chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, route of administration, lot number were not reported). There was no adverse effects reported. Product Quality Company (PQC) was not involved. Additional information has been requested.
Fever of 101.5F, chills, migraine, severe body aches, stomach ache, nausea, no appetite, not able to sleep, constant coughing, dry mouth, short of breath, and bruising at injection site. Adverse event lasted approximately 2.5 - 3 days.
Aches, fever, chills, 6 inches diamater of sewlling at injection site.  The symptoms lasted for two days.  I called to report the reaction and the nurse said that it never happens.
This spontaneous report was received from a certified medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB  lot # L038018/expiration date- 13-SEP-2017, lot # L044694/expiration date- 04-FEB-2018 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. Temperature excursion and time frame was 49F for 142 hours and 34F for 24 hours. There was no previous temperature excursion and call was not because of the data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2016US033368, is an initial spontaneous report received from a pharmacist on 20 Sep 2016. This report refers to a 33 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUAD (unknown whether seasonal or pandemic, bath number: 165803) at a dose of 0.5 ml intramuscularly on an unknown date when the patient was 33 years old. No adverse event reported following this medication error (inappropriate age at vaccine administration).
blisters and pain on left deltoid; arm pain; blisters and pain on left deltoid; area started to feel tender; later to "burn" with blisters; booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 14:15 (Lot number: 33130BA) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; hepatitis b vaccine (HEPATITIS B VACCINE), administered in arm left, administration date 15Dec2021 (Lot number: 9AX5P) as dose 1, single for immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Note: Seasonal allergies.; "Diabetes type II" (unspecified if ongoing), notes: Note: Diabetes type II; "chronic R knee pain" (unspecified if ongoing), notes: Note: Chronic R knee pain; "anxiety" (unspecified if ongoing), notes: Note: Anxiety. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FB-EW0183), administration date: 11May2021, when the patient was 35 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FB-ER8735), administration date: 20Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "booster dose"; MYALGIA (non-serious), BLISTER (non-serious) all with onset 16Dec2021, outcome "recovering" and all described as "blisters and pain on left deltoid"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "recovering", described as "arm pain"; TENDERNESS (non-serious) with onset 16Dec2021, outcome "recovering", described as "area started to feel tender"; BURNING SENSATION (non-serious) with onset 16Dec2021, outcome "recovering", described as "later to "burn" with blisters". The events "blisters and pain on left deltoid", "arm pain", "blisters and pain on left deltoid", "area started to feel tender" and "later to "burn" with blisters" were evaluated at the physician office visit. Therapeutic measures were taken as a result of myalgia, pain in extremity, blister, tenderness, burning sensation. No follow-up attempts are possible. No further information is expected.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Adverse event treatment silvadene 1 % Cr and Motrin 400 mg QID (four times a day).
Pain in arm lasting since 9/11 - patient says Dr diagnosed her with "SIRVA."
receiving a dose of Fluzone High Dose Quadrivalent, it turned out to be Fluzone Quadrivalent, with no advere event; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a female patient of unknown age, who was told to be receiving QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but it turned out to be QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) (wrong product administered), (batch number and expiration date: unknown for both) both via unknown route at unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was not reported.  It was an actual medication error case since the patient was at another facility and who was told to be receiving QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but it turned out to be QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) (wrong product administered).  The pharmacist wanted to know if patient met the age requirement for QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), and received QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) and that if the patient can receive high dose as well and  information in regards to safety and reactions.  At the time of reporting, no adverse event was reported.  No lab data was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information about batch number was reported for this case.
The night after he got flu shot he was sweating, in a confused state and weak. The next morning he had uncontrollable bowel movements. He is still weak.
Patient experienced nausea, numbness in the arm to the point where she said she could not use it normally, pain at injection site and chills. I advised her to go to the ER if she felt necessary or if symptoms worsened and to call her doctor at a minimum in the morning if needed. I called her back later to check on her again and she was contemplating going to the ER. Nausea had begun but other symptoms remained the same. No trouble breathing reported.
Patient states she received flu shot about 1pm after only sleeping a "few hours" after working 3rd shift. She states she was fine for the afternoon but woke up during the night cold and had to "cover up". At about 8am on the next day, she work up weak and tired, went back to bed. She was back to normal by morning.
