chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Covid-19 vaccine at 4:50 pm. patient's daughter,  informed observer that her mother  has complaints of her face feeling warm and itchy and a scratchy throat.  Assessment completed by Dr.,  daughter to translate due to patient speaking  limited English .  50 mg of Benadryl administered orally at 5:05pm.  Reassessment completed at , 5:18 PM, face appears to be  more reddened and facial swelling noted. Daughter also stated that her mother's  voice  is becoming hoarse.   125 mg of solumedrol given IM by, RN. at 5:20pm. Patient reassessed at  5:40PM, facial swelling and redness improving. Daughter states that mother 's voice is returning back to normal. and stated that the patient has informed her that she is feeling better. Patient discharged by Dr.  at 5:43 PM at daughters request,  stating that she will be monitoring her all night and will take her to the ER if symptoms return or worsen.
This case was reported by a consumer and described the occurrence of diarrhea in a 2 year old male pt who received Engerix-B. The reporter is the mother of the pt. A physician or other health care professional has not verified this report. On an unspecified date, the pt received a dose of Engerix-B. Approx. 2 days following the administration of Engerix-B, on an unspecified date, the pt experienced diarrhea and nausea. Outcome of the events was unknown.
t99.6 po;pt states arthralgia started lt knee & 4th finger lt hand approx 12hr p/vax;p/additional 12hr c/o pain lt knee on ambulation, aching in lt 4th finger inc & appearance of erythematous, swollen, painful area;skin appears as ora
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 and patient previously received covid 19 vaccine.  Follow-up attempts are completed. No further information is expected.
muscle soreness over injection site; fever; body aches; very tired; slept mostly; feeling that bad; This case was reported by a consumer and described the occurrence of muscle soreness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad. On an unknown date, the outcome of the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad were unknown.   It was unknown if the reporter considered the muscle soreness, fever, general body pain, tiredness, sleepiness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle soreness over injection site. The patient had fever, body aches, very tired and slept mostly 25hrs out of 48hrs. The patient could not afford to miss 2days of work after being out of work 2 months for the Covid virus. The patient was very hesitating to get 2nd dose. This case linked with US2020AMR091587, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR091587:Same reporter
Rash behind my ear, now its spreading; Eyes start to close and shut a little bit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The medical history was not reported by reporter.  Concomitant products included PROBIOTICS NOS, LAMOTRIGINE (LAMICTAL), CLOPIDOGREL, CARVEDILOL, DULOXETINE, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ATORVASTATIN CALCIUM (LIPITOR), DIAZEPAM (VALIUM), CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include emgality shot.
p/vax pt lt clinic turned 15min later w/angioedema of eyes, rhinorrhea, sneezing;recv Epi & DPH observed x 1 1/2hr;sx improved;
Circular spot of red on left arm where I got the vaccine, hot tender and itchy. It also has a bumby red ring around area. And a tiny hole on spot of injection.
On the next day i started feeling  like allergy symptoms come on, had a terrible headache and started coughing. I also had a runny nose uncontrollably and was coughing as well which lasted four days then eventually it stopped.  I started to feel better as the days went by.
little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night; allergies due to the pollen; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer reporting for himself.  A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for COVID-19 immunisation.  Medical history reported as none. Family history included wife who passed away 2.5 years before, on an unspecified date and his daughter and her (daughter) son, who lives with the patient, tested positive for COVID virus. There were no concomitant medications. The patient experienced little bit of fever, allergies, and feeling unwell, but described as not horribly bad. Patient stated he is ok and doesn't think it has anything to do with the COVID-19 Vaccine. He stated that he thinks it is just allergies due to the pollen. Patient was taking two to three Ibuprofen once or twice a day when he goes to sleep. He has been perspiring quite a bit at night, which he stated was ok. Aside from that he was pretty much ok. He doesn't get second dose until 15Feb2021. Stated we have come a long way from beginnings of time where people would just die. He asked if he should get tested. Patient was advised to follow up with his primary care physician. He stated his symptoms began in the evening of 16Jan2021 at 8pm. He started getting a little feverish and sluggish. He took three Ibuprofen. He thought he lost some weight with the COVID-19 Vaccine. Weight was between 169-170lbs on 16Jan2021. The patient operates a daycare center with children. He was not taking any medication except for the Ibuprofen. He is very active and runs a business. Only thing is, he is sad because he does not have his wife with him. He stated everything was fine. He wanted to know if it was possible one can get the COVID virus even with the injection. He asked about the second COVID-19 Vaccine and what does the first dose do. Treatment included ibuprofen for little bit of fever, sluggish, and Feeling unwell. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of fever, sluggish, weight decreased, night sweats and feeling unwell  due to temporal relationship  Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of pollen allergy, which likely represent intercurrent medical condition.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
rhabodomyolysis so weak he could barely pick his head up. was hospitalized with rhabo & ARF
Patient developed strange bruising and pinprick spots all over her body, including her mouth and ears.  She was diagnosed with Immune Thrombocytopenia.
