chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: headache; Runny Nose; Soar Throat; This is a spontaneous report from a contactable consumer. A 68-years-old female patient received first dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 VACCINE, Formulation:solution for injection, Lot Number: EN6201) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 13:00 as single dose for covid-19 immunization. The patients medical history was and concomitant medications were not reported. Patient did not received vaccine in four weeks. Patient had no covid prior to vaccination. Patient was not tested for covid post vaccination. On 28Feb2021 at 01:00 AM Patient experienced runny nose- rhinorrhea, Sore Throat and headache. The outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: Very mild headache; shortness of breath; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 35-years-old male patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 18Feb2021 as 1st dose, single for COVID-19 immunization (at the age of 35 years). The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Feb2021, the patient experienced very mild headache and shortness of breath for about 1-2 hours. Patient did not receive any treatment for adverse events. The outcome of event was recovered on an unspecified date.    No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache; Light headedness/dizziness; Body ache; Fatigue; Sore lung muscles on front and back; Tightness in chest; This is a spontaneous report from a contactable consumer.   A 28-years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6168), via an unspecified route of administration in left arm on 26Feb2021 at 14:00 as a single dose for COVID-19 immunization. The patient received vaccination at field house facility. The patient did not receive any other vaccine with in four weeks of COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not undergo COVID test post vaccination. The patient had no known allergies. The patient's medical history and concomitant medications were not reported. On 27Feb2021 at 17:00, the patient experienced headache, dizziness, light headedness, body ache, fatigue, sore lung muscles on front and back, tightness in chest. The patient did not receive any treatment medication for the events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: Headache; Light headedness/dizziness; Body ache; Fatigue; Sore lung muscles on front and back; Tightness in chest; This is a spontaneous report from a contactable consumer.   A 28-years old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6168), via an unspecified route of administration in left arm on 26Feb2021 at 14:00 as a single dose for COVID-19 immunization. The patient received vaccination at field house facility. The patient did not receive any other vaccine with in four weeks of COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not undergo COVID test post vaccination. The patient had no known allergies. The patient's medical history and concomitant medications were not reported. On 27Feb2021 at 17:00, the patient experienced headache, dizziness, light headedness, body ache, fatigue, sore lung muscles on front and back, tightness in chest. The patient did not receive any treatment medication for the events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information was expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Vomiting
Clinical narrative: Severe headache; extreme body aches; extreme fatigue; light headed when not lying down; feeling like I was going to vomit if not lying down; This is a spontaneous report from a contactable consumer (Patient). A 61-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202), via an unspecified route of administration, administered in arm left on 26Feb2021 09:45 as single dose for covid-19 immunisation. Medical history included high cholesterol, penicillin allergy, allergies to sulfa and covid-19. Patient previously took thiomersal and had allergy from it. Concomitant medication included rosuvastatin (other medications in two weeks). The patient did not receive any other vaccines within 4 weeks. Patient had covid prior vaccination. The patient was not tested for COVID post vaccination. On 26Feb2021, the patient experienced severe headache, extreme body aches, extreme fatigue, light headed when not lying down, feeling like I was going to vomit if not lying down. The treatment was not received for adverse event. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Headache; body aches; sore arm; This is a spontaneous report from a non-contactable consumer or other non hcp (Patient herself). A 36-years-old female (Non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 22Feb2021 at 14:00 (Age at time of vaccination 36-years-old) as unknown single, dose for covid-19 immunization. The patient medical history, concomitant medications were not reported.  