chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinus pain
Clinical narrative: Flu like symptomss; congestion; runny nose; body aches; sore throat,; sinus pain; POPPING EAR; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) as unknown dose on 20Mar2021 at 10:15am for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 21Mar2021 at 08:00, the patient experienced flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for the reported events. The clinical outcome of the events flu like symptoms, congestion and runny nose, sore throat, body aches, headache, sinus pain and popping ears was not resolved. No follow-up attempts are possible. Information about lot number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysphonia, Gait inability, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. An 84-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route administration in right arm on 10Mar2021 at 12:00 (at the age of 84-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown the patient allergic to food medication or other product. It was unknown the patient received any other vaccine within 4 weeks prior to the covid-19. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 the patient experienced flu-like symptoms, hoarse voice, weakness, hard to walk. The patient received vaccine on 10Mar2021 and still had some of the symptoms today, that is on 23Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures and treatments were not taken for the reported events. The clinical outcome of the events experienced flu-like symptoms, hoarse voice, weakness, hard to walk were not resolved (still have symptoms today i.e., 23Mar2021) at the time of reporting.  Information on lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - both ears; This is a spontaneous report received from a contactable consumer, the patient. A 71-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 14:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medication included trandolapril (MANUFACTURER UNKNOWN) 2mg per day for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. On 13Mar2021, the patient experienced tinnitus in both ears. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatments for the event. The clinical outcome of the event tinnitus in both ears was not recovered.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Feeling abnormal
Clinical narrative: short term memory was off; very foggy head; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 03Mar2021 at 16:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had allergies to mangos, cashews and morphine drug allergy. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 04Mar2021 at 10:00, the patient experienced very foggy head and her short term memory was off. This had lasted for two days and when it cleared up, it was like a cloud being lifted that was very noticeable within a given hour. The patient never had any arm or injection soreness or any other symptoms. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the very foggy head and short term memory was off was recovered on 06Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Accident, Ankle fracture
Clinical narrative: broke his ankle; He had accident slipped on ice; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 28Jan2021 (at the age of 72-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Feb2021, the patient had accident slipped on ice and broke his ankle. He underwent a surgery. He was unable to get the 2nd dose scheduled for 18Feb2021 due to surgery. He asked if he can still get the 2nd dose of the vaccine and would like to know what were his options. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pyrexia, Viral infection
Clinical narrative: Different virus; slight temperature; what to do if she cannot get the second dose within 6 weeks; This is a spontaneous report from a contactable consumer (Patient) reporting herself. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, caller stated she cancelled her second dose appointment today, since she has "a different virus, slight temperature, and is on antibiotic". She enquired how long should wait between the infection and getting the second dose of the COVID-19 vaccine. She also asked for what to do if she cannot get the second dose within 6 weeks. Caller asked: is there a recommended interval to wait between the end of an antibiotic therapy and the Pfizer-BioNTech COVID-19 vaccine vaccination. Therapeutic measures were taken as a result of different virus, slight temperature, was on antibiotics. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fever; headache; nausea; vomiting; diarrhea; exhaustion; full body aches; muscle pain; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a non-contactable consumer or other non hcp (patient) . A 26-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, administered in left arm on 24Mar2021 15:00 (Age at vaccination: 26 Years) (not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation.The patient medical history was not reported. The patient previously took codeine and experienced allergy. (Allergies to medications, food, or other products was reported as Codeine). Concomitant medication included desvenlafaxine taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, headache, nausea, vomiting, diarrhea, exhaustion, full body aches body aches and muscle pain on 25Mar2021 01:00. The outcome of events was recovering. No treatment was given to the patient. 