chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving HPV # 1 client waited in reception area for 10-15 minutes and with departure in hall vomited.
Information has been received from a licensed practical nurse concerning an 8 year old female with no past medical history who on 05/28/1997 was vaccinated with the first dose of varicella virus vacicne ive. SC. There was no illness at the time of vaccination. On 01/17/2002 the pt developed chickenpox. The pt's mother stated that her daughter had "about 25 lesions mostly on the buttocks, one on face and several under each arm." It was reported that the pt recovered on 01/21/2002. It was noted that the pt did not have any adverse events following previous vaccinations. No further info is expected.
Patient had 4 moderna with our office, and a pfizer bivalent at another facility , not Primary Health 10-2-2022 and then came to our office for a moderna bivalent booster 2-28-2023 . I did not see her injection that she had somewhere else 10-2021.
47F, MMC employee, with pmhx of HTN, presents with sore throat since this morning. Pt notice her uvula is enlarged and touching her tongue which is not normal for her. Tolerating PO. Pt received 1st dose of Pfizer vaccine yesterday and is concerned this may be a reaction to the vaccine.
Red spotted rash on both arms; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 18Apr2021 at 00:00, the patient experienced red spotted rash on both arms. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with prednisone (MANUFACTURER UNKNOWN) and clobetasol (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had been tested for COVID-19. On 26Apr2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. The clinical outcome of the event red spotted rash on both arms was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
upper back discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (upper back discomfort) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (upper back discomfort). At the time of the report, MUSCULOSKELETAL DISCOMFORT (upper back discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  patient reported having vaccinated a week before event.
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 61-year-old male patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown. The reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The reporter stated that the patient reported to him that at some point after receiving the SHINGRIX vaccine, he experienced an itchy rash on his chest. The reporter did not have any additional details regarding the rash.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : Patient did not receive any other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient has known syncopal history, but did not inform vaccinator. After vaccination, he had a near-syncopal event. Patient laid down with feet elevated. He received evaluation from EMS, but refused further treatment/transport.
Information has been received from a consumer who received an e-mail from a friend, which received the email from his friend concerning "one of his adult daughters" who on an unspecified date received GARDASIL. It was reported that within hours the patient went into anaphylaxis shock. The patient went to the ER where she was told that she had been within 10 minutes of dying. At the time of the report the patient status was unknown. The reporter considered anaphylaxis shock to be immediately life-threatening. No further information is available.
DAY 1 POST-VACCINATION (4/1):  NOTICED RINGING IN BOTH EARS WHEN I WOKE UP IN THE MORNING.  ACCOMPANIED BY SINUS CONGESTION ALL DAY (NOSE, EARS).  FEELS LIKE WHEN YOU HAVE WATER IN YOUR EARS AND YOU WANT TO HOLD YOUR NOSE TO TRY AND BLOW IT OUT. DAY 2 POST-VACCINATION (4/2):  EXPERIENCED MILDER RINGING IN BOTH EARS MORNING TO EVENING.  NO SINUS CONGESTION.  RINGING SHIFTED PREDOMINANTLY TO LEFT EAR. BY END OF DAY.  PERSISTED AT BED TIME. DAY 3 POST-VACCINATION (4/3):  WOKE UP TO HIGHER INTENSITY RINGING IN LEFT EAR.  INTENSITY INCREASED MID-MORNING AND SHIFTED TO LEFT EAR.  NO SINUS CONGESTION, BUT LEFT EAR WHERE RINGING HAS INTENSIFIED FEELS LIKE IT IS PLUGGED UP LIKE WHEN YOU HAVE WATER IN YOUR EAR AND WANT TO HOLD YOUR NOSE TO TRY AND BLOW IT OUT.