The patient has not covid tested before vaccination and after vaccination. No treatment received. The patient had no other vaccine in four weeks. On an unspecified date the patient experienced Headache, body aches, sore arm. The outcome of event was recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache; dizziness; fatigue; chills; body aches; This is a spontaneous report from a contactable other hcp. A 41-year-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6202; Expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:00 (age at vaccination 41-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. The vaccine facility was other. Medical history included asthma, allergy, depression, ADHD, long haul Covid symptoms, covid-19, known allergies: Cats and mold. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); escitalopram oxalate (LEXAPRO); dienogest, ethinylestradiol (LARISSA); montelukast sodium; budesonide, formoterol fumarate (SYMBICORT). On 26Feb2021 at 19:00, the patient experienced headache, dizziness, fatigue, chills, body aches. Patient reports about the covid vaccine. Patient had no other vaccination in four weeks. Reported that patient had covid prior to vaccination and not tested post vaccination. Patient was not received any treatment. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable pharmacist.   A 30-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL1284, Expiration date not reported), intramuscular in left arm on 23Dec2020 at 13:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to azithromycin and ibuprofen. Medical history included covid-19 prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced no reaction with 1st vaccine 1155 c/o headache on an unspecified date. The seriousness of headache was reported as non-serious. The outcome of headache was reported as recovered.  No follow up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Chills; Body ache; Sore arm; This is a spontaneous report from a contactable pharmacist (patient) who reported events after first and second dose of the vaccine. This case is for events after the second dose.  A 31-year-old Female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810), via an unspecified route of administration, in Right arm on 24Feb2021 (at 31 years) at single dose for covid-19 immunisation . Patient had known allergy to Cantaloupe. Concomitant medications included multivitamin; ascorbic acid/herbal nos/levoglutamide/lysine/magnesium/manganese/retinol/riboflavin/selenium/tocopherol/zinc (AIRBORNE) and ibuprofen (ADVIL) for 2 days between doses. Previously on 03Feb2021 at 16:30 (at 30 years) patient receive first dose of the vaccine (lot EL9262) in Right arm for covid-19 immunisation and experienced sore arm for 2-3 days. On 24Feb2021 the patient experienced chills starting 12 hours after dose and lasting until about 28 hours after; body aches starting 16 hours after dose and lasting until about 28 hours after and sore arm for 2-3 days. No treatment given. The outcome of the events was recovered in Feb2021. No follow up attempts are possible; information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219538 same patient/vaccine, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling jittery, Headache
Clinical narrative: a little tired hazy headache; intense burning in my chest; shaking jittery/ frightend; This a spontaneous report from a contactable consumer (patient).  An elderly non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN62020 and expiry date was not provided), via an unspecified route of administration, in the left arm on 24Feb2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included skin cancer, kidney stones, HBP treated, arthritis and had skin cancer surgery removed 5 weeks ago center upper chest which involved injected anesthesia. Patient had allergies (unspecified). Concomitant medication included levothyroxine, liothyronine (NP THYROID); Olmesartan; citalopram and vitamins nos (MULTI-VITAMINS). She did not receive other vaccine in four weeks of vaccination. She did receive other medications in two weeks of vaccinations. She was not diagnosed with COVID, prior vaccination. She had not been tested for COVID, post vaccination. On an unknown date, patient experienced no problem for the first hours then a little tired hazy headache. Took paracetamol (TYLENOL) and went to bed early. Patient awoke in night by an intense burning in chest and was shaking jittery/ frightend. Patient had no serious fever and could breathe ok. She took 2 paracetamol (TYLENOL) and tried to go back to sleep. She felt better in the morning but still lingering burning sensation almost like underneath skin and was scalded or sunburn. She went to physician office and took diphenhydramine hydrochloride, paracetamol (TYLENOL PM) 2nd night. Better by 4th day but still did not feel normal. It was unknown if any treatment received. The outcome of events was recovered with lasting effects.  No follow up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Muscle spasms, Myalgia
