chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Severe chills alternating w and 99.6 fever; 99.6 fever; joint pain; fatigue; Nausea; Vomiting, would vomit any water; No appetite; This is a spontaneous report received from a contactable consumer or other non hcp.A 59-years-old female patient received 2nd dose of bnt162b2 (Pfizer covid19 vaccine,Batch/Lot Number: EN6204),via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:00,at the age of 59 years old, as Dose 2,single for covid-19 immunization.Medical history included drug hypersensitivity,asthma,dust allergy and mycotic allergy from an unknown date and unknown if ongoing mold. Concomitant medication(s) included mometasone and levothyroxine taken for an unspecified indication,start and stop date were not reported.The patient experienced severe chills alternating w and 99.6 fever, 99.6 fever, joint pain,fatigue, vomiting, would vomit any water and no appetite on 11Mar2021 04:00. The patient underwent lab tests and procedures which included body temperature: 99.6 on 11Mar2021 and sars-cov-2 test negative: negative on 04Mar2021.The patient previously received her 1st dose of Pfizer covid 19 vaccine on 17Feb2021,10:00 am,lot number EL9266.The patient was not pregnant at the time of vaccination.The patient received other vaccines within 4 weeks of vaccination.The patient was not diagnosed with covid prior vaccination and not tested post vaccination.covid test name post vaccination was Abbott BinaxNOW Covid-19 Ag card.The patient received no treatment for the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: sense of taste is off.; This is a spontaneous report from a contactable consumer (patient's parent) reporting for a patient (daughter). A female patient of age 43 (unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as single dose for covid-19 immunisation. It was reported that the patient received her second dose of the Pfizer vaccine and now says that her sense of taste is off on an unspecified date. The reporter asked, Is this a reported side effect of the vaccine? The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Arthropathy, Asthenia
Clinical narrative: 36hr of lethargy; headache; running nose; extreme weakness; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; lack of apatite; chills; low grade fever; loss of taste and smell; loss of taste and smell; nausea; lymphadenopathy; dry sore throat; increased heart rate; This is a spontaneous report from a contactable other hcp (patient). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via intramuscular, administered in Arm Right on 11Mar2021 10:00 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, drug hypersensitivity (amoxicillin) from an unknown date and unknown if ongoing known allergy, covid-19 from an unknown date and unknown if ongoing; If covid prior vaccination: yes. Concomitant medications included trazodone taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; sitagliptin taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; loratadine taken for an unspecified indication, start and stop date were not reported; fluticasone taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 22:00, the patient experienced 36hr of lethargy, headache, running nose, extreme weakness, muscle / joint pain and cramps, lack of appetite, chills, low grade fever, loss of taste and smell, nausea, lymphadenopathy, dry sore throat, increased heart rate. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Heart rate increased, Lethargy
Clinical narrative: 36hr of lethargy; headache; running nose; extreme weakness; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; lack of apatite; chills; low grade fever; loss of taste and smell; loss of taste and smell; nausea; lymphadenopathy; dry sore throat; increased heart rate; This is a spontaneous report from a contactable other hcp (patient). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via intramuscular, administered in Arm Right on 11Mar2021 10:00 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, drug hypersensitivity (amoxicillin) from an unknown date and unknown if ongoing known allergy, covid-19 from an unknown date and unknown if ongoing; If covid prior vaccination: yes. Concomitant medications included trazodone taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; sitagliptin taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; loratadine taken for an unspecified indication, start and stop date were not reported; fluticasone taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 22:00, the patient experienced 36hr of lethargy, headache, running nose, extreme weakness, muscle / joint pain and cramps, lack of appetite, chills, low grade fever, loss of taste and smell, nausea, lymphadenopathy, dry sore throat, increased heart rate. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle spasms, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: 36hr of lethargy; headache; running nose; extreme weakness; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; lack of apatite; chills; low grade fever; loss of taste and smell; loss of taste and smell; nausea; lymphadenopathy; dry sore throat; increased heart rate; This is a spontaneous report from a contactable other hcp (patient). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via intramuscular, administered in Arm Right on 11Mar2021 10:00 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, drug hypersensitivity (amoxicillin) from an unknown date and unknown if ongoing known allergy, covid-19 from an unknown date and unknown if ongoing; If covid prior vaccination: yes. Concomitant medications included trazodone taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; sitagliptin taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; loratadine taken for an unspecified indication, start and stop date were not reported; fluticasone taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 22:00, the patient experienced 36hr of lethargy, headache, running nose, extreme weakness, muscle / joint pain and cramps, lack of appetite, chills, low grade fever, loss of taste and smell, nausea, lymphadenopathy, dry sore throat, increased heart rate. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: 36hr of lethargy; headache; running nose; extreme weakness; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; muscle / joint pain and cramps; lack of apatite; chills; low grade fever; loss of taste and smell; loss of taste and smell; nausea; lymphadenopathy; dry sore throat; increased heart rate; This is a spontaneous report from a contactable other hcp (patient). A 63-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via intramuscular, administered in Arm Right on 11Mar2021 10:00 (at the age of 63-year-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hyperlipidaemia from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, insomnia from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, drug hypersensitivity (amoxicillin) from an unknown date and unknown if ongoing known allergy, covid-19 from an unknown date and unknown if ongoing; If covid prior vaccination: yes. Concomitant medications included trazodone taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; sitagliptin taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported; glipizide taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; loratadine taken for an unspecified indication, start and stop date were not reported; fluticasone taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021 22:00, the patient experienced 36hr of lethargy, headache, running nose, extreme weakness, muscle / joint pain and cramps, lack of appetite, chills, low grade fever, loss of taste and smell, nausea, lymphadenopathy, dry sore throat, increased heart rate. No treatment was taken as a result of events. The outcome of the events was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Illness
Clinical narrative: was very sick; splitting headaches; chills; aches; freezing; she has a 102 fever; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 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 very sick from the vaccine. The patient stated that there must be something wrong with either screening or the Pfizer was not getting the word out. The patient received the first dose on a Thursday around 06:00 hours and by Friday at 04:00 hours, the patient experienced splitting headaches, chills that the patient never felt before, and aches. The patient was freezing on an unspecified date but took Ibuprofen and felt a little better. The patient believed to have COVID around the holidays, but she did not get tested before because the testing was a joke around there. The patient experienced a 102 fever around the holiday time. The patient underwent lab tests and procedures which included body temperature: 102 fever around the holiday time on an unspecified date. Therapeutic measures were taken as a result of freezing. The patient also stated that if she knew that she was going to be as sick as she was, she would have never gotten the vaccine. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: was very sick; splitting headaches; chills; aches; freezing; she has a 102 fever; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on 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 very sick from the vaccine. The patient stated that there must be something wrong with either screening or the Pfizer was not getting the word out. The patient received the first dose on a Thursday around 06:00 hours and by Friday at 04:00 hours, the patient experienced splitting headaches, chills that the patient never felt before, and aches. The patient was freezing on an unspecified date but took Ibuprofen and felt a little better. The patient believed to have COVID around the holidays, but she did not get tested before because the testing was a joke around there. The patient experienced a 102 fever around the holiday time. The patient underwent lab tests and procedures which included body temperature: 102 fever around the holiday time on an unspecified date. Therapeutic measures were taken as a result of freezing. The patient also stated that if she knew that she was going to be as sick as she was, she would have never gotten the vaccine. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: We had achy deltoids for a day or so; This is a spontaneous report from contactable consumer or other non-health care professional (patient). This consumer reported similar events for 2 patients. This report is for 1st of 2 patients. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EM9809) dose 2 via an unspecified route of administration on 08Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration on 18Jan2021 as dose 1, single for Covid-19 immunisation. It was reported that after 2 dose of vaccine administration, on an unspecified date in 2021, the patient had achy deltoids for a day or so, otherwise they had no adverse reactions. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021284066 Same reporter/drug/event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Fever; Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 12Mar2021 (at the age of 51-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included Blood pressure high, Thyroid, Water retention. Concomitant medications included amlodipine, levothyroxine, atenolol, Montelukast, losartan, potassium, salbutamol sulfate (PROAIR HFA), budesonide, formoterol fumarate (SYM-BICORT), fluticasone all taken for unspecified indication and Furosemide for Water retention. The patient experienced fever, chills, diarrhea on unknown date in 2021. Patient received treatment for the event fever with Ibuprofen and not received treatment for the other events. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: headache; Injection site very sore; extreme fatigue; entire body achy; fever of 100.8; This is a spontaneous report from a contactable consumer. This is a 44 year-old female consumer(patient) reported that:   A 44-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in Arm Right on 11Mar2021 13:00 (at the age of 44 years old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing (known allergies :Strawberries).The patient's concomitant medications were not reported.  It was reported that no other vaccine in four weeks was administered. No covid prior vaccination. Patient was not covid tested post vaccination. The patient experienced headache, injection site very sore on 11Mar2021 21:30, entire body achy on 11Mar2021 09:30, fever of 100.8 on 11Mar2021, extreme fatigue on 11Mar2021 21:30. The patient underwent lab tests and procedures which included pyrexia: 100.8. Therapeutic measures were taken with Tylenol as a result of injection site very sore, entire body achy, fever of 100.8. The outcome of events was recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Within 24 hours developed rash size of softball in armpit of left arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: en6206), via an unspecified route of administration, administered in arm left on 11Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Patient had no known allergies. The patient relevant medical history includes have low producing thyroid and thyroid. The patient concomitant medications include levothyroxin from an unspecified start date for thyroid. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Within 24 hours that was on 12Mar2021 developed rash size of softball in armpit of left arm and still had it 4 days later. The patient did not had prior vaccination for covid. The patient did not had covid test post vaccination. The patient did not received any treatment for adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; body aches; headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206 and expiry date was not reported), via an unspecified route of administration, in Arm right, on 13Mar2021 at 02:30 PM (age at vaccination: 44-years-old), as dose 2, single for COVID-19 immunization. The patient medical history included hypothyroidism. Concomitant medications included synthyroid (Levothyroxine sodium). Previously patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, in Arm right, on 20Feb2021 at 12:00 PM, as dose 1, single for COVID-19 immunization. The patient was allergic to penicillin. The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 13Mar2021 21:30, the patient reported that, approximately 7 hours after she got vaccinated, she experienced extreme fatigue, and on 14Mar2021 12:30, 10 hours after she had a 102 fever with horrible body aches and headache. This lasted for about 30 hours until she started feeling better. The patient did not receive any treatment for the adverse events. On an unspecified date, the patient underwent lab tests and procedures which included body temperature of 102. Outcome of the events was recovered on 15Mar2021.    No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Rash papular
Clinical narrative: Rash beginning on neck and spreading up face, down check to waist and into hair line; Raised red bumps; splotchy; Slightly itchy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 09Mar2021 13:00 (at the age of 23-year-old) at dose 1, single for covid-19 immunisation. Medical history included eczema on hands and patient had no known allergies. Concomitant medications were not reported. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not have other vac-cine in four weeks. Patient did not have other medications in two weeks. On 12Mar2021 07:00 the patient experienced Rash beginning on neck and spreading up face, down check to waist and into hair line. Raised red bumps, splotchy. Slightly itchy. Rash appeared 3 days after vaccine given. Ad-verse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment with Topical ointment and Benadryl for the adverse events. Outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleeds for more than 3 hours/nose bleeds were worse; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6207) via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:00 AM, as dose 1, single for COVID-19 immunization. Medical history included hypertension and known allergies: Sulphur drugs from an unknown date and unknown if ongoing. There were no concomitant medications reported in two weeks. No other vaccine in four weeks. No COVID prior to the vaccination. No test for COVID post vaccination. On 12Mar2021, Starting Friday after vaccine, nose bleeds for more than 3 hours. Sunday nose bleeds were worse and lasted appx. 5 hours. No treatment was given for adverse event. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Epicondylitis, Pain in extremity
