chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician. A 22-year-old female patient received TRUMENBA, (lot number J28923, Expiry Date JUN2016), intramuscular on 27JUN2015 at 11:05 AM at 0.5 ml, single in the left deltoid. No other vaccines were administered on the same date or within four weeks. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medication included EFFEXOR for anxiety from FEB2015 to 23JUL2015 at 37.5 mg once a day orally. The patient experienced extreme fatigue on an unknown date in 2015. Outcome as recovered after 3 weeks on unspecified date in 2015. The patient underwent lab tests and procedures which included full blood count: normal in JUL2015. No treatment was provided. The physician considered that TRUMENBA had not a casual effect to the adverse event. Follow-up (04AUG2015): New information received from the same contactable physician includes: route, vaccination time, anatomical location of vaccination, casual relationship, outcome and information on treatment and concomitant medication. Follow-up attempts completed. No further information expected.
I had the normal sore arm, swelling that lasted a long time. 15 days later, April 10th I woke up really stiff with a lot of backpain. A sore and painful neck as well as lower back. It has been ongoing. I also experienced nausea and vomiting around April 12th. It subsided shortly after.  It returned a few days later. I experienced hot and cold sweats. I also experienced a racing heart. These symptoms have subsided.
I was fine immediately after the shot on Friday 1/8/21. I experienced slight muscle soreness in the left arm near the administration site. At about 8:30PM, I started to get chills and started to have muscle soreness all throughout my body (shoulders, arms, back, legs, abdomen, etc.). I went to bed at about 11:30PM with the soreness and chills. I woke up at about 7AM and the chills had resolved. The muscles soreness and now a headache remained up until about 5:30PM on Saturday 1/9/21. After that, I felt right back to normal.
Significant swelling, redness at the injection site. Area was very hot to touch. Significant pain radiating from the shoulder to my wrist lasting three days. Pain level in the arm/wrist on the night of Nov 7th was 8/10.
Became light headed when needle was uncapped. Vaccinated. Lightheadedness continued. Pt has dx of Tourette's was given orange juice and observed x 20 min.
A patch of skin redness and warmth 1 inch below injection site; A patch of skin redness and warmth 1 inch below injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: Gj3377), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ewo172, Location of injection: Arm Left), administration date: 23Apr2022, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Ewo177, Location of injection: Arm Left), administration date: 19May2022, for COVID-19 Immunization; Bnt162b2 (Dose Number: 3, Batch/Lot No: Fd7218, Location of injection: Arm Left), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 21Nov2022, outcome "unknown" and all described as "A patch of skin redness and warmth 1 inch below injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. A patch of skin redness and warmth 1 inch below injection site, developed on day 3 after getting bi-valent booster. Prior to vaccination, The patient not diagnosed with COVID-19. Since the vaccination, The patient has not been tested for COVID-19. Device Date: 21Nov2022.    No follow-up attempts are possible. No further information is expected.
fever of 103 for 2.5 days; migraine; worst bone pain I have ever had; My skin hurt to go though; lymph nodes in armpit are still very swollen; This is a spontaneous report from a non-contactable other hcp (patient). A 42-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in right arm on 28Jan2021 at 14:30 (at the age of 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included Hashimoto's, covid prior vaccination. Patient had known allergies to antihistamine and narcotics. The concomitant medications were not reported. The patient previously received first dose of (BNT162B2, Solution for injection, Lot Number: EK9231) via an unspecified route of administration, administered in left arm on 05Jan2021 at 12:30 for covid-19 immunisation. No other vaccine in four weeks. No other medications in two weeks. No covid tested post vaccination. On 28Jan2021 at 19:00, the patient experienced fever of 103 for 2.5 days and reported a migraine (never had one before), and the worst bone pain she ever had. The patient reported my skin hurt to go though, and 2 weeks later lymph nodes in armpit were still very swollen. The patient underwent lab tests included fever 103 on 28Jan2021 (for 2.5 days). Patient did not receive any treatment. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
diagnosed with COVID-19 illness; diagnosed with COVID-19 illness; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Feb2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021), dose 1 via an unspecified route on an unspecified date (lot number: EK4176, expiration date: 30Jun2021) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had been diagnosed with COVID-19 illness on an unspecified date in 2020. Outcome of the events was unknown.
