chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Still got them; Pain; Got the shot and still got them/Suspected Vaccination Failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and still got them/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got them) (serious criteria hospitalization) and pain (Verbatim: Pain) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient interactive digital media. The patient had shingles and the medication put him/her in the hospital. The patient was still suffering from pain and it was been a year. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Hospitalization criteria was captured conservatively.
Ringing in ears worsened; Migraine Worsened; This is a spontaneous report from a contactable consumer or other non-healthcare profession (patient reported for herself). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 13:35 (at the age of 65-year-old) as dose 1, single for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing, tinnitus from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing, spinal fusion surgery from Oct2020 to an unknown date. Investigation Assessment was reported as yes. There were no concomitant medications. On 12Feb2021, the patient experienced ringing in ears worsened, migraine worsened. Can the COVID vaccine make tinnitus worse and how long will the symptoms last. Caller reported that she received her first dose of the covid vaccine on Thursday, on 11Feb2021 and then started to experience worsening ringing in her ears and a migraine. She asked if this was normal and if the vaccine can make tinnitus worse and how long the symptoms will last. Caller was a consumer, asking, are the first and second dose the same and do you have to get the second vaccine for it to work. She was calling about the Covid Vaccine, she was having really bad ringing in the ears and migraines, she noticed it got worse after she got the vaccine. She got the first dose on 11Feb2021 Thursday and noticed that it was worse since she got the vaccine. Caller clarifies that her First dose was on 11Feb2021 Thursday and she got the vaccine at like 1:35PM, she explains that she has always had ringing in the ears, but it got worse on Friday 12Feb2021. She also explains that she has always had migraines, however that also worsened along the same time. Caller stated that the ringing was really loud right now. Caller stated that the Expiry was not written on her card, but when she had a conversation with the nurse, she thinks she said it was good for 6 months. The hearing test was maybe in Sep2020 or around that, she was recently fitted with a hearing aid. Caller apologizes for speaking over this call handler, stating that if she does not continue to talk, she loses her train of thought. The patient underwent lab tests and procedures which included acoustic stimulation tests: fitted with a hearing aid on an unspecified date in Sep2020. No product quality complaint was reported. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old male. 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: 1808980, expiry: UNKNOWN) dose was not reported, 1 total administered for left arm on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JAN-2022, the patient experienced headache, nasal congestion (suspected covid-19 infection) On 18-JAN-2022, the patient tested positive for Covid-19 with an Abbot home kit test (suspected clinical vaccination failure).The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.; Sender's Comments: V0: 20220140177-JANSSEN COVID-19 VACCINE Ad26.COV2.S- SUSPECTED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Within a few weeks of the second dose (1/13/2021) - starting about 2/3/2021 - began having recurrent episodes of wheezing & night-time cough (Asthma/reactive airway symptoms). This has occurred for 1-2 weeks every other month. I have never had this issue before the vaccine. It lasts about 2 weeks and required me to treat it with breathing treatments.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On 23-MAY-2017, the patients was vaccinated with improperly stored doses of PEDVAXHIB injection (lot # M045206, expiry date 27-JUN-2019, dose, site and route of administration were not provided). Sterile diluent used for vaccines reconstitution was properly stored. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 24 hours. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA012848.
Pt w/ hx of allergy to amoxicillin (unknown rxn).  Pt c/o flushing/sweating, feeling tired, "head heavy", and right sided tiredness.  BP 120/71, HR 80, RR 16.  Pt stable and released from the vaccination site.
non-necrotizing (M-type) skin granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to an 11 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced non-necrotizing (M-type) skin granuloma. Skin biopsy of right index finger was positive for iVDRV, M-type granuloma. At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (MARRS 2201USA004372, 2202USA004885, 2202USA004886, 2202USA004887 and 2202USA004888).; Sender's Comments:  US-009507513-2201USA004372:
Received dose from temperature excursion vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029a21a and 013m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 07-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial). On 07-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from temperature excursion vial) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs.
Seemed to acutely develop PMR 10/12. Had been having bilateral groin pain from his hips 8/8, and clearly has significant DJD on plain films, but never had pain before, and the groin pain resolves almost instantly with steroids. Timeline below:  8/5 drove 7 hours to beach in DE, they think he felt fine. 8/8 BL groin pain starts, possibly related to a short jog as he never does. 8/14 drove home. Doesn?t recall much pain. 9/3 you thought maybe R ing. hernia 9/7 had both hips injected. Amazing result, pain free. 9/15 PT visit restarted the  BL groin pain 9/22 Pfizer COVID booster. 9/30 saw ortho, said consider hip replacements. 2nd opinion said a bit odd for DJD Sx to start so acutely, but possible. 10/2 started meloxicam 15, helped a little 10/6 started prednisone 30 taper?pain free. 10/11 took last prednisone 5 mg, went to mountains, pain free, good enough to carry suitcases up 3 flights? 10/11 R CTS began, likely from carrying luggage, severe, sees provider Tuesday. Splint helps. Felt feverish that night only. Mild anorexia but no HA/dizziness/URI Sx/CP/SOB/abd pain/N/V/D/GU Sx/back pain/rash. No tick bites. 10/12 in addition to the BL groin pain, started with the neck pain and stiffness, both shoulders stiff and hurt, both hands feel ?weak? and painful PIP joints sparing L thumb (almost certainly R CTS but had L CT release in past), both thighs and knees hurt. No red/warm/swollen joints. Sx so bad he didn?t even go out with friends for dinner and he?s usually the life of the party. 10/13 started Motrin 800 bid, helpful. 10/16 flu shot 10/18 Needed to go to ED as couldn't walk. Started on steroids. Doing better now on high dose steroids. Seeing optho next week to r/o GCA.
Experienced all symptoms that occured for my actual covid disease.  These include dizziness, aches in joints and muscles, extreme chills, injection site soreness(4-5 days), headache, complete lack of appetite and overall weakness.  All symptoms lasted for approximately 36 hours.
Fatigue; Muscle pain; Headache; Fever; Chills; Joint pain; Nausea; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle pain), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has been using Antihistaminic ( every morning) , Annihilator and vitamins as a concomitant medication.  As treatment the AEs patient took Advil.  Action taken with mRNA-123 is not applicable.
Pediatric patient  was given an adult dose of Hep A vaccine 1.0 mg instead of the 0.5 mg recommended by GSK
Pt was exposed by daughter she lives with.  She has symptoms of palpitations, headache, and sore throat.  She was admitted with acute hypoxic respiratory failure with atrial fibrillation with RVR.
Pt seen on 2/23/09. Complaining of Hx of itching started after given her MENACTRA,/Tdap/Varicella vaccine about 315pm 2/19/09 and at home 715pm started hives on and off - No SOB- No wheezing x 3 days. Seen on 2/23/09 with 2 hives on back-No other symptoms. Pt was given BENADRYL tabs Q6 PRN
Developed a mild case of hives.  Had 3 hives on my chest and stomach, 5 on my back, 1 on my hip and 2 on my thighs.  Took Benadryl for them and after about 48 hours they disappeared.  I had not eaten anything new nor been exposed to or used any new products other than the Covid vaccine.
Information has been received from a 24 year old female with no drug reactions or allergies and no pertinent medical history who on 07-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. The patient reported that she was pregnant when she received her first injection of Gardasil. The patient reported that she did have an appointment with OB/GYN and the physician did not hear a heartbeat and she was therefore being referred for an ultrasound. The patient stated that her physician advised her to continue the injections with Gardasil, but the patient decided not to get the other two shots. Upon internal review it was determined that "physician did not hear a heartbeat" was considered an other important medical event. Additional information has been requested.
No adverse event. Pt received duplicate immunization. She had received Influenza FLUZONE QUAD vaccine on 10/31/19. Lot UI998AC.
MILD ACHINESS; This spontaneous report received from a patient concerned a male 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced mild achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild achiness on 09-APR-2021. This report was non-serious. This case, from the same reporter is linked to .
BODY ACHES; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a male 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue, fever, body aches and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210336193.
SEVERE MIGRAINE; LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included arterial venous malformation in brain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: MVX1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced leg pain. On 14-MAR-2021, the subject experienced severe migraine. Laboratory data included: CT scan (NR: not provided) arterial venous malformation in brain, details of scan unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine, and leg pain. This report was non-serious.
Temp of 103 deg F next day. Controlled with Tylenol and Motrin for 3 days. Lethargic and sleeping 3 days.
Immediately after vaccine In about 12 hours, I experienced chills and probably mild fever for about 8-10 hours. The next day I was fine. My arm was sore - for probably a day (24 hours) - it lessened through the 24 period. I felt, in the latter part of March, a protrusion - a hard sort of lump in the area that I had had the cancer before. I noticed it in the shower. I thought it was a lymph node from the vaccine but after two weeks, I went in to get it checked. I had a biopsy and there were two lumps; surgery then on June 1st. I started radiation treatment on July 13th -set up was before that and I am almost done tomorrow is my last big one and then 5 more boosts into incision site. I am burned to a crisp. I could die from the treatment. I am hoping that it will help me get rid of the stray cancer cells. My skin is starting to open up (yesterday) - I am using lots of creams and Aloe Vera. It will take a while to get back to normal. I am hoping it stays. Four years ago, I didn't get any burn.
could not work; back was so sore I could not be comfortable.; tired; injection site; right deltoid, was very sore.; muscles of my legs and back started to feel sore.; The muscles of my legs and back started to feel sore; This case was reported by a consumer and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 1st dose of Shingrix. On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, myalgia of lower extremities and back pain. On 3rd November 2020, the patient experienced discomfort, tiredness and impaired work ability. On 5th November 2020, the outcome of the impaired work ability was recovered/resolved. On an unknown date, the outcome of the injection site pain and discomfort were recovering/resolving and the outcome of the myalgia of lower extremities, back pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, myalgia of lower extremities, back pain, discomfort, tiredness and impaired work ability to be related to Shingrix.  Additional details were reported as follows: The patient himself had reported this case. The patient had received 1st dose of Shingrix vaccine and by that night  the injection site at right deltoid was very sore. The patient said that the muscles of his leg and back started to felt sore. On 3rd November 2020, the symptoms both the injection site and all muscles were worse and muscle were so sore, like when he got a Flu. The patient described that his back was so sore that he could not be comfortable and he could not work and was tired. The patient reported the symptoms were much better on 4th November 2020 and he was able to work. On 5th November 2020, the day of reporting, the patient said that  symptoms were much better and were nearly gone. The patient enquired that were his symptoms normal and was there a patient brochure that educated and warns people of the possible side effects. The reporter was requesting to follow up.
Information has been received from a physician concerning a 5-year-old patient who on 19-MAR-2002 was vaccinated with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck) (lot# 638495/1904X). On 11-FEB-2007 the patient experienced a break through case of chicken pox. On an unspecified date, the patient was seen at an urgent care facility and was diagnosed with chickenpox. No further action was to be taken. The patient provided date-stamped photographic evidence of chickenpox. The patient was not sent for ser-testing. No further action was to be taken. Subsequently, it is reported that the patient recovered from chicken pox. No product quality complaint was involved. No further information is expected.
Twinrix vaccine administered on 4/28/06-reports very large bruise deltoid (R) muscle times 2-3 weeks. Also reports numbness 4 fingers (R) that still remains but has improved. Still c/o numbness in fingers-encouraged client to see MD. Bruising resolving/client stopped taking ASA.
Site: Itching at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Nausea-Medium
Pharmacy student gave flu shot in my presence (Student is certified through APhA.  I verified the quantity given as 0.5ml and pt. was asked prescreening questions and nothing stood out as a problem.  Pt. did have a cold and was coughing a bit but nothing seemed abnormal.  Shot was given and patient was in our presence for about 10 minutes then went to talk to another clinic associate and was counseled to let us know if she had any problems before she left talking to that person (we estimated this would take at least 5 minutes to finish out the 15 minute observation period).  Pt. did not get the H1N1 last year, but has received the flu shot multiple times in the past. She came back to the pharmacy window 30 minutes after the shot was given saying that should couldn't breath and was obviously under distress.  She was rushed back to the the treatment room here at our clinic and was administered diphenhydramine 50mg IM, solu-medrol 125mg IM, 0.3mg epinephrine IM, and albuterol nebulization with 2 liters of O2.  An ambulance was called and she was shipped to Medical Center for observation.  When she left in the ambulance she was doing much better.  It appears to have been an anaphylactic reaction but there may have been some anxiety involved.  The clinic course at medical center is unknown at this time.