chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Chest X-ray normal, Culture urine negative, Full blood count normal, Metabolic function test
Clinical narrative: Approximately 5 days after receiving vaccine patient presented to office complaining of worsening resting hand tremors and had a temperature of 101 F. No other source of infection found including negative chest x ray and urine studies. CBC was within normal limits. Patient with seizure history however never had symptoms similar to this. Neurological exam normal in office. Fever resolved the next day.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological examination normal, Pyrexia, Thyroxine, Tremor, Urine analysis normal
Clinical narrative: Approximately 5 days after receiving vaccine patient presented to office complaining of worsening resting hand tremors and had a temperature of 101 F. No other source of infection found including negative chest x ray and urine studies. CBC was within normal limits. Patient with seizure history however never had symptoms similar to this. Neurological exam normal in office. Fever resolved the next day.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AE information available.; Caller reporting AE for PROQUAD. Caller states a dose was given today (1/11/2021) that expired on 1/5/2021.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 11-JAN-2021, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported, lot number S021328 which has been verified to be valid, expiration date reported and validated as 05-JAN-2021). There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given a first dose of the Moderna vaccine of 1ml instead of .5 ml; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was given a first dose of the Moderna vaccine of 1 mL instead of 0.5 mL.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 29 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. During the administration, the pharmacist stated that the patient was given a first dose of the vaccine of 1.0 ml instead of 0.5 ml. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event was not reported.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot 011L20A), reporting Incorrect dosage administered without any associated adverse events.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Underdose
Clinical narrative: vaccine leaked; Very minimal pain in my arm; A spontaneous report was received from a non-health professional concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced very minimal pain in arm and vaccine leaked.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273  intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 29 Dec 2020, during vaccine administration, the patient experienced vaccine leaked and very minimal pain in arm. The patient was unsure whether he received the full vaccine dose due to the leak. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, very minimal pain in my arm, was not reported. The outcome of the event, vaccine leaked, was considered resolved on 29 DEC 2020.; Reporter's Comments: This case concerns a 55 year old male patient. The patient's medical history is not provided. The patient who experienced an unexpected event of vaccine leakage. The event occurred on 29 Dec 2020 during administration of the first dose of mRNA-1273. The event is unrelated to mRNA-1273. The patient experienced very minimal pain in the arm. This will be assessed after the updating of the event term.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: PAIN INJECTION SITE,HEADACHE,CHILLED,FEVER, SWELLING INYECCION SITE AND INFLAMATION IN GANGLIOS.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN INJECTION SITE,HEADACHE,CHILLED,FEVER, SWELLING INYECCION SITE AND INFLAMATION IN GANGLIOS.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patients under the age of 18 were administered a COVID vaccine; A spontaneous report was received from a pharmacist concerning a 17 year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patients under the age of 18 were administered a COVID vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received his first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec 2020, a male patient, age 17 years old, was administered the COVID vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, patients under the age of 18 were administered a COVID vaccine, was considered resolved 29 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Muscle twitching, Pyrexia, Vomiting
Clinical narrative: FEVER, HEADACHE, VOMITING, ARM TWITCHING, ARM RED
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Gastrointestinal pain, Headache
Clinical narrative: Body aches, joint pain, headache, feeling light headed, intestinal cramping, chills
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches, joint pain, headache, feeling light headed, intestinal cramping, chills
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test negative
Clinical narrative: Patient developed a sustained headache after vaccine, that has persisted to this day, though has gotten a bit better
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Impaired work ability, Oropharyngeal pain, Vomiting
