chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 8 days after my vaccine, the injection site started itching; swelled up; became red; hot to the touch; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL3262), dose 1 via an unspecified route of administration, administered in left arm on 28Jan2021 09:15 as dose 1, single for COVID-19 immunization (at the age of 39-year-old). Medical history included known allergies: Compazine, Reglan, and Phenergan. Concomitant medications included minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), zinc and elderberry [sambucus nigra]. No other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 05Feb2021 15:00, 8 days after his vaccine, the injection site started itching, swelled up, became red and hot to the touch. The patient was treated with Benadryl as a therapeutic measure of all the events. On an unspecified date, the patient recovered from all the events.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL9262), at the age of 71, via unknown route, in left arm, on Feb 19, 2021, at 08:15, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications reported as none. Prior vaccinations (within 4 weeks): Patient did not receive other vaccines. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EL3246), at the age of 71, via unknown route, in left arm, on Jan 29, 2021, single dose, for COVID-19 immunisation. On Feb 19, 2021, patient experienced soreness in arm. On Feb 20, 2021, patient had chills, body aches and headache (which was gone now). On Feb 21, 2021, patient had dizziness, still having body aches and soreness in arm. The patient did not visit the emergency room or physician office due to the events and not hospitalized. No relevant test was performed. The patient received treatment for the events with Tylenol. The outcome of soreness in arm and headache resolved on Feb 21, 2021; and of the other events: not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node swelling / slight pain to touch.; Lymph node swelling / slight pain to touch.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received second 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 20Feb2021 at 12:45 (at the age of 34-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient's concomitant medications were reported as none. The patient previously took 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 30Jan2021 at 12:00 PM (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccine in four weeks and no medications in two weeks. Patient had no COVID prior vaccination. Not tested for COVID post vaccination. On 21Feb2021 at 14:00, the patient experienced lymph node swelling and slight pain to touch. No treatment was received for events. Outcome of the events was recovering at the time of reporting.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: First dose on 06Feb2021 and Second dose on 20Feb2021; no appetite; I had body aches; Chills; Headache; This is a spontaneous report from a contactable 60-year-old Female consumer (patient). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 06Feb2021 at 15:00 and second dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 20Feb2021 (age at vaccination: 60-year-old), both as a single dose for COVID-19 immunization. Medical history included covid-19. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. After both shots patient had body aches, chills, headache, and no appetite. Event onset date for body aches, chills, headache and no appetite were 07Feb2021 at 15:00. First dose of bnt162b2 was administered on 06Feb2021 and second dose on 20Feb2021. Patient did not receive any treatment for the events. The patient underwent lab test and procedure post vaccination which included on 21Feb2021 COVID PCR test, nasal swab negative. The clinical outcome of the events was recovering at the time of this report and of first dose of bnt162b2 was administered on 06Feb2021 and second dose on 20Feb2021 was unknown. Follow-up attempts completed. No further information expected. Reporter's Comments: Reporter assessed the events as non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: First dose on 06Feb2021 and Second dose on 20Feb2021; no appetite; I had body aches; Chills; Headache; This is a spontaneous report from a contactable 60-year-old Female consumer (patient). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 06Feb2021 at 15:00 and second dose of bnt162b2 (Pfizer COVID-19 vaccine, solution for injection, Lot number: Not available), via an unspecified route in the right arm on 20Feb2021 (age at vaccination: 60-year-old), both as a single dose for COVID-19 immunization. Medical history included covid-19. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. After both shots patient had body aches, chills, headache, and no appetite. Event onset date for body aches, chills, headache and no appetite were 07Feb2021 at 15:00. First dose of bnt162b2 was administered on 06Feb2021 and second dose on 20Feb2021. Patient did not receive any treatment for the events. The patient underwent lab test and procedure post vaccination which included on 21Feb2021 COVID PCR test, nasal swab negative. The clinical outcome of the events was recovering at the time of this report and of first dose of bnt162b2 was administered on 06Feb2021 and second dose on 20Feb2021 was unknown. Follow-up attempts completed. No further information expected. Reporter's Comments: Reporter assessed the events as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 22Feb2021 14:30 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. No known allergies, no allergies to medications, food, or other products. On 23Feb2021, the patient experienced injection site pain next day. The patient did not receive any treatment for the event. The seriousness of the event was non-serious. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Migraine, Tension
Clinical narrative: tired; sore from the tension; migraine; extreme discomfort; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot: EN6201, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 19Feb2021 at 08:30 (at the age of 71 years old) as dose 2, single for covid-19 immunisation. Also, patient has previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EL9262, Expiry date was not reported) via an unspecified route of administration, administered in Right arm on29Jan2021 at 08:45 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes, Metastatic melanoma, post-menopausal migraine, known allergies were reported as Sulfa and Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), desvenlafaxine succinate (PRISTIQ), latanoprost (LATANOPROST), vitamins. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has received other medications in two weeks which includes, synthroid, pristiq, latanoprost, vitamins. The reporter reported that, after he was administered with second Covid vaccine in the morning he was fine. At 3 am (on 20Feb2021) he woke with a migraine, one of the worst that he has had in eight years. Was in extreme discomfort and in bed the rest of the day. Next day, besides being somewhat tired and sore from the tension of the prior day, he was fine. he has been under the care of a neurologist for many years for postmenopausal migraine, complex. Just wanted others to know that this might occur and be prepared for it. It was not just a headache. Patient received no treatment for the event. The outcome for the event migraine, extreme discomfort and tired was recovered and for the event sore from the tension was recovering.   Follow-up attempts completed. No further information expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; got his first dose gave him the shot/his arm might get sore and it did/it little puffed up/redness and circle around the injection site/throbbing pain in circle around injection site; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6203) via an unspecified route of administration, administered in right arm on 20Feb2021 09:15 as dose 1, single (age at vaccination 79-year-old) for covid-19 immunisation. Medical history included ongoing blood pressure high (diagnosed at 40 years old) it was controlled and ongoing diabetes from 2000 (controlled). The patient's concomitant medications were not reported. The patient reported that he got his Pfizer Covid 19 first dose 20Feb2021 and was told by the nurse that his arm might get sore and swollen. The following day there was redness and circle around the injection site that was 1-2 inches and also experienced throbbing pain. Asking if that was one of the reported side effects. The patient reported that the lady that gave him the shot said that his arm might get sore, and it did and it puffed up. He reported that it was just sore and a little puffed up, then the day before it started aching every once in a while, and then there was a red circle around it about 1.5 inches. He was not in deep pain, but it throbs. Throbbing pain in circle around injection site was reported as worsened. He wanted to know whether that was a side effect and should he have worried about it. The patient did not remember when his arm started getting sore and puffed up, it was either Saturday night or Sunday morning. The throbbing pain started the day before and even woke him up last night. The redness around the injection site was about the same as when he noticed it the previous day, but he did not know when it started. He was scheduled to get his 2nd dose on 10Mar2021. Outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: caller states she and her husband both had a sore arm for 2 days; This is a spontaneous report from a contactable other hcp. A 71-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 26Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on un specified date (at the age of: 71-years-old) as dose 1, single for covid-19 immunisation. It was reported that the reporter states that she and her husband both had a sore arm for 2 days after the vaccine was administered. She states that she also had a sore arm after her flu shot. She takes B12 injections every 30 days and is wondering if it would be safe for her to take the B12 injections before the vaccine or should she wait. she wanted to know if it's ok to take pain/fever reducing medication after receiving the Pfizer vaccine. Outcome of the events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223134 same drug/reporter/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Headache
Clinical narrative: headaches; dizziness; loose stomach feeling/ loose stools; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 19Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headaches for several days and today he woke with a horrible headache it so happens that when they gave her the vaccine it started to hurt again, it was hurting the side of her forehead, probably had to do with the ear, dizziness, loose stomach feeling on an unspecified date. Therapeutic measures were taken as a result of headaches. She took Meclinizine and antivert for headache and dizziness. The outcome of the events was unknown.  Information of lot/batch number is requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling unwell; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (wife) that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown), via an unspecified route of administration as dose 2, single on 23Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller reported that his wife received the second dose of the vaccine today and was feeling unwell on 23Feb2021. Caller wanted to know if she ever starts to feel any joint or muscle pain can she take Tylenol. At the time of this report, the outcome of event was unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection site; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Feb2021 at 14:45 (Lot Number: EL3247, unknown expiration) as dose 1, single at the age of 47 years old for COVID-19 immunisation.  Medical history included allergies to gluten and dairy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). No other vaccine in four weeks. No history of COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient experienced sore at injection site on 23Feb2021 at 16:30. The patient did not receive treatment for the event. The patient has not yet recovered from the event.   No follow-up attempts are possible; information about batch number was already obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A 71-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Feb 26, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously took the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. Reportedly, she and her husband both had a sore arm for 2 days after the vaccine was administered. She stated she also had a sore arm after her flu shot. She took B12 injections every 30 days. She wondered if it would be safe for her to take the B12 injections before the vaccine or if should she wait. She wanted to know if it was ok to take pain/fever reducing medication after receiving the Pfizer vaccine. The outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: felt like he had a terrible cold; This is a spontaneous report from a Pfizer-sponsored program, received from an other-HCP (parent). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization. The patients medical history and concomitant were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization and experienced sleepy. On an unspecified date the patient experienced terrible cold. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Irritability
Clinical narrative: feeling a little ill; irritated; This is a spontaneous report from a contactable consumer (patient) from a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling a little ill and irritated. The reporter got the first dose and she called for two concerns. First she was feeling a little ill or irritated after the first shot but now she was better. Second she was asking if she can go out and meet her family. The outcome of the events was recovering.    Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenitis
Clinical narrative: inflamed lymph nodes left armpit; headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Feb2021 at 14:15 (Lot Number: EN5318, unknown expiration) as dose 2, single at the age of 49 years old for COVID-19 immunisation. Medical history reported as none. No known allergies. No history of COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) on 29Jan2021 at 14:00 in left arm at the age of 49 years old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced inflamed lymph nodes left armpit and headache on 23Feb2021. The patient did not receive treatment for the events. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Feb2021 at 11:00 (Lot Number: EN6201, unknown expiration) as dose 2, single at the age of 75 years old (as reported) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL9263) on 22Jan2021 at 14:30 in left arm at the age of 75 years old (as reported) for COVID-19 immunization. The patient called because he was concerned that his second COVID shot seemed extremely quick in a matter of few seconds. The patient wanted reassurance that the shot could be administered that fast. The patient experienced sore arm on unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EL3247), via an unspecified route of administration, administered in left arm on 23Feb2021 at 09:30, (at the age of 42-years-old) as dose number unknown, single dose for covid-19 immunization. Patient was non pregnant at the time of vaccination. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID) (daily prescribed medicine) taken for an unspecified indication from an unspecified start date and ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid 19 prior to vaccination and patient not tested for covid 19 since the vaccination. On 23Feb2021 at 09:30, the patient experienced sore arm. No treatment received for adverse event. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non-HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 19Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patients arm was sore. The patient was wondering when she would need to go back for second dose. Relayed 21 days between doses and said everything went well after vaccine just arm was sore. The patient was advised to contact facility of 1st dose to make 2nd dose appointment. The clinical outcome for the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: hurt to raise her arm the day after the shot.; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 70-years-old female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hurt to raise her arm the day after the shot on an unspecified date. The outcome of the event was unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; vaccination site pain; This is a spontaneous report from a contactable consumer based on the information received by Pfizer. (Mfr Report #: UNT-2021-003071). A contactable 58-year old female consumer reported. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 11Feb2021 (at the age of 58-years-old) as a single dose for covid-19 immunization; treprostinil sodium (REMODULIN, Lot Number: 2101713; Expiration Date: 31Mar2022; concentration of 1.0 mg/ml), intravenous drip on 20Dec2019, at unknown dose,0.02 µg/kg for primary pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included ambrisentan; sildenafil citrate. The patient experienced the event of sore arm from COVID vaccine (vaccination site pain) on Feb2021. Action taken with IV Remodulin was dose not changed due to the event of vaccination site pain. At the time of reporting, the outcome of events was resolved on an unspecified date in 2021. The reporter assessed the causal relationship between IV Remodulin, and the event of vaccination site pain as not related.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Decreased appetite, Disturbance in attention, Fatigue, Headache
Clinical narrative: Mind fog; Head ache; Body ache; night sweating; inability to concentrate; sense of balance; loss of appetite; general feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), administered in the left arm, on 08Mar2021 at 13:15 (at the age of 69-years-old) at dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination; Kienbock's disease; chronic lymphocytic leukemia; rheumatoid arthritis. No COVID tested post vaccination. The patient had not known allergies. No other vaccine received in four weeks. Concomitant medications included allopurinol, pravastatin, fluoxetine, meloxicam; reported as other medications in two weeks. The patient experienced headache, body ache, night sweating, inability to concentrate, sense of balance, mind fog, loss of appetite and general feeling of exhaustion on 09Mar2021 at 01:00. No treatment administered for the events. The patient was recovering from the events.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment, Night sweats, Pain
Clinical narrative: Mind fog; Head ache; Body ache; night sweating; inability to concentrate; sense of balance; loss of appetite; general feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), administered in the left arm, on 08Mar2021 at 13:15 (at the age of 69-years-old) at dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination; Kienbock's disease; chronic lymphocytic leukemia; rheumatoid arthritis. No COVID tested post vaccination. The patient had not known allergies. No other vaccine received in four weeks. Concomitant medications included allopurinol, pravastatin, fluoxetine, meloxicam; reported as other medications in two weeks. The patient experienced headache, body ache, night sweating, inability to concentrate, sense of balance, mind fog, loss of appetite and general feeling of exhaustion on 09Mar2021 at 01:00. No treatment administered for the events. The patient was recovering from the events.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore upper arm for 24-36 hours after injection; pregnant at 35 weeks at the time of vaccination; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in the right arm, on 09Mar2021 09:15 (Lot number: EL9264), at age 32 years old, as dose 1, single, for COVID-19 immunisation, at a school/student health clinic. Relevant medical history and concomitant medications were not reported. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for immunisaiton on 24Feb2021; sertraline, loratadine (CLARITIN) and an unspecified prenatal vitamin all for unknown indications, start and stop dates not reported. The patient was pregnant at 35 weeks at the time of vaccination. The pregnancy due date was reported as 12Apr2021. On 09Mar2021 at 12:00, the patient had sore upper arm for 24-36 hours after injection. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19 via nasal swab in 2021 with negative result. The patient recovered from sore upper arm for 24-36 hours after injection in Mar2021.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of PNEUMOVAX23 expired on 10/3/2021 and was administered on 10/7/2021; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 07-OCT-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T021329, expiration date 03-OCT-2021, 0.5 milliliter) for prophylaxis (expired product administered). The vaccine had no previous temperature excursions. No additional adverse event (AE) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: flu like malaise; general fatigue; fogginess; This case was reported by a consumer via sales rep and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, fatigability generalized and foggy feeling in head. On an unknown date, the outcome of the malaise, fatigability generalized and foggy feeling in head were recovered/resolved.   It was unknown if the reporter considered the malaise, fatigability generalized and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's co-worker. The age at vaccination was not reported. The patient from different location after receiving Shingrix had flu like malaise, general fatigue and fogginess after vaccine that lasted one day.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot 10/5/2019; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 05th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable. Till the time of reporting, patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient asked if it's okay to get the second shot now. Follow-up would not be possible as no contact details available.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Feeling abnormal, Sensory disturbance
