chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effects reported; One patient was administered improperly stored PROQUAD; This spontaneous report has been received from a registered nurse referring to a patient with 13 months old of unknown gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies were not reported.    On 31-MAR-2020 the child was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot # S022917, expiration date 19-JAN-2021) subcutaneous, as prophylaxis (concentration, frequency, dose, route of administration were not reported).  The use of sterile diluent (MERCK STERILE DILUENT) was reported as "properly stored".  It was informed that the temperature excursion was -14.1 celsius degrees in a time frame of 26 minutes, there was no previous temperature excursion and a digital data logger was involved.  No additional adverse event was provided by the reporter.
Chills, and violent shaking , could barely speak , and stuttering. Vomiting for 3 hours Following day: brain fog and exhaustion
Injection site  got really red started about a quarter in diameter and swelled to about 9 inches in diameter.  Itched and was painful. Lasted about 1 weeks time.  Ibuprofen and diphenhydramine.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 18th March 2021) for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional information was provided as follows: The pharmacist reported that they administered the SHINGRIX to a patient in left arm and the patient experienced arm soreness with redness and pain. The patient came in the pharmacy a couple of days after the vaccination to report the reaction and she claims that the side effects lasted for 3 months. Consented to follow up was provided.
Tachycardia, essential hypertension, POTS Syndrome - was totally non functional for 3 months.
This spontaneous report as received from a nurse refers to 8 patients of unknown age and gender. The nurse states that 8 patients were vaccinated with improperly stored (oka-merck) PROQUAD (lot#, expiry date, dose and route not reported) from 12-JUL-2014 till "today" (05-SEP-2014). No adverse effects reported. Additional information is not expected.
syncopal episode; itching; fullness; feeling funny; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), intramuscular on 19Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included manual vacuum aspiration (MVA), traumatic brain injury (TBI) from 2007 to an unknown date, vagovasal and hypotension post TBI, Celiac disease, allergy to milk products, diagnosed with COVID-19 from Aug2020 to an unknown date prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included famotidine, methylphenidate, fludrocortisone, omeprazole, desvenlafaxine succinate (PRISTIQ), brexpiprazole (REXULTI), and folic acid. The patient was previously vaccinated with the first dose of bnt162b2 (lot number: EL3246) at the age of 30-year-old, intramuscularly for COVID-19 immunisation on 19Jan2021 at 14:15 and experienced heart flutters and "fell faint" (fainted). The patient also previously took ibuprofen and experienced allergies. After approximately 5 minutes after the patient had the second dose of vaccine (19Feb2021 14:20), the patient had syncopal episode, itching/ fullness. Covering physician present and assessed with EMS on Duty: VS: 110/80-BP, 18-RR, 96-HR, SaO2-98% on RA, CBG: 138. Patient awakened and reported "feeling funny" on 19Feb2021, but was A &Ox4, MAEW x4 with equal strength, Lungs Clear to auscultation. At 14:20 the patient was given Benadryl liquid PO given along with 8oz of water. Patient able to drink without issues. At 15:00, EMS called for ER transport to due prolonged recovery. The events resulted in emergency room/department or urgent care. The outcome of the events was unknown.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I developed an ulcer in upper GI tract. Severe stomach pain. Deterred from eating due to the pain. This I started having internal bleeding. I had an endoscopy which confirmed the ulcer.
He started feeling cold.  Came home from work with a severe headache, fever, swollen extremely painful arm, rash, puffy red face, accelerated heart rate, numbness in his face, hands, feet.  It progressed to worse.  Ended up in the ER two times.
