chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring 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 03-FEB-2017 at 11:00, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. 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-009507513-1704USA000416: 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-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
2/22  right hip spasm    2/25  right shoulder blade pain    2/30  right hip socket very painful  3/1-3/15 pain in right knee  3/15 pain now in left knee  3/16  extreme pain at 3AM  in BOTH  knees,  thought might go to Emergency
Patient presented to the ED and were subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was NSTEMI.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for hyperlipidemia, hypertension, CKD, anemia, prostate cancer, advanced age (95 years of age). No information regarding death or recent illnesses available.
Myocarditis; Appetite was steadily going away; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (Myocarditis) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DECREASED APPETITE (Appetite was steadily going away). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; SPIRONOLACTONE ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; FUROSEMIDE ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; DIGOXIN ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form and WARFARIN ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form. At the time of the report, MYOCARDITIS (Myocarditis) and DECREASED APPETITE (Appetite was steadily going away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   While admitting in the hospital, patient had a right and left heart catheterization, a heart biopsy, MRI and PEt scan and results are unknown.  No relevant concomitant medications were reported.   Patient was given number of medications and treatment in the hospital and details of the treatment medications at hospital are unknown.  Company comment: This case concerns a 37-year-old male patient with no relevant medical history reported, who experienced myocarditis among other events. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The events were considered related to the product. The rechallenge was not applicable since the subject received 2nd dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.; Sender's Comments: This case concerns a 37-year-old male patient with no relevant medical history reported, who experienced myocarditis among other events. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The events were considered related to the product. The rechallenge was not applicable since the subject received 2nd dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.
This spontaneous report as received from a medical assistant at the physician's office refers to approximately 16 year old male patient. The patient drug allergies were none. On 24-NOV-2015, the patient was vaccinated with third dose of GARDASIL (lot #K016966 and expiry date: 10-MAY-2017) intramuscularly. Concomitant medication were none. On 24-NOV-2015, the patient experienced dizzy and lightheaded. The patient did not sought medical attention. The patient was treated with water and cold compresses. On an unknown date, the patient experienced slight reaction to second dose of GARDASIL. The outcome of dizzy and lightheaded was recovering/resolving (reported as patient was doing fine on 25-NOV-2015 during the check). The outcome of slight reaction was unknown. The reporter considered slight reaction to be related to GARDASIL and causality of dizzy and lightheaded was not reported. Additional information has been requested.
Patient stated that she had fever, chills, sweating, weakness , insomnia, and vomiting  for few days after getting a vaccine.  She is still feeling weak and sick after one week of getting vaccine. She stated " she feels out of it". She had tele visit with her primary care physician and he recommended to report the side effects to the pharmacy. Patient also received a flu shot on the same day. VIS was provided for both  flu and pneumonia vaccines and she was counseled about possible side affects.  She was recommended to see her PCP in person for further evaluation and rule out any other illness; Covid, cold, flu but  she was unwilling and sure that it is caused by the pneumonia vaccine.
PATIENT GIVEN FIRST DOSE OF MODERNA VACCINE 1/11/2021 . SHE DEVELOPED PAIN IN RIGHT DELTOID.  ON THE NEXT DAY, SHE DEVELOPED LOW GRADE FEVER, FATIGUE, BODY ACHES, HEADACHE.  LATER ON 1/12/2021 PATIENT BEGAN TO NOTICE PAIN IN RIGHT AXILLA.  SHE HAS SINCE DEVELOPED RIGHT AXILLARY LYMPHADENOPATHY
Closed nondisplaced intertrochanteric fracture of left femur, procedure - Left - Left TROCHANTERIC FIXATION NAILING. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
red flat rash on body/ non itchy red flat rash; felt it was not allergic or, if it was, it was minor.; This case was reported by a nurse via sales rep and described the occurrence of red rash in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H524, expiry date unknown) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced red rash and allergic reaction. In February 2020, the outcome of the red rash and allergic reaction were recovered/resolved.   It was unknown if the reporter considered the red rash and allergic reaction to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in left deltoid. On 26th February 2020, the patient called to clinic and reported a rash that began within 24 hours of receiving dose 1 of Shingrix. It was a non itchy red flat rash on body, not near the injection site.  The rash resolved within 24 hours of onset of the rash. The rash was not itchy, the patient had no difficulty breathing, and had no related allergic symptoms. No medical visit or hospitalization was required subsequent to the event. The reporter stated that she felt it was not allergic or, if it was, it was minor
I experienced a delayed hypersensitivity reaction ("COVID arm") after receiving the first Moderna COVID vaccine (1/20/21). Exactly one week after being vaccinated (1/27/21, ~6:30 PM), my arm began to swell up again at the vaccination site and was itchy, warm, and red. The maximum diameter of the swelling was ~12cm. My axillary lymph nodes were also swollen and painful. This lasted for ~8 days with symptoms improving as time went on.
