chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Nurse Practitioner refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with GARDASIL (dose, strength, route and site of administration was not reported). The reporter stated that those doses of GARDASIL were exposed to temperatures outside of the proper storage range. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 20 years old female patient. The patient was vaccinated with a dose of expired MMR II (exp date: 11-AUG-2012, lot #, dose, route were unspecified) on 22-JAN-2013. No adverse effect reported. Outcome of the events were unknown. Additional information has been requested.
Elevated blood pressure since receiving first dose.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bone cancer.    On 08-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 BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) (seriousness criterion death). The patient died on 13-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) Elevated blood pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Company Comment: Very limited information regarding the event has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07 Jul 2021 included relevant history detail (bone cancer), seriousness (death) and outcome of the event (fatal).; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death
Hypoxia (92%) on right thigh. Fever, cough, wheezing. Atypical pneumonia.
I started to  get hives on my legs, back, stomach and arms every evening for about two months.
Information has been received from a physician via a company representative referring to a female patient, who was currently in eighth grade. The patient had no remarkable medical history and she was not in stressed fashion. The patient's concurrent condition and concomitant therapy were unknown. On an unknown date (reported as "when she was a young child"), the patient was vaccinated with one dose only of VARIVAX (dose, route, lot # and expiration date not reported). On an unknown date of August 2016 (reported as "the last month"), the patient experienced shingles. The patient sought medical attention via visiting the physician. The shingles subsided on an unknown date in 2016 and the patient was okay at the time of this report. The causality between VARIVAX and the event was not provided. Additional information has been requested.
Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic
Fever, Chills. Nausea, Flu symptoms, body aches. Sick for 2 days.
2days later..swollen lymph node on collar bone.. lasted 23 days Stiff neck.. lasted over a week Rash on both sides of neck and back Tingling in left side of face.. 2 days
1hr post vax pt scalp began itching-becoming more intense-lip felt funny-was swollen called hosp instructed to take DPH;significant itching all over body;face swollen, hives on thighs, some wheezing, abd cramps, diarrhea, splotchy;
Chill, fatigue. Numbness on her face. Massive Cole sore on left side of her face. Head ache behind left eye.
14Mar90 pt vax;  01Apr90 devel right facial swelling, w/out redness, fever, cough, or earache.  Facial swelling resolved w/in 2-3 days.
This case was reported by a nurse via sales rep and described the occurrence of headache in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity. On an unknown date, the outcome of the headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity were unknown. It was unknown if the reporter considered the headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX was received at Pharmacy and the patient came in 1 day later to report her symptoms. The patient experienced neck stiffness and activity changes (not as active as usual).
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004890:
I just had my first Covid vaccine shot and I am experiencing frequent urinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLLAKIURIA (non-serious), outcome "unknown", described as "I just had my first Covid vaccine shot and I am experiencing frequent urinations".  Additional information: Clinical Trial Information (provide if caller indicated they are enrolled in a Pfizer Clinical Trial remove if not applicable): NA. Any other additional information provided (sample size, etc.): None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & exp rash on rt hand & arm w/swelling; 3 days p/vax the rash & swelling involved both hands, face & rt arm; pt seen by MD; treated w/Seldane & Pred;
W/in 12 hrs following vax pt developed n. 7Jan89 developed a T lasted approx 5 days. 8Jan89 developed enlarged & painful axillary lymph nodes. For next several mo exp lethargy & malaise. Exp episodes of hypoglycemia. 14Feb90 sxs persisted.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unknown date the patients were vaccinated with unsupported PROQUAD (Merck) (lot # J002931, expired date: 12-SEP-2013, dose not reported) which reached a temperature of 39F for 101 hours. No adverse effects. Additional information has been requested.
Pt. felt very short of breath, weak, faint 3 hours after Tdap. Was seen at an urgent care for evaluation. Neg. exam.
