chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse Event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD).    Patient registry ID was reported as Unknown.  No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
constant nausea, extremely fatigued, malaise ever since injection.    body aches, chills, numbness in hands all went away but had them for over a week
Pt administered expired Moderna vaccine LOT: 046L21A EXP: 7/6/22.
The evening after the shot I had pain in the my right femur and hip. My gait was affected. The pain was  3.5 out of 5. The next 1/23 2021 my left leg developed the same problem but more severe.  My gait was severely affected. On 1/24 the right leg was better but  I could hardly put any weight on the left leg in the am hours. In the pm hours both legs got some better. On Monday 1/25 both legs were much better and both finally cleared up on 1/27.
Onset of rash 2-3 days after vaccine admin. Progressing from thighs to abdomen/under breast & to bilat arms. No pruritus. No burning sensation. Given DEPO MEDROL 80 mg IM today. TMC 0.1% BID cream to involved areas. ZYRTEC 10 mg PO QD x 7 day.
Moderate headache for 5 hours the following day.  I very rarely get headaches (one every few years, often when ill)
No adverse events reported.  However, child was >32 weeks at time of visit.  Physician did NOT order third Rotavirus vaccine but medical assistant inadvertently administered the vaccine without an order for it.
injection site hard; feels pain/hurt; covid arm; injection site red; injection site itchy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PRURITUS (injection site itchy) and NAUSEA (nauseous). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 23-Mar-2021, VACCINATION SITE PRURITUS (injection site itchy) had resolved. At the time of the report, VACCINATION SITE INDURATION (injection site hard), PAIN (feels pain/hurt), VACCINATION SITE REACTION (covid arm), VACCINATION SITE ERYTHEMA (injection site red) and NAUSEA (nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
c/o feeling tingly and itchy one hour after the shot- arms, face, all over. No SOB. On further questioning, pt has "reacted to eggs once with similar symptoms."
Headache, mild Fever, mild Chills, mild Muscle and joint pain, mild Nausea, prevented normal activities All lasted about 30 hours
Vaccine at 330pm, during night-sleep was agitated next morning-mini seizure, manic next evening, following day full seizure in AM.
Two polyps; COVID Vaccine caused sore arm; This spontaneous case was reported by a consumer and describes the occurrence of POLYP (Two polyps) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced POLYP (Two polyps) (seriousness criterion medically significant) and VACCINATION SITE PAIN (COVID Vaccine caused sore arm). At the time of the report, POLYP (Two polyps) and VACCINATION SITE PAIN (COVID Vaccine caused sore arm) had resolved.            Concomitant medications were not reported.  The patient had found 2 polyps which were removed and everything was doing fine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient experienced COVID vaccine caused sore arm with HUMIRA (ADLIMUMAB).  Treatment information was not provided.  CC: This spontaneous case concerns a 46-year-old, male patient, with a relevant history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Two polyps, which occurred unknown days after receiving the first dose of mRNA-1273 vaccine. The patient had found 2 polyps which were removed. The outcome of the events was reported as resolved. Underlying history of Crohn's disease remains a confounder for the event Two polyps. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 46-year-old, male patient, with a relevant history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Two polyps, which occurred unknown days after receiving the first dose of mRNA-1273 vaccine. The patient had found 2 polyps which were removed. The outcome of the events was reported as resolved. Underlying history of Crohn's disease remains a confounder for the event Two polyps. The benefit-risk relationship of mRNA-1273 is not affected by this report.
2ND Covid dose was administered too soon.  Covid -19 vaccine exceeded 4 day grace period.  2nd dose was administerd on day 16 No adverse reaction was reported by the patient
Pt came in to say that left arm still hurt/some limited mobility. Not severe but troubling her. Instructed to speak to PCP at next OV.
Gave pt 3 IMZ on 7/18. BOOSTRIX and HAVRIX in left arm and ENGERIX-B in right arm. Right arm is ok however, Left arm has bruising at the top of the shoulder and a raised red streak around the middle of the deltoid muscle. Pt said her left arm itched a little but had no pain. These symptoms occurred the day following IMZ. The BOOSTRIX injection bled at the time of injection but HAVRIX injection was fine. Pt came in on 7/24 to report adverse rx. Pt has been taking BENADRYL and I recommended she put an ice pack on the red raised area and continue the BENADRYL. The bruise was fading when she came in on 7/24. Recommended she see a physician if it got any worse.
SLEPT SO MUCH; CHILLS; HOT FLASHES; REALLY LETHARGIC; This spontaneous report received from a patient concerned a 38 year old male. 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: 20UB21A, expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-AUG-2021, the patient experienced hot flashes. On 28-AUG-2021, the patient experienced really lethargic. On 28-AUG-2021, the patient experienced chills. On 30-AUG-2021, the patient experienced slept so much. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes, really lethargic, slept so much, and chills on 31-AUG-2021. This report was non-serious.
Redness, itchy rash erupted on 1/28/21 on the upper left arm where vaccine was administered.  Resident reported event today 2/2/21 to nurse at assisted living.  Resident stated that this is 2 weeks and 2 days after being vaccinated.  Resident does not report any other symptoms.  Daughter will be notifying medical provider.
tooth abscess; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (tooth abscess) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced TOOTH ABSCESS (tooth abscess). At the time of the report, TOOTH ABSCESS (tooth abscess) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes antibiotic for tooth abscess.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.  Patient reported of no adverse event.   This case was linked to MOD-2021-390578 (Patient Link).
G47.33 OBSTRUCTIVE SLEEP APNEA 3/24/2023 OBSTRUCTIVE SLEEP APNEA
A report has been received from a Health Professional concerning a 58 year old, female subject, Height: 63.0 inches; Weight: 135.0 pounds. It was reported that the patient was administered by expired FLUMIST, 0.2 millilitres, once/single administration for vaccine on 26-Jan-2016. The FLUMIST was expired on 21-Jan-2016. Patient was older than 49 years of age and this information was also considered as off label use. The outcome of the events of received an expired vaccine, FLUMIST was given to the patient older than 49 years old-off label use and off label use is unknown. The report was considered to be non-serious.
Patient complained of congestion and tongue tingling while in observation area. Symptoms lasted for several minutes.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (lot #N021583 and expiration date: 18-NOV-2019). On 01-NOV-2017 or 21-NOV-2017 the patient was vaccinated with unspecified doses of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N017700 and expiration date: 09-JUN-2019). Reporter informed that, the lot# N017700 had multiple temperature excursion as follows, on 27-NOV-2017, temperature excursion was at 5.60 F for the duration of 1 hour, on 29-NOV-2017 at 16.50 F for 1 hour, on 30-NOV-2017 at 6.00 F for 1 hour, on 04-DEC-2017 at 22.80 F for 1 hour, on 05-DEC-2017 at 19.00 F for 2 hours, on 06-DEC-2017 at 16.70 F for 1 hour, on 07-DEC-2017 at 18.70 F for 1 hour, on 11-DEC-2017 at 20.10 F for 1 hour, on 12-DEC-2017 at 11.80 F for 1 hour, on 13-DEC-2017 at 19.80 F for 1 hour, on 14-DEC-2017 at 16.00 F for 2 hours, on 18-DEC-2017 at 14.50 F for 1 hour, on 20-DEC-2017 at 19.90 F for 1 hour, on 21-DEC-2017 at 19.00 F for 1 hour, on 27-DEC-2017 at 19.00 F for 1 hour and on 28-DEC-2017 at 7.70 F for 1 hour. It was reported that there was multiple previous excursions for the VARIVAX. Reporter did not state that sterile diluent was improperly stored. No adverse effects (no adverse event) reported. No product quality Complaint was involved. No further information was provided. This is one of the 8 reports (Same reporter link).; Sender's Comments: US-009507513-1802USA003097: US-009507513-1802USA005088: US-009507513-1802USA005084: US-009507513-1802USA005089: US-009507513-1802USA005087: US-009507513-1802USA005086: US-009507513-1802USA005085.
Red coalesced skin rash upper chest and back; onset 3 hours, post vax, with Menomune. No respiratory symptoms. Temperature 98.4F.
swellling; redness; itching; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose, refer case US2019AMR235142).   On 20th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site itching. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the right deltoid. after vaccination, the patient had injection site swelling, redness and itching. Additional details were provided as follows: The patient received dose of shingrix in the right deltoid. after vaccination, the patient had injection site swelling, redness and itching.
Chills, severe headache, body aches. Upon waking next morning, feeling faint and sweaty. Ran temperature in evening of next day - up to 101.4 degrees. Tenderness at injection site. Note: injection given on empty stomach due to blood being drawn for routine analysis.
This spontaneous report as received from a physician and a healthcare worker refers to a patients of unknown age and gender. Information on concurrent condition and medical history was not reported. On an unknown dates, the patients were vaccinated with improperly VAQTA, lot # L041676 (expiry 15-MAR-2017) and L035105 (expiry date 14-MAY-2017) (dose and route not reported). The temperature excursion time frame was reported as "11 C for 3 hours (also reported as 34 hours)". No previous excursion was reported. No adverse effects was reported. This case is one of the several reports from the same reporter. Additional information has been requested.
pt states she has swelling under the skin around the injection site.  The spot is 3 x 2 1/2" in size and it red and itching.  Pt has not contacted her PCP at this time.
Pt noticed red itchy skin around the tetanus injection site a few days after PREVNAR vaccination. Today seems to be better. Patient was started on 4 day course of prednisone 40 mg today taper in 4 days.
Four hours after the injection, my wife was complaining of sever aching and dizziness, then she bagan to shake uncontrollably with chills. I put her to bed and took her temperature. 102.5. We used ibuprophen ,Tylenol , and cold compresses to bring the temperature down. She finally was able to fall asleep . The next morning, we were both pretty ill ( I had gotten the flu vaccine also, and had come down with the same symptoms, only in the middle of the night) and had to remain bedridden pretty much until this morning.
This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored M-M-R II (lot # L015282, expiration date of 30-APR-2019 and lot # M000768, expiration date of 05-JAN-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 9.6 degrees for 19 minutes. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
shingles behind his ear on his hairline near his scalp; red dots with white heads on the abdomen; tiny bumps; bumps; Skin lesion; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix. In September 2019, 4 days after receiving Shingrix, the patient experienced shingles, red rash, injection site papule, papular rash and skin lesion. On an unknown date, the outcome of the shingles, red rash, injection site papule, papular rash and skin lesion were recovered/resolved.   It was unknown if the reporter considered the shingles, red rash, injection site papule, papular rash and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection and four days later he developed shingles behind his ear on his hairline near his scalp. He went to the dermatologists and they did a scraping and it was confirmed it was shingles. A few days later he went to urgent care because the lesions had gotten worst and he was prescribed an antibiotic. A week later he went to his primary doctor for a regular visit and blood was drawn the next day he developed tiny bumps at the insertion site where the blood was drawn and had seven tiny red dots with white heads on his abdomen. His physician stated that they were either shingles or chicken pox. The lesions have all healed and was told he can get his 2nd injection in December.
Trouble at work and thought he was high on drugs; Began acting strange/acting goofy; acting like he was drunk; Glazed over and falling asleep randomly/friday night falling asleep in the car; Lethargy; This is a spontaneous report from a contactable consumer (patient mother). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 intramuscular, administered in Arm Left on 14May2021 13:55 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included attention deficit hyperactivity disorder from 2010 and ongoing Her son would have behavioral ticks associated with his ADHD. The patient's concomitant medications were not reported. Historical Vaccine includes BNT162B2 1st dose at right arm for COVID-19 immunisation. On 14May2021 the patient States her son received the second dose, and afterwards had lethargy as everyone else seemed to have after their second dose, on15May2021 but he began acting strange acting goofy, acting like drunk. States it took a while for her to put two and two together. He has ADHD and his demeanor for 24-36 hours was very goofy and he was acting like he was drunk. On 14may2021 States he was giggling a lot and glazed over and falling asleep randomly. On 16may2021 States he was then having trouble at work and they thought he may have been high on drugs and they ended up questioning him. States after it subsided after a couple days, they thought it had to do with his second dose. States with his ADHD he has less ability to control his emotion when he is in stressful situations or over tired. Added this was much more pronounced. Outcome of the events lethargy abnormal behaviour was recovering, somnolence, acting like drunk was recovered on 16May2021, loss of personal independence in daily activities was recovered on 17May2021.    Information on lot/batch number has been requested.
Almost immediate swelling of tongue and face.   Taken to ER for assessment.   Treated with IV methylprednisolone 10:56 AM and IV benadryl 50 mg.  10:53AM Facial edema improved but swallowing became more difficult.  Doctor then ordered epinephrine injection 11:37 AM Nausea continued and promethazine was given IV at 13:51 Symptoms slowly improves and I was discharged to home at 1530
On Sunday (2 days after the Moderna vaccine) I started having ringing in my ears (tinnitis). It continues and it is nearly a week after the vaccination.
Patient came in for her second Pfizer vaccine. Patient started having light-headedness and dizziness. Her BP was normal. Her HR was was elevated between 90-110's.  Pt was given 50mg of Benadryl and attached ER came and got the patient and took to the ER observation and IV fluids.
pt recv vax & devel cellulitis @ the inj site;tx w/augmentin & recovered;
I had the Moderna series to start, then a J&J booster because we thought I the J&J would be easier on me. I had strong reactions, including fever, and chills after the first three shots.I developed mild  granuloma annulare which became worse after each of the covid vaccines. I skipped the 4th dose but decided to get the bivalent booster to protect me from Omicron. My rash had been localized until then and was beginning to fade. A month after the bivalent, the rash progressed and despite efforts to control it with injections and salves, it has become generalized, The condition has caused anxiety and hopelessness. I am considering future treatments which may include immunosuppressant therapy,