chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency and route were not reported) lot # N005274 with expiration date of 03-APR-2018, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the VAQTA was between 9 °C and 25 °C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004409: US-009507513-1706USA006312: US-009507513-1706USA006313:
evening p/vax became limp. unresponsive, ?apneic;paramedics brought pt to ER;no sz;had URi sx;trial of albuterol but no clear wheezing;recovered w/in hr during overnoc stay;
Employee reported event to PCP, received 1st dose Moderna and approximately 30 minutes later had an anaphylactic reaction. Went to hospital, treated and released without work restriction.
headache; chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced headache and chills 6 to 8 hours after the second dose of the vaccine which lasted around 24 hours. It was mentioned that the event took place after use of product. The outcome of the event was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Dizziness and nausea on changing position from sitting to standing, standing to sitting, standing to lying down (veritigo)
7x9 cm area of erythema, induration left deltoid with fever. Resolved slowly with treatment.
Systemic: Fainting / Unresponsive-Medium, Additional Details: PT PASSED OUT AFTER VACCINATION. WAS MONITORED AFTERWARDS
pain at injection site; Can't lift arm above shoulder; flu like symptoms; fever; chills; muscle aches; dizziness; felt tired; Slept for 24 hours straight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination, the patient had pain at injection site, can't lift her arm above her shoulder, flu like symptoms, fever, chills, muscle aches, dizziness, felt tired, and slept for 24 hours straight. Till the time of reporting, the issues were improving. The reporter did not consent to follow up.
Freezing hands. Two weeks after second shot there is still a stinging feeling on the backs of my hands.
Information has been received from a LPN concerning a 4 yr old white female with no pre-existing allergies, birth defects, or medical conditions who on 08Noc00 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot 634502/0538K). The pt had otitis media at the time of vaccination. Concomitant therapy that day included a first dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR) (batch 473-810) admin IM in the right thigh. On 22Oct04 the pt experienced chickenpox with fewer than 50 vesicular lesions. No other symptoms were noted. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Follow up information indicated that the AE onset date was 21Oct04. The pt was seen in the office on 22Oct04. It was noted that she had just returned from vacation. She arrived home 2 days prior and on 21Oct04 the mother noted some rash on her abdominal area that spread to her legs and pelvic area. She was diagnosed with chickenpox. She had less than 50 lesions, and the mother stated that she recovered on 26Oct04. There were no diagnostic tests or lab data. It was also noted that the pt's brother developed an adverse event (WAES0411USA03493). No additional information is expected.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012 the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions prescribed by a health professional. On an unspecified date, patient was treated by a physician for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a physician concerning an 18 year old female who in 1989 was vaccinated with MMR II and subsequently had low titers of measles after being dosed with MMR II twice in the past. The patient did not report any side effects. No other information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt c/o dizziness @ 11:34 after injection. Resident remained oriented x4. Medics on site and took V/S 1138 BP 104/66, HR 108, RR 22, OxSat 98%. Continue to monitor pt for additional 15 min. Pt stated he was nervous and he had just got off work.  Resident continued to be monitored per medics. Pt vitals were re-taken @ 1151 BP 103/67, HR 107, RR 20, OxSat 98% RA. Pt stated he feels better, no more dizziness. Alert and oriented x 4. Pt was advised to eat something when he gets home.  He states he catches the bus home. Pt drank all of his water. Pt was observed standing up without incident and walked out of the room w/o problems. Pt was also advised to call 911 if he feels any worse when he gets home.
