chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 PATIENTS WERE GIVEN THE JANSSEN AFTER 6 HOURS OF BEING PUNCTURED.; This spontaneous report received from a pharmacist concerned a 49 year old female. The patient's weight was 315 pounds, and height was 167.64 centimeters. The patient's pre-existing medical conditions included patient had no known allergy, no history of hospitalization in last 30 days, no pre-existing acute illness 30 days prior to vaccination, no illness at the time of vaccination, no past history of similar events, no adverse events after any previous vaccination. she was not currently breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820095 expiry: 04-JUL-2021) 0.5 ml, administered on 03-JUN-2021 11:40 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced 2 subjects were given the janssen after 6 hours of being punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2 patients were given the janssen after 6 hours of being punctured was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612064.
This spontaneous report was received from a Licensed Practical Nurse refers to a 13 month old patient(gender unknown). On an unknown date, the pediatric patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Admitted to hospital on 11/29/2019 with symptoms of abdominal pain. Diagnosed with acute pancreatitis. No previous episodes. Drinks 2 units a day. Treated with IV fluids, analgesics.
Broke out with COVID arm 10 days after shot. Had rash all over but where the shot was given was swollen and very red. Was very hot and just didn't feel good from being itchy.  Dr. put me on a steroid (prednisone) and a steroid cream.
Dose #3: Moderna, dose #4: Pfizer; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose 3, left arm, vaccine administration time: 12:00 PM,), administration date: 10Sep2022, for COVID-19 immunization; Covid-19 vaccine (Primary series, manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 01Oct2023, outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose #3: Moderna, dose #4: Pfizer". Therapeutic measures were taken as a result of covid-19, vaccination failure which includes paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt had a spontaneous sz 3 days p/vax; pt hosp evaluated w/no etiology determined;pt has been placed on phenobarbital;
Patient presented with infection the week after the vaccine (swelling and erythema at the site that increased over a week). Patient was seen by her PCP and was prescribed oral Bactrim and topical mupirocin.
skin rash in full bloom; itching; This is a spontaneous report from a contactable consumer (Patient) via Regulatory Authority. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 31Mar2021 as single for covid-19 immunisation. Medical history included penicillin allergy. The patient's concomitant medications were not reported. She stated it has been more than the recommended time since she had her first dose, that it has been about 5 months since her first dose on 31Mar2021. She asks if she can get the second dose now? She stated she had an allergic reaction to an antibiotic, Clindamycin, that she took for a dental procedure right at the time for her second dose and the doctor said don't go for the vaccine because she had a skin rash in full bloom. She stated her doctor gave her a steroid shot that lasted for 2 months in her system to get rid of the allergic reaction, so she was told not go get the vaccine until the steroids were out of her system. She stated she wanted to make sure it's ok to have the second shot this far out because she read in other countries they have had success with people taking the second dose several months after the first dose. She stated she had an allergic reaction 4 weeks after the first vaccine and they don't believe it had to do with the vaccine, she feels it was strictly related to the antibiotic she was taking. She stated she took the antibiotic twice within 6 weeks. She stated it was a pretty bad reaction and it took a long time to get back to normal because of the steroid shot she had never taken before. She stated she was allergic to penicillin so when she got the shot they showed her the ingredients and it's nothing she's had a reaction to. She stated she was taking 300mg of Clindamycin 3 times a day for 10 days. She stated she started it on 08Mar2021 and then again on 05Apr2021. She stated one was for a dental tooth infection and the other was in preparation for a dental implant procedure. She stated that on 31Mar2021 she then had her first dose of the Pfizer Covid-19 vaccine. She stated the rash and itching didn't show up until the second course of antibiotics, the end of that about 18 days after the vaccine. She stated they said because there was no way to determine if it was related to the vaccine because there was not enough allergy testing available for that, but that they're pretty confident it's coming from the Clindamycin. Reporter considered events as non-serious. Therapeutic measures were taken as a result of skin rash in full bloom, itching. The outcome of events was unknown.  Follow-up activities closed. Batch/lot number not available for vaccine BNT162B2.
