen but not real painful, just a little swollen nothing big. She was asking that anything she can do for that or put an ice on it. Patient stated that she had waited already a long time or had been on the phone a long time and did not want to wait longer to speak with a safety team member.  The outcome of event vaccination site swelling was not recovered and contraindication to medical treatment was unknown.  Follow up(21Mar2021): No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: then tested positive; This is a spontaneous report from a contactable consumer or other non HCP via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14Mar2021, the patient tested positive (COVID-19). The patient scheduled to take second dose on 26Mar2021 and wanted to know if patient was okay with taking the second shot of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: He tested positive for Covid-19; This is a spontaneous report from a Pfizer sponsored program . This consumer reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 10Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient received his first dose on 10Mar2021, and then he tested positive for Covid-19 on 15Mar2021. tested positive for covid for like a week and a half now. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Mar2021.The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive Covid test done; This is a spontaneous report from a contactable consumer. A 65 year old female patient received first dose bnt162b2 via an unspecified route of administration on 04Mar2021 (Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included ongoing she take something for allergy, antihistamine. The patient concomitant medication included she take something for allergy, antihistamine. On 04Mar2021 she had the first dose of the Covid vaccine. On 16Mar2021, she had a positive Covid test done and she does have the second dose scheduled on 25Mar2021 and they are wondering if she needs to get the second dose. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she has a friend who tested positive for COVID-19 virus infection 2 days after receiving Pfizer's COVID-19 vaccine; This is a spontaneous report from a non-contactable consumer (reporter's friend). A 69-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter called requesting information about whether she can be administered with the first dose of Pfizer's COVID-19 vaccine after being with somebody 15 days ago who was now sick with COVID-19. During the call the consumer reported she has a friend who tested positive for COVID-19 virus infection 2 days after receiving Pfizer's COVID. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This is a spontaneous report from a contactable consumer (patient) or other non HCP received via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as 1ST DOSE, SINGLE  for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and nausea. patient queried if she could take tylenol. She also mentioned that her second dose schedule was beyond 3weeks, she was scheduled on April 22 and wanted to know this was okay. The outcome of the events were unknown.    Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cold sweat, Headache, Malaise, Nasopharyngitis
Clinical narrative: have not been feeling well; headache; nausea; a clammy feeling; I also have a sore throat; occasional runny nose; a cold symptom; Arm was very sore and very tender; Arm was very sore and very tender; balance is a bit off; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 10Mar2021 (at age 70-year-old) at single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown) on 13Feb2021 at single dose for COVID-19 immunization and had sore arm. Since second dose of vaccine he was not been feeling well. He had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes. He also had a sore throat and occasional runny nose like a cold symptom. He has no underlying health issues. He does not take pharmaceuticals. His arm was very sore and very tender, he was close to be in sick, headaches on and off, his balance was a bit off, all in 2021. The outcome of events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, Tenderness
Clinical narrative: have not been feeling well; headache; nausea; a clammy feeling; I also have a sore throat; occasional runny nose; a cold symptom; Arm was very sore and very tender; Arm was very sore and very tender; balance is a bit off; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 10Mar2021 (at age 70-year-old) at single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown) on 13Feb2021 at single dose for COVID-19 immunization and had sore arm. Since second dose of vaccine he was not been feeling well. He had the second dose 3 weeks ago and still have a headache and nausea every day and a clammy feeling that comes and goes. He also had a sore throat and occasional runny nose like a cold symptom. He has no underlying health issues. He does not take pharmaceuticals. His arm was very sore and very tender, he was close to be in sick, headaches on and off, his balance was a bit off, all in 2021. The outcome of events was unknown.  No follow up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Condition aggravated, Dehydration, Dizziness, Eye irritation
