chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient recieved an expired vaccine with no reported adverse event; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional and non-healthcare professional via Agency (Global Medical Information- 00787339).  This case involves a 62-years old male patient who was vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 25-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number QFAA2060 and expiry date 30-Jun-2021 reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Covid symptoms as of 7/2/2022 while on vacation; Tested positive for covid 7/4/2022.  Paxlovid prescribed 7/5/2022 and taken along with Coricidin Cold/Flu formula for symptomatic relief (Headache, fever, severe nasal congestion).  Symptoms abated within a couple days of starting the Paxlovid medication.  Continued to test positive for covid until 7/20/22 despite being asymptomatic.    (FYI:  original 2-dose vaccinations and first booster were Pfizer)
p/vax pt exp cellulitis & phlebitis of lt upper arm;arm was swollen & hot to touch;pt was taken to ER for tx;
TROUBLE BREATHING/WHEEZING; HANGOVER; HOT FLASHES; CHILLS; SWOLLEN ARM MUSCLE; INJECTION SITE RED SCAB; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced trouble breathing/wheezing. On APR-2021, the subject experienced hangover. On APR-2021, the subject experienced hot flashes. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced swollen arm muscle. On APR-2021, the subject experienced injection site red scab. On APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hangover, hot flashes, trouble breathing/wheezing, chills, injection site pain, swollen arm muscle and injection site red scab was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Describe Event, Problem, or Product Use Error: Patient was to receive Pfizer Covid-19 vaccination for age > 12 years old but received dose for 5-11 year olds.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 05-JUL-2016 the patient was vaccinated an expired dose of with VARIVAX (0.5 ml, lot# K008822, expiration date 19-JUN-2016) subcutaneously. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Initial report was received 11 June 2009 from a health care professional.  A 35-year-old female patient with a history of chronic hepatitis B had received a second dose injection of JE - VAX (lot number, route/site and date of administration not reported), and an unspecified amount of time later, she developed neuralgia, back pain and leg pain.  The patient also had a CT scan performed on an unspecified date which revealed lesions in the liver.  The patient had previously received a first dose of JE - VAX on an unspecified date and it was unknown if the patient had received any other vaccines within four weeks of JE - VAX.  No further information was provided at the time of the report.  Documents held by sender: None.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administrated improperly stored doses of GARDASIL (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 C degrees. No adverse effects were reported. It was reported that all the vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient had started feeling tingling in the hands and rest of the body, SOB, and chest tighten after vaccination. She was taken to Med OBVs at around12:40 and upon arrival had rapid breathing. VS at 12:45 were: HR: 117, RR: 25, BP: 140/84, SPO2: 100. Patient was given an emesis bag to help breathing.  VS at 12:56 were: HR: 90, RR: 18, BP: 135/79, SPO2: 98.  Patient's hyperventilation started subsiding and at 1:04 VS were: HR: 84, BP: 132/84, SPO2: 98. Patient was released at 1:16 and went home with others.
The patient was supposed to receive her second dose of the Moderna covid shot.  However, the technician mistakenly administered the Pfizer shot.  No adverse reaction reported by patient.
Splotchy red raised areas with an outer red ring. Painful. These symptoms appeared less angry after I was up for awhile. Pain still present and only if touched. I just wondered if I should ever have the injection again.
Sore arm the next morning; Headache; Disorientation; general tiredness/fatigue; This is a spontaneous report from a contactable consumer (Patient). A 47-years-old female (non pregnant) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (at the age of 47-years-old) (Batch/Lot number was not reported) as 1ST dose, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have any known allergies and no allergies to medications, food, or other products. Concomitant medication (within 2 weeks of vaccination) included doxepin (DOXEPIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 03Mar2021 at 02:00PM, the patient experienced sore arm the next morning; general tiredness, sore arm the next day, headache, fatigue and disorientation. There was no treatment received for the adverse event. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient reports that yesterday evening after the vaccine she experienced itching and a rash on her ankle.  Today the rash has gotten worse and is appearing on both legs and is spreading to the rest of her legs.
Dizziness, headaches, sore throat, tightness in throat, pain in arm (site) and all over aches.
pt recv vax & devel extreme pain in arm p/vax 4OCT96;pt could not use arm d/t pain;took anti-inflammatories which did not help;x-ray of arm showed biceps inflamed;pt MD gave cortisone inj which relieved pain, but did not help mobility
On 01/04/01, this patient was given the Influenza injection to the left arm. Within 1 1/2 hours after the injection, the patient's upper arm became warm to the touch with a discoloration of red approximately 6 x 6 inches in diameter. Tenderness at the sight. Reaction lasted for 4 days. No sickness, nausea or vomiting, headaches, difficulty breathing. Informed to take Tylenol. Also the patient was seen by a military doctor who prescribed Benadryl and Hydrocortisone cream.
THERE WAS A WARM BURN FEELING IN MY CHEST AFTER RECEIVING THE VACCINE.  ALSO HAD A HEADACHE THAT LASTED FOR ABOUT 3-4 DAYS WHICH ALSO GAVE A SWAY FEELING WHEN STOOD. THERE'S A CONGESTED FEEING THAT HAS MY THROAT FEELING SWOLLEN.
Arm pain couple hours after injection lasting a few days, chills/body aches/headache began the night of injection and lasted until the following day. I?ve also had trouble sleeping which has persisted since  after the vaccine but I?m unsure if it?s related to vaccine or other factors.
This spontaneous report as received from podiatrist who was also a patient's mother and refers to her 4 month old son with no drug reactions or allergies and no pertinent medical history who on 12-JAN-2015 was vaccinated with an expired dose of ROTATEQ, 2 ml, oral (lot # not reported, expiration date September 2014). There was no concomitant medication. On 12-JAN-2015, after receiving the vaccine the patient developed a fever, then on the same date the patient recovered from fever. No treatment was given for the adverse event. No laboratories diagnostic tests were performed and the patient did not seek medical attention. Additional information has been requested.
Mom called clinic on cell phone, reported child had developed a rash, red and watery eyes. Advised to take patient to ER, which she did. Was treated with Benadryl and symptoms resolved.
continuous headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (continuous headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced HEADACHE (continuous headache). At the time of the report, HEADACHE (continuous headache) outcome was unknown.            Concomitant medications were not provided.  Treatment medications was not given.
About 3 weeks post vaccination first dose, I was diagnosed with shingles. The rash is on my face and head affecting my eye.  Face is the left side of body. Shingles rash is still present. Eye is swollen shut. Following routine visits with eye specialist.
Patient reported their throat felt closed and swollen and it was hard to swallow the night of receiving the vaccine. Patient also stated they had that same feeling the next day. No treatment reported by patient nor did patient contact their provider.
fever; chills; sore arm; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation (at the age of 42 years). The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On an unspecified date patient experienced fever and chills as well as a sore arm after receiving her second dose of the COVID-19 vaccine. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
three to four days after receiving the vaccine client developed rashes throughout body rash which were blister like.  Also swelling to left arm from injection site to his fingers.  Her went to emergency room for treatment, he was given prednisone to take for about a week which help improve the swelling and the rashes.
Pt. received 2 vaccines (HEP A and FLU 6-35 mos) in right thigh, pt. immediately became lethargic, mom observed "blackout". Pt eyes open; after stimulating by touch showed some responsiveness, Dr retrieved, pt. became lethargic again. After approx. 10 sec., crying and responsiveness. Pt. had cried through both vaccines, determined lack of breath was or most likely cause.
No adverse symptoms or events; given DTaP with Polio instead of just DTaP at 15 mo WCC.
