chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vaccine administered to the patient after more than 12 hour post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after more than 12 hour post puncture) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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) 1 dosage form. On 22-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after more than 12 hour post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after more than 12 hour post puncture) 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 EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after more than 12 hour post puncture).    No concomitant medications were reported. No treatment medications were reported.  Reporter stated that they received the bivalent Moderna vaccine, and they had been administering them. Reporter stated that they stored the vaccines in a fridge.  On 19-Sep-2022, the vial (of size 2.5 ml) was initially stored in the refrigerator. On 21-Sep-2022, the staff pulled a bivalent vial from the fridge and pierced it around 8:29 AM and the vial was returned to the refrigerator. On 22-Sep-2022, the opened vial was pulled and administered to the patient around 8:30 AM. The vial did not undergone any temperature excursions. The total amount of time the vial was exposed to room temperature was only to draw up syringes.  The patient had already received 4 doses of Moderna and the last dose was on 15-Jun-2022. The reporter wants to know whether the patient needs to be re-vaccinated.
p/vax pt presented to MD office w/bilat testicular pain & diffuse tenderness of both tests;dx w/orchitis;
encephalitis; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient was allergic to UTI(urinary tract infection) infection medication (i.e. sulfamethoxazole, trimethoprim etc.). Concomitant medications were not reported. The patient got encephalitis and was put in the ICU(intensive care unit) after getting vaccinated, led to hospitalization. Outcome of event was unknown. Information about lot/batch number has been requested.
Information has been received from a nurse practitioner, who mentioned a magazine's article concerning 70 young female patients who, on an unspecified date, were vaccinated with a dose of GARDASIL (lot #, expire date and route not reported), 0.5 ml. On an unspecified date the patients died from "neurological causes" after being given GARDASIL. "Neurological disorders" were considered to be immediately life-threatening and disabling by the nurse practitioner. Additional information has been requested. This is one of two reports from the same source. Attempts are being made to verify the existence of identifiable patients. This is one of two reports from the same source.
Chills and fever of 101.3 on and off for 36 hours. Body aches and sweating.
Knee is so swollen that he cannot stand up/walk; knee is so swollen that he cannot stand up/walk; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown); via an unspecified route of administration in the left arm on 25Mar2021 at 12:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 19:30, the patient experienced swollen knee that she cannot stand up/walk. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the knee swelling and walking difficulty was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Administration of Kinrix to a 4 month-old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments:  A reporter called to ask for information about the administration of Kinrix to a 4 months old patient. The reporter asked for safety information and she asked how to proceed with patient vaccination. The reporter did not provide patient initials.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered Kinrix at 4 months of age, which led to inappropriate age at vaccine administration.
First day a little dizzy but I was fine went to work came home arm was sore but not bad at all . Fell asleep had chills bad got hot felt like a fever but didn?t have one  and had a migraine from hell and sick to my stomach my lower back and hip hurt a little  then my resting heart rate started going from 124-134 resting not moving at all I laid back down woke up with a stiff neck the headache the necked day wasn?t bad  but still hurt and that?s when my husband seen I had a huge bruise where I got my shot  I have a dry cough but not bad at all but the bruise is very dark and purple
Day 1: palpitations, dizziness Day 2: headache, redness, swelling, itching on vaccination site; GI disturbance Day 3: vaccination arm had paresthesia, heaviness, almost stroke-like symptoms; the symptoms started suddenly ** treated in the ER; IV steroids- for possible allergic reaction; tpa- for the stroke-like signs; halfway through the tpa, I felt an improvement with the arm
c/o pain on 10JUL96 w/swelling; on 12JUL96 red in color & warm to touch-apply cold compresses of 15mins;remove q 30minutes;
2-3 hours after 1st vaccine Gardasil, started feeling hot, dizzy, light headed, pre-syncope.  No LOC.
I woke up with a really sore throat and feverish. I took Ibuprofen during the day and didn't get better so I contacted the urgent care center and they recommended a telehealth visit so I did that. They prescribed an antibiotic for strep throat. I looked at my throat and I had white patches.  The symptoms lasted 3 to 4 days.
a lot more tired; no energy; redness spread all the way under her right arm; At the injection on her right arm; there was a knot that was hard; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (a lot more tired), ASTHENIA (no energy), ERYTHEMA (redness spread all the way under her right arm), VACCINATION SITE PAIN (At the injection on her right arm; there was a knot that was hard), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            treatment given included Sama-HC .
