chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 15:00 - Client was brought by her mother to the clinic, to receive her 1st dose of Pfizer Pediatric vaccine. Client and mother were greeted at the door by RN. RN confirmed with mother that client was here for Pfizer Pediatric 1st dose and mother was here for a Moderna booster. RN stated to client's mother "you can get your booster at a Moderna station and your daughter will get vaccinated at station 3 with Pfizer Peds but I'm about to draw it up now so it may be a wait".  Mother of client verbalized understanding and then mother stated "I want the vaccinator at station 1, I heard she is really good". RN stated, "we are all really good". RN then returned to station 6 to draw Pfizer Pediatric vaccine. Client and mother then entered room at station 1 set up for Pfizer Adult. RN asked mother of client "are you here for Pfizer?". Mother of client stated "yes" and had her daughter sit down in the chair to be vaccinated. RN then asked client "what is your date of birth?", client stated her DOB. RN then proceeded to vaccinate the client with 0.3 mL of Pfizer (lot #FK9729) in the client's left arm. Client and mother then walked to station 2 for mother to receive Moderna booster. Ancillary alerted co-lead of the situation. 15:13 - Co-lead RN alerted Lead RN of the situation. Lead RN met client and mother in room at Moderna vaccination station 2. Lead RN stated to mother of client "I am going to collect you and your daughter's information and then we will have your daughter monitored in observation for 30 minutes and we are going to have a medical consult to get a recommendation going forward for your daughter's next vaccine", client's mother verbalized understanding and were walked to observation by co-lead. 15:25 - Co-lead RN contacted clinical lead to elevate for a medical consult. Per County MD "client is to return 21 days later for age appropriate dose, no special follow-up needed". 16:15 - Co-lead shared MD's recommendation with mother of client, educated mother on emergency precautions, and to follow up with client's primary care physician, mother of client verbalized understanding. 16:25 - Co-lead took the client's vitals: BP: 95/64, HR: 93, SpO2: 99%, RR: 24. 16:30 - Co-lead RN escorted client and mother to exit, client A&Ox4, steady gait, no complaints.
red rash, more on trunk than extremities, x 2 days; t99-100 R; congested, runny nose, feet & hands swollen x 2 days;
Patient had a recurrence of her osteosarcoma after scans were clear prior to the booster
Swollen/painful lymph node in left armpit, swollen/painful left deltoid; large round red rash Treated at home with ice, rest, healthy diet Not resolved yet
Reaction began on 01/19/21, several days after the injection was given. It began with itching on the left upper arm in the morning that turned into redness that same afternoon. Over the 20th and 21st, the redness continued to worsen, turning very dark maroon/purple and spreading to cover almost the entire lateral aspect of the left upper arm. The area was very hot to the touch, swollen, itchy, and tender to the touch as well. At 4:45pm on January 21st, I (the patient) saw a doctor at my normal physician's office. Dr. was concerned about the severity of the reaction and also could not completely rule out cellulitis. Dr. prescribed an IM steroid injection and a 10 day round of Keflex. Today (01/24/21) the rash is still present, itchy, and warm to the touch, although it is improving in appearance and is no longer tender or swollen.
