chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A telephone report from a friend of the mother; Temperature under arm 102.8F in PM of 2/6/01 X 3 days. A few spots on chest, total 10-15 bumps by 2/12/01. Began on chest and down to legs "looks like mosquito bites". Doctor saw pt and dx'd fever from shots and pus in tonsils with reaction from chicken pox vaccine. On antibiotics and no longer has fever since 2/11/01 PM; is playing. On 2/12/01, called mother and she completed the above information.
Rash on eyelids, scalp psoriasis flares, joint inflammation. Pt's auto-immune condition has flared.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GJ2529) at the age of 39 years 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 was not reported. Concomitant medication(s) included: ALLOPURINOL. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid (start date: 07Dec2022, stop date: 11Dec2022) as treatment.  No follow-up attempts are possible. No further information is expected.
Swelling of face and neck, eyes itchy, red rash on face and large patches of rash on face, neck and chest.
First dose was JJ, the booster was moderna. Severe right sided parotitis. Progressed and started improving after 5 days with conservative care, hydration, ibuprofen and amoxicillin
Itchy welts all over but concentrated underarms, thighs, hips, buttocks. Sporadic on trunk, neck,  arms. Swelling to lips and eyes.
Very swollen arm. Fever 103. Severe weakness and malaise for 2-3 days.
I randomly got my period after just having it. So - I had my period, went through a cycle, did not have my period for 5 days, then randomly got it again. I also have a kyleena IUD and my cycles are usually very regular.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/9/2021 and 3/2/2021. Patient received sotrovimab on 12/26/2021. Patient was hospitalized for COVID-19 on 12/27/2021 to 1/1/2022 and treated with dexamethasone and remdesivir. Patient presented to the ED on 1/2/2022 with complaints of chest pain, altered mental status, and shortness of breath. Patient was admitted to the hospital for acute respiratory failure, multifocal pneumonia, and pyelonephritis. Patient received oxygen supplementation, antibiotics, dexamethasone, and had PEG tub placed. On 1/8/2022, the patient went into cardiac arrest and expired at 10:05.
After the  Moderna COVID-19 Vaccine EUA, the injection site was extremely tender for about a week, but then full shoulder pain began in the left shoulder. Certain movements like putting on a jacket send crippling pain throughout my body as if something is torn or out of place. There has been no injury to this shoulder and no activity to bring on such debilitating pain. I have postponed the 2nd shot for fear it will make it worse, and am too afraid to have it happen in the other arm. I notified the pharmacy and am waiting to see my doctor.
Patient with hives and swollen hands that started 3 days after vaccine given and was intermittent and lasted for 4-5 days. relief with BENADRYL.
The vaccine was received in my right arm the morning of 06/27/2017; By afternoon, from the injection site to my elbow was swollen. I returned to the pharmacy, same day as injection was given. Pharmacist instructed me to apply ice and stated, " that he must have hit a nerve." I called my PMD, Dr, the following day. All visits are documented.  I visited the PMD on 6/28/17, 10/18/17, 12/14/17, 3/26/18, 5/20/18. I was told at each visit that there was nothing that could be done and a nerve was hit. The PMD agreed with the pharmacist in that a nerve was hit.
Became ill the day after returning home from 6 day vacation in. Moderate/Severe headache, neck pain (not stiff), pain under ears, fever (highest recoded was 100.6 degrees), extreme fatigue, loss of appetite but not smell or taste. Sick for 7 days - most intense the first 3 days.  Prescribed Doxycycline Hyclate on 7/8/21-7/28/21
Information has been received from a physician concerning a female who was vaccinated with a dose of PNEUMOVAX. Subsequently, the patient developed "chills and fatigue" and her clavicle hurt. "A few days later" she developed a "lump" on her neck which looked like it was in a lymph node. The patient sought unspecified medical attention. The physician did not give details on the patient's status or if she had improved or not other than to say "she was fine". Additional information has been requested.
Gabapentin (captured as suspects) they gave me, that made me sick and vomit; Gabapentin (captured as suspects) they gave me, that made me sick and vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0158), dose 2 via an unspecified route of administration on 03May2021 (at the age 57-year-old) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation; gabapentin (Formulation: Unknown), via unspecified route of administration, from unspecified date, unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient stated 'gabapentin (captured as suspects) they gave me, that made me sick and vomit' on an unspecified date. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt received first dose of Moderna 0.5ml. 15 minutes post injection pt c/o feeling sweaty and skin was flushed.  30 minutes post injection pt c/o tongue and throat swelling.   Epi-pen was immediately administered (0.3mg) was administered to left thigh.  911 was called per protocol and albuterol (2.5mg/3ml) nebulizer was administered per protocol.  EMS arrived 5 minutes after being called and pt was transported to ED.  Pt symptoms were resolving upon departure.
