chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of tremor muscle in a 61-year-old male patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. Co-suspect products included FLUCELVAX for prophylaxis. On 6th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and FLUCELVAX. In October 2018, 3 days after receiving SHINGRIX, the patient experienced tremor muscle. In October 2018, the outcome of the tremor muscle was recovered/resolved. It was unknown if the reporter considered the tremor muscle to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient experienced muscle tremors all over his body that lasted approximately 30 minutes. In October 2018, 3 days after receiving FLUCELVAX, the patient experienced tremor muscle.
Child stood still.  Child's eyes went back into her head.  Seizure lasted about 25 seconds.  Doctor said to watch for reoccurrence.
Pt recvd 3 doses of Engerix-B 31AUG89, 16OCT89, 22FEB90 & p/1 yr titer=9; 4th dose of Engerix-B was given on 18APR91 pt seroconverted p/4th dose titer=60;
On Wednesday afternoon she had a fever of 103, was very fatigued.  Got up in the middle of the night and had dry heaves, went back to bed and was okay.  Her arm got really red, hot and blisters all over it like a sunburn.  It is down to about the size of a half dollar today.  The blisters burst and have made places, is still warm and sore and looks like it is drying up.  Did look like a severe sunburn.  She ran a little fever until Thursday night 2/18/21.  The arm is still sore to touch today, 2/22/21.  She took some Tylenol the night her fever was 103, then it went to 101.   The fatigue is diminishing, she has slept a lot, but wonders if her arm is ever going to be right.
Currently the patient is not experiencing signs or symptoms. Patient received 1mL dose of Moderna for their first dose instead of the recommended 0.5mL dose.
Patient developed acute coronary syndrome, ST-elevation myocardial infarction, and ventricular fibrillation cardiac arrest on April 9, 2021.  He had no prior history of coronary artery disease.
Even with the shot, you can get it again, but it won't be as bad/ Suspected vaccination failure; Even with the shot, you can get it again, but it won't be as bad; still have the pain a year later / is the most painful thing I have ever had / so painful; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient stated that if you have chickenpox, then you have virus in you that's what comes out later as shingles. It was so painful more than a chickenpox. The patient stated that he/she had been on medication for a year and still had a pain. Side effects were not good. The patient tried to take less medications. The patient stated that event after receiving shot you can get the shingles but it won't be as bad. The patient was on Gemopatin and did not like side effects. The patient still had a pain a year later. The patient stated that it was most painful thing he/she ever had. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. No other information was reported. The follow-up would not possible, as no contact details were available. The events weight gain, muscle loss, dizziness, balance and its driving him/her crazy was captured only in narrative since it was seems to be developed after medication which was taken in past.
On 4/6/ 21 patient had an appointment at my office and  I noticed Leukopenia and elevated liver enzymes. Patient was with severe weakness, abdominal pain, ictericia and was referred to a GI doctor and Hematooncologist. She had an schedule vacation to and was hospitalized for hemolytic anemia and Hemato ocologist told her it was secondary to the covid vaccine.
PT states Saturday morning she started feeling lethargic, weak, she had nightmares, high pulse rate, chills and diarrhea. Pt states she spent two days in bed because she couldn't function. She also states she had muscle pain in opposite shoulder as well as the arm the vaccine was given along with redness and swelling.
severe pain in the right arm; The injection site area  looks  kind of "sunken" in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in the right arm) and VACCINATION SITE REACTION (The injection site area  looks  kind of "sunken" in the muscle) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (severe pain in the right arm) and VACCINATION SITE REACTION (The injection site area  looks  kind of "sunken" in the muscle). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (severe pain in the right arm) and VACCINATION SITE REACTION (The injection site area  looks  kind of "sunken" in the muscle) outcome was unknown.            Other treatment medications included steroids and psicotherapy.  Concomitant product use was not provided.
fall; received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated; received her 1st dose on 15Jan2021 and the 2nd dose was scheduled on 12Feb2021 but she was not able to get the 2nd dose because she was hospitalized and was rehabilitated; This is a spontaneous report from a contactable consumer (who is also the patient) via a Pfizer-sponsored program. A female patient of an unspecified age (reported as 73, unit not reported) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 15Jan2021, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient fell on an unspecified date. This resulted to hospitalization (unspecified date) and rehabilitation. The patient reported that she received her 1st dose on 15Jan2021, and the 2nd dose was scheduled on 12Feb2021, but she was unable to get the 2nd dose because she fell and was hospitalized and rehabilitated. It was reported that the patient just got out of the hospital. The patient was asking if she should just continue with the 2nd dose or start over again with the vaccine. The outcome of the event fall was unknown.  Information about lot/batch has been requested.
stroke-like symptoms; left side extreme weakness; gran mal seizure with loss of cognitive function; gran mal seizure with cognitive awareness; loss of depth perception and dizziness.  Treatment: increase in lamotrogine from 200mg/150mg to 200mg/200mg
On the day after getting the dose 4, I woke up around 4:00 AM that morning and felt extremely fatigued and that lasted a couple days. Two days after dose for still extreme fatigue and very sore arm. On May 29th around dinner time I started feeling really bad and the next day it was worse so I went to the drive through testing site at a clinic and had a PCR test done. I had fever, nausea and also had vision problems like there was a film over my eyes that lasted around a week. I still am having some shortness of breath and low energy.
Sore arm, neck pain, lower back pain, and chills on first night and next morning. Took three 200mg Advil that night and next day.  Swollen lymph node in left armpit for three days, starting the 2nd night.  Hives starting second night and lasting through third day. They were located under both armpits, breasts, sides of neck, sides of face & forehead, and all along back.
Diaper changed immediately prior to exam, vaccine followed exam.  Baby was fussy and diaper change between 1 and 2 hours following the shot showed hives on the diaper area.  Hives turned into sores and diaper rash within 1 hour.  Scabbed over sores and rash lasted 3-5 days.  The nurse was contacted regarding this and asked which leg the vaccine was in.  I reported that both vaccines were given in the right leg.  I was then told that couldn't be possible, but I watched the vaccination and was looking at two bandages on the baby's leg.  The nurse assured me she would discuss this with the doctor, but never did.  I asked to have this noted in the child's chart, also, and she did not do that either.
legs are heavy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "legs are heavy".  Additional information: Patient said that she has never had side effects before. Patient said after her shot her legs are heavy and it comes and goes. Patient said she had it in the beginning and it comes and goes. Patient asked, are there any exercises she can do to help that?. Patient said that she will see her primary care provider this month.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
about 1 month after receiving the vaccine, patient reported that she noticed dark diamond sharp on the injection site; redness,  blue/black and swells up, sore arm , aches and pains, patches/discoloration spread to top of arm and shoulder.  antihistamine was recommended.
PT RECEIVED THE COVID VACCINATION AND STARTED C/O RAPID HEART BEAT; VACCINE CLINIC OBSERVED PT AND THEN TRANSPORTED  HER TO THE ED FOR MONITORING.  PT WAS GIVEN IVF AND PLACED ON CARDIAC MONITOR.
received the vaccine on 12/22/2020. Took a nap on 12/26/2020 around 1400 and woke up and noticed that left eye had blurry vision. He washed it and it was still blurry. After 1 hour, he decided to go to the ED- was worried about possible stroke in his eye or retinal detachment.  No retinal detachment found in ED; was discharged from the ED, not admitted into the hospital. Followed up with ophthalmologist as instructed on 12/27/2020.  Retinal scan done and found no retinal detachment but the doctor found fluid found behind the retina.  MD recommends rest, less stress at work.   Unknown if related to vaccine per MD - mentioned no data is available to compare.
approximately 1 week after receiving the vaccine the patient developed a rash on her arm, it started as a small annular rash close to her left bicep. It has since spread to cover her deltoid. The rash is not warm or swollen or tender to palpation, she denies any other ill symptoms or fevers.  There is no lymphadenopathy in that arm.
The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 16-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, 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 22-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 22-Feb-2023).    No concomitant medications were reported.  It was reported that, the patient received the COVID vaccine a couple days after the BUD. The vial was initially stored in the fridge on 18-Jan-2023 and 20-Jan-2023. The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713016 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2023: Follow-up information received includes patient demographics (initial, DOB and gender), vaccine start date, and event onset date were added. I-narrative supplement was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713016:Master case (child case)
4:00 back itch, hives on back, then spread to stomach by 7PM, sides & upper arm by MN, then legs, top of feet, calves & eyes swelling by 7AM;also exp lameness in legs & weakness in knees;pt took antihistamine & noted some relief;
This case was reported by a consumer via call center representative and described the occurrence of pimples in a 67-year-old male patient who received SHINGRIX (batch number 4ZF42, expiry date 30th April 2019) for prophylaxis. On 19th November 2018, the patient received SHINGRIX .5 ml. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pimples. On an unknown date, the patient experienced crust and skin discoloration. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the pimples, crust and skin discoloration were unknown. It was unknown if the reporter considered the pimples, crust and skin discoloration to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in the left deltoid. After receiving SHINGRIX the patient got a pimple thing, like a white head about 4 inches above his wrist. After receiving SHINGRIX, less than a year after the patient experienced crust and skin discoloration. On the same arm where he got the injection. This happened within a week of getting the SHINGRIX injection. The patient tried to pop the pimple and used antibiotic to treat it locally but it did not heal for 3 or 4 days. It eventually fell off. The white crust fell off but he still had that pink thing on his arm. Consent to follow up was provided.
pt reported not feeling well-nauseous, headache, vomited once before he came in on the 6/6/19. On arrival he has a temperature of 99.7. He also reported left arm swelling and pain where vaccine was given.
patient felt generally unwell starting night of 6/3/22 and started having some mild difficulty breathing, enough to be uncomfortable and aware of breathing but not gasping for air that continued to 6/4/22 (date of reporting). Patient also had increased blood pressure around the 150s/90s when it was previously controlled. Patient denies chest pain, heart palpitations and other symptoms.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The RECOMBIVAX doses were exposed to 50 Fahrenheit since 07-NOV-2013. On 09-NOV-2013 the patient was vaccinated with RECOMBIVAX HB (dose, lot and expiry date were unknown). The patient has received improperly stored RECOMBIVAX. No adverse effect was reported. This is 1 of 3 reports from same reporter. Additional information has been requested.
After administration of COVID vaccine, it was discovered that the vaccine had expired. Vaccine diluted 11/30/22 at 11:35AM, expired 11/30/22 at 11:35PM. Vaccine administered 12/1/22 at 8:50PM, approximately 9 hours and 20 min after expiration. Pfizer contacted for stability report. No further information available. Pfizer recommending communicating with their supply chain department as they may have further stability report. Dr. called and informed mom of event. Pt doing well, no adverse symptoms. Received word from supply chain department that they do not have stability reports to support effectiveness of vaccine.  Called and spoke with mom. Pt is doing well and does not appear to have any adverse symptoms from vaccine.
pt recvd vax 13MAY94 & following vax pt devel sz, apnea, & turned blue & was transferred to ICU; felt that the exp was life-threatening & prolonged hospitalization;
Sob, wheezing, eyes swelling, 5-10 minutes after vax given. Epi-0.1ml/sq given x1 Nebulizer treatment. Pt recovered w/i 10 minutes.
Fatigue, moderate injection site swelling/edema, significant axillary lymph node swelling
One week after the vaccine my left arm showed a bright red rash (1 1/2 inches wide by 3inches  long) over the injection site.  it faded over the next 9 days.  No pain.  Initially felt a little fatigue after shot, but this side effect was delayed.  Since I am unble to get second dose in right arm due to Lymphedema from Breast Cancer surgery (2004), I want to be sure I can get second dose in  that arm.
pt recvd vax; w/ 2nd dose devel hives that come & go
muscle and joint aches primarily in the, shoulders, neck arms, wrists in particular and ankles, and along the spine; muscle and joint aches; generally not feeling well; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EL3247), via an unspecified route of administration, administered in left arm on 17Feb2021 15:00 (age at the time of vaccination was 35 years old) as dose 2, single for covid-19 immunisation. The facility type was other. The medical history included cough variant asthma from an unknown date and unknown if ongoing. Also known allergies were reported as no. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EL3247), via an unspecified route of administration, administered in left arm on 27Jan2021 15:00 as dose 1, single for covid-19 immunisation. It was reported that no other vaccine was administered in four weeks. The patient had no covid prior vaccination. On 18Feb2021 21:30, the patient experienced muscle and joint aches, muscle and joint aches primarily in the, shoulders, neck arms, wrists in particular and ankles, and along the spine. It was reported that, the onset 28-32 hrs post second dose, muscle and joint aches primarily in the shoulders, neck, arms, wrists in particular and ankles, and along the spine and generally not feeling well. It was reported that the patient first noticed the symptoms of an AE on 18Feb around 9:30pm. She did not realize they were part of an AE until the morning of 19Feb, when they had not improved. The patient was not tested for covid post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Was diagnosed positive with Covid 3 days after receiving vaccine Extreme pain in left shoulder and arm for 4 weeks Excessive diarrhea for 2 months Delay in mensural cycle for 2 months
Complained of sweating, dizziness Onset approximatelly 35 minutes after administration of the shot. Effect was transient 1-2 hours. No treatment was required
My daughter had a single injection of GARDASIL on 2/16/15. Within one month she developed severe arthritis and had increased ANA, inflammatory blood readings, etc. She was RA negative. She started having issues walking and with mobility. She had a migraine. She was hospitalized for 4 days in late March and was diagnosed with SLE. Her kidney function became impaired but is now somewhat improved.
Returned 5/19/08 with cough, chills, sweats, and pain across shoulder at low scapular level. Right upper lobe rashes. Treated with IM Rocephia a 2pack CXR and CBC on 5-20-08- normal cough persistent with hemoptisis 5-22-08. CT scan of chest 6-05-08 Medrol dospit 6-04-08 cough gradually improved the flu c/o loss of sense of smell which still persists now.
Got shot, and got Shingles / Suspected vaccination failure; Got Shingles twice; Lots of pain; 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 shot, and got Shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got Shingles twice) and pain (Verbatim: Lots of pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   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: 06-MAR-2023 This case was reported by the patient via interactive digital media.  The patient stated that he/she had paid 200 dollars for the Shingles shot and got Shingles twice. Lots of pain ensued. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
pt recvd vax & w/in 1 hr post vax was cold,clammy,faint,& had a low grade fever;sx subsided w/in 1 hrs;
Moderna  COVID-19 Vaccine EUA   after 2nd shot  this one in left arm after 3 days  had pain near injection sight and a  also a red spot about 1.5 in by 3 in. that was wormer than the rest of my skin and itched real  bad .   started to get better in about 4 days