ELEVATED TEMPERATURE FOR TWO DAYS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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: Unknown) 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 number. No concomitant medications were reported. On an unspecified date, the patient experienced elevated temperature for two days. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated temperature for two days. This report was non-serious. This case, from the same reporter is linked to 20211212497.
pregnant women received Adacel/No AE; Initial information was received on 03-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 33 year old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], at 30 weeks of pregnancy, during third pregnancy trimester.  Data regarding this pregnancy were received prospectively, before pregnancy outcome was known.  The date of last menstrual period was reported as 07-May-2019.  The estimated due date is 11-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  On 03-Dec-2019, the patient received a 0.5 cc dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6539AA via intramuscular route in the left deltoid.  It was case of vaccine exposure during pregnancy. The patient was 30 weeks pregnant when she received vaccine.  At the time of report, no adverse event was reported.  Pregnancy outcome was unknown at the time of report.
On 3/24/02, the vaccinee received his 1st injection of Engerix-B. On 3/25/02, 1 day post immunization, he experienced nausea. The nausea persisted on 3/27/02.  Follow up on 01/16/04: "On 04/07/03, the physician indicated that the subject was lost to follow up .  No further information is available."
3days p/vax pt had low grade fever, vomit p/feeding, appetite was off, fussy at times, began having diarrhea, gassy, colicky at time.
Perspiring; Covid arm; Itching; Covid arm/hot; Covid arm/swollen; Exaggerated flu like; Grapefruit size 10 days po; Body aches; I slept off and on for three days; Body aches; Fever; Chills; sleeping for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping for 3 days), HYPERHIDROSIS (Perspiring), VACCINATION SITE REACTION (Covid arm), PRURITUS (Itching) and VACCINATION SITE WARMTH (Covid arm/hot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Fibromyalgia, Spinal stenosis and Arthritis. Concomitant products included THYROID (ARMOUR THYROID), POTASSIUM, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MAGNESIUM and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 01-Aug-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (sleeping for 3 days), HYPERHIDROSIS (Perspiring), VACCINATION SITE REACTION (Covid arm), PRURITUS (Itching), VACCINATION SITE WARMTH (Covid arm/hot), VACCINATION SITE SWELLING (Covid arm/swollen), INFLUENZA LIKE ILLNESS (Exaggerated flu like), UNEVALUABLE EVENT (Grapefruit size 10 days po), PAIN (Body aches), SLEEP DISORDER (I slept off and on for three days), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HYPERSOMNIA (sleeping for 3 days), HYPERHIDROSIS (Perspiring), VACCINATION SITE REACTION (Covid arm), PRURITUS (Itching), VACCINATION SITE WARMTH (Covid arm/hot), VACCINATION SITE SWELLING (Covid arm/swollen), PAIN (Body aches), SLEEP DISORDER (I slept off and on for three days), MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and INFLUENZA LIKE ILLNESS (Exaggerated flu like) and UNEVALUABLE EVENT (Grapefruit size 10 days po) had resolved.            Patient reported that the concomitant medication armour thyroid was indicated for use of rovustatin. Patient reported that the concomitant medication Lasix was indicated for use of gabepetin. No treatment medications were reported.  18 hours after receiving the second dose of the Moderna vaccine patient  began to experience fever, chills, perspiring, body aches. Patient went to bed requesting more and more blankets. Patients husband reported that patient slept off and on for three days. Patient remember very little of this time. Patient enquired was it safe to receive booster.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Updated reporter information, patient demographics and added past relevant history, and concomitant medications and new events were added.
Dizzy and very nauseated. I was fine until about 11-12 hours after vaccination. Before only symptom was arm pain. I am filling this out as I am not feeling well
The next morning there was pain and redness at the injection site. The area felt warm. The area was hard like a knot. The pain has subsided but it is still painful when touched. On Sunday, the redness was estimated to be about 6 to 7 cm. The patient says it feels like it is slowly getting better.
I received booster shot on Monday 12/6/2021.  The next morning while working (stilling in front of a computer) I noticed a headache. It wasn't until around 2pm that I thought it could be related to the booster shot. The injection site (left arm) also sore, But I also have soreness on my left arm pit, but I didn't equate that to the shot. Wednesday 12/8/2021 morning after showering I checked my left arm pit because it is extremely sore and noticed it's swollen.  As I'm filling out this form (Wed. 12/8/2021 @ 8:30am) I have the headache, injection site soreness and soreness and swelling on arm pit
Hyporesponsive/ hypotonia episode immediately after vaccination- pale, sleepy, periodic breathing.
