chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Tested positive to COVID-19/tested positive to COVID-19; Tested positive to COVID-19/tested positive to COVID-19; This is a spontaneous report received from a contactable consumer (Patient). This 42-year-old male consumer (patient) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration at 11Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient developed symptoms of COVID-19 around 22/23 March 2021 and tested positive to COVID-19 on 25Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test positive on 25Mar2021. Patient was explained received different recommendation about the second dose, which was due on 1Apr2021.The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: supposed to get her 2nd dose but got Covid; I received the first dose of the Pfizer vaccine on march 6 2021. I got COVID; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer sponsored Program . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER COVID-19 mRNA VACCINE, Lot number- UNKNOWN) via an unspecified route of administration on 06Mar2021, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient had COVID (encoded as Covid-19 and drug ineffective). Her second dose of vaccination was scheduled for Saturday (prior to this report, 27Mar2021), however she could not receive it due to COVID. The outcome of the events of COVID-19 and drug ineffective was not reported.  No further information was available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: had an ache in the arm after receiving their Covid 19 vaccines; This is a spontaneous report received from a contactable consumer. A 72-years-old female patient received first dose of bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EK9231) via unspecified route of administration on 13Jan2021 in left arm and second dose of bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EL8982) via unspecified route of administration in left arm on 01Feb2021 09:15 at a SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced ache in the arm on 02Feb2021. Patient tested positive for Sars-Cov-2 IGM after receiving both covid 19 vaccines on 23Mar2021.The patient underwent lab tests and procedures which included blood test was positive, COVID-19 PCR Test and Sars-Cov-2 IGG was negative on 23Mar2021. She had gone to her doctor on 02Mar2021 for a normal blood draw and received her blood work results. The doctor's office called her and told her she had IGM markers. Her doctor told her she needed to get a Covid 19 virus test. She also had the nasal swab test for Covid 19 and that was negative. She's never been symptomatic for Covid 19, she's never had a fever, shortness of breath, or cold like symptoms. The outcome of events Sars Cov 2 IGM positive test after receiving both Covid 19 vaccines (COVID-19) and Sars Cov 2 IGM positive test after receiving both Covid 19 vaccines (vaccination failure) were unknown and pain in arm was recovered on 03Feb2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood pressure increased, Blood pressure measurement, Burning sensation, Erythema
Clinical narrative: Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; BP 183/90; This is a spontaneous report from two contactable consumers (one is the patient). A 66-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), in left arm on 09Mar2021 at 13:00 (at the age of 66-years-old) at single dose for COVID-19 immunization. Medical history included known allergies at lemon, lime, green peppers, mushrooms, walnuts, sleep apnea, asthma, obesity, anxiety/antidepressants for 35 years from 1986. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), albuterol (salbutamol), duloxetine hydrochloride (CYMBALTA), colecalciferol (D3), ascorbic acid (C), antidepressants. The patient previously took furosemide and theophylline and experienced allergies. The patient experienced numbness on the left side of the face, started 25 minutes after the injection, on 09Mar2021 at 13:30 and resolved fully within 30 hours. ER visit immediately. MRI showed nothing. Blood pressure (BP) 183/90. Left side of face hot, red, and a mild burning sensation on 09Mar2021 at 13:30. Diagnosis bells palsy probably. Follow up visit to the doctor concurred. The events resulted in emergency room/department or urgent care; no treatment was received for the events; no Covid prior vaccination; no Covid tested post vaccination. No other vaccine in four weeks. The patient had recovered from the events on 10Mar2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Bells Palsy; Numbness on the left side of the face; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; Left side of face hot, red, and a mild burning sensation; BP 183/90; This is a spontaneous report from two contactable consumers (one is the patient). A 66-year-old female patient (no pregnant) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), in left arm on 09Mar2021 at 13:00 (at the age of 66-years-old) at single dose for COVID-19 immunization. Medical history included known allergies at lemon, lime, green peppers, mushrooms, walnuts, sleep apnea, asthma, obesity, anxiety/antidepressants for 35 years from 1986. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), tiotropium bromide (SPIRIVA), albuterol (salbutamol), duloxetine hydrochloride (CYMBALTA), colecalciferol (D3), ascorbic acid (C), antidepressants. The patient previously took furosemide and theophylline and experienced allergies. The patient experienced numbness on the left side of the face, started 25 minutes after the injection, on 09Mar2021 at 13:30 and resolved fully within 30 hours. ER visit immediately. MRI showed nothing. Blood pressure (BP) 183/90. Left side of face hot, red, and a mild burning sensation on 09Mar2021 at 13:30. Diagnosis bells palsy probably. Follow up visit to the doctor concurred. The events resulted in emergency room/department or urgent care; no treatment was received for the events; no Covid prior vaccination; no Covid tested post vaccination. No other vaccine in four weeks. The patient had recovered from the events on 10Mar2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in groin area; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration, administered in gluteus medius right on 25Mar2021 at 09:00 as single dose for COVID-19 immunization. Medical history included ER+/HR+HER2- IDC and DCIS, left breast. The patient did not had allergies to medications, food, or other products. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration, administered in right buttocks on 04Mar2021 09:00 as single dose for COVID-19 immunization. Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN), fish oil (OMEGA 3 FISH OIL [FISH OIL]) and curcumin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swollen lymph node in groin area on 27Mar2021 at 06:00. The patient did not received treatment for the adverse event. The outcome of event was not recovered. The reporter classified the event as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: injection site pain; extreme tiredness; headache; chills; sweating; feeling unwell; dizziness; This is a spontaneous report from a contactable consumer. A 60-year-old male consumer (Patient himself) reported that he received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration in arm left on 28MAR2021 11:00 AM (at 60-years-old) as a single dose of administration. Patient medical history included high blood pressure, prostate cancer. No record of allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On29Mar2021 3:00, patient experienced injection site pain, extreme tiredness, headache, chills alternating with profuse sweating, feeling unwell, dizziness. No therapeutic measures were taken for the event caused. Outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: injection site pain; extreme tiredness; headache; chills; sweating; feeling unwell; dizziness; This is a spontaneous report from a contactable consumer. A 60-year-old male consumer (Patient himself) reported that he received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via unspecified route of administration in arm left on 28MAR2021 11:00 AM (at 60-years-old) as a single dose of administration. Patient medical history included high blood pressure, prostate cancer. No record of allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On29Mar2021 3:00, patient experienced injection site pain, extreme tiredness, headache, chills alternating with profuse sweating, feeling unwell, dizziness. No therapeutic measures were taken for the event caused. Outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: A touch of fever about 12 hrs after injection; the area of injection (left arm) got sore for about 3 days and then it went away.; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in left arm on 26Mar2021 02:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, early diabetes. Patient was not allergic to anything. Concomitant medications included metformin hydrochloride, amlodipine besilate, Olmesartan, atorvastatin calcium. The patient had not received any other vaccines prior to the COVID vaccine. On 26Mar2021 18:00 patient experienced a touch of fever about 12 hrs. after injection. Also, after about 24 hrs. the area of injection (left arm) got sore for about 3 days and then it went away. No treatment received for reported adverse event. The outcome of the events was resolved.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: fever for 48 hrs; arm swelling; This is a spontaneous report from a non-contactable consumer (parent). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date in Mar2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.. The patient experienced fever for 48 hrs and arm swelling on Mar2021 05:00. Treatment received for the adverse event was unknown. Any other vaccines taken in four weeks was unknown. It was unknown that the patient diagnosed with COVID-19 prior to vaccination and also since the vaccination, the patient been tested for COVID-19 was unknown. The outcome of the events was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Nausea, Pruritus
