chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atopic dermatitis; Pruritis; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 05Apr2021 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. Medical history included allergic asthma, rhinitis and COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included levocetirizine dihydrochloride (XYZAL) 5mg once daily (QD) and montelukast sodium (SINGULAIR) 10 mg once daily (QD), both taken from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced atopic dermatitis and pruritis. Therapeutic measures were taken as a result of the events and included treatment with benadryl. The clinical outcome of the events atopic dermatitis and pruritis was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
5 Minutes after patient had the 1st Dose of the the Pediatric Pfizer vaccine, she fainted, hit her head, then showed signs of a seizure. Emergency Support was called to the scene. She was examined.  Mom will follow up with Pediatrician.
didn't eat; didn't feel well; This is a spontaneous report from a contactable consumer (patient's herself) via Pfizer-sponsored program COVAX US Support. This 76-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Feb2021 (at the age of 76-year old) at single dose for COVID-19 immunization at the hospital. Relevant medical history included broken of tooth when she fell "on Oct3rd" for which an implant will be inserted and antibiotic therapy will be required. Concomitant medications were not reported. After the second dose the patient had gone all day without eating. The next day (Monday morning) she was fine but by the afternoon she didn't feel well but she didn't eat. The outcome of the events was unknown.   Follow-up attempts completed. Information about lot/batch number cannot be obtained.
Pt complained of indigestion and tongue feeling larger than normal. Pt was assessed by ems. Pt started feeling better about the situation and wanted to leave. Ems let her know about the symptoms of a severe reaction and if any show up, to call 911.
01/17/22 presents to ED for "chest pain". PMHx of "coronary artery disease, hypertension, OSA, DVT"
Patient has completed 2/3 vaccines for Covid 11 months ago and was admitted today with Covid 19 infection following a fall at home
Very sore left deltoid at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Very sore left deltoid at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2(or Z)0A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy.   On 28-Jan-2021, the patient received first 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Very sore left deltoid at injection site). At the time of the report, VACCINATION SITE PAIN (Very sore left deltoid at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Severe pain in breasts and headache.  She had to put cold press on breast and after call her aunt we gave her IBphrophen because Tylenol was not working for pain.  Had 3 periods in two months (May & June) and missed a period in July
Muscle pain, feeling tired, headache, fever-like, upset stomach. In to day 2 of these side effects.
Vaccine was given on 10/3/22 and unknowingly expired on 9/30/22.
Significant arm pain from shoulder to elbow, tired, body aches in shoulders neck and back,  pounding headache
Acute Bronchitis due to RSV. This visit was within 6 weeks of receiving vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing); "High BMI" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2004, stop date: 28Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  No follow-up attempts are possible. No further information is expected.
The patient experienced no symptoms; on 6/11/2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-JUN-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T003833, expiration date 01-AUG-2021, subcutaneously (exact dose, dose number and vaccination site were not provided) for prophylaxis. Diluent (lot # T000494, expiration date 06-JUL-2022) was properly stored.  Administered dose of vaccine was exposed to the temperature excursion of 43.8 degrees Fahrenheit for 29 hours and 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved. The patient experienced no symptoms.
58kg 29 yo F with NKDA and no significant PMH was given COVID-19 vaccine booster and Flu vaccine 10/25 ~1125 at vaccination clinic.  After administration of the influenza shot (lot # CA52L ) in the right arm and the COVID-19 vaccine in her left arm (undocumented lot) the patient complained of pruritis at the injection COVID19 site on the left arm.  Shortly after the arm started to itch, the patient complained of swelling in tongue and itching at throat.  25mg of liquid diphenhydramine was given at 1125.  Symptoms did not improve.  After another 40 minutes, pruritis began to improve but employee complained of feeling cold.  Pt stated she usually takes a Claritin daily and did not take it that morning.  10mg of loratadine given since symptoms were not resolved yet.    Patient went to ED for monitoring.   Discharged later that evening on long acting antihistamine.  Allergy not added to the patient's profile.
Shortness of Breath (Pt presents to ED via EMS with complaints of SOB and being fluid over loaded. Her and husband were covid tested yesterday and result is positive. Pt uses 3 liters of oxygen at home at baseline. )
This spontaneous report as received from a medical assistant refers to currently 15 year female patient. The reporter stated that on an unknown date, the patient was administered the GARDASIL that was exposed to temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse effect was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.
1 week after the 1st dose, I started having pink spotting and discharge. It started with a small dot and increased in amount and clotting. It wasn't continuous. It would come and go and happen for 1-2 days then stop. I did not have any cramping or pain. The spotting occurred for 1 and 1/2 weeks followed clotting and by a large amount of bleeding. Then I actually got my period which lasted for 5 days. The actual period resembled my real mensural flow.  I did go see my OBGYN who did an transvaginal ultrasound and everything was normal. By this time, I was due for my 2nd vaccine and proceeded to get my 2nd dose. After the 2nd dose, I had no changes to my mensural cycle and everything is back to normal.
