chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure/got both doses, had shingles; shingles; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 times prior to vaccination).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the doses of Shingrix vaccine 4 years ago and received them when it first came out and recently experienced shingles. The patient asked if another dose of Shingrix should be recommended. When the patient got the vaccine (both doses), he/she was told it was for life. But he/she read now that it was good for 4 years or more. The patient was waiting for a call from the doctor but would respond after the reporting day. The reporter consented to follow-up. This case was considered as suspected vaccination failure since the detail regarding laboratory test confirming shingles was unknown at the time of reporting.
death I26.99 - Other pulmonary embolism without acute cor pulmonale J18.9 - Pneumonia, unspecified organism
After all three vaccines I have experienced heavy and irregular menstrual bleeding and bleeding in between menstrual cycles . After this booster I woke up with vaginal bleeding the next day.  It is not my regular cycle .
Patient had soreness for a week in her left arm.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient had soreness for a week in her left arm.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 012M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Patient had soreness for a week in her left arm.). At the time of the report, VACCINATION SITE PAIN (Patient had soreness for a week in her left arm.) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-576700, MOD-2022-576746, MOD-2022-576600 (Patient Link).
Fever and headache next day; sore arm next day; headache and sore arm lasted through 1/11/21
Rash that developed one day after vaccination and worsened over 3 days It is a urticaria like reaction
This  81 year old male received the Pfizer Covid shot on 3/01/21    and went to the ED on  3/20/21     and was admitted  on 3/20/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified
Normal injection site soreness and swelling for a few days immediately after the shot.  But a week later, the injection site started to get hard, red, really itchy, and hot to the touch.
I felt like I was having a heart attack but by the time I went to the hospital around 6am the effects had subsided.
Initial unsolicited report received from a pharmacist on 28-Sep-2015. This case involves a female patient of approximately 73 years of age who was vaccinated with a first dose of FLUZONE HD (batch number and expiry date was not provided) via intramuscular route in the left deltoid on 17-Sep-2015. The patient had a history of penicillin allergy. There was no illness at the time of vaccination. Concomitant medications were not reported. On 20-Sep-2015, 3 days post vaccination; the patient developed rash which was described as "12 x 4" plaque scaly on leg, scaly rash developed on armpits, groin, chest. The rash was scaly and was not like hives or bumps. The patient was advised to see a physician. Laboratory data and corrective treatment were not provided. The patient had not recovered from the above mentioned events. List of documents held by sender: none.
Patient came to pharmacy Arm Swollen. Referred to MD. As per MD Incorrect technique and cellulitis. Pt was given Antibiotic.
Got sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 20-Nov-2020.  This case involves a patient with unknown demographics who got sick (Illness), when received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu shot twice and both times got sick (Illness) it was the worst ever been sick so patient called bull shot on it not making you sick, unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective medication.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Patient displaying behavioral problems starting 1 week after the vaccine administration.  pt. states "I  am stupid. I want to die". Acting Inactive, Impulsive, Restless. In the doctors office patient was repeatedly climbing the exam table and getting off.
pt recv vax 10JUL96 & 23JUN97 pt devel approx 10 lesions & fever of 102;
Pt developed fever within 1 hr post vax up to 102 degrees. Pt febrile 18 hrs post vax administration. Pt also had pain and swelling involving right deltoid (site of vaccine). Pt treated with Ibuprofen 200 mg po q6-8hr PRN.
t104 on Thursday shot on Tues cried for 2 hrs; fever lasted x 2 days inspite of APAP & Advil; temp on TUes & Wed 103;
Patient is an elderly male that stated that he experienced memory loss the evening of his vaccination and that it lasted a few days.  He also has depression and he states that since he received the vaccination that his depression has became worse with bouts of crying while speaking.   He said he has not sought medical treatment as of today, 6/7/21.  A friend of the patient encouraged him to seek medical help earlier, but he was going to see his primary care physician instead.  He has an appointment with his physician.  Patient stated that he did not have severe or persistent headaches.  He also denied having blurred vision.  As of today, his memory has improved.  He feels his depression has not improved.
A nurse described the occurrence of Hep A in an adult male of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 11/5/02, the subject received his first injection of Havrix. The subject reported to the nurse that 19 days later, on 11/24/02, his MD made a Dx of Hep A. As of 12/18/02, the event persisted. Hep A is considered GSK medically serious.
Information has been received from a physician concerning an 11 year old female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not provided).  Subsequently a couple days after the vaccination, the patient experienced a rash all over her body.  The patient was not hospitalized and no medication.  The patient's outcome was not reported.  Additional information has been requested.
At 4 am one week after having received my second dose of Covid-19, I awoke very nauseated and proceeded to start vomiting.  Around 7 am I began having uncontrollable diarrhea with weakness and dizziness following.  No fever, just flu-like symptoms.  With rest and liquids by mid-day I was starting to feel a little better.
Severe pain from Rheumatoid Arthritis; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ep7534 and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 23Mar2021 at 00:30 (at the age of 68-years-old) as dose 2, single for covid-19 immunisation. Medical history included rheumatoid arthritis, heart and diabetes. There were no concomitant medications. The patient previously took lopressor and experienced allergy and first dose of bnt162b2 (Lot Number: En6198), administered in left arm on 02Mar2021 at 13:30 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On 03Apr2021 at 00:30, the patient experienced severe pain from rheumatoid arthritis. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received Meloxicam for the treatment of event. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient underwent lab test and procedure which included nasal swab, covid test: negative on an unknown date. The outcome of event was not recovered.
GI bloating; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (GI bloating) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (GI bloating) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISTENSION (GI bloating) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Patient had events 4 days after the first vaccination. No treatment information provided.
HORRIFIC SHINGLES POST SHINGLES VACCINATION/Suspected vaccination failure; HORRIFIC SHINGLES; 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: HORRIFIC SHINGLES POST SHINGLES VACCINATION/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: HORRIFIC SHINGLES). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-MAR-2023 The case was received from the consumer via interactive digital media. The reporter reported that funny 3 people he/she know personally contracted horrific shingles post shingles vaccination. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This is 2 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR050695:same reporter US-GSK-US2023AMR050704:same reporter
1:00 became light headed with dry throat and 1:15 states feeling better will advise MD of any further sx
First 2 days upset stomach, then throbbing brain and ear clogged. On Saturday, I began to have sporadic sharp pain to the left side of my head and also experiencing stiffness/soreness of the left side of my neck; at times painful in my left ear when I swallow. 2/23 nausea and abdominal pain.  ER visit on 2/24, meds ciprofloxacin optic, cyclobenzaprine and lidocaine patches. 2/26 pain in the back of my head.
PATIENT FELT HEAVINESS IN THE ARM.  IT HAS BEEN 2 DAYS SINCE THE VACCINATION AND SHE IS STILL EXPERIENCING THE PAIN/HEAVINESS IN ARM.
This spontaneous report as received from a physician refers to a 16 year old female patient. The reporter stated that the patient received M-M-R II (also reported as M-M-M) on 01-JAN-1998 and 12-SEP-2012. No medical conditions and medical history was reported. The physician also stated that patient was healthy with no immunosuppression or immunocompromise. Concomitant medications were not reported.  On 25-JUN-2014 the patient visited physician for revaccination because of an unspecified date titers were performed and the titers were negative for measles and rubella but was barely positive for mumps. ON 25-JUN-2014 the patient was vaccinated with M-M-R II. The vaccine dose was administered intramuscularly. The outcome of the event was unknown. The patient experienced same event while on therapy with VARIVAX (captured in case# 1407USA001603).  Follow up information has been received from the physician. Information about administration of M-M-R II was updated. patient demographics was updated. Patient current condition included allergy to sulfa containing drugs. On 25-JUN-2014 at 10:30 AM, patient received third dose of M-M-R II (dose 3) (lot # J008533, expiry date: 12-JUL-2015) in left deltoid intramuscularly because of non-responder as documented by negative titers after 2 previous vaccine were given intramuscularly instead of subcutaneously. Relevant diagnostic test and laboratory data were reported as none. There was no other adverse event following prior vaccination. Illness at the tine of vaccination was reported as none. Vaccine was purchased with public fund and vaccinated at public health clinic or hospital. Additional information has been requested.
MINUTES AFTER RECEIVING COVID VACCINE PATIENT FAINTED. HE DID NOT HIT HIS HEAD. RESCUE WAS CALLED AND HE REGAINED CONSCIUOUSNESS MOMENTS AFTER FAINTING. WHEN RESCUE CAME PATIENT DENIED ANY FURTHER SERVIES AND STATED HE WAS FEELING BETTER AND LEFT THE PHARMACY.
After first covid shot (L arm), got a little bit of chest pain, went away 9 days after, got a large whelp on L deltoid, eventually went away  Had 2nd shot 5/12/2021 (R arm), next day had some malaise "completely what I expected" The Sunday after, had pain on R FA and veins were larger/darker than normal Some ankle pain Repeat on chest pain again Would be worse after deep breathe or laying down, other times no apparent rhyme or reason
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 08-APR-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously(lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported  and patient was asymptomatic.  This is one of several reports from the same reporter; Sender's Comments:  US-009507513-2104USA002751:
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium
Received TRUMENBA on 8/16/17 in left arm. Developed redness swelling and pain on arm below site of injection since yesterday. No fever. Cellulitis of left upper extremity. Clindamycin (CLEOCIN) 300 MG capsule; Take 1 capsule by mouth 3 times daily for 7 days.
Area of injection of flu vaccine became reddened and itchy Approximately 20-30 minutes post receiving med. Within 24 hours arm had increased redness, itching. Worse on 10/16. Hot to touch. Improved on 10/17/01
Pt proceeded to check out after receiving HPV vaccine. Started to say "I don't feel so", passed out hitting head on counter then floor. Pt was unresponsive/out of it for approx 2 minutes. After approx 5 min., pt was moved to exam room, monitored then released.
My daughter received Moderna vaccine and had a rash breakout on her chest and back several hours later.
Pain, pressure, discomfort in left chest heart area. If sleeping on left side, pain will wake me up.
J&J vaccine given beyond the vial open time. It was give after 45 min of opening the vial. no adverse reaction occurred.
Information has been received from a physician concerning a 66 year old female who in 2008, "a few months ago", was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Merck). The physician reported that the patient developed shingles after she was given ZOSTAVAX (Merck). At the time of the report, the outcome was unknown. Unspecified medical attention was sought. Additional information has been requested.
patient started to feel lightheaded. His mother asked how he was, his eyes rolled back in his head and he was unresponsive for a few moments. we moved him to the floor and called 911. his remained very lightheaded for the next 25 minutes until which time his mother decided to transport him to the hospital for observation.
Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache, dull neck pain that extended all the way down to my left foot and left arm soreness. She noticed facial droop on the left side at which case, she decided to sleep it off. When she woke up the following morning, She still had a slight droop but not as noticeable.  Symptoms disappeared approximately 24 -30 hours post injection.
Patient called reporting redness around the injection site from her first COVID-19 Moderna vaccine on 2/27 (lot # 029L20A). She says this symptom developed today (3/9/21) and is approximately 2 inches in diameter. She denies any discomfort to this area.
Acute pain radiating down arm. Approximately 12 hours after vaccination, left shoulder/arm acutely plegic, accompanied by nerve pain. Hand sensation and function remained intact, but markedly paretic. Patient was unable to dress self or drive with left arm. Paresis slowly resolved, but significant functional limitation lasted 4 weeks (about 80% improvement at 4 weeks) and 6 weeks to fully resolve.
Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EN6202) at the age of 73 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension.  The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "Dizziness".  Additional information: When probed for the start date of dizziness: Consumer stated, "The dizziness started after the 1st dose of vaccine like I said I did not take any attention that was approximately the end of the 1st week. Also patient did not pay any attention to that because it was very mild okay.   No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 02:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney transplant" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (pain left leg) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included Hip surgery. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain) and PAIN IN EXTREMITY (pain left leg). At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (pain left leg) outcome was unknown. It was reported that all these symptoms were on the left side of patient's body. No concomitant medication was reported. Patient had back pain and was treated with cortisone. This case was linked to USMODERNATX INC. MOD 2021 081430 (E2B Linked Report).; Sender's Comments: USMODERNATX INC. MOD 2021 081430:First Dose.
On 2/23/08 at 4 yrs of age received DTaP, Hib, Rotateq. On 2/24/08 brief staring episode, blue lips, quiet, T 100.2 some cyanosis on 2/25/08 and on 2/26/08 went to hosp. EEG: seizures starting.  4/11/2008 MR received for DOS 2/28-3/1/2008 with D/C DX: Seizure.  R/O Sepsis. Pt presented with 4 day hx of staring spells of increasing frequency and duration which began s/p 4 month shots.  Initially seen by neuro as outpt.  EEG showed 5 episodes of seizure focality in the tempoarl lobe.  Admitted for further w/u. Sepsis w/u (-). D/C on phenobarb, Trileptal, and Diastat PRN
Patient received vaccine in right arm at 8:42am on 31Mar2021.  On the same day, at 7:00pm the patient experienced a dull headache and chills(both grade1) and started taking Tylenol (acetaminophen)). At 10:00pm, the patient began experiencing joint pain in right shoulder both knees and ankle(grade 1).  Due, to joint pain, the patient did have trouble sleeping. On the morning of 01Apr2021, the joint pain subsided, but the patient experienced nausea (grade 2) and as the day progressed she experience vomiting (grade 1). The patient treated symptoms with Tylenol (acetaminophen) and Nausea Relief Liquid (dextrose,levulose, phosphoric acid). The patient stayed in bed most of the day. On 01Apr2021, the patient woke up and realized her nausea was disapating. On 02Apr2021, the events had resolved.
pt broke out in a rash 2 days p/vax;the rash is a red papular rash w/some vesicles;it is located on inner thigh area;