Patient stated she had a formaldehyde allergy, after thorough review of ingredients and discussing risk with pharmacist patient decided to get the vaccine. She was observed for 30 minutes after vaccination. At 15 to 20 minutes after vaccine patient started to experience hives, 50 mg of oral benadryl was given. The patient was offered IM Benadryl and an Epipen, she declined both.
This case was reported by a healthcare professional and described the occurrence of systemic itching rash in a 21-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included LEXAPRO, Birth control and Hyosycamine. On 21 September 2009, between 1:00pm and 3:00pm, the subject received unspecified dose of FLUARIX (.5 ml, unknown, left arm). On 02 October 2009, 11 days after vaccination with FLUARIX, the subject experienced systemic itching rash. The nurse practitioner reported that the subject developed an itchy rash that started at her feet and had spread over her body. At the time of reporting the systemic itching rash was unresolved. The healthcare professional considered the event was probably related to vaccination with FLUARIX. Follow up information was received on 27 October 2009 via the nurse practitioner. The healthcare provider diagnosed the subject with Exanthema, and reported that systemic itching rash and Exanthema were associated with the subject having an allergy to vaccination. A biopsy was not performed. The subject had received FLUARIX in 2007 and 2008 without any adverse events following vaccinations. At the time of reporting the systemic itching rash systemic itching rash, exanthema and allergy to vaccine were resolved.
Both doses have caused irregularities in menstrual cycle(bleeding and early period); headache; unable to lift arm in which received injection; whole body soreness; nausea; constipation; fever; Heart rate remains elevated; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 2 via an unspecified route of administration, administered in Arm Left on 02Aug2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included partial seizures (Other Medical History: Complex partial focal epilepsy). Concomitant medication(s) included bifidobacterium lactis (PROBIOTIC) and norethisterone (DEBLITANE) and Womens multi. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 1 via an unspecified route of administration, administered in Arm Right on 12Jul2021 as dose 1, single for covid-19 immunisation and experienced Both doses have caused irregularities in menstrual cycle (bleeding and early period) and headache. The patient reported, both doses have caused irregularities in menstrual cycle (bleeding and early period), first dose caused headache but the second dose has caused headache, unable to lift arm in which received injection, whole body soreness, nausea, constipation, fever. Heart rate remains elevated. Worst part is the pain and soreness with inability to lift the arm and the racing heart on 02Aug2021 19:00 PM. The patient underwent lab tests and procedures which included heart rate: high on 02Aug2021 19:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. Outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had a sore arm and woke up Sweaty. On Sunday around 4 pm my right calve had a cold sensation, this then progressed to both calves and up to thighs and lower back. It feels as if I put icy hot on them. It has not improved since Sunday.
Dizzy, displayed pupil, heart rate, pale with blue around eyes and fingers. No epi pen given as patient wasn?t too short of breath and came out of it quickly. 911 was called
numbness in her legs; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness in the legs after she received first dose of covid-19 vaccine. The outcome of the event was unknown.  Batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
pt recvd vax 19SEP94 & mom called & stated pt broke out in hives on abdo & chest first, then face & arms; also lethargic & whining; pt seen by MD 20SEP & recvd steroid inject & was placed on Atarax; MD recommends no further Hep B vax;
developed a rash 2 weeks after receiving a dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient developed a rash 2 weeks after receiving a dose of Shingrix. The reporter consented to follow up.
Red, hot swollen arm at site of injection, body aches and chills, fever and flu-like symptoms.
Resurgence of shingles in one eye was an adverse correlation (causation not possible to determine).  Occasional outbreaks of shingles in that eye have been a recurring issue under medical treatment for 3 years.  My eye evidenced no shingles at a 12-22-20 eye appointment and had been free of shingles for over a year.  I had no noticeable side effects from the vaccine on either 01-28-21 or 03-01-21.  However, at my next ophthalmologist appointment on 03-04-21, shingles had returned to the eye and is persisting.  I am active and healthy except for this issue.
13 hours later I threw up saw swelling left side of my face, my left arm was tingling numb to my hand went to Er next am. Decreased strength in left hand, MRI TIA 24 + hours sleep, went through three set of sheets 10 night gowns, headache dizziness
never got shot #2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (prior vaccination with Zostavax) and shingrix (received 1st dose on an unknown date, 1 year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist did not want to share the patient's date of birth. The patient got the Shingrix shot 1 years ago but never got shot, which led to incomplete course of vaccination. The pharmacist did not have any further information since the first shot was not given at her pharmacy.