The patient had a possible seizure. The patient's mother states the child is unresponsive with cool clammy skin.
received a third Shingrix dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number H49MA, expiry date 29th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose was received in January 2022) and Shingrix (2nd dose was received in April 2022).   On 24th August 2022, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml. On 24th August 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.      Additional Information: GSK Receipt Date: 25-Aug-2022:  Reporter's comments: The reporter was the HCP (paramedic/office manager). The Healthcare professional reported that patient received first and second dose of Shingrix. The patient mistakenly received a third dose of Shingrix. The Healthcare professional had nothing else to report. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up. Additional Supportive Information: The patient was mistakenly administered a third dose of Shingrix, which led to extra dose administered.
Persistent muscle twitches/spasms that started in the muscle that the vaccination went in about 10 minutes after vaccination. By the next morning, I had muscle twitches/spasms in different muscles all over my body. This has now been persisting for over 10 months; however, the severity of the twitches wax and wane. I have also noticed that my hands go numb very easily.
This case was reported by a physician via regulatory authority and described the occurrence of injection site oedema in a 10-year-old female patient who received BEXSERO (batch number 16E221, expiry date unknown). Additional patient notes included Medical history: insignificant. On 10th November 2017, the patient received BEXSERO (intramuscular) .5 ml. On 10th November 2017, less than a day after receiving BEXSERO, the patient experienced injection site oedema (serious criteria other: serious as per reporter), injection site pain (serious criteria other: serious as per reporter), extremities hot feeling of (serious criteria other: serious as per reporter) and subfebrile. On 13th November 2017, the outcome of the subfebrile was recovered/resolved. On 18th November 2017, the outcome of the injection site oedema, injection site pain and extremities hot feeling of were recovered/resolved. It was unknown if the reporter considered the injection site oedema, injection site pain, extremities hot feeling of and subfebrile to be related to BEXSERO. Initial information was received from a physician via regulatory authority on 30th May 2018: Subfebrile, vaccination site oedema, site of vaccination painful, hot feeling of upper extremity.
Psoriasis, 2 weeks after second dose; Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis, 2 weeks after second dose) and SKIN LESION (Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PSORIASIS (Psoriasis, 2 weeks after second dose) and SKIN LESION (Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body). At the time of the report, PSORIASIS (Psoriasis, 2 weeks after second dose) and SKIN LESION (Lesions in legs/Lesions in pubic area/Lesions in buttocks/Lesions in most of the body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Two weeks after the second dose, the patient was diagnosed with Psoriasis and is ongoing. As treatment ointments were added. the lesion in one place better, the other seem to be emerging.  Patient tested for COVID-19 four times with negative results .  No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received on 22Oct2021 contains significant information like lab data.
This spontaneous report as received from a registered nurse via a company representative concerning a female patient "two patients were also reported" of unknown age who on an unknown date started therapy with (therapy unspecified) (dose, duration and indication were not provided). The registered nurse stated that on an unknown date the patient had "0 titres". It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a male patient. He was vaccinated with a dose of Hep B (manufacturer unknown). Patient had no antibodies to hepatitis B. This patient was being revaccinated with the Hep B vaccine (manufacturer unknown). No patient names were provided. This is one of the several reports from the same source. Additional information has been requested.
COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).; Left arm was red; Left arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Left arm was red) and VACCINATION SITE PAIN (Left arm was hurting). On an unknown date, the patient experienced COVID-19 (COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19 infection (diagnosis date not asked/Hospitalization due to COVID-19 (dates not asked).), VACCINATION SITE ERYTHEMA (Left arm was red) and VACCINATION SITE PAIN (Left arm was hurting) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.  Company Comment: This case concerns an 89-year-old, female patient with previous relevant medical history of cancer, who experienced the unexpected events of COVID-19. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-346692 (Patient Link).; Sender's Comments: This case concerns an 89-year-old, female patient with previous relevant medical history of cancer, who experienced the unexpected events of COVID-19. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Itchy raised rash at injection site on 6/18 had break out in back left shoulder went to the ER was prescribed VALTREX for 5 days 6/23 broke out on back again, different spot, itchy burning rash.
