chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was administered to a patient after temperature excursion occurred; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drugs reactions or allergies, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # 1660704, expiration date reported and validated as 20-MAR-2021) for prophylaxis. The vaccines were exposed to the following temperature excursion: 55 degrees Fahrenheit for 35 minutes as recorded by a data logger. There were no previous temperature excursions.   This case has been considered non-valid due to the lack of patient's identifiers.
cold sore outbreak; Itchy red patches on skin that come and go; Itchy red patches on skin that come and go; clear blister on chin under lip; This is a spontaneous report from a contactable consumer or other non hcp. A 35-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: en6199), via an unspecified route of administration, administered in Arm Left on 06Mar2021 07:45 (at the age of 35-year-old) as dose 1, single for COVID-19 immunisation. Medical history included cold sores in past, but every few years. Only on upper or lower lip. Patient did not receive any other vaccine in four weeks. Patient did not receive covid prior vaccination. Patient had no known allergies. Patient received other medications in two weeks was Daily multivitamin. On 06Mar2021 17:00, the patient experienced itchy red patches on skin that come and go, clear blister on chin under lip, cold sore outbreak. Adverse event: Itchy red patches on skin that come and go. Below injection shot in left arm and upper right arm. At 5pm that night, noticed a clear blister on chin under lip. The next morning, realized the shot triggered a cold sore outbreak. Single blister, turned into a cluster. I have had cold sores in past, but every few years. Only on upper or lower lip. This time it was on my chink skin below my lips. They are only triggered when I have demanding dental work or mild sickness above a common cold. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
No AE reported; report a temperature excursion on ROT ATEQ and product administered to 6 patients; This spontaneous report has been received from a medical assistant referring to a 6 month old patient (unknown gender). No information was provided regarding the patient's medical history, concurrent conditions, drug/allergy history or concomitant medications.  On 01-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) single dose, orally,  lot # T033812, expiration date 29-DEC-2021 (strength and dose were not provided) for prophylaxis.  The doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) were exposed to a temperature excursion of 47°Fahrenheit (°F) during a time frame of 1 hour, which was not detected by the data logger. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports from the same reporter (MARRS#2106USA004039, MARRS#2106USA004087,MARRS#2106USA003971, MARRS#2106USA004106, MARRS#2106USA004335); Sender's Comments:  US-009507513-2106USA004106: US-009507513-2106USA004039: US-009507513-2106USA004087: US-009507513-2106USA003971: US-009507513-2106USA004335:
I started getting extremely sharp pain in my right jaw near the right ear.  When I bit down it would make an enormous cracking sound and pain would sear through the top of my jaw into my ear.
Patient was brought to pharmacy in wheelchair for a pneumovax 23 vaccine and received a  menactra vaccine on accident. Pharmacy proceeded to give intended pneumo vaccine in the other arm.
Extreme pain/soreness (scale 9 out of 10) in right arm (deltoid). Pt reports being unable to sleep due to pain and took hydrocodone already at home for relief on her own accord not upon recommendation. Patient asked for treatment options today 11-1-16. I recommended using a heating pad to the muscle and ibuprofen if not contraindicated.
I received the vaccine at the Pharmacy on 4/7/21. On June 17th, I had a stroke and was taken by ambulance to hospital.  At hospital they discovered I had a blood clot on my right carotid artery and that what was caused my right arm to go numb. They then transported me by ambulance to another medical facility's ICU, where they began to try and dissolve the blood clot. I am going to physician for my follow up. I got the actual vaccine at pharmacy.
Received vax at 8:20 AM. By 8:50 c/o pain at site then radiating down arm. Progressed to numbness in both arms, then legs. C/o dizziness, flushing, progressed to SOB. Received Epinephrine 1:1000 0.3ml SQ. Paramedics summoned. To ER.
Could not be put on his back without screaming, flaring arms, and holding breath (resembled moro reflex). Extremely unusual behavior that happened the within 12 hours of vaccination. Lasted for 5 days.
38 week pregnant female felt really hot and slightly dizzy after vaccination.  Pt had been drinking her own water and eating her own snacks when arriving to Observation.  Husband arrived  to observation area @1654 after his vaccination. Symptoms resolved by that time.  Pt. released @1715 with husband. VITAL SIGNS- 1652 B/P LYING 143/81  HR 86  RR 18 SpO2 99% 1654 B/P SITTING 131/85 HR 83 RR 18 SpO2 100% 1712 B/P SITTING 124/83 HR 86 RR 16 SpO2 100%
Excessive menstrual crampng and significant menstrual blood for hours of pfizer injection  *concerned because IUD (mirena) has prevented24 menstrual cycles and spotting for 5+ years and within 24 hours of pfizer vaccine my menstrual cycle began along with a nose bleed
Quadracel vaccine was administered to 32 months old female patient/ NO AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 32 months old female patient received a 0.5 mL first dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number: C5656AA, expiry date: 13-Aug-2021 via an intramuscular route in left deltoid) which was intended for patient of four year old and above on 29-Jul-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration(latency: same day).  At the time of reporting, no adverse event was reported.  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.
