chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: lightheadedness/dizziness; Hot; sweaty; This is a spontaneous report from a non-contactable other health professional. A 46-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN6205) via an unspecified route of administration on 18Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience light-headedness and dizziness. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The patient complained of dizziness, hot and sweaty. The treatment given for the reported events included water and ice pack and the patient responded very well to treatment. The patient was discharged and was stable to go home. The clinical outcome of the events light-headedness, hot and sweaty was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination facility country was added and lead sentence in narrative was updated to non-contactable healthcare professional.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat clearing, Throat tightness
Clinical narrative: Difficulty breathing; Throat tightness; frequent throat clearing; shortness of breath; This is a spontaneous report from a non-contactable healthcare professional.  A 34-year-old male patient received the first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6207) via an unspecified route of administration on 18Mar2021(at the age of 34-year-old) as a single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On 18Mar2021, during the patients 15-minute waiting period after the injection, the patient began to experience difficulty breathing and throat tightness. He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient complained of frequent throat clearing and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The therapeutic measures included treatment with water and the follow up response to treatment was excellent. The patient was discharged and was stable to go home and was advised to follow up with PCP (primary care physician). The outcome of the events dyspnoea, throat tightness and throat clearing was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: shortness of breath added, for all events, stop date added 2021, and final sentence should be updated to No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush
Clinical narrative: Red hot and flushed face; Red hot and flushed face; This is a spontaneous report received from a non-contactable consumer (patient). A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 22Mar2021 at 13:45 as a single dose (at the age of 19 year) for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. The patient didn't have known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 14:30, the patient experienced red hot and flushed face. The patient did not receive any 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 visit. The clinical outcome of the event red hot and flushed face was unknown at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: narrative lead sentence updates, and The patient didn't have known allergies added as allergies: No, event face red added.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: but in between we caught the virus; We never got the second one; but in between we caught the virus; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on Jan2021 as dose 1, single for COVID-19 immunization. No medical history and concomitant medication were reported. Caller stated that "I'm calling for me and my wife we both had first dose of the Pfizer-COVID-19 Vaccine in January, we would do a try to get the second one 3 weeks later, but in between we caught the virus, we were treated for the virus and we tested negative the last time we had a test. We never got the second one (second dose of the vaccine). Caller asked what the protocol was and would they need to repeat the vaccination series. The patient underwent lab tests which included SARS-CoV-2 test and tested negative last time on an unspecified date. The outcome for COVID-19 was recovered on an unspecified date in 2021 and remaining 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-2021312736 same reporter/drug/event different patient
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Racing heart; Face tingling; This is a spontaneous report received from a contactable health care professional. A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207) via an unspecified route of administration on 22Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 22Mar2021 during her 15-minute waiting period after the injection, the patient began to experience racing heart and face tingling. The patient denied rash, difficulty breathing, difficulty swallowing, throat tightness and facial swelling. Treatment included water and snacks. The follow up response to treatment was good. During discharge the patient was stable to go home and follow up with PCP (Primary Care Physician). The clinical outcome of the events racing heart and tingling were recovered on 22Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment (30Jun2021): This follow-up report is being submitted to amend previously reported: 1. Country added for patient in patient tab 2. Event Occurred Country of event Tingling updated from 3. Treatment received box checked for event Heart racing 4. Final sentence in analysis tab updated to No follow-up attempts needed. No further information expected
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Pain, Pyrexia
Clinical narrative: shortness of breathing; fever; cough; soreness; blue lacy rash on the arms and legs; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (Husband).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced for almost 10 days after getting the first dose of the vaccine. The patient got all the symptoms like fever, cough, soreness, shortness of breathing, diarrhea and blue lacy rash on the arms and legs. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: shortness of breathing; fever; cough; soreness; blue lacy rash on the arms and legs; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (Husband).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced for almost 10 days after getting the first dose of the vaccine. The patient got all the symptoms like fever, cough, soreness, shortness of breathing, diarrhea and blue lacy rash on the arms and legs. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: large bumb under armpit; large bumb under armpit, tender to touch and moderate pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 21Mar2021 at 14:00, the patient experienced large bumb under armpit, which was tender to touch and had moderate pain 24 hours after receiving the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the event. The clinical outcome of the event large bumb under armpit which was tender to touch and moderate pain was resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained"  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Age and unit 43 years added in Historical Vaccine 2. Row# 1 none removed in relevant history tab  3. Final sentence should be updated to "No follow-up attempts are needed; information about lot/batch number cannot be obtained"
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Heart rate increased, Nausea