Fever of 102 F; she didn't feel comfortable receiving the vaccine at that time; This is a spontaneous report from a contactable Nurse (patient).  This 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 19Dec2020 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient had fever of 102 Fahrenheit two weeks ago (Jan2021).  She waited 29 days instead of the 21-day recommended to receive the second dose as she didn't feel comfortable receiving the vaccine at that time.  The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Information has been received from a consumer referring to her daughter, a 15 year old female patient with none drug reactions/allergies and none pertinent medical history. On unknown dates, the patient was vaccinated with her first and second injections of GARDASIL series. On 12-FEB-2016, unidentified Merck HPV vaccine was administered (name and lot number not provided) to the patient (injection, the third dose, route and dose were unknown). There was none concomitant medication. About 5 hours after receiving the third dose, the patient experienced hives from the neck. The patient called to pediatrician for medical attention. Unspecified BENADRYL was given to treat the event. None lab diagnostics studies were performed. The patient's hives was recovered in February 2016. On 14-FEB-2016 (also reported as on Sunday), the patient's hives recurred and again early on the morning of 15-FEB-2016. The patient had not had any reaction to the first two injections in the GARDASIL series. She was watched for several days. The outcome of hives was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
PATIENT REPORTED FEELING UNWELL AND THEN BECAME UNRESPONSIVE FOR SEVERAL MINUTES WITH ONLY A COUPLE BREIF RESPONSES TO INDICATE SHE WAS LIGHT HEADED AND DIZZY BUT EVENTUALLY REGAINED CONSCIOUSNESS AND LEFT WITH PARAMEDIC /EMT FEELING OK AND STATING SHE DID NOT WANT TO GO TO THE HOSPITAL
Information has been received from a consumer concerning her 15 year old daughter with allergies to penicillin and other antibiotic and no pertinent medical history who in approximately 2008 ("about a year ago"), in fall 2008, and on 26-JAN-2009 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # not provided). There was no concomitant medication. On approximately 26-JAN-2009 ("right after she received the third dose") the patient experienced extreme fatigue, vomiting and headache that seemed to be getting worse everyday. Blood panel and CAT scan were performed (no results provided). At the time of reporting, the patient's extreme fatigue, vomiting and headache persisted. The patient sought medical attention via visiting primary care physician and pediatrician. Additional information has been requested.  5/13/09 medical records received DOS 1/26/09 to 3/31/09. FINAL DIAGNOSIS: Nausea and vomiting secondary to psychological issue. Post-vaccination feeling weak, tired, abdominal pain, fever, projectile vomiting, diarrhea. Bloody urine and cramps. Sore throat and swollen glands. Upper quandrant tenderness. Burning sensation in chest. Dizzeness, not eating well. Othostatic hypotension. Referred to counseling center. To schedule STD screening and pelvic exam.
Breakthrough case admission after 3 vaccines Moderna 1/8/21 Lot# 012L20A;  Moderna 2/5/21 Lot# 038K20A; Moderna 12/4/21 Lot# 029H21B
temp up to 104.5; developed rash, head to toe; Hives; This case was reported by a nurse via call center representative and described the occurrence of fever in a infant female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix Quadrivalent with an associated reaction of urticaria (received 1st dose of Fluarix Quadrivalent 2018-2019 season in 2018 and developed hives refer case US2022061845).   On an unknown date, the patient received the 2nd dose of Fluarix Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, 24 hrs after receiving Fluarix Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced fever, generalized rash and hives. Rechallenge with Fluarix Quadrivalent 2018-2019 season was positive. On an unknown date, the outcome of the fever, generalized rash and hives were recovered/resolved.   It was unknown if the reporter considered the fever, generalized rash and hives to be related to Fluarix Quadrivalent 2018-2019 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022061845   Additional Information: GSK Receipt Date: 07-Apr-2022 Reporter's Comments: The reporter stated that the patient reacted to Fluarix vaccine quadrivalent. The vaccine was administered in 2018, 24 hours after the vaccine administration developed rash, head to toe, hives and temperature up to 104.5 degree F.   Temperature reportedly lasted 1.5 days and rash/hives 2.5 weeks. The reporter wanted to resume vaccinations. The reporter was unable to provide exact date of vaccine or additional details as the vaccines were administered at a different facility. The reporter consented to follow up via post.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061845:same reporter
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. About three years ago (in October 2010) the patient may was vaccinated with ZOSTAVAX (lot #, dose, anatomical location and indication not reported). The pharmacist reported that the patient might have received with ZOSTAVAX about three years ago, and he still got shingles on an unknown date. The outcome of the event was unknown. He was not sure that the patient had ever received ZOSTAVAX previously. The pharmacist stated that he would call the patient to see if that was correct, and then he would call back. It was unspecified if the patient sought medical attention.
Nausea (no vomit), fatigue, injection site arm swollen and sore, local rash appeared a few days later. Took 2 acetaminophen for aches (no fever). Pt also took a Claritin 10mg via ongoing rx for allergies. Rash is still lingering.
