chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had all of the shots and still got shingles/Suspected vaccination failure; Very mild shingles/was a spot near of wrist; Some itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had all of the shots and still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Very mild shingles/was a spot near of wrist) and pruritus (Verbatim: Some itching). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient had all of the shingles shots and still got shingles but very mildly.  It was a spot the size of a quarter near his/her wrist. The reporter stated that some was itching but no pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
blacking out; Dizziness; weakness; violent tremors in extremities; heart rate in 130's; slight shortness of breath; pressure in lungs; cough; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Aug2021 12:15 (Batch/Lot Number: EW0177) (at the age of 43 years old) dose number was unknown, single dose for Covid-19 immunisation. Medical history included asthma, allergies, Penicillin allergy, and Covid-19, all from unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced allergy. On 10Aug2021 at 00:15, the patient experienced blacking out, dizziness, weakness, violent tremors in extremities, heart rate in 130's, slight shortness of breath, and pressure in lungs with cough. Therapeutic measures were taken as result of all the events. The patient was given apple juice, Pepcid, 2 Zyrtec, and 2 Benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
Fever 101.2. Aching in all muscles and joints, vomiting, nausea. Dysuria. Lower legs and feet and hands tingling. Sore throat.
Around 7 pm on the night the vaccine was administered (5/14/21), I noticed my legs felt heavier and weird. When I looked at my legs, they were swollen and slightly red. This did concern me, but given that I can not afford health insurance, I laid in bed with my legs elevated and eventually went to sleep. When I woke up the next day around 9 am, my legs were no longer swollen, but my hands now were. The swelling went away by 5 pm that day(5/15/2021). Thus far, besides a headache that persisted for three days straight from 5/21/21 until 5/24/21, I haven?t experienced any other abnormal swelling and I currently feel fine today.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received PNEUMOVAX 23 (Lot # J015522, expiry date: 21-FEB-2015) that was exposed to 47 Fahrenheit for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011937, 1405USA011938, 1405USA009508 and 1405USA011939 (same reporter link). Additional information has been requested.
mom  reported pt exp h/a, nausea 9APR & 10APR returned to school w/o s/s;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 11-JUN-2015, the patient was vaccinated with a dose of improperly stored M-M-R II, lot number K015374, expiration date 18-SEP-2016 (dose and route were not reported). No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.
Pt was preemie triplet in ICU at med ctr. Given vaccines 2/11/16. Discharge 2/15/16. Seen 2/16/16. Died of SIDS 2/19/16.
Patient received vaccines; shortly after ~2-5 mins. fainted to floor; immediately arousable; no injury; patient laying supine with legs elevated over heart level; patient oriented x4 reports did not have breakfast. Received graham crackers with peanut butter observed for ~20 minutes; Vital Signs stable; Neuro checks WNL; reports no pain; walked out with steady gait with Mother of Child.
Not feeling well; Fever of 100.7; Headache; Chills; Body aches; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache) and CHILLS (Chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm). On 15-Nov-2021, the patient experienced MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE REACTION (COVID Arm), MALAISE (Not feeling well), PYREXIA (Fever of 100.7), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2021, Body temperature: 100.7 (High) Fever of 100.7.         No concomitant medications were reported. No treatment medications were reported.
On October 4, 2021 I had a blood clot which resulted in a heart attack. There were no events or illness that occurred prior to this event. I am a healthy, female with no health conditions.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 01/27/2021 and 02/24/2021. I do not have lot numbers, facility, or injection site available; only dates and manufacturer.   The individual became symptomatic on 10/20/2021 with shortness of breath, weakness, fatigue, and low oxygen. They tested positive for COVID-19 twice via antigen test on 10/25/2021 at the nursing home at which they were a resident. They then presented to a clinic on 10/26/2021, where they tested positive for COVID-19 again, this time with a PCR test. They were then brought to emergency department on 10/30/2021 with primary complaints of unresponsiveness and very low oxygen levels (in the 40's). They were admitted to hospital on 10/30/2021 and found to be septic, in A-fib,  in respiratory failure, and have encephalopathy due to COVID-19. They remained hospitalized until their death on 11/06/2021.