Patient received the 2nd dose of Shingrix; Expiry date 05 august 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number B4999, expiry date 05-AUG-2021) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 16-JUN-2023, the patient received the 2nd dose of Shingrix. On 16-JUN-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: Patient received the 2nd dose of Shingrix) and expired vaccine used (Verbatim: Expiry date 05 august 2021). The outcome of the drug dose administration interval too short and expired vaccine used were unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter reported that the patient received 2nd dose earlier than the recommended schedule. The vaccine administration facility was the same as primary. The reporter did consent to follow up. The patient received 2nd dose of Shingrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule. The patient administered vaccine beyond its expiry date, which lead to expired vaccine used.
Injection site itches. Dizziness and nausea followed by vomiting within a half hour of injection.
pt died w/in 24 hrs from time of vax Dx; coroner's office autopsy-sids;
Patient left pharmacy under there own power, and interacted with staff fine. Uncle of patient stated in the car ride home, approx. 15min after vaccination, the patient threw up, convulsed, and loss conciseness. Our Pharmacist meet patient in the parking lot, approx. 20min after vaccination, patient was visibly sweeting and had a loss of color to face.
Patient filled out info sheet stating he had fainted w/previous injection at Dr's office(date unknown, but in 2008). He came to get FLUVIRIN, TWINRIX and YF-Vax. I gave him Flu and TWINRIX in left arm. Within <1 minute his head went back against the wall and he lost his color in his face. Then he slid off his chair to a sitting up position on the floor and moaned a few times. I panicked, thinking "what should I do first?" and came into the pharmacy asking to call 911. I grabbed the ekit and went back out to patient. He immediately snapped out of it and said that once he heard my voice he was ok. But then he needed to lie down soon after this- and his color was not better. He also was sweaty on his face and felt nauseous and asked for a bag to breathe in and out of. I gave him a bag and a dixie cup of water-but before I got these for him I came back into pharmacy and call 911. They came w/in 10 minutes and measured BP, pulse, etc. He continued lying on the floor while they questioned him and then about 10 minutes later they asked me to give his YFVax while they were still there. I did, and he seemed fine. They recommended he, go to the hospital and the next time I checked the hallway they were gone.
HEADACHE, DIZZINESS, OVER 102 DEGREES FAHRENHEIT TEMPERATURE - TOOK TYLENOL FOR SYMPTOMS
experienced vertigo in early Feb; Contracted Covid in late Jan2022; Contracted Covid in late Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 52 years, in left leg, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: STATIN [NYSTATIN]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovered" and all described as "Contracted Covid in late Jan2022"; VERTIGO (non-serious) with onset Feb2022, outcome "recovered", described as "experienced vertigo in early Feb". The events "contracted covid in late jan2022" and "experienced vertigo in early feb" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2022) Positive, notes: Covid test post vaccination: covid test type Post vaccination: Nasal Swab, Covid test date: 20Jan2022, Covid test result: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, vertigo.  Clinical course: Facility type vaccine was pharmacy or drug store. He received no other vaccine in four weeks. He received Statin and blood pressure medications in two weeks. He had no Covid prior to vaccination. He was covid tested post vaccination. He had no known allergies. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EM9809 and EN6203 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EM9809, and the formulated drug product lot EM9809. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Magnets sticking to the injection site.  This is not a hoax I am very concerned and this needs to be addressed. The magnets tent my skin and pull at my skin ONLY where the vaccine was administered.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 6-months-old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 22-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) of lot # S004398 with expiration date 31-OCT-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
Approximately 2 weeks after being vaccinated, I started having joint pain and stiffness throughout my body. It continues to bother me.  It is especially noticeable in the morning after rising from bed, or after sitting for a long period of time.  After pushing through the pain into normal activities, the pain lessens, but afterwards, the pain returns. I especially notice numbness and stiffness in my calves and feet after waking in the morning.  I do not feel pain while not moving.  Only when I attempt to move. My range of motion has been decreased because of the pain.  I am normally an active person.Taking Ibuprofen seems to relieve the symptoms, but pain returns after the medication wears off.