Clinical narrative: Pain in elbows and fingers that is worse at night - both arms; Pain in elbows and fingers that is worse at night - both arms; Pain in elbows and fingers that is worse at night - both arms.; Felt like tennis elbow and arthritis; Felt like tennis elbow and arthritis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported, expiry date: not reported, Age at vaccination: 56-year-old) via an unspecified route of administration in right arm on 12Mar2021 03:30 PM as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, allergy, severe food allergies to nuts, rice, potatoes, onion, nightshades, Legumes, several antibiotics. Concomitant medications included Benadryl, Excedrin, Hydrochlorothiazide, Ibuprofen. On 14Mar2021 07:00 PM, patient experienced pain in elbows and fingers that is worse at night - both arms (pain in elbow, pain in fingers, pain in arm), felt like tennis elbow and arthritis (tennis elbow and arthritis). No treatment received for adverse event. Facility type vaccine was hospital. No other vaccine in four weeks. No covid present prior vaccination. Covid was not tested post vaccination. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site mass
Clinical narrative: bump where shot was; very large red area and very itchy; very large red area and very itchy; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 16:00 (at the age of 69-years-old) as a dose 1, single for covid-19 immunisation. The patient medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications received in two weeks of vaccination included blood pressure medicine (unspecified). The patient had no known allergies. No other vaccine was received in four weeks of vaccination. Patient did not have covid prior vaccination and has not tested for covid post vaccination. On 11Mar2021 at 17:00, the patient experienced bump where shot was, very large red area and very itchy. The patient reported that, she had very large red area and very itchy and it was still very red and itchy today which is 4 days after the shot. Also, a bump where shot was. No treatment was received for the event. Outcome of all the events were not resolved.  No follow up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen upper lip the next morning.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6203, expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Mar2021 13:30 (at the of 41-years-old) as dose 1, single for covid-19 immunization at public health clinic/veterans administration facility. The patient medical history included rheumatoid arthritis, asthma, anxiety, covid-19. Concomitant medications included levonorgestrel (MIRENA), tofacitinib citrate (XELJANZ), venlafaxine hydrochloride (EFFEXOR), folic acid, sumatriptan, all taken for unknown indications from an unknown date. The patient previously took amoxicillin and experienced known allergies: amoxicillin. The patient did not receive any other vaccine within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced swollen upper lip the next morning on 13Mar2021 12:00 AM. The patient did not receive any treatment for the adverse event. The outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: muscle and joint pain; muscle and joint pain; low grade temp (99.3); chills; headache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non pregnant female patient received first dose of BNT162b2 (COMIRNATY, formulation: solution for injection, Lot number: ENG207) via unknown route of administration in left arm on 12Mar2021 at 10:45 AM (at the age of 78 year old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included losartan, HCTZ, clonazepam (KLONOPIN) and fluticasone taken for unspecified indication. The patient did not receive vaccine in four weeks. On 13Mar2021 at 14:30, the patient experienced muscle and joint pain, low grade temp (99.3), chills, headache and tiredness. On 13Mar2021, the lab data included body temperature was low grade temp (99.3). The patient did not receive treatment. The outcome of the events were recovered.  No follow-up attempts were possible. No further information was expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle and joint pain; muscle and joint pain; low grade temp (99.3); chills; headache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non pregnant female patient received first dose of BNT162b2 (COMIRNATY, formulation: solution for injection, Lot number: ENG207) via unknown route of administration in left arm on 12Mar2021 at 10:45 AM (at the age of 78 year old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included losartan, HCTZ, clonazepam (KLONOPIN) and fluticasone taken for unspecified indication. The patient did not receive vaccine in four weeks. On 13Mar2021 at 14:30, the patient experienced muscle and joint pain, low grade temp (99.3), chills, headache and tiredness. On 13Mar2021, the lab data included body temperature was low grade temp (99.3). The patient did not receive treatment. The outcome of the events were recovered.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itchiness all over her body; break out in hives; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included food allergy. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced pruritus with outcome of unknown and urticaria with outcome of recovered. Consumer said that 3 days after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, she had itchiness all over her body, and started to break out in hives. She said the hives already disappeared, but she now wants to know if it would still be safe for her to receive the 2nd dose. She also mentioned that she has a history of food allergy. Consumer also mentioned that her HCP already told her not to receive the 2nd dose since she had an allergic reaction.  No follow up attempts are possible; information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: generalized rash; This is a spontaneous report from a contactable Physician. This Physician reported for 74-year-old non-pregnant female patient who received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient's medical history included hyperlipidemia, GERD and lactose allergy. The patient's concomitant medications included colecalciferol (Vitamin D) taken at unknown dose. It was unknown if any other vaccine in four weeks and if patient was tested for covid post vaccination. The patient did not have covid prior vaccination. On 05Mar2021, the patient experienced generalized rash. The patient required healthcare professional office/clinic visit. The patient received treatment with Methylprednisolone. The patient was recovering.  No follow-up attempts were possible; information about lot/batch no could not be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever; nausea; chills; headache; This is a spontaneous report from a contactable consumer (patient) via self reporting system. A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 14Mar2021 16:00 (lot number: EN6208; expiry date: unknown) at the age of 24-years-old, as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. The patient was not diagnosed with Covid-19 prior vaccination. The patient had no known allergies. The patient was not taking concomitant medications. The patient was not pregnant at the time of vaccination. The vaccine was administered in other facility. The patient did not receive other vaccines in four weeks, or other medications in two weeks. On 15Mar2021, at 8:00 AM, the patient experienced fever, nausea, chills, and headache. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for Covid-19 post vaccination.   No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Flushing, Nausea
Clinical narrative: Immediately after vaccine caller experienced a flushing feeling; Later that day she felt nauseated and fatigue.; Later that day she felt nauseated and fatigue.; I felt a strange feeling from my chest; She thought was her second Pfizer Covid vaccine. However, the gentleman that gave her the shot told her she was receiving the Astra Zeneca vaccine, but on her vaccination card it says Pfizer EN6199; She thought was her second Pfizer Covid vaccine. However, the gentleman that gave her the shot told her she was receiving the Astra Zeneca vaccine, but on her vaccination card it says Pfizer EN6199; This is a spontaneous report from a contactable consumer (patient) reported for herself. Report from a Pfizer-sponsored program. This report was not related to a study or programme. A 77-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: EN6199, expiry date: 30Jun2021), via an unknown route of administration on 16Feb2021 (at the age of 77-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The caller calling about the Covid-19 Vaccine and said that the first shot she received was the Pfizer vaccine on 16Feb2021. Immediately after vaccine caller experienced a flushing feeling. Later that day she felt nauseated and fatigue. Caller also stated "I felt a strange feeling from my chest up". The second one was administered on 09Mar2021. States she did not experience adverse events following second dose. She thought her second shot was Pfizer Covid vaccine. However, the gentleman that gave her the shot told her she was receiving the Astra Zeneca vaccine, but on her vaccination card it said Pfizer EN6199 and he did not sign his name. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: blotches on upper leg forearm/Rash on lower back and lower abdomen; This is a spontaneous report from a contactable consumer (patient). An elderly male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: en6200) dose 2 via an unspecified route of administration, administered in Arm Left on 27Feb2021 11:15 as dose 2, single for COVID-19 immunization. Patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history was none. Patient had no known allergies. The patient's concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On Mar2021 the patient experienced rash on lower back and lower abdomen, blotches on upper leg forearm which occurred 13 and 14 days after second dose. No treatment was received. The clinical outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Gait disturbance, Myalgia