Information has been received from a physician concerning an approximately 11 week old female who on 31-OCT-2008 was vaccinated orally with the second dose 2 ml dose of ROTATEQ. "After receiving her second dose", the patient experienced "red and watery stools" and the patient did test positive for rotavirus. On 15-JAN-2009 the series of ROTATEQ were decided to discontinue. The patient recovered on an unspecified date. Unspecified medical attention was sought. Follow-up information was received from the physician concerning the 8 month old patient with no illness at time of vaccination, no pre-existing allergies or birth defects or medical conditions. On 31-OCT-2008 the patient was vaccinated orally with the first dose of ROTATEQ (lot # 660880/0923X). Concomitantly, the patient was vaccinated IM with the second dose of PANTACEL (lot # C3176AA) on the same day. On 15-JAN-2009 the patient was vaccinated orally with the second dose of ROTATEQ (lot # 662876/1169X). The physician reported that the patient got only 2 doses of ROTATEQ. She developed diarrhea at 8 month of age. On 27-APR-2009 the sample of the patient's stools was collected for rotavirus antigen test. The following lab tests for stools were also ordered: routine ova and parasites exam, C. Difficile toxins A and B test, white blood cells, direct giardia lamblia, stool culture. On 06-MAY-2009 the patient's mother was notified and diarrhea was improving. The results on 08-MAY-2009 revealed that rotavirus antigen test was positive (also reported as on 05-MAY-2009 the rotavirus antigen test was positive) and the stool C. Difficile toxins A and B test was abnormal. The other lab test results were not provided. The physician also reported that the patient's rotavirus antigen test was positive at the age of 8 month, the time of the "third" dose of ROTATEQ. The patient was recovered on 09-MAY-2009. Additional information is not expected.
family getting covid after vaccination; family getting covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "family getting covid after vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. News Article regarding family getting covid after vaccination. The patient was tested positive for Covid-19 post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt came in 10/24 and reported arm still bruised from immunization give 10/9/15. It also is a little hard. Was concerned. Let him know bruising should go away at seeing his MD Monday 10/29. Anyway so have him look at it.
Patient had soreness/pain at the injection site the night of the injection. Still have pain at the same site as of today on and off taking motrin and alternating with tylenol. His doctor is aware of the situation.
Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out with friends. Spoke to father on phone at or around 9:00 pm. Failed to show up to work and was found dead at home. Other details pending
This spontaneous report as received from a pharmacist, via company representative, refers to a male patient of unknown age. Concurrent conditions, pertinent medical history, drug reactions or allergies were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. On an unknown date the patient experienced bumps/spots on his arm that then traveled to the other arm. Treatment given for the adverse event and laboratory diagnostic studies performed were unspecified. It was unknown if the patient sought medical attention. The outcome of mass was reported as resolved on an unknown date. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a nurse referring to a 4-year-old male patient. The patient's concurrent conditions included overweight and anaemia. The patient had no concomitant therapies, and no known allergies.      On 11-DEC-2020, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # T021302 (also reported with lot # T011302), expiration date 19- DEC-2020, 0.5 milliliter, subcutaneous for immunisation (vaccination scheme frequency and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of -5 degree Celsius (°C) for 10 hours as recorded by a data logger. There was no previous temperature excursion reported.  Lot # T011302 has been verified to be an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot number T011302 is a valid lot number for sitagliptin phosphate (XELEVIA).
Dizzy and light-headed. Methylprednisolone 4MG Dospak21's.
majority of  vaccine leaked onto the patients arm; vaccine leaked onto the patients arm; vaccine leaked onto the patients arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: The reporter stated that, she had a patient that was administered Shingrix, but the reporter had a needle malfunction, and the majority of the vaccine leaked onto the patients arm.  The reporter believed complete dose was not received by the patient adverse event filed. The reporter provided limited information. Additional Supportive Information: A patient that was administered Shingrix, but the reporter had a needle malfunction, and the majority of the vaccine leaked onto the patients arm and reporter believed complete dose was not received by the patient, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Approximately 10 minutes after receiving MMR, hepatitis B & influenza vaccines employee felt "thick tongued" & "loopy".  "Loopy" feeling lasted about 30 minutes. "Thick-tongued" for 1 hour.  History of several allergies (food, seasonal allergies & Type I, latex allergy).
Loss of balance, falling. Weakness in limbs.  Pins and needles in limbs.
Injection site swelling and tingling ("like I hit my funny bone"). According to treating provider, swelling may be pushing on ulnar nerve. Dr placing on employee on prednisone.