Fever 101.7, flu like symptoms (extreme body aches and weakness) for 6 hours, fever broke after taking Tylenol
sinus headache above eyebrows; light headedness; not dizzy but balance has been off; have to be careful and walk slowly; it's like a swimming effect; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), BALANCE DISORDER (not dizzy but balance has been off), GAIT DISTURBANCE (have to be careful and walk slowly), FEELING ABNORMAL (it's like a swimming effect) and SINUS HEADACHE (sinus headache above eyebrows) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus headache and Neuropathy (Neuropathy in both Legs). Concomitant products included LEVETIRACETAM (KEPPRA), WARFARIN SODIUM (COUMADIN), SOLIFENACIN SUCCINATE (VESICARE), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), TIMOLOL MALEATE, LATANOPROST and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIZZINESS (light headedness), BALANCE DISORDER (not dizzy but balance has been off), GAIT DISTURBANCE (have to be careful and walk slowly) and FEELING ABNORMAL (it's like a swimming effect). On 03-Mar-2021, the patient experienced SINUS HEADACHE (sinus headache above eyebrows). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, DIZZINESS (light headedness), BALANCE DISORDER (not dizzy but balance has been off), GAIT DISTURBANCE (have to be careful and walk slowly), FEELING ABNORMAL (it's like a swimming effect) and SINUS HEADACHE (sinus headache above eyebrows) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up information received on 21 Jul 2021 contains significant information. event outcome of all events updated to recovered
Pt. reports bruising on (L) hand from fingers to knuckles, swelling to (L) deltoid where shot was given but no bruise to area of shot; bruising to (R) arm, shoulder and side, posterior (R) calf, denies falling or having sxs prior to getting vaccines; no tx received; says an MD she saw at a hospital while visiting a pt told her sxs were probably a result of vaccines given.
Patient states she "could not sleep on on that arm that night" and could not raise arm the next morning.  This lasted a few days afterward. Still currently has intermittent pain when using arm (shoulder area) especially lifting or with pressure.
watering eyes; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer, the female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 11Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 20Mar2021 for covid-19 immunisation. On an unspecified date in Apr2021, the patient experienced watering eyes. The patient wants to know if she can take Benadryl. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Starting at 6 am 5 days after receiving the flu vaccine, employee experienced sor throat, low grade fever, chest congestion, coughing, chills, and burning eyes. The same day vaccine was administered she developed soreness in the right upper arm where her injection was given. These symptoms had improved but not resolved as of 10/12/2009.
red rash at the injection site , 2 inches wide , 4.5 inches across , some itching
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 18-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
Severe itchiness across the trunk and down the legs, in addition raised bumps accompanied the itchiness.
red spots developed over my chest, stomach, back, abdomen and legs.; red spots developed over my chest, stomach, back, abdomen and legs.; red spots developed over my chest, stomach, back, abdomen and legs.; This is a spontaneous report from database. A contactable consumer (patient) or other non HCP.    A 46-years-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number EN206, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 04Mar2021, at 03:30 (age at vaccination: 46-years-old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, hyperlipidaemia and Perimenopause from an unknown date and unknown if ongoing. Concomitant medication included lisinopril 10mg; ezetimibe (ZETIA) 10mg; and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) all taken for an unspecified indication, start and stop date were not reported. patient previously took Amoxycillin and experienced Drug hypersensitivity. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. On 06Mar2021, 2 days after vaccination the patient experienced red spots developed over my chest, stomach, back, abdomen and legs, then a spot on left wrist the next day, then over the next two weeks red spots developed over chest, stomach, back, abdomen and legs. The spots are dime sized or smaller, and don't really itch, but continue to spread over the last 2 and a half weeks. Patient visited Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event was Hydroxyzine 10 mg, it hasnt helped at the time of reporting. The outcome of the events were not recovered.  No follow-up attempts are needed, no further information is expected
Acute flare of UC Blood in stool  Mucous  Diarrhea  Started on prednisone 40 mg for 6 weeks then tapering.
About 12-15 hours after my shot I started to feel general malaise.  By 6am on 1/16, I had a bad headache and felt nauseous, and dizzy. These feelings lasted until 10pm on 1/16/21, and then I went to bed and felt better in the morning.  I was barely able to get out of bed that day (1/16) because of how sick I felt.  Besides the sick feeling,  I had bad pain at the injection site, and had a 3cm x 3cm raised red lump at the injection site.  This stayed painful for 48-60 hours, then the swelling subsided and was left with a bruise.
Symptoms:  swollen lips, tongue, inside of mouth, sores inside mouth, crust at corners of mouth. Treatment:  steroid therapy; currently on tapered dosage. Outcome: symptoms have diminished but flare up a bit when going down in dosage; inside of mouth still has some swelling.
