chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatal autoimmune disease; had shots still had them twice/ suspected vaccination failure; lost hearing forever totally deaf; Bells Palsy; shingles in ear; still had them twice; Vertigo; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: fatal autoimmune disease) (serious criteria GSK medically significant and life threatening), vaccination failure (Verbatim: had shots still had them twice/ suspected vaccination failure) (serious criteria GSK medically significant), deafness (Verbatim: lost hearing forever totally deaf) (serious criteria GSK medically significant), bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles in ear) (serious criteria GSK medically significant), shingles (Verbatim: still had them twice) and vertigo (Verbatim: Vertigo). The outcome of the autoimmune disorder, vaccination failure, bell's palsy, herpes zoster otitis externa, shingles and vertigo were not reported and the outcome of the deafness was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shots for shingles and still had them twice . The reporter reported that last time had the shingles in patients ear and totally lost all hearing forever. The reporter reported that It did not come back so patient was totally deaf. The patient was also hit at the same time with Bells Palsy and Vertigo and also had a fatal autoimmune disease. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
There was no adverse event instead it was a medication error. The provider prescribed Hepatitis B and MA administered FLULAVAL.
Left hand began itching end of February 2020 (approximately 1 month following 2nd dose), followed by itching on chin. Within days, a vivid rash developed on left hand and circling mouth. Rash on hand was typical of "shingles," with severe itch and pustules oozing, although pain was not as bad as itch. Rash around mouth extended over chin, with flat exuded areas. When I (patient) recognized this to be zoster, I began taking Valtrex, which I had been prescribed for HSVI outbreaks. The rash responded to Valtrex, confirming the presumed diagnosis. Despite taking large doses of Valtrex for a week, the itch and rash continued to expand, going up onto wrist, then up onto arm.  Both areas, hand and arm, continued to itch and have oozing for over a month. The rash around mouth was both very sore and very itchy. I consulted with dermatologist, who recommended continuing Valtrex 1000 mg x 3/day until symptoms subsided, which was another 2 months - end of May. Symptoms were better, but still present, but I was able to reduce Valtrex dosage gradually to 1000 mg/day. As I reduced dose of Valtrex, additional symptoms appeared in several areas on my forehead, with a large, red, swelling area with pustules over my left eyebrow, then over my right eyebrow, and last area (last week, early July) on right side of forehead near hairline.   The most effective "treatment" was continuing Valtrex, which made the symptoms more bearable. I also used a very thick cream made for "shingles," which greatly reduced itching for several hours.   By the first week of July, the rash on hand, wrist, and arm had cleared "active" itch, and all pustules had flattened and dried up. The rash around my mouth was mostly healed, but still required thick cream layers to reduce itch. At that time, the areas on my forehead were still active. Now, July 17, the forehead areas seem to be cleared, except for a small amount of redness and swelling above my left eyebrow.   The symptoms began and extended over a period of over four months. Most of this time I felt sick. I had great fatigue, headaches, difficulty eating, swollen lymph glands, and muscle soreness.
L deltoid inflammation, HA, malaise, bodyaches, fever, chills, tachycardia, on CBC neutrophil count 30,000
Fever 102F, fatigue, slight muscle soreness, lasting 2 days after shot
Narrative:  Patient reported hives and some SOB approximately 2 weeks after receiving vaccine. Unclear if the vaccine was the cause given the time frame.
Ingredient: mRNA: Fast-beating heart; sodium chloride -fast heartbeat, itching, joint pain; dibasic soduim phosphate dihydrate : irregular heart beat; sucrose--slow or fast heartbeat
On 2/9/21, patient received one dose of Pfizer COVID-19 vaccine (lot EN6201). On 3/2, due to an error by a vaccinator, patient received his second dose. Instead of receiving Pfizer, however, he received a Moderna shot (lot 022M20A). Patient waited 15 minutes for observation and was let go afterwards as he was feeling fine.