Clinical narrative: Summary from patient: On 13. March 2021, I had to be taken with an ambulance to the Emergency Department, due to uncontrolled vomiting (vomiting by each head movement) and severe headaches. I was unable to move any longer and experienced severe dehydration. Since childhood I pass out, when I need to vomit, which made the situation extremely serious. A MRI done in the evening was normal. Diagnosis: Severe Migraine Attack Low Platelet count noticed by attending Physician (mild, rebounded) I had to stay in the hospital overnight. For the following two weeks, I experienced constant nausea and irritation of both eyes, dizziness on and off, headaches at the back of my head on and off. ?Feeling the eyes?, eyes easily strained (phone + computer), light sensitivity.  On 27. March 2021, I was referred to a Neurologist, due to my ongoing symptoms, who confirmed diagnosis, Severe Migraine Attack. Neuro Exam: normal. He stated that it is extremely unusual to get such a severe event at my age, particularly, since I had never experienced anything like this before. He gave me an intravenous injection of Solu Medrol 500 mg, which resolved most of my symptoms, except the issue with my eyes. In addition, he prescribed some Migraine prophylaxis, which made me drowsy and therefore I stopped the medication after two days.  On 3. April 2021, I went for a follow up visit with the Neurologist. He said, he gave me these strong medications, as I had a Status Migrainosus. My eyes continue to bother me, getting strained on screens and they are still light sensitive. My head is more sensitive, for example to abrupt movements and heat.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging normal, Migraine, Mobility decreased, Nausea
Clinical narrative: Summary from patient: On 13. March 2021, I had to be taken with an ambulance to the Emergency Department, due to uncontrolled vomiting (vomiting by each head movement) and severe headaches. I was unable to move any longer and experienced severe dehydration. Since childhood I pass out, when I need to vomit, which made the situation extremely serious. A MRI done in the evening was normal. Diagnosis: Severe Migraine Attack Low Platelet count noticed by attending Physician (mild, rebounded) I had to stay in the hospital overnight. For the following two weeks, I experienced constant nausea and irritation of both eyes, dizziness on and off, headaches at the back of my head on and off. ?Feeling the eyes?, eyes easily strained (phone + computer), light sensitivity.  On 27. March 2021, I was referred to a Neurologist, due to my ongoing symptoms, who confirmed diagnosis, Severe Migraine Attack. Neuro Exam: normal. He stated that it is extremely unusual to get such a severe event at my age, particularly, since I had never experienced anything like this before. He gave me an intravenous injection of Solu Medrol 500 mg, which resolved most of my symptoms, except the issue with my eyes. In addition, he prescribed some Migraine prophylaxis, which made me drowsy and therefore I stopped the medication after two days.  On 3. April 2021, I went for a follow up visit with the Neurologist. He said, he gave me these strong medications, as I had a Status Migrainosus. My eyes continue to bother me, getting strained on screens and they are still light sensitive. My head is more sensitive, for example to abrupt movements and heat.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination normal, Pain, Photophobia, Platelet count decreased, Status migrainosus
Clinical narrative: Summary from patient: On 13. March 2021, I had to be taken with an ambulance to the Emergency Department, due to uncontrolled vomiting (vomiting by each head movement) and severe headaches. I was unable to move any longer and experienced severe dehydration. Since childhood I pass out, when I need to vomit, which made the situation extremely serious. A MRI done in the evening was normal. Diagnosis: Severe Migraine Attack Low Platelet count noticed by attending Physician (mild, rebounded) I had to stay in the hospital overnight. For the following two weeks, I experienced constant nausea and irritation of both eyes, dizziness on and off, headaches at the back of my head on and off. ?Feeling the eyes?, eyes easily strained (phone + computer), light sensitivity.  On 27. March 2021, I was referred to a Neurologist, due to my ongoing symptoms, who confirmed diagnosis, Severe Migraine Attack. Neuro Exam: normal. He stated that it is extremely unusual to get such a severe event at my age, particularly, since I had never experienced anything like this before. He gave me an intravenous injection of Solu Medrol 500 mg, which resolved most of my symptoms, except the issue with my eyes. In addition, he prescribed some Migraine prophylaxis, which made me drowsy and therefore I stopped the medication after two days.  