This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown demographics. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On an unknown dates in approximately February 2017 (reported as "since the beginning of February") the patients were vaccinated with improperly stored doses of GARDASIL 9 lot numbers M031557, expiration date: 07-APR-2019 and M013636, expiration date: 15-FEB-2018 (doses, routes and sites of administrations were not reported). The GARDASIL 9 doses were stored in the temperature of 35 Fahrenheit for 9 days. No other temperature excursions were reported. No adverse events were reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA006301: US-009507513-1703USA006309: US-009507513-1703USA006310.
This spontaneous report as received from a 58 year old female patient refers to herself. The patient's current condition included migraine headaches. The patient thought she had a prior case of shingles in 2006. On 02-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date were unknown, dose 1 injection, therapy route was reported as injection). Concomitant therapies included tramadol hydrochloride, ZOPITAN and Flu shot (unspecified brand name). On 09-OCT-2014 the patient had been experiencing an extreme painful, itch on the back side of her arm where she received her ZOSTAVAX injection. When the patient scratched this area it turned a fiery red. On 03-NOV-2014, the patient looked at the affected area she saw "raised bumps" and the area look bruised. The patient had been experiencing an itching sensation for the last three weeks in October 2014 (unspecified dates) and the area affected seems to be spreading and her symptoms did not seem to be subsiding. BENADRYL tablets and cream, alcohol and hydrocortisone were given for the adverse events by self administration. The patient did not seek for medical attention. Additional information has been requested.
Extreme migraine off and on for about 2 weeks after the second dose. No other history of headaches.
Case number PHEH2013US023020 is an initial spontaneous report received from a nurse on 31 Oct 2013. This report refers to a 50-year-old male patient. He was vaccinated with FLUVIRIN (batch number:  unknown) intramuscularly on an unspecified date. On 31 Oct 2013, one month after receiving FLUVIRIN, he experienced flu. Outcome, seriousness and causality of the event were not reported.
Information has been received from a physician concerning a 15 year old male who on 23-MAY-1995 was vaccinated with a first dose of MMR II (route, site, and lot number not reported). On 05-JAN-1998, the patient was vaccinated with a second dose of MMR II (route, site, and lot number not reported). Subsequently, the patient had a headache for two days and was afebrile. On 10-NOV-2009, the patient experienced mumps (diagnosed on 12-NOV-2009). The patient was afebrile and had left parotitis. On 19-NOV-2009, the patient had an IgM and IgG performed, The results were <1:10 and 8.11 respectively. At the time of the report, the outcome was not reported. On 24-NOV-2009, the patient had an IgM and IgG performed. The results were less than 1:10 and 8.2. No further information is available.
This spontaneous report was received from a pharmacist. The pharmacist was reporting the packaging of the MMR II and the sterile diluent (manufacturer unknown) were similar and were the same color, which could potentially cause confusion between the products. The pharmacist stated no misadministration had occurred. Additional information has been requested.
He got a rash on his trunk (stomach, chest, and back).  Rash looked like a pinpoint rash.
restless; tired; head hurt; arm hurts; body aches; cold chills; couldnot sleep; tongue burning; This is a spontaneous report from a contactable consumer (Patient's daughter).  A 84-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jan2021 19:00 (at the age of 84-years-old) as a single dose for COVID-19 immunization). Medical history included diabetes mellitus and arthritis from 20 years. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) at a dose of 200 mg as needed. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecifie date consumer stated her mom got the first shot of the Pfizer COVID 19 vaccine 28Jan2021 at 19:00PM in the right arm. After the shot she was fine but during the night her head hurt, she had body aches and cold chills, she was tired but she couldnot sleep because she was so restless and her tongue was burning up and she couldnot feel it. Clarified she can feel her tongue and it feels really hot. It was questioned that this a side effect of the vaccine. She was scheduled to receive the second dose of the vaccine on 18Feb2021. Added her mother took two Advil before the shot getting the shot because she was anxious and worried about the side effects. It was reported that the events couldnot sleep, tongue burning and tired were worsened. Outcome of the event cold chills was recovering and not recovered for other events.  Information on the lot/batch number has been requested.
