chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant, concerning a patient of an unknown age and gender. Medical history and current conditions were not reported. On 28-JAN-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number, lot number and expiration date were not reported), 0.5 ml dose, subcutaneous route, that underwent a supported temperature excursion. No adverse experience reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested. This is one (1) of four (4) reports from the same source.
Patient reported localized inflammation around injection site described as red and warm, but not painful. This occurred 2-3 days following administration of a ZOSTAVAX immunization.
This spontaneous report was received from a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # M029681, the expiration date: 22-JAN-2018 and Lot# M037533, the expiration date: 17-MAY-2018 (dose and route were not provided) for prophylaxis. No adverse effects reported nor Product Quality Complaint involved (PQC). The call was made due to data logger with a temperature of 35°F during 45 minutes. There was no previous temperature excursion reported.     This is one of several reports received from the same reporter.    Additional information is not expected because the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA009966: US-009507513-1704USA001678: US-009507513-1704USA001680:
Left anterolateral thigh, raised reddened area, warm to touch. Complained of itching. Applied warm compresses to relieve discomfort.
Rash on Stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on Stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash on Stomach). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at a dose of UNK dosage form. At the time of the report, RASH (Rash on Stomach) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.
pt recv vax  2 days ago in AM & by evening inj site sl raised, reddened-50mm x 50mm, warm to touch;no c/o itching;states skin is very sensitive;advised to apply cool compressor, ice pack & call if ineffective & can take APAP;
Painful rash on backside, that felt like a burn.  Rash on arm where vaccine was issued and on Back.
Initial and follow-up information has been received from a certified medical assistant concerning a 21 year old female who was vaccinated on 14-JUN-2007 in the pm, was vaccinated IM in the left deltoid with Gardasil (lot # 658100/0529U). On 14-JUN-2007 the patient experienced dizziness. Unspecified medical attention was sought. Subsequently, the patient recovered  from dizziness and warm for 20 seconds the same day. She had loss of consciousness for 20 seconds. The patients blood pressure measurement was hypotensive and was reported as 94/50 with a total heartbeat count of 56. The patient was layed down for approximately a half hour and reported that she felt fine. Her blood pressure measurement was reported as normal. On 14-Jun-2007, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/6/2007. Additional information is not expected.
Patient reported intense itching to left arm 45 minutes after receiving vaccine. Itching proceeded to worsen and spread across chest, and down the patient's left side. No hives were reported. Patient took BENADRYL and symptoms began to lessen.
Shingles; This initial spontaneous report was received from a lawyer, regarding a case in litigation and refers to a male patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   On or about 26-JAN-2011, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (strength, dosage regimen, route, lot number and expiration date were not reported) for the long-term prevention of shingles and/or zoster related conditions.   On an unspecified date, subsequent to patient's inoculation, he experienced shingles and was treated for a physician due to the event. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of the report, the patient had not recovered from the event.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
17 hours after first dose of Pfizer vaccine I experienced a fast heartbeat, vomitting, chills , sweats. Both of my arms went numb and I was unable to move my hands for about 3 minutes.
My right leg at the knee could a longer bend and it went up into my right thigh this happened the next day in about two days it went into my left leg also and a little into my arms I called my rheumatologist and he prescribed prednisolone I took that for 10 days after the 10 days is all happened over again I had to wait two weeks before he was back From vacation to get to steroid shots in each knee. This is helped tremendously the prednisone was a waste of time but my right knee still hurts when I bend it a try to go up the steps I did not have this pain before the second shot of Pfizer. Also I have cramps in the right leg
Headache, vision disturbances, blurry, continuous cold sweating from 1:25pm until 8:00pm the day the vaccine was given. No problems 7/29/2017.
This spontaneous report as received from a health professional refers to a 4-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative: Patient presented to ER on 12/1/21 with cough and SOB. Reported cough, myalgias, fatigue, and generally not feeling well for several days. Home O2 sats have been lower than his normal. O2 in ER dropped to <90% with SOB. Dx with COVID-19 pneumonia. Past medical history of COPD, diabetes, continued tobacco use. Treated with dexamethasone (12/1-12/10), remdesivir (12/1-12/5), and supportive care. Pre-renal AKI upon admission, but improved. Discharged on 12/5/21 with dexamethasone. Received Pfizer COVID-19 VACCINE ON 12/30/21.