Clinical narrative: Within one hour of getting first dose of vaccine PT sts she experienced a headache and sore throat, a few hours later, vomiting, and diarrhea began.  on 20DEC20 PT sts headache continued and vomiting began.  Diarrhea and vomiting continued intermittently over following 48 hrs.  Pt went home 20DEC20 from work and was able to resume regular duties the next day with intermittent diarrhea.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Injection site pain, swelling, tenderness and redness;  fatigue, headache, muscle pain, chills, nausea and fever (101), some lightheadedness
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Injection site pain, swelling, tenderness and redness;  fatigue, headache, muscle pain, chills, nausea and fever (101), some lightheadedness
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Did not have the Lot #.  Jan4-Jan11 had no reactions.  1/12, 8am notice the right arm was itching at the inj site all day. 1/13 8am  saw a red circle around the inj site with swelling and hardness, redness and heat.  No pain no fever.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Starting 24 hours after injection, employee started to develop a red, hot, tender patch of induration around the injection site.  This steadily increased in size and severity over days 2 and 3 post injection.  The reaction finally resolved 14 days after injection.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Numbness and tingling around lips  started 18 minutes following administration of injection and began spreading to cheeks.  Administered one epi-pen in left thigh.  Improvement of symptoms took 15 minutes post-administration of epi-pen.  Seen by PA on-site
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Mild headache prior to receiving the Vaccine but the head pain has increased to severe in the hours and day afterwards. All other symptoms (body aches, sore arm etc) are minor Patient has taken 500 mg Tylenol the afternoon of the vaccine and 1000 mg the day afterwards with little affect.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Fatigue, Headache
Clinical narrative: Got menstrual cycle like almost two and a half weeks early; Abdominal pain radiating to upper and middle back; Abdominal pain radiating to upper and middle back; Stomach cramps; Nausea; Fatigue; Headache; Sinus infection; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (04Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left deltoid on 15Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included irritable bowel syndrome.  Concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), ethinylestradiol, norgestimate (CILIQUE) for birth control and multivitamin. It was stated that the patient got the vaccine on 15Dec2020. On 17Dec2020, she developed severe abdominal pain radiating to her upper and her middle back with pretty bad nausea, fatigue and headache. It was also mentioned that the patient had stomach cramps. These continued all the way until like Christmas. And then on the 19Dec2020, she actually got her menstrual cycle though she was not due to start that till that week. So, it came like almost two and a half weeks early (which was super weird as for her). The patient took ondansetron (ZOFRAN) for the nausea; aluminium hydroxide, magnesium hydroxide (MAALOX); famotidine and hyoscyamine for like stomach cramping. She also took that as well, acetaminophen (TYLENOL) and ibuprofen (MOTRIN). It was mentioned that the symptoms stopped on 26Dec2020 then she sinus infection right after in Dec 2020. Outcome of the event of sinus infection was unknown while the remaining events recovered on 26Dec2020. The patient stated that the she don't think that sinus infection was correlated at all but all other symptoms were happening right after the vaccine (reported as related).  Information on the lot/batch number has been requested.; Sender's Comments: The event sinus infection is likely intercurrent and is unrelated to suspect drug BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Nausea, Sinusitis
Clinical narrative: Got menstrual cycle like almost two and a half weeks early; Abdominal pain radiating to upper and middle back; Abdominal pain radiating to upper and middle back; Stomach cramps; Nausea; Fatigue; Headache; Sinus infection; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on (04Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left deltoid on 15Dec2020 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included irritable bowel syndrome.  