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 was not tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever; headache; nausea; vomiting; diarrhea; exhaustion; full body aches; muscle pain; This is a spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a non-contactable consumer or other non hcp (patient) . A 26-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration, administered in left arm on 24Mar2021 15:00 (Age at vaccination: 26 Years) (not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation.The patient medical history was not reported. The patient previously took codeine and experienced allergy. (Allergies to medications, food, or other products was reported as Codeine). Concomitant medication included desvenlafaxine taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, headache, nausea, vomiting, diarrhea, exhaustion, full body aches body aches and muscle pain on 25Mar2021 01:00. The outcome of events was recovering. No treatment was given to the patient. 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 was not tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; Fever of 103 chills nausea headache body aches started at 3 am. Still having them and its 7.50 pm next day. This is awful.; This is a spontaneous report from a contactable other health care professional (patient). A 49-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration administered in Left arm on 26Mar2021 14:30 (age at vaccination: 49-year-old) as single dose, for covid-19 immunization. (vaccination facility: Hospital). Medical history included Allergies to medications, food, or other products: Wellbutrin alveoli penicillin from an unknown date and unknown if ongoing. No concomitant medications were not reported. patient was diagnosed with COVID-19, Prior to vaccination. Did not received any other medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 on unspecified date for covid-19 immunization. On 26Mar2021 (12:00 AM, as reported), the patient experienced Fever of 103 chills nausea headache body aches started at 3 am. Still having them and on 7:50 pm next day. This was awful. Patient was not received any treatment for the events. Patient was not tested for COVID-19, Since the vaccination. The outcome for the evens was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dizziness, Fatigue, Pyrexia, Tension headache
Clinical narrative: Fever of 100F next day lasted for several hours; Tension headaches; extreme fatigue; lightheadedness; depression lasted for two weeks.; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A 45-years-old non pregnant female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EL6198), dose 2 via an unspecified route of administration, administered in Arm Right on 10Mar2021 15:45 (Age at vaccination 45 Years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple allergies, Mild allergies to bactrum, pollen, and some foods. The patient's concomitant medications were not reported. Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 11Mar 2021 Fever of 100F next day lasted for several hours. Tension headaches, extreme fatigue, light-headedness and depression lasted for two weeks. No treatment received for the adverse events. The outcome for all events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Headache; body aches; injection site pain; This is a spontaneous report from a contactable pharmacist, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 09:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) (not specified) 1000 IU oral daily for an unspecified indication. The past drug history included known allergies: acetaminophen, nonsteroidal anti-inflammatory drug (NSAIDs). The patient did not receive any other vaccines within four 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. On 23Mar2021 at 15:00, the patient experienced headache, body aches and injection site pain (vaccination site pain). The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, body ache and vaccination site pain were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; chills; Headache; Nausea; stomachache; This is a spontaneous report received from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3247), via an unspecified route of administration in left arm on 23Mar2021 at 09:30 (at the age of 44-year-old), as a single dose for COVID-19 immunisation. The patients medical history was reposted as no. The patient did not receive any medications within two weeks of vaccine. The patient was not allergic to medications, food and other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 06:30, the patient experienced fever, chills, headache, nausea, stomach-ache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for the events. The clinical outcome of the events fever, chills, headache, nausea and stomach-ache was resolving at the time of this reporting.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 101.5F; headache; chills; Body aches; Nausea; This is a spontaneous report received from a non-contactable Other Healthcare Professional (HCP). The patient reported for self.  A 27-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: solution for injection: Lot/Batch number: EP 6955, Expiration date: not reported), via an unspecified route of administration on 27Mar2021 09:15 (at the age of 27-year-old) administered in the left arm as dose 2, single dose for COVID-19 immunisation. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: solution for injection: Lot/Batch number: EN 6202) via an unspecified route of administration on 06Mar2021 at 10:00 administered in the left arm as dose 1, single dose for COVID-19 immunisation. Patient medical history included IBS (Irritable bowel syndrome) and allergy to mangoes both from unspecified dates and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications with in two weeks of vaccination included: Skin supplement, Trazadone, lactobacillus nos (CULTURELLE), melatonin for unspecified indication and unknown if ongoing. Patient was not diagnosed with COVID prior vaccination. COVID post vaccination was none. On 28Mar2021 at 05:00 am, the patient experienced fever of 101.5F, headache, chills, body aches, nausea. Since the vaccination, the patient has not been tested for COVID-19. The patient did not visit emergency room or a physician for the events. The patient was treated with ibuprofen for the events. The events were reported as non-serious. The outcome of the events was Not recovered.  No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: felt terrible and had fevers; diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for herself and for her husband. This report is for her husband. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient felt terrible and had fever, and the patient was diagnosed with COVID on 28Mar2021. The second dose is on 13Apr2021. The patient's wife wanted to know how long they should wait to get the second vaccine, considering the COVID diagnosis. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :PFIZER INC-2021345482 same reporter, vaccine, and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for coronavirus; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 17Mar2021 (Batch/Lot number and Expiry was not reported) as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive for coronavirus. It was reported that the patient received first dose of 17Mar2021 and next Sunday tested positive for coronavirus. Laboratory tests on an unspecified date included sars-cov-2 test positive. Patient was scheduled for second dose on 07April2021. Patient wanted to cancel the appointment. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; very sick; This is a spontaneous report from a contactable consumer (patient). This 57-years-old male consumer received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was not reported), via an unspecified route of administration on 20Mar2021 (age at vaccination was 57-years-old male) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. On an unspecified date following Tuesday after vaccination patient became sick and then he tested positive for COVID-19. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; This is a spontaneous report received from a contactable consumer, the patient. A 59-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207), via an unspecified route of administration, administered in left arm on 17Mar2021 15:30 (at the age of 59-years-old) as dose1, single for covid-19 immunization. Medical history included fibromyalgia, gastrooesophageal reflux disease(GERD), irritable bowel syndrome. The patient had allergies to morphine, levsin. Concomitant medications and received within 2 weeks of vaccination included zolpidem tartrate (AMBIEN); famotidine; paracetamol (TYLENOL). The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the patient experienced fever, chills, fatigue, feeling not well, aches, severe nausea, headache. The patient did not receive any treatment. Outcome of all the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; Fever chills fatigue feeling not well aches severe nausea headache; This is a spontaneous report received from a contactable consumer, the patient. A 59-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207), via an unspecified route of administration, administered in left arm on 17Mar2021 15:30 (at the age of 59-years-old) as dose1, single for covid-19 immunization. Medical history included fibromyalgia, gastrooesophageal reflux disease(GERD), irritable bowel syndrome. The patient had allergies to morphine, levsin. Concomitant medications and received within 2 weeks of vaccination included zolpidem tartrate (AMBIEN); famotidine; paracetamol (TYLENOL). The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the patient experienced fever, chills, fatigue, feeling not well, aches, severe nausea, headache. The patient did not receive any treatment. Outcome of all the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; symptoms of Covid-19 infection; difficulty breathing and sleeping; difficulty breathing and sleeping; an arm sore for a day; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the arm on 20Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient previously tested negative Covid-19 on 18Mar2021 on a preoperative routine test. He had surgery on 24Mar2021. And on 27Mar2021, the patient came down with symptoms of COVID-19 infections. The patient has asthma and reported of having difficulty in breathing and sleeping since COVID. The patient also reported that he had a fever earlier today (01Apr2021). The patient informed that he didn't have any first dose reactions to vaccination, only for an arm sore for a day on an unspecified date in Mar2021, until a week later started having symptoms of COVID. The patient was due for his second dose on 10Apr2021 and asked if having contracted COVID-19 could affect getting his second dose. The outcome of the events was unknown.    