This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms. On an unknown date, the outcome of the loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Four hours after receiving vaccination, the patient experienced swelling and redness at the injection site. The patient also experienced feel like she did not have energy, she felt like she had the flu, was achy all over, and slept most of the day. All of these symptoms resolved after four days. For tolerability of 2nd dose of SHINGRIX, refer case US2018GSK209484. The patient had denied permission to contact their physician.
pt recvd flu vax 18NOV93 & 20 hrs later was noted to be febrile, 24 hrs p/inject devel a rash on lower extremities, 49 hrs later was noted to have hematuria & proteinuria;
Dizziness when standing. Tingling whole body. VS @ 12181 82,18, 1 Sat 99%.
Diffuse pain upon examination of (R) deltoid muscle on 7/2/13. Pain with activation of deltoid muscle only. Ordered PT and started on oral steroid to decrease inflammation.
elevated was my cholesterol; Looking on my hip area of my right hip and the rash on my face is just starting to get better/ This whole week my face is breaking out with rash; itching quite a bit; shingles; pretty big blister; I got fatigued; This is a spontaneous report from a contactable consumer. A 42-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA6780 Expiration date was not reported), dose 1 via an unspecified route of administration on 17Jul2021 17:00 (age at vaccination 42 years) as dose 1, single for covid-19 immunisation. Medical history included epilepsy, covid-19 from 10Dec2020 to an unknown date. Concomitant medication(s) included lacosamide (VIMPAT) taken for epilepsy; topiramate (TOPIRAMATE) taken for epilepsy (Both of them are 100 mg and they both are once a day). Prior to vaccination, the patient was not diagnosed with COVID-19. On Jul2021 the patient experienced elevated was my cholesterol, looking on my hip area of my right hip and the rash on my face is just starting to get better/ this whole week my face is breaking out with rash, itching quite a bit, shingles, pretty big blister, I got fatigued. Patient stated, Right after this shot, had a big bump on my chin. Most of the rash spots are on the right side of my body. it's been itching quite a bit and I am not so hairy so, thats why I don't know, whether they are shingles or not. I have been trying to figure it out, where it is coming from and then thinking may be If feeling some difference or I can pinpoint back to this vaccine. So, I just didn't take it today. cancelled the appointment." When probed to confirm, if you should go for second shot, stated, Well. That is a part of it. Yes. I mean, I cancelled it for, That's the reason also because, I have to go flyout somewhere so, I am just concerned, When I get back. Should I be taking the second one or just wait? I had a big bump on my chin, But I didn't think anything else did because, I thought it was because I ate a tomato and I thought it was some acid from that and I had a humongous bump on my chin and then it kind out of went down and it went away. Okay, Then I thought, it must be, what it was and then suddenly couple weeks later, I hadn't eaten tomatoes. It had been and my whole face started around to rash getting really really red and it started itching like crazy, but how I am scratching myself and I haven't changed any soaps. I havent changed anything that. I didn't have any much arm pain that, they kept saying you will have, Even that bad. I got fatigued but, they said you will have. I was fairly, Okay and I thought everything went very smoothly and then this rash happened so, that was all about it. The patient underwent lab tests and procedures which included blood cholesterol was slightly elevated/little elevated on Jul2021, blood test was normal on Jul2021. Patient received treatment of, over the counter Neosporin. The outcome of event fatigue was rest of all events outcome was unknown.  Follow-up attempts are completed. No further information is expected
Could not get out of bed; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of bedridden in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced bedridden (Verbatim: Could not get out of bed). The outcome of the bedridden was not reported.   It was unknown if the reporter considered the bedridden to be related to Shingrix.     It was unknown if the company considered the bedridden to be related to Shingrix.   Additional Information: GSK receipt date: 24-Mar-2023 This case was self reported by the patient. The patient could not get out of bed day after first dose of Shingrix.  The patient did not had issues after the second dose. The reporter consented to follow up.
Patient began with injection site pain, lethargy, stomach pain, runny nose worsening, urinary hesitancy.