Clinical narrative: I was having trouble breathing/she had to use her inhaler more than once; Felt nauseous in the morning; I felt fuzzy; My heart began beating rapidly (not normal for me); This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: en6208), via an unspecified route of administration, administered in left arm on 15Mar2021 16:30 (age at vaccination was 63 years) as dose 1, single for covid-19 immunization at Public Health Clinic/facility. Medical history included asthma, osteoporosis, sciatica. Patient Allergies to medications, food, or other products included Penicillin, Prozac, Darvon, Erythomycin, Codeine, Percoset, Bactrin Sulphur drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported and Clonazapin taken for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 16:45, after receiving vaccine patient stayed for 30 minutes since had a history of allergic reactions, she was fine and felt nauseous in the morning and as she worked through the day, she had to use her inhaler more than once. She had Asthma and felt fuzzy and decided to close her store early. Before leaving at 5 PM, her heart began beating rapidly (not normal for me), when she finally got into her car, she had trouble breathing. she always kept and EPI pen in her car and her bag. she injected into her thigh and within minutes, she could breathe again, and the pounding stopped. The EPI saved her life. Therapeutic measures were taken as a result of Asthma and trouble breathing and Patient received treatment for the events included inhaler more than once, while Treatment received was reported as no for all other events.  The events were recovered on unspecified date in Mar2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Vomiting
Clinical narrative: Vomiting; Constipation; This is a spontaneous report from a contactable consumer or other non hcp.     A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Unknown), via an unspecified route of administration, on an unknown date in Mar2021 (at the age of 74- years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. It was unknown if the patient had allergies to medications, food, or other products. It was unknown if the patient received any other vaccines within 4 weeks prior to COVID vaccine. It was unknown if the patient took any other medications within 2 weeks of vaccination.  The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. It was unknown if the patient was tested positive for COVID-19, since having the vaccine. It was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown is any other medications patient received within 2 weeks of vaccination. The patient experienced vomiting and constipation on an unknown date in Mar2021. It was reported that she was quite healthy and active so these issues were not normal for her. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Patient said that she had several issues. Vomiting & constipation were the primary issues that I remember. She's a retired nurse, quite healthy and active so these issues are not normal for her. She is okay with you contacting her for more information. The treatment received for the vomiting and constipation was unknown. The clinical outcomes of the vomiting and constipation were recovered on unknown date in Mar2021.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's Country captured as "country name". Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." Initial information need review.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Paraesthesia, Periorbital swelling, Peripheral coldness
Clinical narrative: Cold sensation on arms; Puffy eyes; Slight/brief tingling; Cold sensation on feet; Occasional itchiness on different spots all over body; Injection site pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: En6206) via an unspecified route of administration in her left arm on 18Mar2021 at 13:00 (at the age of 23-year-old), as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced headache, injection site pain, occasional itchiness on different spots all over the body (no rash), puffy eyes, slight/brief tingling and cold sensation on feet and arms. The patient did not receive any treatment for events. The clinical outcome of events headache, injection site pain, occasional itchiness on different spots all over body, puffy eyes, slight/brief tingling and cold sensation on feet and arms were not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient First and Last Initial combined and entered in First name field 2. Narrative sentence "Concomitant medications included multivitamins" updated as "Concomitant medications included multivitamin" 3.Vaccination Facility Country added as US.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: Cold sensation on arms; Puffy eyes; Slight/brief tingling; Cold sensation on feet; Occasional itchiness on different spots all over body; Injection site pain; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 23-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: En6206) via an unspecified route of administration in her left arm on 18Mar2021 at 13:00 (at the age of 23-year-old), as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced headache, injection site pain, occasional itchiness on different spots all over the body (no rash), puffy eyes, slight/brief tingling and cold sensation on feet and arms. The patient did not receive any treatment for events. The clinical outcome of events headache, injection site pain, occasional itchiness on different spots all over body, puffy eyes, slight/brief tingling and cold sensation on feet and arms were not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient First and Last Initial combined and entered in First name field 2. Narrative sentence "Concomitant medications included multivitamins" updated as "Concomitant medications included multivitamin" 3.Vaccination Facility Country added as US.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Throat tightness
Clinical narrative: Tight throat; Body aches; Sore arm; Headache; This is a spontaneous report from a non-contactable consumer (patient). 36-years-old non pregnant female patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, expiration Unknown), via an unspecified route of administration, administered in left arm on 17Mar2021 at 16:45 (At age of vaccination 36-years-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Other vaccine was not received in four weeks. No COVID prior to vaccination. COVID was not tested post vaccination. On 18Mar2021 02:15 AM the patient experienced tight throat, sore arm, body aches, headache. No treatment received. The outcome of all event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhoea; This is a spontaneous report from a non-contactable consumer, the patient.   A 43-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7534) via unspecified route of administration as a single dose in the left arm on 19Mar2021 at 12:45 (at an age of 43-year-old) for COVID-19 immunisation. Medical history was not reported. No concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 17:30, the patient experienced diarrhoea. The patient was not treated with any medication for the events. The clinical outcome of diarrhoea was unknown at the time of reporting.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Update the leading sentence as- This is a spontaneous report from a non-contactable consumer.
