chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st shot left my arm a little sore; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included blood pressure high (The reporter mentioned blood pressure under control). Concomitant products included lisinopril.   On 4th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR096161   Additional Information: GSK receipt date: 20-June-2022 Reporter's comment: The patient received 1st covid 19 vaccination on the 25th February 2021 and 2nd dose on 18th March 2021 on right arm. The shingles 1st dose were given on 4th January 2021 and 2nd dose on 28th June 2021 on the left arm. The patient reporterd that after 1st shingles shot left arm little sore and second was without pain. By the end of june patient's hand was terrible and refer to neurologist in looking Parkinson symtoms. Blood test and urine test were done for looking kidney function,A-1C, cholesterol level, vitamin deficiency, thyroid problem. The patient reported all blood test were excellent and no abnormalities. The patient had 2check up with Lisinopril for high blood pressure which was control under 3 year. On 3rd visit physician prescribed carbidopa-levodopa since 9th march 2022 and stop taking on 6th June 2022. For 2nd dose refer case US2022AMR096161.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR096161:Same reporter.
Felt like a current  of electricity from Left elbow down to Left wrist  and numbness in same location plus also  from Left knee down to Left foot; went to ER per advise of health center; diagnosed with radiculopathy affecting upper extremity and paresthesia of Left upper and lower extremity; has been taking ibuprofen and acetaminophen - symptoms lasted 48 hours then resolved.
This spontaneous report as received from a healthcare worker refers to a 79 year old female patient. The patient persistent medical history included osteoarthritis and thalassemia. On 16-APR-2014, the patient was vaccinated with ZOSTAVAX lot # J012660, 0.65 ml once subcutaneous. Concomitant therapies included ATIVAN, NEXIUM, Aspirin, MOBIC, TOPROL XL and Meclizine. On 16-APR-2014 (also reported as immediately after receiving ZOSTAVAX) the patient experienced macular rash that was 7 inches in length down her arm past the injection site. The reporter stated that the physician gave the patient BENADRYL and told her an ice pack over it for 20 minutes. The reporter stated that the patient left the office but the rash was still present. The reporter also stated that this was the second time a muscular rash reaction occurred with the lot number J012660. The outcome of the event was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1404USA010316 (same reporter link). Additional information has been requested.
Syncope with lightheadedness. Patient never lost consciousness. Patient placed on floor and feet elevated.
no adverse event. administration error.  0.3 ml Pfizer vaccine given to patient aged 11. monitored x 15 minutes. no adverse effects
administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   On 12th October 2022, the patient received Boostrix. On 12th October 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The licensed practical nurse called to inquired regarding any guidance. The reporter confirmed expired dose was administered at their facility. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Boostrix inadvertently on the day of reporting, which led to expired vaccine used.
Pt was a little nervous before receiving the vaccine, but did fine. He was sitting with his brother for the 15 minute wait period when his brother called for help. I told my staff to call 911. Pt had his head back and his legs outstretched in front of him. He was unresponsive at first and pale. Then he sat upright and said he thought he had just hallucinated. He was distraught and did not understand what had just happened to him. I asked the brother if an adult was with them. He called for his mom and she suggested we lay patient down on the floor. She sat with him until EMS arrived. A paramedic took his blood pressure and EKG. He drank some soda and was able to sit up, his color returned, and he was able to stand.
Severe pain at inj site w/in 5 min. Same day pain spread to L scapula. 1/23 myalgia, arthralgia, severe headache, followed by L facial paresthesias. 1/26 febrile 101-102, progressed to L arm, leg, foot paresthesia.
pain on the right side of my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 00:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1st), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd), for Covid-19 immunization; Covid-19 vaccine (Dose: 4th), for Covid-19 immunization. The following information was reported: NECK PAIN (non-serious) with onset 26Sep2022 at 05:30, outcome "not recovered", described as "pain on the right side of my neck". Therapeutic measures were taken as a result of neck pain.  Additional information: Woke up the following morning after receiving shot with pain on the right side of neck, the same side patient received the injection. Took 2 Extra Strength Excedrin, which always help with pain. The pain Extra Strength Excedrin, which always help with pain. The pain continued throughout the day, sometimes throbbing. Patient tried to massage it, but could not locate a precise point where the pain was coming from. Patient is unable to turn head to the right, or look down, without causing pain. No covid prior vaccination. No covid tested post vaccination. No Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient felt flu like symptoms for two weeks after receiving the vaccination. Patient also reported the appearance of shingles on her upper back during the two weeks that she felt ill.
Patient has general malaise  unknown cause . Onsite EMS was called vitals BP 118/64  100% O2 room air HR 72 Patient efused evaluation/care went home against medical advice.
