chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bullseye rash, 3 inches, at injection site; itching like crazy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching like crazy at injection site) and VACCINATION SITE RASH (bullseye rash, 3 inches, at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching like crazy at injection site). On 21-Feb-2021, the patient experienced VACCINATION SITE RASH (bullseye rash, 3 inches, at injection site). At the time of the report, VACCINATION SITE PRURITUS (itching like crazy at injection site) and VACCINATION SITE RASH (bullseye rash, 3 inches, at injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
pt devel cold like sx in early OCT93; MD prescribed medication & administered flu vax; over the next 24 hrs pt devel a flu-like illness characterized by fever, nausea, fatigue, chills, dizziness, h/a & generalized aches; dx w/lyme disease
About 5 minutes after receiving vaccine, patient felt very hot, faint, nauseated, and had to lie down to keep from passing out. Patient did not pass out. Patient felt better after about 10 minutes.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 27-JUN-2017 the patient was vaccinated with M-M-R II lot # M010426, expiration date: 01-MAR-2018; lot # M032157, expiration date: 01-JUL-2018 and lot # M039913, expiration date: 26-SEP-2018, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced no adverse event. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002800: Original Case : 1708USA002800
swollen upper arm where the shot was given after 24 hours soreness in the lymph node underneath the armpit and across the to the chest
Patient received vaccine that had an undetermined beyond use date of either 3/25/22 0r 4/5/2022
Patient had an episode of vasovagal after getting 1st dose monkey pox vaccine, intradermal on left forearm.  Safety maintained, vitals initiated right away, b/l legs elevated, patient gained conscious and denies any chest pain or discomfort. Water provided, ice packs  applied. Patient has history of fainting after blood draw. Observation period extended.  All symptoms resolved.
child received 2 doses of H1N1. The first was a spray on 10/7/09, injection was 10/16/09. Pt. has no adverse events as of 10/29/09
This spontaneous report as received from a physician via company representative refers to a unknown number of patiens (gender and age unknown). On an unknown date the patients were vaccinated with VARIVAX (Merck) (dose and route of administration were not provided). On an unknown date the patients developed rash after administration of VARIVAX (Merck). Patients sought medical attention. The outcome of rash was unknown. Relatedness between rash and vaccination with VARIVAX (Merck) was not reported. Additional information is not expected. Reporter did not wish to be contacted.
Feeling slow; First dose of Shingrix in 2018 and second dose of Shingrix October 7, 2020; Administered high up on her arm; Stiff Arm; This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in 2018).   On 7th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2020, less than a day after receiving Shingrix, the patient experienced sluggishness, drug dose administration interval too long and vaccine administered at inappropriate site. In October 2020, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness and sluggishness were not recovered/not resolved and the outcome of the drug dose administration interval too long and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the limbs stiffness, sluggishness, drug dose administration interval too long and vaccine administered at inappropriate site to be related to Shingrix.  Additional details were reported as follows: The patient received first dose of Shingrix in 2018 and second dose of Shingrix 7th October 2020 (inappropriate schedule of vaccine).  The patient felt slow and a stiff arm after vaccine that has not resolved.  The vaccine was administered high up on her arm (wrong Injection Technique). The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202295:same reporter
On 8/5/14, patient received Gardasil (left arm) and Menactra (right arm).  He immediately developed erythematous papules.  Over the next two days he developed, papules, hives, and periorbital edema.  The papules turned into nodules and become secondarily infected after he scratched.  The hives did not improve with Benadryl.  He was seen at urgent care on 8/7/14 at 4:30 AM and he recieved Benadryl and Prednsione.  2 hours later he had no improvement and stated that he had shortness of breath (no tachypnea, hypoxia, or wheezes on examination).  He was given an EpiPen and had improvement of all of his symptoms.  He was observed for 6 hours and continued to improve and was discharged home.  Pediatric allergy was consulted over the phone, and could not determine if this was an allergy to Gardasil but recommended no further doses and reporting to VAERS.  The patient had no other known reason for hives, periorbital edema, shortness of breath, or nodules.  He had no viral symptoms, bug bites, or new medications/drugs.
This spontaneous report was received from a registered pharmacist refers to a 74 years old male patient who on 30-NOV-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included eye drops (unspecified name and manufacturer). It was reported that about 8 days ago on approximately 30-DEC-2012, the patient developed a systemic rash on his back, chest and arms after vaccination with ZOSTAVAX. The rash was itchy with pustules. Three days after vaccination the patient started a MEDROL dosepak. The pharmacist stated that the patient was not sure if he had chickenpox. At the time of the report, the patient was recovering. The relatedness for patient developed a systemic rash on his back, chest and arms after vaccination. The rash was itchy with pustules was unknown for ZOSTAVAX. Additional information has been requested.
pt recvd vax & w/in hrs post vax exp hypertension & a fever of 103;ER or MD visit was required & HTN was treated (treatment not specified);sx resolved;vax series discontinued;
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer reporting same event(s) under the same suspect product(s) for 37 patients. This is 1 of 37 reports. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration on 23Jan2021 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunisation at health department. Medical history included ongoing chronic obstructive pulmonary disease (COPD) AND ongoing congestive heart failure (CHF). The patient's concomitant medications were not reported. After being fully vaccinated, on 29Jul2021, patient tested positive for COVID virus. The patient underwent lab tests and procedures which included body mass index (BMI): 28.7 and NAAT COVID test: positive on 29Jul2021. Outcome of the event was unknown.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Covid 19 pcr positive. Employee is fully vaccinated. Breakthrough case reported in system.
had a "strong reaction" to the first dose of the Pfizer-BioNTech COVID-19 vaccine\really bad allergic reaction after her first dose; This is a spontaneous report from a Pfizer-sponsored Program.  A contactable consumer reported that a 37-year-old female patient (reporter's daughter) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included iodine allergy from an unknown date and unknown if ongoing, cat and environmental allergies to animal from an unknown date and unknown if ongoing, environmental allergies from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The reporter is 70 years old, has medical conditions including asthma and COPD for which she takes steroid medications.  She said she received her first dose of the Pfizer-BioNTech COVID-19 vaccine on 10Feb2021. She explained she had slight pain in her arm, [her] heart was racing, and [she] felt her heartbeat was faster. She described this experience as nothing out of control. She explained she does have this problem, [her] heart raises easily with different things. She added her 37-year-old daughter who is very healthy, had a strong reaction to the first dose of the Pfizer-BioNTech COVID-19 vaccine. She specified it was to the point where they almost had to give her an EpiPen injection. She explained her daughter's face, tongue and lips swell. She said it was a little better, but when she off the [vaccination] site, it got worst and she was given 1c.c. of Depo-Medrol, a corticosteroid, which got it under control. She mentioned the only time her daughter had a similar severe allergic reaction was with iodine, a colorant dye, or contrast dye. She then explained her daughter also has cat and environmental allergies. She then mentioned her daughter was worried because she is also nursing her baby. She expressed her concerns as to whether or not they should receive the second dose. She stated her second dose is scheduled on 03Mar2021. She asked: will steroids, injectable steroids, EpiPen and epinephrine interfere with the vaccine's efficacy? The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021230246 same reporter, different patient, same product, and different event (Baby case)
First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times") in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times"). On 11-Mar-2021, PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (First dose of vaccine administered after excursion/vaccine was exposed to temperatures of 77 degrees F or higher after being  "transported in hot car 4 times") to be not applicable.    No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-250545 (Patient Link).
Idk what type flu shot it was but my daughter has a huge red mark the size of and egg on her thigh.and its hard
Shortly after the vaccine I got a really bad headache and body ache, I went to the ER on August 3rd 2021 about the headache and they gave me medicine in a IV to soothe it and some over the counter medications. The medicine prescribed didn't work so on 3/10 My doctor ordered me a MRI and it came back normal and on 3/29 I was back in the hospital due to the same issues. This is still a on going issue after all my tests came back clear and I am just taking tylenol to try and help.
hives; shingles; This is a spontaneous report from a contactable consumer (parent). A 28 (unit not reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE, solution for injection), via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives and shingles on an unspecified date in Jan2021. The course of the events was as follows: The patient took the vaccine in January. She has had hives every since. They had put her on steroids and that did not help. They told her she had shingles, but the reporter did not believe it was shingles. She has had hives since she got the first shot and then they gave her the second shot and that was when they thought it was shingles. The doctors did not know how to help her. They kept passing her off. No one was helping her. Her body was shutting down. She was not anaphylactic but can it turn anaphylactic. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE) on an unspecified date for COVID-19 immunisation. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After patient received vaccine they fell to one side of the chair while sitting down. The patient woke within 10 seconds of passing out. Patient did not report any signs of allergic reaction. Patient was given water and monitored for 15 minutes.
Hypertension Blood Pressure 185/110 taken 5 days after vaccination  Prior BP s have been 120s/70s
Cough; Sore throat; Nausea; Distorted taste and smell; Distorted taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 31Mar2021 at 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 the patient experienced cough, sore throat, nausea and distorted taste and smell. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cough, sore throat, nausea was resolved on an unknown date in Apr2021; while that of distorted taste and smell was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
- fever for 3 straight days between 102-104 F. (with stacking aspirin and advil) - chills (first 2 days)  - shortness of breath first night  - joint pain for 3 days (diminished over time) - pain on bottom of feet  for 1.5 days (I checked for pedal edema, but my feet didn?t seem bloated) - back pain first night -  numbing of right hand fingers (day 2-present), but getting sensation back slowly - shooting headache (on and off) - Day 3 and 4 (present): low energy, fatigue, temp b/w 99-101. Mild joint pain
New guidelines for PF 12+ Bivalent required 8 weeks . It was given at a 4 week interval. NoTreatments, signs or symptoms noted as a result of the early treatment.
Hoarse and a cough x 4 days, fever x 3 days, loss of appetite x 3 days, bilateral ear pain with drainage x 4 days and loose stools 3-4 days. Acute Otitis, acute RAD. No rash at injection site, no redness or swelling.
March 20 (day of vaccine) soreness at site of injection, some fatigue March 21-22  fatigue, headache, diarrhea, muscle pain, chills, nausea and vomiting March 23  fatigue, diarrhea, chills, muscle pain
Site of shot in left arm and one hour after receiving the shot she has had moderate/severe pain in shoulder and left arm.
Rheumatoid Arthritis started in right thumb, on 4/3/2021.  Second dose of  Pfizer/BioNTech (EW0151) given intramuscular, left arm on 4/10/2021. On 5/17/2021, Rheumatoid Arthritis started in left and right knee joints.  All joints listed above were swollen, red and extremely painful and still ongoing as of the date of this report.
5/27/08 states she is nurse practitioner.  Had reaction 3 mins after vacc went to car.  Started itching, throat closing up, face swelling.  Said she had anaphylactic reactions.  Went to urgent care sent to ER via ambulance.  2 more doses of epinephrine.  Still has itching (chronic problem) taking prednisone.  Has had 7 or 8 yellow fevers vac before with no problems.  Last one 2001 in military.  Still having lorengic spasms.  Under care Dr.
Felt "crummy"; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (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: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: MALAISE (non-serious), outcome "recovered", described as "Felt "crummy"". Therapeutic measures taken as a result of malaise was unknown.   Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Anaphylaxis with EpiPen administered at 60 min. after injection to treat sever breathing difficulty.
25mm red raised with center vesicle with small vesicle and center with scale in center small indurated area in arm.
Got an urinary tract infection (UTI) the day she was to take the second dose of Vivotif; Took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020; Spontaneous report received on 09JAN2020. Additional information received on 13JAN2020.  A 59-year-old female pharmacist reported that she "got an urinary tract infection (UTI) the day she was to take the second dose of Vivotif" (PT: Urinary tract infection) and also she "took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020" (PT: Labelled drug-drug interaction medication error). She was receiving Vivotif for immunisation and Augmentin (amoxicillin/clavulanate) for UTI. The consumer took first dose of Vivotif on 03JAN2020 and developed urinary tract infection on 05JAN2020. She took Augmentin as a treatment medication for urinary tract infection from 05JAN2020 to 11JAN2020. Moreover, she stated that she did not take the remaining three doses of Vivotif. Action taken with Vivotif with respect to the reported event "got an urinary tract infection (UTI) the day she was to take the second dose of Vivotif" was drug withdrawn, while with respect to the event "took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020" was not applicable. Action taken with Augmentin with respect to the reported events was not applicable. The consumer had recovered from the event "got an urinary tract infection (UTI) the day he was to take the second dose of Vivotif" while the outcome of the event "took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020" was unknown.  Company Comment: A consumer took first dose of Vivotif on 03-Jan-2020 and was diagnosed with urinary tract infection on 05-Jan-2020, and on the same day she started taking amugmentin ( Labelled drug-drug interaction medication error). The consumer stopped taking Vivotif doses and urinary tract infection was resolved with augmentin course. Considering the infectious pathogenesis of urinary tract infection, the causality of the event is assessed as not related to Vivotif. There should be at least three days gap between Vivotif dose and antibiotic dose. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif on 03-Jan-2020 and was diagnosed with urinary tract infection on 05-Jan-2020, and on the same day she started taking amugmentin ( Labelled drug-drug interaction medication error). The consumer stopped taking Vivotif doses and urinary tract infection was resolved with augmentin course. Considering the infectious pathogenesis of urinary tract infection, the causality of the event is assessed as not related to Vivotif. There should be at least three days gap between Vivotif dose and antibiotic dose. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.
Patient developed an injection site skin reaction 24 hours after receiving the 2nd dose of Shingrix.
Pt recv vax on 2/10/99; on same day pt exp swelling/red LA, fever
Extreme fatigue, enlarged lymphnodes along neck, enlarged lymph nodes under arms (size of a golf ball), headache, muscle aches
Menopause for 16 months and started bleeding 3 days after shot 2 of Moderna