Clinical narrative: Headache; muscle soreness; cramping/diarrhea; fatigue; sight injection pain; cramping; This is a spontaneous report from a contactable consumer (the patient). A 54-Year-old non-pregnant female patient received first dose bnt162b2 (Pfizer's COVID-19 vaccine, Solution for injection (Batch no: not reported, expiration: not reported), via an unspecified route of administration on Right arm on 27Feb2021 at 11:30 AM at single dose for covid-19 immunization. The patient medical history include neuropathy. The concomitant medications include Gabapentin, Eliquis, CBD/THC, Bariatric Vitamins. Patient was allergic to PCN, Demerol, Percocet, Iodine, latex, Tetanus. Patient did not have covid prior vaccination. Patient had not tested covid post vaccination. Patient did not had other vaccine in four weeks. On 27Feb2021 at 04:00 PM, the patient experienced headache, muscle soreness, cramping/diarrhea, fatigue and sight injection pain. The outcome of the events was recovering.  No follow-up attempts are possible. Information on the batch/lot number cannot be requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; muscle soreness; cramping/diarrhea; fatigue; sight injection pain; cramping; This is a spontaneous report from a contactable consumer (the patient). A 54-Year-old non-pregnant female patient received first dose bnt162b2 (Pfizer's COVID-19 vaccine, Solution for injection (Batch no: not reported, expiration: not reported), via an unspecified route of administration on Right arm on 27Feb2021 at 11:30 AM at single dose for covid-19 immunization. The patient medical history include neuropathy. The concomitant medications include Gabapentin, Eliquis, CBD/THC, Bariatric Vitamins. Patient was allergic to PCN, Demerol, Percocet, Iodine, latex, Tetanus. Patient did not have covid prior vaccination. Patient had not tested covid post vaccination. Patient did not had other vaccine in four weeks. On 27Feb2021 at 04:00 PM, the patient experienced headache, muscle soreness, cramping/diarrhea, fatigue and sight injection pain. The outcome of the events was recovering.  No follow-up attempts are possible. Information on the batch/lot number cannot be requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: headache; cold chills; Fever; Had aches; This is a spontaneous report from a contactable consumer(patient). A 72-year-old female received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number; EN6198 and Expiration date was not reported), via an unknown route of administration in right arm on 24Feb2021 at 16:00(at the age of 72-year-old), as 1st dose, single for COVID-19 immunization. The patient medical history including any illness at time of vaccination were none. The vaccine was not administered at military facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the Pfizer suspect was not provided. Prior vaccinations within 4 weeks were none. The concomitant medications were not reported. Patient received the first dose of the Pfizer Covid 19 vaccine last wednesday on 24Feb2021. She felt fine after vaccination. On 28Feb2021, she started having fever (of 99.8, which her normal is 97.4), fever broke at 11pm last night and no other fever. The fever broke, she discovered she had a fever and then about 7 hours later it broke, she had taken some Tylenol. She had cold chills and had a real bad headache that lasted for about 24 hours and today she does not have a fever, her fever broke. She said it started, about all day long she had a headache and they have had some crazy weather so she thought it may have been the barometric pressure and then she started having the cold chills in afternoon and the temperature, usually she did not run a fever, so she was a little concerned, she said she hopes she didn't have COVID but she still had her taste and smell and she checked her temperature and she has no fever today. The chills are somewhat resolved but she was still chilly even with the heat on and extra clothes she was cold. She said the chills are ongoing but improved. She no longer has the headache today. She confirmed fever chills and headaches was everything she experienced following the vaccine. She doesn't feel really good either and she was wondering if it is normal that many days after the vaccination to have side effects. The events did not require visit to emergency room and physician office. She complained a product complaint.The outcome of the event had aches was unknown and for the event chills was recovering, whereas headache and fever was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Lethargy
Clinical narrative: Generally feeling horribly; Four days later terrible body aches; chills; vomiting and a headache that lasted for 36 hours; Headache; Seven days later, still lethargic and fatigued; fatigue; This is a spontaneous report received from a contactable consumer (patient).   A 58-year-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration, administered in left arm on 22Feb2021 at 10:30 AM as 1st dose single for covid-19 immunisation. The patient medical history included breast cancer on an unknown date in 2015. The patient had known allergy with penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included tamoxifen, ergocalciferol (VIT D), calcium,, acetylsalicylic acid (BABY ASPIRIN) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos (MULTI VIT) in two weeks of vaccination. On 22Feb2021 (the night of 1st shot vaccination), the patient experienced headache. On 26Feb2021, four days later, the patient experienced terrible body aches, chills, vomiting and a headache that lasted for 36 hours. The patient was generally feeling horribly and seven days later still lethargic and fatigued was continued. The patient did not receive treatment for the events. The patient had not covid tested post vaccination and patient had no covid prior vaccination. The outcome of the events was recovered on an unknown date in 2021. It was reported that patient was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Generally feeling horribly; Four days later terrible body aches; chills; vomiting and a headache that lasted for 36 hours; Headache; Seven days later, still lethargic and fatigued; fatigue; This is a spontaneous report received from a contactable consumer (patient).   