Parent reports pt developed urticarial rash on 8/9/03, was evaluated at hospital ER. Dx urticaria, possibly secondary to DT. Was prescribed Benadryl with resolution of rash.
He developed shingles on left arm in c6 dermatome despite Varivax 04/04 mom not immune to varicella and she is pregnant so she had to get VZIG
Caller received the Pfizer Covid vaccine on 21Mar2021 and subsequently tested positive for Covid 19.; Caller received the Pfizer Covid vaccine on 21Mar2021 and subsequently tested positive for Covid 19.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer covid vaccine on 21Mar2021 and subsequently tested positive for COVID-19. She was scheduled for the 2nd dose, more than 21 days apart, she also asked if she is still recommended to get the 2nd dose of covid-19 vaccine after. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive for COVID 19 on an unknown date. The outcome of the events was unknown.     Information on lot number/batch number has been requested.
sore arm, sore throat, flu like symptoms, facial skin began sluffing / peeling like from a bad sun burn,  resulting in bacterial infection in left ear, ruptured ear drum secondary effect
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with a dose of PROQUAD injection (albumin status: recombinant human albumin (rHA), lot# M015699, expiry date 26-SEP-2017; exact dose and route of administration were not reported) and with a dose of M-M-R II injection (albumin status rHA, lot# M008589 and expiration date 16-FEB-2018 ; exact dose and and route of administration were not reported) at the same time. Doses were reconstituted with sterile diluent. No adverse affects were reported. Additional information has been requested.
ADVERSE EFFECTS; 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. The patient's past medical history included: history of pulmonary embolism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse effects was not reported. This report was non-serious.
Pulmonary Embolism  Symptoms: Shortness of breath when climbing stairs.  Pulse Oxygen level 85% prompted visit to Emergency room.  Symptoms thought to be COVID but tests during ER visit showed nagative COVID result but Pulmonary Embolism in both lungs found.
Headache, fever, chills and fatigue began 15-16 hours post shot. Most symptoms resolve within a few hours. Fatigue and headache lasted 24 hours. Reaction overall was mild.
severe dizziness; her heart was not functioning; This is a spontaneous report from a contactable consumer (reported for herself). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included iron (IRON), zinc (ZINC), potassium (POTASSIUM) and blended ginger. On an unspecified date, patient experienced severe dizziness. Refused to go at first, eventually let him take the emergency room. She didn't want the ambulance to take me to the hospital. She was there for hours at midnight, her heart was not functioning transferred to (name withheld). States she has never been admitted to the hospital other than having her son who was 29Y. Before second dose started taking zinc, potassium and blended ginger trying to get her system together corona stuff in there. State takes iron. States received second dose of product with no adverse event. In the home and unemployed for a while. She was asking for aid for medical bills. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
received pneumococcal vaccine on 06-DEC-2006 and 13-APR-2010; This spontaneous report has been received from an health professional and a lawyer, referring to a 61 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported.      On 06-DEC-2006 and 13-APR-2010 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis (inappropriate schedule of vaccine administered).  The case is linked to case# US-009507513-1704USA011055 due to the same patient.; Sender's Comments:  US-009507513-1704USA011055:
Given (DTAP/IPV/HIB/PREVNAR) (1st set of vaccines).  Within 2 hours of getting above, patient very irritable with high pitched continuous crying (13 hours).  Sent to ER.  Temperature: 99F.
Information has been received from a physician concerning a 15 month old male with atopy who on 08-AUG-2006 was vaccinated with a dose of Varivax. Concomitant vaccination included an unspecified hepatitis vaccine. On 10-AUG-2006, "two days after vaccination" the patient developed lesions on his face and left foot. There were three lesions on the face and multiple lesions on the foot. Some lesions were papular vesicles and some were crusting. It was reported that the patient was not having any pain. It was reported that a "culture" was done. At the time of the report the patient had not recovered. Unspecified medical attention was sought, there was no product quality complaint involved. Additional information has been requested.
No adverse event; the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C i) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose) 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 WRONG PRODUCT ADMINISTERED (the patient received a dose from that lot on 08-Sep-2022 and it was inadvertent dose).    No concomitant medications were reported.   No treatment details were reported.
Arm swelling- upper-around injection site-bilateral arm sore-bilateral 24 hours.