My arm started hurting the next day. It feels like the nerves are damaged and I can barely move my arm and can't sleep at night. It's horrible.
pt recvd vax & 3 wks post vax exp poss serum sickness w/rash,fever of 102 & lethargy;sx cont;
as an adult she has only had the pneumonia shot and the side effect she experienced was a sore arm; This spontaneous report was received from an adult female consumer of unknown age, via Pfizer, referring to herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (also reported as "pneumonia shot") as prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). The reporter stated that as an adult she only had the pneumonia shot.   On an unknown date, the patient experienced the side effect of sore arm (pain in extremity).  The outcome of the event pain in extremity, and the causal relationship between the event pain in extremity and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) were not provided.
Shortly after receiving vaccine the patient began feeling healrt racing. Took BP and HR. BP was 137/97 and HR originally was 117 @9:57, then quickly began to drop. @9:59 HR was 85. Received water and a granola bar and was monitored.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient in her 60's. The patient's historical drug included PREVNAR, received about a year prior to PNEUMOVAX 23. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed cellulitis at the injection site. She used over the counter medicine (unspecified) for the cellulitis but it was not specified if this patient was seen by a physician. The outcome of injection site cellulitis was reported as resolved (date was not reported). The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA001166.
HAD A FEW SIDE EFFECTS; This spontaneous report received from a patient via a company representative . 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 not reported and is requested) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced had a few side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had a few side effects was not reported. This report was non-serious.
slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, there was pain; arthritis; it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there; nerve problems; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in left arm on 01Apr2021 11:30 (Batch/Lot number was not reported) at the age of 74 years old as single dose for covid-19 immunisation. Medical history included pain from back and neck surgery she had predating treatment with the vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 11Mar2021 11:30 am in her left arm at the age of 74 years old for covid-19 immunisation and didn't feel anything different. The patient received the second dose on 01Apr2021 at 11:30 am in her left arm. Reported the first dose she didn't feel anything different. This time she didn't feel anything different until this morning. Added her arm was feeling heavy (Apr2021), she thought maybe she needed to exercise it, and she slept on that side mostly. She reported she was having a slight pain in her arm. Mentioned she also had arthritis and nerve problems (Apr2021). Added it was not swollen, but right where she got the vaccine, just a little, there was pain (Apr2021). She was asking should she just exercise it. Added it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there (Apr2021). Added it was young and it had not scattered out yet. She thought the slight pain in her arm started a few days after the second dose of the vaccine, about 05Apr2021, and now it was better than when she first noticed it. Mentioned she was concerned about getting the vaccine because of her other problems but her doctor told her to go ahead and get it. The outcome of the event slight pain in her arm was recovering, of the other events was unknown.  Information about lot/batch number has been requested.
pt recv vax 26JUN96 & devel fever 102 on 4JUL96 & scattered maculo papular rash on face & chest w/petechial rash on rt arm;
OBSTRUCTIVE SLEEP APNEA ACUTE STROKE OF BRAINSTEM, UNSPECIFIED TYPE AND ARTERY
urticaria, facial swelling, wheezing, resp distress;given susprin, ventolin, prelone, DPH;
Skin irritation and swelling at injection site. Runs from shoulder down his arm. About the size of my hand. Hot to the touch. Feels very firm/swollen
received the first dose of Shingrix a few years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose few years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix a few years ago).The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 22-AUG-2023 The reporter called to report that a patient over 70 years of age received the first dose of Shingrix a few years ago, although they were unsure if it had been Zostavax and wished to know how to proceed.  The information about the event, vaccine and patient was scarce and was not provided as the provider mentioned they had not received consent from the patient. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt states she feels a lot better today. Temperature today was 98.8 F at 8am. Dizziness and nausea have resolved. R arm is still very swollen down to elbow. Arm redness has decreased and itchiness has resolved. Pt states she will apply a cool compress to arm to help with swelling. Advised pt to call back if symptoms do not continue to improve or worsen or if previous symptoms  local reaction with erythema and itching, certainly seems like some mild local allergic reaction. I agree that if this has not happened previously with tdap or 1st dose of Covid vaccine then ok to get these. patient can also premedicate with Advil and Benadryl
Tingling and numbness in left arm, hand, left side of neck and across shoulder and back.
1. Date given- 3/30/2010 2. Dose- 0.5ml 3. s/s of RXN- erythema and swelling 4. previous h/o of similar rxn to this drug or similar agents- none 5. and any other pertinent information- n/a
pt recvd vax & Lt Arm muscle felt heavy; inject site got red & warm; pt had very itchy & swollen arm; 20sep94 woke up sick & dizzy; pain on Lt side of forehead & eyes hurt; felt hot & sweaty; weak ;
(Pharmacy was the pharmacy that provided the Vaccination.)  I had fever, headache and body aches that started 24 hours after and they lasted about 36 hours. OTC cold and pain medication was taken for those. I had significant swelling under my left arm in the armpit. That lasted for about a week. At the same time as the fever, headache and body aches started, I had swelling under the eyes that started in the upper eyelids for about a week and that went down to the lower lids about a week post vaccination and since then it has been upper and lower eyelids - significant swelling and on March 30th  (started me on the Prednisone on this date)  - it initially helped and then it went back to worse than it was before. and on April 7th  Benadryl and Neomycin- a topical steroid I've been applying under the eyes for that.  The swelling was significant until this last Wednesday when I got on these two meds. Today I had a phone call visit with my doctor as a follow up to how the meds were doing. Recovery is progressing at this time.