Dad brought pt into clinic and this nurse was summoned to lobby. Pt was asleep on dads chest. Pt breathing normally with 02 sat=98% RA, afebrile and HR=89. Pt aroused with physical touch. Pt has pink firm round area 3"X2.5" to R thigh where vaccine was administered. Area is warm to the touch and didn't seem to be painful when palpated. Dad states he has given pt Tylenol for comfort but pt does not complain of pain to area. Dad is not familiar with vaccines so he felt the need to have a nurse visualize area. This RN recommended cold pack to area, Pediatric Benadryl 12.5mg per bottle instructions and Tylenol for pain. Alert placed in chart for future immunization administration. Dad and pt left clinic without s/sx's distress.
Warmth at site; 3" x 3" swelling and pain at site of injection lasted 5 days.
Patient received first COVID-19 vaccine in the left arm on Aug 6, 2021. Within a few days of vaccine administration, patient developed a rash at the injection site approximately the size of a half dollar. The rash seemed to disappear. Approximately a week after injection, the rash returned and was about the size of patient's fist. There was also a small bruise in the middle of the rash. The patient iced the rash and took Zyrtec and Ibuprofen. The patient notified her primary care physician and was given a topical cream. Based on the physician's observation, it appeared as if the vaccine may have been administered below the deltoid muscle. As of Aug 23, 2021, the patient still had a small bruise and the arm was still sore with occasional pain radiating up into the neck.
A report was received from a health care professional on 14 November 2003 concerning a 27 year old female vacinee who experienced closure of the throat, whcih was considered to be medically significant, 12 hours after receiving Fluvirin vaccine on 22 October 2003. On 22 October 2003, the vaccinee's "throat closed" 12 hours after receiving Fluvirin. The vaccinee wsa seen in an emergency room. The acute "throat closure" resolved, however, the vaccinee stated that she was still experiencing night time symptoms of "throat closure" which included wheezing and shortness of breath. At the time of vaccination, information regarding neomycin and polymycin allergies was not obtained. The vaccinee had not recovered at the time of the report. THere was insufficient information to determine the reporter's causality assessment. Update on 05 December 2003: follow-up information was received from the sponsor indicating that an error was made in the reporting assessment of this case during the QC by company pharmacovigilance. This case is to be reported. Follow-up pending.
Constant headahe right above her eyebrows; Always tired; Continuous nose bleed every day/runny nose bloody; Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy; Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), MACULE (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM for Arthritis, LOSARTAN for Blood pressure high, PRAVASTATIN for Cholesterol, DULOXETINE for Fibromyalgia, OXYBUTYNIN for Urinary incontinence, MUPIROCIN, PREDNISONE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy) and MACULE (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy). On an unknown date, the patient experienced HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired). At the time of the report, EPISTAXIS (Continuous nose bleed every day/runny nose bloody), PRURITUS (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), MACULE (Small red dot in her back of  leg they are itchy/Small red dot in her back of  leg they are itchy), HEADACHE (Constant headahe right above her eyebrows) and FATIGUE (Always tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nose bleed started about 3 weeks after the second shot. Lab details reported include blood work, whose results are not provided. Treatment information reported as, itching stops with medication, came back once she stops taking medication. Patient had three appointments at doctor's office on 28 May 2021, 09 June 2021, 12 July at 3:45 Pm Patient had one appointment at ENT on 14 July at 2:00 Pm   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Added patient demographic details, vaccine facility information, new concomitants, events start date and additional captured I narrative
3 days of arm pain,  3 days of strange headache, leg and hip pain which causes a limp
Left arm began to slowly swell up over the day and about doubled in size, there was a lot of severe pain, I could not put any pressure on it.  It turned red and I could feel the swelling creeping up my shoulder to my neck.  I could not use my arm for 10 days.
Caused irregular periods every 2 weeks since getting vaccine, prior to vaccine I had no periods since I was on the iud. Since then periods have been heavy and very painful with a lot of cramping in between.
5-9-13 Spreading redness, swelling and warmth whcih appeared two days after receiving T-Dap and Menactra.
Sore throat, malaise, flu-like symptoms with both GARDASIL shots, #1, #2.
Only adjuvant administered, no antigen; Only adjuvant administered, no antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The HCP (health care professional) reported that administering adjuvant only (no antigen) to 9 total patients.  Three patients were unidentified, 6 were identified. The AE (adverse event) filed separately for the 3 unidentified patients.  The reporter consented to follow up. This is 1 of the 7 cases reported by the same reporter. Additional Supportive Information: The patient received Shingrix vaccine without antigen,  which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022193689:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193687:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter