chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large, well defined, bright red, patches of confluent, non-papular, blanching rash, slightly raised, covering bilateral anterior thighs and partially covering bilateral calves and shins.  areas of rash are not pruritic, but are sensitive to touch and in some areas quite painful to touch.  These areas persisted relatively unchanged for four days and began to fade by day five (today), although still unpleasantly sensitive to touch. I experienced the predicted fever, chills, body aches and headache, but had no cough, wheezing or difficulty breathing.  The fever, chills, body aches and headache have completely resolved.
Diarrhea and fatigue started approx 8 hrs after administration. Fatigue continued next day. At ~9 am following day, began experiencing moderate + pain in and behind right ear and into and throughout lower right jaw. Watery right eye. Some feeling of weakness in right side of face. Symptoms seem to indicate Bells Palsy but no noticeable muscle droop is occurring. Ibuprofen helps the pain but does not eliminate it. Pain persisting as of writing this at 1630 hrs 3/4/21.
it looks like he got a shingle episode on his left side of his chest , neck and back, and it was confirmed by his md as well. it was a mild episode of the disease.
Pt received COVID vaccine on 5/15/2021. Pt called 10 days later on 5/26/2021, reporting bilateral rash on arms from shoulder to elbow.  Started 1-2 days after vaccine administration, continuing until point of reporting.  Pt reported sensitivity to touch, redness, hot/warm to touch, and some itchiness. Pt denied any sharp or shooting pain.  Experienced some itchiness on torso, but no hives.  Pt also reported arm soreness, hurt to lift arm, and weak.  Pharmacist counseled pt to take anthistamine (i.e. Benadryl) in the meantime, to help with possible allergic reaction to the vaccine dose.  Wait for second dose until resolution or medical advice.  Also to follow up with MD/PCP.  Pharmacist called 14 days post-vaccine administration on 5/29/2021, left message, no response yet from pt.
Fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 10:00 (lot number: EN6201) at the age of 77 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced allergies. The patient previously received first dose of bnt162b2 on 04Feb2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9264, administration time: 09:45 AM, vaccine location: left arm). Next morning after vaccination (occurred on 24Feb2021 08:00), the patient felt lightheaded while bending over to empty dishwasher. The patient sat down on chair; and the patient's husband found the patient on floor, as she had fainted. The patient had no recall of fainting. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The patient did not receive other vaccines four weeks prior to COVID vaccine. The patient recovered from the events on unspecified date.
TOOK DOSES EVERY DAY; This spontaneous case (PVX2019-782) was received from a physician on 01-Apr-2019. It describes a female consumer who "took doses every day", while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took the Vivotif doses every day instead of every other day. The physician guessed that she took her doses from 27-Mar-2019 to 30-Mar-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took doses every day" was unknown.  Company's Comment: The causality of the event "took doses every day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took doses every day" was considered as not applicable.
Pt received PEDIARIX, PREVNAR, for on 7-1-15. Went to ER that night with 105 fever, wheezing and cough. Seen in office on 7-2-15 at 2:00 pm with c/o fever and cough. Cxr normal in ER. Temp 99.3 in office. CBC normal. (L) ear red & dull put on abx.
paralyzed my arm and side; Excruciating pain; This case was reported by a consumer via media and described the occurrence of arm paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced arm paralysis (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the arm paralysis and pain were recovered/resolved.   It was unknown if the reporter considered the arm paralysis and pain to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient decided to get the shot and had bad choice and experienced excruciating pain and paralyzed arm and side which lasted for 2 days. The reporter stated not to get any more vaccine. The follow up would not be possible as no contact details were available.
Information has been received from a health professional concerning a 44 year old female with multiple sclerosis and no allergies who "about 10 years ago" in approximately 1995, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "In the past year", in approximately 2005, the patient had titer which was negative. It was reported that the patient has not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information has been requested.
Arm sore, fatigue lasting from April 23 to April 26, and intermittent low-grade fever of 100.4 degrees fahrenheit
PATIENT HAD CHEST PRESSURE, DIZZINESS, AND DOUBLE -VISION 5 MINUTES AFTER VACCINE ADMINISTRATION. ATIENT TO ED, ADMITTED TO ICU FOR PROBABLE CVA
swelling back of ear and neck, around the facial area; swelling back of ear and neck, around the facial area; swelling back of ear and neck, around the facial area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 06Oct2023, outcome "unknown" and all described as "swelling back of ear and neck, around the facial area".  Additional Information: The patient received the vaccine on 06Oct2023 around 11:30am or 12:00pm. At 5:00pm the patient called the pharmacy and notified that she experienced swelling at the back of her ear and neck, like around the facial area, but not inside her throat.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Narrative:  Pt is a 63y.o. male who died on 04/18/2021 w/ h/o DM, cirrhosis of liver, HTN, COPD, HLD, malignant of neoplasm of lung. Pt received Moderna Covid-19 Vaccination 1/2 on 04/06/2021. Pt presented to Hospital on 04/15/2021 w/ Acute upper GI bleed. Pt died inpatient on 04/18/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.
Second dose in right arm had a week of a rash, abdomen soreness, swelling for a week from injection.
Information has been received from pediatric medical records and a physician concerning a 15 week old female with diaper rash who on RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ROTATEQ (manufacturer unknown), PEDVAXHIB (manufacturer unknown), POLIOVIRUS vaccine, DTAP-IPV and PREVNAR.  On 20-AUG-2008, the patient went to the emergency room (ER) because of diarrhea and diaper rash.  It was reported that the patient was having diarrhea movements approximately 5 per day, very watery in nature.  The patient has been on her regular formula plus occasionally some solid food.  The patient has had no vomiting and was also noted to have a diaper rash for which she had been using NYSTATIN cream.  Her physical examination was normal except for the noted diaper rash on her perineum.  Laboratory diagnostic studies performed include: white blood cell count 14,200, hemoglobin 12.9, hematocrit 36.8, lymphocyte count 46, segs 42, monocyte 9, eosinophils 2 and basophils 2.  The infant was diagnosed with gastroenteritis and diaper rash.  She was instructed to continue with the NYSTATIN and to air dry her bottom as much as possible.  She was also switched to clear liquids for 1.5 days, 2 oz s. every 1 hour while awake.  On 04-SEP-2008 the patient was seen in the physician's office for a rash.  The patient was still using NYSTATIN twice a day until clear.  Her physical examination was normal except for the rash that was noted on her skin.  It was reported to be negative for acne.  It was described as no impressive skin lesions, erythematous macular and red in color and it appeared on the patient's right neck.  The patient was diagnosed with candidiasis of skin and nails.  At the time of this report, the patient's outcome was unknown.  Follow-up information was received from the physician's office.  The reporter stated that "we have no records on file of the patient having an adverse reaction to RECOMBIVAX HB (manufacturer unknown) and no relevance to the immunization was ever addressed".  Additional information has been requested.  All pediatric medical records are available upon request.
This is a spontaneous case, initially received on 09-Nov-2018 from other non-health professional and concerns a 70-year-old, elderly, female patient. On 29-Oct-2018, at 11:00 am, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: deltoid, batch number: 250794, expiry date, dose, trade name, manufacturer: not reported). On the same day, by 6 pm, after vaccination, the patient developed fever chills (reported as fiever chills) with body temperature of 100.7 (unit unspecified), aches and pain all over-her muscles and joints, lumps in her armpits, a lump 1-2 inches away from the injection site towards her back. The patient also experienced headache (reported as HA) every morning. The patient was unable to do anything without taking ibuprofen. The patient reported decreased urine output, even though she was drinking the same amount of water daily and just 1 cup of coffee. Ever since, the day of vaccination, the patient wakes up from middle of sleep, with an unbelievable amount of pain. On an unspecified date in 2018, after vaccination, the patient experienced vertigo (reported as some vertigo situations with her right eye). She developed vertigo, when she looked upward toward the right side, and she has a convoluted vision and can see lines. It was reported that, the patient had consulted her Primary Care Physician (PCP) and performed unspecified tests. The patient was treated with ibuprofen which provided relief for about 5 hours. The patient was unable to do anything without taking Ibuprofen. On an unspecified date in 2018 (reported as this morning) the patient's eyes were swollen. On an unspecified date (reported as this morning), the patient was going to get the results of the tests performed. At the time of the report, the patient had not recovered from the events. This reporter assessed the case as non-serious.
Shingles - I took the shingles shot Nov. 19th 2008. Now I have a case of shingles extending from middle of back around the left side to the middle of my navel, now taking VALTREX or the generic Valacyclovir 1 gram and Hydrocodone for pain.
Tenderness, redness, and swelling at the injection site, dizziness, headache; told to use cool compress on injection site and Tylenol for pain; headache and dizziness were resolved, tenderness, redness, and swelling were still present.
In November of 2021, left leg went numb, went to Dr and they thought it was my sciatic nerve. at the beginning of may 2023 the same symptom happened again along with urinary retention. i was diagnosed with multiple sclerosis
Fever x 2 days after vaccination. Temp max 101. Headache x 1 day relieved with TYLENOL & MOTRIN. 3rd day diarrhea.
Starting 20 minutes after the shot she started complaining about lifting her arm ever so high, and through the night it got worse and then the swelling started to happen some time in the middle of the night. The next day her arm is swollen, she says it itches and it is very red.
Patient's grandmother reported that the patient developed a quarter-sized, red, itchy rash at injection site. Patient did not report trouble breathing or rash spreading. Counseled grandmother to take patient to the doctor immediately if she has trouble breathing or if the rash does not improve or spreads. Also counseled grandmother that patient can take Benadryl for itchiness.
lost appetite; very thirsty; increase urination; 102 fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Hypercholesteremia.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 21-Feb-2021, the patient experienced DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue). At the time of the report, DECREASED APPETITE (lost appetite), THIRST (very thirsty), POLLAKIURIA (increase urination), PYREXIA (102 fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 102 (Inconclusive) 102 fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medications included unspecified high blood pressure and cholesterol medication.
pharmacist called to inform that a patient that received the first dose of Shingrix back in December 2018 hadn't received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix back in December 2018).   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: pharmacist called to inform that a patient that received the first dose of Shingrix back in December 2018 hadn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter called to inform that a patient had not received the second dose of Shingrix yet. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented 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.
About 15 minutes after patient received the Gardasil vaccine she felt dizzy, she became very pale. Her lips were white. She said she couldn't see, that everything was getting dark and that she had a loud ringing in her ears. She had to sit down. She wanted to go to sleep, but I encouraged her to stay awake and keep talking to me. It was hard to get her to respond. The Pharmacy called 911. She was like that for about 15 minutes. Then she started talking a little bit but was still quite pale. The 911 responders arrived. She complained of a bad headache and stated she was very thirsty. Slowly she started to regain a more normal level of consciousness. After about 45 minutes she was totally conscious but had a headache and was very tired. She did not go to the hospital. This exact scenario has happened 3 times since her vaccine. The date today is 6/2/16. She has complained of vertigo countless times since the vaccine as well. This has never happened to her before she received this vaccine.
Patient reported right arm at site of injection was tender, warm to touch and formed a "lump" under the skin approximately 5 days after immunization given. No local/topical treatment. Patient took ibuprofen with symptom improvement. Examination by HP today 9/11/2007. Area with mild erythema, indurated local arm, mildly tender to
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with M-M-R II (Lot number, dose and route were not reported) that was stored in an unmonitored freezer and exposed to unknown temperatures for an unknown period of time. Vaccine was unsupported in the absence of temperature excursion details. No adverse symptoms reported. Approximately 7 doses of M-M-R II were administered. This is one of several cases from the same reporter.
Information has been received from SPMSD (manufacturer control# was not reported) on 04-AUG-2016. Information has been received from a female physician of unknown age referring to herself in a video. She was spoke that "vaccine tested" and was told that it was necessary that she received the (wistar ra 27-3) MERUVAX II before she could practice medicine. On an unknown date the patient was vaccinated with (wistar ra 27-3) MERUVAX II (lot#, strength, dosage, frequency and route unspecified) and a few weeks following the vaccine administration the physician reported that she developed arthritis. The outcome of the event was unknown. The causality was not reported. This is one of two reports received from same TV program. Additional information is not expected since no contact information is provided.
Excessive crying, prompted parents pt return to clinic. Crying lasted 2-3 hours.
The Pfizer vial that the patient's dose was drawn from was mixed with less than 1.8ml (but equal or greater than 1.5ml) diluent.
Prolonged inconsolable crying, irritability 18May04 Restless sleep night of 17 May
2 month old patient got Pediarex (vaccine Dtap, Ipv, Hep B combo) and Ipol by mistake on the same date/ no AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months 2 weeks 4 days old male patient who received vaccines IPV (VERO) [IPOL] and PEDIARIX by mistake on the same date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HIB VACCINE (HIB) for prophylactic vaccination.  On 21-Jan-2020, the patient received a dose of suspect IPV (VERO) (lot P1F491M and expiry date: 30-Nov-2020) via intramuscular route in right leg for prophylactic vaccination.   On 21-Jan-2020, the patient received a dose of suspect DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) not produced by Sanofi Pasteur (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered.  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.
2 days p/vax pt began feeling very tired, had nausea, dizziness, & face was flushed while body was cold;
Patient received the Meningococcal ACWY vaccine - MenACWY and MPSV4. Specific details may be obtained through his PCP's office. He also received the Tdap vaccine. Initially he was light headed. His arm hurt through the night. He had a red bump that evening at the vaccination site. Both injections were given in the same arm. Pain persisted the following day and he needed ice packs at school. He came home from school extremely ill. The bump had more than tripled in size. He had a fever, chills, migraine and began vomiting. He vomited multiple times that evening. He was extremely miserable.  He woke up drenched in sweat in middle of the night. I assumed it was the flu. Yesterday (12/13/17), I called his PCP because of the size of the bump growing even more. His flu-like symptoms seemed to be gone. He was just worn out from the event. I was told it should be seen and that it could be cellulitis and he would need an antibiotic. It was suggested since his flu like symptoms had subsided, that I could even wait until the next morning to see how it was doing. Around 7:30 p.m. I checked it and it had grown even more and was significantly more raised. I rushed him to Clinic and he was promptly seen. The physician said he did not have cellulitis and this and his flu like symptoms were most likely due to the vaccines and most probably the Meningococcal vaccine. His fever had also returned.  Unfortunately, we cannot know for sure as the vaccines were both given in the same arm. I was given an antibiotic if the area continued to grow and if red lines developed.
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked to cases 2018SA255093 and 2018SA256110 (same reporter). This case involves a four-years one-month old female patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1J45, expiration date: 05-Oct-2019, subcutaneously in left side on 23-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR VACCINE for Immunization; VARICELLA VACCINE (LIVE) for Immunization; and HEPATITIS A VACCINE for Immunization. It was a case of actual medication error due to incorrect product storage. It was also reported that vaccine was exposed to temperature of 49.8 degrees F. The excursion lasted approximately 4 hours. It was unknown if the patient experienced any adverse event or not. 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. Documents held by sender: none.