A 58-year-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration, administered in left arm on 22Feb2021 at 10:30 AM as 1st dose single for covid-19 immunisation. The patient medical history included breast cancer on an unknown date in 2015. The patient had known allergy with penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included tamoxifen, ergocalciferol (VIT D), calcium,, acetylsalicylic acid (BABY ASPIRIN) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos (MULTI VIT) in two weeks of vaccination. On 22Feb2021 (the night of 1st shot vaccination), the patient experienced headache. On 26Feb2021, four days later, the patient experienced terrible body aches, chills, vomiting and a headache that lasted for 36 hours. The patient was generally feeling horribly and seven days later still lethargic and fatigued was continued. The patient did not receive treatment for the events. The patient had not covid tested post vaccination and patient had no covid prior vaccination. The outcome of the events was recovered on an unknown date in 2021. It was reported that patient was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Headache, Malaise, Pain
Clinical narrative: Generally feeling horribly; Four days later terrible body aches; chills; vomiting and a headache that lasted for 36 hours; Headache; Seven days later, still lethargic and fatigued; fatigue; This is a spontaneous report received from a contactable consumer (patient).   A 58-year-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration, administered in left arm on 22Feb2021 at 10:30 AM as 1st dose single for covid-19 immunisation. The patient medical history included breast cancer on an unknown date in 2015. The patient had known allergy with penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included tamoxifen, ergocalciferol (VIT D), calcium,, acetylsalicylic acid (BABY ASPIRIN) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos (MULTI VIT) in two weeks of vaccination. On 22Feb2021 (the night of 1st shot vaccination), the patient experienced headache. On 26Feb2021, four days later, the patient experienced terrible body aches, chills, vomiting and a headache that lasted for 36 hours. The patient was generally feeling horribly and seven days later still lethargic and fatigued was continued. The patient did not receive treatment for the events. The patient had not covid tested post vaccination and patient had no covid prior vaccination. The outcome of the events was recovered on an unknown date in 2021. It was reported that patient was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Generally feeling horribly; Four days later terrible body aches; chills; vomiting and a headache that lasted for 36 hours; Headache; Seven days later, still lethargic and fatigued; fatigue; This is a spontaneous report received from a contactable consumer (patient).   A 58-year-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration, administered in left arm on 22Feb2021 at 10:30 AM as 1st dose single for covid-19 immunisation. The patient medical history included breast cancer on an unknown date in 2015. The patient had known allergy with penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included tamoxifen, ergocalciferol (VIT D), calcium,, acetylsalicylic acid (BABY ASPIRIN) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos (MULTI VIT) in two weeks of vaccination. On 22Feb2021 (the night of 1st shot vaccination), the patient experienced headache. On 26Feb2021, four days later, the patient experienced terrible body aches, chills, vomiting and a headache that lasted for 36 hours. The patient was generally feeling horribly and seven days later still lethargic and fatigued was continued. The patient did not receive treatment for the events. The patient had not covid tested post vaccination and patient had no covid prior vaccination. The outcome of the events was recovered on an unknown date in 2021. It was reported that patient was recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Lethargy