Pain at injection site - left arm, that became progressively worse to the point where I was not able to move my left arm. Today, 4 days after injection I am still not able to move it, even to drive my car. Excruciating pain, especially at night that keeps me from sleeping. I cannot raise my arm even to put on deodorant.  When I called my doctor on 10/06 to report this, only the receptionist gave me advice - that this is normal, hurts like a tetanus shot, etc.  This does not hurt like a tetanus shot, this hurts like there is something wrong.  I have a good size hard red bump at my shoulder, not the injection site, that hurts the most.
On 5/29, presented with progressive petechial and purpuric lesion over course of one day-seen in ER. Dx of ITP.
Adverse events:  three-day headache, palpitations and shortness of breath requiring visit to urgent care one week after vax.  Administered check for thrombocytopenai/blood test and came back negative.  Main problem:  tinnitus.  Onset four or five hours after shot in left arm.  Significant ear pain in left ear (sharp/stabbing).   Lasted several minutes/intermittent for about an hour.  This symptom segued into a feeling like hearing underwater in both left and a few hours later, my right ear.  A feeling of fullness and intermittent water-in-the-ear.  I did not connect either to the vaccine.  The next day or so these symptoms resolved, but I was left with a high pitched ringing sound in my left ear which lasted several minutes and continued intermittently for minutes at a time over the next days and weeks.  Over the next few months, the ringing increased in occurrence and began in the right ear a few weeks later as well.  A year later, I have permanent ringing in my right ear (low level constant sound) and intermittent ringing in left.  Right ear will increase in pitch and is significantly distracting, including causing sleep deprivation.  Because of COVID, I couldn't get in to get a hearing test and received one on 5/16/2022, audiometry, comprehensive, tympanometry testing.  I have mild hearing loss in my right ear and a sustained, constant mid-level hum/ringing.  Waiting for further medical help with the condition.
Patient was administered Pfizer covid-19 vacc  and asked to remain in waiting area. Within a few minutes, patient started complaining of dizziness. She remained seated in waiting area 20-30 minutes. Dizziness did not subside but did not worsen. Continued to monitor. After another 10+ minutes patient complained of swelling/tingling sensation of lips with no difficulty breathing or swallowing.  Within 10+ later patient experienced difficulty breathing and was administered an Epipen 0.3mg. 911 was called and transported patient to hospital ED.  Patient was later discharged home same day. Followed-up with patient the evening of 10/20/21. She reported doing much better. On follow-up call 10/21/21, patient still reported doing better... sore throat, but no itching or swelling.
Pt went into SVT, nauseated, tachycardic, dizzy.  Pt also reported after she received her first dose of vaccine in July she had irregular heartbeat and smart watch picked up A-fib.
4/3/21- 12:00pm shortness of breath and lung pain develop                 - 9:00pm fever of 102.4 4/4/21- 11:00am nose bleed (first in life not caused by trauma)
Became very ill with extreme flu like symptoms for 24 hours after the 2nd vaccine.  Within 3 days was unable to read aloud, explain and give examples. My brain was a blank. I lose words. I have memory loss.  I have decreased dexterity both hands/fingers. I have headaches. I had onset of vertigo approx a week to 10 days after 2nd vaccine.  Balance issues, sensitivity to loud sounds, voices, chaos. I have fatigue all the time. I think and move slowly.  I have had an MRI. There is isolated focus of increased T2 and FLAIR signal within the left frontal lobe. I am waiting for appointment with neurologist. I have been off work since 03/19/2021.
