chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. In November 2013 the patient was vaccinated with ZOSTAVAX vial, 19400 PFU 10 vials of 1, lot # J007207 expired date 20-SEP-2014 (dose, route and indication not reported). Since unspecified date the patient experienced itchy red spot at the injection site. The outcome of itchy red spot at the injection site was reported as not recovered. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Flu; mild and temporary Injection site pain; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Flu) and VACCINATION SITE PAIN (mild and temporary Injection site pain) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   In October 2022, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE PAIN (mild and temporary Injection site pain). On 26-Dec-2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) and VACCINATION SITE PAIN (mild and temporary Injection site pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Patient received 2 moderna vaccines and a moderna booster. No treatment medication details was reported   This case was linked to MODERNATX, INC.-MOD-2023-694625 (E2B Linked Report). This case was linked to MOD-2023-694616, MOD-2023-694623 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Follow up received included non-significant information. Sender's Comments:  MODERNATX, INC.-MOD-2023-694625:Reporter case
kept on on going to the bathroom to urinate; fever (T-104.6F); joint pains; body aches; real bad headache; chills; This spontaneous case was reported by a health care professional and describes the occurrence of POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches) and HEADACHE (real bad headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches), HEADACHE (real bad headache) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 09-Feb-2021, POLLAKIURIA (kept on on going to the bathroom to urinate), PYREXIA (fever (T-104.6F)), ARTHRALGIA (joint pains), MYALGIA (body aches), HEADACHE (real bad headache) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-022363 (Patient Link).
This is a spontaneous report from a non-contactable consumer who reported for her/him self.  An 83-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose in Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, pretty tired on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Within 3 hours of receiving the vaccines, the patient began to mount a fever (Tmax 103) with decreased appetite. Later that night, the patient experienced a 30-second generalized seizure which involving shaking of all four extremities and the head. This resolved and was followed several minutes later by another 5 second episode of seizure-like activity. When mother attempted to give Tylenol to the patient soon after this, she vomited profusely. She was taken to the ED and subsequently admitted to Hospital. She received Tylenol with resolution of her fever as well as IV fluids. EEG the next morning was found to be normal. There was no recurrence of seizure after this.
Immediate brain fog and continued for 2 days; This is a spontaneous report from a contactable consumer (patient). The 83-year-old female patient receive second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 15Feb2021 on Right arm at single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 25Jan2021on Right arm at single dose for covid-19 immunization. The patient experienced immediate brain fog and continued for 2 days on 15Feb2021 12:00 PM with outcome of recovered. No treatment received. She is not pregnant. Facility type vaccine was other.   Information on the lot/batch number has been requested.
I have continued to have aches, fatigue, and chills more than two weeks after the vaccination
pt's mom called on 6MAY92 to report that pt had a sz the noc of 4MAY92 lasting about 5 mins during which time pt's eyes rolled back, pt was biting tongue, had a fast heart rate & slow breathing;
I have a rash all over my body but especially on both legs; the rash and swelling became much more serious; the rash and swelling became much more serious; Had a bad reaction; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0172), via an unspecified route of administration, administered in Arm Right on 26Apr2021 (at the age of 77-year-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus (Verbatim: Diabetes), hypertension (Verbatim: High Blood Pressure), blood cholesterol increased (Verbatim: High cholesterol), asthma (so I am taking some inhalers and I take Levothyroxine), thyroid (Verbatim: Thyroid). Concomitant medication(s) included levothyroxine taken for an unspecified indication, start and stop date were not reported. Caller stated that he had a bad reaction from vaccine. He has a rash all over his body but especially on both legs. He stated he was experiencing some rash in his legs before that (Covid Vaccine), maybe one week before but after that, the rash and swelling became much more serious. As a part of treatment consumer stated he was using over the counter Gold Bond Diabetes Rash Lotion, it is a lotion and he just apply 4 or 5 times a day and cover his entire leg with the lotion. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Licensed Visiting Nurse (L.V.N.) concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 15-FEB-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (Lot # L031602; 18FEB-2017), which was improperly stored and was exposed to several  defrost cycles. No adverse symptoms reported. This is one of several cases from the same reporter (MARRS # 1507USA010811). Additional information has been requested.
