chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch.; Left shoulder and arm pain; arm pain; This is a spontaneous report from a contactable pharmacist (patient). A 48-year-old male patient received the second dose of BNT162B2 (Lot number: EL1283), via an unspecified route of administration from 09Jan2021 08:30 at single dose in the left arm for COVID-19 immunization. Historical vaccine included BNT162B2 (Lot number: EH9899), received first dose via an unspecified route of administration on 19Dec2020 10:45 at single dose in the left arm for COVID-19 immunization. There were no medical history. Concomitant medication included ibuprofen on 11Sep2020 11:00. On 09Jan2021 09:00, the patient experienced dark purple bruise on injection site about 2 in in size discovered the night of inject 10Sep2020. Painful to the touch. Left shoulder and arm pain. Did not alleviate as of 10Nov2020 when report submitted. No treatment received for the events. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
headache; pain in the right arm; Administered the vaccine in the right arm, but lower than the deltoid / Injected the vaccine in the muscle tissue or fatty tissue; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache, pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the headache, pain in arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.  Additional details were received as follows: Caller is the patient's wife. Caller states that the patient received the 2nd dose of Shingrix yesterday. Caller states that the pharmacist adminstered the vaccine in the right arm, but lower than the deltoid, which led to vaccine administered at inappropriate site. Caller states that she is not sure if the pharmacist injected the vaccine in the muscle tissue or fatty tissue. Caller states that the patient developed pain in the right arm and also experienced a headache following the vaccine. Caller disconnected before providing patient initials, DOB, or mailing address. Caller did not provide any additional information. This case was linked to cases US2019178924 and US2019AMR179518, reported by the same reporter.
Burning sensation on my skin. Pain in my back muscle. Pain in my stomach later that night.
Pt woke up the following morning with a drooping eyelid, like that associated with Bells Palsy. Because the patient has no current health conditions he does not currently see any physician. He felt the condition would improve and after almost 2 months he came back to the pharmacy for advice. I advised the patient that he needs to seek the advice of a medical doctor and I would report to see if there could be any correlation to the vaccine he received.
sick; Initial information was received on 07-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (Non-Healthcare Professional) (patients husband) via social media.  This case involves a female patient of an unknown age who was sick (Illness), while received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergic to egg products. Concomitant medications were not reported.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, patient was sick (Illness) (unknown latency) most of the time, following the administration of INFLUENZA VACCINE. It was reported that the patient was sick because she was allergic to sick.  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
Cold, i.e. viral infection - muscle aches, sore throat, runny nose, coughing Rest, keep warm, wash nasal passages, sudafed
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L042215, expiration date: 02-JUN-2017 (exact dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from the registered nurse regarding a 14 months old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 05-DEC-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
My arm feel a little sore on the right but I am alright for today; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: 72359-016-4), dose 1 via an unspecified route of administration, administered in Arm Right on 12Aug2021 at 10:00 (at the age of 53 year) as dose 1, single for COVID-19 immunisation at facility. The patient medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 12Aug2021 at 10:00 AM, patient arm felt a little sore on the right but patient was alright for today. On 12Aug2021 at 12:00 PM, patient talked to the doctor then wait and did vitals and then went and got examine a deep in my soul patient had did that everything was fine and then patient took a shot when your while then patient have to do some more blood work and that would be. The patient underwent lab tests and procedures on 12Aug2021 which included covid-19: negative (Nasal Swab). It was reported that no therapeutic measures were taken for the events experienced. The outcome of event was recovered on an unknown date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recvd 1st dose of Engerix-B & several hrs later pt exp nausea, vomiting, diarrhea, dizziness, double vision & a 10 lb weight loss;
The pt is a healthy 24 yo who was admitted with concern for myopericarditis. The patient states he received the smallpox vaccination about 10 days prior to chest pain development. However he states that he started getting low grade fever, body aches and fatigue about 3-4 days after immunization. He then came to work and reports that on Saturday he had high fever up to 103F and developed sharp chest pain that was constant but worse with inspiration. He also note 2 episodes of syncope on Thursday. He states he was walking and suddenly woke up on the ground. He denies any prodromal of palpitations or light headedness and he did not suffer any signs of trauma. Cardiologist reports: The patient's symptoms of pleuritic chest pain is consistent with pericarditis. He has elevated troponin consistent with myocarditis. His EKG is consistent with both given tachycardia and PR depression/elevation (for pericarditis) and TWI diffuse which is more of a myocarditis. Currently starting treatment for pericarditis with ASA 650mg TID and colchicine, and discontinue ASA when pain resolves.