Swollen mph node I left armpit and back of neck; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left shoulder on an unknown date in 2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced swollen mph node I left armpit and back of neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen mph node I left armpit and back of neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case received from a non-healthcare professional (office staff). This case involves a 24 months old female patient who experienced croupy cough, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included two doses of INFLUENZA VACCINE on an unspecified date of 2017. The patient's medical treatment(s) and family history were not provided. No concomitant vaccines were given. On 05-Oct-2018, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: U26259A and expiry date: 30-Jun-2019) in the left thigh. On an unknown date, the patient developed a serious croupy cough, 12 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The event was assessed as medically significant. Patient was taken to emergency urgent care around 11:30 PM on 05-Oct-2018. No Lab data was reported. Final diagnosis was croupy cough. The patient was treated with EPINEPHRINE injection, IBUPROFEN and 0.25 ml DEXAMETHASONE on an unknown date. The outcome of the event was not reported. Documents held by the sender: none. Sender's Comments: Patient presented with croupy cough 12 hours after vaccination. Further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
24hr p/vax rt thigh was red w/5 inch wide border swollen area;used warm clothes & advil;
Bumpy, red, peeling skin, pain, soreness, ring around shot area on Flu vaccine. Pt brought to pharmacy attention 10-20-18. Bumpy, red, peeling skin on pneumonia vaccine. Pt brought to pharmacy attention on 10-20-2018.
EARLY MENSTRUAL CYCLE; PALLOR; LIGHT HEADED; WEAKNESS; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have known drug allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced early menstrual cycle. On 13-APR-2021, the subject experienced pallor. On 13-APR-2021, the subject experienced light headed. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from early menstrual cycle, had not recovered from pallor, and weakness, and the outcome of light headed was not reported. This report was non-serious.
administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter US-GLAXOSMITHKLINE-US2021219377:same reporter
During a Mobile Community COVID Vaccine Clinic a 16 y/o male patient was administered the MODERNA Covid-19 Vaccine.  This is an off-label use because MODERNA Covid-19 Vaccine is not authorized in this age group.. This is considered a vaccine administration error.  The clinic participants immediately determined how the error occurred and implemented strategies to prevent it from happening again. After the vaccination the patient was observed for 15 minutes by a covering physician and left the clinic after.
Information has been received through the pregnancy registry from a physician concerning a 29 year old female with no medical history or allergies who on 22-MAY-2007 was vaccinated with a dose of Varivax (Oka/Merck). It was reported that the patient had a positive home pregnancy test on 24-MAY-2007. Her LMP was noted to be 18-MAY-2007 and her estimated delivery date was 22-FEB-2008. The physician reported that the patient was vaccinated by immigration authorities and not at the physician's office. No problem was reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received which stated that the patient had electively terminated the pregnancy on 15-JUL-2007. The patient had 2 previous pregnancies with 1 full-term birth. The patient had no previous history of miscarriage. There was no birth defect in any of previous pregnancies. Upon internal review, patient's elective termination of the pregnancy was considered as an other important medical event. No further information is expected.
This spontaneous report as received from a consumer refers to her cousin of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot #, expiration, dose, route unspecified). On an unknown date the patient developed "MDMA anti-receptor encephalitis" after receiving GARDASIL. As a result, the patient lost the ability to speak and began having seizures. The events outcome was unknown. Upon internal review, the event of "MDMA anti-receptor encephalitis" was considered as medically significant. Additional information is not expected.
sore arm; This is a spontaneous report from a Pfizer-sponsored program,from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm in Mar2021 with outcome of unknown.  Information on the lot/batch number has been requested.
During the administration of the pediatric pfizer vaccine to the 8 year old kid, the kid moved his body/arm and the full dose may not have been administered b/c some of the medicine leaked out the syringe and did not go into his arm.
Patient reports having on and off migraine headaches and freezing chills and sweating since receiving the vaccine. She received the vaccine 6 days ago and I advised her to take TYLENOL for her symptoms and to call her PCP right away. I advised her that I would follow up with her to see how she is feeling.
This spontaneous report was received from an administrator referring to unspecified patients of unknown ages and genders. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (strength, dose number, route, lot number and expiration date were not provided) or prophylaxis. The vaccines experienced the temperature excursions, no product quality complaint was involved. It was reported that the vaccine GARDASIL 9 was not supported. Also the reporter was not sure if the vaccine was administered or not. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1612USA003396: US-009507513-1612USA008792.
Dizziness, Headache, Myalgia,  CHILLS Narrative:
recurrence of her recurrent R flank shingles 3 weeks later on 5/14