On 3. April 2021, I went for a follow up visit with the Neurologist. He said, he gave me these strong medications, as I had a Status Migrainosus. My eyes continue to bother me, getting strained on screens and they are still light sensitive. My head is more sensitive, for example to abrupt movements and heat.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Summary from patient: On 13. March 2021, I had to be taken with an ambulance to the Emergency Department, due to uncontrolled vomiting (vomiting by each head movement) and severe headaches. I was unable to move any longer and experienced severe dehydration. Since childhood I pass out, when I need to vomit, which made the situation extremely serious. A MRI done in the evening was normal. Diagnosis: Severe Migraine Attack Low Platelet count noticed by attending Physician (mild, rebounded) I had to stay in the hospital overnight. For the following two weeks, I experienced constant nausea and irritation of both eyes, dizziness on and off, headaches at the back of my head on and off. ?Feeling the eyes?, eyes easily strained (phone + computer), light sensitivity.  On 27. March 2021, I was referred to a Neurologist, due to my ongoing symptoms, who confirmed diagnosis, Severe Migraine Attack. Neuro Exam: normal. He stated that it is extremely unusual to get such a severe event at my age, particularly, since I had never experienced anything like this before. He gave me an intravenous injection of Solu Medrol 500 mg, which resolved most of my symptoms, except the issue with my eyes. In addition, he prescribed some Migraine prophylaxis, which made me drowsy and therefore I stopped the medication after two days.  On 3. April 2021, I went for a follow up visit with the Neurologist. He said, he gave me these strong medications, as I had a Status Migrainosus. My eyes continue to bother me, getting strained on screens and they are still light sensitive. My head is more sensitive, for example to abrupt movements and heat.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Malaise, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A fifty-six-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 05, Apr2021 11:00 (at the age of thirty-six-year-old) as 1st dose, single for COVID-19 Immunization. The patient medical history, family history and concomitant medications were reported as none. The patient did not receive any prior vaccine within four weeks. No other vaccine administered on same date of Pfizer Vaccine. The patient reported that she received first shot of vaccine (yesterday). The patient stated that on 05, Apr2021 her "arm was sore last night and is more tender" this morning, she had been trying not to touch it. The patient started to feel some side effects on 06, Apr2021 (this morning). On 06, Apr2021, she had chills, was not feeling good, had aches and pains, and a headache. The patient stated that, on 06, Apr2021, the chills were gone but she was experiencing the other symptoms. She "feels like she was coming down with the flu". The patient wanted to know if it was okay to be around others (like an infant) and was, she contagious and could she be around other people if she was feeling side effects. She was asking because she kept her granddaughter on Tuesdays. The patient denied any labs, testing, or treatments. The patient had not been to the emergency room or doctor's office in response to the events. The patient enquired that could she take Ibuprofen for her headache. The outcome of the event chills was reported as resolved on 06, Apr2021. The outcome of other events was reported as not resolved. No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A fifty-six-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 05, Apr2021 11:00 (at the age of thirty-six-year-old) as 1st dose, single for COVID-19 Immunization. The patient medical history, family history and concomitant medications were reported as none. The patient did not receive any prior vaccine within four weeks. No other vaccine administered on same date of Pfizer Vaccine. The patient reported that she received first shot of vaccine (yesterday). The patient stated that on 05, Apr2021 her "arm was sore last night and is more tender" this morning, she had been trying not to touch it. The patient started to feel some side effects on 06, Apr2021 (this morning). On 06, Apr2021, she had chills, was not feeling good, had aches and pains, and a headache. The patient stated that, on 06, Apr2021, the chills were gone but she was experiencing the other symptoms. She "feels like she was coming down with the flu". The patient wanted to know if it was okay to be around others (like an infant) and was, she contagious and could she be around other people if she was feeling side effects. She was asking because she kept her granddaughter on Tuesdays. The patient denied any labs, testing, or treatments. The patient had not been to the emergency room or doctor's office in response to the events. The patient enquired that could she take Ibuprofen for her headache. The outcome of the event chills was reported as resolved on 06, Apr2021. The outcome of other events was reported as not resolved. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache
Clinical narrative: Headache; Chest pain; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, the patient experienced headache and chest pain on an unspecified date. Consumer wanted to know as to what she can take following these adverse events. If she can take Tylenol for this. But definitely referred consumer to her physician as Pfizer is unable to recommend any clinical judgement as to this concern. It was advised to consult with Dr about what experienced/are experiencing. Dr was in the best position to advise about the appropriate action to take as Dr was most familiar with medical condition, clinical history, how your treatment has been conducted and any relevant information to specific case. The outcome of events was unknown.   No follow-up attempts are possible. Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a Spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 26Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history included tooth extraction and have had been taking pain medication after. The patient concomitant medications were not reported. On an unspecified date, the patient experienced headache. Patient asked if this was part of the covid vaccine's side effect. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Slight headache; Slight malaise; This is a spontaneous report received from a contactable consumer (patient himself) in response to the non-HCP letter sent reported that a 69-years old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN8727 and expiration date: unknown), via Intramuscularly on 17Mar2021 14:00 (at the age of 69 years old) at Left shoulder as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL6200 and expiration date: unknown), via Intramuscularly on 24Feb2021 14:00 at Right shoulder as a single dose for COVID-19 immunisation. The patient has not taken any vaccines prior 4 weeks of vaccination. On 18Mar2021 at 06:00, the patient experienced Slight headache and slight malaise. The reporter considered the events as non-serious and no treatment was received. The outcome of the events was recovered on 19Mar2021. AE was milder than an average flu shot for me. My wife had no AE at all with either dose.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain assessment
Clinical narrative: Huge headache right side of eye; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 05Apr2021 (at the age of 47-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, 06Apr2021 patient experienced huge headache right side of eye. Caller is calling regrading the Pfizer Vaccine, clarified as the Pfizer Covid-19 Vaccine. She got her first dose was administered on Monday 05Apr2021 in her left arm. Now she has a huge headache, on the right side of her eye. She has taken Tylenol and it does not go away. She initially stated she took Benadryl and it did not go away. She also initially stated she took Zyrtec and it feels like it is getting stronger. She later stated the Benadryl seemed to help alleviate the pain, but made her sleep. She cannot take it now because it will knock her out. With the Zyrtec it is like the headache is throbbing now. She does not know what to take to make it go away. Stated she does not know how much Zyrtec she can take. Caller later clarified details. She clarified and confirmed with Benadryl the huge headache went away. She took it at night time and it made her go to sleep. She is working from home today and does not want to take it right now because it will make her sleep. She clarified and stated the Zyrtec helped to alleviate it a little bit, for like 2 hours, but now it is coming back strong. When probed for outcome of huge headache right side of eye she confirmed as improved. Details captured as provided. She stated she is still feeling a throbbing feeling. The Zyrtec is wearing off. She can still function with a little pain. On a scale of 1-10, the pain is like a 6. Caller asked for lot/exp/NDC of Tylenol, Benadryl, and Zyrtec. She stated she only has the Benadryl and Zyrtec with her. Tylenol Lot/exp/UPC: Did not have with her to provide. Benadryl: Lot: STC123, Exp: 8 2022, NDC 50580-415-01, 25mg tablets. Zyrtec: Lot: 1741995, Reason for no lot number: of Pfizer Covid-19 Vaccine: Other: Husband has the paperwork and he is not there with her. Therefore, unable to provide. Therapeutic measures were taken as a result of huge headache right side of eye. The outcome of the events was reported as recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.