Clinical narrative: LIGHT HEADEDNESS; PULSING SENSATION AT BACK OF HEAD; RIGHT LEG FEELS LIKE WEIRD CIRCULATION; CHILLS; CHEST PAIN (LOCATED IN THE CENTRE-LEFT SIDE OF CHEST); This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not had any drug abuse or illicit drug use, no prior medical history, did not take any other medications regularly and had not sought medical advice yet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 11-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-OCT-2021, the patient experienced chest pain (located in the centre-left side of chest). On 12-OCT-2021, the patient experienced right leg feels like weird circulation. On 12-OCT-2021, the patient experienced chills. On 13-OCT-2021, the patient experienced light headedness. On 13-OCT-2021, the patient experienced pulsing sensation at back of head. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-OCT-2021, and had not recovered from light headedness, pulsing sensation at back of head, chest pain (located in the centre-left side of chest), and right leg feels like weird circulation. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Fever 102. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer (social media) via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported, frequency time 1 total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "vaccine killed my brother". The patient died from an unknown cause of death. It was unknown if an autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death This report was serious (Death).; Sender's Comments: V0 20211031250-COVID-19 VACCINE AD26.COV2.S-death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Fatigue, Hypoaesthesia
Clinical narrative: SKIN ON FIRE; LOST TASTE; VERTIGO; SPINE BACK PAIN; CHILLS; NUMBNESS IN EXTREMITIES; DEEP MUSCLE PAIN; NAUSEA; FATIGUE; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient experienced skin on fire. On AUG-2021, the patient experienced lost taste. On AUG-2021, the patient experienced vertigo. On AUG-2021, the patient experienced spine back pain. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced numbness in extremities. On AUG-2021, the patient experienced deep muscle pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep muscle pain, skin on fire, lost taste, numbness in extremities, vertigo, chills, nausea, fatigue, weakness, and spine back pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Skin burning sensation, Spinal pain, Vertigo
Clinical narrative: SKIN ON FIRE; LOST TASTE; VERTIGO; SPINE BACK PAIN; CHILLS; NUMBNESS IN EXTREMITIES; DEEP MUSCLE PAIN; NAUSEA; FATIGUE; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient experienced skin on fire. On AUG-2021, the patient experienced lost taste. On AUG-2021, the patient experienced vertigo. On AUG-2021, the patient experienced spine back pain. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced numbness in extremities. On AUG-2021, the patient experienced deep muscle pain. On AUG-2021, the patient experienced nausea. On AUG-2021, the patient experienced fatigue. On AUG-2021, the patient experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep muscle pain, skin on fire, lost taste, numbness in extremities, vertigo, chills, nausea, fatigue, weakness, and spine back pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: BODY ACHES; FATIGUE; FEVER; RECEIVED 2ND DOSE AFTER 57 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on FEB-2021, and dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On FEB-2021, the patient experienced received 2nd dose after 57 days. On FEB-2021, the patient experienced fatigue. On FEB-2021, the patient experienced fever. On APR-2021, the patient experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fatigue, and fever, and the outcome of received 2nd dose after 57 days was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Wrong technique in device usage process
Clinical narrative: The needle got block and didn't went all inside the muscle maybe half a needle stay outside; The vaccine didn't went all into the muscle and some went subcutaneous; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (The needle got block and didn't went all inside the muscle maybe half a needle stay outside) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The vaccine didn't went all into the muscle and some went subcutaneous) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a 20-year-old, female patient with no relevant medical history, who experienced the unexpected events of incorrect route of product administration and wrong technique in device usage process. The events incorrect route of product administration and wrong technique in device usage process occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: 3 blood clots in the leg; 2 boold clot  in the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (3 blood clots in the leg) and PULMONARY EMBOLISM (2 boold clot  in the lungs) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced THROMBOSIS (3 blood clots in the leg) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (2 boold clot  in the lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-Sep-2021 to 02-Oct-2021 due to PULMONARY EMBOLISM and THROMBOSIS. On 02-Oct-2021, THROMBOSIS (3 blood clots in the leg) and PULMONARY EMBOLISM (2 boold clot  in the lungs) had resolved.            No concomitant medication were provided. Patient mentioned that he did not had any cardiovascular issues before. Patient was discharged on blood thinners.  Company Comment This case concerns a 62-year-old, male patient, with no disclosed medical history, who experienced the serious, unexpected, AESI events of pulmonary embolism and thrombosis. The events occurred  7 months after second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The long onset latency of 7 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, male patient, with no disclosed medical history, who experienced the serious, unexpected, AESI events of pulmonary embolism and thrombosis. The events occurred  7 months after second dose of Moderna vaccine. The rechallenge is not applicable as a third dose is not expected. The long onset latency of 7 months remain as confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.