35yo female with hx of R breast swelling and tenderness starting within 3  days  of having her 1st  COVID shot in her R deltoid on 5/20/2021. It is  occasionally painful.  She was seen  in the clinic on July 9th with complaints of the breast swelling and tenderness. Exam reports R> L breast with induration  She put off coming back in till 8/5/2021 for the second shot.  The swelling got much worse.      She was seen  September 1st and started on antibiotics. She had a  punch  biopsy of the skin in the area This showed only foliculitis. She denies any  fevers.  She  got a mammogram today on exam she has dimpling above and below the large mass with matted lymph nodes and obvious peau d'orange skin changes. Core biopsies were obtained and referred to breast surgery/oncology with presumptive inflammatory breast cancer
Numbeness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbeness) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbeness). At the time of the report, HYPOAESTHESIA (Numbeness) outcome was unknown.
Whelps/hives on legs and arms within 60 minutes after injection. Reported to Pediatrician, was evaluated that day. BENADRYL x 3 doses in 24 hours. Also reported a fever on 102, TYLENOL given and fever resolved along with hives.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event. No treatment medications were provided.
Developed swollen left arm, fever 12 hrs post vaccination. Hospitalized, on high doses antibiotics recovered in 2 days.
Breakthrough case admission after two vaccines  Moderna 1/8/21 Lot# 012L20A;  Moderna 2/5/21 Lot# 012L20A
t100-no higher-onest 15OCT94 cont to 19COT94; whelps & fine rash to entire body-started w/inner arms-spread to trunk & all over by 17OCT94; inc nasal secrections 16OCT; h/a 19OCT;
A physician reported that a 4 month old female received Acel-Imune, IPV and Comvax on 8/24/99 and that same day, developed "knots" and an injection site reaction characterized by redness and warmth at the site. The physician noted that this event was related to Acel-Imune; IPV and Comvax were administered in the opposite arm. The infant recovered. This is 1 of 5 pts from this facility who had an adverse experienced following receipt of Acel-Imune. MANUFACTURER'S COMMENT: The reporter indicate that 5 pts experienced an adverse event; however, only 4 pts have been identified. An additional report will be generated when identifying iformation is provided.
RIGHT SIDE ABDOMINAL SWELLING; BILATERAL FOOT SWELLING; BILATERAL LOWER LEG SWELLING TO KNEES; SHORT OF BREATH WITH EXERTION; PAIN FROM SWELLING; BLEEDING SORES ON BACK OF LEGS; ADVERSE EVENT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hip injury (Hip injury from work), and concurrent conditions included: codeine allergy, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 62 years old.  No concomitant medications were reported.  On an unspecified date, the patient experienced right side abdominal swelling, bilateral foot swelling, bilateral lower leg swelling to knees, short of breath with exertion, pain from swelling, bleeding sores on back of legs, and adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from short of breath with exertion, had not recovered from right side abdominal swelling, bilateral foot swelling, bilateral lower leg swelling to knees, pain from swelling, and bleeding sores on back of legs, and the outcome of adverse event was not reported. This report was non-serious.
Chest pressure, from the inside out, smelling urine, front like I just swam for hours in a chlorine pool
Itching at site of vaccine injection on my right arm 6 days after injection, I noticed a rash red and itching, then blotches combined into an "angry" red blotch that grew larger over the next 6 days, was sore, hot to the touch and itchy.  Today, 2-5-21, the red blotch is faded but still visible.  It no longer hurts, and itches intermittently and much less severely.  Treatment: Tylenol mostly at night as pain  disrupted sleep, ice on the red patch, and  I took Benadryl.  First time was helpful, stopped the itching and discomfort.  Second time I had a reverse reaction and was jittery with more itching and discomfort. The outcome is that the redness has faded, no pain, not hot and itching is very low level.  I expect this redness will disappear completely soon.  My sister on east coast, had 1st Moderna shot 2 days before me and had the same experience, a little less severe.
