chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 07-JAN-2016 the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with one improperly stored dose of PROQUAD for prophylaxis (lot number M037011 with expiration date of 21-FEB-2018) (strength, dosage schedule, route of administration and anatomical location were not reported). No concomitant medications were provided. No adverse symptoms were reported. The dose of the vaccine experienced a temperature excursion of greater than -10 Celsius degrees (°C) but less than 8°C  for 25 hours and 48 minutes. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. Additional information has been requested.
Mother of child called and stated that child was in our office today and recieved a Hepatitis A injection. Mother stated that the child now has "red bumps" on face and around right eye. Mother also reported that child was fussy and was "burning up". Mother unable to determine child's temp. d/t not having a thermometer.
?Fainting,  ?body chills, ?fever, ?loss of appetite, ?weakness, ?sleepiness, ?headaches
Pt has hx of vagal reactions and became diaphoretic and felt light headed after vaccination, resolved with feet up, juice and 2 liters O2 NC
Flu-like Symptoms; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on unknown arm. Following 1st dose Shingrix vaccination, the patient experienced flu-like symptoms for 3 days. It was unknown when symptoms began following vaccination. There is a discrepancy with respect to the age group of patient. In source document it was reported as infant while from narrative it is clear that, the patient was adult. Age group captured as per narrative information.
SIDE EFFECTS; This spontaneous report received from a consumer concerned a female of unspecified age. 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 19-MAR-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 19-MAR-2021, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Swelling left thigh, down to knee, redness left thigh 31centimeter, right thigh 29 centimeter, no fever treated with BENADRYL, ice when needed, prescription ZITHROMYCIN for 5 days. Spoke with patient's mother stated everything back to normal after being treated.
Information has been received from a physician referring to a 16 year old female patient. On 14-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (route and lot number not provided) for prevention HPV. Physician reported the patient received MENVEO (GlaxoSmithKline), in the left upper arm, and then received GARDASIL 9, (lot#L043213/unspecified exp. date), in the left upper arm, as the second dose of he GARDASIL vaccination series, on 25-MAR-2016. Physician reported the patient "passed out immediately", recovered rapidly and received oral fluids and rested before leaving the office. Physician reported the patient experienced hives on the left upper arm, down to elbow, on 26-MAR-2016. There were no diagnostics studies lab performed. Physician reported the patient's mother was quite upset and patient was seen in the office on 26-MAR-2016. Patient had been treated with BENADRYL, CLARITIN and a topical steroid cream. Physician reported hives recur, intermittently. The outcome of urticarial was unknown. Additional information has been requested.
I became very fatigue until 10/9/2010. Sore throat started 10/6/2010 with ears hurting until 10/9/10. Bad headache all week yesterday laid down most of day. Thought last night I was going to get a fever. Last year I had no problems with the 2 shots. I seem better today so far.
Urticarial rash to back of neck and upper back that started within 20 min of  Covid-19 vaccine from Pfizer. Rash resolved with Benadryl and famotidine
The sickest person reporter ever saw with the flu got it from a flu shot; Initial information received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient of unknown age and it was reported the sickest person reporter ever saw with the flu got it from a flu shot (influenza), while being received vaccine influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, it was reported the sickest person reporter ever saw with the flu got it from a flu shot (influenza).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Headaches, nausea, vomiting, blurry vision. Given ibuprofen 600mg, Amoxil 500mg, ZOFRAN 4mg.
a 36 hour excruciating migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "a 36 hour excruciating migraine headache". The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "a 36 hour excruciating migraine headache".  Additional information: It was reported that each time, after receiving both primary series doses of the COVID-19 Vaccine, as well as their first booster shot (monovalent) the patient reported having "a 36 hour excruciating migraine headache"   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300095351 same patient and event, different dose;US-PFIZER INC-202300205272 same patient and event, different dose;
Mom noted a flesh colored spot on 5/27/16. (+) pruritic (+) scabbed and more inflamed over next few days Left thigh at injection site. No fever (+) 3 mm with mild erythema. BACTROBAN OT BID prn.