Clinical narrative: she tested positive of the Covid-19 yesterday (March 4,2021); Chills; Headache; body aches; she started feeling sick; This is a spontaneous report received from a contactable consumer (Patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 22Feb2021(at the age of 58 years old) as first dose, single for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included tamoxifen taken for breast cancer, start and stop date were not reported. On 26Feb2021 the patient experienced, consumer states she got the first Pfizer vaccine on Monday 22Feb2021, scheduled to get second 12Mar2021, states in between the two dates, she wound up getting Covid 19 States she started feeling sick on Friday 26 FEB 2021, 4 days after vaccine, states initially she thought it was a reaction, she had the chills, body aches, headache. States by Tuesday 02Mar2021 she was still out of it, states she had a telehealth with doctor on Tuesday she thought she should get tested for Covid, states on Wednesday she got tested, rapid test came back negative, and PCR came back positive, the PCR test resulted on Thursday 04Mar2021. Question: Call back attempt #1 on 10Mar2021 at 6:12 PM EST. called be-cause she tested positive of the Covid-19 yesterday (04Mar2021). She got her 1st dose on 22Feb2021 and scheduled for the second dose on 12Mar2021, and she will not be able to take it on the scheduled date. She wants to know how long she needs to wait to get the second dose and if she needs to get the 1stdose again. The patient underwent lab tests and procedures which included sars-cov-2 test and resulted negative on 03Mar2021 rapid test and sars-cov-2 test and resulted positive on 04Mar2021 PCR test. Outcome of the event was unknown.  Follow up (05Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below information. Query: Attached is an escalated comment from 05Mar2021 for CEP 159558. Response: This is to confirm receipt of inquiry. Please document  case number INT #.  Follow up (16Mar2021): This follow up report contains no new medically significant safety information.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vomiting
Clinical narrative: she tested positive of the Covid-19 yesterday (March 4,2021); Chills; Headache; body aches; she started feeling sick; This is a spontaneous report received from a contactable consumer (Patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 22Feb2021(at the age of 58 years old) as first dose, single for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included tamoxifen taken for breast cancer, start and stop date were not reported. On 26Feb2021 the patient experienced, consumer states she got the first Pfizer vaccine on Monday 22Feb2021, scheduled to get second 12Mar2021, states in between the two dates, she wound up getting Covid 19 States she started feeling sick on Friday 26 FEB 2021, 4 days after vaccine, states initially she thought it was a reaction, she had the chills, body aches, headache. States by Tuesday 02Mar2021 she was still out of it, states she had a telehealth with doctor on Tuesday she thought she should get tested for Covid, states on Wednesday she got tested, rapid test came back negative, and PCR came back positive, the PCR test resulted on Thursday 04Mar2021. Question: Call back attempt #1 on 10Mar2021 at 6:12 PM EST. called be-cause she tested positive of the Covid-19 yesterday (04Mar2021). She got her 1st dose on 22Feb2021 and scheduled for the second dose on 12Mar2021, and she will not be able to take it on the scheduled date. She wants to know how long she needs to wait to get the second dose and if she needs to get the 1stdose again. The patient underwent lab tests and procedures which included sars-cov-2 test and resulted negative on 03Mar2021 rapid test and sars-cov-2 test and resulted positive on 04Mar2021 PCR test. Outcome of the event was unknown.  Follow up (05Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below information. Query: Attached is an escalated comment from 05Mar2021 for CEP 159558. Response: This is to confirm receipt of inquiry. Please document  case number INT #.  Follow up (16Mar2021): This follow up report contains no new medically significant safety information.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Headache, Malaise, Pain
Clinical narrative: she tested positive of the Covid-19 yesterday (March 4,2021); Chills; Headache; body aches; she started feeling sick; This is a spontaneous report received from a contactable consumer (Patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 22Feb2021(at the age of 58 years old) as first dose, single for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included tamoxifen taken for breast cancer, start and stop date were not reported. On 26Feb2021 the patient experienced, consumer states she got the first Pfizer vaccine on Monday 22Feb2021, scheduled to get second 12Mar2021, states in between the two dates, she wound up getting Covid 19 States she started feeling sick on Friday 26 FEB 2021, 4 days after vaccine, states initially she thought it was a reaction, she had the chills, body aches, headache. States by Tuesday 02Mar2021 she was still out of it, states she had a telehealth with doctor on Tuesday she thought she should get tested for Covid, states on Wednesday she got tested, rapid test came back negative, and PCR came back positive, the PCR test resulted on Thursday 04Mar2021. Question: Call back attempt #1 on 10Mar2021 at 6:12 PM EST. called be-cause she tested positive of the Covid-19 yesterday (04Mar2021). She got her 1st dose on 22Feb2021 and scheduled for the second dose on 12Mar2021, and she will not be able to take it on the scheduled date. She wants to know how long she needs to wait to get the second dose and if she needs to get the 1stdose again. The patient underwent lab tests and procedures which included sars-cov-2 test and resulted negative on 03Mar2021 rapid test and sars-cov-2 test and resulted positive on 04Mar2021 PCR test. Outcome of the event was unknown.  