No adverse Event; Received 0.25ml dose of Bivalent Booster instead of 0.5 ml; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse Event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 26-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml).    No concomitant drug were reported.   The pharmacist was talking to the patient, who told him to call this number. The patient was told that the pharmacist was supposed to call. The pharmacist states that he will give the patient the other half of the booster dose.  Patient received First dose on 23-MAR-2021,  Lot# 045A21A and Expiration date was reported as unknown. On unknown date patient received second shot of vaccine, Lot number and Expiration date was reported as unknown. On unknown dates patient received 2 Monovalent Booster doses, Lot number and Expiration date was reported as unknown.  No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Follow up document contain secondary reporter was added.
Patient developed fever 2 days prior to development of rash. Temp ranged 102-103. Patient started breaking out into red, vesicular lesions on trunk, buttocks, and face. Patient positive for headache at onset of symptoms.
Developed flu-like symptoms and asthma got worse after booster. Cough did not go away, went to doctor and prescribed prednisone and have been taking cough medicine for past three weeks. Earlier today woke up in immense pain. Diagnosed with a Kidney stone, a Left ureteral stone, and a UTI.
Cold sweats; headache; muscle and joint aches initially bilateral elbows still sore to date (3/12/2021)
FEVER 103 LESS THAN 12 HOURS AFTER FLUMIST ADMINISTERED.  ALSO COMPLAINED OF SORE THROAT, STOMACH ACHE, DIZZINESS, HEADACHE.
Blood clot in Right leg and bilateral lungs. Patient also reported headache for >1 week, fatigue, shortness of breath and blood pressure that elevated above 210 systolic.
Pt stated arm began itching same day her received shot. 2 days later (today) there is redness that covers the entire deltoid area and is hot to touch. Pt to be on if x 2y hours and received KEFLEX for treatment.
Been having migraines; vision out of focus; muscle pain in arms; lower back and shoulder; all on left side and all lasting a short time period.
Reaction on abdomen and back; Discomforting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin reaction (Verbatim: Reaction on abdomen and back) and discomfort (Verbatim: Discomforting). The outcome of the skin reaction and discomfort were recovered/resolved.   It was unknown if the reporter considered the skin reaction and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the skin reaction and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he/she received Shingles vaccine and experienced reaction on his/her abdomen side and part of his/her back although it was very discomforting and he/she was coped with it. The patient stated that it was gone in about two weeks. Follow-up would not possible as no contact details were available.
lot number in registry...compromised;no updated information; two patients received this lot#; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (lot number in registry...compromised;no updated information; two patients received this lot#) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (lot number in registry...compromised;no updated information; two patients received this lot#). On 06-May-2021, POOR QUALITY PRODUCT ADMINISTERED (lot number in registry..compromised;no updated information; two patients received this lot#) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events was not reported. Concomitant medication use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: No new information On 11-Jun-2021: No new information
Information has been received from a physician concerning a 61 year old female with diabetes who in February 2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not specified). In May 2008, a couple months after the patient received the ZOSTAVAX, she started experiencing hives. The patient went to an allergist who performed multiple tests that all came back negative and she was prescribed prednisone (manufacturer unspecified). The patient has been experiencing itchy hives every day since May 2008. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from the female patient who stated that she still experienced the hives.  Follow up information has been received from the patient who stated that she had been experienceing hives since May 2008.  She had all the blood work and skin biopsy done and everything came back negative.  The patient believed the hives were caused by the vaccine.  Additional information has been requested.
w/in 5min of shot being given pt turned pale, almost cyanotic, PR 60, BP 70/50 alert & would answer questions;sleepy 20-30min before recovery;
Patient was administered HD fluzone at age 63 when patient should have been administered regular flu vaccine.  Patient must be 65 or older to qualify for high dose fluzone.
Patient complained of sore arms after receiving a flu shot and pneumonia shot that disrupted his sleep. Pt found relief by using a pain reliever he had at home.
Patient came in to the office on 4/20/21 for the 2nd HPV vaccine. mother that was with patient signed off for the child to get the HPV vaccine. child did not receive the HPV vaccine, she received the Meningitis (MCV4) by error. Staff made aware of error on 5/12/21. mom called and notified. child did not have any adverse reaction to it.