chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed Loud Tinnitus after taking Moderna booster.  My first Vaccine was JJ, which was no longer being administered.  My tinnitus which I had for years, exploded into a loud noise a few weeks later.  Unable to sleep, I had to take  medical leave from work.
Patient developed pain, redness, swelling, warmth around the injection site (left deltoid), patient came to urgent care for evaluation on 10/03/19- was prescribed keflex for cellulitis
Rash: itchy, on torso only; pink, raised, some lesions with white scale
On 3/29/21, resident laying in bed and began on convulse . Sent out to ER and DX with new onset seizure disorder,
Temperature excursion occurred; Temperature excursion occurred; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred).    Concomitant medications details were not reported by the reporter.  Reportedly, Temperature excursion occurred on 29-Nov-2022. A total of 16 doses were administered on 29-Nov-2022 (5 doses), 30-Nov-2022 (4 doses), 01-Dec-2022 (2 doses), 02-Dec-2022 (2 doses), 03-Dec-2022 (1 doses) and 05-Dec-2022 (2 doses).  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment details were not reported by the reporter.  The case was for one patient among the two adult patients who received the vaccine on 01-Dec-2022, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-687665 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687665:
12 days after injection, arm became hot, bumpy, swollen, itchy near injection site
Patient developed a red streak 1" wide and 2" long in vicinity of shingles shot. It because itchy and faded over the course of 1 week.
Approximately two days after first shot, he was unable to stand in the Am. He had to crawl to the bathroom. The following day he expressed vision problems. He also experienced fatigue. He was very active for his age, but his loss of energy kept him in his room most of the time (very unlike him.) After the second shot, he expressed chill in his body and stated he was unable to feel warm. The fatigue and chills continued. At approximately four weeks after the second shot, he felt it necessary to try to go outside and do some mild yardwork.  His symptoms continued, so he returned to his room. On April the 3rd he passed away in the AM after I had a brief conversation with him on the phone.
lEFT ARM GOT RED, SWELLING WAS NOTED AS WELL AS THE AREA WAS VERY WARM TO TOUCH. Approximate time after injection to first noted symptom was about 24 hours after. I called and was told to go to an Emergency room. Where I was told to keep an ice pack on the area.
Covid19 breakthrough.  1st vaccine received on 01/22/2021, 2nd on 02/13/2021 and 3rd on 09/24/2021.  74 y/o with PMHx of HTN, GERD, TIA and severly debilitating rheumatoid arthritis. presents to ED after having trouble communication associated with confusion that began 2 days ago.  Pt was first diagnosed with Covid19 on 4/27 and has been asymptomatic.  Pt admitted as TIA workup versus UTI.  No Covid treatment as pt afebrile, room air sat 100% and CXR -no acute process.
Had chest pain, dry heaves, shaking, stomach ache and head ache and dizziness. I waited it out. Felt rotten the rest of the day.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown dates in May 2016 (reported as "on unspecified dates starting on or after 03-MAY-2016"), the patients were vaccinated with an improperly stored doses of GARDASIL 9 injection, lot # L016429, expiry date 09-AUG-2017 and lot # L048237, expiry date 08-MAY-2017 (dose, route of administration and administration site were not specified). Administered doses of GARDASIL 9 underwent temperature excursion at 31 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022; Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Vial expired on 20-Mar-2022 but it was initially stored in the refrigerator on 31MAR 2022 and administered booster dose on 31 MAR 2022.   The vial did not undergo any temperature excursions.  Treatment details were not given.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow up received contains no new information.
This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose and route were not reported) lot # K007264, expiration date 02-MAR-2017 and lot # K007828, expiration date 02-MAR-2017, that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The morning following the vaccine my heart rate was elevated into the 190?s. I went to the emergency Dept where I was seen and advised to follow up with a cardiologist. I did and have been diagnosed with POTS ( Postural Orthostatic tachycardia syndrome ) I am still having an elevated heart rate despite treatment with medication. Prior to receiving the vaccine I did not have any heart issues.
extreme fatigue; nauseated; muscle aches everyway; dizziness; headaches really bad; generalized weakness through out the body and it effected her vision; generalized weakness through out the body and it effected her vision; she was sick for about a week; chills; diarrhea; This is a spontaneous report from a contactable other HCP (nurse) via Pfizer sponsored program. An 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patient has mitral and tricuspid leaky valves and faulty heart valves. Ileostomy s/p large bowel removal and clotting problems that patient took Eliquis for this. Patient also has Lupus, Rheumatoid Arthritis, a pacemaker and patient was being watched closely for a blood cancer. Blood cancer runs in patient family. The patient's concomitant medications were not reported. Patient previously took Eliquis for clotting problems. On an unspecified date, patient experienced extreme fatigue, nauseated, muscle aches everyway, dizziness, headaches really bad, and generalized weakness through out the body and it affected her vision, patient was sick for about a week, Felt like patient was going to die, also chills and diarrhea. Reporter further wanted to know that there was any chance that this cardiac inflammation, listed in the possible side effects, could be exacerbated by the fact that patient has the 2 leaky valves? Patient was afraid to get the second dose because they have heard the second dose was worse than the first. Therapeutic measures were taken as a result of events experienced. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
mom reported that client's temperature kept going up (up to 102.3) with no relief from antipyretics. Had given Tylenol around 05:00, tried lukewarm bath and temp kept going up - mom took child to ER where they gave her Motrin for the temp and observed for a couple of hours. client's temp went down and mom reported that temp was totally gone by Tuesday and child was back to normal.
1st dose: fatigue, slight headache, pain in left arm. during arm circles, would be pain during movement pain for a day or two. Took Tylenol 2 tablets 500mg each on the night of the vaccine.    2nd dose: received vaccine at 5pm, during night of vaccine day, got a fever and headache and chills. flu-like symptoms for 24 hours. fever of 101F. soreness of muscles. on second day, fever was almost gone. lasted 2 days total. most severe symptoms on first day. Took Tylenol 2 tablets 500mg in the morning, 2 tablets 500mg in the evening. Took 1 tablet of Advil 200mg on day 2.
Heart rate went up and my lips, tongue and throat started swelling" I took  3 Benadryl  and had taken Allegra that morning. It seemed to work and the swelling went down.  Bad back pain, arm pain headache, general muscle aches, fatigue and my grip strength is very weak
DTaP was given at the Department of health on 12/3/19. Patient presented to our office (PCP- 12/5/19). Mom noticed patient had a rash under the injection site this am (12/5/19), which was growing in size as the day went on. Mom states site felt firm and warm to the touch. Mom states patient was complaining of some itchiness as well.  Site was red and warm to the touch in our office. Site measured 0.5" under injection site, 35" in length, 25" in width. Patient was diagnosed with cellulitis of the left upper arm and started on Cephalexin for 10 days.
DIZZINESS; VOMITING; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; NAUSEA; IN BED X 3 DAYS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 subject experienced dizziness, vomiting, fever, muscle aches, headache, fatigue, nausea, and in bed x 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, vomiting, fever, muscle aches, headache, fatigue, nausea, and in bed x 3 days. This report was non-serious.
Resident was found on floor, less responsive with mental status change at 1800.  Last known well was 1730.  Transferred from location to local ER by ambulance.    CTA head and neck, CT brain perfusion with focal occlusion of right M1 cerebral artery with large right MCA territory stroke, left frontal scalp hematoma with underlying calvarial fracture.  Case was discussed with neurology, patient's family, decision was to proceed with comfort measures.  Family reported that she would intermittently open her eyes, appears to have recognize family members, would make few words but then she goes back to sleeping.
Gastrointestinal symptoms, emesis, diarrhea, fever to 101 (rectal) lasting 3-4 days.
Onset VARICELLA vesicles symptoms started 8/29/09.  Treatment supportive - over the counter medications.
Overwhelming severe pain systemically in joints and muscles on the night of 3/20 that continues to a lesser degree and off and on since the initial several hours.   If it had gone on for much longer I would have had to go the the hospital.  The level of pain was terrifying....and lest you think it's just that I can't handle pain, I've given birth to 5 children without any pain mediation whatsoever.  I am still in the depths of an autoimmune flair-up where severe pain in my joints and muscles occur.  I continue to feel significant fatigue.  I also continue to experience some level of "brain fog" (the inability to follow though streams for long, read more than a few sentences at a time, inability to stay mentally organized).   Mild nausea and inability to digest well continues since the day of the vaccine 3/15.
This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product administration (received the second dose of vaccine when it is outside of recommended timeframe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (received the second dose of vaccine when it is outside of recommended timeframe). At the time of the report, inappropriate schedule of product administration (received the second dose of vaccine when it is outside of recommended timeframe) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Patient to ED from home 5/26 via EMS with complaints of nausea and diarrhea x years. Patient has history of GERD. Patient denies any abdominal pain and tests positive for COVID. Patient's SpO2 noted to drop to 88-89% on room air when patient is talking. Patient placed on 3L NC O2. Increasing short of breath with diarrhea, vomiting, nauseated.  No double vision, blurred vision.  Negative for upper or lower GI bleeding. The rest of the exam was in HPI, otherwise negative. The patient seems dehydrated and fatigued.  The patient was put on isolation and started supportive treatment including steroid, breathing treatment, oxygen with Pulmonary and ID consult. Discharged to group home on 5/28.
Increased Heart palpitations, feeling of chest tightness, tightness In heart, pain/squeezing in heart, shortness of breath and slight vertigo. Symptoms increase when I take my Buspar or medical marijuana
How long will muscle pain last after do you have the vaccine?; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (1st dose received in December 2019, refer case US2020AMR069288).   On 21st April 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than a week after receiving Shingrix, the patient experienced myalgia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient asked how long would the muscle pain last after do you have the vaccine.
A report was received from a health care professional on 10/17/2003 concerning a 63 year old female vaccinee who experienced a red swollen rash on the same day as receiving expired Fluvirin on 10/15/2003. The rash was approximately 30 mm wide. The rash appeared to have stabilized on 10/16/2003. The out come was not reported. Update 1, 2/5/2004: A follow up report was received from a health care professional indicating that the vaccinee's red, swollen rash developed on 10/16/2003 and had completely resolved on 10/27/2003. The reporter assessed the causality as unrelated. No follow up pending all information received.
After the my Jannsen vaccine on 04/09,  the pain at my injection site slowly increased (getting worse every few days) until the reaction on 4/26-4/27. In the middle of the night 11-12 (4/26) my arm began to hurt to the point on near incapacitation. The pain radiated from the injection site down to my fingertips. Upon the next morning I began to loose use of my left hand and became shift in the same arm (left side where I was vaccinated). My hand became numb, loading some color, and almost entirely without use.  Upon going to urgent care, they were concerned I had a blood clot and sent me to Hospital. The hospital denied to file my case as a vaccine related incident, because I was not found to have a blood clot. Sensation and movement returned to my arm progressively on 4/28. Tender maintained for 2-3 days.
H/A, fever, body aches, chills, sore throat and rt-sided chest pain the day after receiving the vaccine on 6/17/2021
Pt felt faint while seated after HPV and Hep A vaccine and mom reports eyes rolled back and he slid off the chair to the side, hitting his right side and head, though not hard per mom. She called for help and the MA went in and I was right behind her. We got him moved to a supine position on the table with close observation and he was talking/ appropriate during this time. His color came back. No HA or dizziness. Pt remained supine for 10-15 min and was doing very well. Mom to watch for any signs of concussion ie. HA, dizziness/ fogginess.
On 8/6/2021 at about 7:00 PM, I noticed I had hives and itching. The hives were on my legs and bikini line, but the itching was all over my body. I also began having esophageal swelling and acid reflux that night. The hives and itching lasted about 4-5 days. After the hives finally went away, I then had itchy, red blotches all over my body; the esophageal swelling and acid reflux continued at this time. At around the time the blotches appeared, I began experiencing severe achiness in my wrists, knees, ankles, and feet. The joints aches lasted about 3 days, but after they went away, the blotches, itchiness, esophageal swelling, and acid reflux still persisted. About a week and a half after their onset, the blotches finally went away. However, I would still get itchy areas, and when I scratched them, they became red and inflamed. This still takes place once or twice a day, but it's now localized to just my back. On 8/10/2021, I went to see a PA, at a HCF. She had me do an autoimmune panel, and no autoimmune disorders were detected. She held off on prescribing steroids, as I was still nursing my son. Instead, she recommended that I continue taking OTC Zyrtec for relief. On 8/16/2021, I saw another dr. That dr. gave me a solu medrol injection, which really helped. She also gave me a GI cocktail, and I noticed a marked improvement in my acid reflux the following day. She also prescribed me sucralfate for acid reflux and recommended that I consult with an allergist before getting a second dose of Moderna. 8/24/2021 was the first day I had real relief from acid reflux and didn't have to take sucralfate. At this time, my symptoms have improved markedly, though I still have some itchiness on my back and some acid reflux.
Severe Arm pain within a few hours of the injection. Rated as a 10/10. 7/10 with Pain meds. No redness at site, no shoulder pain or tenderness. Treated with ice and pain medication.
expired VAQTA administered; This spontaneous report was received from an office manager, via company representative and  refers to a 1 year old female patient. No information given received regarding the patient's concurrent conditions, concomitant medications or medical history.     On 22-JUL-2020, the patient was vaccinated with an expired dose of  hepatitis a vaccine, inactivated(VAQTA), with expiration date on 11-JUL-2020, intramuscular for prophylaxis (dose and lot number were not reported). No product quality issue was reported.  This is one of two reports from the same reporter.
Information has been received from a medical assistant concerning an 8 month old male who on 20-APR-2009 was vaccinated orally with first dose of ROTATEQ (lot number reported as "657360/0508U").  No adverse symptoms reported.  It was not specified if the patient sought medical attention.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown), in left arm, on 05Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Celebrex, reaction: "Known allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive; (Nov2022) Negative, notes: testing negative last week. Therapeutic measures were taken as a result of covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Day after vaccine was administrated the area became red, swollen to the size of palm, hard & painful.  Denied fever.  2 days following area was white with a red ring.  Today symptoms resolved.  Mom treated with cool compresses.