chrisvoncsefalvay/vaers-outcomes huggingface dataset:
softball size welt at the injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site wheal in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 1st October 2020, the patient received FluLaval Tetra 2020-2021 season. On 2nd October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced injection site wheal. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site wheal was unknown.   The reporter considered the injection site wheal to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The  Sales representative called response center to report an adverse event.  The reporter was a pharmacy technician at a hospital.  The pharmacy technician reports that the patient received Flulaval shot and had a softball size welt at the injection site.  It was being treated with a cold compress and ibuprofen.  Reporter provided limited information.  The reporter did not had the patient date of birth in front of her but estimates that she is about 25 years old.   No further details were reported such as lot number or injection site. The reporter provided limited information.
the vaccination site is hot, swollen, red and itchy.   It has continued for several days.
Received vaccine in right arm during skin allergy test. Reaction began with second test at 1:10000 ratio of vaccine. Reaction included numbness in right rear of tongue approx 10 mins after administration of test. 13 mins after next test of 1:000 ratio the numbness spread to entire right side of tongue and part of upper right throat. Symptoms continued to persist during 1:100 ratio test, finally tests stopped and numbing subsided.
Chills, fever, aches-lasted throughout the day and into that evening. Took ibuprofen all day long.
nausea; body aches; black stool; This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received Shingrix. On 7th August 2020, 1 days after receiving Shingrix, the patient experienced nausea, general body pain and black stools. On an unknown date, the outcome of the nausea and general body pain were recovering/resolving and the outcome of the black stools was not recovered/not resolved.   It was unknown if the reporter considered the nausea, general body pain and black stools to be related to Shingrix.  Additional information was received as follows: The patient experienced nausea, general body pain and black stools. At the time of reporting, nausea and body aches had improved but the black stool had not. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a currently 74 year old patient of unknown gender. On an unknown date the patient received a dose of improperly stored ZOSTAVAX (lot# not reported, dose 0.65 ml, subcutaneous), exposed to 32.3F for 70 hours. Concomitant medications were not provided. No adverse effects were reported. This is one of two repors received from the same reporter (other MARRS# 1409USA009346). Additional information has been requested.
Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022; Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information of the seventh patient out of 12 patients who received the vaccine on Jul-2022 as described by the reporter.  No concomitant medication information was provided.  Number of patients who received the vaccine beyond usage date were 12 patients.  Number of doses/vials that were affected were 3 vials and 12 doses.  The vial was initially stored in the refrigerator on 13-Jun-2022.  The number of patients who received the vaccine on 16-Jul-2022 was 3, the number of patients who received the vaccine on 23-Jul-2022 was 5 and the number of patients who received the vaccine on 24-Jul-2022 was 4.  The vial did not undergo any temperature excursion.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Live Follow Up received, reporter details and narrative updated.
fever to 103.8 R for 4 days; red, blotchy rash for 4 days; middle ear fluid; seen by MD for ear infect;
sore arm; felt the best I've felt in a long time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (Comirnaty-COVID 19 Vaccine, mRNA-Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPRIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "felt the best I've felt in a long time".  Additional information: Caller states he experienced a sore arm with first and second dose of Pfizer BioNTech Covid-19 Vaccine, had no fever, and felt the best I've felt in a long time after getting both doses. Caller stated he was a 74 year old male who received his second dose of the Pfizer BioNTech Covid-19 Vaccine 6 months ago. Caller states he was planning on getting the booster dose of the Pfizer BioNTech Covid-19 Vaccine but he takes an 81mg aspirin 6 days a week. Caller asking if he should discontinue the aspirin for any particular amount of time prior to getting the booster dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24-SEP-2021): New information received from a Pfizer-sponsored from a contactable consumer reported that includes HCP details, Products details, Verbatim and Event Description.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Arm soreness, injection site hot to touch, fever of 102, chills, sweats, headache, body aches, lethargy. lack of appetite.
p/vax pt c/o itching at inj site; scratches at site often; 1wk later site reddened & warm to touch; inj site crusty & hardened; referred to PMD however unable to do, leaving town
Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-162163 (Patient Link).; 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.
Symptoms: Redness & swelling. Treatment: Applying an ice pack or massaging  with a cold cloth.
Chills (lasting 4 hours) Body aches (over 12 hours) Headache (over 18 hours) Upset Stomach (12 hours) 100 degree temp ( 4 hours)
Patient received 0.2 ml of undiluted pediatric Pfizer vaccine to her left deltoid at 10:50am 6/5/22  No adverse event noted at the time pharmacist informed mother 12:30 pm 6/5/22
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown ages and gender. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (strength, dose, route and lots unkbown) and a dose of (Oka/Merck) VARIVAX (strength, dose, route and lot # unknown) which were improperly stored. No adverse effects reported. Additional information has been requested,
Local erythema and swelling of left arm.  Some irritability, tactile fever, decreased appetite.
On 10-4-12 pt seen for ataxia & double vision. Pt admitted to hospital initial Dx of cerebellitis. Pt worsened, readmitted now with Dx of Myoclonus-opsoclonus ataxia. Pt is profoundly impaired and her prognosis is very uncertain.
I had normal after-effects post shot (slight redness and soreness at injection site) which went away after about a day and a half. But a new, moderatley more severe rash at site was noticed in shower 7 days later, and has subsequently gotten a tad worse.  Probable case of cutaneous hypersensitivity/"Covid Arm" . Patient slightly concerned and seeks advice on matter.  Not painful, no real itch to speak of yet.  No loss of any motor control, no other symptoms (ie. muscle spasms, nausea, headache, etc.)
Tingling in hands and feet as well as face. Hearing loss in right ear and a locked jaw for 48 hours after receiving vaccine. Also, patient reports distressed breathing.
In 1997 the pt was vaccinated with varicella vaccine. On 2/24/00, the pt developed chicken pox. The reporter noted 2 lesions on his chest, 8 on the back and 2 on the right leg. One lesion on the back is blistered. All lesions are small and very red. The pt sought unspecified medical treatment. Additional information has been requested. Follow up states the patient had 10-11 papular lesions scatters over his body with 1-2 lesions that were fluid filled. The patient developed other symptoms with this event. On approximately 02/24/2000 the patient recovered. No futher information is available.
Breakthrough COVID-19 case with symptom onset 8/28/2021: Aches, Nausea/Vomiting, Fatigue or tiredness. pt is still hospitalized as of 9/10 for COVID sx @ Hospital since 9/5 when she was admitted to ICU, pt dx covid pneumonia, rx antibiotics, not on oxygen.
got my vaccine yesterday/did have an allergy; my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot; my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included severe leg cramps. Concomitant medication included gabapentin. The patient previously took tetanus shot (TETANUS VACCINE) and flu shot (FLU VACCINE) on an unspecified date (reported as November) for immunisation. The patient verbalized, "I just wanted to make sure that this is normal. I got my vaccine yesterday. I waited for 30 minutes because I did have an allergy (further clarification was unknown, hence captured as event), to make sure everything was okay. Nothing happened but after I got home within 2 hours my shoulder down to my elbow it is very sore and swollen. It is very sore and swollen for some days but it is just in the area where they gave the shot. So, I just want to make sure that it's normal." When asked about the treatment, the patient stated, "No I did not I thought about taking some Aleve or whatever but my husband and I decided to wait till this morning and call to see that if it is normal like I said like a tetanus shot or flu shot. I am very sore in that area about 5 days but this was little different that it swelled from my shoulder to my elbow. I do not feel sick, I am not dizzy, and I am not short of breath. I read everything that they ask that they said you have a concern to call." Clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
passed away; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The reporter felt people will get healthier with their own immune systems and that Covid was a cover up. She knew people that have died after getting vaccinated and the CDC had changed their guidelines many times now. She read if 50% were vaccinated and the other half combined with the virus but now that had changed to 70%. The body had been proven for antibodies to work and it's no different than the flu shot. The reporter had a 16 year old girl come to her door today letting her know that her neighbor passed away and she asked the 16-year-old if she could hug her and the little girl said "yes I've been vaccinated". It was unknown if autopsy was performed. Outcome of the event was fatal.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
fever 99.2, Redness around injection site right thigh area, warm to touch. Tx-Infant TYLENOL liquid, Hydrocortizone 0.5% 2x a day for few days
indurated, tender ares 2" below head of humerus 1" x 3/4" oval;sore to touch 2-3d;indurated area grown;simple axilla lymph node;
Vomiting 4 hour and 6 minutes after shot, 5 times in an hour.  Next day flu symptoms started.  Slight fever, chills, nausea, fatigue, coughing, congestion, some diarrhea.  Symptoms continuing, starting to get better, today 9/19/21.  11 days.  Have needed to take Mucinex DM, pseudoephedine, zyrtec, pepto bismol.
GAINED 50-60 POUNDS OF WATER COULDN'T FIT INTO PANTS CLOTHES; LEGS GOT STIFF AND HARD; SKIN BAD ON LEGS; LEG STILL HORRIBLE STILL SWELLED UP; IN STOMACH HAD SOMETHING SIZE OF SOFTBALL; This spontaneous report received from a patient concerned a 66 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: 1805025, and expiry: UNKNWON) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced gained 50-60 pounds of water couldn't fit into pants clothes, legs got stiff and hard, skin bad on legs, leg still horrible still swelled up, and in stomach had something size of softball. Treatment medications (dates unspecified) included: torasemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gained 50-60 pounds of water couldn't fit into pants clothes, legs got stiff and hard, skin bad on legs, leg still horrible still swelled up, and in stomach had something size of softball. This report was non-serious.
Day of shot (3/31/21) patient had sore arm, then it went away. On 4/9/21, sore arm came back and it became warm and rash developed. On 4/11/21, arm was still warm, but less than before, and rash still present.
Two days after my second dose of the Moderna Covid-19 vaccine I developed painful vulvar aphthous ulcers. I was not sexually active at the time of, or time period before receiving the vaccine dose. I had never experienced these symptoms before. Two days after the onset of symptoms I visited my university's health clinic where I was examined. (5/3) The PA & RN were unable to identify my lesions as recognizable symptoms of an STD or STI but tested me anyways (was negative for everything.) They both commented that they had never seen vaginal lesions like this before, and the PA worked in sexual healthcare at a planned parenthood. I was sent home with instructions to apply Aquaphor and to avoid abrasive contact with clothing at the site of the ulcers. Symptoms peaked four days after onset and then began healing, completely resolving in about 10 days. I was seen as a follow up three days after my initial visit to confirm healing. (5/7) My mother has a history of developing similar vulvar ulcers when she was in her 20s & 30s in conjunction with viral infections (is considered to be a rare, non-descript, auto-immune response). My doctor therefore concluded that this was likely a symptom of an immune response to the vaccine. After my booster (Moderna) I developed similar ulcers, but there were less of them, they healed faster, and were less painful. I believe my experience is in line with what has been reported in studies:
Injection site on left deltoid itchy and warm to the touch. Injection done on 10/1/18. Symptoms started 10/2/18. Patient treated with KEFLEX and MEDROL pack.
6 months post vaccination I began to have left hip pain.  The hip pain resulted in my ball and socket deteriorating.  I also had an extreme arthritis event.   I have never had any arthritis issues prior to the vaccine.  I was a healthy individual prior to the vaccine.  I was exercising frequently and eating healthy.  Exactly 6 months after the vaccine, I am disabled by losing my hip joint and extreme pain associated with swelling joints  throughout my body.
Tardive Dyskinesia an hour after 2nd shot/Tardive Dyskinesia has gotten worst about 4 weeks after the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of TARDIVE DYSKINESIA (Tardive Dyskinesia an hour after 2nd shot/Tardive Dyskinesia has gotten worst about 4 weeks after the 2nd shot) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 042J21A and 028?21A) for COVID-19 vaccination.     Concurrent medical conditions included Schizophrenia. Concomitant products included ARIPIPRAZOLE (ABILIFY) and LITHIUM for an unknown indication.   On 06-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, the patient experienced TARDIVE DYSKINESIA (Tardive Dyskinesia an hour after 2nd shot/Tardive Dyskinesia has gotten worst about 4 weeks after the 2nd shot) (seriousness criterion medically significant). At the time of the report, TARDIVE DYSKINESIA (Tardive Dyskinesia an hour after 2nd shot/Tardive Dyskinesia has gotten worst about 4 weeks after the 2nd shot) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by reporter.  An hour after the 2nd Shot, he started having Tardive Dyskinesia and it was still going on. Today 07 Mar 2022, about 4 weeks after the 2nd shot, the Tardive Dyskinesia had gotten worst.  Treatment information was not provided.  Company Comment:This spontaneous case concerns a 31-year-old, male patient with ongoing medication of anti-psychotic drug Aripiprazole (Abilify), who experienced the unexpected, serious (medically significant) event of Tardive dyskinesia. The event was reported to have started an hour after receiving the second dose of mRNA-1273 vaccine and worsened 4 weeks post-vaccination. Use of the anti-psychotic drug Aripiprazole, although treatment duration was not provided, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 31-year-old, male patient with ongoing medication of anti-psychotic drug Aripiprazole (Abilify), who experienced the unexpected, serious (medically significant) event of Tardive dyskinesia. The event was reported to have started an hour after receiving the second dose of mRNA-1273 vaccine and worsened 4 weeks post-vaccination. Use of the anti-psychotic drug Aripiprazole, although treatment duration was not provided, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.