Headache; Chills; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 18Jan2022 (Batch/Lot number: unknown) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FULVESTRANT; IBRANCE taken for breast cancer, start date: 26Aug2021 (ongoing). Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient was administered ibrance 125 mg by mouth daily for 21 days on and 7 days off in conjunction with fulvestrant (faslodex). Patient reported ongoing constipation and unpleasant taste in mouth after taking therapy since starting therapy. Patient reported most recent computed tomography scan resulted liver regeneration. Patient also reported headache and chills since receiving her covid-19 booster shot on 18Jan2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
While on work assignment, I was returning from lunch where I began to exhibit normal allergy symptoms-sneezing. I had eaten the exact same menu item at the exact same restaurant roughly 4 days prior. (The order was identical and I have eaten at the location many times before) I have never in my life had a food or medicinal allergy. Likewise in over 30 years experience in the aerospace field, I have been exposed to a number of chemicals and never had any sort of severe response to any checmical. Upon reaching my office within approximately 5-10 muntes of the allergy manifesting, I continued to sneeze so I took a 25mg benadryl tablet. Shortly after (within 5 minutes) that I noted that my face felt flush so I took my temperature which was normal. I then noted my forearms were beginning to turn red & itch. I noted that I felt like I wanted to sneeze but couldn't but noted that my airway was clear with no adverse breathing. At that point I took a second benadryl tablet and notified a coworker that something was amiss and to keep an eye on me. I returned back to my office and within another 5-10 minutes, I noted my scalp began to itch severely along with the soles of my feet. My tongue became thick and I noted that my breathing was becoming slightly labored. At that point I took a tird benadryl tablet & two hits of fluticasone propionate (50mcg) nasal spray and notified my coworkers that I was experiencing some sort of anaphylaxis event and that if things did not improve in the next 10-15 minutes we would need to call EMS as only epinehrine was likely to help! I also noted at this time that my torso was blotched and covered with numerous hives. Fortunately within the next 10 minutes as we prepared to forgo EMS and make a run to the nearest ER, the symptoms began to subside. Most notably the thickened tongue and breathing issues, then slowly the itching dimished and began to return to normal. After allowing myself to relax for another 30-45 minutes, I then decided I felt well enough to drive myself to a local ER near my hotel and I had a coworker follow me there where I received follow-up treatment. The ER administered methylprednisone Sod Suc (steroidal shot) and famotidine while they kept me under observation for any rebound activity. I was prescribed an Epipen upon being discharged a couple hours later.
pt recv vax 30JUN05 & 26MAY96 pt exp a tremendous number of lesions gen throughout body, including 60 lesions behind each ear;
Pt recvd DTP/OPV/MMR on 12AUG91 @ 430PM; Blotching inside of rt arm w/in several minutes; 2 hrs later mom noted hives on arms which became generalized; MD ordered DPH which did not help; Hydroxyzine ordered 13AUG91 & hives began fading;
Patient is fully vaccinated and boosted. Pt c/o sob, chest pain, fatigue, bodyaches, loss of taste, smell and cough. Pt states covid positive since 2/4/2022. Also positive for low-grade fevers, nausea.  She was prescribed a Z-Pak as well as a course of Decadron.  Patient states today she is like she has been unable to fully catch her breath which is what prompted her to come to the emergency department. CXR: No acute process. Troponin normal. Patient vital signs were stable throughout emergency department stay, specifically no desaturations.Recommend patient take muscle relaxer, anti-inflammatories for symptoms, return to emergency department if symptoms change or worsen. Discharged
No additional adverse events reported; Improperly stored PNEUMOVAX23 was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.      On 14-JUN-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (Lot # T016159, expiration date 28-FEB-2022) 0.5 ml, intramuscular route, anatomical location was not reported for prophylaxis. The reporter stated that the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) administered was improperly stored, as they had a power outage and the temperature reached was unknown but she reported that the product was out of range for one day. No previous temperature excursion was reported it was unspecified if the call was beacuse of a data logger. No additional adverse events reported, no product quality complaint. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
PAIN IN ARMS; PAIN IN SHOULDERS; UNABLE TO LIFT ARMS; This spontaneous report received from a patient concerned a 21 year old male. 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to lift arms. On 14-APR-2021, the subject experienced pain in arms. On 14-APR-2021, the subject experienced pain in shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arms, pain in shoulders, and unable to lift arms. This report was non-serious.
The injection didn't hurt or burn but immediately afterwards it began to get hot, red, itchy and felt like a golf ball under my skin. This has continued and the pain has gotten worse today. The Physicians in my workplace have stated that I'm having an adverse reaction and advised that I take CLARITIN and Ibuprofen, neither of which helped at all.