chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; Inadvertently administered a dose of rotateq, that was delivered late and deemed not viable by the wholesaler; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 20-SEP-2019, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dosage form via oral route(defaulted route) (lot number S006159 with expiry date of 10-NOV-2010) for prophylaxis, which was delivered late and deemed not viable by the wholesaler (poor quality product administered). No adverse effect was reported. No information regarding temperature, time frame, previous temperature excursion and data logger were provided by the reporter. No product quality complaint was filed by the reporter.
I received my second Moderna booster for COVID-19 on 4/13/2022. On 8/4/2022, I was answering questions in a pre-op exam in preparation for rotator cuff surgery. My arms had been aching recently, I had been sneezing, and I had been fatigued. When I described my symptoms to the NP who was interviewing me, it occurred to me that maybe I should take a COVID-19 test, as my partner had recently had it. Later that evening, I took a home test and got a positive result. I called the hospital on 8/6/2022 to notify the NP I had spoken to about my test result and left a message for her. When she returned my call on 8/8/2022, she suggested that I take Paxlovid, because I was still within the 5-day window of time to begin receiving it. However, I was feeling much better by then, so I decided against it. The preparations for my rotator cuff surgery went ahead afterwards, and I underwent the surgery on 8/31/2022.
very muscle hurt; skin felt like it was on fire; had difficulty moving; fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever, muscle pain, burning sensation skin and movement disorder. On an unknown date, the outcome of the fever, muscle pain, burning sensation skin and movement disorder were recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain, burning sensation skin and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient experienced difficulty in moving, very muscle hurt, fever, skin felt like it was on fire. For tolerance of 2nd dose, refer case US2020AMR135190. The case has been linked with the cases US2020AMR135104 and US2020AMR135291 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135104:Same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR135190:same reporter
Vomiting. 4 occurrences over 35-45 min. period. Significant quantity of mucus. Also soreness and redness in eyes along w/ some nasal congestion, lasting to this point - 20 hrs after inoculation.
17MAY96 day p/vax rash noted per mom on pt face brought in MD checked dx herpes simples treatment Zovirax
felt kind of sick; sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt kind of sick) and PAIN (sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ILLNESS (felt kind of sick) and PAIN (sore). On 22-Jan-2021, ILLNESS (felt kind of sick) and PAIN (sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had second dose of vaccine on 15Feb2021 in the same facility with lot number 013M20A.  No concomitant medications were reported.  No treatment medications were reported.
Notice hum in both ears following second phizer covid vaccine injection. May have started earlier but definitely noticed in the month following injection. Tried antihistamine, thinking might be related to allergies or congestion in sinuses/ ears, with no change,. Primary provider checker ears: clear with no fluid. On no medication that lists tinnitus as side effect. Have continued to monitor past 10 months, no change. Have never experienced this in past.
soreness of both breast after 1st shot; Soreness of both breast got worse after second shot; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (soreness of both breast after 1st shot) and BREAST PAIN (Soreness of both breast got worse after second shot) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BREAST PAIN (soreness of both breast after 1st shot) and BREAST PAIN (Soreness of both breast got worse after second shot). At the time of the report, BREAST PAIN (soreness of both breast after 1st shot) had not resolved and BREAST PAIN (Soreness of both breast got worse after second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082968:First Dose
Patient received a 5-11 yo bivalent Covid booster vaccine instead of the 12+ yo bivalent vaccine. The intended 12+ yo bivalent booster was administered 21 days later.
I had an extremely high fever and illness that started 24hrs after the second vaccine that lasted up to 4 days. I was running 104F fever for 2 days that OTC medicine would not break the fever. On 04/20/21 I had my LMP while severely sick. I found out I was pregnant on 05/13/21 and had a miscarriage at around 10 weeks on 06/29/2021. I have 2 prior children with no history of miscarriage or fertility issues and was seen routinely and early on in my care. I wanted to report this in case anyone is studying these kinds of events and would want the information.
Persistent diarrhea; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265 and expiration date was not reported), via an unspecified route of administration in left arm, on 17Feb2021 at 13:00 (at the age of 22 year old) as first dose, single for COVID-19 immunization in doctor's office/urgent care. Medical history included X-linked hypophosphatemia and hypertension. Concomitant medications included amantadine; candesartan; burosumab (CRYSVITA) and vitamin D3. The patient had known allergies for codeine, oxybenzone, nickel and experienced drug allergy. The patient was not pregnant at the time of vaccination and did not receive any other vaccines within the 4 weeks of COVID-19 vaccine. Prior to the vaccination, the patient was not having COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced persistent diarrhea on 18Feb2021 at 02:00. No treatment was received by the patient for this event. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Friday Apr 23rd, started with fatigue and mild fever, by Saturday, April 24th had very noticeable swollen eyes, glands, face and neck with low fever.  by Sunday, April 24th, closed and ringing ears.  Fully resolved by Tuesday, April 27th with only slight ringing in left ear.
7 days after vaccine developed local red, rash at injection site.  Rash resolved on its own
She got the immunizations around 2:30pm.  Her leg was immediately sore and remained sore throughout the day, night, and next day. She fell asleep at 5:45pm, a little over three hours after vaccine, and slept until 8:30am the next morning. Through the night, she complained about her leg hurting. I gave her 5ml children's ibuprofen around 3am, as well as an ice pack for her thigh. She woke up at 8:30am, complaining of a sick stomach. Her face was pale and green. She ran to the toilet and vomited, mostly all yellow bile. She has been on the couch for a few hours since vomiting, and her body feels warm like the beginning of a fever, now at 11:00am, the day after the shots were administered.   She really is not much of a vomiter (maybe once a year) and I have rarely ever seen her face so pale and green, so it seems to me, as the parent, that the symptoms she is exhibiting are related to one or both of the vaccines she received yesterday.
Redness approximately 4" in diameter with annoying itch. Began 36 hours after injection and ongoing 4 days later.
Headache; Fever; Muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Muscle aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Muscle aches). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Muscle aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant and Treatment medications were reported.
Full body joint and muscle pain, nausea, treated successfully with prednisone, ZOFRAN, ROBAXIN.
gave Moderna COVID 19 vaccine to a 17-year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave Moderna COVID 19 vaccine to a 17-year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter doesn't know if patient received the 2nd dose. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
High fever (101), painfully swollen arm, unable to work in the 24 hours after vaccination.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 21-MAR-2017 at 08:53, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000428:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704U.
nursing home patient; tested positive for COVID on 8/26/21; was transferred to location for COVID isolation; overall declined while in isolation; poor oral intake; transferred back to nursing home and never improved; DNR/DNI; pt continued to deteriorate; CKD stage 3; main goal became comfort; dc'd most all medications except for comfort medication; pt passed away in the nursing home
Woke up with a fever of 101.6, sore throat, headache, achyness, and felt like heart was beating hard.  Went to dr in the morning and tested positive for strep.  Prescribed amoxicillin.
Urticarial rash - generalized RX - BENADRYL & PREDNISONE
I woke up on 12/14 and felt extremely fatigued and very achy in my thighs and legs, hips. Very severe headache, which was unusual. I took a home test for COVID-19 and came back positive. I think the symptoms lasted about 3 to 4 days. I called the doctor and was given the option of taking antivirals but declined. I'm still testing positive 12/25 but the doctor said that wasn't unusual. I had a productive cough that I was coughing up green stuff before I contracted COVID-19, and she prescribed a mucus thinner. It turned white, but then turned green again after COVID-19 so my doctor prescribed an antibiotic for sinusitis and possible bronchitis.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 10-OCT-2014, unspecified amount patients were vaccinated with RECOMBIVAX HB lot # reported as J014855, expiry date 16-APR-2016 (dose, route of administration, were not reported) that were improperly stored. No adverse symptom was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.
Vomiting and diarrhea that lasted over a week and required IVF.  Local swelling and erythema at injection site
Patient noticed increase perspiration and increased heart rate around 4pm.  Watch notified them that they may have in irregular heart beat.  They sent the Watches EKG to the Dr who advised the patient to take a dose of Xarelto 20mg and Bisoprolol 5mg.  Patient states they returned to normal Sinus rhythm at 2108 with no other issues and feeling well.
