chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 56-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included hypertension, thyroid disorder, prior to vaccination, patient was diagnosed with COVID-19. No known allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); azilsartan medoxomil, chlortalidone (EDARBYCLOR); nebivolol hydrochloride (BYSTOLIC); cetirizine hydrochloride (ZYRTEC) and antibodies. The patient experienced fever 104.2 fahrenheit for 3 days, sore arm 10 days, hot arm, bones hurt. Loss taste and smell for 10 days (30% better). Pulse ox dropped down to 92 and shortness of breath 3 days. Because she had Covid and was in a long haulers study, patient still had antibodies 11 months post Covid and when she took the 1 vaccine. It was like her body knew this and it rallied. She could not get out of bed for 24 hours. Symptoms began 12 post vaccine on 16Apr2021 at 02:30 AM. She had antibodies drawn 4 weeks after 1 dose and was at the highest limit. The patient also underwent lab tests which included sars-cov-2 test: negative on an unspecified date. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events fever and shortness of breath was recovered on 19Apr2021 for 3 days; sore arm was recovered on 26Apr2021 for 10 days; could not get out of bed was recovered on 17Apr2021 02:30 for 24 hours; outcome of the other events was recovering. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Fully vaccinated patient test positive for COVID upon admission to the hospital.  Admitted 06/20/21 for stroke.  No s/s of COVID throughout stay.  No fever, cough, O2 needs.  Discharged without any COVID concerns.
Severe pain in shoulder around injection site, no loss in function, 4 days, no residual effect.
Light-headedness, slight dizziness, slight numbness in arm that spread to hand then up neck and caused headache, tingling in lips and tip of tongue, later swelling and soreness at injection area in upper right arm.
Reports redness, warmth, swelling to right and left arm; worse in left.  Occurred within 48 hours of injections.  Giving Tylenol.
PATIENT REPORTS THAT A FEW DAYS AFTER IMMUNIZATION HER RIGHT ARM HAD A DULL ACHE THAT HAS NOW SPREAD UNDER HER RIGHT BREAST. ARM FEELS "HEAVY" AND DOES NOT HAVE FULL RANGE OF MOTION.
On 1/18/02, client called and stated she has redness, swelling and pain in the area of the pneumococcal vaccine which was given in the right arm. It was also warm to touch. Swelling was the size of a softball. Referred to PCP. If no appt, told client to go to ER. On 1/21/02, called client. ER dx'd cellulitis and an injection was given with an RX for antibiotic; is in the process of resolving.
Triggered angina, severe headaches, unable to walk due to swelling of the back, sweat outbreaks, coughing.
This spontaneous report was received from a nurse concerning an unspecified number of patients. The patients historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with an unspecified number of doses of PROQUAD subcutaneously, reported lot number R011217, expiry date 15-OCT-2019, reported lot number R011802, expiry date 21-OCT-2019, (laterality, strength, dose and frequency were not reported) and VARIVAX reported lot number R009411, expiry date 29-MAR-2020, reported lot number R003300, expiry date 01-FEB-2020, reported lot number N035940, expiry date 18-DEC-2019 and reported lot number N034551, expiry date 05-DEC-2019 (laterality, strength, dose, route and frequency were not reported) both vaccines for prophylaxis, following a temperature excursion.  The administered doses of the vaccines experienced a temperature excursion of 6°F to 14°F (-14°C to -10°C) for 14 hours 30 minutes and of 15°F to 46°F (-9°C to 8°C) (-6.1°C) for 20 minutes, with multiple excursions, as recorded by a data logger. No previous temperature excursion was reported and there was no adverse effect reported. No product quality complaint was filed. This case was considered non-valid due to lack of patient identifiers. As of 09-NOV-2018, all telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received from the registered nurse on 08-JAN-2019, referring to a 4-year-old male patient. It was reported that the patient had two brothers/sisters. Concomitant therapies included albuterol (VENTOLIN) and beclomethasone dipropionate (QVAR) (also reported as suspect therapies, discrepant information), and his concurrent conditions included asthma and developmental delay. On 18-SEP-2018, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (strength and dose were not provided), lot number R011217 (lot number R011217 was an invalid lot number for M-M-R II(expiration date not provided), subcutaneously, in the left thigh, for prophylaxis; and with diphtheria toxoid, pertussis acellular 1-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV)(strength and dose were not provided), lot number reported as C5497AA (expiration date not provided), intramuscularly, in the left thigh. There was no adverse effect reported . It was also reported that the patient received an unspecified treatment for the event. This is one of several reports received from the same reporter.; Sender's Comments: US-09507513-1809USA010598: US-09507513-1901USA002753: US-09507513-1901USA002754: US-09507513-1901USA002755: US-09507513-1901USA002764: US-09507513-1901USA002763: US-09507513-1901USA002762: US-09507513-1901USA002761: US-09507513-1901USA002760: US-09507513-1901USA002759: US-09507513-1901USA002758: US-09507513-1901USA002765: US-09507513-1901USA002756:
I've had to increase dosage on my blood pressure meds since vaccination AND I've had to add another BP med, and still my blood pressure is not controlled; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6208), via an unspecified route of administration on 11Mar2021 at 17:00 hours (at the age of 42-years-old) in right arm as dose 2, single for COVID-19 immunization. Medical history of the patient included HIV infection, aortic valve disease, hypertension (start date and ongoing status unknown). The patient's concomitant medications were not reported. It was mentioned that the patient received other vaccines on 11Mar2021. He did not get other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination, had not been tested for COVID-19 since the vaccination, had no known allergies. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: E19266) via an unspecified route of administration on 18Feb2021 (at the age of 42-years-old) in right arm as dose 1, single for COVID-19 immunization. On 12Mar2021 , patient experienced and had to increase dosage on my blood pressure meds since vaccination and he had to add another BP med, and still his blood pressure was not con-trolled. he believe the correlation might be the vaccine along with his pre-existing heart disease. A bi cuspid aortic valve. Patient had attended doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Congenital anomaly or birth defect. Patient had received treatment for the event as Increase dosage of BP meds and additional BP med a. The Device timestamp was12Jun2021. Outcome of event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Mild Facial Burning; Tingling to bilat hands; This is a spontaneous report from a contactable Nurse (Patient). A 52-years-old male patient received second doe second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EJ1686) via intramuscular route of administration in right arm on 08Jan2021 09:15 as single dose for COVID-19 immunization Hospital. The patient medical history and concomitant medications were not reported. Patient previously took first dose BNT162B2, Batch/Lot Number: EJ1685) via intramuscular route of administration in right arm on 18Dec2020 for COVID-19 immunization patient had extreme itching, burning over entire body, awoke 08:00 with body ache, headache. On 08Jan2021 11:30 the patient experienced mild facial burning, tingling to bilat hands on 08Jan2021 11:30. Patient had a visit to Emergency room and physician office for the events. Therapeutic measures were taken as a result of mild facial burning, tingling to bilat hands Benadryl, hydroxyzine, Loratadine, Pepsin. The outcome of the events mild facial burning, tingling to bilat hands was recovered on unspecified date.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
I had Open Heart surgery and a Bovine Heart Valve Replacement in July of 2019. I experienced shortness of breath in February of 2021 two weeks after the second dose of the vaccine. I was feeling sluggish, so I visited my Cardiologist, and I changed my blood pressure medication. After investigation it was discovered that my replacement Heart Valve is failing. I have moderate Aortic regurgitation. I saw my Pulmonologist and I was tested for lung function. It has been six months and I still feel some tiredness and occasionally feel chest pain. I have been told that I will have to have the Valve Replaced again. The valve should normally last 10-15 years and it has only been 2 years.
Patient reports developing a severe headache/migraine by the next day requiring a visit to the ED which lasted greater than 72 hours.
His husband tested positive after his 1st shot; His husband tested positive after his 1st shot; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient (husband) tested positive after his 1st shot on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. The patient was scheduled to receive their second dose on 22Mar2021.  Information on the lot/batch number has been requested.
Sore arm for 10 days; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient refused to provide his date of birth (DOB). Two months before the date of reporting, the patient received Shingrix in left arm and experienced a sore arm for 10 days. The patient consented to follow up.
Extreme nervousness at bedtime with many body movements, with very little control.  No fever, but gave her two Tylenol PM gelcaps to help her sleep.
Since my vaccine, I have had ongoing severe pain in my left shoulder and have lost partial use of my arm due to the pain. It is with me 24 hours a day and is not getting better.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included asthma (current condition), patient has a history of having asthma flare-ups "from time to time" and was treated with Prednisone each time. On 03-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot #, dose, route not reported)). Concomitant medications were unspecified inhalers. On an unknown date in October 2014 the patient who received ZOSTAVAX brought a prescription for Prednisone to the pharmacy on 07-OCT-2014 to treat an asthma "flare up". The patient sought medical attention by contacting the physician. There was not product quality complaint. The outcome is unknown. The pharmacist says the patient's flare-up has "nothing to do with ZOSTAVAX" (assessed as causality not related). Additional information is not expected as the pharmacist did not want to provide further details.
severe headache; neck ache; excessive sweating; fatigue; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness). At the time of the report, HEADACHE (severe headache), NECK PAIN (neck ache), HYPERHIDROSIS (excessive sweating), FATIGUE (fatigue) and ASTHENIA (weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Night sweats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NIGHT SWEATS (Night sweats) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Benadryl), Ulcer, Blood pressure, AFib and Enlarged prostate. Concomitant products included METOPROLOL SUCCINATE and PROPAFENONE HCL for AFib, ATORVASTATIN from 04-Apr-2020 to an unknown date for Blood pressure, TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN [TAMSULOSIN HYDROCHLORIDE]) for Enlarged prostate, OMEPRAZOLE from 15-Nov-2020 to an unknown date for Ulcer.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced NIGHT SWEATS (Night sweats). At the time of the report, NIGHT SWEATS (Night sweats) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) Normal. On an unknown date, Tuberculin test: normal (normal) normal. On an unknown date, Ultrasound Doppler: normal (normal) normal. On an unknown date, X-ray: normal (normal) Normal.         No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-095204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up Received: Added Patient demographics, Medical History, Lab data, Suspect Drug Onset date, Concomitant Medications, Event Outcome.
lips swelled up; lips bled; ips peeled off; Clear liquid came out of the rash; On arm noticed little bumps like a mole but not a mole; rash, it itched; skin was soft now its rough; arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (lips swelled up), LIP HAEMORRHAGE (lips bled), LIP EXFOLIATION (ips peeled off), DISCHARGE (Clear liquid came out of the rash) and BLISTER (On arm noticed little bumps like a mole but not a mole) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced LIP SWELLING (lips swelled up), LIP HAEMORRHAGE (lips bled), LIP EXFOLIATION (ips peeled off), DISCHARGE (Clear liquid came out of the rash), BLISTER (On arm noticed little bumps like a mole but not a mole), RASH PRURITIC (rash, it itched), DRY SKIN (skin was soft now its rough) and PAIN IN EXTREMITY (arm was sore). At the time of the report, LIP SWELLING (lips swelled up), LIP HAEMORRHAGE (lips bled), LIP EXFOLIATION (ips peeled off), DISCHARGE (Clear liquid came out of the rash), BLISTER (On arm noticed little bumps like a mole but not a mole), RASH PRURITIC (rash, it itched), DRY SKIN (skin was soft now its rough) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.            No concomitant medications were reported. Treatment medications includes: Antibiotic 1000mg for 7 days, not otherwise specified.    This case was linked to US-MODERNATX, INC.-MOD-2021-116481 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Patient  received the follow up form and patient is having troubles emailing this form back. Patient  doesn't have access to a fax machine. Patient  asked for a mailing address that  can use to mail the form back; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116481:dose 1
Pt reports sx: Pain; Weakness when moving arm worsened around 12 pm; Dulled sensation and numbness along upper arm for 6" to just above elbow. Denies HA, fever.
pt devel rt hemifacial spasm approx 7 wks p/flu vax; noted on 22NOV91 when drooping of rt eyelid occurred;  1 day later pt devel progressive involuntary rhythmical contraction of the rt face which cont; unable to vol open rt eye;
I feel like Covid; tingling in around my tongue/ inside my cheeks / I had tingling or numbness in both lips; I had tingling or numbness in lips, both lips; i was really weak; I feel something hot in me; I feel fever; aching/pain; I feel like nervous; my brain is 'fog' / I felt something really hard in my body /I feel weird; I feel like I am not focused more; I feel like I want to scream; This is a spontaneous report from a contactable consumer. A 57-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot Number: 301358A) via an unspecified route of administration on 18Sep2021, as DOSE 1 SINGLE for covid-19 immunization (age at vaccination 57-Years-old).  Patient medical history includes: The patient stated that pharmacy was not right. She already had COVID in January and she went to the hospital twice because her heartbeat went down to 40. She was afraid to take the medicine, the capsule. She was little bit depressed. Patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Patient concomitant medication was not reported. Patient stated that she was supposed to take the second dose today because it is 21 days on 09Oct2021. The patient wanted to know if she can take the second dose of vaccine today or tomorrow after all the symptoms and reaction she had after the first dose. On 18Sep2021, the day patient got her first dose of Covid-19 Vaccine, she felt something really hard in her body and then she felt tingling in around her tongue, tingling and numbing in both lips and inside her cheeks. Within 15 minutes, she was really weak and got up with turtle leg after the vaccination. She felt something hot in her, felt like she wanted to scream but she started breathing, felt weird, nervous, her heartbeat for a minute went to 40, down to 40, had fever, pain, aching, felt she was not focused, and she doesn't know for some reason her brain was fog. The patient reported that she tasted the vaccine, and it was something like tonic. She could feel how it tastes and that was when she started feeling weak and the numbness. She added she felt like COVID. The patient took 1 Tylenol (500 mg, 1 tablet at night) and Ibuprofen 200 mg, 2 pills as she wanted to sleep and had a lot of pain. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected
Severe induration/erythema of injection site. Fever up to 104.5 with irritability for 4 days. Pt continues to have some indurations, but erythema has resolved.
Headache (very unusual for me) lasting 2 days, heaviness in chest similar to heartburn, shortness of breath with mild wheezing. All have mostly resolved within 2 days of occurence.
I slept for most of the day; Anaphylactic shock; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (to Codeine), Sulfonamide allergy (to sulfa drugs), Allergy to antibiotic (to tetracycline) and Insect bite allergy (to bites of various insects).   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant). On 08-Apr-2021, the patient experienced SOMNOLENCE (I slept for most of the day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 07-Apr-2021 for Allergic reaction, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock) and SOMNOLENCE (I slept for most of the day) outcome was unknown.            Concomitant product use was not provided. The patient stated that she was monitored at hospital for several hours, as well as given another medication to counter the allergic reaction.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.