chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 54 year old white female with a banana allergy and a penicillin allergy and a history of pallor and lightheadedness who on 12 JUL 2001 at 4 pm was vaccinated IM in the left deltoind (while sitting down) with a 1.0 mL second dose of hepatitis b vaccine recombinant (yeast) (lot # 639854/0672L). There were no illnesses at the time of vaccination or known adverse events following prior vaccinations. Immediately after being vaccinated (at 16:05) the patient complained of "feeling faint" and became quite pale. She sat quietly for a short time, took a walk, and reclined on the exercise mat for approximately 10 minutes. She drank a glass of grape juice and then stated she "felt better." Normal color had returned to her face and she stood and ambulated without apparent difficulty. She remained at the facility for observation another 10 minutes and then left. The patient stated that the first dose of hepatitis b vaccine recombinant (yeast) (MSD) had not produced any feelings of "faintness." it was reported that the patient recalled being "stiff" and perhaps more tired than usual for two days after the injection. It was reported that the injection site remained unremarkable and no respiratory distress was noted. It was noted that the patient has had the same feelings of feeling faint (lightheadedness) and pallor in the past when she donated blood. Follow up information has been received from the health professional reporting that the events resolved and that no adverse symptoms continue. No further information is available.
Acute kidney failure, unspecified HYPERGLYCEMIA ALTERED MENTAL STATUS FATIGUE
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with MMR II (lot number: K002816 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with MMR II, live was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
PATIENT RECIEVED PREVNAR 13 ON LEFT ARM 10/21/2020. PT STARTED EXPERIENCING REDNESS AND INFLAMMATION ON INJECTION SITE THE DAY OF ADMINISTRATION.  THE FOLLOWING DAY, PT EXPERIENCED FURTHER INFLAMMATION AND REDNESS, STIFFNESS ON THE LEFT SIDE OF HER NECK, ALONG WITH A LOW GRADE FEVER.  SHE CAME INTO THE PHARMACY 10/28/2020 AND HER LEFT ARE WAS RED DOWN TO HER ELBOW AND ITCHY.  HER ARM WAS STILL SWOLLEN, BUT HAD IMPROVED BASED ON PICTURES SHE SHOWED ON HER PHONE. SHE REPORTED USING A CORTICOSTEROID THAT WAS PREVIOUSLY PRESCRIBED TO HER, BUT SHE COULDN'T CONFIRM THE EXACT PRODUCT.
Gave extra dose of Hep B, employee error due to verbal orders and not verifying chart.
suspected COVID-19 with symptoms; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program, Pfizer First Connect. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that "on 01Jan2021 she had COVID like symptoms. Her husband got COVID-19. She had not received her second dose because she was sick. Her second dose was supposed to be on 20Jan2021. She was scheduled to go back to work on 01Feb2021 and would be able to get a dose on 02Feb2021." The patient wondered if she was supposed to start over or if she could just get the second dose. The clinical outcome of the event "suspected COVID-19 with symptoms" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Both doses in 2022, last week got shingles/suspected vaccination failure; I got shingles, unexpected and very strong; This case was reported by a consumer and described the occurrence of vaccination failure in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 5th July 2022, the patient received the 2nd dose of Shingrix. On 8th April 2022, the patient received the 1st dose of Shingrix. In January 2023, between 6 and 7 months after receiving Shingrix and between 9 and 10 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 3-Feb-2023 Reporter's comment: The patient got both Shingrix doses and last week got the shingles. It was very unexpected and very strong, the patient had it before and knew the symptoms, so the patient knew what to do. But the patient was wondering, why this happened even that, had the vaccine already. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Both my partner and I tested positive for Covid-19 4 days after receiving our vaccines.; This is a spontaneous report from a contactable consumer (patient). The consumer reported same event for two patients. This is the first of two reports.  A 28-year-old female patient received bnt162b2 (Lot Number: EN6206), via an unspecified route of administration, administered in left arm on 10Mar2021 11:15 (at the age of 28-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history was none. Concomitant medication included fluconazole. No known allergies. No covid prior vaccination. The patient and her partner both tested positive for covid-19 on 14Mar2021, 4 days after receiving the vaccines. The patient underwent lab tests and procedures which included Nasal Swab, Rapid and PCR on 14Mar2021 with positive result. No treatment was received for the event. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021292125 same drug/event, different patient.
3 pustules at smallpox site. Some lymph streaking; sore axillary adenopathy.
Developed HA, nausea, about 9:30 pm same day as vaccine. Vomiting started 10:45 am Friday 11/22/02 went to emergenv room that  evening, Seen by family physician doctor, Sunday 11/24/02 diarrhea lasting one day, Symptoms subsided Monday
Tender, erythematous, slightly warm localized reaction to right SQ right arm.  Erythema 2.5 inches in diameter.
Fever, headache, stuffy nose, lethargy 18hrs and continues, tx with acetaminophen.
Client received pediatric dose of Hep B vaccine instead of adult dose. Notified client that this does will need to be repeated, client agreeable and will return as soon as he is able. No adverse s/e experienced.
Itching; Swollen eyelid; Hives all over her body; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 62-year-old female patient (mother). A 62-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 62 years) as dose 1, single for covid-19 immunisation at local drug store. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced itching, swollen eyelid, hives all over her body. Reporter stated that patient took the Pfizer Covid shot and then she was experiencing side effects ever since she got the shot. She has like swollen eyelids and hives all over her body and she was like itching everywhere and went to the emergency room twice and they gave her the cortisone shots and stuff but reporter think it was not working because it comes and goes and it has been like a month. Reporter think it happened after the first shot, it was not as bad it happened like. The patient underwent lab tests which included weight: 135 About a 135. Therapeutic measures were taken as a result of events, includes went to the emergency room twice and they gave cortisone shots. The outcome for all events was unknown.   Information about Lot/Batch number have been requested.
Marked worsening of rhinorrhea, cough, post nasal drip after receiving vax and temp = 102 (tympanic). Clinically diagnosed sinusitis and bronchitis. Started today on Augmentin and IBPF.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 87-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805433 was crossed linked to original cases 201804863 due to same reporter.
02/04 - chills and headache all day; 02/05 - headache, fatigue, nausea; 02/06 - headache (partial day), nausea (am); fatigue all day;  02/07 - minor fatigue most of day
7 x 10 cm area of redness at inject site - temp 101 on 12/3/96 cont temp - elev. to 99 on 12/5/96 area warm to touch.
typical vaccine side effects; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; itchiness, muscle pains, flu-like symptoms; progressed into neck pain, joint pain, fever; progressed into neck pain, joint pain, fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms) and ARTHRALGIA (progressed into neck pain, joint pain, fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever). At the time of the report, VACCINATION SITE REACTION (typical vaccine side effects), VACCINATION SITE PRURITUS (itchiness, muscle pains, flu-like symptoms), MYALGIA (itchiness, muscle pains, flu-like symptoms), INFLUENZA LIKE ILLNESS (itchiness, muscle pains, flu-like symptoms), ARTHRALGIA (progressed into neck pain, joint pain, fever) and PYREXIA (progressed into neck pain, joint pain, fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
drop of the vaccine flew out and landed in the patients eye with no reported adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender who had Accidental exposure to product (drop of the vaccine flew out and landed in the patient's eye with no reported adverse event ), and it involved vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date ,nurse pulled off the safety needle cover and as she did  a  drop of the vaccine flew out and landed in the patient's eye with no reported adverse event (accidental exposure to product) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. Information in batch number has been requested. The product was used for immunization  Action taken : not applicable.  Outcome: unknown   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 the guidelines. 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.
Dizziness started in the early morning approximately 12 hours after vaccination. The sx's come in waves and affect my balance. Sx's are sometimes exacerbated by change in position and first occurred whenever I rolled over in bed. The sx's also occurred while sitting at a desk working on my computer.  No benefit from Eply's maneuvers. No nystagmus with Dix Hallpike maneuver.  Meclizine seemed to be helpful. Sx's have persisted this morning, 1/4/2020.
This is a spontaneous report received from a non-contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Aug 16, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced vomiting/woke up vomiting, pain/progressed body ache, pyrexia/fever, chills and myalgia/muscle ache; all onset Aug 16, 2021, with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Starting 06/22/2022, I developed weakness, fatigue, headache, nausea, coughing and malaise. I tested positive on 06/24/2022 with an at-home COVID-19 test. I called my doctor and they prescribed Paxlovid. I continued with the medicine, quarantined and felt awful. I had no appetite and was very fatigued. Even after the 10 days,  I still had a headache, was feeling malaise and lacking energy and feeling "off" for about a week more. To this day, I still do not have all of my energy back. It was odd because I was the most careful about wearing masks, staying 6ft apart, avoiding crowds and close contact with people than most of my family but was the only one who contracted COVID-19. I believe I was exposed on the airplane I was in where I was masked but the person next to me was not. Also, this past Sunday I went biking then swimming and ended up with hives on my waist and my bra line. I went swimming the next day and they were still present but there were less. I've never had that happen before.
Pfizer-BioNTec Covid 19 Vaccine EUA;   Diarrhea began 6 days after first vaccine  February 4th through February 14th.  Diarrhea began 1 day after second vaccine dose on February 18th and is still present March 26.   Took Immodium 3 different times as it worsened from doctors instructions.  Had some relief, but it keeps returning.
VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no significant past medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 20-AUG-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced vaccine administered to subject of inappropriate age. On 30-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
first day I had chills, tired day three I had a feeling that my herpes was acting up so I took 2 Valacyclovir tablets, and one each day for the next two days, I then noticed on day 4 that my left arm in the area of the shot was very red and very warm, then it has progressed in size down to my elbow and on day 7 it is still red and warm
Mother reports pt. experienced blistering rash on face and body 10 days after MMR vaccine. Lasted 4 days, pt. afebrile. Pediatrician gave abx. ointment.
A nurse reported that a parent told her that she had heard of cases of meningitis post hepatitis b vax. Upon medical review, the experience of meningitis was considered to be an "Other Medical Event". Also reported was the parent's son who was vaccinated and experienced an adverse event. Follow up notes that neither the nurse nor the physicians were aware of such a report, nor were they aware of any cases of meningitis following the hepatitis B vaccine. She stated that the physician and their staff felt the pt's parents were confusing hepatitis b vaccine with another product. No further information is available.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, single), administration date: 2021, for COVID-19 immunization, reaction(s): "had Covid"; Bnt162b2 (Dose: 2, single), administration date: 2021, for COVID-19 immunization, reaction(s): "had Covid". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 03Feb2022, outcome "unknown", described as "booster knocked them out/was reason why not taking part in social activity"; FEELING ABNORMAL (non-serious) with onset 03Feb2022, outcome "unknown", described as "feel bad". Additional information: Do not think literally meant knocked them out unconscious, but that it made them feel bad. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
High fever 102.3F ~15hrs after injection Severe back pain, to the point of immobilization ~30hrs after injection  Nausea ~30hrs after injection
This spontaneous report was received from a Nurse Practitioner and refers to a female patient of unknown age. The patient was believed to reside in a nursing home. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced an unspecified injection site reaction and contacted the nurse practitioner on 02-DEC-2017 to seek medical attention. The patient recovered from the event by 05-DEC-2017. The relatedness between the event and PNEUMOVAX 23 was not reported.
Information has been received from a licensed visiting nurse concerning a 68 year old female who on 21-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#658208/0886U). On 22-SEP-2007 the patient developed injection site itching, tenderness, redness and swelling the size of a golf ball. Unspecified medical attention was sought. Subsequently, on 25-SEP-2007, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Vaccinated on Thursday 9/29 with IPV in left upper thigh and DTaP in right upper thigh.  By Friday afternoon, 3.5" diameter red bulls eye appeared on top of large welt at DTaP vac. site. The center was blistered and weeping. Covering Ped. MD. had us proceed to Emergency Room, where my son was prescribed Keflex 250mg 4x daily.  Sent home only to return a few hours later because infection had grown to 8" in diameter and leg was severely swollen.  Three red streaks appeared on top left part of welt and were traveling up the leg.  Lymph nodes in groin area were found to be swollen.  My son was hospitalized for 48 hours on IV antibiotics.  He needs to continue antibiotics for 6 more days and is doing much better.
One week later, 4 inch red patch and itching (similar to a very large mosquito bite)
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Severe, Additional Details: Covid shot administered at 10:15. Pt complained of tightness in throat. 50mg diphenhydramine administered IM at 10:30am.  Pt given water. Pt said that symptoms were resolved and rose to leave at 11am.  She fell upon standing and reported dizziness.  Pt helped to chair and given more water.  Pt reported swelling lips, difficulty swallowing and throat tightness at 11:20.  EMS was called and arrived at 11:30.  EMS departed store with patient at 12 noon.  Pt was responsive  and calm at departure.
Red swollen big bump on arm that didn't go away for 5 days; Red swollen big bump on arm that didn't go away for 5 days; This is a spontaneous report from a non-contactable healthcare professional (the patient).  A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 30Dec2020 at 14:15 (at the age of 23-years-old) as a single dose for COVID-19 immunization. Medical history included the patient had COVID prior to vaccination. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 30Dec2020, the patient experienced red swollen big bump on arm that didn't go away for 5 days. The patient did not receive any treatment for the events. The clinical outcome of red swollen big bump on arm was recovered on 04Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
practically kill me; This case was reported by a consumer via  interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2017, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by patient. The age at vaccination was not reported. The patient stated that, he/she got the shingles shot and it practically killed him/her. The follow-up would not possible as no contact details were available.
APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION PATIENT REPORTED FEELING ITCHY; NO HIVES OBSERVED. ADMINISTERED ORAL DIPHENHYDRAMINE 25MG. SYMPTOMS RESOLVED WITHIN 30 MINUTES. NO OTHER SYMPTOMS REPORTED AT 6HRS POST DOSE PHONE CALL.