chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Milk soy protein intolerance; Gastrooesophageal reflux disease; Foetal exposure during pregnancy; This solicited pregnancy report received from a consumer concerned a female neonate. The patient was enrolled in a non-company sponsored study: COVID 19 Vaccines International Pregnancy Exposure Registry number: C02188) of unknown race and ethnicity. The patient's height was reported as 55.88 cm and weight was 4.904 kilogram. The patient's pre-existing medical conditions included: the mother did not use drugs for recreational use, tobacco or alcohol during pregnancy. The female foetus mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin trans-placental, batch number: 1802072 expiry: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid, calcium carbonate/magnesium hydroxide, docusate sodium, doxylamine succinate/pyridoxine hydrochloride, ferrous sulfate, folic acid, omeprazole, prenatal vitamins and ondansetron.  On 10-MAR-2021 (at gestational age 17 weeks and four days), the foetal exposure during pregnancy was occurred. On 30-JUL-2021 (at gestational age of 37 weeks), female foetus, was delivered by caesarean method of delivery (C-section). Primary reason for the C-section was reported to be breech presentation of baby. On 09-AUG-2021, the female neonate was diagnosed with milk soy protein intolerance (MSPI) and gastrooesophageal reflux disease and received treatment consisting of omeprazole, malox, lactulose and vitamin D. Baby has not been diagnosed with any genetic or inherited disorder. On unspecified date in 2021, Laboratory data included: Acoustic stimulation tests for which baby passed the hearing test. On unspecified date Laboratory data included: alphafetoprotein, foetal nuchal translucency, prenatal cell-free DNA screening and prenatal screening and results did not show any problem or concern. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the milk soy protein intolerance, gastrooesophageal reflux disease and foetal exposure during pregnancy was not reported.  The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and milk soy protein intolerance, and gastrooesophageal reflux disease was related, and between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy was not related.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958843. This parent/child case is linked to 20210763712.; Sender's Comments: V0: 20210958552-Covid-19 vaccine ad26.cov2.s-milk soy protein intolerance, Gastrooesophageal reflux disease. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
R hand contact dermatitis nearly healed (dermatologist Dr.) on 10/3/19. Day after flu shot, 2 allergic spots showed up on lower L leg, and R hand began worsening with allergic spots becoming more and more pronounced daily. Internist (diabetic) physician seen 10/11/19 - physical. By 10/26/19 ER visit for pronounced allergic spots up to thigh. By 10/28/19 follow-up dermatology visit for spots now on hips, buttocks, and breasts. Hypersensitivity immune response skin reaction probable.
Dizziness, lost balance & falling; nausea; ears "felt full"; back of throat itchy; lasted 2 1/2-3 days;
Received GARDASIL dose #1 on 10/22/14 at 10 am; facial swelling noted on the evening of 10/22/14. By morning of 10/23/14, eyes were swollen shut and face was swollen itchy. Pt with multiple environmental allergies (shellfish, tree nuts) treated with BENADRYL.
Headache, tiredness immediately on the day of.  8 days later, soreness returned in my arm at the injection site. This soreness had originally subsided within 48 hours. It came back 8 days later and lasted another ~48 hours.
RAISED BUMPS AROUND INJECTION SITE, VERY PAINFUL, AREA COVERS ABOUT 3 INCH CIRCLE
Patient received first dose of Pfizer vaccine. Instantly became nauseous and Faint/pale.  Assisted him to the floor elevated legs. No LOC. Pulse was 80, BP 138/80
This is a spontaneous report based on information received by Pfizer from Merck, manufacturer control number 00318555. A contactable pharmacist reported for a patient of an unknown age, gender and race that received PREVNAR 13 for immunization at single dose on unknown date. On unknown date the patient experienced allergy reaction of hives. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
I had a severe rxn . I have only half of 1 kidney total. After second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a severe rxn . I have only half of 1 kidney total. After second vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Solitary kidney (I have only half of 1 kidney total).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a severe rxn . I have only half of 1 kidney total. After second vaccine). At the time of the report, VACCINATION COMPLICATION (I had a severe rxn . I have only half of 1 kidney total. After second vaccine) outcome was unknown.          No Concomitant use were reported.  No Treatment were reported
FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be this record indicates a medical adverse event for the patient. there is no product quality issue reported. Approval to void this record due to no pqc identified. Void:Y based on the PQC evaluation/investigation performed.
Info regarding Prevnar was received from a healthcare professional regarding a 6 year old pt who experienced urticarial rash. The pt received a dose on 3/20/05. Indication for Prevnar was immunization. Product was administered on 3/10/05. Dose regimen was 1 dose. It was reported that the pt has a history of recurrent pneumonia and sinusitis. He was referred by his pediatrician to the infectious disease department at a hospital for follow-up. The pt was given Prevnar on 3/10/05 and developed a urticarial rash. The pt was hospitalized. No additional info was available at the time of this report.
Woman with PCR positive vaccinia rash who was never vaccinated.  Contact transmission.  Positive history of contact, exact dates uncertain.  Woman with rash is a civilian, history of contact is with military personnel.    Rash appeared on 06/11/03 on perineum, first appeared as a vesicle then ulcerated when washed.  Still able to obtain a specimen, positive report to state on 07/22/03.  One lesion only no systemic or local symptoms
rash around the injection site, it is mildly itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash around the injection site, it is mildly itchy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced RASH PRURITIC (rash around the injection site, it is mildly itchy). At the time of the report, RASH PRURITIC (rash around the injection site, it is mildly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by patient  Treatment information was not provided by the reporter.
Patient called on Aug 26 2012 & stated that on 10/14/11 she received a flu shot while pregnant and the next day she had terrible cramping and bleeding and had a spontaneous abortion.
Itching/swelling at injection site. Left upper arm swelling. No treatment - will meet/follow up with Dr 02/17/18.
Varicella vaccine breakthrough. Patient seen 11/29/05 in our office by doctor and diagnosed with varicella. Had body aches starting 11/27/05. Rash started 11/29/05. Had 8 lesions with central vesicle on face with some crusted. No fever. Had varicella vaccine in another country.
Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative:  Rest, fluids, Tylenol and Motrin at home
1 hour after vaccine blurred vision in left eye . Throat felt like it was closing up and ear ringing . all lasted about 2 hours. 9/10 -9 /13 severe headaches and chills . Heart rate over 100
His eyes didn't look good and could not see after his first dose.; His eyes didn't look good and could not see after his first dose.; This is a spontaneous report from a Pfizer- sponsored program received from a contactable consumer (patient's wife) reported for a male patient (reporter's husband). A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced his eyes didn't look good and could not see after his first dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient initially seen in urgent care on 7/15 for symptoms related to COVID-19. Starting 7/7, patient started feeling fatigue, and on 7/11 took a COVID home test which was positive. Additionally, he developed cough, sore throat, and fever. Due to symptoms, patient went to urgent care and while there the patient's SPO2 was 88% on room air so he was placed on 2L NC. It was felt that patient would benefit from an overnight stay in the hospital given his COVID-19 infection, so he was directly admitted to Hospital in on 7/15. During admission, patient developed left sided weakness and was diagnosed with acute ischemic stroke. Patient transferred to Hospital in on 7/17 and was admitted until 7/26. Patient was weaned off oxygen. He is vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Information has been received from a consumer, for the Pregnancy Registry for GARDASIL, concerning a 14 year old female with no relevant drug reactions/allergies and with no pertinent medical history who on 07-OCT-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number reported). Concomitant therapy included influenza virus vaccine (unspecified). It was reported that the patient received her first dose of the vaccine and she was pregnant with a last menstrual period of 04-SEP-2009 (EDD: 11-JUN-2010). Urine pregnancy test was performed and was positive (unspecified date). The patient sought medical attention by an office visit. Follow up information has been received from a nurse. It was reported that the patient terminated the pregnancy early on, in her first trimester. The nurse reported that the patient and her family decided for multiple reasons, not as a result of her having had the GARDASIL during pregnancy. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review termination of the pregnancy was considered to be an other important medical event. No further information is expected.
59 years old received Fluzone HD with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old and unknown gender patient who received fluzone hd with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza quadrival A-B high dose HV vaccine, expiry: 30-Jun-2024 via unknown route in unknown administration site for Prophylactic vaccination (strength, formulation, dose, batch number: unknown), 59 years old received fluzone hd with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 59product administered to patient of inappropriate age   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 the 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.
Intense full body chills, extreme fatigue, fever over 103°. Did not respond to over the counter fever reducers. Lasted about 18 hours.
Pericarditis, chest pain, fever, rigors, vomiting.  Treatment with NSAIDs. Cardiology consultation. Follow up arranged with cardiology and Cardiac MRI
t105 ax about 102 hrs p/vax recvd; tx w/APAP, sponging, office visit examined & afebrile;
PRODUCT STORAGE ERROR; ADMINISTRATION ERROR OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 04-JAN-2022 for prophylactic vaccination. Age at time of vaccination 38 years old. No concomitant medications were reported. On 04-JAN-2022, the patient experienced administration error of vaccine stored outside of the recommended storage conditions. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error of vaccine stored outside of the recommended storage conditions and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558390, 20220558340, 20220558343, 20220558345, 20220558349, 20220558378, 20220558383, 20220558455, 20220558598, 20220558638, 20220558823 and 20220558852.
