chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Prolonged headaches; nausea; abdominal pain; This is a spontaneous report from a contactable nurse (patient herself). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN 5318), dose 1 via an unspecified route of administration, administered in left upper arm on 25Jan2021 at 12:45 as single dose for covid-19 immunization. Medical history included cardiac disorder, hypertension, type 2 diabetes mellitus, hypothyroidism, drug hypersensitivity and allergies to Ace inhibitors. Concomitant medication was not reported. No other vaccine in four weeks. No other medications in two weeks. On 25Jan2021, at 04:00 pm patient experienced prolonged headaches, nausea and abdominal pain. On 01Feb2021, the patient underwent lab tests and procedures which included sars-cov-2 test as negative. No covid prior vaccination. The treatment medications for the events included Zofran. The patient was recovered from the all events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; pain in right armpit; Stiff neck; Dizziness; Fatigue; Headaches; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in right arm on 17Feb2021 15:00 as single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) on 27Jan2021 15:00 in right arm as single dose for covid-19 immunization. Patient was 49-years-old and was not pregnant at the time of vaccination. Medical history included chronic migraine. Concomitant medication included sumatriptan succinate (IMITREX). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph nodes and pain in right armpit, stiff neck, fatigue, dizziness, headaches on 18Feb2021 15:00. No treatment received for reported events. Patient not tested for COVID-19 after the vaccination. The outcome of the events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Swollen lymph nodes; pain in right armpit; Stiff neck; Dizziness; Fatigue; Headaches; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in right arm on 17Feb2021 15:00 as single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) on 27Jan2021 15:00 in right arm as single dose for covid-19 immunization. Patient was 49-years-old and was not pregnant at the time of vaccination. Medical history included chronic migraine. Concomitant medication included sumatriptan succinate (IMITREX). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph nodes and pain in right armpit, stiff neck, fatigue, dizziness, headaches on 18Feb2021 15:00. No treatment received for reported events. Patient not tested for COVID-19 after the vaccination. The outcome of the events was not resolved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: severe chills, teeth chattering; shaking; sweating; swollen lymph nodes; severe intense pain; headache; fatigue; vomiting; nausea; This is a spontaneous report from a contactable other HCP (reported herself). A 43-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in left arm on 16Feb2021 at 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history was not reported. There were no known allergies. The concomitant medication included Zoloft from an unknown date for unknown indication. There was no COVID prior vaccination. There were no other vaccines in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 25Jan2021 at 08:00. On 16Feb2021 at 23:00, the patient experienced severe chills, teeth chattering, shaking, sweating, swollen lymph nodes, severe intense pain, headache, fatigue, nausea and vomiting. Therapeutic measures were not received for the events. COVID was not tested post vaccination. The outcome of the events were recovering.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Tremor, Vomiting
Clinical narrative: severe chills, teeth chattering; shaking; sweating; swollen lymph nodes; severe intense pain; headache; fatigue; vomiting; nausea; This is a spontaneous report from a contactable other HCP (reported herself). A 43-year-old female patient received a second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in left arm on 16Feb2021 at 13:00 as single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history was not reported. There were no known allergies. The concomitant medication included Zoloft from an unknown date for unknown indication. There was no COVID prior vaccination. There were no other vaccines in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 25Jan2021 at 08:00. On 16Feb2021 at 23:00, the patient experienced severe chills, teeth chattering, shaking, sweating, swollen lymph nodes, severe intense pain, headache, fatigue, nausea and vomiting. Therapeutic measures were not received for the events. COVID was not tested post vaccination. The outcome of the events were recovering.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; This is a spontaneous report from a contactable consumer. A 50-year-old female received BNT162B2 (COMIRNATY, Formulation: Solution for injection) dose 2 via unspecified route of administration in Right arm (Lot number: EM9809, Expiry date: Unknown) on 17Feb2021 at 10:00AM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history included Lichen Sclerosis and hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was allergies to Environmental allergies & blue dye. Concomitant medications included liothyronine, unithroid, clobetasol and estradiol for unknown indication. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccines in four weeks. Patient previously received first dose of COVID vaccine. On 18Feb2021, the patient experienced a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches. Obviously some type of allergic reaction. Patient had zero side effects from first dose not even sore injection site. Since the vaccination, patient was not tested for COVID-19. Therapeutic measures were not taken as a result of events. The outcome of the event was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; I have developed a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches.; This is a spontaneous report from a contactable consumer. A 50-year-old female received BNT162B2 (COMIRNATY, Formulation: Solution for injection) dose 2 via unspecified route of administration in Right arm (Lot number: EM9809, Expiry date: Unknown) on 17Feb2021 at 10:00AM as a single dose for COVID-19 immunisation. The patient was not pregnant. The patient medical history included Lichen Sclerosis and hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was allergies to Environmental allergies & blue dye. Concomitant medications included liothyronine, unithroid, clobetasol and estradiol for unknown indication. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccines in four weeks. Patient previously received first dose of COVID vaccine. On 18Feb2021, the patient experienced a red, hot, hard, swollen area around the injection site that is tender to touch. The area seems to be growing and now itches. Obviously some type of allergic reaction. Patient had zero side effects from first dose not even sore injection site. Since the vaccination, patient was not tested for COVID-19. Therapeutic measures were not taken as a result of events. The outcome of the event was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Infected cyst
Clinical narrative: it (cyst) became infected; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) at single dose (at the age of 76 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated that on Feb2021, everything has been just fine not even the sore arm, but couple of days ago the patient had a cyst and that's why she visited her dermatologist for and the couple of days ago it (cyst) became infected. So, he prescribed an antibiotic Clindamycin 300 mg.  The patient just wondered if that was alright to take, as she did not want to mess up the effectiveness of the vaccine.  The outcome of the event was unknown.  The patient stated, "so, this was like a, maybe a pre-existing condition I don't think it has to do anything with the vaccine but I don't know that you know. I just want to know if I can take the medication and not having affect my vaccine."  Information on the lot/ batch number has been requested.; Sender's Comments: The reported cyst was most likely a pre-existing condition, and unlikely causally related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The patient was 76-year-old, and there were probably other factors induced it (the cyst) became infected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 3 -5 days after; This is a spontaneous report from a contactable Physician. The patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot and batch number not reported), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications and past drug history were not reported. A patient received the 1st dose, tested positive for COVID-19; 3 -5 days after, received the bamlinivimab antibody treatment, then got the 2nd vaccine dose 3 weeks after the 1st dose. It is usually recommended to wait 90 days to get the vaccine after monoclonal antibody treatment. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile of the vaccine, there is no temporal relation between the onset of Covid-19 and administration of vaccine.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pain of skin
Clinical narrative: Fever 102.2; chills; headache; joint pain; scalp pain; This is a spontaneous report from a contactable consumer. A 65-years-old female patient (Non-Pregnant) received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown) on 18Feb2021 17:30 via an unspecified route of administration, administered in left arm at a single dose for COVID-19 immunization. Medical history included lupus and allergies to medications included ceclor, dapzone, Vicodin, Atorvastatin. The patient's concomitant medications were not reported. patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Not tested covid post vaccination, Since the vaccination, patient has not tested for COVID-19. The patient experienced fever 102.2, chills, headache, joint pain, scalp pain. The patient's body temperature was 102.2 on 19Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102.2; chills; headache; joint pain; scalp pain; This is a spontaneous report from a contactable consumer. A 65-years-old female patient (Non-Pregnant) received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown) on 18Feb2021 17:30 via an unspecified route of administration, administered in left arm at a single dose for COVID-19 immunization. Medical history included lupus and allergies to medications included ceclor, dapzone, Vicodin, Atorvastatin. The patient's concomitant medications were not reported. patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Not tested covid post vaccination, Since the vaccination, patient has not tested for COVID-19. The patient experienced fever 102.2, chills, headache, joint pain, scalp pain. The patient's body temperature was 102.2 on 19Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Fever 102.2; chills; headache; joint pain; scalp pain; This is a spontaneous report from a contactable consumer. A 65-years-old female patient (Non-Pregnant) received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown) on 18Feb2021 17:30 via an unspecified route of administration, administered in left arm at a single dose for COVID-19 immunization. Medical history included lupus and allergies to medications included ceclor, dapzone, Vicodin, Atorvastatin. The patient's concomitant medications were not reported. patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Not tested covid post vaccination, Since the vaccination, patient has not tested for COVID-19. The patient experienced fever 102.2, chills, headache, joint pain, scalp pain. The patient's body temperature was 102.2 on 19Feb2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: left arm started aching; pain in left shoulder; This is a spontaneous case is received from a contactable consumer (Patient). A 31-years-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 03Feb2021 17:00 as single dose for covid-19 immunization. Medical history included Possible Autoimmune (only diagnosed with vitiligo but monitored for other diseases), known allergies: Seasonal allergies. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), probiotics (PROBIOTICS), vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]) for an unspecified indication. The patient experienced left arm started aching, pain in left shoulder on 11Feb2021 17:00. 8 days after second injection (11Feb2021), left arm started aching and was quickly followed by sharp pain in left shoulder (near injection site) with any movement of the shoulder. Pain made it difficult to move or put any weight on the shoulder. Pain was relieved with ice and heat increased mobility for a short time. Frequent sharp pain events lasted about 48 hours. Alternated ice and heat and took ibuprofen to relieve pain. After 48 hours, most sharp pains subsided. However, the aches in the arm continued with any use of the arm for the next week. The outcome of the events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: loose bowels; aches; chills; fever; Nausea; fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El9265) via unspecified route in left arm on 17Feb2021 at 12:15 at single dose for covid-19 immunization. The patient had allergy to penicillin. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9267), via unspecified route on 27Jan2021 at 11:45 at single dose for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Claritin, vitamin d3, fish oil magnesium, zinc. The patient did not receive any other vaccines within four weeks prior to the vaccination but other medications in two weeks include Claritin, vitamin d3, fish oil magnesium, zinc. On 18Feb2021 at 03:00 patient experienced chills, fever, loose bowels, nausea, aches, fatigue. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: loose bowels; aches; chills; fever; Nausea; fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El9265) via unspecified route in left arm on 17Feb2021 at 12:15 at single dose for covid-19 immunization. The patient had allergy to penicillin. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9267), via unspecified route on 27Jan2021 at 11:45 at single dose for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Claritin, vitamin d3, fish oil magnesium, zinc. The patient did not receive any other vaccines within four weeks prior to the vaccination but other medications in two weeks include Claritin, vitamin d3, fish oil magnesium, zinc. On 18Feb2021 at 03:00 patient experienced chills, fever, loose bowels, nausea, aches, fatigue. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: Have had severe diarrhea for almost 72 hours that is not going away.; Developed fever of 100.2; headache; chills; aching joints for first 2 days; This is a spontaneous report from a contactable consumer(patient).   A 69-years-old female non pregnant patient received second dose of BNT162B2 (BNT162B2, PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via an unspecified route of administration, in arm right on 18Feb2021 at 12:00 as single dose for covid-19 immunisa-tion. The patient medical history was not reported and concomitant medications were none. His-torical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via via an unspecified route of administration, in arm right on 28Jan2021 at 12:15 as single dose for covid-19 immunisation. On 18Feb2021 at 15:00, the patient experienced severe diarrhea for almost 72 hours which did not fo away, developed fever of 100.2, headache, chills and aching joints for first 2 days. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient treatment medications included tylenol for first 2 day and immodium and pepto bismol for three days. Patient did not had COVID-19 prior or since vaccination. The outcome of the events was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Have had severe diarrhea for almost 72 hours that is not going away.; Developed fever of 100.2; headache; chills; aching joints for first 2 days; This is a spontaneous report from a contactable consumer(patient).   A 69-years-old female non pregnant patient received second dose of BNT162B2 (BNT162B2, PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via an unspecified route of administration, in arm right on 18Feb2021 at 12:00 as single dose for covid-19 immunisa-tion. The patient medical history was not reported and concomitant medications were none. His-torical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via via an unspecified route of administration, in arm right on 28Jan2021 at 12:15 as single dose for covid-19 immunisation. On 18Feb2021 at 15:00, the patient experienced severe diarrhea for almost 72 hours which did not fo away, developed fever of 100.2, headache, chills and aching joints for first 2 days. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient treatment medications included tylenol for first 2 day and immodium and pepto bismol for three days. Patient did not had COVID-19 prior or since vaccination. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: I have negative IgG antibody after Pfizer BioNTech vaccine; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative. The patient experienced she have negative IgG antibody after PFIZER BIONTECH vaccine (SARS-COV-2 antibody test negative) on an unspecified date. The outcome of event was unknown.  No follow-up attempts possible. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; 101 temperature; This is a spontaneous report from a contactable consumer.  A 74-year-old male patient received second dose of BNT162B2 (solution for injection; (Batch/Lot Number: EL9266) via an unspecified route of administration in right arm on 20Feb2021 at 16:00 as single dose for covid-19 immunization. The patient medical history not reported. Historical vaccine included BNT162B2 (Dose number: 1; lot number=EL8982; administration date=28Jan2021; administration time=04:00 PM; vaccine location= Right arm) and concomitant medications were not reported. On 21Feb2021, the patient experienced chills and 101 body temperature. Treatment was not received for the events. The patient underwent lab tests and procedures which included body temperature 101. The outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: Arm started hurting all the way down.Started itching, burning and red all way down.; Arm started hurting all the way down.Started itching, burning and red all way down.; Arm started hurting all the way down.Started itching, burning and red all way down.; This is a spontaneous report from a contactable consumer. A 70-years-old non-pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Lot Number and Expiration Date was not reported) via an unspecified route of administration, administered in Arm Right on 20Feb2021 16:45 as single dose for COVID-19 immunization. Medical history included lupus-like syndrome, elevated dsDNA, drug hypersensitivity (Sodium, Thiosulfateel, Ethylenediamine), food allergy (Nuts, Milk, Egg), allergy to metals (Gold, Nickel) from an unknown date and had an anaphylactic reaction to penicillin. The patient's concomitant medications were not reported. On 20Feb2021 16:45 the patient experienced, arm started hurting all the way down, started itching, burning and red all way down. Nurse told her to take Benadryl and she did. Got OK and left after 30 min. Was told to take one more Benadryl that night and she did when it started itching again, next day was OK. Therapeutic measures were taken. The clinical outcome of the event was recovered.     Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Chest scan, Electrocardiogram
Clinical narrative: Long lasting chest pain, became quite severe at the one week mark; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: Not reported), via an intramuscular route of administration in right arm on 05Feb2021at 09:30 as single dose for COVID-19 immunization. Patient previously had historical vaccine BNT162B2 as first dose for COVID-19 immunization. Patient medical history included covid-19 positive. The patient previously took Bactrim. There were no other vaccine same date details. Patient did not receive any other vaccines within 2-4 weeks. The patient took concomitant medications (there were other medications in two weeks). On 05Feb2021, patient experienced long lasting chest pain, became quite severe at the one week mark so that he went to the ER to get checked out. All his tests so far have been normal (CT scan of chest, blood work, EKG), but the pain is. On an unspecified date, patient underwent lab tests and procedures which included blood test, CT scan of chest and EKG all were normal. There was no covid prior vaccination and the patient was not tested with covid post vaccination. Patient received treatment for event. Outcome of the event was not recovered.  Information on the Batch/Lot number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Limb mass
Clinical narrative: My left arm developed a large lump (approx. bocce ball sized) and my arm was very warm to the touch. There was a distinction between the lump and my baseline skin.; I also felt very exhausted.; arm was very warm to the touch; This is a spontaneous report from a contactable consumer (patient).   A 29-Year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EN5318) on 02Feb2021 at 01:15 PM in left arm and first dose (Batch/Lot Number: EL1284) on 12Jan2021 at 01:15 PM in right arm via intramuscular route of administration as a single dose for covid-19 immunisation. The medical history was not reported. Concomitant medications included spironolactone, Tylenol and Ibuprofen. Patient had taken other vaccine in four weeks for Flu Shot on 28Dec2020 in left arm. Patient had Covid prior vaccination. And patient was not tested for Covid post vaccination. On 03Feb2021 at 05:30 AM patient felt that left arm developed a large lump (approx. bocce ball sized) and arm was very warm to the touch. There was a distinction between the lump and my baseline skin. She also felt very exhausted. The patient did not receive any treatment. The outcome of the event was recovered.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: no appetite; Chills; Diarrhea; Fatigue; Pain in arm; Cough; Nasal congestion; This is a spontaneous report from a contactable Nurse (patient herself). A 87-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3249; Expiration Date: May2021) intramuscularly administered in right deltoid on 02Feb2021 at 0.3 ml single, for COVID-19 immunization. Medical history included hypertension (she had hypertension, or high blood pressure, which she was treated for). There were no concomitant medications. Caller says she has not had any other recent vaccinations or started any new medications. On 02Feb2021, the patient experienced cough, nasal congestion, fatigue and pain in arm, on an unspecified date, patient experienced chills, diarrhoea and no appetite. Retired RN (registered nurse) called as patient about the Pfizer COVID-19 vaccine, who says she was wondering about the shot that she got the first dose of last Tuesday. She says she has been looking at the sheet of side effects etc, and she had cough, which was not listed, and nasal congestion, no appetite, chills, and diarrhoea started on the second or third day after getting the vaccine. Caller says her cough started when she came home, and she was really exhausted after that, the cough was not bad. She asks if the vaccine is made in Germany. She says that the fatigue and pain in her arm lasted three days. Caller says that she feels it is medically significant, and she is not going back for the second shot. She took Mucinex for the nasal congestion, and for her diet she ate soup. Caller says this medication was over the counter and not prescription. Caller says that she feels it is medically significant, and she is not going back for the second shot. The outcome of the events was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity
Clinical narrative: no appetite; Chills; Diarrhea; Fatigue; Pain in arm; Cough; Nasal congestion; This is a spontaneous report from a contactable Nurse (patient herself). A 87-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3249; Expiration Date: May2021) intramuscularly administered in right deltoid on 02Feb2021 at 0.3 ml single, for COVID-19 immunization. Medical history included hypertension (she had hypertension, or high blood pressure, which she was treated for). There were no concomitant medications. Caller says she has not had any other recent vaccinations or started any new medications. On 02Feb2021, the patient experienced cough, nasal congestion, fatigue and pain in arm, on an unspecified date, patient experienced chills, diarrhoea and no appetite. Retired RN (registered nurse) called as patient about the Pfizer COVID-19 vaccine, who says she was wondering about the shot that she got the first dose of last Tuesday. She says she has been looking at the sheet of side effects etc, and she had cough, which was not listed, and nasal congestion, no appetite, chills, and diarrhoea started on the second or third day after getting the vaccine. Caller says her cough started when she came home, and she was really exhausted after that, the cough was not bad. She asks if the vaccine is made in Germany. She says that the fatigue and pain in her arm lasted three days. Caller says that she feels it is medically significant, and she is not going back for the second shot. She took Mucinex for the nasal congestion, and for her diet she ate soup. Caller says this medication was over the counter and not prescription. Caller says that she feels it is medically significant, and she is not going back for the second shot. The outcome of the events was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: I received the shot on 05Feb. About 4-5 days later I noticed a small bump on my collar bone. On the same side of the shot I received.; This is a spontaneous report from a contactable consumer (self reported). A 38-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch number and expiry date was not reported) via an unspecified route of administration in left arm on 05Feb2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 09Feb2021 at 12:00 am, About 4-5 days later he noticed a small bump on his collar bone on the same side of the shot he received assessed as non-serious. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Soreness at injection site; headache; fatigue; This is a spontaneous report from a contactable consumer. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration, in left arm on 19Feb2021 13:15 (at the age of 29-years-old) as single dose for covid-19 immunisation. Patient historical vaccine was first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), an unspecified route, in left arm on 29Jan2021 13:15 (at the age of 28-years-old) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), Centrum multivitamin. The patient had not received any other vaccines prior to the COVID vaccine. The patient experienced soreness at injection site, headache, fatigue on 19Feb2021 16:00. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Erythema, Flushing, Hypoaesthesia oral
Clinical narrative: Intense face and neck flush; Skin was red, very warm and tingly; Skin was red, very warm and tingly; Began to have numbness in my lips and tongue; My BP was on the elevated side; skin very warm; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ELI283 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 03:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism and hypertension. The concomitant medication included toprol, pravastatin, levothyroxine, fish oil, CoQ10. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and no covid tested post vaccination. On 09Feb2021 at 15:15 At about 18 minutes after the vaccine was administered, patient had a sudden and intense face and neck flush, skin was red, very warm and tingly. Patient took benadryl 25 mg tablet and after about 5-10 minutes began to have numbness in lips and tongue. At this point, patient returned to the vaccination site to report this and wait for resolution. Patient was immediately seen by a nurse and EMS and her vitals were taken and was advised to take another 25mg of Benadryl. Patient underwent lab test and procedure which included BP was on the elevated side, O2 sat was normal. Her symptoms improved and by 45 mins after the vaccination she was comfortable returning to home no additional symptoms. The outcome of the patient's events was recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Paraesthesia, Skin warm
Clinical narrative: Intense face and neck flush; Skin was red, very warm and tingly; Skin was red, very warm and tingly; Began to have numbness in my lips and tongue; My BP was on the elevated side; skin very warm; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ELI283 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 03:00 PM, as single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism and hypertension. The concomitant medication included toprol, pravastatin, levothyroxine, fish oil, CoQ10. Patient did not take any other vaccine in four weeks. No COVID prior vaccination and no covid tested post vaccination. On 09Feb2021 at 15:15 At about 18 minutes after the vaccine was administered, patient had a sudden and intense face and neck flush, skin was red, very warm and tingly. Patient took benadryl 25 mg tablet and after about 5-10 minutes began to have numbness in lips and tongue. At this point, patient returned to the vaccination site to report this and wait for resolution. Patient was immediately seen by a nurse and EMS and her vitals were taken and was advised to take another 25mg of Benadryl. Patient underwent lab test and procedure which included BP was on the elevated side, O2 sat was normal. Her symptoms improved and by 45 mins after the vaccination she was comfortable returning to home no additional symptoms. The outcome of the patient's events was recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Oral candidiasis
Clinical narrative: Mouth ulcers located inside of lip and under tongue; Thrush in mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of ad-ministration administered at left arm on 28Jan2021 09:00 PM at single dose for COVID-19 immunisation. Patient also received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered at left arm on 22Feb2021 04:30 PM at single dose for COVID-19 immunisation. The patient medical history included asthma and possible lupus. There were no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications (medications the patient received within 2 weeks of vaccination) included cannabidiol (CBD OIL), montelukast sodium (SINGULAIR), montelukast (MONTELUKAST), colecalciferol (VITAMIN D [COLECALCIFEROL]). On 30Jan2021, the patient experienced mouth ulcers located inside of lip and under tongue, thrush in mouth. Occurred 2nd day after the first shot. Started medication and was under control. Flares up again 2nd day after 2nd shot. The patient was not diagnosed with COVID-19 prior to vaccination and patient was not tested for COVID-19 since the vaccination. Patient received clotrimazole 10mg tablets as treatment for event. Outcome of event for mouth ulcers located inside of lip and under tongue was not recovered and for thrush in mouth it was recovering.  Information on the batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eyelids pruritus, Fatigue, Headache, Nausea
Clinical narrative: painful knees; red bumpy rash on face; itchy eyelids, eyebrows; Mild headache; nausea; fatigue; This is spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9810), via an unspecified route of administration on arm Left on 10Feb2021 12:00 PM at single dose for COVID-19 immunization. The patient medical history included Systemic lupus, RA, Minimal Stage Kidney Disease, mild heart failure, allergic asthma and allergies to Nafcillin, cleocin, celebrex, fluorescein dye, lasix, bactrim, flecanide. 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 Concomitant medications included Prednisone 5mg, Plaquenil 200mg, APIXABAN (Eliquis), METOPROLOL SUCCINATE (Toprolxl) taken in two weeks. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 10Feb2021 05:00 PM, the patient experienced mild headache, nausea, painful knees, fatigue, red bumpy rash on face, itchy eyelids and eyebrows. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: painful knees; red bumpy rash on face; itchy eyelids, eyebrows; Mild headache; nausea; fatigue; This is spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9810), via an unspecified route of administration on arm Left on 10Feb2021 12:00 PM at single dose for COVID-19 immunization. The patient medical history included Systemic lupus, RA, Minimal Stage Kidney Disease, mild heart failure, allergic asthma and allergies to Nafcillin, cleocin, celebrex, fluorescein dye, lasix, bactrim, flecanide. 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 Concomitant medications included Prednisone 5mg, Plaquenil 200mg, APIXABAN (Eliquis), METOPROLOL SUCCINATE (Toprolxl) taken in two weeks. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 10Feb2021 05:00 PM, the patient experienced mild headache, nausea, painful knees, fatigue, red bumpy rash on face, itchy eyelids and eyebrows. The patient did not receive any treatment for the events. The outcome of the events was recovered.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: terrible thirst; Fever 100.3; achy pain everywhere; no energy; chills; This is a spontaneous report received from a contactable consumer (Patient). A 84-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 14:00 as single dose for COVID-19 immunization. Medical history included atrial fibrillation and drug hypersensitivity. The patient's concomitant medications were not reported. On 10Feb2021 at 22:00 patient experienced terrible thirst, fever 100.3, achy pain everywhere, no energy and chills. The patient underwent lab tests and procedures which included body temperature as 100.3 on an unspecified date. Treatment received with aspirin and loads of fluids. The outcome of the events was recovered.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: terrible thirst; Fever 100.3; achy pain everywhere; no energy; chills; This is a spontaneous report received from a contactable consumer (Patient). A 84-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 14:00 as single dose for COVID-19 immunization. Medical history included atrial fibrillation and drug hypersensitivity. The patient's concomitant medications were not reported. On 10Feb2021 at 22:00 patient experienced terrible thirst, fever 100.3, achy pain everywhere, no energy and chills. The patient underwent lab tests and procedures which included body temperature as 100.3 on an unspecified date. Treatment received with aspirin and loads of fluids. The outcome of the events was recovered.