I developed a rash 10 days after receiving the 2nd dos of the Covid Moderna Vaccine.  There a red spots, blisters, and it itches. The rash is primarily on the arms and on the neck and upper back.  It started at night, it got a little better during the day , then came back the next night.  I  still have it.  The doctor recommended an antihistamine Hydroxyzine HCL, which I took today.
pt recv vax 25MAY95 & 01JUN95 pt noticed that had 25 lesions (varicella like rash) on body, on scalp, behind ears & back; MD reported son had been exposed to natural varicella @ school about 6wk ago
This spontaneous report as received from a patient's husband refers to his wife of unknown age. On approximately 04-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dosage and route not reported). The consumer reported that approximately on 06-OCT-2014 "earlier this week" his wife developed an injection-site reaction that includes swelling, redness, and itchiness 48 hours after receiving ZOSTAVAX. The same day she received ZOSTAVAX, she received an unspecified flu shot, and with 24 hours of that vaccination, she had flu-like symptoms. The outcome was unknown. It was unspecified by reporter if the patient sought medical attention or not. Additional information has been requested.
Patient was given a Pfizer Covid vaccine that was expired on 1/14/2022, no symptoms
Information has been received from a nurse practitioner for VARIVAX (Merck), a Pregnancy Registry product, concerning a 29 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 07-OCT-2011 was vaccinated with the first dose of VARIVAX (Merck) and on 07-NOV-2011 was vaccinated with the second dose of VARIVAX (Merck) (Lot numbers, doses and routes not reported). There was no concomitant medication. The nurse practitioner reported that the patient was administered with VARIVAX (Merck) while she was pregnant. Her last menstrual period (LMP) was on 13-OCT-2011 and her expected delivery date (EDD) was 19-JUL-2012. No lab diagnostics studies were performed. No adverse effects were reported. Follow up information was received from a Certified Registered Nurse Practitioner (CRNP) refers to the patient that the delivered a healthy baby girl full term at 39 weeks (14-JUL-2012) and the infant had no congential anomalies. The infant weight was unknown at the time of the report but was told that all was good with the child. Additional information is not expected.
This spontaneous report was received from a medical assistant concerning a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-NOV-2018, the patient was administered with improperly stored ROTATEQ (lot# R003149, expiry date: 19-FEB-2019) for prophylaxis. Dosing details were unknown for the vaccine. No adverse effect reported. The temperature excursion occurred between 0 degree Celsius to 1 degree Celsius (0.5 degree Celsius multiple) for a time frame of 13 hours and 18 minutes. There were no previous temperature excursions occurred. Data logger was involved. No product quality complaint was involved. This is one of the two reports received from the same reporter (cross linked case reference: 1812USA002036). Sender's Comments: US-009507513-1812USA002036.
Chills started 5 hrs after injection.  Headache, chills followed by hot flashes continued for 9 1/2 hrs.  Light headed ness upon rising  most of the day following the shot.  Fatigue continued for 3 days.
PREVNAR 13 was given on 06/08/16. Pt called the office on 06/14/16 stating arm was still quite sore from injection and pain into axilla. Had a lump at injection site. No redness or signs of infection.