Concomitant medications included fexofenadine hydrochloride (ALLEGRA), famotidine (PEPCID), ethinylestradiol, norgestimate (CILIQUE) for birth control and multivitamin. It was stated that the patient got the vaccine on 15Dec2020. On 17Dec2020, she developed severe abdominal pain radiating to her upper and her middle back with pretty bad nausea, fatigue and headache. It was also mentioned that the patient had stomach cramps. These continued all the way until like Christmas. And then on the 19Dec2020, she actually got her menstrual cycle though she was not due to start that till that week. So, it came like almost two and a half weeks early (which was super weird as for her). The patient took ondansetron (ZOFRAN) for the nausea; aluminium hydroxide, magnesium hydroxide (MAALOX); famotidine and hyoscyamine for like stomach cramping. She also took that as well, acetaminophen (TYLENOL) and ibuprofen (MOTRIN). It was mentioned that the symptoms stopped on 26Dec2020 then she sinus infection right after in Dec 2020. Outcome of the event of sinus infection was unknown while the remaining events recovered on 26Dec2020. The patient stated that the she don't think that sinus infection was correlated at all but all other symptoms were happening right after the vaccine (reported as related).  Information on the lot/batch number has been requested.; Sender's Comments: The event sinus infection is likely intercurrent and is unrelated to suspect drug BNT162B2. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Received the vaccination on 1/4/21 and then yesterday on 1/12/21; I woke up and felt my right upper arm was very itchy and then throughout the day it got worse at the injection site.  The site is sore, painful, tender, swelling and hard knot and extremely itchy.  Today 1/13/21, I feel some soreness in my lymph nodes under my right arm pit.  The injection site looks a little better and the knot is not as pronounced as the day before.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Received the vaccination on 1/4/21 and then yesterday on 1/12/21; I woke up and felt my right upper arm was very itchy and then throughout the day it got worse at the injection site.  The site is sore, painful, tender, swelling and hard knot and extremely itchy.  Today 1/13/21, I feel some soreness in my lymph nodes under my right arm pit.  The injection site looks a little better and the knot is not as pronounced as the day before.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hot flush, Hypotension, Vomiting
Clinical narrative: Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020.   No follow-up attempts possible. No further information expected.  Lot/batch number was not provided and unable to obtain
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal swelling, Pruritus, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020.   No follow-up attempts possible. No further information expected.  Lot/batch number was not provided and unable to obtain
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Chest heaviness. Denies all other symptoms. Patient transported to ER via wheelchair for evaluation.   Upon re-evaluation in ER, patient felt back to her baseline and was discharged
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Large painful lump under right arm in the armpit about breast level.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer. A 7-decade-old female patient (in her 60s) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. A pharmacy student received this drug information question in which a female patient in her 60s received the first Covid vaccine on 23Dec2020 and tested positive for Covid on 04Jan2021. Could the patient receive antibody treatment? Could she get the second vaccine and when? The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Caller is a respiratory therapist who reports that he tested positive for covid after receiving the first dose of the vaccine on 17Dec; Caller is a respiratory therapist who reports that he tested positive for covid after receiving the first dose of the vaccine on 17Dec; This is a spontaneous report from a contactable consumer (patient) reported that a 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration from on 17Dec2020 at single dose (once by injection in the right arm/bicep) for COVID-19 immunization (Healthcare worker). There were no medical history and concomitant medications reported. The patient/caller is a respiratory therapist who reported that he tested positive for covid after receiving the first dose of the vaccine on 17Dec2020. He called to ask if he can get the second dose. He also wanted to ask if people experienced side effects or what side effects people experience after the second dose. He tested positive for Covid-19 on 21Dec2020, after receiving the first dose of the vaccine. He said it had been 14 days since he tested positive for COVID and he is if he can get the second dose. He says he is actually on his way to get the second dose right now, and thought he should call. The outcome of the event was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Dyspnoea
Clinical narrative: Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Insomnia, Malaise
Clinical narrative: Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pruritus, Pyrexia