Develop cellulitis. Treated w/ 10 day course of Cephalexin.
Complained of headache and vomiting x 6.Also complained of tingling of hands and feet.
Watery discharge from anus for 1 full day and 2 half days (still ongoing);(reacts similarly to stress, but claims she was not stressed and this corresponded w/ flu shot); drank fluids (tea, flat coke).
unresponsive to stimuli; flushing; high temperature; received third booster dose of Comirnaty; This is a spontaneous report from contactable pharmacists. This pharmacist reported similar events for two patients. This is the first of 2 reports. A patient of unspecified age received third dose of bnt162b2 (COMIRNATY) via unspecified route of administration on unspecified date (lot number: FD0810, Expiration Date: 30Nov2021) as DOSE 3 (BOOSTER DOSE), SINGLE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously received the first and second doses of COMIRNATY on unspecified dates for COVID-19 immunisation. On unspecified date, within 24 hours of receiving the booster, the patient experienced flushing, high temperature, and unresponsive to stimuli. The patient had been transported to the hospital and are still hospitalized due to the events. The pharmacist stated, it raised a red flag for them since they have given ten to thousand doses. Outcome of the events was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Unresponsive to stimuli, Flushing and Pyrexia and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101489289 same reporter/drug/events, different patient
VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; This spontaneous report received from a consumer via social media concerned a 33 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 4 decade old. No concomitant medications were reported.  On an unspecified date (post 12 days of vaccination), the patient experienced blood clots (vaccine-induced immune thrombotic thrombocytopenia) and had been in a long-term care facility. The reporter stated "Pls contact this 33-year-old, otherwise healthy male, who presented with blood clots (VITT) 12 days after receiving  J and J covid vaccine. He was now in a LONG TERM CARE FACILITY. YOU DISABLED HIM and many like him" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine induced immune thrombotic thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230258720-vaccine induced immune thrombotic thrombocytopenia. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
bumps has gotten worst since yesterday; quarter sizes bumps and a rash all over his body; body aches; fever; got the first dose around June took two months between shots because he wasn't getting out; quarter sizes bumps and a rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of MASS (quarter sizes bumps and a rash all over his body), CONDITION AGGRAVATED (bumps has gotten worst since yesterday), RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062e21a and 027a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced MASS (quarter sizes bumps and a rash all over his body), RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches), PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose around June took two months between shots because he wasn't getting out). On 05-Sep-2021, the patient experienced CONDITION AGGRAVATED (bumps has gotten worst since yesterday). The patient was treated with NAPROXEN SODIUM (ALEVE) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 31-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose around June took two months between shots because he wasn't getting out) had resolved. At the time of the report, MASS (quarter sizes bumps and a rash all over his body) and CONDITION AGGRAVATED (bumps has gotten worst since yesterday) had not resolved and RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            No  Concomitant medications were provided.
Initial unsolicited report received from a consumer on 04 September 2015. This case involves a 75-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, route of administration not reported) in the left deltoid on 01 September 2015. Illness at time of vaccination was reported as none. Patient had Sulfa and dye allergy, other medical history and concomitant medications were not reported. On 02 September 2015, one day after vaccination, the patient experienced high blood pressure of 20 points higher, shortness of breath and headache. It was reported that the patient received FLUZONE HD vaccine few times before (date was not specified). Lab data and corrective treatment were not reprovided. It was reported that patient felt better and "the events had resolved" (There is a discrepancy in the outcome of structured field and narrative of source document). List of documents held by sender: none.
first dose: 06-APR-2006, second dose: 19-JUL-2020; This spontaneous report has been received from a health care professional via immunization records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)) (2207USA005557), concerning a male patient of unknown age.  The patient was vaccinated with the first, and second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) injection on 06-APR-2006, and 19-JUL-2020) (inappropriate schedule of product administration), respectively; as prophylaxis (strengths, doses, anatomical locations, routes of administration, lot numbers and expiration dates were not reported).; Sender's Comments:  US-009507513-2303USA007136: US-009507513-2207USA005557:
a little body ache very very little like when you get the flu shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little body ache very very little like when you get the flu shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concurrent medical conditions included Hypertension. Concomitant products included NAPROXEN SODIUM (ALEVE) for Pain, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN (a little body ache very very little like when you get the flu shot). At the time of the report, PAIN (a little body ache very very little like when you get the flu shot) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medications also include, blood pressure medication and water pill.
Muscle Acke in Neck and Migraine type headache but moves from side to side and front to back
Rash developed after receiving PREVNAR 13 vaccination. Patient noticed rash about an hour after receiving PREVNAR at pharmacy. The next morning, the rash was gone.
achy all over all day;2nd day p/shot;temp 100 & cough in evening only 26OCT-31OCT nothing p/that time still sl cough;
I developed a relatively severe itch at the injection site. It lasted for about two weeks. I suspect it was an allergic reaction. It is not deterring me from getting the second shot and did not produce any other systemic anaphylactic symptoms. I used hydrocortisone on it for symptom relief.
Vaccines were administered about 10:30am on Feb. 23, 2010, the child reported to his mother that afternoon that his (Rt) arm did not feel right - but it looked normal. That night about 1:00am he awoke with a headache. He was given MOTRIN and went back to sleep. On Feb. 24th, when he awoke his (Rt) arm was reddened, slightly edematous and hot from 2" below top of shoulder to 1" above right arm. * Elbow joint. ROM-normal. Lower arm does not hurt. Able to use (Rt) hand normally. Arm continues to look the same today, Feb. 25th. Left arm not affected.
After receiving the vaccine, I felt bad for 24 hours with body aches and feeling weak. On 12/19/2022 I did not feel well with congestion, runny nose and a slight cough. On 12/20/2022, I tested positive for COVID-19 with a home test. I am taking doxylamine-DM-acetaminophen to help with my symptoms.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) at the age of 15 years as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "recovering" and all described as "Tested positive for COVID". The seriousness criteria not caused results in death, life threatening, prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
3hr p/vax fever, sore throat 6hr later 9PM welts started Wednesday when got up;welts on lt arm;later chest, shoulder blades other arm genitals;referred to MD;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on an unknown deltoid. The batch number and expiry date were not reported. The soreness was lasted for 1.5 days. The reporter had denied permission to contact their physician. This case has been linked with case US2018187570, reported by the same reporter.
Vaccine was administered on 01-13-14. Next day (01/14, 01/15) patient had soreness in arm. On Saturday 01/18 patient broke up in rash (red little needle-prick-like bumps) from waist down. On Sunday 01/19 rash spread to chest and patient went to the ER. Patient today 1-29-14 is reporting that after a course of prednisone she is doing well and rash has vanished.
MINOR SHORTNESS OF BREATH SIX HOURS AFTER THE SHOT; 16 HOURS AFTER SHOT WITH 5 HOURS SLEEP GENERAL FEELING NOT QUITE WELL/ TIRED; EXTREME FATIGUE/TIREDNESS 1 HOUR AFTER THE SHOT FOR 2 HOURS THAT FELT LIKE BEING DRUGGED TO PUT TO SLEEP; MINIMAL SORENESS AT THE VACCINATION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced minor shortness of breath six hours after the shot, 16 hours after shot with 5 hours sleep general feeling not quite well/ tired, extreme fatigue/tiredness 1 hour after the shot for 2 hours that felt like being drugged to put to sleep, and minimal soreness at the vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor shortness of breath six hours after the shot, 16 hours after shot with 5 hours sleep general feeling not quite well/ tired, extreme fatigue/tiredness 1 hour after the shot for 2 hours that felt like being drugged to put to sleep, and minimal soreness at the vaccination site. This report was non-serious.
Patient given Pediarix/Hib/Prevnar and rotavirus vaccines about 10:30am. Within 1 hr, mother reports inconsolable crying that lasted for a total of 4.5hrs. She was able to sleep for 1 hr, but was crying for 4.5hrs. Not better with Tylenol at home.  In office at 5pm; was crying inconsolably. Nl exam otherwise, afebrile.  Given Tylenol again and by 5:45p, crying had ceased. Looked well.
Headache, Arthralgia, Lightheadedness Narrative: Symptoms started day after injection and resolved by the next evening