chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STILL FEELING REALLY SICK; This spontaneous report received from a consumer concerned a 42 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, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced still feeling really sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still feeling really sick. This report was non-serious.
Large reddened and warm/hot to touch area the covid vaccine injection site. Soft ball size.
had pneumonia vacc 10am Sat on 10/26/02 some slight swelling immediately-continued to swell more and inflamed.
3RD DOSE MODERNA COVID VACCINE GIVE 10/27/21, LOT #017F21A 4TH DOSE MODERNA COVID VACCINE GIVEN 4/19/22, LOT #065K21A pt resides in facility; 8/1/22 pt had a positive COVID test; placed on ABX for pneumonia; DNR; transitioned to comfort measures only and patient passed away in the facility
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-SEP-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. She was prescribed acyclovir and oxycodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Constant heart palpitations, fatigue, diarrhea, chest pain, Admitted to the hospital on 08/29, tachycardia.
Patient reported that she experienced seizures about a month after the 2nd COVID vaccination of which she was taken to the ER. Then when she received her 3rd COVID vaccination which was a booster dose. She again experienced a seizure the very next day within 24 hours of the 3rd COVID Moderna vaccination. She was also taken to the ER again and was placed on seizure medication. Patient reported that she had never had seizures prior to having her COVID vaccinations.
This spontaneous report was received from a pharmacist via a company representative and refers to an infant (exact age was not reported) patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately February 2016 (reported as about a month ago), the unspecified patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, lot # and expiration date were not reported). On an unknown date in 2016, after coming in contact with this unspecified patient, an "infant" patient was diagnosed with chickenpox 6 days later. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Arm ache; aches; fever; lymph ache (in armpit); This is a spontaneous report from a non-contactable consumer, the patient. A 45-years- old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 09:00 AM (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6199), via an unspecified route of administration in the left arm on 05Mar2021 at 01:15 PM (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced arm ache, lymph ache in armpit, fever and aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of arm ache, lymph ache in armpit, fever and aches was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Pt became pale & listless for several days p/3rd DTP; Began in evening p/vax cont for 2-3 days;
NIGHT OF SHOTS STARTED FEVER OF 103.0. FEVER LAST 3 DAYS AND WILL ONLY COME DOWN WITH MOTRIN BUT AFTER 6 HOURS WILL COME RIGHT BACK UP TO 103.0 AGAIN.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient hospitalized for atrial fibrillation and underwent cardioversion on 4/26/2021. Patient then received second dose of covid vaccine on 4/28/2021. On 5/5/2021 patient was hospitalized for Longstanding persistent atrial fibrillation and had another cardioversion done on 5/7/21. These visits are within 6 weeks of receiving COVID vaccination.
Hives all over body started night of Sat 12/4 one week after vaccine. Wheals, rashes, itch. Went to urgent care Monday morning 12/6, was prescribed methylprednisolone steroid pack. No improvements, went to allergist on Wed 12/8. Received breathing treatment for cough from before I received the vaccine, in addition to receiving prescription for singulair, zyrtec, pepcid. Outbreaks are currently under control but tend to mildly resurface at night after meds have worn off from the day. Reappear often on hands and arms, more prominent on left side of body. Angioedema in hand knuckles also noticed. Symptoms subside after taking prescribed antihistamines.
Flu shot 10-24-10 next day black & blue large in left arm a little swelling from bruise I put BEN-GAY on it everyday!
9-year-old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The nurse reported that on 8Jun2022, a 9-year-old patient received Kinrix. The reporter gave consent to follow up. Additional Supportive Information: a 9-year-old patient received Kinrix which lead to Inappropriate age at vaccine administration.
Started feeling very hot "head and arms"  then later that day was getting dizzy spells with extreme tiredness. Feeling exhausted.  but took temp and had no fever.  spells lasted about 30 seconds and were on and off seems to be getting better now, But still feel hot and tired today. 1-22-10  but not as extreme as it was.
Patient is 9 years old and was mistakenly given the adult COVID Pfizer Bivalent vaccine dose at 30 ug instead of the 5-11 year old dose at 10 ug.