Clinical narrative: Shortness of breath when performing normal exercise routine on Mar 26,27, and 29; Severe itching (pruritis) on Mar 20; minor nausea and fatigue on Mar 19; minor nausea and fatigue on Mar 19; This is a spontaneous report from contactable consumer (patient, self-reported). A 64-years-old female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in right arm at 18Mar2021 at 04:30 PM, as single dose for COVID-19 immunization. The patient had medical history of high blood pressure, breast cancer in 1994 and Heart attack in 2011. The concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.)) and IRBESARTAN/HCTZ GA. It reported that, on 19Mar2021 at 06:00 AM patient experienced minor nausea and fatigue, Severe itching (pruritis) on 20Mar2021, it continued for over a week and Shortness of breath when performing normal exercise routine on Mar 26, 27, and 29. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, not been tested for COVID-19. There was no known allergies to medications, food, or other products. The pharmacy or drug Store where the vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the patient's events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: cannot move my shoulder sever pain in motion; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number er8732 and expiration date were not reported) via unknown route in left arm on 24Mar2021 at 15:30 at SINGLE DOSE for covid-19 immunization. Patient had no other medical history. Patient had no allergies to medications, food or other products. The patient received empagliflozin (JARDIANCE) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. It was reported that on an unknown date patient could not move his shoulder severe pain in motion. Patient did not receive any treatment for the adverse event. The outcome of the event was recovering.   No follow-up attempts are possible and no further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Appendix disorder, Burning sensation, Computerised tomogram, Constipation
Clinical narrative: constipation; Severe lower right side pain, felt like burning and stabbing, thought my appendix was rupturing; felt like burning and stabbing; appendix was rupturing; This is a spontaneous report from a contactable consumer (reported for herself). A 53-year-old female non pregnant received second dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number ER2613, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 19MAR2021, for covid-19 immunization. Medical history included Gastrooesophageal reflux disease, diverticulitis, Graves Disease in left eye, full hysterectomy, high bp, high cholesterol, depression, hypothyroidism, Gastric bypass and heart ablation. Concomitant medications included an unspecified 5 different medications and daily vitamins. Historical vaccine includes first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number EN6203, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 25FEB2021 06:00 PM, for covid-19 immunization. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Neither was she tested for it since the vaccination. On 24Mar2021 19.00, she experienced severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing. On an unknown date, she went to an emergency room (ER), had a computerized tomography scan that showed constipation. Her pain was at a level 9, was doubled over for 6 hours while seeking care. She had complete sudden onset of pain, with no warning. She was treated with Fentanyl shot that took almost an hour to provide minimal pain relief. Had continuing pain for three days after the initial onset. No real treatment other than pain medication were given at ER. She was told to get collace and mirilax. The outcome of the events of severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash morbilliform
Clinical narrative: Morbiliform rash face, ears, neck; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206), via an unspecified route of administration on 15Mar2021 in left arm as single dose for COVID-19 immunisation in Doctor's office/urgent care. The patient's medical history included arthritis, blood pressure and cholesterol. no known allergies. Patient was not pregnant at the time of vaccination. Concomitant medications included secukinumab (COSENTYX), leflunomide, duloxetine, atorvastatin and Traza. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) on 19Feb2021 in right arm at the age of 64-years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced Morbiliform rash face, ears, neck on 25Mar2021 at 02:00 PM. Events resulted in Doctor or other healthcare professional office/clinic visit. The patient received steroid as treatment for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal
Clinical narrative: Today, the test was positive;  This is a spontaneous case received report from a contactable consumer or other non hcp. A male patient of an unspecified age (61 age unit unknown) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8733) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced today; the test was positive (pending clarification) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included lab test: positive on 30Mar2021. The action taken in response to the event(s) for bnt162b2 was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lump on the left clavicle, suspected to be lymphatic swelling; This is a spontaneous report from a contactable consumer (Patient). A 33-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot# ER2G13), via an unspecified route of administration in left arm on 17Mar2021 at 2.45 PM (at the age of 33 years-of-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Mar2021, patient experienced lump on the left clavicle, suspected to be lymphatic swelling. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the event. It was unknown if the patient had COVID prior vaccination. The patient was not tested for COVID post vaccination. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Felt exhaustion the following day and evening.; woke up at 1 am with aches pains and a slight fever; woke up at 1 am with aches pains and a slight fever; This is a spontaneous report from a contactable consumer. A 32-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunization. Other medical history was none. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. On 22Mar2021 01:00AM, the patient woke up at 1 am with aches pains and a slight fever. Felt exhaustion the following day (23Mar2021) and evening. The patient received second dose of BNT162B2 (Lot number EP6955) via an unspecified route of administration, administered in Arm Left on 28Mar2021 10:30 PM as SINGLE DOSE for covid-19 immunization. The events were assessed as non-serious. No treatment received for the adverse event. Outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive COVID; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), dose 1 administered via intramuscular route of administration on arm left on 20Mar2021 at 12:00 as single dose for covid-19 immunization. Medical history reported that patient is overweight but has not diagnosed with diabetes, has a lot of symptoms though, seasonal allergies and was really young around 14-15 and had two surgeries for it. One surgery at age 16 and another later to deal with it. All prior to getting the vaccine and family medical history: Diabetes. Concomitant medications were not reported. On 30Mar2021, the patient tested covid positive and scheduled to get second dose in 13 days and is not sure what to do. He would like to get some guidance about when to get second dose. Outcome of event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nausea
Clinical narrative: cough; chills; nausea; This is a spontaneous report from a contactable consumer (patient) reported for himself. This 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 13Mar2021, and was scheduled for the second dose this Saturday. This last week (unspecified date in Mar2021), patient had been experiencing cough, chills and nausea when he was about to eat. The outcome of events was unknown.   No follow-up attempts are possible; Information about batch/Lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective
Clinical narrative: very weak; Caller states her mom was diagnosed with COVID-19 yesterday/Received first dose on 15Mar2021; diagnosed with Covid on 29Mar2021; Caller states her mom was diagnosed with COVID-19 yesterday/Received first dose on 15Mar2021; diagnosed with Covid on 29Mar2021; This is a spontaneous report from a contactable consumer or other non HCP. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that her mom was scheduled to receive the second dose on 02Apr2021. Her mom was diagnosed with COVID-19 on 29Mar2021. The patient had called (health department name) and they told her that her mother should wait 90 days to receive the second dose and then she would have to restart the series. The reporter would like to know what guidance there was for people who are diagnosed with COVID between doses and receiving their second doses and would like to know what the maximum amount of time is you should not go over between the first and second dose of the Pfizer COVID vaccine. Her mother's doctor doesn't know, nobody knows, if they need to reschedule her second vaccine. The patient  just wanted to know what was right,  Wants to know when her mom can get the second vaccine, if she has to start over. Caller declines to complete safety report. States she has been on hold for 45 minutes and was on hold prior to that with someone else. She stated they took down all of her information and that she just wants to get her question answered and Caller stated she did not have the Lot number from her mom's vaccine as it is with her mom who was not with the caller at this time, declined to provide mailing address and stated that its already been given to previous department she was speaking with. Caller was concerned because her mother will be placed under a 14-day quarantine and she was not sure on how her mother will receive the 2nd vaccine or whether her mother will repeat the entire process of vaccination because her mother was very weak and will still be on quarantine on the 2nd dose vaccination appointment. The outcome of the events was unknown.  Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's mom) that: patient was diagnosed with COVID on 29Mar2021.  Follow-up (30Mar2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a patient (Reporter's mother) new event asthenia.  Information about Batch/Lot number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate, Heart rate increased, Pain