Approximately 2 hours postvaccination, patient began to feel "puny." When she woke up today (vaccine was yesterday), her right arm (injection site was right deltoid) was painful, hot to the touch, and swollen and red from the injection site down to the elbow. It has now been 24 hours since the vaccine and the symptoms persist. She has taken oral OTC pain relievers to this point but nothing else.
Pt presented to the Medical Clinic on 6/19/07 with c/o rash to his abdomen following smallpox vaccination which was given on 6/6/07. Returned on 6/20/07 with c/o rash to lower legs and face. Smallpox vaccination site with surrounding erythema. Seen on follow up on 6/21/07 and 6/23/07 with resolving of rash noted. Was given Atarax on the 19th, prednisone and traimcinolone on the 20th, Atarax on the 21st and pseudophredrine on the 23rd for developing URI sx.
Initial report was retrieved from the scientific literature on 06 September 2012. The following information is verbatim from the abstract: "Meningococci have historically caused extensive illness among members. Three successive meningococcal vaccine types were used from 1971 through 2010; overall disease incidence dropped by >90% during this period. During 2006-2010, disease incidence of 0.38 (cases per 100,000 person-years) among members was not significantly different from the incidence of 0.26 among the age-matched general population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis serogroup Y. Incidences among 17- to 19-year-old were significantly higher than among comparison populations (p<0.05). No apparent change in epidemiology of meningococcal disease was observed after replacement of quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with meningococcal vaccine is effective." According to the report, the cases were confirmed by culture, PCR or both. The information included in this case concerns a 20-24 year-old female patient who had received MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not reported) and 43 months after vaccination developed meningitis and sepsis, year reported as 2010 (Q 2). Neisseria meningitidis serogroup was determined to be serogroup Y. Treatments were not reported. No further information was available at the time of report. Death was reported as "No", however the patient's outcome was not reported. The reporter for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.
Redness, swelling, heat, hard to touch - 4 cm x 2 cm - L upper outer arm, L deltoid area.
This spontaneous report as received from a consumer via Regulatory Authority refers to a 67-year-old female patient. Her medical history included colon cancer and shingles. The patient suffered the first outbreak of Shingles on an unknown date, in approximately 2006, when she was recovering from an unspecified colon cancer treatment. No other details about her medical history, concomitant therapies and concurrent medical conditions were provided. On 05-AUG-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (formulation, dose, lot number, expiration date, route of administration and site of administration were not reported) for prophylaxis. On 14-MAR-2021, the patient was vaccinated with her first dose of tozinameran (COMIRNATY), lot# EN6207 (formulation, dose, expiration date, site of administration and route of administration were not reported) for prophylaxis. On 04-APR-2021, the patient was vaccinated with her second dose of tozinameran (COMIRNATY), lot# ER8729 (formulation, dose, expiration date, site of administration and route of administration were not reported) for prophylaxis. On an unknown date in 2021, the patient experienced stress. On an unknown date in 2021, the patient experienced an outbreak of shingles due to "stress of everything". The intensity of this event was reported as mild. On 19-OCT-2021, the patient started therapy with valaciclovir hydrochloride (VALTREX) for Shingles. On 26-OCT-2021, the therapy with valaciclovir hydrochloride (VALTREX) was discontinued. On 16-NOV-2021, the patient was vaccinated with her third dose of tozinameran (COMIRNATY), lot# _D0809 (formulation, dose, expiration date, site of administration and route of administration were not reported) for prophylaxis. The outcome of the events was unknown. The causality assessment between the events and the suspect vaccines was not provided.
patient felt nauseated 20 minutes after receiving first vaccination, vitals remained stable, patient improved after juice and crackers given.
sore throat/my throat is now currently hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: other medical history: Irritable bowel syndrome; "can't eat spicy food" (unspecified if ongoing), notes: I can't eat spicy food. Concomitant medication(s) included: FLUOXETINE; BUPROPION; HYOSCYAMINE; OMEPRAZOLE.  The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat/my throat is now currently hurting". Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional information: Patient did not receive any other vaccine in four weeks. Other medications in two weeks were Fluoxetine, Bupropion, Hyoscyamine and Omeprazole. A week after the first vaccine patient had a sore throat. After 2 weeks, her throat was then currently hurting, which started yesterday. Ae resulted in None of the above. There was no covid prior vaccination. Patient did not test covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Swollen, extremely painful lymph nodes in the armpit and inner arm beneath the injection site. Began almost exactly 24-hours after administration. Was painful to the point that it prevented me from sleeping or holding my arm to my side. The whole area swelled to the size of a grapefruit. Symptoms lasted about a week.
