chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site nodule in a 28-year-old female patient who received ENGERIX B adult (batch number J2J9R, expiry date 14th September 2021) for prophylaxis. On 23rd January 2019, the patient received the 3rd dose of ENGERIX B adult (intramuscular). On 23rd January 2019, less than a day after receiving ENGERIX B adult, the patient experienced injection site nodule, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site nodule, injection site erythema and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site nodule, injection site erythema and injection site pain to be related to ENGERIX B adult. Additional details were provided as follows: The patient received a dose of ENGERIX-B adult in left arm. The patient developed a nodule at the injection site and were still visible with a little redness in the center. It was painful when pressure was applied. The reporter consented to follow up.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4453153-00. A 74-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RINVOQ oral. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 2021, outcome "recovered with sequelae" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Unknown results, notes: the patient experienced COVID-19. Additional information: Causality as per reporter (Drug/Vaccine): Possible  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-PV202200019625 same patient, drug; different dose, event;
COVID 19 Treatment; COVID 19 Treatment; Vaccine_brand_other=Moderna, Vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Lot number: Fj4989) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2021 as dose 1, single (Lot number: 031mzoa), on 23Mar2021 as dose 2, single (Lot number: 030a21a) and on 10Nov2021 as dose 3 (booster), single (Lot number: 034F21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown", described as "Vaccine_brand_other=Moderna, Vaccine brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (COVID 19 Treatment) from 15Mar2023 to 19Mar2023.
Developing in evening after Flu Shot, pt is currently experiencing Chills, Low-grade fever, abdominal pains, nausea (no vomiting), fatigue, and mild diarrhea (no blood in stool). Patient instructed to take OTC MOTRIN (her pain med of choice) to help with chills, low-grade fever, and malaise - and to report any worsening of symptoms or symptoms lasting longer than 24 hours to her primary care doctor.
very bad headache, chills, fever 101, body aches, malaise for 24-36 hrs took fluids, tylenol
Arthritis developed one day after receiving shot. He has been under a doctors care since Sept 99 after receiving his 5th Anthrax shot.
This spontaneous report received from a patient via a social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose, 1 total, administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced torn retina for which patient had surgery. The reporter stated that, "I just read your post 2 to 3 weeks after shot torn retina. One-week later 2d torn retina. Same eye different location. 4th surgery coming 1 by 4." The action taken with covid-19 vaccine was not applicable. The outcome of torn retina was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211260786-COVID-19 VACCINE Torn retina. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that after first dose the patient experienced slight headache. The reporter did not consented to follow up. The case has been linked with the case US2019111302, reported by same reporter for same patient.
Second dose taken before day 25 after the first dose; sore arm (in the right arm).; felt "blah"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm (in the right arm).), VACCINATION COMPLICATION (felt "blah") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken before day 25 after the first dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included CREST syndrome. Concomitant products included PANTOPRAZOLE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm (in the right arm).) and VACCINATION COMPLICATION (felt "blah"). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken before day 25 after the first dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm (in the right arm).) and VACCINATION COMPLICATION (felt "blah") outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken before day 25 after the first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient also mentioned that she has an autoimmune disorder called CREST, and got the flu shot the first week of October   This case was linked to MOD-2021-363419 (Patient Link).
Developed a rash 10 days post immunizations at 12 mo. visit. Rec'd MMR, VAR, Hep. A, and PCV 4.
pt recvd Typhoid vax & devel achiness & erythema of the injected arm;
This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13 at single dose on 11Mar2019 in left arm. Relevant medical history and concomitant medications were unknown. On 11Mar2019 redness and swelling appeared at injection site, with fatigue, muscle pain, and loss of appetite. Redness and swelling increased until approximately 4 inches in diameter, radiating from the injection site on 14Mar2019. Sensation of fluid in ear and decreased hearing started on 13Mar2019, with fluid draining continuously from right ear on 14Mar2019. The outcome of the events was reported as unknown except for ear discomfort with outcome of not recovered. Information on the batch/lot number has been requested.
Itchy rash 8x4 cm raised and red 9 days after dose given, treated with 1% hydrocortisone cream X 4 days
child received pediarix on 25-May-2023 instead of dtap inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date 21-OCT-2024) for prophylaxis.   On 25-MAY-2023, the patient received Pediarix (other). On 25-MAY-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: child received pediarix on 25-May-2023 instead of dtap inadvertently). The action taken with Pediarix was unknown. The outcome of the wrong vaccine administered 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:25-May-2023 The medical assistance reported a 15 month old child received Pediarix instead of dtap inadvertently, which led to wrong vaccine administered. The reporter consented to follow up.
Child rec'd HPV#1 & MENVEO on 7-16-12 - was fine when left office. On 7-19-12 presented ER - Dx: small bowel obstruction.
High fever above 102 degrees, nausea and vomiting that required intravenous fluids, chills, body aches
On March 23, 2007 I had a routine shingles vaccination and a routine thyroid test.  The thyroid test was normal.  By April 23 I had full blown Graves disease.  Am currently being treated with Tapizole for Graves disease.  Concidence?
I have tinnitus already. After the second vaccine it became much worse. It is louder and very disruptive.
This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that SHINGRIX may have been administered to a patient subcutaneously, which led to inappropriate route of vaccination. The patient and product details were unavailable.
Erythema, edema, pain, redness x 1 week.  Current treatment includes recommending Zyrtec and hydroxyzine and pepcid.   Advise patient to watch for worsening symptoms EXAM: mild erythema and edema on the right arm and hematoma on the left arm
Swelling/redness from shoulder to elbow lasting approximately 48 hours, with joint stiffness and numbness/tingling in arm.  Also generalized malaise, headache, muscle ache, nausea, cramping, & generalized rash.  All symptoms recorded.
Perhaps a couple of days after the the vaccine, certain  foods began tasting/smelling spoiled or putrid. This has not changed since that time. I have never had a problem with these foods in my life. Now all of a sudden, cream cheese, sour cream, yogurt, and other random dairy items have tasted and smelled spoiled. At first, I was eating broccoli and carrots, and dipping them in ranch. My father in law had brought the items over for a family gathering. I just assumed that he had brought spolied food to the get together. This continued for several days before I finally asked my wife if certain things tasted bad to her. She would say, "No, it tastes normal." When she makes dinner now, she has to modify the meal to accommodate me. Strangely, the smell of coffee beans has the foul smell too. It doesn't taste spoiled like dairy. I'm just hoping this goes away so I can enjoy the things I used to.
22 mo old given DTP #4/HBCV#1 on 4Jun91.TC from mom 5Jun91-chilling,T 103 (AX).No other sxs.Seen by MD on 5Jun91.Order for further doses to be DT rather than DTP.Fully recovered per mom report
Information has been received from a registered nurse concerning unknown number of patients who on an unknown dates were vaccinated with doses of GARDASIL (doses, routes and lot numbers not reported) which were stored at lower than recommended temperatures on multiple occasions. No adverse effect reported. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, dates of events, recovery status. All attempts to obtain follow-up information has been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
mouth pain; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization.  The patient medical history included root canal procedure on 27Jan2021.  The patient's concomitant medications were not reported.  The patient experienced mouth pain on an unspecified date. Therapeutic measures were taken as a result of mouth pain and included treatment with ibuprofen 800 mg. The patient outcome of the event was unknown.  The information on the batch number has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Total number of doses were 168 doses and the vial did not undergo any temperature excursions. Dates of administration of vaccine on 10-Nov-2021 and 11-Nov-2021. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant Follow up information was received.
Vasovagal syncope resulting in loss of consciousness for approximately 1/2 to 1 minute. Followed by nausea and and multiple rounds of emesis over the course of the next fifteen minutes.  Patient remained in pharmacy for approximately another 15 minutes before her mom and her felt she had recovered enough to leave under her own power.
fever & 1min, tonic-clonic sz;croup dx by MD on f/u visit 14NOV96;
3rd & 4th day post vaccine shoulder (left) swelled with severe pain (fever 102 degrees F oral) for 1 day only (3rd day). Shoulder returned to normal on days 5 & 6 - slight shoulder swelling & moderate pain returned on days 6 & 7. Small knot felt by PA.
Sweating, dizzy, cramping and stiffness in fingers, trouble breathing, elevated heart rate
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K012875, expiration dates 27-AUG-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
I experienced a delayed onset of systemic urticaria that occurred daily for 5 weeks. I have small and itchy raised bumps that are most commonly on my arms and trunk, but have shown up on my thighs and legs as well. My symptoms improved with Zyrtec, which I took twice daily for 7 days as directed by my PCP one month after my 3rd dose of the Moderna vaccine. The hives returned the following week after I ceased taking Zyrtec and remained a daily occurrence for one additional week. The hives then went away spontaneously and without medication for two weeks. Now, about 9 weeks later, my skin reaction has returned and I have had them daily again for the past three days.
18 hr post vaccination extreme persistent dizziness, vertigo, head pressure and SVT requiring local emergency evaluation.  Work up unremarkable referred to Neurology by PCP for further evaluation..  Treated with Meclezine with x4 days patient reporting 85% improvement.   Previous documented sx s/p series 2 administration:  Persistent cough, Lung hyperinflation  r/o URI, chronic Lung disease resolved with steroid course.
The time of injection was a stinging sensation. Nurse stated that this was the second time someone said it stung this week. The left arm was sore. Could not sleep because of pain. Saturday,  07/25/2020pain still present with heaviness to arm. Limited range of motion. To move arm above head there was pain. To have left hand touch left should there was pain.  Sunday 07/26/2020, fatigue, weakness pain BOTH arms (right and left). There was pain when she tried to extend either arm. Stiffness in neck. Pain in eyes when looking to the left side. Fever of 100.5 was first documented at 21:57. Took equate acetaminophen 500 mg at 22:18.  On Monday 07/27/2020 at 04:11 temperature was retaken and it read 98.2. However, at 6:51am the temperature was 100.2
Information has been received from a registered nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 22-JUL-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L001332, expiration date 13-JAN-2017, route not reported) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
LOCAL IRRITATION AND REDNESS AT INJECTION SITE, APPROXIMATELY 2.5 INCHES IN DIAMETER.
Approximately 1 year after last Anthrax shot, pt developed soreness at injection site. Pt had soreness to the touch and when moving arm in certain directions.
Symptoms only after 2nd shot:  Severe chillblanes about 14 hours after shot; fever (100 to 102.1) through 3rd day after shot; total loss of appetite 1st day after shot (drank water, threw up once, could not eat) and only slowly able to eat 2nd to 4th days after 2nd shot; sharp frontal headache for 1 1/2 days, severe fatigue (felt semi-comatose on first day after 2nd shot,  exhaustion only slowly lessening over next 3 days ); dizziness and slight disorientation.  Acetominophen and ibuprophen did not seem to help much with fever or headache.  Drank lots of water throughout.
Lower back  pain radiating around to the rib cage.  Went to ER and had ultrasound, cat scan, blood work, urine culture.  All scans negative awaiting results of urine and blood work.  Possible uti but not sure. Prescribed Keflex
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 26-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. West Point; manufactureraddress: 770 Sumneytown Pike; manufacturercity: West Point; manufacturerstate: PA; manufacturercountry: UNITED STATES; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002986: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002985: US-009507513-2104USA002971: US-009507513-2104USA002984: US-009507513-2104USA002972: US-009507513-2104USA002988: US-009507513-2104USA002989:
Individual received Janssen vaccine on 9/16/2021 and Pfizer on 10/20/2021.  Janssen vaccine was under wrong date of birth in state registry so when individual arrived to be vaccinated on 10/20/2021 no doses were listed on his state immunization record.
Janssen COVID-19 Vaccine EUA (3/6) Fatigue began 4 hours after vaccine. (3/6) Severe headache, severe fatigue, moderate fever, mild aches, mild nausea beginning the next day (3/7) and lasting until (3/8).   Mild headache and mild fatigue all day (3/8)
Woke next morning with swollen eyelids, pink skin, itchy/tingling sensation on left side of face, pain left arm/ache, pinching sensation in left side/middle of neck, fatigue.  Eye swelling gone by end of day after taking shot. Have had continued lowered blood pressure, low pulse pressure, increased blood pooling in hands and feet, left leg pain (no swelling) behind the calf and upper inner thigh, left arm numbness that comes and goes particularly at inside wrist and top of shoulder front near armpit since the shot.