Extreme fatigue, numbness tingling left arm, hand, shoulder, neck pain. Tremor, (L) hermittes sign symptoms began about 12-23-09. Facial numbness. Transverse myelitis, cis diagnosed 1-14-10.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 43rd of 43 adult patients described by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number
Fever up 103°, chills, shaking, aches, injection site pain and swelling, swele).ling of lymph nodes under arms - more so on left (injection side)
Hot Flashes lasting 2 days. Sweating profusely lasting 2 days.  Arm Soreness/pain lasting 3 days - 500mg Acetaminophen  q4-6hours PRN  Headache 45 mins after injection - 500mg Acetaminophen  Fatigue lasting 3 days.
never had shingles until I got the shot!/ suspected vaccination failure; never had shingles until I got the shot! it lasted over a month.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient never had shingles until the patient got the Shingles vaccine. Shingles lasted over a month and the patient would never get a vaccine again. The patient stated that he/she did not need to read anything to know the truth. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for were unknown.
Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself).  This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation.  Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.
Severe sudden onset nausea with vomiting 8 hours after vaccine. She also had a HA, body aches and fever
Fatigue, chills, fever, +2 pedal edema, joint pain, chest pain
Erythema, tenderness & induration 2cm x 2cm at site left deltoid. Also c/o tenderness, swelling left axilla. BENADRYL / ice.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # J014855, expiration date 01-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 16, 59 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same reporter. Additional information has been requested.
Bruising at the injection site; Spontaneous report received on 11FEB2020.  A male consumer reported that he developed bruising at the injection site (PT: Injection site bruising) following the immunisation with BioThrax (anthrax vaccine adsorbed). On 05FEB2020 at 11:05 am, the patient received BioThrax via intramuscular route in left arm. Few days after administration of BioThrax, he developed bruising at the injection site. It was reported that there was no requirement of treatment. The event was resolved at the time of report.  Company Comment: A consumer received BioThrax via intramuscular route on his left arm and after a few days, he developed injection site bruising which resolved without any treatment. Emergent considers the reported term of bruising at the injection site (PT: Injection site bruising)  a non-serious event, although expected according to the CCSI and package insert. Local injection site reactions like bruising could happen after BioThrax vaccination, therefore given the temporal relationship causality of the event is assessed as related.  .; Sender's Comments: Company Comment: A consumer received BioThrax via intramuscular route on his left arm and after a few days, he developed injection site bruising which resolved without any treatment. Emergent considers the reported term of bruising at the injection site (PT: Injection site bruising)  a non-serious event, although expected according to the package insert. Local injection site reactions like bruising could happen after BioThrax vaccination, therefore given the temporal relationship causality of the event is assessed as related.  .
Patient received Moderna booster on 1/31/23 and reported to the ER on 2/1/23 with very high blood pressure readings of around 180/110 per patient. She also had symptoms of cloudy vision and severe headache at that time. She states that it took several medications before it came down and they could discharge her. She's not sure if the hypertensive episode was caused by the vaccine the day before, but wanted us to report the reaction just in case.
Information has been received from a medical assistant referring to a 9 week old male patient. No relevant medical history or concurrent conditions were reported. On 24-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 10/28/21 and the second dose of Moderna COVID-19 Vaccine on 11/18/21 which is earlier than 28 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
I tested positive for Covid on 06/06/22 and was ill for about a week.  I was prescribed Paxlovid and recovered from the Covid infection.  On 07/14/22 I woke up with a headache that worsened over the next 5 days.  I went to the ED on 07/20/22 with severe headache, especially around the left eye.  I was diagnosed with a sinus headache and prescribed tordol for pain.  I went home and had two doses of the tordol before waking up on 07/21/22 with impaired vision in the left eye, a drooping left eyelid, and still a severe headache.  I saw my opthalmologist on an emergency basis on 07/22/22 and he sent me immediately back to the ED for a brain MRI.  I returned to the ED and was admitted to the hospital.  After a 2-day hospitalization and extensive testing I was diagnosed with Tolosa Hunt Syndrome.  I began steroid treatment and continue on prednisone currently.  Most of my symptoms have resolved, but not all.  I still have double vision when looking up, down and to the left.