Clinical narrative: Nose is stuffy; Shortness of breath; Felt not really ok; itchy; Muscle soreness, like arms would fall off; Couldn't sleep; joint pain; had to miss work; fever reaching 104 degrees; chills; muscle ache; headache; tiredness; weakness; This is a spontaneous report from a contactable consumer (patient). This 41-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on at arm left 05Jan2021 at single dose (lot number: EK9231) for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient previously received flu vaccine and felt a little tired and sore with Flu vaccine. The patient got his first dose and then worked all day on 05Jan2021. Around 18:00-19:00 on 05Jan2021, he had fever, chills, muscle aches, headaches, joint pain, tiredness, and weakness. Fever was up to 104. The patient was referring to the Pfizer COVID-19 Vaccine first felt short of breath on 05Jan2021. He was wearing a mask and felt like he couldn't breathe. He did not feel really ok on 05Jan2021 like with a flu shot. He was working and felt a little itchy. He came home around 18:00-19:00 and had chills, headache, muscle soreness like arms would fall off. He couldn't sleep. He had fever and chills through the night. He had fever up to 104 on 05Jan2021 and had to miss work. The patient stated his nose was stuffy on an unspecified date. No additional vaccines administered on same date of pfizer suspect. No prior vaccinations within 4 weeks. Outcome of all events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Feeling abnormal, Lip erythema, Lip swelling, Oropharyngeal discomfort
Clinical narrative: At 1134 patient c/o  tingling to lower lip.  Pt. examined lip in mirror stating it is swollen.  This nurse noted the lips very red.  BP 148/88, P 64, R 20, SpO2 98%.  Given water to drink.  At 1146 given  25 mg oral Diphenhydramine solution for increase in swelling to lip and 'weird' feeling in throat..  At 1150 pt.'s PCP notified via [hone call by RN .  Informed of pt.'s current status & VS.  At 1150 BP 152/90, P 62, R 20, SpO2 98%.  At 1204 BP 158/80, P 62, R 20, SpO2 98%.  At 1210 BS 301. Per RN,  states Dr. requested a BS check.  At 1215 RN, notified Dr. of pt.'s current VS, BS and pt. reporting the tingling in lip has resolved but continues with 'weird' feeling in throat.  At 1220 pt. released to go home.  Instructed by Dr. to take Benadryl every 4-6 hours today, given ER precautions & has a f/u  appt. for 1/16/21.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: At 1134 patient c/o  tingling to lower lip.  Pt. examined lip in mirror stating it is swollen.  This nurse noted the lips very red.  BP 148/88, P 64, R 20, SpO2 98%.  Given water to drink.  At 1146 given  25 mg oral Diphenhydramine solution for increase in swelling to lip and 'weird' feeling in throat..  At 1150 pt.'s PCP notified via [hone call by RN .  Informed of pt.'s current status & VS.  At 1150 BP 152/90, P 62, R 20, SpO2 98%.  At 1204 BP 158/80, P 62, R 20, SpO2 98%.  At 1210 BS 301. Per RN,  states Dr. requested a BS check.  At 1215 RN, notified Dr. of pt.'s current VS, BS and pt. reporting the tingling in lip has resolved but continues with 'weird' feeling in throat.  At 1220 pt. released to go home.  Instructed by Dr. to take Benadryl every 4-6 hours today, given ER precautions & has a f/u  appt. for 1/16/21.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: Fatigue; chills; nausea; vomiting; This is a spontaneous report from a non-contactable other health professional. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, from 30Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included anxiety and intermittent SVT (supraventricular tachycardia). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Concomitant medication included escitalopram and buspirone for anxiety. On 01Jan2021 19:00, the patient experienced fatigue, chills, nausea and vomiting. The outcome of events was recovered. No treatment was required/received due to the events.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient said he felt like someone was holding his throat but he mentioned that he had a history of throat tightening. We gave him 2 Benadryl and checked on him about 8 times (roughly every 10 minutes or so) and he said he felt like normal. We checked on him a couple more times and he said he felt fine. We left him 2 more Benadryl just in case he needed it and we alerted the facility
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypertension, Tachycardia
Clinical narrative: hypertension like 190/90; I had tachycardia to 165; Flushing; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK9231, intramuscular on 06Jan2021 at single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included cyproheptadine for migraine, unspecified multivitamins; and diphenhydramine (BENADRYL) and famotidine as pre-medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 for COVID-19 immunization, and experienced dizziness, palpitations, tingling in face and legs, myalgia, nausea, headache, fatigue. It was reported that patient got the second dose and had tachycardia to 165 and hypertension like 190/90 and had some flushing (event onset: 06Jan2021). Patient was no longer tachycardiac or hypertensive; lasted for about 30-40 minutes. Outcome of the events tachycardia and hypertension was recovered on 06Jan2021. Outcome of the event flushing was unknown.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Rash papular, Rash pruritic
Clinical narrative: Initially had a red circle at the injection site for a couple days and it went away, then on 1/11 the red circle has returned bigger, raised, and itchy