Rash and itching on arms within two hours of vaccine.  Itching on legs within 12 hours.  Itching on palms of hands and soles of feet within 24 hours.  Swelling of hands and feet within three days of vaccine. Numbness and tingling of hands, legs and feet within four days.  Numbness has subsided but still some tingling right away in the morning and still some swelling of hands and feet.
Left side got tight including brain/ brain was not cooperating with the eyes/ Brain shaking; Profuse sweating; Never had low blood sugar before/Blood sugar crashed; Left side got tight; This is a spontaneous report from a contactable other hcp (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 08:45 am (Batch/Lot Number: EN6203) at age of 61-years-old as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes. No pregnant. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No other vaccine in four weeks. Concomitant medication included semaglutide (OZEMPIC), metformin (METFORMIN), lisinopril (LISINOPRIL), all empagliflozin, linagliptin (GLYXAMBI) taken for an unspecified indication, start and stop date were not reported. The patient experienced left side got tight including brain/ brain was not cooperating with the eyes/ brain shaking, profuse sweating, never had low blood sugar before/ blood sugar crashed on 03Mar2021 09:30. Adverse event: Left side got tight including brain. After maybe 20 minutes while she was driving back. Blood sugar crashed and brain was not cooperating with the eyes. Brain shaking. Profuse sweating. Ate something when she got to work and started improving. Never had low blood sugar before. No treatment for events. The patient underwent lab tests and procedures which included blood glucose: low/crashed on 03Mar2021 09:30. The event outcome recovered in Mar2021.
Few days of rash; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Few days of rash) and VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 21-Feb-2021, the patient experienced RASH (Few days of rash). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 25-Feb-2021, RASH (Few days of rash) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   This case was linked to MOD-2021-044252 (Patient Link).
Information has been received from an approximately 22 year old male pharmacist technician who in approximately 1994 about 10 years ago was vaccinated with a dose of MMR. The patient had a titer test performed and it showed that he seroconverted for measles and rubella, but not for mumps. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
COVID vaccine was diluted with the incorrect dosage. Dilution was 0.2 mls instead of 2.2 mls. MOP was notified and no side effects were reported.
About 1 day after receiving  my second dose of the moderne shot, my left arm where I got the shot started to get warm, itchy, swollen and red. 7 days after receiving my first dose of moderna I had the same adverse reaction.
Shaking and chills, fever of 101.5, arm soreness, nausea when trying to stand or move, cold sweats
Vaccine given 3/22/06-next three days fever, fatigue, dizziness, HA-4th and 5th day hives over upper body and arms.
Patient received Pfizer dose . Son called out for assistance as patient appears "passed out". Patient was sitting in chair.  Vitals 1205: 97.8, 52, 117/70, 98%. Patient states she feels "faint, dizzy and nausea". Patient looks flushed. Legs elevated, patient laying down.  Last set of vitals at - 52, 102/66, 98%. No meds given. Patient nausea gone. States she feels "much better"
This spontaneous consumer report (initial receipt 28-Jan-2013) concerns a 47 year old male patient. On 17-Jan-2013, the patient received one injection of AFLURIA (batch 06949211A). On 26-Jan-2013, the patient developed Bell's Palsy. The patient's entire left side of his face is paralysed. The patient went to the ER (emergency room) and was treated with steroids and anti-virals. The event outcome was recovering.
Severe asthma, no cardiac reserve could not go about normal daytime activities without using inhaler several times a day.
Hives/rash red deep itch sacrum, upper hips, lower front abdomen
Patient positive COVID test on 10/8/21; admitted to hospice on 10/21/21; per death certificate, pt died in the Rehab Center with condition contributing to death as  recent COVID 19
PATIENT CAME IN FOR F/U MEDICAL APPOINTMENT AND COMPLAINED OF LT ARM STILL BEING SORE FROM INJECTION GIVEN 4/9/18 AT VISIT ON 8/28/18. HE ALSO STATES THAT IT HURTS TO EXTEND ELBOW. THE SPOT OF INJECTION IS SORE, THOUGH IS IMPROVING SIGHTLY. HE DOES NOT FEEL WEAK. HEAT IN SHOWER MAKES IT FEEL BETTER. HE WAS INSTRUCTED TO CONTINUE HEAT, DOESN'T' WANT TO DO HOT COMPRESSES. ADVISED TO OBSERVE FOR NOW GIVEN NORMAL STRENGTH AND MUSCLE BULK.