Noted swelling and tenderness under left axillary (arm pit) in morning when showering.  Seen by MD 3 days later and diagnosed with swollen lymph node left axillary.  No treatment.
pt recv vax 15JUL96 & 11JAN97 pt devel chickenpox w/more than 500 lesions;14JAN97, pt devel a low grade fever;21JAN97 pt recovered;
After having LYMErix vaccine, I experienced extreme stiffness, soreness, and lack of mobility in my hands and wrists. This resulted in a Vioxx prescription.
tremor in his hand; Bullous pemphigoid; blistery rash all over; Blisters on abdomen, chest, back, arms and hands; Itching; This case was reported by a other health professional via sales rep and described the occurrence of bullous pemphigoid in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blister (1st dose received on 2nd January 2019 (for tolerance refer US2019AMR126789)).   On 4th April 2019, the patient received the 2nd dose of Shingrix. On 7th April 2019, 3 days after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant), blistery rash, blister and pruritus. On an unknown date, the patient experienced tremor of hands. The patient was treated with ranitidine hydrochloride, cetirizine hydrochloride (Cetrizine), prednisone, hydroxyzine and doxepin. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bullous pemphigoid, blistery rash, blister and pruritus were not recovered/not resolved and the outcome of the tremor of hands was unknown.   It was unknown if the reporter considered the bullous pemphigoid, blistery rash, blister, pruritus and tremor of hands to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 65 or 66 years old. The patient received Shingrix and had blisters presented on abdomen, chest, back and migrated down to arms and hands. The blisters were itchy and too numerous to count. The patient was treated with cetirizine and ranitidine and itching improved some. On 23rd May 2019, teleconference med consult with dermatologist diagnosed with bullous pemphigoid.  The patient was given 3 bursts of steroids over the next 6 weeks. The blisters improved while on the steroids but returned upon weaning off the steroids. The physician discontinued steroids during the 3rd course of treatment due to a developing tremor in his hand. In June 2019, the patient had emergency visit (no exact date provided) and was given hydroxyzine and doxepin for rash. Near this time dermatologist scheduled 12th July 2019 appointment for further evaluation of the rash.
Arm was hurting the day; Lots of discomfort in the arm where she received the shot; Felt like having the flu for a couple of days; Fever; To the point she cannot even lift her arm; It's getting worse each day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting the day), CONDITION AGGRAVATED (It's getting worse each day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot), MOBILITY DECREASED (To the point she cannot even lift her arm) and INFLUENZA (Felt like having the flu for a couple of days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 01FE21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting the day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot) and PYREXIA (Fever). 11-Oct-2021, the patient experienced INFLUENZA (Felt like having the flu for a couple of days). In October 2021, the patient experienced CONDITION AGGRAVATED (It's getting worse each day) and MOBILITY DECREASED (To the point she cannot even lift her arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 13-Oct-2021, INFLUENZA (Felt like having the flu for a couple of days) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was hurting the day), CONDITION AGGRAVATED (It's getting worse each day), LIMB DISCOMFORT (Lots of discomfort in the arm where she received the shot) and MOBILITY DECREASED (To the point she cannot even lift her arm) had not resolved and PYREXIA (Fever) outcome was unknown.            Concomitant products included blood pressure medication for an unknown indication and inhaler for autoimmune system disease.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received SHINGRIX (subcutaneous). On 4th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The patient received SHINGRIX subcutaneously behind the right arm, which led to inappropriate route of vaccination. This case has been linked with US2018163138, reported by the same reporter. Follow up information received by a consumer on 16th October 2018: The new medical assistant gave the vaccine subcutaneously. In 2018, less than a month after receiving SHINGRIX, the patient experienced body ache, headache and sweats. The patient also being weaved by antidepressant at same time by his psychiatrist. No long term effects were noted. The VAERS details were updated.
SORENESS IN ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm. This report was non-serious.
Rash appeared at site of injection of left thigh. Skin pink. Numerous raised papules with pink blotchiness. Physician immediately notified.  Rash spreading onto abdomen, back, arms. Gave 1/2 tsp BENADRYL 12.5mg/5mL and 3/4 tsp TYLENOL 160mg/5mL. Child observed for 30 min s/p reaction with significant improvement. No swelling noted. No resp distress.
Post vax, the pt fell down. Took one hour to recover and able to take home. No treatment.