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Facial paralysis, Hypoaesthesia, Lip swelling, Nausea
Clinical narrative: Nausea, lightheadedness, and finally numbness to right side of face, slight drooping on right corner of mouth and right side of bottom lip. It began with a tingling feeling in lip. Observing staff did not notice any swelling, or other impairments, asked me if I had anxiety, and sent me on my way. Shortly after, it felt as if I had gotten a shot at the dentist, and had the tingling numbness left over on the right side of my face. About 4 hours later, my bottom lip and right side of my mouth drooped slightly, but I could still smile, talk, raise my arm, so there was no other impairment. By the next day the numbness had mostly subsided, and the nausea and lightheadedness was gone. This vaccine was given to me at a work clinic in the administration building. I do not have contact information for them but was provided a packet with this website. I don't have any pre-existing conditions, do not have anxiety, am not a hypochondriac, did not even know about the Bell's Palsy issues in trials until after I felt numbness, and the right side of my face felt as if it fell asleep, like a foot falling asleep but it was my face. It was not to the extent of Bell's palsy, and may have even been my bottom lip swelling slightly on the right side that caused the droop. It infuriates me that this side effect was dismissed as me having anxiety because I was nervous that my face was going numb which would be a natural reaction for anyone.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Nausea, lightheadedness, and finally numbness to right side of face, slight drooping on right corner of mouth and right side of bottom lip. It began with a tingling feeling in lip. Observing staff did not notice any swelling, or other impairments, asked me if I had anxiety, and sent me on my way. Shortly after, it felt as if I had gotten a shot at the dentist, and had the tingling numbness left over on the right side of my face. About 4 hours later, my bottom lip and right side of my mouth drooped slightly, but I could still smile, talk, raise my arm, so there was no other impairment. By the next day the numbness had mostly subsided, and the nausea and lightheadedness was gone. This vaccine was given to me at a work clinic in the administration building. I do not have contact information for them but was provided a packet with this website. I don't have any pre-existing conditions, do not have anxiety, am not a hypochondriac, did not even know about the Bell's Palsy issues in trials until after I felt numbness, and the right side of my face felt as if it fell asleep, like a foot falling asleep but it was my face. It was not to the extent of Bell's palsy, and may have even been my bottom lip swelling slightly on the right side that caused the droop. It infuriates me that this side effect was dismissed as me having anxiety because I was nervous that my face was going numb which would be a natural reaction for anyone.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Syncope
Clinical narrative: Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday 06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block right, Dizziness, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal
Clinical narrative: episodes of severe dyspnea and lightheadedness over the past couple of weeks; episodes of severe dyspnea and lightheadedness over the past couple of weeks; ventricular tachycardia with a rate of 270; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; This is a spontaneous report from a contactable physician (patient). A 4-decade-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that on 18Dec2020, she received the first dose of Pfizer / BioNTech vaccine. On 30Dec2020 (Wednesday), she was diagnosed of ventricular tachycardia with a rate of 270, severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement. On 30Dec2020, EKG showing RBBB with PR 234 (in presence of normal EKG and ECHO from Dec2016), and positive troponin 0.07 that has remained stable in the following week. On unspecified date in Jan2021, the patient had been having episodes of severe dyspnea and lightheadedness over the past couple of weeks, but it had been sporadic - it became significantly worse in the last 2 weeks, which is why patient sought out an electrophysiologist (and purchased at-home EKG monitor on which she saw the VT). Patient do not know the cause at all. She was tested for SARS-CoV-2 antibody yesterday (unspecified date in Jan2021), which was negative. Patient was also trying to determine if she should get the second dose or not. She will have cardiac PET scan next week, which hopefully further elucidate causes. Outcome of the events dyspnea and lightheadedness was not recovered; while outcome of other events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the available information, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Fibrosis, Inflammation, Right ventricular dilatation, Right ventricular dysfunction, SARS-CoV-2 antibody test negative
