chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED on 5/11/2021 and was subsequently hospitalized with UTI and severe sepsis within 6 weeks of receiving COVID vaccination.
stored in the refrigerator is 20Jan2022, experied on 16Apr2022, administered on 18Apr2022; administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (stored in the refrigerator is 20Jan2022, experied on 16Apr2022, administered on 18Apr2022) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022 at 10:25 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored in the refrigerator is 20Jan2022, experied on 16Apr2022, administered on 18Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (stored in the refrigerator is 20Jan2022, experied on 16Apr2022, administered on 18Apr2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   A nurse reported that they inadvertently administered an expired Moderna Covid-19 vaccine to 2 patients on 18Apr2022. Lot number 007J21-2A; expiration date per expiration date look up tool online is 16Apr2022. Initial date the vial was stored in the refrigerator is 20Jan2022. They wanted to know what to do with the 2 patients who have been administered with the vaccine. Additional information was reported as follows: Dose administered after 30-day Use By Date or after manufacturer date of expiry Lot number was 007J21-2A; 16Apr2022 The Number of doses/vials: was 2 doses It was reported that the vial was initially stored in the refrigerator on 20Jan2022 The Date of administration of vaccine was18Apr2022 The vial did not undergo any temperature excursions  It was reported that  the patients received 1st doses and neither reported any side effects   Concomitant medications were not reported.  Treatment medications were not reported.    This case was linked to MOD-2022-543432 (Patient Link).
brain fog since first injection, unable to remember common words used in everyday communication   joint pain of neck, lower back and elbows   fatigue that has continued since first injection  headaches that has continued since first injection
I had shoulder pain with the shot as expected, but the shoulder pain persisted. The pain dulled within a month or two, but remained, even though slight.  Any physical activity involving my shoulder worsens the pain, which was never an issue for me prior to the shot. Now it August, I still have pain from it.
Patient developed fever, fussiness, rash, refusal to eat and grunting within two hours after receiving immunizations.  He was seen again at the clinic for assessment and then referred to the Hospital Emergency Room.  There he had blood work and Urinanalysis obtained and was monitored for some time.  Rash was a flesh colored papular rash on extremities and neck.
Took the Pfizer COVID19 vaccine back in April/ "made her feel better"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID19 infection", start date: Jan2021 (unspecified if ongoing), notes: Verbatim: COVID19 infection; "long hauler" (unspecified if ongoing), notes: Verbatim: long hauler; "sinuses", start date: 2021 (ongoing), notes: still having problems with her sinuses and smell and taste.; "smell", start date: 2021 (ongoing), notes: still having problems with her sinuses and smell and taste.; "Taste", start date: 2021 (ongoing), notes: still having problems with her sinuses and smell and taste. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "Took the Pfizer COVID19 vaccine back in April/ "made her feel better".  Additional information: Patient had COVID19 infection on January and is still having problems with her sinuses and smell and taste. Patient is considered as long hauler' suffering from long term effects. Patient stated she took the Pfizer COVID19 vaccine back in April which made her feel better', but has not been tested for COVID again. Patient was due for the third dose on 29th of this month.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid arm swelling; pain; redness; itching; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, lot no: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 19:45 as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, bulging back discs and migraine headaches. Concomitant medication included acyclovir (ACYCLOVIR); sumatriptan succinate (IMITREX); magnesium (MAGNESIUM) and multivitamin taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient didn't have COVID prior vaccination. The patient did not test COVID post vaccination. The known allergies were none. On 02Mar2021 01:00, The patient experienced Covid arm swelling, pain, redness and itching around site of injection which continues to this day (06Mar2021).  There was no treatment provided for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Started with lethargy and hot flashes, followed by extreme shortness of breath, difficulty speaking and holding up my head and keeping my eyes open. Then trembling. The local nurse at the vaccination sight reported high blood pressure, rapid pulse and seemingly extremely low blood sugar. I didn?t go to the ER because my supervisor agreed to take me home since we were volunteering at the sight prior to me receiving the vaccine. I had to keep eating every hour or so due to blood sugar seeming very low. Shortness of breath continued. Pulse rate still high as I could sleep with my head down due to racing pulse in my head. Later that night I had small bumps on my arms with no itch. Then I had extreme fatigue and muscle fatigue. I kept experiencing extreme episodes of hot flashes. I woke up in the middle of the night with a headache and uncomfortable hot flashes. I drank 100% juice and ate a few goldfish. I had mild nausea and food aversions. The next day the bumps were gone. I went to work but was sent home. I was told I should have gone to the ER but I don?t have insurance. Once home, I went through 5 hours of extreme chills unlike anything I have ever experienced. I had to cross my arms over my chest and stack on blankets to regulate. If I moved my arms for more than five minutes or pulled the blanket down, I began uncontrollably trembling. I still had trouble regulating my blood sugar on day two. It?s day three and no bumps and no chills. Less muscle fatigue as well. I am still pretty exhausted and tire easy when doing things. I did experience the common soreness in the muscle the vaccination was administered, but I figure that is normal.  I am hopeful that I am improving and out of the danger zone. I took Garden of Life Elderberry with added nutrients last night and today I took my normal detox probiotic. I have been pushing fluids and have broken my intermittent fasting to try and keep my blood sugar up. I feel like my system is finally regulating and now I just have lingering exhaustion from the events that took place.