Patient slumped immediately after injection then went into a seizure.  He revived and EMS responded.
threw up; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The reporter was the mother of the patient. The reporter reported that the patient received fist dose of Shingrix and on same day patient threw up and this had been resolved. The reporter did not indicate if the HCP was the same for her as was for her daughter. She only provided the HCP information for herself. The reporter did not consent to follow up. Additional supportive information: This case was linked with case US2022133812 reported by same reporter.; Sender's Comments:  US-GSK-US2022133812:Same reporter
1/3/2021 developed facial drooping later to be diagnosed by ER on 1/4/2021 as Bels Palsy status post  COVID-19  Vaccine administered on 12/28/2020.  The long-term outcome is unknown.  The patient returned to the center and was doing well.
Headache same day (Tylenol). Next day headache, fever and chills, dizziness, sore arm (Tylenol)
Pfizer-BioNTech Covid-19 Vaccine EUA 15 minutes after receiving the vaccine, when I stood to leave the facility, I felt light-headed which went away after a few deep breaths. 20 minutes after receiving the vaccine, having left the facility, my right hand hand had tingling. I took ibuprofen. The tingling lasted until 1:20 P.M. (at least 3 hours from receiving the vaccine).
Developed increased swelling at the injection site, with warmth;  tender to touch.  Noted that mildly itchy and ?indurated about 1 day later.  Swelling and firmness persisted several days.  At 2 weeks out,  visually can see circular red rim, larger than silver dollar size but swelling inside the circle is decreased and less hard to touch.  Feels overall warm to touch compared to non-injected side.  No fevers or other symptoms noted during this time.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-OCT-2015, (reported as "today"), the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L011537, expiration date: 03-JUL-2016 (dose and route were not reported). No adverse experiences had been reported and there was no PQC involved. No concomitant medication provided. Additional information has been requested.
Muscle weakness and pain, bone and joint pain - felt arthritic, could not drive because of muscle weakness. Could barely walk for 10 days - chiropractic care, E.R. visit, phys. visit - lab tests.
SWELLING ABDOMEN; BODY ACHES; TIGHTNESS IN THE CALF; MIGRAINE HEADACHE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included caller usually suffer migraine headache for about 2 days a month.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced swelling abdomen, body aches tightness in the calf, migraine headache, chills and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling abdomen, chills, body aches, tightness in the calf, headache and migraine headache was not reported. This report was non-serious.
Two days after vaccine:  extreme fatigue and chills.  Symptoms lasted just that one day.   Four-five days after  vaccine, full-body itching.  Just thought it was my eczema flaring up (it's worse in the winter).  After about 2 weeks, developed red areas on my body (torso, arms, legs and feet)  - self-monitored - but got progressively worse.  Dermatologist believes it is eczema aggravated by the vaccine.  Provided  a cortisone injection (right arm).  Will monitor for two weeks to determine improvement or lack of improvement.
This spontaneous report was received from a licensed practical nurse refers to 4 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or drug reactions/allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L030589, expiry date 10-FEB-2017 (dose, route and site of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA72AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Bexsero, it expired on 31st October 2021 and was administered on the same day as reported it, which led to expired vaccine used. The reporter consented to follow up.
No adverse effects; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C (-7.4C) during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005488: US-009507513-1905USA005504: US-009507513-1905USA005507: US-009507513-1905USA005503:
Seizures; Bacterial meningitis; deaf in one ear; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a 5-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced seizure (Verbatim: Seizures) (serious criteria GSK medically significant), bacterial meningitis (Verbatim: Bacterial meningitis) (serious criteria GSK medically significant) and deafness unilateral (Verbatim: deaf in one ear) (serious criteria GSK medically significant). The outcome of the seizure and bacterial meningitis were not reported and the outcome of the deafness unilateral was not resolved.  It was unknown if the reporter considered the seizure, bacterial meningitis and deafness unilateral to be related to Flu vaccine.  It was unknown if the company considered the seizure, bacterial meningitis and deafness unilateral to be related to Flu vaccine.  Additional Information: GSK receipt date: 26-APR-2023 This case was reported by the patient's parent via interactive digital media.  The patient had got the flu vaccine and started having seizures then it led to bacterial meningitis, now (at the moment of reporting) she was deaf in one ear. The reporter was so overwhelmed right now (at the moment of reporting). Follow-up would not possible, as no contact details were available.