Day of vaccination arm was so sore I could not lift it high enough to brush my teeth.  The following morning the upper arm became violently red and hot to the touch.  During the day it seemed to calm down but on Saturday morning the area was most of the upper arm and I went to ER at Community Hospital.  The doctor gave me a perscription for an antibiotic and instructions to take them IF it worsened but did not think it was celulitis.  I purchased the Rx but on Sunday the redness had mostly turned to yellow bruising so I did not take the Rx.
Pediarix vaccine (Diphtheria, tetanus toxoids, acellular pertussis, recombinant hepatitis B, and inactivated poliovirus vaccine (DTaP-HepB-IPV)) was administered instead of Infanrix vaccine (Diphtheria, tetanus toxoids, and acellular pertussis vaccine (DTaP and Tdap)) on 3/11/21.
On 12/11/2021, came to the Vaccination Site located on the campus.  With her was her legal guardian. She was told that She was eligible for the Pfizer Booster shot. She is currently 13 years old, and therefore is not eligible to receive the Pfizer Booster shot. She received the Pfizer Booster shot in error.
Myalgia inj site pain x3 days, body ache, fatigue Narrative:
MUSCULAR PAIN ON LOWER LEG; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, cholesterol, and hypertension, and other pre-existing medical conditions included: Patient was taking unspecified blood pressure and cholesterol medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced muscular pain on lower leg, and fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and muscular pain on lower leg was not reported. This report was non-serious.
Patient experienced pain in arm vaccine was administered. Patient also did not have full range of motion in arm.
Day 2: 102°F fever- took 400 mg Advil, sore, painful arm at injection site Day 3: 100°F fever - took 400 mg Advil, sore arm at injection site, small improvement Day 4: Normal temp, arm soreness almost gone
Pt devel t103 r, screaming for 2 hrs; taken to ER, mom states MD checked & was dx w/ear infect; MD says sx were not due to immun;
This case was reported in a literature article and described the occurrence of paralysis in a child subject of unspecified gender who was vaccinated with DTPA. The present retrospective cohort study of acute flaccid paralysis was conducing using computerized diagnosis data and medical record review of potential cases among children aged 1 month to less than 15 year and diagnosed from 1 January 1992 through 31 December 1998. The subjects were hospitalized or seen in the emergency room None of the children were known to have a preexisting immunocompromising condition. The literature article included the description of 16 children with vaccine exposure prior to development of paralytic syndrome (B0642827A, B0642828A, B0642829A, B0642811A, B0642830A, B0642836A, B0642841A, B0642832A, B0642846A, B0642847A, B0642849A, B0642850A, B0642851A, B0642852A, B0642853A). Concurrent vaccination included oral POLIO vaccine (manufacturer unspecified), On unspecified date the subject received unspecified dose of DTPA. On the day of vaccination with DTPA, the subject experienced paralysis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The clinical diagnosis was adverse reaction to DTPA vaccine.
Symptoms after getting her second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms after getting her second dose) 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 VACCINATION COMPLICATION (Symptoms after getting her second dose). At the time of the report, VACCINATION COMPLICATION (Symptoms after getting her second dose) outcome was unknown.            No concomitant medications were reported.  No treatment information were reported.
2 hours after vax on 5/8/2000, patient had a "limp", unresponsive episode for 3 to 5 min, then aroused, but slept 10 min. Did not seek care until it happen again, on 5/15/2000. History suggest an atonic seizure and post ictal period. Referred for EEG and Neurology Consult. Occurred again on 5/23/2000.
Seven days after receiving the 1st dose of Moderna vaccine, the area where shot was injected in my left arm is red, itchy, sore and swollen.  Area is approximately 3 to 4 inches in diameter.
