chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of hepatitis in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 1st May 2019, the patient received SHINGRIX. In May 2019, less than a week after receiving SHINGRIX, the patient experienced hepatitis (serious criteria GSK medically significant), malaise, fatigue, fever and atypical lymphocytes. On an unknown date, the outcome of the hepatitis, malaise, fatigue, fever and atypical lymphocytes were unknown. It was unknown if the reporter considered the hepatitis, malaise, fatigue, fever and atypical lymphocytes to be related to SHINGRIX. Additional details were provided as follows: The reporter wants to know whether SHINGRIX causes hepatitis like syndrome or not. The reporter did not consent to follow-up.
left hand turned bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left hand turned bright red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (left hand turned bright red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (left hand turned bright red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include medicine for her depression and for constipation.
PATIENT CAME INTO STORE THE NEXT DAY AND COMPLAINED OF A RED AND SWOLLEN LEFT ARM. PATIENT DECLINED HAVING TROUBLE BREATHING. RECOMMENDED TO PATIENT TO CONTACT HER PCP TO SEE IF SHE WOULD NEED TO BE SEEN AND WHAT RECOMMENDATIONS TO TAKE CARE OF HER ARM WOULD BE RECOMMENDED.
the patient received the wrong COVID 19 vaccine. He should have received a 2nd dose of Pfizer but received a Moderna.
Migraine headache (still current as of report). Started gradually and worsened over time.
pt recv vax 3MAY96 & 6MAY96 pt exp flu like sx;
The three days after I received my vaccine, I experienced flu like symptoms and a severe headache. The flu like symptoms went away, but the headache did not. On day six, I started to have double vision and I went to the ER because of that. At the ER, (05/15), they kept me all day. They ran a lot of tests. They took me through a "stroke" protocol. They performed a non-contrast CT scan, drew blood work and then they admitted me. I was put on a neurological floor. I had another non-contrast CT, a contrast CT scan, non-contrast MRI, a contrast MRI, a doppler to check my veins for blockages, I was checked for autoimmune diseases and a bubble test. I was told I had high blood pressure. I was given medication for that. I was at 169/97. By the time I was released, it had come down to 139/84. As of today, my blood pressure is normal. I'm still experiencing double vision from time to time. I have to wear a patch on one of my eyes and alternate every 4-6 hours. Right now, I have monocular vision and I'm having to do this until it resolves. I had an ophthalmological assessment and I was sent to a neurological consult with another ophthalmologist. I went to the eye care doctor, with Dr. (Name) (05/25), and she told me that I have a cranial line stick nerve palsy. My right eye is not moving the way it should. It's like it's frozen in place. That is where my blurred vision comes from. My vision is cris-crossing and that is where the double vision is coming from. I have a follow-up appointment on June 29th to see if the patch is working. It was close enough to the vaccination to make me question that it was from the vaccine. With this I have to wait it out for the next six months.
I held the methotrexate/MTX for 24 days to allow the antibodies to build up in the system. And I had a flare in that, CK went up. I had to take a short course of Prednisone and had labs done in 4 weeks, around 11/22/2021.
6/26/2012 fever that night after receiving shots of 104 degrees. Then 103 degrees fever the next night 6-27-12. Vomited x 1 today 6-28-12. (Dad also reports 103 degrees fever after 6 mo shots).
Headache, shaking, jittery approx. a two hours after vaccine. By tree hours later he was feeling himself. He has not had any further problems.
Chills all night, no fever or sweating occurred, body aches and headaches, very lethargic for all of Tuesday 12/07/2021.  I had the flu one week prior to receiving the Pfizer booster shot (the week of Thanksgiving), but had recovered from it.
Epilepsy NOS w/ intr epil 2012-12-23, clinician comment: known seizure disorder, well controlled with TEGRETOL, about two weeks after flu vaccine had a breakthrough seizure.
Case number PHEH2011US01197 is a combined initial and follow-up spontaneous report received from a physician on 10 Aug 2011 and 16 Aug 2011. This report refers to a 17 years old female patient. She was vaccinated with MENVEO (batch number: M10059) intramuscularly at a dose of 0.5 ml on 08 Aug 2011. On 10 Aug 2011, she developed a silver dollar sized raised, red, tender area at the injection site. Outcome of the event was unknown.