Medical Assistance accidently administered DTAP instead of TDAP to 12 yo patient. Talked with nurse educator and they stated there is no adverse events that will occur. I have called family to advise of mistake and request if patient is having any abnormal symptoms and they did not answer, I called and left voicemail.
pt recv vax; devel v in pm of vax; afebrile sz; hosp x 2 days; sz characterized by arching of back;also cried for a period of 12 hr;
No AE/PQC reported; product was administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 10-OCT-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot # X010531, expiration date: 11-APR-2025; strength, dose and route of administration were not reported). The vaccine had been stored under -1.8 degrees Celsius for 1 hour and 6 minutes (product storage error). There was no previous temperature excursion. No adverse event (AE) or product quality complaint (PQC) was reported.
This spontaneous report was received from a nurse regarding to 4 patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (data digital logger)(lot # J013394, expiry date: 25-AUG-2016). The vaccine was exposed to temperature: 54.4F for a time frame of 24 hours. No adverse effects were reported. There was no previous temperature excursion reported. This is one of 4 reports received from the same reporter. Additional information has been requested.
When patient stood up to leave vaccination area he experienced light headedness and dizziness.  He was instructed to take slow breaths and lower his head to his knees. Patient also was warm and sweating. He was observed in the immunization area for approximately 5 minutes when he began to feel better and moved to observation area for 1/2 hour. Patient left stating he was feeling ok.
Fever, HYPOtension,  Lymphadenopathy, Elevated TSH, Cholesterol levels  per employee.
Pt c/o chest pressure, heartburn, R - shoulder pain 10 mins after vaccination -- > relieved w/ rest and decreased environmental stimuli.  BP 168/56, HR 72, RR 18 SPO2 100% -- > 129/78, 78,18, 100% -- > 146/80,69, 18, 99%  .  Pt stable and released from vaccination site w/ family.  Pt had steady gait.  Pt was advised to f/u w/ her provider and seek ER if symptoms return or worsen.
She reports having a surgery on 1/4/2021. Received vaccine on 3/5/2021 and went to ED on 3/7/2021 and diagnosed with bilateral PE's.
Clinical Summary Patient is a 43 y.o. male with a history of CKD on PD, T1DM who presented to the HCF 11/24/2022 with fever, nausea and emesis.  Found to have COVID-19      1. Acute Covid-19 Virus Infection/Sepsis?POA: Home test + 11/24/2022.  Positive at HCF 11/25/2022.  Vaccinated.  No booster.  Chest x-ray does not show any acute changes.  Febrile, leukocytosis.  Procalcitonin elevated.  No Decadron or abx as per infectious disease.  S/p Paxlovid .  ID followed 2. Acute Hypoxic Respiratory Failure: Likely due to COVID.  Does not use oxygen at home.   Weaned to room air. 3. Elevated troponin: 365?316.  No chest pain.  Likely demand ischemia due to hypoxia and ESRD.   4. Hypertensive urgency: Improved.  Continued home meds.  5. ESRD: on PD, last dialysis 11/23/2022 with reported clear dialysate. Follows with Dr. (Nephrologist).  Nephrology followed 6. IDDM1: A1c 5.3?11/25/2022.  Basal home insulin was decreased initially due to hypoglycemia.  Blood sugars were then elevated due to patient's refusal to take sliding scale as advised.  Resume home dose at discharge.  Patient to follow blood sugar closely at home and use SSI as needed along with basal.  7. History of Right Foot OM: S/p right 5th ray amputation on 8/30/2019. S/p right foot debridement with partial 5th metatarsal resection and right foot application of skin substitute graft on 10/3/2019. XR Right Foot showed concerns of osteomyelitis.  No need for MRI as per infectious disease.  Follow-up with podiatry as outpatient.  Initially patient said that he has appointment for BKA, then asked for referrals?provided. 8. Abnormal CT Finding: Admit CT revealed few punctate bilateral nonobstructing renal stones, bulging annulus at L4-5 flattening anterior thecal sac. Follow up as outpatient with PCP.
Vomiting, arm swelling, fever, chills, body aches and fatigue.