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: severe pain in the kidney on the injection side; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection, Lot Number and Expiration date: unknown), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Mar2021, the patient experienced severe pain in the kidney on the injection side. Outcome of event was recovering.   Information lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021305789 same reporter/drug/event, different patient;US-PFIZER INC-2021316652 same reporter/drug/event, different patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, SARS-CoV-2 test
Clinical narrative: Triggered shingles; neuralgia; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 04Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, psoriasis and hypothyroidism. The patient was allergic to latex adhesive, cinnamon and pineapple. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine, dapagliflozin propanediol monohydrate (FARXIGA), ezetimibe and methotrexate all for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. On 06Mar2021, the patient experienced triggered shingles, which the patient was still battling, as well as neuralgia. The events resulted in doctor or other healthcare professional office/clinic visit. Post the vaccination, on 09Mar2021 the patient underwent nasal swab test (COVID-19) and tested negative. Therapeutic measures were taken as a result of adverse events and included acyclovir, tramadol and Zofran. The clinical outcome of the events triggered shingles and neuralgia were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nervousness
Clinical narrative: feeling like she "was seeing stars but not passing out" Lightheaded; the patient began to experience shaky; This is a spontaneous report from a non contactable other healthcare professional. A 20-year-old female patient received first dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; lot number: EN6207) via an unspecified route of administration on 19Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication details were not provided. On 19Mar2021, during her 15 minutes waiting period after the injection, the patient began to experience shaky, feeling like she was seeing stars but not passing out - Lightheaded. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. It was reported that the treatment included: water and snacks and follow up response to treatment was excellent. The patient was discharged and was stable to go home and follow up with PCP (primary care physician). The clinical outcome of the events feeling shaky and light headedness was unknown.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality in reporter tab was unticked. Patient name updated since First Name and Last Name should be captured separately.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via unknown route of administration in the left arm on 13Mar2021 (at the age of 35-year-old) at 12:00, as a single dose for COVID-19 immunisation. Medical history included Hashimotos. The patient was allergic to codeine, PCN(penicillin) and environmental/seasonal allergy. Concomitant medications included sertraline(MANUFACTUER UNKNOWN) 50 milligram (mg) Q HS, ibuprofen(MANUFACTUER UNKNOWN) 400mg PRN. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 13Mar2021, the patient experienced intermittently dizzy/light headed on the day of vaccine and throughout next week/week and a half. The patient did not receive any treatment for the adverse 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 intermittently dizzy/light headed was not resolved. No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More tired than usual; This is a spontaneous report from a contactable consumer or other non hcp.   A 67-years-old female patient received BNT162B2 (Formulation: Solution for injectin; Batch/Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Right on 08Mar2021 09:15 (at the age of 67-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Sulfonamide allergy, depression from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine (FLUOXETINE), pramipexole (PRAMIPEXOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took flagyl [metronidazole] and experienced drug hypersensitivity. The patient previously received BNT162B2 (Batch/ Lot number: EN9581) on 15Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccine within four 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 for COVID-19. On 08Mar2021 at 09:30, the patient had been more tired than usual after getting his second shot. The patient continued to be tired even after 2 weeks. 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 treatment for the event. The clinical outcome of the tired was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: My daughter is having strange dreams as well since her second dose of the Pfizer vaccine; This is a spontaneous report from a contactable consumer, parent. A female patient of an unspecified age received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. No known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. 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 patient was having strange dreams since the second dose of the Pfizer vaccine. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aching; slight fever; This is a spontaneous report received from a non-contactable consumer (patient). A 43-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7532, Expiration date: Unknown) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 43-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The medical history was not reported. The patient concomitant medications included Paroxetine (PAXIL), start and stop dates were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198, Expiration date: Unknown) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 43-years-old), as 1ST DOSE, SINGLE for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 02:00, the patient had experienced body aching and slight fever. The patient received treatment with TYLENOL for the reported events. The clinical outcome of the events body aching and slight fever were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Follow-up (29Jun2021): Amendment: This follow-up report is being submitted to amend previously reported information: country added in patient information, patient's details added, concomitant medication Paxil was recoded, allowed to contact hcp was updated as no, age and age unit was added in historical vaccine and lead and final sentence (Since provided allowed to contact as No) in narrative was updated.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Skin discolouration