PMH includes hx of severe preeclampsia in the 3rd trimester of pregnancy (2015) and latent TB infection (s/p treatment). 22mins post vaccination pt c/o difficulty breathing.  Pt was given 25mg PO Benadryl @10:26am.  Vitals: @10:23 BP 124/83, HR 86, RR 20, SPO2 100% -- > @10:30 124/83, 76, 15, 100% -- > @10:45 124/86, 84, 18, 100%.  Pt stable and released from vaccination site.  Recommended that the pt f/u w/ their healthcare provider, f/u instructions provided.
STROKE; This spontaneous report received via social media/news from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced stroke three weeks after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2. s- stroke This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
3/5/16 Sx blisters on arm. Spreading red and yellow fluid filled. 3/8/16 left arm rash started 3 days ago. Increased in vesicles in past 24 hrs. Left arm only. Color erythematous. Sx sudden in onset. Left arm multiple clusters of vesicles. Dx acute supportive otitis media with spontaneous rupture of ear drum, left ear. Zoster with complications rx amoxicillin 400 mg/5 mL 5 mL PO BID x 10 days. ZOVIRAX 200 mg/5mL 6 mL PO QUD x 10 days.
Feeling sluggish and fatigued, starting on March 16th. More tired than usual, especially in the evening. Intermittent headache throughout the day but not constantly hurting.
Swelling of face; difficulty swallowing; chest hurt to breathe; rash head to toe - pinprick rash; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: FF3389) via an unspecified route of administration at left arm on 01Oct2021 at 14:15 (at the age of 15-year-old) as dose 2, single for COVID-19 immunisation. Medical history included irritable bowel syndrome, known allergies Peanuts, cashews, augmenting, covid-19 on an unspecified date. There were no concomitant medications. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously took augmentin [amoxicillin sodium; clavulanic acid] and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 Prior to vaccination and since the vaccination patient has not been tested for COVID-19. Patient was not done with covid test post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: FC3182) via an unspecified route of administration at left arm on 03Sep2021 15:30 (at the age of 15-year-old) as dose 1, single for COVID-19 immunisation. The patient experienced swelling of face, difficulty swallowing, chest hurt to breathe, rash head to toe - pinprick rash on 02Oct2021 at 15:30. Case was reported as non-serious. Patient received treatment with Ibuprofen and Benadryl for the events. Outcome of all events was recovered on Oct2021.   Follow-up attempts are completed. No further information is expected.
Approx 5-10min postvax c/o nauseated, had dry heaves & spit up some phlegm; Sat down, was sweating profusely, very pale, hives on his face, became sleepy, en route to ER developed bradycardia;
I became very Sick the next 2 days following the Moderna vaccine unlike my first 2 doses. And then developed a very loud high pitch tinnitus in right ear  following flu like symptoms. Never experienced this before. I was not able to sleep at night.
Pt recvd a series of 3 Engerix-B vax 9JAN90, 4FEB90 & 12JUN90 & pt did not respond; 5MAY91 recvd an Engerix-B dose & immunoglobulin; Pt then had a surface antibody of 19.4; AUG91 suffered another needlestick & titers were found to be 8.4;
This spontaneous report as received from a healthcare worker refers to a 6 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 12-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Complains of arm pain and swelling at injection site. Symptoms continued for at least 10 days. Patient noted significant swelling 8 days post vaccination. Seen in office on day 10. Normal exam. No rash, swelling noted. Able to perform ADLS independently. Good ROM on exam. Treated with ibuprofen in office.
12 hours after vaccine I got chills, fever, nausea. Felt better next day with just fatigue and lightheadedness. Tuesday after the vaccine I got diarrhea with constipation along side the fatigue. Those symptoms lasted throughout Thursday. Friday night after the vaccine I got small haves around my head, neck, and upper back that would not away after an hour or two. That continued throughout Saturday and midday trough Sunday. Sunday I had shortness of breath after moving some water bottle cases around and lightheadedness along with the small hives at around 2pm I went to the ER to get checked out. Doctors said it was a reaction caused  by the vaccine. They gave me Benadryl for the reaction and injected me with a "Steroid" to the my upper buttock. I don't remember the name of what they injected with me. It is now Monday April 19th a day after the ER and I feel much better. The Benadryl made the  hives go away.
Patient received shot 11/12/15. She then came back to the pharmacy on 3/9/16 (almost 4 months after flu shot) asking if she had gotten the shot here. She had. She wanted the date so she could tell her physician. She said since her flu shot she has had severe bursitis in her shoulder.
Body aches/ The sore intensified when pushed; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches/ The sore intensified when pushed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040821A and 006821A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYALGIA (Body aches/ The sore intensified when pushed). At the time of the report, MYALGIA (Body aches/ The sore intensified when pushed) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-408589, MOD-2021-408587 (Patient Link).