Injection site pain (for 2 days following shot), swelling (hardness), redness, and itchiness (for week after shot). Headaches on and off during the week following.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, lot number was L016125 and expiration date of 06-MAY-2017 (strength, route of administration and dose were not reported), which was stored at 6 Celsius Degree for 179 hours and 30 minutes. Then, the vaccines were back in range. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
didn't feel well; felt like hell broke loose; couldn't eat; burning up, felt like he was on fire; hurting; chills; muscle pain; Fever; nauseated; broke out in sweat; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (broke out in sweat) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced PAIN (hurting), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat) and SKIN BURNING SENSATION (burning up, felt like he was on fire). On 11-Apr-2021, the patient experienced MALAISE (didn't feel well). At the time of the report, HYPERHIDROSIS (broke out in sweat), PAIN (hurting), FEELING ABNORMAL (felt like hell broke loose), FEEDING DISORDER (couldn't eat), SKIN BURNING SENSATION (burning up, felt like he was on fire), MALAISE (didn't feel well), NAUSEA (nauseated), CHILLS (chills), MYALGIA (muscle pain) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 100.9 (High) 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non significant information On 19-Jul-2021: Follow up  document contains No New Information
Patient received his first dose of the Pfizer vaccine on 5/7/21. On 5/13/21 he began to feel feverish (unsure Tmax, never took temperature) and was intermittently febrile until hospital admission on 5/20/21. On 5/18/21 he was seen in the ED for fever and tested positive for strep throat and started on amoxicillin. His inflammatory labs were elevated at this time and did not notice improvement on amoxicillin. He returned to the ED on 5/20/21 at which time patient reported headaches on the right side, sharp 7/10 pain which come and go with the fevers as well as fatigue, muscle/body aches, and sweats in addition to persistent fever. He also noticed maculopapular rash on palms and soles and on distal extremities which was not pruritic or painful on day of hospital admission. All infectious workup was negative and patient did not improve on broad spectrum antibiotics. Given his persistent fever, hypotension, and inflammatory labs without other cause, patient was empirically treated for MIS-C and was given IVIG and methylprednisolone as well as being started on prophylactic dose enoxaparin for his elevated D-dimer. Repeat echocardiogram identified a new coronary aneurysm, supporting the diagnosis of MIS-C. Following IVIG and steroids patient remained afebrile and inflammatory markers down trended, however liver enzymes remained elevated at time of discharge. He improved and was discharged to finish steroid course at home with close follow up.
Sore dry throat and upper chest. Started about 4 days after administration of FLUMIST (H1N1). I had a fever of 101 degrees a few days later. I didn't take any medication for it. The fever lasted 2 days. It all resolved just before Thanksgiving. Two-three days ago my skin (on upper back, upper chest and both arms developed a burning sensation. Some itchiness. Feels normal temp. to touch. Recommended evaluation by PMD.
SWELLING DUE TO COVID-19 VACCINE; BODY DID NOT WORK LIKE IT USE TO; LOST HAIR DUE TO COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (SWELLING DUE TO COVID-19 VACCINE), IMPAIRED WORK ABILITY (BODY DID NOT WORK LIKE IT USE TO) and ALOPECIA (LOST HAIR DUE TO COVID-19 VACCINE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen. On an unknown date, the patient experienced SWELLING (SWELLING DUE TO COVID-19 VACCINE), IMPAIRED WORK ABILITY (BODY DID NOT WORK LIKE IT USE TO) and ALOPECIA (LOST HAIR DUE TO COVID-19 VACCINE). At the time of the report, SWELLING (SWELLING DUE TO COVID-19 VACCINE) and ALOPECIA (LOST HAIR DUE TO COVID-19 VACCINE) had not resolved and IMPAIRED WORK ABILITY (BODY DID NOT WORK LIKE IT USE TO) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. Reporter did not have the lot number information, because the information was not available in the patient file.The reporter causality for the events of swelling due to COVID-19 vaccine, body did not work like it use to and lost hair due to COVID-19 vaccine with co-suspect HUMIRA was reported as no reasonable possibility. No treatment information was reported.
Site-Red, itching, swollen, hand swelling tight feeling, aching-red, lips swollen-itching   Pt. states "she took Benadryl and symptoms were better this morning when she go up".
Pain in arm at the injection site.  fever of 100 degrees, sweats and chills, extreme tiredness, total body aches for about 36 hours
broke out with the shingles.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: broke out with the shingles.). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-JUN-2023 This case was reported by a consumer via interactive digital media. The reporter stated he/she had the vaccine 6 months ago and was ready to  go back for the second dose and he/she broke out with the shingles. It was awful stuff to the reporter. The reporter did not consent to follow up.
Racing heart, flutter, palpitations, rash on neck and chest, fatigue for days, migraine, loss of appetite, blurred vision.