Sore arm as expected.  Flu symptoms more severe with second dose than with first.  First dose had flu-like symptoms for 2-3 days.  More severe flu-like symptoms with second dose.  Body aches woke me up in the middle of the night - took one extra strength acetaminophen and 1 Aleve.  At 9am took another dose of each.  Body aches, headache, arm extremely sore, difficulty raising arm.
Patient woke up about 36-48 hours after receiving vaccine aching head to toe- no fever- heavy feeling on chest but no change in heart rate- shallow breathing- headache- stomach muscle pain and extremely lethargic. The next day brought left knee pain so severe that she was not able to put weight on it. Through all of this there was no injection site redness or pain; this lasted a total of 3 days / and resolved after 5 days.
IV antibiotic IV Fluid/PEDIALYTE. Patient developed severe diarrhea (2) days after vaccine. Febrile episode (104 degrees). Denies vomiting. Seen at hospital (inpatient) (+) for bowel obstruction.
T102 x 3 days then emesis (multiple); 30AMR92 hospitalized sepsis r/o & discharged in 3 days; no obvious site of infect ? related to DTP;
Pt. received a BOOSTRIX vaccine at our pharmacy. After administration pt. had an event of syncope. His face turned pale and fainted for a second. He woke up right away but appeared weak. Pt. remained seated for 20 minutes and recovered.
This spontaneous report was received from a healthcare worker and refers to unspecified patients of an unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX injection (dose and route of administration were not reported; lot# L027287 and expiration date 21-JUL-2017). There were no concomitant therapies reported. The doses of (Oka/Merck) VARIVAX were stored at a temperature of -1.9 degrees Celsius for 7 hours and 30 minutes, on an unknown date. The doses of the vaccine were exposed to previous temperature excursion of -14 degrees Celsius for a time frame of 2 hours an -13.7 degrees Celsius for a time of 7 hours and 30 minutes (dates unspecified). A Digital data Logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received form the same reporter. Additional information has been requested.
Vaccines given 5/18/15. Rotavirus given to baby 14 months old. KINRIX given instead of PEDIARIX. No advers effects.
Chills, achy, 101 temp, tired. Day and 1/2 felt these symptoms.
I got a very bad nose bleed that has been bleeding for about 30 minutes now; This is a spontaneous report from a contactable consumer, the patient. This 44-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route in the left arm on 22Apr2021 at 15:30 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have any known allergies. The patient did not receive another vaccine within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via unspecified route in the left arm on 30Mar2021 as a single dose for COVID-19 immunization. Concomitant medication included fluticasone propionate (FLOVENT). On 24Apr2021 at 22:00, the patient experienced a very bad nose bleed that had been bleeding for about 30 minutes now. When he put gauze up his nose to try and stop it the blood clotted into a very thick globule but it was continuing to bleed. The patient was not treated for nose bleed. The clinical outcome of nose bleed was not recovered. The patient was not tested for COVID post vaccination.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a nurse practitioner/health professional concerning a 15-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 29-Mar-2010. On 31-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Mother described hypotonic "collapse" episode with child limp head dropping and less responsive then usual for "several minutes", associated with 101 fever.
veins poking out of tip of fingers; This spontaneous case was reported by a consumer and describes the occurrence of SUPERFICIAL VEIN PROMINENCE (veins poking out of tip of fingers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced SUPERFICIAL VEIN PROMINENCE (veins poking out of tip of fingers). At the time of the report, SUPERFICIAL VEIN PROMINENCE (veins poking out of tip of fingers) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at injection site".  Additional information: The report was not related to a study or programme. NDC number, expiry date, investigation assessment were not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stomach cramping & diarrhea after receiving Moderna booster. Lasted about an hour. Fever, fatigue, body aches lasted approximately 24 hours after vaccine.