Clinical narrative: episodes of severe dyspnea and lightheadedness over the past couple of weeks; episodes of severe dyspnea and lightheadedness over the past couple of weeks; ventricular tachycardia with a rate of 270; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; This is a spontaneous report from a contactable physician (patient). A 4-decade-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that on 18Dec2020, she received the first dose of Pfizer / BioNTech vaccine. On 30Dec2020 (Wednesday), she was diagnosed of ventricular tachycardia with a rate of 270, severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement. On 30Dec2020, EKG showing RBBB with PR 234 (in presence of normal EKG and ECHO from Dec2016), and positive troponin 0.07 that has remained stable in the following week. On unspecified date in Jan2021, the patient had been having episodes of severe dyspnea and lightheadedness over the past couple of weeks, but it had been sporadic - it became significantly worse in the last 2 weeks, which is why patient sought out an electrophysiologist (and purchased at-home EKG monitor on which she saw the VT). Patient do not know the cause at all. She was tested for SARS-CoV-2 antibody yesterday (unspecified date in Jan2021), which was negative. Patient was also trying to determine if she should get the second dose or not. She will have cardiac PET scan next week, which hopefully further elucidate causes. Outcome of the events dyspnea and lightheadedness was not recovered; while outcome of other events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the available information, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Ventricular tachycardia
Clinical narrative: episodes of severe dyspnea and lightheadedness over the past couple of weeks; episodes of severe dyspnea and lightheadedness over the past couple of weeks; ventricular tachycardia with a rate of 270; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement.; This is a spontaneous report from a contactable physician (patient). A 4-decade-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient reported that on 18Dec2020, she received the first dose of Pfizer / BioNTech vaccine. On 30Dec2020 (Wednesday), she was diagnosed of ventricular tachycardia with a rate of 270, severe right ventricular dilatation and dysfunction with inflammation and fibrosis throughout the RV and septum, but minimal LV involvement. On 30Dec2020, EKG showing RBBB with PR 234 (in presence of normal EKG and ECHO from Dec2016), and positive troponin 0.07 that has remained stable in the following week. On unspecified date in Jan2021, the patient had been having episodes of severe dyspnea and lightheadedness over the past couple of weeks, but it had been sporadic - it became significantly worse in the last 2 weeks, which is why patient sought out an electrophysiologist (and purchased at-home EKG monitor on which she saw the VT). Patient do not know the cause at all. She was tested for SARS-CoV-2 antibody yesterday (unspecified date in Jan2021), which was negative. Patient was also trying to determine if she should get the second dose or not. She will have cardiac PET scan next week, which hopefully further elucidate causes. Outcome of the events dyspnea and lightheadedness was not recovered; while outcome of other events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the available information, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. 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.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Skin discolouration, Ultrasound scan normal
Clinical narrative: My right leg from the knee down was purple and they thought I have a blood clot; My right leg from the knee down was purple and they thought I have a blood clot; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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. Three days after vaccination the patient felt very sick and he/she was so bad that he/she thought he/she might die with outcome of recovered after one week. The patient reported also that on unknown date his/her right leg from the knee down was purple and they thought he/she have a blood clot, due to which the patient was hospitalized for 14 days. The patient ended in the hospital because his/her right leg from the knee down was purple and they thought he/she have a blood clot but they did an ultrasound that was not the case but they put he/she on antibiotic. The patient was still taking them but his/her leg has got better.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling hot, Flushing, Headache, Musculoskeletal discomfort
Clinical narrative: Metal taste immediately after injection.  8:20 felt hot and flushed.  blood pressure 118/78 heart rate 100.   8:32 b\p 130/80 Heart rate 100 discomfort in neck back and headache. Reported she had a headache with the first dose.  8:50 states she is better and ready to go home. b\p 128/88 heart rate 90 Advised to seek medical help if symptoms worsen.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia oral
Clinical narrative: STAFF C/O FEELING TINGLING IN HER TONGUE, A LUMP IN HER THROAT, AND A RACING HEART. CLINICIAN EXAMINED AND ORDERED BENADRYL 50MG IM.  THE SITUATION WAS RESOLVED AFTER THE IM MEDICATION.