Excessive redness and swelling and pain at the injection site. Benadryl by mouth and cold compress to arm.
I got my shot at 2:30 pm on 2/11. I woke up 2/12 slightly achy. By 2:00 pm on 2/12 I had a moderately severe headache, had chills, was a lot more achy, and had some neck pain. At about 7 pm, my headache was only minor and the aches were minor. Chills were gone and neck pain was minor. By 8, headache and aches were gone. I woke up this morning feeling back to normal. I never took Tylenol or ibuprofen.
Very swollen (L) arm x injection site. Warm to the touch & hard to raise. Suggested pt to take acetaminophen or Ibuprofen and place cold compress to injection site, has been going on 7 / day.
Information has been received from a 56 year old female with no pertinent medical history and no drug reactions/allergies who on 15-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23. There was no concomitant medication. On 16-OCT-2009 the patient developed redness, swelling and tenderness to touch at the injection site of the right upper arm. The patient also experienced fatigue and fever of 101.5F. The patient self-treated with ibuprofen and fully recovered on 19-OCT-2009. Additional information is not expected.
This spontaneous report was received from a pharmacist via Pfizer regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot number were not reported) for prophylaxis. On an unknown date the patient experienced allergic reaction (hypersensitivity). The pharmacist enquired of the patient can be vaccinated with Prevnar 13.  The outcome of hypersensitivity was unknown. The causality was not reported. Additional information has been requested.
Erythema multiforme minor developed on 10/10/02 after receiving MMR, Varivax, and Comvax 10/7/02. Pt also on Augmentin 250mg/5ml BID since 10/4/02.
Denies any flashes of light; Herpes zoster opthalmicus; VISION IS BLURRY; glare problem; Floaters right eye; Vision is getting worse; This case was reported by a physician and described the occurrence of ophthalmic herpes zoster in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) unknown for ophthalmic herpes zoster.   The patient's past medical history included herpes zoster, ophthalmic herpes zoster (zoster conjuctivitis with redness on eyelid, pressure, eye pain and pulling around right eye. eyes got tired more than usual.), double vision (brief episode of transient double vision), photophobia (right eye light sensitive and tearing), nerve compression, arm operation, temporal headache, ex-smoker, reading disorder (struggling to read), facial pain, hyponatremia and excessive drinking. Previously administered products included Erythromycin, Vigamox, Cyclopegic, Atropine, Zirgan, Cyclogel, Prednisolone and Trileptal. Concurrent medical conditions included post herpetic trigeminal neuralgia, anterior membrane dystrophy, corneal guttata, headache, palpitation, cataract (left eye) and vitreous detachment. Concomitant products included gabapentin.   On 31st August 2018, the patient received the 1st dose of Shingrix. On 5th July 2016, the patient started Valtrex (oral) 1000 mg twice daily (2000 mg daily). On 29th July 2016, the dose was changed to 1000 mg 3 times daily (3000 mg daily). On an unknown date, the dose was changed to 1000 mg once daily (1000 mg daily). On 19th August 2016, the dose was changed to 1000 mg 3 times daily (3000 mg daily). On an unknown date, the dose was changed to 1000 mg once daily (1000 mg daily). On an unknown date, less than 2 months after receiving Shingrix and unknown after starting Valtrex, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), blurred vision, glare, eye floaters and vision decreased. On an unknown date, the outcome of the ophthalmic herpes zoster, blurred vision, glare, eye floaters and vision decreased were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, blurred vision, glare, eye floaters and vision decreased to be related to Shingrix and Valtrex.  Additional details were provided as follows:  The patient presented for follow up of post herpatic trigeminal neuralgia and reported that vision on right eye was doing ok. The patient's left eye had cataract and can't see very well even after correction. Post vaccination the patient had floaters right eye but denied any flashes of light. The reporter stated that in left eye onset was gradual, vision was blurred with moderate severity and occurred constantly. In left eye the vision was getting worse and had glare problem at night and had herpes zoster opthalmicus. The patient denied any eye pain or irritation. This case is linked to case US2020AMR013062 and US2020AMR012677AA reported for the same patient.
VASOVAGAL SYNCOPE (PER NOTE)  Narrative:  Patient received vaccine, became dizzy, and cold without sweats.  Albuterol was administered though patient does have breathing problems. O2 stats  dropped and patient heart elevated. Patient was observed and once o2 was given  via NC, O2 increased to 95-96% in minutes and HR returned to baseline of in the  70s. Patient was provided a warm blanket to offset feeling cold.
Extensive swelling reaction in right arm after 5th dose of DTAP vaccine.  Two days after vaccination swelling = 45x60mm.  Redness = 60x90mm.  Increase of mid-arm circumference of 1.3cm.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-DEC-2014, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot # H020901, expiration date: 05-JUL-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.