chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive covid test result, PCR, taken Wednesday 01Sep2021. First symptoms Monday 30Aug2021; Positive covid test result, PCR, taken Wednesday 01Sep2021. First symptoms Monday 30Aug2021; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), both doses via intramuscular administered in left arm as dose 2, single on 04Mar2021 and as dose 1, single on 11Feb2021 (at the age of 44-year-old) for covid-19 immunisation. The patient medical history was not reported. No concomitant medications were administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received no other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. On 30Aug2021, the patient experienced first symptoms and on 01sep2021, he was tested PCR nasal swab resulted positive. Lab tests and procedures which included SARS-COV-2 test: positive on 01Sep2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date in Sep2021.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information regarding patient's medical history, concurrent conditions or concomitant therapies were not provided. On unspecified dates, unspecified number of patients were vaccinated with one dose of improperly stored RECOMBIVAX HB lot #L027733 expiry date 13-SEP-2017 or lot # L040458 expiry date 04-FEB-2018 (dose number, dose units, route and anatomical location were not reported). Concomitant medications were not reported. No symptoms were reported. The reporting nurse was not sure which lot numbers were administered but the lot numbers mentioned were the ones possible involved. It was reported that the administered vaccines were exposed to temperatures of 46.9 Fahrenheit degrees for 15 minutes and 34.9 Fahrenheit degrees for 2 hours. This is one of the several reports from the same reporter. Follow up information has been received from Registered Nurse on 09-AUG-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Low grade fever, joint pains, fatigue, arm pains after Tdap given 5 days ago.
SORE ARM; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-APR-2021. This report was non-serious.
no adverse event; Incorrect dose administered; accidental underdose; This spontaneous report as received from a nurse refers to a 19 year old male patient.     The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 05-MAR-2021, the patient was inadvertently vaccinated with a 0.5 mL pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # T020442 with expiration date of 26-JAN-2022, instead of a 1 mL adult, for prophylaxis (route of administration was not provided) (accidental underdose and incorrect dose administered). Caller reported no additional adverse event (AE) or product quality complaint (PQC) at time of call.
Symptoms is a sore arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:00 as second dose single, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reports they just received the second Pfizer Covid vaccine at 9am. Patient did not have any reactions to the first or second dose expect for a sore arm. Inquiring if vaccine is effective because her only symptom is a sore arm. The side effects she has read about indicates it is working. The outcome of the event was unknown.  Information about the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021126380 same reporter, drug, event and different patient
I had runny nose for the first 24 hours then became very lethargic and had headaches. That's as far as it went, I slept it off for a couple of days. I took over the counter TYLENOL and SUDAFED since it didn't get any worse I didn't need to take any antivirals. I'm a little stuffy today but feel fine and don't have any other symptoms.
Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Sick for one day) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 106M20A) for COVID-19 vaccination.     No past medical history was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Sick for one day). At the time of the report, VACCINATION COMPLICATION (Sick for one day) had resolved.            No treatment or concomitant medications were reported.   This case was linked to MOD-2021-034173 (Patient Link).
Red lines and redness on the back heading down to the butt cheeks; Itching around the eyelids; At the injection site had a red blotch 2 inches wide for 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red lines and redness on the back heading down to the butt cheeks), EYE PRURITUS (Itching around the eyelids) and VACCINATION SITE ERYTHEMA (At the injection site had a red blotch 2 inches wide for 3 inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (flu shot every year and ). Concomitant products included ESTRADIOL for Estrogen, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ATORVASTATIN, OMEPRAZOLE and ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL, TOCOPHEROL, VITAMIN B NOS (MULTIPLE VITAMINS) for an unknown indication, LISINTROL.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the injection site had a red blotch 2 inches wide for 3 inches). On an unknown date, the patient experienced ERYTHEMA (Red lines and redness on the back heading down to the butt cheeks) and EYE PRURITUS (Itching around the eyelids). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red lines and redness on the back heading down to the butt cheeks), EYE PRURITUS (Itching around the eyelids) and VACCINATION SITE ERYTHEMA (At the injection site had a red blotch 2 inches wide for 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol: 8 hours after vaccination.  The patient told had no history of allergic reactions, get's the flu shot every year and had no reaction and only time she had a reaction was with the shingles vaccine first dose (redness at the injection site).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Went to dermatologist after and reported adv was not related to vaccine. She stated that the other events that were reported other that of of the redness at the injection site was not related to the vaccine.
A few hours after the immunizations, he developed swelling of the right leg (where vaccines were given). It became red. The swelling had extended beyond his hip and down to the knee.  He was admitted for IV steroids, antibiotics, and oral antihistamines.
tested positive for COVID; This spontaneous report was received from pharmacist via Pfizer and refers to a 75-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2020 (reported as two years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (dose, lot #, expiry date, route of administration and anatomical location were not provided) for prophylaxis.  On 23-OCT-2020 (reported as 9 days ago), the patient's COVID test showed positive result (SARS-CoV-2 test positive). The outcome of the event was not reported  The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
This spontaneous report as received from a other health professional refers to a 68-year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (Lot#, expiry date not reported) for aftercare prophylaxis after liver transplant. On 05-DEC-2018 the patient experienced drug hypersensitivity and cellulitis. The outcome of drug hypersensitivity and cellulitis was unknown. The reporter considered cellulitis and drug hypersensitivity to be related to PNEUMOVAX 23.
Started with headache/dizziness - side of face became numb within 24 hours of shot. From there, it went to neck/back pain. Those are main symptoms experiencing with multiple hospital visits. Patient believes that MS or viral meningitits could be present.
tested positive for Covid; This is a spontaneous report from a contactable pharmacist (patient, self-reported. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in right upper shoulder muscle, on 01Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID vaccine on 01Mar2021 and tested positive for COVID on an unknown date in Mar2021 (reported as on 04Mar2021 or 05Mar2021). The patient also reported that her father received the first dose of the vaccine on 26Feb2021 and tested positive for covid on 08Mar2021. Her father's 14-day quarantine was up this coming Monday and his second dose was scheduled for next Friday. There was a product complaint. No lot number or expiration date were obtained as the patient declined to file a safety report. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021309428 Different patient, same drug/event
w/in 10min of inject, pt returned w/reddened area approx 2" diameter was around the inject site; ice applied immediately; no SOB, no dizziness w/in 15min; arm & fingers were swollen; arm elevated VS remained stable T/0, BP 130/70, P68, R16;
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-SEP-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 120, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Caused a flare of my rhuematoid arthritis/inflammatory disease. Flare lasted approximately 5 weeks.  Treatment has included 400mg Celebrex and topical anti-inflammatory NSAID.
High fever, chills, low blood pressure, diarrhea, flushing, then hives
Feeling like shingles trying to start on back/shingles attempting to begin; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 19th April 2022, the patient received the 1st dose of Shingrix. On 28th April 2022, 9 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comments: On the day of reporting, the patient felt like shingles was trying to start on patient's back, where it was appeared previously. The patient asked if it was normal for shingles attempting to begin 9 days after vaccination. Follow up would not be possible as no contact details were available.
Tested positive for Covid with rapid test and PCR test after receiving the Moderna vaccine; A spontaneous report was received from a 70-year-old male patient who received Moderna's COVID-19 (mRNA-1273) Vaccine and later tested positive for SARS-COV-2 with a COVID-19 rapid Polymerase Chain Reaction(PCR) test 5 days after receiving the Moderna (mRNA-1273) Vaccine.  The patient's medical history was not provided. The patient denies past medical history, allergies and any concomitant medications.   On 24 Dec 2020, prior to the onset of any symptoms, the patient received his first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient tested positive for SARS-CoV-2 using the rapid test and PCR test.   On 01 Jan 2021 he received the Regeneron COV 2 cocktail.  The patient did not report any specific events. No event outcomes were reported.; Reporter's Comments: This case concerns a 70-year-old male who experienced NS unexpected event of SARS-CoV-2 test positive.  Event onset occurred 6 days after the first dose of mRNA-1273. Treatment included "Regeneron COV 2 cocktail". Event outcomes not reported. Based on 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.
Patient reported terrible headache and pain up shoulder into neck. Reported symptoms to doctor. After a day of rest, acetaminophen, and ice there was no improvement. Doctor referred patient to ER where blood work was done. This came back normal and the patient was released.
significant swelling, redness, pain. there was a hard, hot, red spot about 8 inches long and 3 inches wide for about 3 days
Sudden pain and rash appeared, took a single Zyrtec pill and rash and burning sensation went away. No other medications or change in diet at the time of the reaction were present.
Left upper posterior arm edema with swelling, and redness in area where vaccine was administered. Active ROM LUE as directed. Temp. 98.8 (ear), (+) radial brachial pulse. Telephone f/u 5/23/16.
8 days after first shot, had a seizure. Within hours of second shot, had a seizure followed by multiple seizures on following days. Placed on Lamictal and had no more seizures until four weeks, then had multiple seizures in one day, today.
Initial report received from health care professional on 21 Jan 2010: This patient was vaccinated with FLUVIRIN (Lot number 102138P1) on 21 Jan 2010. On 21 Jan 2010 immediately after vaccination the patient experienced lightheaded, queasy and metallic taste. The outcome of the events were reported as condition unchanged. The seriousness and causality of the events were not reported.
Reason for Visit   Abdominal Pain  Other   Diagnosis  Urinary retention  discharged with catheter/leg back and will return to follow up.
severe neck and shoulder pain; severe headaches; severe neck and shoulder pain; Pain at injection site; Swelling at injection site; Tingling sensation in the face (Eyelid, jaws and lips); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation in the face (Eyelid, jaws and lips)), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE SWELLING (Swelling at injection site), HEADACHE (severe headaches) and NECK PAIN (severe neck and shoulder pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 04-Apr-2021, the patient experienced PARAESTHESIA (Tingling sensation in the face (Eyelid, jaws and lips)).   On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site).   On an unknown date, the patient experienced HEADACHE (severe headaches), NECK PAIN (severe neck and shoulder pain) and ARTHRALGIA (severe neck and shoulder pain).   At the time of the report, PARAESTHESIA (Tingling sensation in the face (Eyelid, jaws and lips)), HEADACHE (severe headaches), NECK PAIN (severe neck and shoulder pain) and ARTHRALGIA (severe neck and shoulder pain) had resolved and VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   She is concerned about the tingling sensation and she wants to know if that is a common adverse event.Concomitant medications were not reported.  Treatment details include ibuprofen for symptom relieve. She consents to follow up.   This case was linked to MOD-2021-139354  (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: new information received
Received immunization Thursday 04/10/2003.  Started with fever Thursday PM, along with rash on back, legs and right forearm.  Patient had febrile seizure Thursday PM.  Brought to ER-treated with Motrin.  Also had positive strep.  On Omnicef for OM.  Finished this all.
Arm was red; swollen; gum infection; injection site is very red; injection site is swollen; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Arm was red), PERIPHERAL SWELLING (swollen), VACCINATION SITE ERYTHEMA (injection site is very red), VACCINATION SITE SWELLING (injection site is swollen) and GINGIVITIS (gum infection) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is very red) and VACCINATION SITE SWELLING (injection site is swollen). On an unknown date, the patient experienced ERYTHEMA (Arm was red), PERIPHERAL SWELLING (swollen) and GINGIVITIS (gum infection). The patient was treated with CLINDAMYCIN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Arm was red), PERIPHERAL SWELLING (swollen), VACCINATION SITE ERYTHEMA (injection site is very red), VACCINATION SITE SWELLING (injection site is swollen) and GINGIVITIS (gum infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL (lot # K011562 with expiration date 08-APR-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pts arm has remainded sor, but has noticed it is red/hot, approx 3x4 in area. This is 6 days later. she just noticed when getting out of shower today, recommended to call her dr and could try zyrtec or claritin
now right hand can not move / can not grasp anything; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (now right hand can not move / can not grasp anything) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (now right hand can not move / can not grasp anything). At the time of the report, MOBILITY DECREASED (now right hand can not move / can not grasp anything) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Reporter did not allow further contact