Information has been received from a registered nurse concerning a 5 year old patient who on 04-JUN-2009 was vaccinated with the second dose of VARIVAX (lot# 662576/0046Y, route and site of administration not reported). 48 hours later the patient developed blister around the injection site where the second dose of VARIVAX was given. It was reported that there were also blisters located on the "left upper arm" and "covered more than on dermatone". The nurse stated the physician reported the blisters as "not typical of varicella. Unspecified medical attention was sought by the patient. The patient's outcome was unknown. Additional information has been requested.
Essential tremor became noticeably more severe after receiving the second dose of COVID-19 Moderna vaccination.  The current medication which was controlling my tremor is no longer effective.
Patient reported local erythema with redness and induration approx 7cm circumferentially. Patient reported soreness and area warm to touch. Patient vaccinated 10/13/06 and had edema 10/14/06 in am. Patient states she took Tylenol for discomfort. Monday 10/16/06, patient signs and symptoms had subsided. Employee Health Nurse did review symptoms with patient, no further signs are present.
PRESENCE OF PHLEGM; SORE THROAT; BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced presence of phlegm. On 06-APR-2021, the subject experienced sore throat. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced headache. For phlegm, body ache, fever, headache, Sour throat patient visited to Doctor/healthcare professional office. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from presence of phlegm, body ache, fever, headache, and sore throat. This report was non-serious.
Patient had pre-existing small spot of vitiligo for 3 years on the right chest. Patient got vaccine on 7/11/2005 in the left arm, five months later patient got 2 areas of alopecia on back of head, with increasing patches of hair loss and generalized hair thinning over the next 6 months.
The patient had a rash on his left arm. He went to see the doctor regarding the rash and they gave him a script for KEFLEX to treat cellulitis.
shivers; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ethanol (Alcoholic Beverage) for an unknown indication.   Concurrent medical conditions included weight loss diet.   On 17th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Alcoholic Beverage at an unknown dose and frequency. In September 2019, less than a day after receiving Shingrix, the patient experienced shivers. On an unknown date, the outcome of the shivers was not recovered/not resolved.   It was unknown if the reporter considered the shivers to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter's wife received dose 1 of Shingrix and later had some alcohol beverages. The reporter stated that the patient had been in bed since last night shivering. The reporter did not consent to follow-up. The reporter did not have vaccine information. The reporter declined HCP follow up and declined to provide any further information. It was unknown if the reporter considered the shivers to be related to Alcoholic Beverage.
pt recv vax 1AUG96 & 6AUG96 pt exp sl nasal congestion & a fever;10AUG96 pt devel erythematous maculopapular rash which began centrally but spread to trunk, arms, legs, & face;spit up twice;to MD suspected rash viral exanthem;
32 weeks pregnant inadvertently received the GARDASIL-9 vaccine; Inadvertent exposure to vaccine; This spontaneous report was received from a healthcare worker referring to a 32 weeks pregnant female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On an unknown date, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (anatomical location, strength, dose, lot #, expiration date and route of administration were not provided) (accidental exposure to product; exposure during pregnancy). It was unknown whether the patient sought medical attention, treatment was provided or lab diagnostics/ studies were performed.  On 22-JUL-2022, the patient was pregnant with last menstrual period (LMP) of 08-JUL-2022 and estimated due date (EDD) of 14-APR-2023. The pregnancy outcome was lost to F/U. The fetal outcome was unknown.
1. Within 3 minutes of getting the vaccine I had the closing of the throat, sneezing, feeling of a closed throat, rapid heart rate, high blood pressure- 145/74. My normal rate is 104/69. I began to have very numb toes on the next day and burning in the toes in the evening. I also had itchy toes and on the 3rd day had several sores on my right foot making it difficult to walk. On the 5th day the pain was so intense that I could not sleep. It felt like fire was in my toes.  A call to Dermatology  suggested that I had "Covid-Toes" brought on from the vaccine and they suggested that I see a medical Dr for a check up. Dr saw me on that Friday and I had also acquired a rash on my belly.
Pt c/o chills, body aches, swelling at injection site - erythema.
Itchy; tiredness; headaches; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 17Mar2021 at 11:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient has received concomitant medication (unspecified drug), within 2 weeks of vaccination. The patient had a history of drug allergy to hydrocodone. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecific date in Mar2021 the patient experienced mild headaches, Itchy and extreme tiredness. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, Itchy, and tiredness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
no other adverse events; temperature excursion; This spontaneous report was received from a consumer and refers to a 12-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-OCT-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S031494 (also reported as: 5031494 but upon internal investigation established as a valid # S031494) with an expiration date of 07-OCT-2021 (formulation, strength, dose and route of administration were not reported) for prophylaxis. It was reported that the door to the freezer was left open overnight from 6 PM last night to 7:30 AM this morning. The temperature excursion was also reported as: temperature -1.0 Celsius, time frame 13 hours and 20 minutes. There was no information available on previous temperature excursions. A data logger was not used to capture the temperatures. No other adverse events reported. The outcome was reported.
Aches, Chills, constant sleep, throwing up, headache, foggy head, cold sores
Pt developed mild erythemic rash in upper extremities and face in AM, no other symptoms except for pruritus. Pt was treated with Benadryl. rash became generalized and raised in PM.