7 severe armpit boils (unter the skin) with 103 degree fever. Dark bruising, severe tenderness of skin, boils approx. 1 - 3 inch diameter. I have never had this happen before. I have never had any abcesses this bad before. Lanced on 5/21 in. Applied Emu oil/Neem oil mixture. Utilized warm wet washcloth. Started course of antibiotics on May 19. The left arm was sore and painful since 2nd dose of vaccine with tingling and pain in finger tips from 5/6 - 5/22
This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 57-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 November 2008 at 10:15, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 12 November 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus and injection site redness. The healthcare professional reported that a subject received a FLULAVAL vaccination at an on job site flu clinic at 10:15. Immediately after receiving the dose, she developed redness and itching at the injection site. The subject was followed up with at 13:00 and the events had resolved. On 12 November 2008, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. Follow-up information was received on 24 November 2008, via healthcare professional. No new information was provided.
PC-1820PM crying hard x 7hr (2mo old cried off & on 6hr);lt leg getting real hot, swollen;inc APAP & DPH, cool pack;
localized mild right upper lip swelling Narrative: Employee reporting localized mild right upper lip swelling >2 hours after 1st dose (when arrived to obtain 2nd dose). No associated tongue./throat or other facial swelling increase salivation difficulty swallowing secretions, change in breathing/difficulty breathing, wheezing, stridor, diaphoresis pruritis, urticaria, changes in skin color, tachycardia, angioedema, nausea/vomiting/abdominal cramps, confusion, dizziness, or changes in speech/fluency of communication. Noticed issue while eating dinner. Was able to eat dinner without any difficulty and issue self-resolved in less than an hour. Has had similar reactions in past to food, but does not know what she may be allergic too. Sister recently underwent allergy testing. Denies other personal or family history of allergic rhinitis or asthma. Denies facial fillers. Observed for 30 minutes without issues, ER precautions provided. Working in area around LIPs and medical equipment.
Pt given Zostavax in L arm 6/10/08 with onset of vesicular rash on L side of face and pain/ hyperesthesia. Seen by Dr 6/30/08
No adverse effects were reported; patients received one separate dose each of the improperly stored PROQUDA; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  There were three separate patients received one separate dose each of the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number reported as R022566 and expiration date 04-FEB-2020, subcutaneously for prophylaxis) (product storage error). The three separate doses of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were administered on 22-FEB-2019, 19-MAR-2019 and 15-APR-2019. It was unknown as to which patient which dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on which day. It was unspecified if the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly. No adverse effects were reported. No product quality complaint (PQC) was involved.  The other two patients were captured in case# 1906USA000042 and 1905USA003408.; Sender's Comments:  US-009507513-1906USA000042: US-009507513-1905USA003408:
she had a little soreness in her arm.; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9367) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "She has had reactions in the past to sulfa drugs" (unspecified if ongoing), notes: She has had reactions in the past to sulfa drugs. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she had a little soreness in her arm.".  Additional information: Patient was not visited to emergency room or physician office visit. Patient not received any vaccine within 4 weeks.
Vaccine expiration date 04/10/2023 after leaving ultraviolet freezer.
Mother of pt stated redness, heat on (R) arm site of IZ, first noticed on afternoon of 9/13/11. At upper arm erythematous, hot to touch, not painful as reported by pt.
My daughter received the vaccine at about 11am on 10-21-15. By 4:30pm that same day, she spiked a fever of 101.9. She had a fever for about 24 hours. She had no other symptoms than a fever. We had to give her 2 extra strength TYLENOL to contain the fever. With 2 extra strength TYLENOL in her, the fever remained at a 101.7, it barely went down, for hours. We continued to give her TYLENOL every 4-6 hours to try to reduce the fever and the chills and headache she experienced.