tachycardia/pulse rate was 135; blood pressure was 150/110; felt very lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia/pulse rate was 135), HYPERTENSION (blood pressure was 150/110) and DIZZINESS (felt very lightheaded) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 040B21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Postural orthostatic tachycardia syndrome (POTS). Concomitant products included METOPROLOL for Blood pressure abnormal, ALPRAZOLAM (XANAX), QUETIAPINE FUMARATE (SEROQUEL) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced TACHYCARDIA (tachycardia/pulse rate was 135), HYPERTENSION (blood pressure was 150/110) and DIZZINESS (felt very lightheaded). The patient was treated with METOPROLOL for Adverse event, at a dose of 0.25 mg. At the time of the report, TACHYCARDIA (tachycardia/pulse rate was 135), HYPERTENSION (blood pressure was 150/110) and DIZZINESS (felt very lightheaded) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Blood pressure measurement: 150/110 (High) 150/110. On 04-Nov-2021, Heart rate: 135 (High) 135.         The patient reported possible adverse events after her booster. On the evening of 04-Nov-2021, she experienced tachycardia, blood pressure was 150/110, pulse rate was 135, and felt very lightheaded. The patient immediately called emergency medical services and was transported to the local hospital. She stated the wait time was long therefore she left prior to being admitted and evaluated by HCP. She had reached out to her HCP twice regarding the event, once was on the evening of events and once on 05-Nov-2021. Her HCP had suggested that booster dose may be exacerbated her condition. She was advised by HCP not to take another dose of booster if needed in future. No previous diagnosis of COVID. No previous history of pericarditis or myocarditis.  For her events she took another dose of her blood pressure medication (self-treated with 0.25 mg metoprolol).
pt recv vax 22JAN97 & 28JAN97 urticaria & redness, swelling area @ site of inj;30JAN97 10x10cm redness worse;
Little itchy; like sensitive skin; I felt a warm tingling sensation; was warm while sitting; This is a spontaneous report from a contactable consumer reported for herself .  A female patient of an unknown age reported that received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 25Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown.  When she got injection, the injection site was warm while sitting for 15 minutes, she felt a warm tingling sensation, then normal like being punched in the arm feeling, how you normally feel when you get a shot. She didn't take anything, didn't sleep on it that night, the second day hurt a little more, it went a way a day or so. She just always felt like her arm didn't feel 100% right, no rash, not swollen, just feels like sensitive skin. Not pain, but as she went through the day, it was feeling more sensitive, when touched it felt a little black and blue, nothing to the eye, just doesn't feel right. Her right arm she felt nothing. She didn't know if it is a tingling sensation, it feels a little itchy, if she was wearing a shirt, it's itchy a little, she was not scratching. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
82 year old female who presented from assisted living with c/o decreased appetite. She has asymptomatic bacteriuria for which no antibiotics are prescribed, false positive COVID-19 test (confirmed with two subsequent negative COVID test).
TWO DAYS AFTER VACCINATION, PATIENT REPORTED WARMTH, INFLAMMATION, AT INJECTION SITE AND INDURATION THAT GRADUALLY GREW TO APPROXIMATELY 5 CM IN DIAMETER. SYMPTOMS RESOLVED AFTER APPROXIMATELY 10 DAYS AND NO LONGTERM EFFECTS WERE NOTED.
10/12/00, complained of headache and right arm sore. On 10/13/00, complained of right sore arm. On 10/18/00, phone contact with mother, no medical treatment needed and no other problems.
redness at the site of injection; Sunburn-like rash at the site of the injection on left arm; Warmth at the site of the injection on left arm; Itching at the site of the injection on left arm; Pain at the site of the injection on left arm; chills; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), RASH ERYTHEMATOUS (Sunburn-like rash at the site of the injection on left arm), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) and VACCINATION SITE PAIN (Pain at the site of the injection on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CLOPIDOGREL, PANTOPRAZOLE, ZOLPIDEM and CICLOSPORIN (RESTASIS) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (Runny nose) and CHILLS (chills). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Sunburn-like rash at the site of the injection on left arm), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) and VACCINATION SITE PAIN (Pain at the site of the injection on left arm). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the site of injection). At the time of the report, RHINORRHOEA (Runny nose) and CHILLS (chills) had resolved and RASH ERYTHEMATOUS (Sunburn-like rash at the site of the injection on left arm), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm), VACCINATION SITE PAIN (Pain at the site of the injection on left arm) and VACCINATION SITE ERYTHEMA (redness at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included diphenhydramine.