No follow up attempts are possible; information about lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: fever; symptoms of Covid-19 infection; difficulty breathing and sleeping; difficulty breathing and sleeping; an arm sore for a day; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the arm on 20Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient previously tested negative Covid-19 on 18Mar2021 on a preoperative routine test. He had surgery on 24Mar2021. And on 27Mar2021, the patient came down with symptoms of COVID-19 infections. The patient has asthma and reported of having difficulty in breathing and sleeping since COVID. The patient also reported that he had a fever earlier today (01Apr2021). The patient informed that he didn't have any first dose reactions to vaccination, only for an arm sore for a day on an unspecified date in Mar2021, until a week later started having symptoms of COVID. The patient was due for his second dose on 10Apr2021 and asked if having contracted COVID-19 could affect getting his second dose. The outcome of the events was unknown.    No follow up attempts are possible; information about lot/batch cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, COVID-19, Fatigue, Pyrexia
Clinical narrative: had my first dose of my vaccine on March 17th and this past Saturday I was positive for Covid 19; she had a fever Friday night; she was very tired; she had a 99.4 degree temperature that night; This is a spontaneous report from a contactable consumer or other Non-health care professional via Pfizer sponsored program.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry Date: unknown, Batch/Lot number: EN6206), via an unspecified route of administration, in left arm on 17Mar2021 10:00 AM (at the age of 64-year-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported and patient did not have any illness at time of vaccination. Family Medical History reported that She was exposed to her 3 grandkids, who all tested positive for the COVID-19 Virus. The patient's concomitant medications were not reported. patient had not received any other vaccines priorly within 4 weeks of vaccination. Patient stated had her first COVID-19 Vaccine, she tested PCR test and resulted as positive for the COVID-19 Virus on 27Mar2021. She said she was in contact with all 3 of her grandkids, and all 3 of her grandkids were positive for the COVID-19 Virus. She said she went to her grandkids house on 21Mar2021. She said she started to have symptoms before she knew her grandkids had the COVID-19 Virus. she said on 25Mar2021 she was very tired and had a 99.4 degree temperature that night. She said that Friday, 26Mar2021 she found out her granddaughter was positive for the COVID-19 Virus. She said that night, she had a fever on 26Mar2021. She said she went on Saturday, 27Mar2021 to be tested for the COVID-19 Virus, and found out on late Sunday night, 28Mar2021 that she was positive for the COVID-19 Virus. She said she was scheduled to get her second COVID-19 Vaccine on 08Apr2021 would be 2 weeks after she had her minor COVID-19 Virus symptoms. She said she wanted to know if she should still get the second vaccine dose, since she had tested positive for the COVID-19 Virus. It was reported she took 2 Extra Strength Tylenol 500mg caplets twice (6 hours apart, Lot Number: AAA103, Expiration Date: Sep2024) on Friday, and then she took another dose right before she had her COVID-19 Virus testing on Saturday, 27Mar2021. Patient was not attended emergency Room, or Physician Office on experiencing events. Reporter wants to know if you get the first dose of the vaccine then tested positive for COVID-19 after the dose, how long will it take before you can take the second dose. The outcome of all event was outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: had my first dose of my vaccine on March 17th and this past Saturday I was positive for Covid 19; she had a fever Friday night; she was very tired; she had a 99.4 degree temperature that night; This is a spontaneous report from a contactable consumer or other Non-health care professional via Pfizer sponsored program.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry Date: unknown, Batch/Lot number: EN6206), via an unspecified route of administration, in left arm on 17Mar2021 10:00 AM (at the age of 64-year-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported and patient did not have any illness at time of vaccination. Family Medical History reported that She was exposed to her 3 grandkids, who all tested positive for the COVID-19 Virus. The patient's concomitant medications were not reported. patient had not received any other vaccines priorly within 4 weeks of vaccination. Patient stated had her first COVID-19 Vaccine, she tested PCR test and resulted as positive for the COVID-19 Virus on 27Mar2021. She said she was in contact with all 3 of her grandkids, and all 3 of her grandkids were positive for the COVID-19 Virus. She said she went to her grandkids house on 21Mar2021. She said she started to have symptoms before she knew her grandkids had the COVID-19 Virus. she said on 25Mar2021 she was very tired and had a 99.4 degree temperature that night. She said that Friday, 26Mar2021 she found out her granddaughter was positive for the COVID-19 Virus. She said that night, she had a fever on 26Mar2021. She said she went on Saturday, 27Mar2021 to be tested for the COVID-19 Virus, and found out on late Sunday night, 28Mar2021 that she was positive for the COVID-19 Virus. She said she was scheduled to get her second COVID-19 Vaccine on 08Apr2021 would be 2 weeks after she had her minor COVID-19 Virus symptoms. She said she wanted to know if she should still get the second vaccine dose, since she had tested positive for the COVID-19 Virus. It was reported she took 2 Extra Strength Tylenol 500mg caplets twice (6 hours apart, Lot Number: AAA103, Expiration Date: Sep2024) on Friday, and then she took another dose right before she had her COVID-19 Virus testing on Saturday, 27Mar2021. Patient was not attended emergency Room, or Physician Office on experiencing events. Reporter wants to know if you get the first dose of the vaccine then tested positive for COVID-19 after the dose, how long will it take before you can take the second dose. The outcome of all event was outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cystitis escherichia, Escherichia urinary tract infection