Follow up (05Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below information. Query: Attached is an escalated comment from 05Mar2021 for CEP 159558. Response: This is to confirm receipt of inquiry. Please document  case number INT #.  Follow up (16Mar2021): This follow up report contains no new medically significant safety information.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: she tested positive of the Covid-19 yesterday (March 4,2021); Chills; Headache; body aches; she started feeling sick; This is a spontaneous report received from a contactable consumer (Patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 22Feb2021(at the age of 58 years old) as first dose, single for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. Concomitant medication included tamoxifen taken for breast cancer, start and stop date were not reported. On 26Feb2021 the patient experienced, consumer states she got the first Pfizer vaccine on Monday 22Feb2021, scheduled to get second 12Mar2021, states in between the two dates, she wound up getting Covid 19 States she started feeling sick on Friday 26 FEB 2021, 4 days after vaccine, states initially she thought it was a reaction, she had the chills, body aches, headache. States by Tuesday 02Mar2021 she was still out of it, states she had a telehealth with doctor on Tuesday she thought she should get tested for Covid, states on Wednesday she got tested, rapid test came back negative, and PCR came back positive, the PCR test resulted on Thursday 04Mar2021. Question: Call back attempt #1 on 10Mar2021 at 6:12 PM EST. called be-cause she tested positive of the Covid-19 yesterday (04Mar2021). She got her 1st dose on 22Feb2021 and scheduled for the second dose on 12Mar2021, and she will not be able to take it on the scheduled date. She wants to know how long she needs to wait to get the second dose and if she needs to get the 1stdose again. The patient underwent lab tests and procedures which included sars-cov-2 test and resulted negative on 03Mar2021 rapid test and sars-cov-2 test and resulted positive on 04Mar2021 PCR test. Outcome of the event was unknown.  Follow up (05Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow up spontaneous report from a contactable consumer.  Follow up (10Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below information. Query: Attached is an escalated comment from 05Mar2021 for CEP 159558. Response: This is to confirm receipt of inquiry. Please document  case number INT #.  Follow up (16Mar2021): This follow up report contains no new medically significant safety information.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Pain
Clinical narrative: Severe Headache; major fatigue; body ache; stomach pain; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self Reporting. A 70-years-old non-pregnant female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in arm right on 27Feb2021 at 12:00 (Batch/Lot Number: EN6205) (at the age of 70-years-old) as a single dose for COVID-19 immunization. Medical history included thyroid and high cholesterol. Patient was allergic to CAT scan dye. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in arm left on 06Feb2021 at 12:00 (Batch/Lot Number: EL9269) (at the age of 70-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested for COVID post vaccination. The patient took other medications (unspecified) within two weeks near to vaccination date. On 28Feb2021 at 02:00 AM, the patient experienced severe headache, major fatigue, body aches and stomach pain. No treatment was provided for the events. The outcome of the events was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; chills; ache; This is a spontaneous report from a contactable consumer (patient). A 71 years-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (Solution for Injection, lot number: EL9269, Expiration date: unknown), via an unspecified route of administration on 26Feb2021, at 06:00 PM (at 71-years-age) as 2nd dose, single dose for covid-19 immunisation and received first dose of BNT162B2 (Solution for Injection, lot number, Expiration date: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. Other vaccination date reported as Feb2021. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. On an unspecified date, the patient experienced headache, chills and aches after 24 hours of vaccination. No Treatment received for the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Headache, Pain in extremity