COVID-19; had a break thorough case of Covid after receiving both doses of the Pfizer Covid 19 Vaccine; Stroke; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included stroke from an unknown date and unknown if ongoing (Had the previous stroke several months ago. States that they were still picking up evidence of the previous stroke on the MRI. So it was probably within the last 6 months). The patient's concomitant medications were not reported. The patient had a break thorough case of covid after receiving both doses of the pfizer covid 19 vaccine and had a 2nd stroke on 08Aug2021 after getting covid. The patient was hospitalized due to the events. The caller states that they do not think that the stroke was related to Covid or the vaccines, but he still wanted to mention it. The patient's son does not know that the caller is reporting this. The patient went home from hospital yesterday (17Aug2021), but date of admission into hospital was not known. The caller thinks the patient was hospitalized due to the stroke, but was unsure if Covid played any part in the hospitalization. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): stroke on an unknown date. The outcome of all events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Shingles diagnosis/Rash/Blister; Right ribcage bone and muscle pain; Right ribcage bone and muscle pain; This is a spontaneous report from a contactable consumer or other Non-HCP reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. It was unknown if the patient has received any other vaccine in four weeks. The patient experienced Right ribcage bone and muscle pain on 03Mar2021, developed rash on 07Mar2021, blister on 09Mar2021, and on 11Mar2021, diagnosed with Shingles and has been prescribed valacyclovir and naproxen. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and treatment was received. Therapeutic measures were taken for the adverse events which includes Valacyclovir and naproxen. It is unknown if the patient got Covid prior vaccination and unknown if tested for Covid-19 post vaccination. The reporter became aware of the adverse events on 12Mar2021. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
A dose of FLUBLOK was inadvertently administered to a 15-year-old patient, no AE~; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 15 years old male patient who was inadvertently administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines   On 17-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2013, expiry date: 30-Jun-2021, Strength: standard) once via intramuscular route in the deltoid NOS for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  No adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
After giving patient his first COVID vaccine, he fainted. He was only out for about five seconds, but was weak and had low BP upon awakening. We gave ice packs, he sipped on water, then orange juice. We then laid him down on yoga mat and elevated feet to help blood pressure recover. Initial BP was 91/37, then 76/32. After lying him down in floor BP increased to 119/67, then 120/71. He declined going to the hospital. After about 20-25 minutes, he said he felt fine and left.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient with no pertinent medical history. The patient's drug reaction/allergies were not reported. On 06-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot number J014809 expiration date 20-FEB-2015 (dose and route not reported). Concomitant therapies were hydrochlorothiazide, cyclobenzaprine hydrochloride, PERCOCET, ELIDEL cream and desonide cream. Approximately on 07-MAY-2014, reported as a day or two after receiving the vaccine, the patient experienced a rash around the injection site that was about the size of the palm of the hand. The patient contacted the pharmacist for medical attention and was treated with BENADRYL. At the time of the report the patient was not recovered from rash at the injection site. Additional information has been requested.
Myalgia puff upper eyelids x 2 mornings; waxing and waning aches and fatigue Narrative:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 06-DEC-2016, the patient was vaccinated with M-M-R II, via intramuscular for prophylaxis (dose, lot# and expiration date were not reported) (Inappropriate route of vaccination). No adverse effects were reported and a product quality complaint was not involved.  Additional information is not expected as there is not consent to follow-up.
Severe headache on night one.  Headache persists with decreasing severity but lasting until present (6 days later).  Nausea and vomiting on 5/17 and 5/18
Information has been received from a nurse concerning a 15 year old female patient who on 30-JUL-2007 was vaccinated IM with a first dose of Gardasil lot #658488/0930U.  The nurse reported that the patient "fainted" after getting the Gardasil injection.  She also reported that the patient experienced "tingling around the lips and her fingers after she recovered from fainting."  The physician provided the patient with ice.  No further information was provided.  The patient "left office feeling better".  Additional information has been requested.
Lot of pain in arm; Bit woozy; Hot/cold sweats; Sore back; This is a spontaneous report from a non-contactable consumer or other non hcp. A 57-years-old non-pregnant female consumer (patient) reported for herself that who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on 22May2021 11:00 (Batch/Lot number unknown) (Age at Vaccination: 57 years) as unknown, single dose for covid-19 immunization. Medical history included allergic to salmonids and juniper. The patient's concomitant medications were not reported. Any other vaccines within 4 weeks prior to the COVID vaccine as unknown. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient developed lot of pain in arm, bit woozy, hot/cold sweats and sore back for which she did not received any treatment. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.