Clinical narrative: each time after getting the shot I got a bladder, Urinary tract infection I was hospitalized once; each time after getting the shot I got a bladder, Urinary tract infection I was hospitalized once; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER2613, Expiration date not reported, NDC number: unknown), via an unspecified route of administration in an unspecified anatomical location on 23Mar2021 (at the age of 64-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes, cholesterol, partially deaf and heat. Concomitant medication(s) included isosorbide mononitrate (ISOSORBIDE MONONITRATE) taken for heat and diabetes, once a day for 8 years, metformin (MANUFACTRURE UNKNOWN) taken for diabetes mellitus, insulin (MANUFACTRURE UNKNOWN) taken for diabetes, metoprolol (METOPROLOL); atorvastatin (LIPITOR) taken for cholesterol. Consumer Stated that in her whole life she never had a bladder or urinary tract infection and each time after getting the shot she got a bladder, Urinary tract infection and was hospitalized for three days after the first shot and went to the emergency room just an hour to the second shot and was not admitted and left with medication antibiotics on 28Mar2021. On 23Mar2021, she got some symptoms but the result was from a urinary track and bladder infection, the first one was E.coli and the second one they didn't tell her what kind of infection it was. The seriousness of event was reported as serious. The outcome of the events was unknown.  Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Swelling
Clinical narrative: his body seems to be swollen; patient also thinks that he had corona and has been suffering from the side effects of corona specifically; This is a spontaneous report from a contactable consumer (patient) A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: ER8733 and Expiration date: unknown) via an unspecified route of administration, administered on the right arm on 31Mar2021 (at the age of 32 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history and concomitant medications. There was no investigation assessment. On an unspecified date in 2021, patient reported that his body seems to be swollen after receiving his 1st shot yesterday (clarified as 31Mar2021) and was asking if it was normal. The patient also thinks that he had corona and has been suffering from the side effects of corona specifically but he was not taking any medication. The patient did not receive any treatment for the events. The outcome of the reported events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: felt a little woozy; This is a spontaneous report received from a contactable consumer (patient). This male consumer reported in response to consumer letter sent to consumer via telephonic follow-up activity.A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN9581), via an unspecified route of administration on 15Mar2021 as single for CVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266) on 18Feb2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced felt a little woozy on an unspecified date in Mar2021. Investigations Not Provided. Caller stated that he read it takes 2-4 weeks for the vaccine to be effective. Patient wanted to ask if that was a side effect even though it's 2 weeks later. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Lymphadenopathy, Nausea, Peripheral swelling
Clinical narrative: Then armpit swelling, lymph nodes were swollen; Then armpit swelling, lymph nodes were swollen; backache and arm swelling/tenderness; Fever; chills; nausea; backache and swelling/tenderness; backache and swelling/tenderness; This is a spontaneous report received from a contactable consumer (patient). A 33-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution injection, Lot Number: EN6200), dose 2 via intramuscular, administered in arm right on 18Feb2021 at 15:30 (at the age of 33-years-old) as single for COVID-19 immunisation. Medical history included caesarean section in 04Aug2017 for birth of daughter, caesarean section from 03Feb2020 for date birth of daughter and anxiety. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA) for birth conrtrol, zinc taken for immune enhancement therapy from Aug2020 and ongoing, and escitalopram oxalate (LEXAPRO) taken for anxiety from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 (Lot Number: EL1283), intramuscular, administered in arm right on 23Jan2021 at 11.00 as single for COVID-19 immunisation. Patient did not receive any prior vaccination within 4 weeks. On 19Feb2021 at 03:00, within 14 hours of vaccination, the patient experienced fever, chills, nausea, backache and swelling/ tenderness. After 24 hours of these symptoms, it stopped. On 20Feb2021, she experienced armpit swelling and lymph nodes were swollen for 3 days after other symptoms stopped. The patient did not receive treatment for the events. The outcome of all the events was resolved.