8-24-15 - Hep B - 1st dose. Week after first shot pt. developed pain in left hip and knee and general weakness of that side of body. 9-24-15 - 2nd Hep B - on 9-28-15 pt. woke up with feeling of pressure on right side. Shot given right arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years 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's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: day 1; (31May2022) negative, notes: antigen day 8; (05Jun2022) positive, notes: antigen day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19. Potential COVID-19 rebound after completing Paxlovid treatment. First day of symptoms is Day 0. Positive test day 1, began Paxlovid day 2, completed Paxlovid day 6. Tested negative (antigen) day 8, symptom reemergence day 12, positive test (antigen) day 13. The treatment Antiviral details included for the COVID 19 Treatment and the start date 24May2022 and the end date was on 28May2022.
Pt reports waiting 30 min post injection at clinic and leaving without any s/s. States about 1.5 hours later, noticed hives on chest and abdomen as well as a headache and reports her "mouth was raw". She did not take any medications or seek medical attention then. The next day around 10 am, she took one dose of Benadryl. The rash on her chest resolved thereafter, but patient states she then noticed a rash under her panus, the top of her legs, and upper buttocks.  Pt states rash totally resolved by Monday. Reports headache was worst on Saturday and Sunday. Reports taking Excedrin Migraine as part of her daily routine for other chronic pain and reports headache relief. Denies SOB, tongue swelling, or dyspnea.
After second dose of Covid vaccine, right arm and shoulder were sore/tender at injection site thru Day Four.  Within 24 hours had severe stomach and lower abdominal cramps.  Within 36 hours had body aches, stiffness, sneezing, and was extremely tired.  Third night had itching on arms, legs, and abdomen, nor visible rash.  Symptoms started to ease by day four.
nurse mistakenly gave a 7 month old and 3 1/2 year old FLUBLOK with no adverse event; nurse mistakenly gave a 7 month old and 3 1/2 year old FLUBLOK with no adverse event; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case (reference number: US-SANOFI-00396192) via other health professional.  This case is linked to case 2020SA362391.  This case involves a 3-year-old patient for whom it was reported that nurse mistakenly gave a 3 1/2 year old flublok (Product administered to patient of inappropriate age ),  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site.   On an unknown date, it was reported that nurse mistakenly gave a 3 1/2 year old flublok (Product administered to patient of inappropriate age and Overdose), (unknown latency) INFLUENZA QUADRIVALENT RECOMBINANT VACCINE .  It is also an actual medication error case due to inappropriate age at vaccine administration.  Relevant laboratory test was not reported.  The outcome was not applicable for both the events.  There would be no information available on batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
menstruation changes occurring after vaccination, such as early periods (I did not have this before), also more severe/noticeable period symptoms.
Report A0365444A descrbes whole limb swellin gin four vaccinees (ages and genders unspecified) who received Infanrix. Medical history, concurrent conditions, and concurrent medications were not specified. On 03/15/2002, these vaccinees received their fourth injections of Infanrix. On 03/17/2002, two days post-immunization, they expeirenced whole limb swelling. The vaccinees wee seen by a physician. Treatment and outcome were unspecified.
This spontaneous report was received from the patient's mother concerning a female patient who was 22 years old at the time of the report. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On an unknown date (reported as when she was teenager), the patient was vaccinated with GARDASIL (lot# and expiration were unknown) 0.5 ml one time for prophylaxis, and the patient started shaking (tremor) and fainted (syncope). At the reporting time, the outcome of the events of tremor and syncope was unknown. The causality between GARDASIL and the events of tremor and syncope was not assessed. Additional information is not expected as no contactable information was provided.
Reported a temperature excursion for VAQTA which was supported; Patient had no known side effects; Information has been received regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 05-JAN-2022, the patient was vaccinated with 1 dose of hepatitis a vaccine, inactivated (VAQTA) lot # U024505 with expiration date on 15-OCT-2022, for prophylaxis (strength, route of administration and anatomical location were not provided) that underwent a temperature excursion. Patient had no known side effects.
reaction of fainting and was taken to the hospital; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (parent) reported that a female patient (daughter) of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller calling about her daughter who received her first covax in a mall on 15Apr2021 and had reaction of fainting and was taken to the hospital. She was asking what they should do about the second covax. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
pt recv vax 14PAR97 & pt came back on 19APR97 w/fever of 102 & a sl rash;pt was put on med for tonsillitis;pt came back again on 25APR97 w/a fever & severe rash on body w/watery eyes;pt was referred to ER for second opinion;
Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3246; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 13Jan2021 13:00 (at age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient's historical vaccine included shingles and flu vaccine for immunization; for that patient experienced minor aches, pain and a sore arm. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm on an unspecified date in 2021. Adverse event did not require a visit to emergency Room but visited to physician office. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
itching of arms and upper back about 15 min after injection.  History of hives Benedryl 50mg administered  patient itching not progressing and seems improved about 35 min later and d/c home with advice to return to ER with ominous signs or symptoms
This information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 with lot number M034780 and expiration date on 15-APR-2019 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA011951:
-Patient was schedule for and received Moderna primary dose vaccine; although he was not yet eligible (EUA date 06/27 for 17 years of age).  No side effects or adverse events occurred as a result, and he received the second dose in the series to complete primary series on 07/07/2022.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-FEB-2013 the patient was vaccinated with ZOSTAVAX (lot # H018088). Improperly stored ZOSTAVAX (12 for unspecified amount of time) was administered to the patient. No adverse event was reported. Additional information is not expected.
A report was received from a health professional on 28Oct02, concerning a 30 year old pt who experienced welt formation and redness at injection site after an inadvertent administration of Fluvirin on 22 and 28Oct02. The pt received an initial Fluvirin injection on 22Oct02 IM. On 28Oct02 received the pt inadvertently a second dose of Fluvirin SC in the right forearm. Initially the welt measured approx 16mm in diameter, at the time of reporting the welt was decreased to 4mm in diameter but had not resolved and subsequently experienced redness and formation of a welt at the injection site. The pt was administered a dose of Benadryl as treatment. The reporter has assessed the relationship of study medication to the injection site as probable. (OMIC)
Complete pneumovax injection was given to patient.  Patient complained of generalized ache and flu- like feeling afterwards.  Arm that received injection was sore and warm to touch.  Injection arm was also swollen across anterior, lateral, and dorsal portions and extended to about the middle of the lower arm.  There was no discoloration of the appendage.  Patient was afebrile before the injection and had a fever of 101.4 after injection.
Severe headache, fever, leukocytosis, myalgias, neck stiffness
Woke up with stomach pain, went away immediately after. Flu like symptoms, swollen lymph nodes, chills. Develop more chronic symptoms when sick now.
Mother described onset of swelling and redness at the site of injection of DTAP (left thigh). Area of swelling is slightly larger than a quarter. Denies other symptoms, including fever. This RN advices watching and waiting, as symptoms were listed as a common reaction for this vaccine.
Delayed local site reaction occurring Day 8, evening through night - injection site swollen, red, itchy, sore with circular shape of 2 inch diameter, Soreness and warmth woke me up from sleep throughout night.
R leg (thigh) with local reaction, redness and swelling approx. size quarter.
Nausea, Vomiting, Diarrhea symptoms began day after 3 pill, no symptoms with pill 1 or 2.
PATIENT IS MENTALLY DISABLED. PATIENT AND STAFF AT FACILITY REQUESTED A FLU VACCINE FOR PATIENT  . IT WAS NOT NOTED BY STAFF HE HAD A FLU VACCINE ALREADY THIS SEASON AT PCP OFFICE.   RECIEVED SANOFI LOT UJ891AC LEFT DELTOID IM AT CLINIC ON 10-14-22.  DR. HEALTH OFFICER NOTIFIED AS WELL AS DIRECTOR OF FACILITY.  ERROR WAS DISCOVERED WHEN 10-17-22 VACCINE WAS ENTERED INTO THE SYSTEM.  NO ILL EFFECTS HAVE BEEN NOTED TODAY, 10-17-22.
back spinal arthritis; This case was reported by a consumer via call center representative and described the occurrence of spondylarthritis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced spondylarthritis. On an unknown date, the outcome of the spondylarthritis was unknown.   The reporter considered the spondylarthritis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was not on any medication when had the vaccination. The patient experienced the back spinal facet arthritis, which had not been a problem for three years. The patient assumed that it was because of the vaccination. The patient was hoping it was only temporary.
Extreme body aches, chills, fever, headache, unable to sleep, bedridden next day (Thanksgiving Day) began to fell better the 25th. Considered going to ER but did not.