chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received second dose of Pfizer vaccine.  Vaccine expiration time 0930 on 5/12/2021. Patient received vaccine on 5/12/2021 at 0933. MD made aware.  No harm to patient or adverse reactions.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On 25th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the common side effects post vaccination. The patient wanted to know how long the side effects would last.
Pro BNP was way high; fatigued; feeling lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 92 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN NATRIURETIC PEPTIDE INCREASED (non-serious), outcome "unknown", described as "Pro BNP was way high"; LETHARGY (non-serious) with onset Feb2021, outcome "unknown", described as "feeling lethargic"; FATIGUE (non-serious), outcome "unknown", described as "fatigued". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: A day or two after having the shot, he was feeling lethargic, had no energy and wanted to sleep. He went to his cardiologist and he did some labs and is Pro BNP was way high (952). His doctor had him do a chest x-ray which was normal except for some deterioration in his shoulders and he is scheduled to have an echo tomorrow. His second shot is scheduled 18Mar and he doesn't know what to do. Patient's cardiologist did not think this increase was from covax. Now he is afraid to get the second covax scheduled for this Thursday.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case, initially received on 17-Oct-2016, was reported by a non health professional and concerns a(n) female patient. Weight: not provided; Height: not provided. Past medical history included Surgeries for the melanoma, Needle biopsy, Cold sores, LEEP (loop electrosurgical excision) procedure. Drug history/allergy included Opioids (Reaction: Drug Reactions/Allergies). At the time of the event the patient had Chronic fatigue syndrome, Malignant melanoma on legs and chest. Concomitant medications: pembrolizumab, dexamethasone, valacyclovir and corticosteroids. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Drug reaction/allergies to flu shots (outcome: Not Reported).
A spontaneous report has been received from a physician via medical representative concerning female patient. The health professional reported when her daughter got the nasal FLUMIST (intranasal) vaccine 6 or 7 years ago, she noticed the daughter had irritability, like a temper tantrum. The infectious disease physician said the daughter probably was experiencing headaches from the medication, but she just could not tell, as the daughter was 3 or 4 years of age at the time of this event. The patient recovered from irritability, like a temper tantrum and probably was experiencing headaches on an unspecified date. Company physician considered irritability, like a temper tantrum and probably was experiencing headaches to be non-serious.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. Approximately in 2015, an unspecified number of patients were vaccinated with unspecified doses in series of GARDASIL 9 lot number L004014, expiration date 04-MAR-2017 (dose and route of administration were not reported). The vaccine was improperly stored between 26-AUG-2015 and 01-SEP-2015. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Twenty five (25) minutes after flu vaccine was given colleague developed a rash on upper chest and neck. Given BENADRYL at that time, rash was worse on day #2 and sent to physician the next day for treatment.
DOS 6/19/2021- Patient was given his 2nd Pfizer vaccine 7 days before the recommended time between the 1st and 2nd dose.
3 hours post vaccination, felt very sick to stomach.  After finishing shift and returning home.  I ate a little dinner.  About an hour after that vomited.  I had stomach cramping thru the night.  By morning, I was feeling better.  4 days after shot, arm still sore and noticed golf ball sized lymph node on left clavicle, which is the side where the vaccine was given.  I saw my family doctor who said he thought it was from the shots - monitor side of lymph node.  Lymph node is slowly returning to normal size.
Chest pain,, elevated heart rate (110-120's), and palpitations/heart fluttering.
He had no adverse effects or symptoms after receiving the dose; Caller is a nurse manager who reports that a 4 month old patient received his first dose of ROTATEQ today. He had no adverse effects or symptoms after receiving the dose. Caller reported dose as "dose one/first dose" when asked for dose and frequency; This spontaneous report has been received from a nurse manager, referring to a 4-month-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unknown date, , the patient received a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, dose one/first dose, lot number 1821811 which was verified to be a valid lot number with an expiry date of 27-JUL-2022 for prophylaxis (dose and vaccination scheme were not reported).  On 24-MAY-2022, the patient received his first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product administered to patient of inappropriate age). Therefore, the patient had no adverse effects or symptoms after receiving the dose of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (No adverse event).
9/30- felt side stitch on left side of chest, same side as vaccinated arm. Then had difficulty breathing. Clocked duration at 12 mins.
Very swollen and itchy arm with redness around the injection site lasting for 2 weeks with a fever. Absence of menses
He had a lung infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (He had a lung infection) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (He had a lung infection) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (He had a lung infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on immunotherapy.   Treatment for the event included amoxicillin as an antibiotic.  Based on the current available information and temporal association between the use of the product and the start date of this 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 this event, a causal relationship cannot be excluded.
Extreme muscle soreness and tenderness to the touch, sore with movement and lifting; ached in whole arm at times; took TYLENOL at approx 2:00 am.
Patient states reporting numbness, weakness, with paralysis to the left side of the face and left eye. He states he first noticed his left eye not closing and drooping of the mouth when brushing his teeth on 07/03/2021.  Patient was seen by a provider and was palced on medication and diagnosed with Bells Palsy.