Fever, red raised rash about 2x2 inches, redness around raise area, extending 1 1/2 inches around raise area.
OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
This spontaneous report as received from the mother of a 17 year old male patient. Pertinent medical history was not reported. On MAR-2013 the patient was vaccinated with his third dose of GARDASIL. He received his first dose in 2012 (month and date unspecified) without symptoms. It was not specified when he received his second dose. Concomitant therapies included amoxicillin (reason taking not identified). Within days of receiving the third dose, the patient experienced full body rash, intermittent swelling in arms from hand to shoulders, "alligator and chicken like scales", itchiness and flu like symptoms. Upon visiting a physician (date unspecified), the patient was referred to a pulmonary allergist. No diagnosis to date had been made. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.
On 04/19 I woke up that morning at 630 with a sore throat. Nothing too major. I went to work all day. But that evening I began to run a fever and had headaches and body aches. In the middle of that night I woke up with shortness of breath and chest pain and went to the ER on 4/20. In the E.R. they did a chest X-ray, inhaler treatment, and monoclonal antibody therapy. I was treated in the E.R. and released without being admitted. All of my symptoms subsided on 4/21 with the exception of weakness, mainly in my legs, and I still struggle with some shortness of breath.
When reconstituting the Pfizer COVID19, an error was made but not discovered until 3 doses (0.3ml ea) had been given.  There were only 3+ doses in the vial. Upon review it appears only 1 ml of NaCl had been used to dilute
2-19-07 child had well check up, received vaccines of Gardasil, Hep A, Menactra, Varicella. Approx at 3:00pm had syncopal episode on the way out of the office. First aid rendered for lip laceration. B/P and vital signs checked, reverse trendelenburg position. Sent to dental office for tooth repair.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- HYPOXIA 4/7/2023 ACUTE CHOLECYSTITIS HYPOXIA 4/7/2023 RHEUMATIC MITRAL VALVE STENOSIS W REGURGITATION HYPOXIA 4/7/2023 RHEUMATIC MITRAL VALVE STENOSIS W REGURGITATION
The day after I got my second dose, I went to the gym and afterwards I got really nauseated, and really tired. I went home and took a big nap that I felt like I couldn't wake up from. Then the next day ( Sunday) I got a really bad headache. Monday it got worse, that is when I took Tylenol. Tuesday I traveled, I got a huge migraine. When I arrived it got worse so I started taking Tylenol regularly. Thursday, I talked to my PCP through a Tele-health appt. My symptoms got worse, migraines, aches, nausea etc. They gave me some antibiotics to take for 10 days, and another one for 5 days, but they didn't help at all. Friday, I slept all day, I couldn't move, or even keep my head up. Late Friday night/Early Saturday morning, I got a stabbing pain in my neck. When I woke up officially the next day I felt a little better, but I continued to have a severe headache/migraine for about 2 weeks after that. I have now recovered from this.
Pericarditis; Somnolence; Pain; Tired out; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Pericarditis) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SOMNOLENCE (Somnolence), PAIN (Pain) and FATIGUE (Tired out). At the time of the report, PERICARDITIS (Pericarditis) had resolved and SOMNOLENCE (Somnolence), PAIN (Pain) and FATIGUE (Tired out) outcome was unknown.            No concomitant medications were reported.  On unknown dates, the patient experienced pericarditis and covid-19 injection which made to felt wore out and hurt and the patient slept for 24 hours.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Company comment: This spontaneous case concerns a 67 year old male patient with concurrent condition of Plaque psoriasis, who experienced the expected, serious (medically significant) AESI of  Pericarditis, unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, 1 month ago with no reported adverse events. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67 year old male patient with concurrent condition of Plaque psoriasis, who experienced the expected, serious (medically significant) AESI of  Pericarditis, unknown days after receiving the second dose of mRNA-1273 vaccine. The patient received the first dose with the same vaccine, 1 month ago with no reported adverse events. No information on risk factors, detailed clinical course, relevant investigations, treatment and outcome of the event was available in the report. Co suspect adalimumab could be confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
rainbow vision going across her eye; looked one way and saw like rainbow, kind of halos/I had rainbow vision, floating in front of my eyes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection,Batch/Lot Number: EW0217; Expiration Date: 30Sep2021), via intramuscular, administered in left arm on 27Jul2021 14:00 (at age of 51-year-old) as dose 1, 0.3 ml single for covid-19 immunization. Medical history included respiratory illnesses in the past, pneumonia and bronchitis, this was a couple of years ago, and recovered completely. The patient previously had an allergic to Erythromycin, allergic reaction as a baby and never took it again.Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. No AE(s) following prior vaccinations.Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none.The patient's concomitant medications were not reported she took vitamins, but no medicine. On 28Jul2021, 11:15 next day after receiving the vaccine the patient experienced rainbow vision going across her eye; looked one way and saw-like rainbow, kind of halos/patient had rainbow vision, floating in front of her eyes, but it was impeding her vision. The patient confirmed this rainbow vision was not ongoing and persisting at this time.She was driving home today and all of a sudden, her vision got a little weird.It just happened that one time. The caller wants to know if that is a side effect. The patient did not visit emergency room or physician's office. The patient underwent lab tests and procedures which included blood test: everything was fine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Slight itch/rash; Rash as patches in various parts of the body; This is a spontaneous report from a contactable pharmacist. A 22-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 30Apr2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via intramuscular route of administration in the left arm on 21May2021 at 10:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Other medical history was unknown. It was unknown whether the patient was pregnant. The patient had no known allergies to food, medications, or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021, 2-3 days before the second vaccination, the patient experienced slight itch/rash and that rash got worse since receiving her second dose. The patient described the rash as patches in various parts of the body, but not too severe at the time. The patient had no breathing difficulties, oral rashes, or anaphylaxis symptoms. The patient was advised to contact prescriber if they got worse and take benadryl if the rash bothered her. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events slight itch/rash and rash as patches in various parts of the body was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pain in left arm.  Two weeks after vaccination I got a rash. I am currently drinking Benadryl 25 mg 3 times a day.
This spontaneous report was received from a pharmacist regarding an unspecified infant of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 with expiration date 27-AUG-2016 or lot number K020216 with expiration date 17-SEP-2016). There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp flu sx;also devel chickenpox w/30 lesions;also exp low grade fever;
On 4/13 patient's daughter in law called public health department to report that patient was found by EMS on 3/12/21.  They believe patient had passed away over night.  No autopsy was done.  Family member reported that EMS believed the cause to be heart attack or pulmonary embolism.
Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 18 months old male patient (at the time of reporting patient was 9 year old) who developed a rash after receiving, vaccine ADACEL. The patient's past medical history included Milk allergy with anaphylactic milk allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious developed a rash (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It is also a medication error case due to inappropriate age at vaccine administration. It was reported that the patient was vaccinated when he was 18 months old and was given with concomitant vaccines. Other relevant tests were not reported. Final diagnosis was developed a rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for developed a rash. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Severe allergic reaction anaphylactic shock Hives, rash,swelling, headache, stomach ache, body aches, elevated heart rate, uncontrollable body spasms, loss of appetite
Patient received flu shot. After leaving room and approaching doors to leave store patient fainted and claims that he hit his head on the floor and broke his glasses
Muscle pain (all over), headache, chills (but no fever), exhaustion.  Treatment - alternating tylenol and ibuprofen, which generally helped. Symptoms would come in waves.
The guard at the base of the Heplisav B vaccine was not removed by an immunizing tech and the vaccine not primed before the needle was introduced into the patient's deltoid muscle. The patient therefore was poked by the needle but did not receive the vaccine since the vaccine was still in the lock position. I was immediately informed by the tech afterwards, but the patient was extremely upset and did not want to receive the vaccine from me.  Patient reports today that she is experiencing soreness at the injection site and said she is very sad and anxious.
Pain, swelling, blister on the left arm after an hour of the injection. Blood pressure went up from a normal of 140 to 204 at the Emergency. Left the emergency with BP at 180. Was given Prednisone 20 mg 3 tabs daily for 3 days and BENADRYL 50 mg at bedtime.
began feeling bad about 6hr p/flu vax;muscles aching h/a, stomachache, bottom of feet ached;sx lasted almost 24hr then felt better & feeling only weakness;
Vaccines administered 10-26-07. 11-2-07 noticed sores on tongue. 11-3-07 Swollen gums, ? elevated temp, mild chills off and on. 11-4-07 Noted lymph node swelling in (L) neck area, sores in mouth increased. 11-5-07 Generalized tiredness, malaise, gums and mouth sore, swollen. 11-6-07 Lips swollen, gums may be more swollen? 11-7-07 Seen by doctor.
Developed redness, pain, warmth, mild swelling, mild itching in 10 cm area on left arm at vaccine site, occurred 2 weeks after injection, lasted for 5 days.  Was treated for cellulitis, due to underlying diabetes, but I favor this being a delayed injection reaction.  No systemic symptoms, no fever, no chills, no other rashes.
syncopal episode following immun w/MMR full recovery p/ 1/2 hr;
Pt reported dizziness when getting up after his 15 min wait post vaccination.  Only ate protein bar for breakfast & chips at noon. Mother reports pt has gotten dizzy after blood draws and gets really hungry around this time when his ritalin wears off. After water, juice & crackers pt reports dizziness is almost gone and he's ready to leave
1 week after ProQuad administration patient developed erythema raised area at injection site and multiple vesicles on trunk and in diaper area.