redness at site of 2nd injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Jun2021 10:30 (Lot number: EW0196) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid adenoma", start date: Jan2017, stop date: Mar2017, notes: Thyroid Removal; "Hypothyroidism", start date: Jan2017, stop date: Mar2017; "DCIS", start date: May2015, stop date: Jun2015, notes: Unilateral Mastectomy right breast w/5 Lymph nodes; "High Cholesterol" (unspecified if ongoing); "Hot Flushes" (unspecified if ongoing); "Supplement" (unspecified if ongoing), notes: Supplement; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: May2017 (ongoing); SIMVASTATIN taken for blood cholesterol increased, start date: Sep2019 (ongoing); AMBEREN taken for hot flush, start date: Feb2021 (ongoing); VITAMIN D NOS taken for supplementation therapy, start date: Mar2021, stop date: Aug2021. Vaccination history included: Bnt162b2 (1st Dose time : 10:15, Anatomical site: Left arm shoulder, Route: Intramuscular , Lot: EW0179), administration date: 04Jun2021, for COVID-19 Immunization, reaction(s): "Quarter size swelling of lymph node at Collar Bone". The following information was reported: INJECTION SITE ERYTHEMA (non-serious) with onset 25Jun2021 21:00, outcome "recovered" (2021), described as "redness at site of 2nd injection". Therapeutic measures were not taken as a result of injection site erythema.  Additional information: Vaccination facility type was pharmacy/drug store. Vaccine was not administered at military facility. No any prior vaccinations. No any relevant test.  No follow-up attempts are possible. No further information is expected.
Received vaccine on 4/4/03 - noted fever, body aches. 4/15/03 - then rash appeared 4/16/03. Fever intermittent for 3 days. Saw MD 4/18/03. Off work since 4/16/03 thru 4/23/03. Asymptomatic on 4/20/03. Return to work 4/23/03.
Redness, itching and swelling of Right upper arm.  No fever.  Treated for presumed cellulitis with Keflex.
5 cm diameter area of swelling and erythema just inferior to Varivax injection site- O.U to eval 3/10/08. No Rx-thought to be local reaction.
Thyroid disease. Every symptom, except elevated thyroid levels.  Extreme fatigue, lack of stamina, weight gain, memory issues, brain fog, bulging eyes,  debilitating headaches caused by pressure inside head, blurry vision, seeing floaters in my eye. Pseudo tumor reaction behind my right eye.
No adverse effects were reported; administered the first dose ofGARDASIL 9 (L040054 12/26/2017) on 10/4/2017 and was administered the second dose of GARDASIL 9 (R004689 11/29/2020) on 7/21/2019; Information has been received from a pharmacy intern referring to a 20 years old patient of unknown gender. The patient's concomitant medication, medical history, drug reactions or allergies were not reported.  On 04-OCT-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number: L040054, expiration date: 26-DEC-2017; strength and route were not reported) for prophylaxis. On 21-JUL-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number: R004689, expiration date: 29-NOV-2020; strength and route were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects were reported. The outcome of the event was unknown.
Patient passed out for about 15 seconds about 3 to 5 minutes after receiving vaccine.  pharmacy staff called EMS. Patient woke up after 15 seconds and was alert.  He was given a bottle of water and stated that he was okay. He refused to go to hospital.  Pharmacy followed up with him the next day and patient stated that he was completely back to normal health status.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2 NOS), on 07Jan2023 as dose number unknown, single (Lot number: FL329) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: mango" (unspecified if ongoing); "Menopause" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid treatment from 16May2023 to 21May2023. Patient also took concomitant in 2 weeks.  Suspect product: HET for menopause with start date: 01Dec2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300204129 same reporter/patient, different drug/event;
After receiving 2mo imm. inc. dtap, ipv, comvax and prevnar child was reported to have high fever ie. 103-104*F and inconsolable x 24hrs. Pt was given same vaccines at 4 mos of age with same reaction.  At 7 mos of age physician gave ipv and prevnar.  Mom reported did better without fever or fussiness after holding dtap #3.
passed 58 days without receiving the second dose/60 days since my first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (passed 58 days without receiving the second dose/60 days since my first dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (passed 58 days without receiving the second dose/60 days since my first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (passed 58 days without receiving the second dose/60 days since my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided.  Treatment medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-JUN-2021 contains No Significant information.
pt devel mild cold sx 23AUG;devel fever day & @ noc had sz-felt to be secondary to high fever 104.5;adm overnoc for observation;no further fever or sz;no meds other than antipyretics-APAP, Ibuprofen used;
11 adult patients received the expired Bivalent booster beyond 30 days; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) outcome was unknown and NO ADVERSE EVENT (no adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days).    No concomitant and treatment medications were provided.
Severe Shoulder Pain, unable to fully move arm, pain radiating up neck and down arm, tingling sensation into pointer finger and thumb- unable to fully dress self, use bathroom, reach for items, complete normal work and home tasks.