NOTES FROM 10/28/2022 VISIT:.   NEW SCATTERED VESICLES ON FOREHEAD, LOW BACK, UPPER ABD EYES ARE UNCOMFORTABLE, SITTING IN DARK PREFERABLY BUT LOOKING AT LED/PHONE LIGHTS    NOTES FROM 10/27/2022 VISIT: 10/13 VZV VACCINE, DIDN'T GET FULL DOSE AS IT WAS EXTREMELY PAINFUL, SOME RAN DOWN ARM   FELT OK AFTER A DAY OR SO UNTIL 10/25, L ARM PAIN IN SAME SITE AS VAX, NOW WITH TENDERNESS AT SITE, NO SPREAD ON ARM, NEW LESION ON MID FOREHEAD LOOKING LIKE A BLISTER    NO GENERALIZED FEVER BUT NOT FEELING GOOD WORRIED AND "A BIT MAD"   CAT IN APT BUT NOT HERS, NOT DEALING WITH FEEDING OR
Nausea, oral tingling, dizziness, leg/oral numbness. Evaluated by EMS-Transported to Emergency room/department or urgent care.
patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured; exposed to room temperature range (8° to 25°C= 46° to 77°F); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured) and PRODUCT STORAGE ERROR (exposed to room temperature range (8° to 25°C= 46° to 77°F)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured) and PRODUCT STORAGE ERROR (exposed to room temperature range (8° to 25°C= 46° to 77°F)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got a dose of the Moderna vaccine from a vial that was used through multiple days, once punctured) and PRODUCT STORAGE ERROR (exposed to room temperature range (8° to 25°C= 46° to 77°F)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No additional patient identifiers are available. Concomitant medication details were not reported by the reporter.  There are no patient identifiers and state doses were administered from 11-Oct-2021 till 13-Oct-2021, probably.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): HCP  was not sure, but probably less that 2 hours, the vial was only out of the fridge to draw up the doses to be administered.  Treatment details was not reported by the reporter.
Pt experienced rectal temp at 105 within 24 hours of receiving vaccines. Pt was fussy, cried for several hours and would not take bottle. Tylenol .8ml given.
5 minutes after HPV vaccine was given patient became pale, her eyes rolled back in her head, and she became rigid, she lost conscious 30 seconds. When she came to she had postical s/s of a blank stare for about 5-10 seconds. She did become A x O x S. BP 116/ 78 P 64, Pulse O2 97%. Before vaccine BP 115/65
Vaccine does was given too soon. It is considered an invalid dose. Patient is known for having Migraines. He did receive 2 vaccines that day Menveo and Fluzone by Sanofi.
Information has been received from a healthcare worker (medical assistant) referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. ON unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # L008353, expiration date: 11-SEP-2016 and/or lot # L002419. expiration date: 23-JUL-2016, dose, frequency and route were unknown. The patient's concomitant medication was not reported. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt fainted, her mom caught her she did not bump her head.  pt had difficulty forming sentences and answering questions.  Pt was placed laying down on a bench and given water to sip on and quickly recovered.
Patient notified RN that she had previously had a seizure with first vaccine. Patient was stable, awake alert and oriented. Shortly after, patient began convulsing around 1528. Called nurse manager and provider of the day. Patient's O2 saturation began dropping to 85%, placed patient on 5L O2, raised HOB, removed all harmful objects and turned patient to side with assistance. Patient began seizing again while on the phone with physician at approximately 1532, was instructed to call 911. Called 911 and informed them of incident, was told to call again if patient began convulsing. Patient began seizing for a 3rd time at approximately 1540, called 911 again. Paramedics arrived on site at approximately at 1546 and took patient to ED. Husband and site manager notified.
Breakthrough COVID case. Patient tested positive for COVID on 9/23/21 at nursing home after experiencing cough and shortness of breath.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for HTN, hypercholesterolemia, GERD, Nodular prostate. Pt received first dose of Pfizer covid vaccine on 04/05/2021. Deceased on 4/25. No cause of death or any information regarding recent illness documented.
01/22/04: Vaccines, swelling and erythema on left thigh.  24 hours seen in office on 01/24, given Keflex, Locoid cream and Benadryl.  1-30 seen again with resolution of symptoms.
Second dose administered beyond 80 days after the first dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 80 days after the first dose) 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.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 80 days after the first dose). On 18-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 80 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.     Reporter did not allow further contact
Stiff neck/ muscles , daily headache, cough, fatigue and diarrhea  Shingles on face resultant after 4 days.  Oral medication/ valacyclovir 1 G tab  every 8 hrs.  For 7 days.
Pain, itching, hard lump, and warmth at injection site. Arm of injection "feels funny", tingling. Vein area in crook of arm feels hard, unsure if it is related. Told patient to take Benadryl and Ibuprofen to aleviate symptoms.