Clinical narrative: Headache; Rapid heartbeat; Body aches; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose bnt162b2 (Pfizer, Lot Number: EP69SS) on 30Mar2021 01:30 PM at the age of 64-year-old as single dose for COVID-19 immunisation in left arm. The patient was not pregnant at the time of event and vaccination. Medical history included anxiety, and was allergy to Septra. Concomitant medications received within 2 weeks of vaccination included duloxetine, calcium, magnesium, vitamin D. The patient had taken the first dose COVID 19 Vaccine (Pfizer, Lot number: EN6206) on 08Mar2021 for COVID-19 immunisation in left arm. The patient was not diagnosed with COVID-19 prior to vaccination, and hasn't been tested for COVID-19 since the vaccination. The patient experienced non-serious events: headache, rapid heartbeat, body aches, dizziness on 30Mar2021 10:00 PM with outcome of not recovered. No treatment received for the events.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: he had a bad fever; This is a spontaneous report from a contactable consumer. A contactable consumer of 60-years-old male patient (himself) reported for himself that received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that after receiving first dose of vaccine he experienced a bad fever on an unspecified date that lasted for half an hour. He wanted to know if this is normal. He wondered if he could take the second dose as he heard that some people had worse reactions after the first dose if they had COVID in the past. She wondered if she could take Tylenol before vaccination. The outcome of the event was unknown.  Information about batch/lot number is not provided. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue in arm that shot was administered in; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 16:30 (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunization. No other medical history. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 04:00 PM (Batch/Lot Number: EN6199) as SINGLE DOSE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications were not received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.: No Allergies to medications, food, or other products. On 27Mar2021 03:00 PM, the patient Extreme fatigue in arm that shot was administered in. The event was assessed as non-serious. No treatment received for the adverse event. Outcome of the event was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Ear discomfort, Nasopharyngitis
Clinical narrative: More swelling in left hand; Increase in joint pain; Common cold symptoms; Right ear felt weird; Increase blood pressure within 15minutes of the injection; This is a spontaneous report received from a contactable consumer (reporting on herself). A 50-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration in Arm Right on 23Mar2021 16:15, as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis, hypothyroidism, hypertension all from an unknown date and unknown if ongoing. Concomitant medication(s) included prednisone (PREDNISONE) and meloxicam (MELOXICAM) both taken for an unspecified indication, start and stop date were not reported. The historical vaccine includes flu vaccine on an unspecified date. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 23-MAR-2021 18:00, more swelling in left hand, increase in joint pain, common cold symptoms, increase blood pressure Within 15minutes of the injection. Right ear felt weird. Patient was not received any treatment for the adverse reactions. Since the vaccination, patient was not tested for COVID-19. The outcome of the events recovered with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: More swelling in left hand; Increase in joint pain; Common cold symptoms; Right ear felt weird; Increase blood pressure within 15minutes of the injection; This is a spontaneous report received from a contactable consumer (reporting on herself). A 50-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration in Arm Right on 23Mar2021 16:15, as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis, hypothyroidism, hypertension all from an unknown date and unknown if ongoing. Concomitant medication(s) included prednisone (PREDNISONE) and meloxicam (MELOXICAM) both taken for an unspecified indication, start and stop date were not reported. The historical vaccine includes flu vaccine on an unspecified date. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 23-MAR-2021 18:00, more swelling in left hand, increase in joint pain, common cold symptoms, increase blood pressure Within 15minutes of the injection. Right ear felt weird. Patient was not received any treatment for the adverse reactions. Since the vaccination, patient was not tested for COVID-19. The outcome of the events recovered with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Sinus disorder, Tremor