Clinical narrative: Woke up the morning following my vaccine shot to find my right eye swollen.; Right eye swollen and discolored under the eye, with a darker, swollen area extending from under the tear duct along the bottom of eye socket to eye's outer edge; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 22Mar2021 at 10:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, osteoarthritis, high blood pressure, diabetes and psoriatic arthritis (PsA). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) 800 mg tablet, gabapentin (MANUFACTURER UNKNOWN), and empagliflozin (JARDIANCE) 25mg tablet; all for an unknown indications from an unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since having the vaccine. On 23Mar2021 at 05:00, the woke up the morning following his vaccine shot and found his right eye was swollen and discoloured under the eye, with a darker, swollen area extending from under the tear duct along the bottom of eye socket to eye's outer edge. The patient did not receive any treatment for the events. The clinical outcome of the events right eye swollen and discoloured under the eye was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Confusional state, Decreased appetite
Clinical narrative: Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confusion; vertigo; body aches; dry eyes; back pain; light sensitivity; migraine; hot / cold; hot / cold but mostly very cold; no hunger; Brain fog; no thirst at all; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208), via an unspecified route of administration in the left arm on 13Mar2021 at 14:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish (only on a blood test), penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. Since the vaccination, the patient had been tested for COVID-19. On 14Mar2021 at 07:00, the patient had sore left arm first 2 days. Then, on unknown dates in Mar2021, the patient experienced brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back and head pain, light sensitivity, migraine, no hunger or thirst at all and hot / cold but mostly very cold with chills. On 18Mar2021 (Thursday), the patient missed work for the back and head pain. On 20Mar2021 (Saturday), the patient progressed to being very sick. Since 20Mar2021 to 24Mar2021 (reported as today), the temperature was 99.5. The patient missed the work from 22Mar2021 to 24 Mar2021 (at least). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 22Mar2021 which included PCR with test type of nasal swab and the test result was negative. The patient received telemedicine prescribed nausea medication for the event of nausea. The clinical outcomes of the events sore left arm first 2 days, brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back pain, light sensitivity, migraine, no hunger or thirst at all, hot/cold, hot / cold but mostly very cold with chills, chills, head pain, progressed to very sick and temperature 99.5 were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Dry eye, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confusion; vertigo; body aches; dry eyes; back pain; light sensitivity; migraine; hot / cold; hot / cold but mostly very cold; no hunger; Brain fog; no thirst at all; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208), via an unspecified route of administration in the left arm on 13Mar2021 at 14:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish (only on a blood test), penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. Since the vaccination, the patient had been tested for COVID-19. On 14Mar2021 at 07:00, the patient had sore left arm first 2 days. Then, on unknown dates in Mar2021, the patient experienced brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back and head pain, light sensitivity, migraine, no hunger or thirst at all and hot / cold but mostly very cold with chills. On 18Mar2021 (Thursday), the patient missed work for the back and head pain. On 20Mar2021 (Saturday), the patient progressed to being very sick. Since 20Mar2021 to 24Mar2021 (reported as today), the temperature was 99.5. The patient missed the work from 22Mar2021 to 24 Mar2021 (at least). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 22Mar2021 which included PCR with test type of nasal swab and the test result was negative. The patient received telemedicine prescribed nausea medication for the event of nausea. The clinical outcomes of the events sore left arm first 2 days, brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back pain, light sensitivity, migraine, no hunger or thirst at all, hot/cold, hot / cold but mostly very cold with chills, chills, head pain, progressed to very sick and temperature 99.5 were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Migraine, Nausea, Pain