Info has been received from a physician concerning a 4 year old male who was "supposedly" vaccinated at another office with a dose of MMRII. It was noted that there was no documentation. On 2/1/05, the pt developed mumps. The pt was referred to an ENT who verified the dx. It was noted that no treatment was listed. On 3/29/05, the pt was re-vaccinated as a precaution with a dose of MMRII. The pt's outcome was unknown. No product quality complaint was involved. Additional info has been requested.
Patient received vaccination 8/23/16. On 8/26/16 she had muscle aches, pain, fever 102. Still experiencing some muscle ache (taking TYLENOL). Rash 9/6/16, seen Dermatologist and primary (no meds)  9/8/16 - blood work showed UTI (CIPRO).
The vaccine was given in the rear of my left shoulder. Three days following the administration, I developed severe pain in my left shoulder and arm. I have needed to take Tylenol, use alternating heat and cold, as well as alternating Biofreeze and Salonpas. The pain continues today. It negatively impacts movement including dressing, lifting, sleeping, etc.
This spontaneous report was received from a pharmacist concerning an approximately a female patient of unknown age. Pertinent medical history and drug reactions/allergies was unspecified by the reporter. In approximately July 2011, the patient was vaccinated with ZOSTAVAX (dose, duration and lot # not reported). Concomitant therapy was unspecified by the reporter. On an unknown date, reported recently, the patient experienced mild cases of shingles (described as a numb arm) following vaccination with ZOSTAVAX. On an unspecified date, the patient sought medical attention, contacted the pharmacist. Subsequently, on an unspecified date, the patient recovered of mild cases of shingles (described as a numb arm). Additional information has been requested.
Erythema macular generalized. T 38.5C (febrile) DPH 5 mgs IM stat
PAIN AND SWELLING AT INJECTION SITE LEFT DELTOID, DECREASED LIMB MOBILITY (PALM DOWN ELBOW LOCKED ARM LIFT TO APPROXIMATELY 45 DEGREES).
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 2:09 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Nov-2021 at 2:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with COVID-19.  The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been.  The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator.  The vials were returned to the freezer/refrigerator, or maintained at room temperature.   The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.  No vaccine state changes were noticed. The vaccine was never refrozen.  None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
giving an expired dose of ACT-HIB with no advese event; Initial information was received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old patient of unknown gender who received an expired dose of hib (prp/t) vaccine [Act-hib] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine (Polio) for Prophylactic vaccination; hpv vaccine vlp rl1 4v (yeast) (Gardasil) for Prophylactic vaccination (immunisation); and pneumococcal vaccine conj 7v (crm197) (Prevnar) for Prophylactic vaccination (Immunisation).  On 16-Aug-2023, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection at dose of 0.5 ml (strength: standard) (lot number: UJ803AA, expiration date: 13-Aug-2023) via intramuscular route in the left deltoid for Immunization (immunisation) with no adverse event (expired product administered) (latency: same day).   No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event giving an expired dose of act-hib.  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 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.
Dizziness occurred 3-4 hours after each dose. It lasted about 2 hours after the first dose and 5 hours after the second dose.
This spontaneous report as received from a medical assistant and refers to a 6 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date, the patient was vaccinated with VAQTA (dose, route, lot# and expiration date were not provided) for prophylaxis. No adverse symptoms were reported.
Information has been received from a registered nurse concerning a 4 year old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 14-OCT-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female employee with no known medical history or allergies who was vaccinated with hep B vaccine recombinant in the left arm. There was no illness at the time of vaccination. Subsequently the pt experienced an injection site reaction-sore left arm. The nurse reported on follow-up that the pt had recovered from the arm discomfort within approx 2 weeks of receiving the vaccine. No further info is available.
cannot lift anything up or drive; painful arm between the elbow and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder). At the time of the report, MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder) outcome was unknown.            No concomitant medications were reported No treatment information provided by the reporter.
Delayed onset Right deltoid arm pain. Started 2 weeks after injection. Patient sent for physical therapy.
After my second dose of the Moderna  COVID vaccination,  with in 24 hours I felt achy and had a headache and tired.  Within 30 hours I had a temperature of 100.4 along with the other symptoms.  Those all went away within 48-50 hours of the second dose.  6 days after the second dose, I broke out in a red itchy rash on the front and back of my torso as well as shoulders and neck.  I am on day 3 of having the rash.  Benedryl does not seem to help.