my left side from my face became numb; my facial muscles began to droop; could not feel my left side until my hand; I feared I was having a stroke; I was diagnosed with Bells Palsy; I sometimes lose vision in my left eye; numbness; nerve pain; migraines; This is a spontaneous report from a contactable HCP (patient). A 34-year-old female patient (not pregnant) received the second dose of BNT162B2 (Pfizer COVID 19) via an unspecified route of administration on the right arm in Mar2021 as single dose for COVID-19 immunization. Medical history included endometriosis, hit by a car as pedestrian in 2008, past migraines and sensitive to latex. Known allergies: gluten intolerant (no celiac disease). The patient performed Nasal Swab in Sep2021 and result was negative. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm in Feb2021 at the age of 34-year-old as single dose for COVID-19 immunization. Four days after the shot, the patient left side from face became numb and facial muscles began to droop. The patient also could not feel left side until hand. The patient went to the emergency room because he feared he was having a stroke. The patient was diagnosed with Bells Palsy, and was told it was perhaps due to the 2nd shot he received. The patient had since visited neurologist, as he sometimes lose vision in left eye, continue to have numbness and nerve pain, and migraines only on that side of face. The patient wear an eye patch at times to rest eye. The patient had also followed up with primary physician who had prescribed Gabapentin for nerve pain. The patient also had O-blood. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Treatment was received included toridol, steriod shot, nerve pain and migraine meds. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional 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: Unknown) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Shortly after receiving influenza vaccine individual began experiencing local burning/irritation. Exam revealed erythema. 5 x 5 at side site of sxs.
grunting about 608hrs p/vax given-otherwise healthy pt t100 R @ home & T104.2 @ ofc
LUMP ON NECK; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and heart arrhythmia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021 16:00, the subject experienced lump on neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lump on neck. This report was non-serious.
Patient states on 2/16/21 to the pharmacy at 2:48pm, that 6 hours after her 2nd dose of the Covid vaccine she started to feel "nerve ending tingling sensations" with itching at random places throughout her body at random times.  One specific place she noted that she felt this was at the tip of her nose.  She stated that they would be "bursts" of sensations that would last for approximately 1 second each and occur throughout the day, all day.  These sensations did not disturb her daily activities, but were noticeable for her when she was "just sitting there."  She called her primary doctor on 2/15/21, but received no call back.  She tried to call them again today (2/16/21) and was passed to a voicemail.  I encouraged her to try and reach the doctor again to see if it was anything significant to be seen by them, or seek evaluation by another healthcare professional.
arm was stif; lightheaded; not feeling like herself; started freezing; Really really cold; bed was soaked and wet, mattress was wet, pillows, covers, everything; just not feeling good and shaking; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm was stif), DIZZINESS (lightheaded), FEELING ABNORMAL (not feeling like herself), FEELING COLD (started freezing) and FEELING COLD (Really really cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (arm was stif), DIZZINESS (lightheaded), FEELING ABNORMAL (not feeling like herself), FEELING COLD (started freezing), FEELING COLD (Really really cold), HYPERHIDROSIS (bed was soaked and wet, mattress was wet, pillows, covers, everything) and TREMOR (just not feeling good and shaking). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm was stif), DIZZINESS (lightheaded), FEELING ABNORMAL (not feeling like herself), FEELING COLD (started freezing), FEELING COLD (Really really cold), HYPERHIDROSIS (bed was soaked and wet, mattress was wet, pillows, covers, everything) and TREMOR (just not feeling good and shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 04-Aug-2021, the age was corrected to 60 years.
1/22/08 Cried uncontrollably since shots (R) temp 101 deg. "Like you were cutting his leg off" 2 runny limegreen BM's. legs are swollen diaper and socks mad indention
eyes red & swollen, watery & burning;visit to ER, MD placed on pred x 5 days, atarax & zantac;
warm itchy rash around vaccination site, sore throat, chills, headache, fatigue, body aches.  flu like symptoms lasted 3 days, rash persisted for 1 week.  Took benadryl and tylenol.  rash covered entire upper arm by the end of the week and disappeared overnight.