The day of getting the vaccine she had redness and itching right away. She had urinary tract bleeding and abdomen pain. Nigh sweats. She went to the doctor and was given Zipro Xlozaix . She still continue to bleed and docs stopped the meds. She went back and had a pelvic exam which came back negative along with negative UTI. All this went on from the beginning of April to Mid May and the bleeding with stop and restart. June 16th she contacted her urologist for the bleeding which the test was negative results, however the bleeding continued.  On Aug 12th she went back to the GYN and was prescribed meds it made the bleeding worse. On Oct 12th she came down with COVID and on Oct 18th she had an infusion to stop COVID.  Nov 10th. she started to have diarrhea in the night and around 3am it turned into rectal bleeding. She went to medical facility and they couldn't determine anything. The rectal bleeding lasted until Nov. 11th and stopped.
ache in joints; tightness in chest; Headache; body aches; ache in eyes; This is a spontaneous report from a contactable consumer. An elderly patient of an unknown age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: En6204 Expiry date: UNKNOWN) via an unspeciied route of administration at left arm on 05Mar2021 12:00 as a single dose for COVID 19 immunization. The patient's past drug history included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot no: EN5318 Expiry date UNKNOWN) via an unspecified route of administration at left arm on 12Feb2021 10:30 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 05Mar2021 13:00 the patient experienced headache, ache in eyes, body aches, tightness in chest and ache in joints. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered   Amendment(25May2021): This follow-up report is being submitted to amend previously reported information: reporter details, patient demographics and suspect drug details were update. Past drug details were added. Event details were updated.  No follow-up attempts are needed. No further information is expected.
Body aches and chills began approximately 6-7 hours after receiving the vaccine. The following morning I woke up at 6am with a fever, lower back pain, chills, injection site soreness accompanied by redness at the injection site and surrounding tissue. The fever reached 103 degree at it?s peak. I was nauseated and had half a cup of soup all day. I developed a mild headache and fatigue 3/26/22 until 3/29/22. At 4am 3/27 I woke up and threw up liquid only. I alternated acetaminophen and ibuprofen to relieve pain and fever from 6am 3/26 until 11pm 3/28. At the time is entry the injection site area is still red and tender.
expired IPOL vaccine was administered to patient; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health care professional.  This case involves a patient (unknown demographics) who was administered expired IPV (VERO) [IPOL] vaccine lot number and expiry date not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Information has been received from a physician assistant concerning an 83 year old female who on approximately 17-JAN-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included Synthroid, Celebrex, LESCOL, Flonase, Zyrtec, Prozac, Avapro. Subsequently shortly after receiving the vaccine, the patient developed shingles and rash on the right side of her back. At the time of the report, the patient had not recovered. Unspecified medial attention was sought. There was no product complaint involved. Additional information has been requested.
felt a bit of nausea; clammy; Shivers; felt feverish, but my temp was 97.7; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, 4 days after receiving Shingrix, the patient experienced nausea, clamminess, shivers and fever. On an unknown date, the outcome of the nausea, clamminess, shivers and fever were unknown.   It was unknown if the reporter considered the nausea, clamminess, shivers and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 1st dose of Shingrix and felt a bit of nausea, clammy, shivers and feverish with the temperature 97.7 degree fahrenheit. The reporter was asking if it was consistent to the side effects. The reporter did not consent to follow up.
Client developed sharp stomach pain 4/7/16 that was intermittent. On 4/8/16, client developed swollen (L) armpit nodes, size of a kidney bean. States very tender and unable to wash the area. Saw the physician 4/8/16 and prescribed CLARITIN and BENADRYL daily. 4/19/16 client called area still swollen, no stomach pain.
1.5 X 1.5 irregular area of erythema at site of two month Comvax injection-size and intensity of erythema not decreased now at 6 months. Annual follo wup staes 1 x 1 .5 cm red discoloration of skin  at site of vaccine. Looks like a flathemorgiama. Has done fine with Hep B and HIB given seperately.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 21.24 for dose administered on 03-Apr-2021. No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
pt recvd vax & devel fever of 101 & had sz 530PM was shaking, eyes not focused; pt quit breathing & turn bed blue; CPR was started;
Constant tremors all over, equilibrium off, hypersensitive to noises, fatigue.  No treatment.  Still continuing
Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the night that traveled up my forearms. On a scale from 1-10 the pain was about a 7.  After the first dose, the pain went away in the morning and I was fine. On the third day after the second dose, I woke up with a rash all over my body and again had pain throughout the night only this time I woke up with swollen hands. It?s now been two weeks since my second dose and I am still experiencing hand pain, though improving. My hands feel sore and tight.