Once poked, Janssen should be discarded after six hours. The patient was administered a dose after the vial had been poked for six and a half hours. I have reached out to Johnsons and Johnson's medical team.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-JUN-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX lot # L045953 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to urgent care six hours post-vaccination with rash covering entire body. Patient was told by urgent care physician that rash was likely due to allergic reaction caused by vaccination and instructed patient not to get second dose.
received a dose of that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 13th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 16-AUG-2022 Reporter's Comments: The pharmacist reported that the patient received a dose of Twinrix that had expired on 7th August 2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired Twinrix, which led to expiry vaccine used.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported similar adverse event for two different patients. This is the second of two reports. A patient (age, gender and Ethnicity unknown) received PREVNAR 13 (Lot Number: H07344, Expiration Date: Apr2015, NDC Number: 0005197101) single dose, on an unspecified date. Relevant medical history and concomitant medications were unknown. Illness at the time of vaccination was unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On an unspecified date, while on PREVNAR 13, the patient experienced rash and due to the adverse event was hospitalized. Relevant sibling information was unknown. At time of this report, clinical outcome of the event was unknown. Follow-up (24Jan2014): Follow-up attempts completed. No further information expected.
Patient was given the "booster" (3rd dose) 12 days before the required 5 month period from 2nd to 3rd dose. No signs or symptoms reported, no adverse effects felt from the vaccination.
Patient received the incorrect vaccine. Came in for COVID-19 Pfizer booster, but instead was accidentally given a Shingrix vaccination. Patient states he had already received both Shingrix vaccinations prior to COVID pandemic beginning. He did not experience any symptoms or signs while in the pharmacy for approximately 30 minutes. I told him that if any issues arose, to either reach out to a doctor or the ER if necessary. Patient's doctor is currently closed so unable to follow-up with them.
Information regarding Prevnar was received from a healthcare professional regarding an unknown number of patients who experienced pain and crying after receiving an injection. Dates were not provided. It was reported that an unspecified number of patients experienced painful injections with the administration of Prevnar. The outcome is unknown. Additional reports will be generated when identifying information is received. No additional information was available at the time of this report.
Racing heartbeat which gets worse when eating food; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Racing heartbeat which gets worse when eating food) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HEART RATE INCREASED (Racing heartbeat which gets worse when eating food). At the time of the report, HEART RATE INCREASED (Racing heartbeat which gets worse when eating food) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-018027 (Patient Link).   Reporter did not allow further contact
Child fainted 15 minutes after receiving vaccines. He did have blood test also after vaccines were given.
BODY ACHES; CHEST PAIN; A LOT OF THINGS; WEAKNESS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. 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 AUG-2021 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 AUG-2021, the patient experienced body aches. On AUG-2021, the patient experienced chest pain. On AUG-2021, the patient experienced a lot of things. On AUG-2021, the patient experienced weakness. On AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, weakness, body aches, chest pain and a lot of things was not reported. This report was non-serious.
Muscle ache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EN6207) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing). Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus (ongoing); VARICELLA ZOSTER VACCINE. The following information was reported: MYALGIA (non-serious) with onset 18Mar2021, outcome "recovering", described as "Muscle ache"; CHILLS (non-serious) with onset 18Mar2021, outcome "recovering", described as "Chills". Therapeutic measures were taken as a result of myalgia, chills.  Additional information: The events reported to occurred on the night of 18Mar2021, 9 hours after the vaccination. The patient took Aspirin as treatment of the events.  No follow-up attempts are possible. No further information is expected.
I received the COVID 19 vaccine booster from Pfizer and experienced a weird sensation in my face and difficulty opening my mouth for a short amount of time. I believe this is refer to as Bell's Palsy. I never heard of it until after I looked up my symptoms.
Swollen gums off/on; Gums tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Gums tingling) and GINGIVAL SWELLING (Swollen gums off/on) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA ORAL (Gums tingling). On an unknown date, the patient experienced GINGIVAL SWELLING (Swollen gums off/on). At the time of the report, PARAESTHESIA ORAL (Gums tingling) had resolved and GINGIVAL SWELLING (Swollen gums off/on) had not resolved.            Treated with Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: TCR. Patient received second dose didn't experience any adverse reactions and experiencing the swollen gums since first dose.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that there were no power outages, but the facility was not able to download digital data logger. The data logger was unable to download the data for Dec-2021, Jan-2022 and Feb-2022  No treatment medication information was given.
EUA Pfizer-BioNtech vaccine reaction Patient was hesitant about vaccination because she is afraid of the needels. in observation room she had a syncopal episode lasting 10 min. she had a vaso-vagal reaction , she has history of similar episodes.