Patient received pediatric dosage (0.5mL) instead of adult dosage (1.0mL).  No signs or symptoms present.  Manufacturer was contacted for redosing recommendations.
Child has reddened slightly swollen area on R deltoid that is 3 inches x 2 1/2 inches and warm to touch. Child c/o pain Tuesday evening 3/8/06 and came in Thursday morning to Clinic. MD treated a Keflex and will return to clinic 3/16/06.
Became diaphoretic @ 0855. b/p was 135/95. Emt's reported that she recovered, b/p 110/86. Refused ambulance and any further care. Stated that she "felt fine."
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Improper preparation of thawed vial) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) 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 21-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Improper preparation of thawed vial). On 21-Apr-2021, PRODUCT STORAGE ERROR (Improper preparation of thawed vial) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided by reporter.
Patient states that after the initial discomfort of receiving the vaccination, about 7 days, her left arm continued to hurt.  She denies redness or swelling at the site of injection.  She has  full range of motion in the arm, but she states that she can not sleep on her left side.
Information has been received from a healthcare worker concerning a patient who "last week" was  vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Subsequently, the patient experienced swelling of the injection arm, edema, redness, heat, and itching.  Ice packs, ibuprofen (ADVIL) and acetaminophen (TYLENOL) were the recommended treatments.  Subsequently, the patient recovered.  Additional informational has been requested.
LOW GRADE FEVER APPROX. 99.2 AND MOUTH ULCERS/SORES
49 Y  male with history of of gastric bypass surgery, severe obesity (BMI 48), CHF (EF "within normal limits" during rest and exercise at 11/2019 VMC Stress echo), MDD, Gout, OSA, Osteoarthritis, who presented with dyspnea, found to have COVID PNA.    Hypoxic on road test in ED on initial presentation.  CTA chest negative for PE.  Improved with 3 days of steroids and remdesivir.  Passed road test on 1/6/22 without further hypoxia.  Stable for DC.    Had mildly elevated transaminases in setting of known fatty liver disease. Asymptomatic from this standpoint.  Further elevated likely 2/2 active COVID and possibly from remdesivir use.    Will have repeat LFTs in ~ 2 weeks after de-isolation   Completes 20 day isolation on 1/20/22, can de-isolate starting 1/21/22.    Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  CORONAVIRUS COVID-19 DISEASE
2nd dose - severe flu like symptoms for two days; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos Disease" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "2nd dose - severe flu like symptoms for two days"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache". Therapeutic measures were not taken as a result of influenza like illness, headache.  Additional information: No covid prior vaccination. No covid tested post vaccination. No known allergies.Other vaccine in 4weeks was Flu Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), CHILLS (Chills) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 14-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received included no new information.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left arm. The healthcare professional reported that the patient developed fever, chills and shivering later in the evening after receiving SHINGRIX. No further information was reported.
pt recvd 2 doses of Engerix-B & following 2nd dose had multiple follicular erythematous papula pustules of thigh & legs;
At 12:01 AM she woke up with a fever of 102.5 so we gave her Tylenol and waited for the fever to go under 100 and put her back to bed. The only other symptom she had at this time was hyperactivity. Then at 4 am I awoke to a noise and went to her crib and she was having a seizure, drooling, eyes rolled back, and unresponsive. I picked her up and immediately took her to bathtub to splash some water on her to try to get a reaction. Nothing happened. We rushed her to the hospital and they took care of her from there.
Janssen COVID vaccine was administered to a patient 17 years old , patient turned 18 4 days after dose was given and no adverse effects reported by patient.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 8th April 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. As per pharmacist the patient received her 1st dose of SHINGRIX and was still complaining of injection site soreness. The pharmacist was unsure of the lot number as it was hard to read.
I had severe head congestion, a continuous cough, muscle aches and fatigue. I also vivid chills, a lost of appetite with a sore throat.
Mild Nausea and fatigue 5 hrs after injection  Moderate nausea and mild diarrhea 10 hrs after injection.
Information has been received from a physician concerning a 5 year old male who on 19-JAN-2009 and 19-FEB-2009 was vaccinated with the first and second dose of MMR II (lot # not reported) respectively. On 16-NOV-2009 the patient was diagnosed with mumps. The patient had bilateral parotitis (parotitis count was 102). On 16-NOV-2009 the patient was diagnosed. The patient had an exposure to his father with mumps 2 weeks PTA. The first blood work on 16-NOV-2009 revealed serum IgM (immunoglobulin M) 14.67, serum IgG (immunoglobulin G) 0.73 and serum amylase 276. The outcome of the mumps was unknown. Additional information has been requested.
lip & throat swelling p/3rd dose in post exposure series;no epi used & sx passed in 2hrs;
Dizziness, nauseous, vision blurred to black then breathing rapidly, unable to stand, difficulty breathing, ringing in ears. EPIPEN administered, helped recover - EMTs examined and deemed patient OK.
Itchy rash on her arm that is rectangular with 2 inches on each side; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on her arm that is rectangular with 2 inches on each side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash on her arm that is rectangular with 2 inches on each side). At the time of the report, RASH PRURITIC (Itchy rash on her arm that is rectangular with 2 inches on each side) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  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. Further information has been requested.; Reporter'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. Further information has been requested.
Mother states child left arm swelled "to the size of a baseball" 2 days after shots were given.  "area was hot and red".  "Fever of 101 orally".  Took child to clinic who administered IM antibiotics and repeated this several days later.  As of today, swelling is decreased, but still present.
Injection site and shoulder sore, difficulty lifting arm above shoulder. painful shoulder 3 out of 10. no radiating pain, no redness or swelling.
hives over chest back & face 1JUN98;saw PMD 2JUN98;hives fading & less apparent in cool (air conditioner);
After FLUVIRIN immunization, Pt developed "black arm" - same arm as immunization - Pt has been to Emergency Department an primary physician - D/c Warfarin therapy.
Patient reports lower lip feels tingly and puffy, denies other symptoms. Given Benadryl 25 mg PO per MD. Approx 20 min later reports feet feel tingly, provider ordered another dose of Benadryl 25 mg PO. Symptoms subsided and MD cleared for discharge. Friend will drive patient home.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX (strength, route, lot number and expiration date not reported) which was exposed to a maximum of -6.8 C for 33  hours. No adverse effects were reported. This is one of two reports received from the same reporter (1407USA012390). Additional information has been requested.
I had acute liver failure and was in the hospital for 9 nights/10 days. Symptoms started February 11th, I went to the ER February 16th, and was discharged February 25th.
Within 30 mins of administration I had chest pain, lung heaviness and vertigo. Within a few days developed a terrible unrelenting cough that continued for three weeks and nausea for the first 3 days. It caused me extreme fatigue for weeks and difficulty even concentrating. I had my first dose 10/21/2021 and I still to this day have vertigo several times a day and chest pain intermittently even at rest. I don't feel "well".
Initial unsolicited report received from a non-healthcare professional on 12 December 2015. This case involves a female patient who was vaccinated with a dose of PENTACEL (batch number: C4937AA, expiration date:29 January 2017, dose, dose number, route and site not reported) on 17 December 2015. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not available. On 17 December 2015, same day following the vaccination, the patient was taking the flip cap off the DTaP- IPV vial of PENTACEL, the neck snapped off and cut her finger. It was a minor cut that patient consulted Occupational health at her facility and patient has had no further issues. Laboratory investigations were reported none. The patient's wound was clean and band aid was applied. Outcome of the event was recovered. List of documents held by sender: none.
After the first vaccine I started to have regular muscle spasms in my left arm. After the second dose I noticed constant ringing in my ears and it has not gone away. I tried two OTC remedies without success and I am now taking Zoloft which has not helped.
c/o chest heaviness 45 mins after vaccine. assessed by provider for 30 minutes and dc'd back to work to follow up with pcp
PATIENT STATES AS SHE WAS WALKING TO THE WAITING AREA, HER MOUTH AND TONGUE BEGAN TO FEEL TINGLY AND SWOLLEN.  SHE FELT A BIT LIGHT HEADED.  SHE REPORTED THIS TO THE NURSES.  VITALS WERE TAKEN AND A COLD PACK WAS PLACED ON THE BACK OF HER NECK.  HER VOICE WAS NOTED TO BE RASPY, WHERE IT WAS NOT BEFORE.  SHE STATES HER THROAT WAS DRY.  SHE WAS GIVEN 25 MG BENADRYL PO AND A GLASS OF WATER.  HR 107, O2 SAT 96-97%,  BP 160/78.  PT FEELING BETTER ABOUT 5 MINUTES AFTER RECEIVING BENADRYL.  SHE CLAIMS SHE HAD A TIA AFTER HER FIRST MODERNA COVID VACCINE, BUT WAS ONLY PUT ON ASPIRIN AFTER DISCHARGE AND WAS INSTRUCTED TO COMPLETE THE VACCINE SERIES, INCLUDING THE BOOSTER.  PT REMAINED SEATED WITH NURSES PRESENT.  CONTINUES TO FEEL BETTER, FEELING IS NORMAL WITH HER TONGUE AND MOUTH/THROAT AT 328PM.  PT WAS OBSERVED FOR 30 MIN AND STATED SHE FELT BETTER, LEFT AMBULATORY WITH HUSBAND TO DRIVE HER HOME.
5 days after injection patient got a warm red raised area at site of injection, warmth and redness improved after 24 hrs but still present at visit
Around 5 days after vaccine, patient developed bright red blood in urine, including blood clots.  Patient describes that it was difficult to pass the urine at times because of the clots.  He also felt extremely dizzy and fatigued.  All side effects lasted 3 days where he was unable to perform normal work functions.  He was very concerned about what was going on.  Then the symptoms went away and he felt better after the 3 days.