Clinical narrative: 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; 13 hours after receiving 2nd vaccine, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613), via an unspecified route of administration, administered in arm left on 28Mar2021 at 12:00 as single dose for COVID-19 immunization. Medical history included breast cancer from 2013 and blood cholesterol increased. The patient had allergy to sulfa. The patient previously received first dose of bnt162b2 (lot number: EN6202), in left arm on 07Mar2021 at 15:30 as single doses for COVID-19 immunization. Concomitant medication(s) (received within 2 weeks of vaccination) included atorvastatin, colecalciferol (VITAMIN D [COLECALCIFEROL]), ascorbic acid, betaine hydrochloride, boric acid, calcium carbonate, calcium citrate, calcium lactate, calcium pantothenate, calcium phosphate, citric acid, colecalciferol, copper gluconate, cyanocobalamin, folic acid, fumaric acid, magnesium aspartate, magnesium oxide, malic acid, manganese aspartate, menaquinone-7, nicotinamide, oxogluric acid, phytomenadione, pyridoxine hydrochloride, riboflavin, silicon dioxide, sodium molybdate, sodium selenite, strontium chloride, succinic acid, thiamine, zinc picolinate (OSTEOPRIME ULTRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Mar2021 at 03:00, the patient experienced 13 hours after receiving second dose, woke up with chills, shaking, extreme muscle aches, headache and sinus drainage. The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Very sore immediately in arm. Hurts to even lift it the slightest; very nauseous; stomach upset; loose bowels; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization. Medical history included allergic to Hydrocodone. Concomitant medications (received within 2 weeks of vaccination) included levothyroxine sodium (LEVOXYL), bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL) and aprazalam. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. In Mar2021, the patient experienced very sore immediately in arm, hurts to even lift it the slightest, very nauseous, stomach upset and loose bowels. It was unknown whether the patient was admitted to the hospital. No treatment received for the events. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Eating disorder, Hyperhidrosis
Clinical narrative: sweating; loss of appetite; diarrhea; vomitting lasted for a day; chills; could hardly eat anything for 5 days; This is a follow up spontaneous received from a contactable Consumer (patient). This 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (manufacturer: Unspecified) first dose on 11MAR2021 2 weeks ago (Lot: EN6207, NDC/UPC number: Unknown, Expiry Date: Unknown) at single dose for COVID-19 immunisation. Medical history included COPD, allergies, asthma, all from unspecified date to unspecified date and probably diagnosed from 10-15 years ago. Concomitant medications included Montelukast, Fluconazole, Trazodone for Muscle relaxant, tiotropium bromide (SPIRIVA), oxycodone hydrochloride (OXYCONTIN) for bad back and hip replacement and all of his pain medicine, Nebulizer at 2 times a day, all from unspecified date to unspecified date and other unspecified Concomitant Products. He took a sleeping pill at night so that he could sleep. He took 'Steopus' that was 2 times in the evening for his allergies. The patient previously took multivitamin at one dose every day for couple of months for low on some Vitamins. Received on 2021-03-30 19:21:32 UTC, Originating AE Request: REQ-219680. Submitted by Call Centre 1 Reference: W2021379399; PRIMA: 21-181755. Reporter was warm connected with agent with ID reportum number 542ANWOH. Reporter received the Pfizer covid vaccine, first dose 2 weeks ago and 3 days after that he had diarrhea, vomitting lasted for a day, chills, sweating, he could hardly eat anything for 5 days. The symptoms come and went but from yesterday he stated to feel better now. Probably about 13MAR2021 was when patient first had started with diarrhea and stuff and he vomited just for one day because he had quit eating so then giving up his appetite and from then it was like he would say, it had set off yesterday but he had had chills on and off possibly all day long and all night long, not really heavy heavy sweat but sweat and loss of appetite. Reported event seriousness was unspecified. When probed if the events are improved, worsened or persisting, the patient stated they were about gone now. He was scheduled for his second shot on the first of this month, not this month the coming month. He hoped his second won't be that bad, second shot was 01APR2021. The patient underwent lab tests and procedures, which included did a lab test month and they said he was low on some Vitamins. He was low in some vitamins, he thought. The outcomes of the events was Recovered.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Vomiting