Clinical narrative: sore arm; Headache and dizziness as if I had hit my head or got anesthesia and was about to go out; Headache and dizziness as if I had hit my head or got anesthesia and was about to go out; feeling of heaviness/heaviness in my head; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration, administered in left arm on 01Mar2021 at 13:00 (at the age of 51-year-old) at a single dose for covid-19 immunisation in workplace clinic. Medical history included hypothyroidism and autoimmune disorders. 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 vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) at a dose of 112 mg daily, calcium and vitamin supplement. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 at 13:15, minutes after vaccination when the patient was sitting in the waiting/observation area the patient experienced headache and dizziness as if the patient had hit her head or got aneathesia and was about to go out and had feeling of heaviness/heaviness in her head. Patient stayed a bit longer when she thought she could leave 15-20 minutes after the feeling started to subside and but when she tried to walk and go upstairs dizziness and feeling of heaviness was persisted, got better with lots of water. Overall, about 2 hours later around 3- 3.30 pm she was feeling better and went home. That evening around 8 pm, she felt ok without the dizziness or heaviness in her head. She only had a sore arm and was ok the next day. No treatment was received to the patient for the events. The outcome of event sore arm was recovering, rest of the events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Neck pain
Clinical narrative: Headache with little bump on the neck area (lymph node swollen); Headache with little bump on the neck area (lymph node swollen); Headache with little bump on the neck area/The bump was sore; This is a spontaneous report from a contactable consumer or other non healthcare. A 27-years-old non-pregnant female patient received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318), via an unspecified route of administration, administered in arm right on 16Feb2021 at 09:45 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient was not covid prior vaccination. On 17Feb2021 at 08:00 the patient experienced headache with little bump on the neck and lymph node swollen. The patient was vaccinated at the workplace clinic. It was reported that the patient had headache with little bump on the neck area (lymph node swollen) on the next day. The bump was sore. Headache and the little bump was gone by the third day of vaccination. Patient was not covid tested post vaccination. Patient did not received treatment for AE. Outcome of the event neck pain was unknown and the outcome of the other two events were recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: headache; neck pain; This is a spontaneous report from a contactable consumer, on behalf of his wife via Pfizer-sponsored program. A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient slept wrong and experienced neck pain. Patient also had headache. Reporter was asking ibuprofen could be taken for the headache due to the wrong sleeping position. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Dull on and off headache 24 hours post second dose that lasted for 24 hours; Diarrhea 34 hours post second dose that lasted approximately 6 hours.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiry date was not reported), via an unspecified route of administration, administered in arm right on 25Feb2021 at 02:15 as a single dose for covid-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiry date was not reported), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. Patient had no known allergies. Prior to the 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. No medications in 2 weeks. On 26Feb2021 (reported as at 16:00), 24 hours post second dose patient experienced dull on and off headache post second dose that lasted for 24 hours and diarrhoea 34 hours post second dose that lasted approximately 6 hours. No treatments were received for the events. The outcome of the events was recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Headache, Neck pain
Clinical narrative: pain/fatigue in neck and shoulders; sharp pains in the head, like a burning sensation; pain/fatigue in neck and shoulders; pain/fatigue in neck and shoulders; sharp pains in the head, like a burning sensation; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced, the patient received first dose Pfizer on 16feb2021 4 days after the shot she developed sharp pains in the head, like a burning sensation, with pain/fatigue in neck and shoulders. Pain was still ongoing. The outcome of events headache, burning sensation, fatigue was unknown whereas pain was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Nasal congestion, Pain in extremity
Clinical narrative: headache; Sore arm; muscle aches; weakness; congestion; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 11:45 (Batch/Lot Number: EN6200) as 2nd dose, single for covid-19 immunization. Medical history included High blood pressure, high blood cholesterol and ascending aortic aneurysm. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27Jan2021 at 4:30 (Batch/Lot Number: EL982) as 1st dose, single for covid-19 immunization.Concomitant medications within 2 weeks included rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), omeprazole (PRILOSEC [OMEPRAZOLE]) and low dose acetylsalicylic acid (ASPIRIN ). Patient did not take other vaccines in four weeks. Patient did not had Allergies. The patient had Covid prior vaccination.The patient tested Covid post vaccination on 19May2020 which was negative. On 20Feb2021 at 09:00 the patient experienced headache, sore arm, muscle aches, weakness, congestion for about 36hours. No treatment was administered for the events. The patient was recovered from the events in 2021.  No follow up attempts are possible. No further information is expected.