chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, concerning a 3 months old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 14-NOV-2017, the patient was vaccinated with an expired dose of PROQUAD with lot # M022399 and expiration date on 01-NOV-2017 (strength, dose, route of administration, and anatomical location were not reported), administered for prophylaxis; and was reconstituted with a not expired sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 21K-163-3850576-00 (AbbVie).  A 70 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral since 01Jun2020 (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day. Relevant medical history included: "epilepsy" (unspecified if ongoing); "sulfa antibiotics allergy" (unspecified if ongoing); "headache" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; CELECOXIB taken for arthritis; CEPHALEXINE; HYDROMORPHON AL; ONDANSETRON ODT; TRIAZOLAM; NP THYROID. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 10Nov2021, outcome "not recovered", described as "Rheumatoid arthritis flare up"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizziness aggravated"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain aggravated"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache". The action taken for upadacitinib was dosage not changed.  Clinical Course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of couple of flares of dizziness with mild pain un-known onset, couple of flares of dizziness with mild pain unknown onset, headache and rheumatoid arthritis flare ups on and off was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded.
Received the Pfizer COVID-19 Vaccine and passed away days later/Unknown cause of death; This is a spontaneous report from the Pfizer-sponsored program. A contactable consumer reported that a female patient (aunt) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The received the Pfizer COVID-19 Vaccine and passed away days later, Unknown cause of death. She passed away after receiving the vaccine, the Pfizer COVID-19 Vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. Case was reported as serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Unknown cause of death
Pt. scratching at site & next day arm red, swollen. Reactions in arm VARIVAX given.
circle of redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (circle of redness around the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (circle of redness around the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (circle of redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
t101 on 29JUL93 w/ 9cm in diameter area, erythema-center sl purple w/puncture on lt anterior thigh; redness occurred almost immed per mom; no cellulitis; seen in office 30JUL93;
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 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Felt itchy at injection site, throat also itchy; Patient given 25 mg Benadryl and observed for 45 minutes Patient reported feeling much better, no rash or redness , and left
Left arm redness and purple bruising starting the night of the same injection day. Middle of the night woke up with sweats and aching joints, headache. Breastfeeding my four month old infant, green watery diarrhea for her the following day/ general crankiness/fussy. I had to work the following day, Friday, and had to pump breastmilk. My supply was literally half the amount of ounces I normally pump, and I consume 90-120 ounces of water from my water bottles  everyday , plus other liquids so reduction in breastmilk is not something normal for me.
immunocompromised; sickly; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An 1-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 19Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 months for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: prevnar (DOSE 1, SINGLE), administration date: 13Oct2021, for Immunization; prevnar (DOSE 2, SINGLE), administration date: 13Dec2021, for Immunization; prevnar (DOSE 3 (BOOSTER), SINGLE), administration date: 14Feb2022, for Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; ILLNESS (non-serious), outcome "unknown", described as "sickly". The health care professional reported an adverse event for Prevnar 13. Explained that a patient received Prevnar 13 vaccinations on 13Oct2021, 13Dec2021, 14Feb2022, and 19Aug2022. Reported that the patient is sickly, immunocompromised, and at high risk for developing pneumonia.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The association between the event "immunocompromised" with PREVNAR 13 can not be fully excluded.  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.
I have never had eczema before.  I started to get an eczema type rash on my inner elbows, back of the neck, and behind the ears. A teledoc dermatologist prescribed a topical cream that seemed to clear it up, however, it came back. I have it on all of my whole neck, lowers legs, arms, belly, upper thighs, and inside my ears. I also have little red dots on much of my body.  I have no idea if this is related to the Covid Vaccine.
11/00, I was severely crippled with arthritis like symptoms and pain. I saw many doctors who prescribed several drugs. Prednisone worked the best after a month.  Nurse follow up on 07/23/04 states: "joint pain, stiffness of joints, joint effusion, and numbness of hands."
Patient had Pfizer Covid -19 Vaccine at 13:15  in left deltoid and Fluad   at 13:25  in the right deltoid  and as she was walking to get out of the store she alerted one of the store clerk at front desk that she has trouble breathing at 13:30. She was helped by the store clerk and a fellow customer in store and alerted the pharmacist. I ran out to help her seated and she was gasping for air and kept telling me she can not breath. I immediately alerted Tech to call  911 and another tech to grab Epipen and I gave her Epipen 0.3 mg IM in left thigh and she was feeling better immediately.  Paramedics arrived shortly and all her vitals were normal. Her family daughter and Husband arrived  and they elected not to go to ER for observation. I have checked on patient in the evening and she is doing fine at home.
Patient came in the office to receive pneumococcal vaccine and was given Vexelis (DTaP+IPV+Hib+HepB) instead. Once realized, parent and PCP were informed. Patient was then given the correct vaccine, PCV15.
Swelling, fever in injection site, 8 days later fever again in the location of injection and swelling.
Fatigue; muscle aches; headache; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. On an unspecified date after the second dose, the patient experienced fatigue, muscle aches, and headache. The clinical outcome of fatigue, muscle aches, and headache was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Hoarseness next morning x 48 hrs. Called off work. No treatment. Resolved.
Light soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Light soreness in the arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021 at 2:00 PM, the patient experienced MYALGIA (Light soreness in the arm). At the time of the report, MYALGIA (Light soreness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment medication not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever, Muscle/body aches, cough, congestion, runny nose, headache, no taste and smell, fatigue
Vesicular rash appeared 24 hrs after FLUMIST - antiviral meds done thinking varicella at first (immunized).
The patient developed multiple sclerosis after receiving the vaccine. The patient has a family history, but had no symptoms prior to the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adult female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown), for Covid-19 immunization. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant, life threatening), outcome "not recovered", described as "The patient developed multiple sclerosis after receiving the vaccine. The patient has a family history, but had no symptoms prior to the vaccine". The event "the patient developed multiple sclerosis after receiving the vaccine. the patient has a family history, but had no symptoms prior to the vaccine." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of multiple sclerosis. It was unknown if 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.
Large, hard, hot,  red,  itchy lump about 2 inches below site of injection on right arm. Appeared the next day after the shot (I got the shot @ 8:20 PM and had the reaction by the morning. I am reporting this day 2 and the lump is less red, but same size, still hot, and very very itchy.
Patient was supposed to received Moderna BIVALENT vaccine and received Moderna MONOVALENT instead.
Information has been received from a medical assistant concerning a 7 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 17-OCT-2016, the patient was vaccinated with a dose of GARDASIL 9 (expired date: 30-APR-2018) (Reporter reported GARDASIL 9 with Lot # M026306 which was not valid for GARDASIL 9. However, lot # M026306 is valid for GARDASIL) intramuscularly. The patient has not experienced an adverse effect. Additional information has been requested.
headaches that lasted about 10 days. he could not attend school, they were severe. Tylenol helped for a short period of time, so he could sleep. But it was not impossible to concentrate due to headaches.
Patient received second Pfizer covid vaccine at pharmacy in late June, then had very heavy menstruation in mid July lasting 6 days and is now having no period for two months which is very unusual for this patient who has been quite regular since the start of menarche at age 12.
One week later getting vaccine large (3 1/2 in) skin reaction - hot, raised, red, itching reaction - applied cool pack and applied triamcinolone ointment. Arm stayed red, hot to warm, itching for 5 days. Also I didn't make the connection at the time - about 3 days after the injection I felt really bad - even hot all day - never dreamed it could be the shot.
After my second vaccine, I experienced worsening low back pain and bilateral pelvic pain. I tested positive for pregnancy.  I followed up with my gynecologist due to my vaginal bleeding and worsening low back pain.
Body aches starting in the morning on 1/23/21, lasting less than a day.
Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 24-Jan-2022, the vial was moved from freezer to refrigerator. It was reported that the vaccine was stored refrigerated at the time of the excursion in normal refrigerated temperature range 38 F to 40 F. The pertinent details for the vial were that they it was unpunctured and had no previous excursion. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each).  No abnormality was reported during visual inspection of vaccine state change. There was no product complaint associated. The vial location was in a nursing home and was not sure if they discarded the vial or still had it in the refrigerator.  No treatment medications were reported.   This case was linked to MOD-2022-493214 (Patient Link).
Skin rash with itching very suddenly developed on 06/07/21 along with hives in the same area. Over the course of an hour, I also felt fatigued and slightly feverish. These lesions appeared randomly and especially in folds of skin but also on the skin around my eyes. It did not appear on hands or feet. I took 12 mg Diphenhydramine HCL which took about 40 minutes to provide relief and the beginning of diminishing of the rash. When the diphenhydramine wore off in about 12 hrs, the rash began to appear again in multiple areas, upon which I continued with 12 mg of diphenhydramine.  The appearing of the rash was again very random and sudden.  Again, when the diphenhydramine wore off, the rash was returning, but this time it was not as intense and I was able to manage symptoms with topical diphenhydramine. By 6/11/21, the rash returned on small areas of my neck but did not progress
It started out as a fullness in my ears and cracking noises. I was able to hold my nose and blow to open my ear. It was happening in both ears back and forth for 4 weeks. I have never experienced this. On the weekend both ears were blocked. I went to urgent care at the beginning of June where I was diagnosed with an ear infection in one ear. I was put on an antibiotic drop which healed for a week and then it came back. I went to my doctor where he did a cleaning and told me to take a antihistamine. Again, things were good and a week later it came back. I went back to the doctor who again, cleaned it. After a week It was back again so I then went to the ENT who injected a medication into the right ear. The right ear has been okay so far while the left ear currently has pain and blockage again. I have had no fever, no coughing. Everything is just in my ears.
WEAK ARM; SORENESS ON INNER ASPECT OF ARM/TENDER ARM; This spontaneous report received from a patient concerned a 70 year old female. The patient's concurrent conditions included arthritis, non-alcohol user, non-smoker, rosacea, essential tremors at right side only, tendonitis/tennis elbow, and seasonal allergies, and other pre-existing medical conditions included the patient have no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: T308612, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included primidone for for essential tremors, and paracetamol. On 2021, treatment medications included: diclofenac, and paracetamol. On APR-2021, the subject experienced soreness on inner aspect of arm/tender arm. On an unspecified date, the subject experienced weak arm. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness on inner aspect of arm/tender arm and weak arm was not reported. This report was non-serious.
Within 12 hours, very large red welt appeared around the injection site, about 5x6 inches. At first the red spot was swollen, very hot and sometimes itchy.  Sore to touch. Self treatment has included Advil, Tylenol, Zyrtec and a topical benedryl cream to curb itching. As of today,  4 days after the vaccination, swelling has gone down, but red area is still the same size, but not as itchy, and color has slightly faded, but still very noticeable. Soreness has also subsided. This reaction happened with the first shot on my right arm, but was not as severe.
Severe pain in groin area; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe pain in her groin area, and she might see a doctor. It was reported that patient was in too much pain and would have to go to an orthopedic surgeon for her groin pain. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Nausea, vomiting, & diarrhea. Did not have an elevated temp. per parent.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. This case is one of 8 cases, reported by the same reporter.
SKIN HAD BEEN CRAZY SINCE TAKEN VACCINE; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced skin had been crazy since taken vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin had been crazy since taken vaccine was not reported. This report was non-serious.
headache, very tired, achy muscles, chills, fever, nausea, chest discomfort