Information regarding Flumist nasal solution was received from a mother regarding her 5 year old son who experienced nasal congestion and cough. At 5 years of age, the patient received a dose on 12/12/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. On 12/13/03, 1 day post immunization, the child experienced nasal congestion and cough. He was treated with Children's Motrin Suspension and Triaminic Cough Syrup; however all symptoms were unresolved at the time of this report. No additional information was available at the time of this report. Follow-up information receveived rom the physician confirmed the child had no previous doses of Flumist, no other vaccines within four weeks of receiving Flumist, and no history of adverse events following prior vaccinations.  It was not reported if the patient had recovered.
1st 24 after receiving immunization MMR febrile 104.3 after 24 hours continues to run temp 99 degrees - 102 degrees with medication given c/o HA, left arm with one swollen lymph node.
headache, small rash inside of elbow left arm, fatigue, muscle pain, body aches, chills that lasted all night into the next morning, but all went away later in the morning (04/10/2021) except the fatigue, which lasted a full 6 days, and the rash which is still there.
12 hours after 2nd dose - severe body aches for 24 hours - self-treated with Ibuprofen 6 weeks after 2nd dose - shingles - treated with Valacyclovir and Gabapentin (7 days)
she had a stroke; ischemic stroke; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00AM, as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, allergic to bees and patient says there are members of her extended family that had strokes but they were almost 100 years old when they had them. her uncle died in October around Thanksgiving and he was 3 months shy of 100. She says they checked her heart and she was fine. Patient did not receive other vaccine in four weeks of vaccination. Concomitant medication's included levothyroxine sodium 50 mg once a day patient has been taking this for probably 5 years for inactive thyroid and General multivitamin for general health, patient says it is recommended by her general practice physician and she has been taking this for maybe 8 years, she guesses. Patient says she had an ischemic stroke 5 days after the second COVID vaccination. She says she is calling to see if there are any records of that happing to other people. She says she has to leave the call in 25 minutes. Patient says she had a stroke then went to the Emergency Room. For the outcome of the ischemic stroke she says there may be some things that she doesn't know. She says her doctor said she was ok and she can go back to what she was doing. Patient says the first shot says BioNTech and the second one just says Pfizer. She says the first one is a sticker and the second one is hand written. Second dose was on 15FEB2021, lot number EN6 then 2 or Z, she says she assumes it is a 2 based on the other lot number, then she thinks 01. For indication patient says she is all for the vaccinations, she thinks it's important to get the vaccine. She says she is the daughter of a physician. She says she is not scared of the vaccine, she believes in it. The patient previously received first dose of (BNT162B2), via an unspecified route of administration, administered in Arm Left, on 25Jan2021 11:00 PM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 19Feb2021 (probably late morning), the patient experienced ischemic stroke and on unspecified date of 2021 she had a stroke. The patient was hospitalized for the events from 19Feb2021 to 21Feb2021. The patient underwent lab tests and procedures which included echocardiogram: unknown, her echocardiogram was fine, magnetic resonance imaging: unknown and ultrasound scan: unknown on 2021. Outcome of the events was unknown.  Follow up (PRD/SRD 04May2021): This is a Follow-up spontaneous report from a contactable consumer.  Follow up(10May2021): This is a Spontaneous report from a Medical information Team. This consumer(patient) reported that: Follow-up attempts are completed. No further information is expected
expired dose of Ipol was inadvertently administered to a patient/no AE; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 4 years old female patient who received an expired dose of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Immunisation.  On 20-Aug-2019, the patient received a 0.5 ml single first dose (unknown whether it was primary/booster dose) of suspect IPV (VERO) lot N1G511M (expiry date: 02-Aug-2019) via intramuscular route in the right thigh.  It was of actual medication error case due to expired vaccine used.  It as reported that no adverse event was experienced by the patient.  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.