I expected to not feel well. I had a raging fever, I was in extreme full body agony, I'm used to being in chronic pain, this was worst then anything I had ever experienced, It felt like all my autoimmune diseases flared at once. I slept for 3 days, I was sweating, drenching through my clothes. The fever and body sweats went away, but the pain did not, and it did not go away. I made an appointment with my rheumatologist because had been in remission. The vaccine boosted my immune system so much and brought everything back. I had to go back on to Humira and Naproxen. I was now going back on several meds. I have had multi surgeries been having polyps. Next week I'm having surgery on my right foot because it is deformed now and I was running and walking up to 3 miles a day before this, when I was in remission. I'm seeing every kind specialist now. I'm seeing a nerve specialist to have a nerve test done. I have been going to doctor weekly for various test.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027067, expiration date: 06-APR-2017, orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes daily for two weeks. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
second dose is consider invalid because it was stored in the freezer for longer than the recommended time frame; second dose is consider invalid because it was stored in the freezer for longer than the recommended time frame; uncomfortable feeling; fever; sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jun2021 (Lot number: EW0186, Expiration Date: 31Aug2021) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose No: 1, Batch/lot number: EW0186 Lot# EW0186, Expiry 31Aug2021, Why was the patient taking Covid 19 vaccine (Verbatim): to prevent the covid 19 virus), administration date: 15May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 06Jun2021, outcome "unknown" and all described as "second dose is consider invalid because it was stored in the freezer for longer than the recommended time frame"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "uncomfortable feeling"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat".  Additional information: Reporter reported that her son thinks he received both injections in his left arm but he is not 100 percent sure. The vaccine was not administered at facility. AE(s) did not require a visit to emergency room and physician office. There were no other vaccinations within four weeks prior to the first administration date of the suspect. There were no AE(s) following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease; has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease; has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease; diagnosis of a brain blood clot; her mental status decline; This is a spontaneous report from a contactable Nurse (reported for his/her mother). A 61-year-old non-pregnant female patient received second dose of bnt162b2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in May2021 at the age of 61 years old as single dose for covid-19 immunisation. Medical history included hypertension and shellfish allergy, both from an unknown date.  The patient did not experienced Covid-19 prior to vaccination and the patient was not tested for Covid-19 post vaccination. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Batch/Lot No: Unknown. Unable to locate or read the details) on an unspecified date in Apr2021 at the age of 61 years old for COVID-19 immunization. There were no other vaccines received in four weeks and there were no other medications received in two weeks. After the patient received the Pfizer vaccine bnt162b2, her mental status decline in Jul2021 and in Aug2021 the patient was brought to the Emergency room with diagnosis of a brain blood clot the patient has been treated with pradaxa for blood clot, although now in Nov2021 the patient has had 3 subacute ischemic strokes with possible CNS vasculitis a very rare autoimmune disease - possibly brought out by bnt162b2. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for 5 days. The patient underwent lab tests which included blood work, multiple CT scans, magnetic resonance imaging with unknown results on an unknown date in 2021. Therapeutic measures which included multiple CT scans, magnetic resonance imaging, spinal tap, blood work, and blood thinners were taken as a result of reported events. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Mental status changes, Thrombosis, Ischaemic stroke, Central nervous system vasculitis and Autoimmune disorder. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax & became fussy, pt had screeching cry, painful like an ear infect type cry;pt would cry for 10-15min, fall asleep then wake up 10-15min;
I had a lymph node in the left collar bone that was inflamed and tender. They went ahead and did an ultrasound, that it wasn't something bad going on. I've had a follow up since then but nothing has changed except the tenderness.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unkonwn age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PROQUAD (Merck). Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that improperly stored PROQUAD (Merck) about 6-7 doses) were administered to patients (on an unknown date). No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
Patient received the varicella vaccine on 11/06/1996. On 12/24/2001, they started to have a moderate amount of blisters and called the doctor's office. By 12/26/2001, they were "covered" with spots. They also have a high fever.
Patient received Prevnar vaccination about a week ago, then worsening right upper extremity pain, swelling, erythema, warmth over the right shoulder in the area where the vaccine was placed.
Information has been received from a nurse referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 24-NOV-2015, the patient was inadvertently administered an expired dose of (Merck) VARIVAX (lot # J014407, 13-NOV-2015, strength, dose and route unknown). No adverse effects were reported. Additional information has been requested.
pt reports by phone 8SEP98 severe aching pain & muscle wasting;advised to see MD;pt to ER;