Vomiting x1 on day of onset. Substernal chest pain x 3 days.  Pt recently vaccinated with Small Pox vaccine 12 days prior, subsequent viral URI type symptoms 1 week later, resolved and two days later CP symptoms began.  CP located substernal L>R side of chest.  Described as throbbing/aching in nature.  No aggravating factors.  Alleviated w/ Ibuprofen, learning forward, rest.  Pt presented to ED at MC for eval and treatment of myopericarditis.
ADVERSE EVENT: DIZZINESS/ SYNCOPE AND NAUSEA, PATIENT ALS O TURNED PALE DURATION OF 15 MINUTES. TREATMENT: MONITORED PATIENT ENTIRE TIME AND PROVIDED SUPPORTIVE THERAPY. GAVE PATIENT WATER   OUTCOME: PATIENT RECOVERED IN 15 MINUTES AND WAS OBSERVED FOR AN ADDITIONAL OF 15 MINUTES (30 MINUTES TOTAL) AND PATIENT WAS RELEASE TO THE CARE OF HER GUARDIAN
MY DAUGHTER FAINTED WITHIN 30 SECONDS AND FELL FLAT ON HER FACE FROM THE DOCTORS TABLE. STAFF BEGAN VITALS, OXYGEN, I.V... X-RAYS OF HER FACE WERE TAKEN, NOTHING BROKE BUT HER FACE AND NOSE IS SWELLED AND GASHED. HER RIGHT KNEE IS SWOLLEN AND IS CAUSES HER PAIN AS WELL. SHE IS SHAKEY. SHE WAS RELEASED AFTER A FEW HOURS OF EVALUATION AT URGENT CARE. WE WERE TOLD IT WAS BECAUSE SHE WAS ON HER PERIODAT THE TIME OF VACCINATING WITH GARDASIL. NO MEDS PERSCRIBED. WE WERE TOLD TO COME BACK IN 2 MONTHS. THIS HAPPENED TODAY. MY FATHER CONSENTED TO THIS VACCINATION BECAUSE HE IS LEGAL GUARDIAN. HE WAS TOLD SHE SHOULD GET THIS BECAUASE SHE IS SEXUALY ACTIVE. AND IT WAS SAFE.. I HAVE BEEN EDUCATING MYSELF WITH THIS GARDASIL AND I AM VERY FEARFULL THERE IS IRREVERSABLE DAMAGE DONE.... 11/16/2009, PCP/Urgent Care records from 10/22/2009,Dx syncopal episode  post vaccine, patient with a syncopal episode that resulted in a fall, patient striking her nose. xrays neg for fx. tx: ice pack and Motrin,
2nd shot side effects: Headache - within an hour or two Arm pain within an hour or two Fatigue, severe arm and body pain at around 12 hours continuing through 24 hours low-grade fever around 24-28 hours intense scalp itching and pain around 36 hours  (this happened for both 1st and 2nd shot)
CUSTOMER IS COMPLAING SHOULDER PAIN. SHE IS STILL HAVING SHOULDER PAIN AFTER GIVING INJECTION  IN 9/19. PAIN IS THERE EVEN NOW. CAME TO PHARMACY AND COMPLAINED TO PHARMACIST IN LAST WEEK OF NOVEMBER.
Initial physician report received on 13 Aug 2010: This patient was vaccinated with the MenCWY liquid conjugate component of MENVEO (batch number: 0900901), (dose: 0.5 ml) intramuscularly on 13 Aug 2010. No adverse events were noted following this medication error. Follow up received from physician on 24 Aug 2010: It was reported that the patient received MENVEO vaccine on 16 Jul 2010. The date of medication error was reported as 16 Jul 2010.
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 13-month-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 27-APR-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location , and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion were reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Chest tightness and cough starting 20min after injection. Got better as day went on. 9pm body aches and chills started. Fever 101.6. Lasted 36 hours. Also severe body aches, severe headache. Had to call out of work 2 days in a row. Severe headache and back ache still present 48hrs after vaccine. Still breaking out in a cold sweat.