Patient was in the lobby area of pharmacy when he passed out. The pharmacy manager tried to talk to the patient, but he appeared to be having a seizure (his eyes were rolled up in his head, he was shaking). When the patient came to he seemed confused about where he was. He began sweating profusely. He said he was nauseated and lightheaded.  He said he was tingling all over his body. We also noticed that he was bleeding where he hit his head on the ground when he passed out. He stayed seated while the pharmacy manager held a paper towel to the bleeding part on his head. He sipped some water until the EMS arrived and took over. The patient left to go to the ER with the EMS crew after 3:00PM.
Information has been received from a physician concerning a 2 month old female who in 10/99 was vaccinated with second dose of Hep B. Subsequently, the pt developed brownish discoloration at the injection site with swelling about the size of three silver dollars. Additional information has been requested.
The evening after the injection I got sick, achy body, feverish, body was having internal spasms and tremors. The spasms and tremors didn?t go away. I thought they would with time but after 4 months I got worried and reached out to my primary. Still happening g 6 months later with no explanation.
This spontaneous report was received from a pharmacist refers to a 77 year old female patient with penicillin and sulfa allergy. On 22-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported) subcutaneously. No concomitant medications were reported. On 24-OCT-2013, the patient began to experience stiffness of the neck and upper arm. No treatment was given. No laboratory tests were performed. Patient sought medical attention-called pharmacy. The outcome of patient began to experience stiffness of the neck and upper arm was reported as not recovered. Additional information has been requested.
I woke the next morning after the 2nd shot at 5:30am to use the bathroom and I fainted.
Pt. was lightheaded at observation lane.  paramedics assessed pt. once pt. was stable paramedics released her to leave.
Smallpox vaccinee recipient states she was pregnant at time of vaccination. She states conception between 12/29/03 and 1/3/04. No adverse event; pt was pregnant at time of vaccination. Pt was reported to vaccinia pregnancy registry. Doctor appointment 2/11/04
Flu like symptoms (sore throat, stomach ache, fatigue, and body rash).
L shoulder-  shoulder sore, aches, pains, rash R arm- joint pain
Bell's palsy which developed about a week after receivng 3rd Pfizer vaccine (booster). Currently treating with prednisone.
Pain/swelling at injection site; extreme fatigue; chills/fever; muscle pain (back, wrist); loss of appetite; diarrhea.
Patient was in for preventive visit and received vaccination for COVID on 8/21/23. On 8/21/23 it was discovered that that lot number had expired on 8/1/23. The error likely occurred due to confusion with multiple expiration dates, one being a revised manufacturer date and one being the 10 week "out of freezing" date.  Patient's mother notified the day after the event. Patient had a little fever,  but is otherwise feeling normal. No pain at injection site.
Big red circle on arm,  below injection site; Big swollen circle on arm; Arm very sore to touch; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2023, the patient received the 1st dose of Shingrix. On 24th January 2023, less than a day after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient received first dose of Shingrix into unknown arm and afterwards developed a big red swollen circle on arm that was very sore to touch and it was about an inch below the injection site and it was still ongoing. The reporter did not have the lot number/expiration date of the dose. The patient reported that she was still experiencing these symptoms. Inadvertently did not collect if the affect arm was right of or left side. The reporter gave permission to save contact information. The reporter consented to follow up.
received Infanrix instead of the indicated ( as part of catch-up schedule) Adacel, no AE; Initial and follow-up information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 years old patient who received DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (unknown lot number, expiry date and dosing details) on 19-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was an actual medication error due to wrong product administered. It was reported that the patient received Infanrix instead of the indicated ( as part of catch-up schedule) Adacel.  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.
Eyes Red / Swollen within 15 mins. Local rxn - red/hot. Large local reaction. Seen by pediatrician today 11/04/2014. RX: oral prednisone.
Pt had Td booster and 3 days later developed redness and swelling with pain (no fever).
Case number PHEH2013US026006 is an initial spontaneous report received from a pharmacist on 13 DEC 2013. This report refers to a 63-year-old male patient . His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml dose of FLUVIRIN 2013/2014 (batch number: 13391P) intramuscularly on 09 DEC 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 DEC 2013 at 6 PM; at 08:55 AM on 04 DEC 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 DEC 2013 at 5 PNM. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in rage since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
pain in both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in both shoulders) in a 74-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in both shoulders). At the time of the report, ARTHRALGIA (pain in both shoulders) outcome was unknown.            no treatment medication and concomitant medication reported.