ACTHIB was administered via the subcutaneous route instead of the recommended intramuscular route with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 year old female patient to whom HIB (PRP/T) vaccine [ACT-HIB] was administered via the subcutaneous route instead of the recommended intramuscular route with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine inact (Vaqta); diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix); and pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Immunisation.  On 07-Feb-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (with unknown lot number and expiry date) via subcutaneous route instead of the recommended intramuscular route in back of right arm with no reported adverse event (incorrect route of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event acthib was administered via the subcutaneous route instead of the recommended intramuscular route with no reported adverse event.  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 the guidelines. 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.
checked pt arm 2 days p/vax & pt arm had erythema, redness & swelling measuring @ 16.5cm long by 11 cm wide;pt mom advised to use a cold compress;
at the end of pt's 30 minute observation, he was brought to me due to report of redness/rash at vaccine site as well as itchy sensation/tightness in his throat as he has had with prior anaphylactic reactions;   no diaphoresis, no pallor.  mild erythematous patches around vaccine site; HR 70 BP 126/76
Narrative:  Pt received Zoster Shingles vaccine on 7/15/22. On 7/17/22 around midnight pt experienced lip swelling and rash. Pt presented to ER dept early morning of 7/18/22. Pt was treated with famotidine iv, diphenhydramine iv, & methylprednisolone ivp. Pt was admitted to hospital for monitoring but discharged home with EpiPen & Oral Prednisone Rx same day. MD flagged chart with ADR.
FAINTING; NAUSEA; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose,1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient's experienced dizziness, nausea and fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and fainting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-fainting. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with 0.5 ml doses of (Oka/Merck) VARIVAX (lot # not reported) subcutaneously that were improperly stored due to temperature excursions. No adverse effects were reported. Additional information has been requested.
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Weakness-Medium, Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 12-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not reported.
Patient contracted COVID after being fully vaccinated 9/6/2021 - Headache, Congestion, fever
Symptoms began approximately 12 hours following the injection; fever of 104, chills, muscle and joint pain, dizziness, neck, arm and shoulder discomfort, headache, runny nose, sore throat, watery eyes  I felt like I had a really bad case of the fu.  This was the second injection of two.  I experienced the same symptoms with the first injection approximately 2 1/2 months ago.  Symptoms will last approx. 3 days if following the same duration as the first injection. Spouse has had both shots and experienced no side effects other than soreness around the injection
bumpy and itchy; rash has started to develop all over my body; bumpy and itchy; This is a spontaneous report from a contactable consumer (Patient). A 19-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: Ew0153), via an unspecified route of administration, administered in arm left on 14Apr2021 at 14:15 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient received concomitant medications within 2 weeks of vaccination which included citalopram and clonazepam, both drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: Fn6207), via an unspecified route of administration, administered in arm left on 17Mar2021 at 14:15 (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. The patient previously took amoxicillin for drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On 24Apr2021 at 09:00, the patient experienced bumpy and itchy, rash has started to develop all over my body. Reported Event: 10 days after taking my second dose of the Pfizer COVID-19 vaccine, a rash has started to develop all over my body. It's bumpy and itchy everywhere. Patient did not receive any treatment for the events. The outcome of all the events was not recovered. Device date was 24Apr2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 13-MAR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K006191, expiration date 02-FEB-2017). There were no adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 inch X 3 inch lump where needle pierced the skin. Arm was red, warm, & swollen 3 inches below armpit to 3 inches below the elbow bend. Patient iced area, took diphenhydramine 25 mg at bedtime.  Each day the redness and swelling and warmth decreased.  This lasted 3 days.
pt has had ? sz activity prior to vax-nl EEG;evening of vax had bicycling of feet & legs later bradycardia & 3min sz;EEG nl;med held per neurology
Dizziness, Headache, Myalgia, Fever, c/o sore throat,ftigue,lymph node under left clavicle swollen,sore,and warm to touch. Told to see primary care doctor if no improvement.
side effects of the first shot of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects of the first shot of the Moderna vaccine) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects of the first shot of the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (side effects of the first shot of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported   No treatment medication was reported by reporter   Reporter did not allow further contact