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: Then armpit swelling, lymph nodes were swollen; Then armpit swelling, lymph nodes were swollen; backache and arm swelling/tenderness; Fever; chills; nausea; backache and swelling/tenderness; backache and swelling/tenderness; This is a spontaneous report received from a contactable consumer (patient). A 33-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution injection, Lot Number: EN6200), dose 2 via intramuscular, administered in arm right on 18Feb2021 at 15:30 (at the age of 33-years-old) as single for COVID-19 immunisation. Medical history included caesarean section in 04Aug2017 for birth of daughter, caesarean section from 03Feb2020 for date birth of daughter and anxiety. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA) for birth conrtrol, zinc taken for immune enhancement therapy from Aug2020 and ongoing, and escitalopram oxalate (LEXAPRO) taken for anxiety from an unspecified start date and ongoing. The patient previously received the first dose of bnt162b2 (Lot Number: EL1283), intramuscular, administered in arm right on 23Jan2021 at 11.00 as single for COVID-19 immunisation. Patient did not receive any prior vaccination within 4 weeks. On 19Feb2021 at 03:00, within 14 hours of vaccination, the patient experienced fever, chills, nausea, backache and swelling/ tenderness. After 24 hours of these symptoms, it stopped. On 20Feb2021, she experienced armpit swelling and lymph nodes were swollen for 3 days after other symptoms stopped. The patient did not receive treatment for the events. The outcome of all the events was resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm was sore; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ XR) taken for an unspecified indication, start and stop date were not reported. The patient experienced my arm was sore on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: both tested positive for covid; both tested positive for covid; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer (patient) reported similar events for 2 patients. This is a first of two reports.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that him and his wife received first vaccine and then both tested positive for covid on an unspecified date, they did quarantine and had no symptoms. He wanted to know if they should receive second vaccine or not. The outcome for the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382886 Same reporter/product/Event, Different patient
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; did quarantine have no symptoms; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer reported similar events for 2 patients. This is second of two reports. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive for covid and did quarantine have no symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382885 Same reporter/product/Event, Different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: However 8 days later after completing the dosing series. he went to urgent care and tested positive for the COVID19 virus using the rapid test; However 8 days later after completing the dosing series. he went to urgent care and tested positive for the COVID19 virus using the rapid test; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medication were not reported.On an unknown date, 8 days after completing the dosing series, the patient tested positive for Covid19 virus. It was reported that reporter's son was exposed to someone last week who was positive for Covid 19 and became symptomatic on Wednesday and son tested positive for Covid 19 on Thursday, however reporter and his wife tested negative for the Covid19 virus. The patient had his 2nd dose of the Pfizer Biontech Covid-19 Vaccine, at that time he was negative for the Covid19 virus, however 8 days later after completing the dosing series, he went to urgent care and tested positive for the Covid19 virus using the rapid test. The patient underwent lab tests which included sars-cov-2 test: negative on an unspecified date and 8 days after 2nd dose patient had lab test for sars-cov-2 test: positive on an unspecified date. The patient mentioned that his HCP told him that as long as he was negative, he can get vaccinated but if he is positive, he would have to wait out 90 days before getting the shot. He also mentioned previously that he called us before and talk to safety department and asked if he can take the second shot post exposure to someone who tested positive for the virus. He wanted to know if the second dose was as effective if he was infected or does he have to be revaccinated again, because he read somewhere that the vaccine may cause false positive result for the tests. Outcome of the events were unknown.  Information on the Lot/Batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint effusion, Joint range of motion decreased, Joint stiffness, Joint swelling
Clinical narrative: approx 12 hours woke up to left knee swelling/stiffness/ could barely bend knee/great difficulty walking. Also fever to 100.4 for about 24 hours.  Knee pain/swelling persisted  Seen by urgent care physician on 2/5 am regarding knee who prescribed prednisone; x ray of knee showed small to moderate knee effusion. Prescribed Prednisone 50mg daily for 4 days.  I took 50mg on Friday evening, 25mg on Saturday and Sunday.  Swelling reduced after first dose of prednisone.  Physician at Urgent care did not believe that swelling to knee was related to vaccine.  Saw orthopedic doctor by Tuesday and received steroid injection to knee.  I have a history of left knee issues with some swelling but never to that extent and have had no issues since.