Clinical narrative: Joint pain all over body; Weakness  in arms and legs; Trouble rising from chair, getting out of bed; Trouble walking; Soreness in muscles; This is a spontaneous report from a contactable consumer (patient).   A 79-year-old male patient reported for himself who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6203), via an unspecified route of administration in right arm on 25Feb2021 at 08:15 (at the age of 79-year-old) as dose 2, single for covid-19 immunization at other facility. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9264), via an unspecified route of administration in left arm on 02Feb2021 at 13:15 (at the age of 79-year-old) as dose 1, single for covid-19 immunization at other facility. Medical history included anemia, kidney stones, aoric valve stenosis, stage 3 kidney disease and cardic pacemaker. Patient known allergies included niacin, cephalexin and cephalosporins. Concomitant medications included atrovastatin, buspirone, Eliquis (apixaban), sertraline and Toprol (metoprolol succinate). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received some other medications like atrovastatin, buspirone, Eliquis, sertraline and Toprol in two weeks. On 28Feb2021, patient experienced joint pain all over body, weakness in arms and legs, trouble rising from chair, getting out of bed, walking and soreness in muscles resulted in visiting doctor or other healthcare professional office/clinic visit. Therapeutic measures were reported as no. The outcome of the events was reported as not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EM9810, Expiry date: Unknown) via an unspecified route of administration in Arm Right on 27Feb2021 (at the age of 84-year-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing dyspnoea. Concomitant medication included inhaler from an unspecified date. Patient states he had bad lungs due to welding smoke. He can't mow his grass or rake. Last year right before COVID started, his lungs started going bad. He has been going to the doctor every month for over a year. He was short of breath. The shortness of breath got worse yesterday. He has been on a medication for his chest for two years now. When asked for the name of the medication the caller didn't know. On 09Mar2021, the patient experienced shortness of breath. He was at the grocery store today with his mask on and everything else. He was in the store running around, and by the time he got home, he was out of breath and could hardly do anything. He is short of breath very much so, especially in the morning. If he works outside in the heat, it starts bugging him. He hasn't been able to mow the grass for 2 years because of his shortness of breath. His shortness of breath is just acting up today. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry mouth, Dry throat, Eyelid disorder, Feeling abnormal
Clinical narrative: nausea; joint pain; injection site very red and swollen; injection site very red and swollen; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; head ached; felt out of sorts; left arm kept going numb; eyelids were heavy; Swollen gland; This is a spontaneous report from a contactable consumer (patient) reporting for herself.    A 68-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Feb2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 68 years). Medical history included asthma and allergies from an unknown date and unknown if ongoing. Concomitant medications included vitamins and thyroid medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced nausea, joint pain, injection site very red and swollen, throat and mouth felt swollen and very dry, head ached, felt out of sorts, left arm kept going numb, eyelids were heavy, swollen gland on 20Feb2021 23:00. Reporter stated that, later that night at bedtime, started with nausea, joint pain, injection site very red and swollen, then my throat and mouth felt swollen and very dry as if someone put a wad of cotton down my throat. My head ached and felt out of sorts. My left arm kept going numb. My eyelids were heavy. Swollen gland. This intensity continued for 5 days, and still had some side effects now, 3 weeks later. Therapeutic measures taken as a result of the events included started taking antihistamines. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lymphadenopathy, Mouth swelling, Nausea
Clinical narrative: nausea; joint pain; injection site very red and swollen; injection site very red and swollen; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; Throat and mouth felt swollen and very dry; head ached; felt out of sorts; left arm kept going numb; eyelids were heavy; Swollen gland; This is a spontaneous report from a contactable consumer (patient) reporting for herself.    A 68-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20Feb2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination 68 years). Medical history included asthma and allergies from an unknown date and unknown if ongoing. Concomitant medications included vitamins and thyroid medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced nausea, joint pain, injection site very red and swollen, throat and mouth felt swollen and very dry, head ached, felt out of sorts, left arm kept going numb, eyelids were heavy, swollen gland on 20Feb2021 23:00. Reporter stated that, later that night at bedtime, started with nausea, joint pain, injection site very red and swollen, then my throat and mouth felt swollen and very dry as if someone put a wad of cotton down my throat. My head ached and felt out of sorts. My left arm kept going numb. My eyelids were heavy. Swollen gland. This intensity continued for 5 days, and still had some side effects now, 3 weeks later. Therapeutic measures taken as a result of the events included started taking antihistamines. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.