TC from TR states woke up this am (10/24/03) with acute pain base of skull to L hip area-including L arm and "muscle spasms." L side of body-neck to hip and L arm-also states L fingers "tingle" spoke with MD and instructed to take a muscle relaxant and pain pill already available to her from previous back surgery and to go through ER-if not improved. 10/27-follow up TC to pt. States feeling better-pain did progress from L side as previously indicated, throughout entire body. States relief from meds as recommended by MD and improvement of sx's seen after about 24 hours.
vaccine paralyzed his left leg; extreme leg pain; This is a spontaneous report from a non-contactable consumer or other non hcp via Pfizer sponsored program. A male patient of an unspecified age received the second dose of bnt162b2 (Pfizer Covid-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was unknown if the reporter was a health care professional. It was unknown if the reporter was the prescribing HCP. The patient previously took BNT162B2 as the 1st dose for COVID 19 immunization. On an unspecified date, the patient experienced vaccine paralyzed his left leg and extreme leg pain. The patient took 2nd dose of Covid vaccine 7 weeks ago tomorrow and said the vaccine paralyzed his left leg and caused extreme leg pain. The patient would like to know if there are tests people are supposed to get prior to receiving the vaccine as he says he did not sign up to be a human Guinea pig. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
The Nurse reports that on an unspecified date, "during allergy testing, the patient had a localized allergic skin test reaction to NEOMYCIN"; Information has been received from a nurse referring to a 4 years old male child. The patient has none concomitant therapy or pertinent medical history.  In approximately 2016 (reported as about three years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(strength, dose, frequency, route, lot#, therapy type and expiration date were unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. Serile diluent (strength, dose, frequency, route, lot# and expiration date were unknown) was used. The Nurse reports that "the patient did not have any adverse reactions to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX)".  On an unknown date, during allergy testing, the patient had a localized allergic skin test reaction to neomycin. It was unknown if a treatment was given for the event. No lab diagnostics or studies were performed for the event. The patient went to doctors' office to seek medical attention. The outcome of the event was recovered on an unknown date. The causality assessment was not provided by the reporter.
5-22-12 started as small red dot at injection site. 5-23-12 expanded to larger red are with warm to the touch sensation. Advised pt to call MD.
1st dose on september missed 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient self-reported this case. The patient asked what if it had been longer than 6 months since his/her 1st Shingles dose. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Approx 10 minutes after flu vaccine, patient developed hives on face.  Parents brought back into clinic for examination.  No history of allergy to egg or previous immunizations.  Received flu vaccine as an infant.  On exam patient had several 1-3mm blanching pink wheals on both cheeks and a few on stomach.  Not itchy.  No facial swelling, tongue or lip swelling, no wheezing or cough.  Playful and active.    Administered 5mL cetirizine.  Instructed to watch closely tonight and to take to ER if worsening rash, any swelling of tongue, lips, or face, or if any wheeze, cough, shortness of breath, or vomiting.  Will refer to allergist for skin testing prior to next influenza vaccine.
Dizziness, Headache, Myalgia, Arthralgia, Fever, inj site soreness day1-2; fever, chills, fatigue, HA, weakness,  joint pain, dizziness, myalgia, diaphoretic episodes day 2-3 Narrative:  self admin acetaminophen and ibuprofen with little effect
Symptoms-pain extending from deltoid to elbow redness upper half of upper arm, lg (45mm) "knot" in deltoid-redness, knot-lasted > wk soreness lasted 2 weeks.
COVID vaccine given to a patient under the age of 12 due to error in parental reporting of patient's date of birth.
Received a call from mother stating this morning, 3/14/18, she noticed a red, hot to touch, hard lump the diameter of a baseball 1 1/2 inches below the injection site on the right thigh.
got the Flu and almost died the this time; Initial information was received on 05-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a patient (age and gender unspecified) who got the flu and this time almost died (influenza), after patient received INFLUENZA VACCINE.  The patient had past vaccination with flu vaccine [INFLUENZA VACCINE] and had flu [influenza]. Past medical treatment, family history and concomitant medication were not reported. The patient had no other medical history, concomitant disease or risk factor.  On an unknown date, the patient received a second dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other doing details were not reported] for prophylactic vaccination.  On an unknown date, the patient got the flu and this time almost died (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was reported, product name was not provided and it was a public post on the Sanofi flu shot campaign and the Race to 200 M hence reporter assumed that the consumer was referring to the Sanofi flu vaccine.   It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for influenza.   There will be no information available on the batch number for this case.
hospitalized 1 month after my 1st / vaccine in 2019; This case was reported by a nurse via call center representative and described the occurrence of hospitalization in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On 16th July 2019, 1 month after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On 16th July 2021, the outcome of the hospitalization was recovered/resolved.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional details were provided as follows: The patient had reported for herself. The age at vaccination was not reported. One month after receiving Shingrix, the patient was hospitalized. The patient did not give specifics about the hospitalization. She received 2nd dose of Shingrix on 10th July 2021. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2021153990 and for the tolerance of Valtrex, refer linked case US2021AMR155432.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR155432:Same reporter US-GLAXOSMITHKLINE-US2021153990:Same reporter
Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away
I got a quarter-sized scaly red patch on my upper left thigh. I?m not entirely sure when it first appeared, but I first noticed it around April 20th, 2021. A couple weeks later, on May 4th, 2021, I noticed small red spots spreading, concentrated in the middle of my chest & branching out. The spots continued to spread & blossom all over my trunk, neck, hairline, arms & upper thighs. It was eventually suggested by a family friend that it was Pityriasis Rosea, which fit all of my symptoms & matched the timeline to a T.
She felt horrible for 5 days; She had bone pain; She had body aches/everything hurt; She had joint pain; She was really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt horrible for 5 days), BONE PAIN (She had bone pain), MYALGIA (She had body aches/everything hurt), ARTHRALGIA (She had joint pain) and FATIGUE (She was really tired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 038C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and DULOXETINA [DULOXETINE] for an unknown indication.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-May-2021, the patient experienced FEELING ABNORMAL (She felt horrible for 5 days), BONE PAIN (She had bone pain), MYALGIA (She had body aches/everything hurt), ARTHRALGIA (She had joint pain) and FATIGUE (She was really tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 06-May-2021, FEELING ABNORMAL (She felt horrible for 5 days), BONE PAIN (She had bone pain), MYALGIA (She had body aches/everything hurt), ARTHRALGIA (She had joint pain) and FATIGUE (She was really tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-258011 (Patient Link).
Started to see something was wrong with my eyes; In the afternoon it got really bad; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (Started to see something was wrong with my eyes), CONDITION AGGRAVATED (In the afternoon it got really bad), HEADACHE (Headaches) and CHILLS (Chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINE A) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Headaches) and CHILLS (Chills). On 05-Mar-2021, the patient experienced EYE DISORDER (Started to see something was wrong with my eyes) and CONDITION AGGRAVATED (In the afternoon it got really bad). On 03-Mar-2021, CHILLS (Chills) had resolved. On 04-Mar-2021, HEADACHE (Headaches) had resolved. On 06-Mar-2021, EYE DISORDER (Started to see something was wrong with my eyes) and CONDITION AGGRAVATED (In the afternoon it got really bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
"Chickenpox" rash on face, hand and back, lasting 1 week, accompanied by headache and mild URI.
had the shingle shots end of 2018; Shingle in my eye; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th September 2018, the patient received the 1st dose of Shingles vaccine. On 3rd December 2018, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine and Shingles vaccine.  Additional information was received as follows: The patient's age at vaccination was not reported, however it was captured as adult as per vaccine indication. The patient received Shingrix and experienced shingles in eye. This case considered as suspected vaccination failure as time to onset from 2nd dose was not satisfying criteria. The reporter consented for follow up.
PATIENT REPORT ON DAY 6/12/23 HAVING HIVES, BURNING, ITCHING ALL OVER BODY. PATIENT REPORT HAVING SHORTNESS OF BREATH TOO. PATIENT REPORT STILL HAVING ITCHING
Erythema, pain and tenderness at injection site (about 5-6 cm circular area of erythema), pain in left shoulder with decreased range of motion and numbness in left upper extremity(s) (decreased sensation left upper extremity).
received Pediarix and Engerix-B pediatric dose at the same time; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old female patient who received HBV (Engerix B) (batch number 95SN2, expiry date 1st January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 8th April 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th December 2021, the patient received Engerix B 10 mcg, Engerix B Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device. On 8th December 2021, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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 details were provided as follows: The patient received Pediarix and Engerix B pediatric dose at the same time yesterday, which led to accidental overdose. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M041212, expiration date: 21-JUN-2019). The doses of the vaccine experienced temperature excursion of 13 degrees Celsius for 1 hour and 58 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the nurse. Sender's Comments: US-009507513-1706USA011354.