Clinical narrative: Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confusion; vertigo; body aches; dry eyes; back pain; light sensitivity; migraine; hot / cold; hot / cold but mostly very cold; no hunger; Brain fog; no thirst at all; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208), via an unspecified route of administration in the left arm on 13Mar2021 at 14:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish (only on a blood test), penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. Since the vaccination, the patient had been tested for COVID-19. On 14Mar2021 at 07:00, the patient had sore left arm first 2 days. Then, on unknown dates in Mar2021, the patient experienced brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back and head pain, light sensitivity, migraine, no hunger or thirst at all and hot / cold but mostly very cold with chills. On 18Mar2021 (Thursday), the patient missed work for the back and head pain. On 20Mar2021 (Saturday), the patient progressed to being very sick. Since 20Mar2021 to 24Mar2021 (reported as today), the temperature was 99.5. The patient missed the work from 22Mar2021 to 24 Mar2021 (at least). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 22Mar2021 which included PCR with test type of nasal swab and the test result was negative. The patient received telemedicine prescribed nausea medication for the event of nausea. The clinical outcomes of the events sore left arm first 2 days, brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back pain, light sensitivity, migraine, no hunger or thirst at all, hot/cold, hot / cold but mostly very cold with chills, chills, head pain, progressed to very sick and temperature 99.5 were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia, Pyrexia, SARS-CoV-2 test, Thirst decreased
Clinical narrative: Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confusion; vertigo; body aches; dry eyes; back pain; light sensitivity; migraine; hot / cold; hot / cold but mostly very cold; no hunger; Brain fog; no thirst at all; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208), via an unspecified route of administration in the left arm on 13Mar2021 at 14:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish (only on a blood test), penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. Since the vaccination, the patient had been tested for COVID-19. On 14Mar2021 at 07:00, the patient had sore left arm first 2 days. Then, on unknown dates in Mar2021, the patient experienced brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back and head pain, light sensitivity, migraine, no hunger or thirst at all and hot / cold but mostly very cold with chills. On 18Mar2021 (Thursday), the patient missed work for the back and head pain. On 20Mar2021 (Saturday), the patient progressed to being very sick. Since 20Mar2021 to 24Mar2021 (reported as today), the temperature was 99.5. The patient missed the work from 22Mar2021 to 24 Mar2021 (at least). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 22Mar2021 which included PCR with test type of nasal swab and the test result was negative. The patient received telemedicine prescribed nausea medication for the event of nausea. The clinical outcomes of the events sore left arm first 2 days, brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back pain, light sensitivity, migraine, no hunger or thirst at all, hot/cold, hot / cold but mostly very cold with chills, chills, head pain, progressed to very sick and temperature 99.5 were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Progressed to very sick; Temperature 99.5; head pain; Sore left arm first 2 days; depression; confusion; vertigo; body aches; dry eyes; back pain; light sensitivity; migraine; hot / cold; hot / cold but mostly very cold; no hunger; Brain fog; no thirst at all; chills; nausea; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208), via an unspecified route of administration in the left arm on 13Mar2021 at 14:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish (only on a blood test), penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received escitalopram oxalate (LEXAPRO) and experienced drug allergy. Since the vaccination, the patient had been tested for COVID-19. On 14Mar2021 at 07:00, the patient had sore left arm first 2 days. Then, on unknown dates in Mar2021, the patient experienced brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back and head pain, light sensitivity, migraine, no hunger or thirst at all and hot / cold but mostly very cold with chills. On 18Mar2021 (Thursday), the patient missed work for the back and head pain. On 20Mar2021 (Saturday), the patient progressed to being very sick. Since 20Mar2021 to 24Mar2021 (reported as today), the temperature was 99.5. The patient missed the work from 22Mar2021 to 24 Mar2021 (at least). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab test on 22Mar2021 which included PCR with test type of nasal swab and the test result was negative. The patient received telemedicine prescribed nausea medication for the event of nausea. The clinical outcomes of the events sore left arm first 2 days, brain fog, confusion, vertigo, nausea, body aches, dry eyes, depression, back pain, light sensitivity, migraine, no hunger or thirst at all, hot/cold, hot / cold but mostly very cold with chills, chills, head pain, progressed to very sick and temperature 99.5 were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Heart rate increased, Tremor
Clinical narrative: Pressure in chest; difficulty breathing; fast heartbeat; dizziness; shakiness; This is a spontaneous report from a contactable consumer. A 57-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6208), via an unspecified route of administration on arm right on 19Mar2021 04:15 AM (age at vaccination: 57 years) as DOSE 1, SINGLE for COVID-19 immunisation at Hospital. The patient medical history included Asthma and trouble sleeping. The patient had known allergies to Compazine. Other vaccine in four weeks was reported as no. Covid prior vaccination and covid tested post vaccination was reported as no. The patient Concomitant medications were not reported. On 19Mar2021 05:00 PM, the patient experienced Pressure in chest, difficulty breathing, fast heartbeat, dizziness, shakiness. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken for all events and treatment included as Xanax for trouble sleeping. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.