Heàdaçhe  réally tired stayed in bed and slept most of dày. Next dày nót só tired felt some better bút still had heàdache linger for another 2 dàys
Headache, fever, body aches, nausea, fatigue, lethargy, injection site pain over first 12-18 hours. Fluids only for treatment
No additional adverse effect reported; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included sterile diluent (STERILE DILUENT) that did not experience a temperature excursion.  On 31-JAN-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (exact dose was not reported) (lot # S024364, expiry date 06-AUG-2021) for prophylaxis. The storage temperature range was from -14 Celsius degrees (C) to - 10 C (-12.6 C) during the time frame of 9 hours and 53 minutes. Previous temperature excursion was from -14 C to -10 C (-13.00 C) for 14 hours and 22 minutes. The digital data logger was involved. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001486: US-009507513-2002USA001358: US-009507513-2002USA001459:
I felt mildly feverish, had body aches and fatigue as expected day 2 after the second shot. Two weeks later I started getting hot flashes and have had them randomly ever since. I haven't had hot flashes before and didn't have them when I went thru menopause five years ago so this is new and seemed to possibly be triggered by the vaccine.  Since I have read that some women have had reactions related to their periods (heavier periods, etc.) I wanted to reach out even though hot flashes are not obviously life threatening. They do compromise quality of life. If there is more evidence that this vaccine adversely impacts women's hormones I wanted to weigh in. This should be studied.
3 weeks after receiving the second dose of the Pfizer vaccine, complaint of bilateral knee pain, swelling on the right side, mainly hip, leg, feet, and ankles; was advised to see a medical provider.; Doppler test results normal, labs normal. Diagnosed delayed immune response reaction by the treating physician
Heart Rate 170 for 2 hrs; vaccine is administered outside the range19 - 42 days after the first dose; Insomnia; Fever; Sweets; Chills; Headache; This is a spontaneous report from a non-contactable consumer (Patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 22Apr2021 10:15 (at the age of 31-year-old) as single dose for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 25Feb2021 10:15 as single dose for covid-19 immunisation. On 22Apr2021 23:00, the patient experienced heart rate 170 for 2 hrs, vaccine is administered outside the range19 - 42 days after the first dose, insomnia, fever, sweets, chills and headache. The patient underwent lab tests and procedures which included heart rate: 170 for 2 hrs. No treatment was received to treat this adverse event. The events insomnia, heart Rate 170 for 2 hrs, fever, sweets, chills, headache were recovered on an unspecified date in 2021 and outcome of vaccine is administered outside the range19 - 42 days after the first dose was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rt upper arm red @ inject site some swelling; pt c/o tingling in 4th & 5th finger; r/o cellulitis pt started on Duricef & Seldane
This is a follow up to report (s) previoulsy submitted on 2/14/2007. Information has been received from a nurse practitioner concerning a 20 year old female on contraception, and supplements with iron deficiency anaemia and no allergies, who on 18-JAN-2007 was vaccinated IM with a first dose of HPV vaccine (yeast) (lot# 655165/1425F).  Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN 24FE) and iron (unspecified).  Two hours after, the patient called the office and complained of nausea and vomiting.  The patient came into the office the next day because her vomiting lasted throughout the night and she stated that she passed out.  By the time she came to the office she was doing better.  No diagnostic studies were performed.  At the time of this report, the patient was  recovered.  No product quality complaint was involved.  Additional information has been requested. In follow-up it was reported that the patient's symptoms of nauea, vomiting and fainting lasted several hours and improved without treatment. The patient recovered on 18-JAN-2007. Additional information is not expected.
Migraine: onset at 7:25pm, rest did not help. Ibuprofen 800mg did not help. I take topiramate for migraine prevention in general and this did not curb the migraine. It was a sudden onset with aura. Light sensitivity present. Pain localized to the frontal lobe. Pain 10/10. Body aches: bilateral knee aches regardless of whether they are extended or bent, pain 9/10. Ice or heating pad did not help. Lumbosacral spine aches 8/10.  Chills: Temp set to 72 and under 3 throw blankets, still having chills.  GI sxs: N/A Respiratory: N/A Muscoskeletal: neck stiffness radiating down to both shoulders, bilateral calf muscle stiffness (although I did have a flight from overnight 8/24 to 8/25 which could be from that)