Left arm pain. Left chest pain. Left neck pain. Tingling in Left hand fingers. Sometimes a feeling of numbness.  Tingling in left arm. Tingling in Left chest. Tingling in Left neck. Tingling up back of Left side of head. No medical doctors have been able to give reasoning why. Visited emergency room in april 2021. Could not explain why these feeling were happening. Visited pain management doctor November 2021. They said it was a heart issue. Saw a cardiologist and did stress test and stress echo test in February of 2022. Test said heart was fine. Could not explain other symptoms. All symptoms are still occurring as of 1/17/2023.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. Past drug history included: Salicylic acid, reaction(s): "Drug Allergy", notes: Known allergies: Salicylic acid. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Negative, notes: positive tests after 2 days of negative tests; (Oct2022) Positive, notes: Indication=Treatment of COVID-19; (21Oct2022) Positive, notes: positive tests after 2 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine and other medication in 2 weeks. COVID 19 treatment start date 13Oct2022 and stop date reported as 18Oct2022. Reoccurrence of symptoms & positive tests was found after 2 days of negative tests.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information was received on 20-OCT-2016 from a medical assistant who was reporting on a female patient who received the following vaccines: On 30-AUG-2011, the patient was 11 years old and received a dose of an unspecified "HPV" vaccine (manufacturer unknown). Lot number and expiration date were unspecified. On 29-OCT-2012, the patient received a dose of GARDASIL lot H009746, expired 11-JAN-2015. On 16-JAN-2015, the patient received a dose of either GARDASIL or GARDASIL 9. The reporter did not know which of the two vaccines were given. Lot reported K005881, exp. 14-JAN-2017 which is a valid lot for GARDASIL. On 20-OCT-2016 the patient received a dose of GARDASIL 9, lot M023169, exp. 13-JUN-2018. The patient did not report an adverse experience. No other information was provided. Additional information has been requested.
Information has been received from a medical assistant concerning a 21 year old female with no allergies or medical history who was vaccinated intramuscularly, 0.5 ml, with the first dose of GARDASIL (Lot # 661766/0652X) on 23-FEB-2009, and with the second dose of GARDASIL (Lot # 661766/0652X) on 23-APR-2009. There was no concomitant medication. The patient called the physician on 28-APR-2009 and reported that on 25-APR-2009 she developed a rash on her shoulders, back and hands. The patient also reported she felt dizzy but none of the symptoms started until 2 days after getting GARDASIL. The patient reported the rash looked like red dots and were itchy. The physician prescribed (BENADRYL) for the itch. The physician advised the patient not to get the third dose of GARDASIL. The patient sought medical attention by calling office and was recovered. Additional information has been requested.
Pt with sl swelling at site of injection (thighs) with refusal to walk 2 days later day. Pt seen & was able to bear weight but refused to walk next morning otherwise Nl PE.
This spontaneous report was received from a healthcare worker refers to a 62 year old female patient with lupus. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient experienced varicella-like rash on her legs after receiving ZOSTAVAX. No pain was associated with the rash. No treatment was given. Laboratory diagnostics studies performed were none. No medical attention sought. The outcome of varicella-like rash on her legs was reported as recovered. Additional information is not expected.
Mild/Slight Rash; Itchiness; Redness due to Scratching; Feeling Nauseated; "Hot"; Sweating; Initial Report Received 30-Jan-2020 and 31-Jan-2020  On 25-Jan-2020, a physician reported that a female employee (approximate age 18 to 22 years) received her first injection of HEPLISAV-B (Lot #933621).  No concomitant vaccinations were administered.    One hour after vaccination, the employee reported mild/slight rash at injection site, itchiness, redness due to scratching, feeling nauseated, sweating, and "hot".  No treatment was administered.   On 26-Jan-2020, the events were all considered resolved.      None of the events were reported as serious.   Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
PATIENTS BROKE OUT IN RED SPLOTCHY HIVES ON HER FACE, NECK, IMMEDIATELY AFTER ADMINISTRATION OF THE HEP A VACCINE. PT WAS ADMINISTERED 17.5MG OF ORAL BENDERYL X 1 DOSE; PT HAD NO RESPIRATORY DISTRESS, NO LIP SWELLING; NO WHEEZING ON AUSCULTATION.
This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 46-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml. (Medication error). No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
Lasted roughly 24 hours: Fever (102), aches, headache, lethargy
Local arm pain; lasted 48 hours Chills and sweating; lasted 48 hours Trouble sleeping; lasted 48 hours
I noticed having tinnitus and vertigo. With the vertigo, I could not walk a straight line and then when I would move my head, my head would spin. I felt lightheadedness and off balance. The tinnitus started ringing with a buzzing sound in both ears that is worse at night. I went to my doctor about the dizziness. I went to the ER on 11/3/2022 where I had an incident that I pitched forward on my desk. A stroke was ruled out. I had a CT Scan and X-rays. I seen a cardiologist and neurologist. Everything has been ruled out. I went to an ENT and had was told that I had positional vertigo. I have been seeing physical therapy since. I still have the tinnitus as well but not as severe. The vertigo got worse with my 4th dose which was on 04/27/2022, lot FJ4989.