Clinical narrative: sweating; loss of appetite; diarrhea; vomitting lasted for a day; chills; could hardly eat anything for 5 days; This is a follow up spontaneous received from a contactable Consumer (patient). This 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (manufacturer: Unspecified) first dose on 11MAR2021 2 weeks ago (Lot: EN6207, NDC/UPC number: Unknown, Expiry Date: Unknown) at single dose for COVID-19 immunisation. Medical history included COPD, allergies, asthma, all from unspecified date to unspecified date and probably diagnosed from 10-15 years ago. Concomitant medications included Montelukast, Fluconazole, Trazodone for Muscle relaxant, tiotropium bromide (SPIRIVA), oxycodone hydrochloride (OXYCONTIN) for bad back and hip replacement and all of his pain medicine, Nebulizer at 2 times a day, all from unspecified date to unspecified date and other unspecified Concomitant Products. He took a sleeping pill at night so that he could sleep. He took 'Steopus' that was 2 times in the evening for his allergies. The patient previously took multivitamin at one dose every day for couple of months for low on some Vitamins. Received on 2021-03-30 19:21:32 UTC, Originating AE Request: REQ-219680. Submitted by Call Centre 1 Reference: W2021379399; PRIMA: 21-181755. Reporter was warm connected with agent with ID reportum number 542ANWOH. Reporter received the Pfizer covid vaccine, first dose 2 weeks ago and 3 days after that he had diarrhea, vomitting lasted for a day, chills, sweating, he could hardly eat anything for 5 days. The symptoms come and went but from yesterday he stated to feel better now. Probably about 13MAR2021 was when patient first had started with diarrhea and stuff and he vomited just for one day because he had quit eating so then giving up his appetite and from then it was like he would say, it had set off yesterday but he had had chills on and off possibly all day long and all night long, not really heavy heavy sweat but sweat and loss of appetite. Reported event seriousness was unspecified. When probed if the events are improved, worsened or persisting, the patient stated they were about gone now. He was scheduled for his second shot on the first of this month, not this month the coming month. He hoped his second won't be that bad, second shot was 01APR2021. The patient underwent lab tests and procedures, which included did a lab test month and they said he was low on some Vitamins. He was low in some vitamins, he thought. The outcomes of the events was Recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/fever and chills; bone pain; arm pain; This is spontaneous report from a contactable consumer (patient) via Medical information team. This consumer reported similar events for herself and 1 patient (reporter's husband). This is a 1st of two reports. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband both tested positive for COVID-19 on 15Mar2021. Their second vaccination was originally scheduled for March 31, 2021. On 15Mar2021, the patient and her husband experienced fever and chills, the husband felt worse and had to go to a hospital, where he was diagnosed with COVID-19 and was prescribed "medicine for the chills." Then, the patient and one of their children also tested positive for COVID-19 but had no symptoms. They were recommended to stay isolated for 14 days. The patient experienced mild symptoms of arm pain, fever for 1 day, and bone pain after vaccination. She felt better after a couple of days, unlike her husband.The patient underwent lab tests and procedures which included COVID-19 (nasal swab) test: positive on 15Mar2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021353312 same product and event, different patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Neuralgia, Pain
Clinical narrative: Excruciating pain that night in joints, bones, and nerves; Excruciating pain that night in joints, bones, and nerves; Excruciating pain that night in joints, bones, and nerves; Excruciating pain that night in joints, bones, and nerves; This is a spontaneous report received from a contactable consumer (reporting on herself). A 71-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration in Arm Left on 06Mar2021 11:00, as SINGLE DOSE for covid-19 immunization. Medical history included nerve injury, osteoarthritis, cerebrovascular accident (stroke 5 years prior) and covid-19 (Prior to vaccination) all from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM); atorvastatin (ATORVASTATIN); gabapentin (GABAPENTIN); oxymetazoline hydrochloride (CLARITIN ALLERGIC) all taken for an unspecified indication, start and stop date were not reported. The patient previously took antibiotics for drug hypersensitivity and experienced drug hypersensitivity and have allergies to most antibiotics. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that 06Mar2021 20:00 Excruciating pain that night in joints, bones, and nerves. Severe to moderate pain up to 13 days after injection. Patient did not receive any treatment for the events. Patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering.