chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweety hand; Having trouble sleeping waking up every 3 hours; Sore throat; Cannot taste his food; Stomach hurt; Pain in the lower left chest; Pain that come and goes in the upper right side of the jaw; Dizziness; Not feeling well; Weakness; Extremely strong headache; Very very nauseous; General fatigue\ Tiredness; Muscle pain; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food) and ABDOMINAL PAIN UPPER (Stomach hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Past medical history includes in 2011 Patient had a minor brain stroke
Patient had severe tenderness, redness and swelling in arm in which injections were administered. He said he felt sick, achy and headache after he had the shots. Rxn last 2-3 days.
Constant Tinnitus (mainly left ear), Ear fullness and pain (both ears), ear popping (both ears), dizziness, possible hearing loss.
admitted for abdominal pain and found to have fluid around the spleen consistent with blood.  On previous imaging, there was a splenule in this location that is no longer seen, so this may be the source of bleeding. Hgb was stable and pain improved and patient was discharged home the day after admisssion
Pt is 4 years old and received an adult of Havrix Hepatitis A vaccine. No adverse events have been reported yet by the parents but they are very concerned.
Headache / Chills / Body Ache / Fever / Site Pain  Approximately 36-hours beginning 10/05/2022 @ 8pm
soreness, tenderness, lump under armpit-swollen to left breast, fever 2.5 days, warn and swolen in arera
I just feel yucky; This spontaneous case was reported by an other and describes the occurrence of TASTE DISORDER (I just feel yucky) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (I just feel yucky). At the time of the report, TASTE DISORDER (I just feel yucky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Body aches, nausea, headache, lack of appetite, loss of smell  for 4 hours, treated with 200 mg ibuprofen
MODERATE INDURATION, ERYTHEMA, AND MILD TTP OVERLYING THE SUPERIOR LEFT TRICEP.
Pedvax  Hib was given in error instead of Hepatitis B.  Patient's mother was called and told of incident.  She was to call us if any kind of symptoms occurred such as fever, vomiting, redness at injection site, etc.  Dr. called the mother.  No report from mother of any problems.
Pt recvd vax & exp diarrhea 1SEP92 only), dizziness, nausea, vomiting, incapacitated for 2 days; seen by MD; Meclizine was prescribed; appeared jaundiced;
body ache;3wk started w/extreme fatigue;chills, dizziness;
This case was reported by a physician via sales rep and described the occurrence of pitting edema in a 19-year-old female patient who received BEXSERO (batch number 151401, expiry date 31st December 2016). On the 24th July 2016, the patient received BEXSERO. On 25th July 2016, 1 days after receiving BEXSERO, the patient experienced pitting edema and ankle swelling. On an unknown date, the outcome of the pitting edema and ankle swelling were recovering/resolving. The reporter considered the pitting edema and ankle swelling to be related to BEXSERO. Additional details were provided as follows: this case was previously reported to a doctor. The patient received the BEXSERO vaccine in left deltoid and next day when she woke up, she noted that both of her ankles were swollen, described as pitting edema. The field representative was unable to provide any further details. He stated that the patient was the reporting physician's daughter.
redness/flushing/warmth in chest, neck & face with hives later same day headache several days tingling/prickling feeling in hands & face ongoing minor swelling with itching in hands & feet ongoing lymph node swelling and pain/tenderness in left arm pit began 1/5/22
PATIENT FELT HEAVY AND TIRED AFTER RECEIVING THE TETANUS VACCINE ALONG WITH THE SHINGLES VACCINE.  THIS WAS THE SECOND DOSE OF THE SHINGLES VACCINE AND THERE WERE NO ISSUES WITH THE FIRST ONE.  THEY DID TELL ME HE HAD A PREVIOUS PROBLEM WITH THE COVID VACCINE .  THE PATIENTS REPRESENTATIVE (CARETAKER) CALLED HER SUPERVISOR AND SAID HE HAD NOT HAD THE TETANUS SHOT AND TO GO AHEAD AND GIVE IT.  AFTER GIVING IT APPROX 45 MINUTES LATER I WAS CALLED TO AISLE WHERE HE WAS LIGHT HEADED AND UNABLE TO WALK AND NEEDED TO SIT.  HE WAS VERY CONSCIOUS AND ANSWERED ALL OF MY QUESTIONS.  CAREGIVER STATES HAS HAD THESE EPISODES BEFORE RANDOMLY AND USUALLY WILL GO HOME AND LIE FOR A WHILE AND FEEL BETTER.  SHE DID NOT STATE HE WAS ON SEIZURE MEDS OR HAD SEIZURES WHEN ANSWERING QUESTIONAIRE BUT MENTIONED HE HAS BEEN TOLD THESE EPIDOSES ARE SEIZURE LIKE.  THEY DID NOT WANT HELP LEAVING THE STORE AS WE HELPED HIM INTO A MOBILITY SCOOTER.
Information regarding PREVNAR 13 was received from a physician assistant regarding a patient who experienced cellulitis, erythema, tenderness on palpation, warmth and swelling. The patient received a dose on an unspecified date. On an unknown date, after the immunization the patient experienced erythema, swelling, warmth and tenderness on palpation at the injection site. The child was treated in an unspecified manner for cellulitis. They suspect a problem with the product. Outcome of the events was unknown. No additional information was available at the time of this report.
This spontaneous report as received from a License Practical Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were administered improperly stored (Oka/Merck) VARIVAX (dosage, lot # and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
High fever (104.5 degree tympanic at home) then complex febrile seizure lasting 10-20 minutes. Stopped spontaneously. Hospitalized. Had large, erythematous, tender, indurated skin reaction at injection site with CRP 17.6, ESR 93. Treated with antibiotics, no confirmed infection.
Fever, nausea, back pain, dizziness/feeling faint, severe chest/rib pain like being punched,
pt said she bruished from her shoulder to neck area.  bruise went away except for site of injection.  but she said she has a lot of pain running from shoulder to neck area .
I had extreme sharp chest pain and enormous lung pressure. I thought I was having a heart attack. I also had weakness, dizziness, nausea and headache. I went to the ER three time in a row and the fourth time was in an ambulance. These symptoms have lasted form 10/8/2021 to today 10/19/2021. I have been completely incapacitated. It's hard to move around or do anything at all. They ran a number of tests in the ER but all came back normal.  No diagnosis at this point.
I tested positive for COVID on February 4th, 2023. I got a notification on my phone that I had been in an area someone tested positive. I was given something for my cough, benzonatate 200 MG capsules after I went to urgent care. I was having chest pressure so I went to the ER, I developed over the weeks and ear and sinus infection. My doctor put ZPAK antibiotic. I started feeling much better after the antibiotics.
Leg hurt; This is a spontaneous report from a contactable consumer (patient herself), received from a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot/NDC/UPC number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's leg hurt due to baby sitting and not because of the COVID-19 vaccine. The patient wanted to know if she could take paracetamol (TYLENOL) or ibuprofen (ADVIL). The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information provided, the reported leg pain is an intercurrent medical condition and unrelated to BNT162B2.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: moderna, vaccine dose number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: a57144b) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25May2023 as dose 5 (booster), single (Lot number: a57180b), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: cats" (unspecified if ongoing), notes: Known allergies: cats. The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25May2023, outcome "unknown", described as "Vaccine brand other: moderna, vaccine dose number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
5-11 Covid vaccine not diluted 0.2 ml of undiluted was administered to left arm. After drawing up 5th dose LVN notice there was no sufficient amount for 10th doses. LVN noticed vial was not diluted. LVN notified MD. MD verbalized that they will contact parents.
This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # L040419, expiration date 14-OCT-2017; lot # M008171, expiration date 15-FEB-2018; lot # M024683, expiration date 18-MAY-2018; and lot # M027347, expiration date 01-JUN-2018 (dose and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 6°°Fahrenheit (F) to 14°F (11.2F), for a time frame of 8 hours. There was no previous temperature excursion and no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
fever; red spots that move around the whole shoulder; This spontaneous report as received from a consumer, an elderly male patient of currently 91 years old. The patient's pertinent medical history, history of drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date approximately in 2014 (also reported as "4-5 years ago"), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) vial, 1 dose (strength, frequency, lot # and expiry date was not reported) via subcutaneous route (also reported as underneath the skin) for prophylaxis. On an unknown date approximately in 2018, the patient experienced fever (pyrexia) and he was hospitalized on 04-FEB-2018 for the same. On an unknown date, the patient also developed "red spots that moved around the whole shoulder" (generalised erythema) after receiving zoster vaccine live (ZOSTAVAX). The patient sought medical attention by talking with physician. It was reported that no treatment was provided for the adverse events. No lab diagnostics/ studies were performed and no product quality complaint was reported. The outcome of the events, pyrexia and generalised erythema was reported as not recovered. Causality assesement was not provided by the reporter.
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 06-SEP-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA005873: US-009507513-2209USA010274: US-009507513-2209USA010275:
my Mom and I have been light headed and had some  diarrhea; my Mom and I have been light headed and had some  diarrhea; This is a spontaneous report from a non-contactable consumer (patient's son).   A female patient of an unspecified age received second dose of (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller stated that his mom (the patient) and he have been light headed and had some diarrhea. She had her 2nd Pfizer vaccine dose 4 weeks ago and he had 2nd dose 2 weeks ago, the caller asked that if the side effects from the Pfizer vaccine can still be present after 2-4 weeks after the 2nd dose. The outcome of events was unknown.  No follow-up attempts are Needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) :different patient, same reporter, drug, event
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/23/2022 -- RECURRENCE OF SAME SYMPTOMS
High temperature of 105; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High temperature of 105) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Multiple sclerosis, Asthma, Seasonal allergy, Allergic to dogs, Allergic to cats, Hay fever and Allergy (Oak tree allergy). Concomitant products included OCRELIZUMAB (OCREVUS), ALBUTEROL [SALBUTAMOL], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VALPROATE SEMISODIUM (DEPAKOTE) and VITAMIN D NOS for an unknown indication.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High temperature of 105) (seriousness criterion hospitalization). At the time of the report, PYREXIA (High temperature of 105) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.  Company comment: This spontaneous case concerns a 52-year-old female patient with a relevant medical history of Multiple sclerosis undergoing treatment with Ocrelizumab, who experienced the unexpected serious (hospitalization) event of Pyrexia after mRNA- 1273 vaccine. The event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Pyrexia is consistent with the known safety profile of the vaccine, but since it had a serious outcome it is considered unexpected. Very limited information is available regarding hospitalization and diagnostic work-up. At the time of the report, the event had resolved. Concomitant medication Ocrelizumab might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Follow-up information received on 27-DEC-2021 contains no new information.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient with a relevant medical history of Multiple sclerosis undergoing treatment with Ocrelizumab, who experienced the unexpected serious (hospitalization) event of Pyrexia after mRNA- 1273 vaccine. The event occurred on an unknown date after the dose of mRNA- 1273 vaccine, dose number unknown. Pyrexia is consistent with the known safety profile of the vaccine, but since it had a serious outcome it is considered unexpected. Very limited information is available regarding hospitalization and diagnostic work-up. At the time of the report, the event had resolved. Concomitant medication Ocrelizumab might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Pt's eyes became red and swollen 48 hours after vaccination. Mother advised to seek medical advice. Pt was seen by MD and is all right now.
Patient received the influenza vaccine on 12/30/2020 (unclear which version). On 1/9/2021, she presented to Hospital with 5 days of numbness, paresthesias, and weakness in both lower extremities. Neurological exam, lumbar puncture, and MRI of brain/spine were all consistent with acute inflammatory demyelinating polyneuropathy (a subset of Guillain-Barre Syndrome). She was admitted to the Neurology service, and treated with IVIG. She has been receiving physical therapy, and her strength/sensory symptoms are improving, but still significant.
This literature marketed report has been received from the authors of a published literature article, and refers to a 15-year-old patient of unknown gender. The patient's concurrent condition included cartilage hair hypoplasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant were not reported. On an unknown date at the age of 1 year, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin, liver, kidney, larynx, palate and bone marrow but rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin, liver and kidney. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 550 cells/uL, CD4 count was 450 cells/uL, CD19 count was 120 cells/uL and natural killer (NK) cell count was 120 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient was treated with azathioprine, azithromycin, mycophenolic acid and intravenous immunoglobulin (IVIG) with no improvement. The patient received also cyclosporine and steroids with partial response. Nitazoxanide was used largely as salvage therapy in this extremely ill patient but it had no obvious benefit. After 2 months of treatment with nitazoxanide, lesions in the skin, liver and kidney improved and improvement was sustained until the patient's death. The patient died from progressive multifocal leukoencephalopathy (PML). The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked # 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA004787, 1902USA003143). Sender's Comments: US-009507513-1902USA003143.
I am not sure where the patient received the Moderna vaccine. He received his second dose on 3/9 and came to our Emergency room the same day with altered mental staus and very lethargic. He had a temp of 102.9 upon arrival to the ER. He was hurting all over. He was hospitalized from 3/9-3/12 and was found to have agonal respirations during his hospitalization and a code blue was called and he was moved to the ICU. He did not have to have any code blue medications and only minimal chest compressions were performed. He was discharged home on 3/12 without further complications.
headache, sore throat, nonproductive cough, fever, body aches, loss of taste, sinus congestion, nasal congestion, post nasal drainage, sneezing. starting 11/28/21
16cm blue-black area @ site of inj;had immed tingling @ site;now feeling very tired;