chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 12-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 28-OCT-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
On 01/08/2021 developed red rash around the injection on the left arm. Arm has redness the size of softball and warm to touch.
Swelling and inflammation of right upper arm almost immediately following injection lasting for two days at least. Pt also experienced pain in right upper arm.
Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) in a 52-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion assessment was ongoing(possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
Rash on (L) arm, (L) arm pain, blisters on lips and buccal mucosa of mouth, fever of 102 within 12 hours when 2 vaccines were administered. Fever for 2 days, better with TYLENOL. Rash, blisters lasted 6 days.
Arm had started to get few blotchy red spots day after, but today almost entire humerus solid red not blotchy.
This is in follow-up to report (s) previously submitted on 4/23/2007. Information has been received through the pregnancy registry, from a registered nurse, concerning a 25 year old female patient, who on 17-JAN-2007 was vaccinated with the first dose, 0.5ML, IM, of Gardasil (Lot # 655617/1447F). There was no concomitant medication. The nurse reported that the patient is pregnant. The date of the last LMP was 22-JAN-2007, with an estimated date of delivery on 29-OCT-2007. Pregnancy was confirmed by a positive serum pregnancy test and a "fetal ultrasound" was performed (results not provided). The nurse stated that on 23-FEB-2007, the patient experienced vaginal spotting; she added the patient also had a "low" serum progesterone level (date and result not provided). Subsequently, the patient recovered from the vaginal spotting (date unspecified). It was unknown if the low serum progesterone recovered. The patient sought unspecified medical attention. Additional information has been requested. Follow-up phone call information was received from a registered nurse who reported that the patient delivered a normal, healthy full term baby on 13-OCT-2007. There were no reported complications with the birth whatsoever. The VAERS number is 276862. No additional information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "parkinson" (unspecified if ongoing), notes: Parkinsons; "chronic pain" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing), notes: bronchiactisis. Concomitant medication(s) included: SINEMET, start date: Mar2022; MYRBETRIQ, start date: Jan2020; CELECOXIB, start date: Jan2019; WIXELA INHUB nasal, start date: Aug2020; MONTELUKAST, start date: Jan2020; DULOXETINE, start date: Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: (since day 1 of diagnosis & paxlovid start) She tested positive on rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
syncopal episode- 1:33 pm individual fell head-first off from chair in observation area and hit her head. I was called over by the observation person that someone needed attention right away. I ran over the individual was lying on the floor and her husband was sitting on a chair right next to her. He said she fainted and fell forward. The individual appeared to be unconscious when I arrived and was very diaphoretic. I loudly asked if she was okay and then tapped her chest. She looked up at me and said ?oh snap.? She was oriented to person and place and her pupils were equal, round, and reactive. She denied that she had any tingling in her arms or legs. She said she heard everyone talking to her, but thought she was dreaming. She said that she has a history of passing out with finger-pricks (she cannot donate blood anymore because of this), shots, and she passed out when she got a piercing in the past. She said she felt her HR slowly starting to climb, but she felt she would be okay. She said she then started feeling lightheaded and passed out. I took HR BP at  1:35 128/74, 62 and again 5 minutes later 128/80, 62. Individual was given an ice pack for her head. She had a bump on the upper right side of forehead. She said she had not eaten or drank much before her shot. She said her stomach was a little upset. She was given water and granola bars and sat up for a while before standing up. She asked if I thought she should get her head checked out. I said it is never a bad idea to get checked and since she did hit her head hard enough for a bump to happen right away. Individual was feeling better before she left, stating just her head hurt. We told her to ice and ibuprofen or Tylenol to treat discomfort.
Starting with my first dose on 2/5/21 my psoriasis and psoriatic arthritis (worsened.  After my second dose I had chills, lethargy and severe joint and body pain (difficult to sleep) which improved after 36 hours--except worsening of left knee pain--by 3/5/21 I was unable to stand, walk or move my left knee due to pain.  I self treated with Naprosyn (400 mg bid) and went to urgent care on 3/6/21.  The XRAY was negative with slight effusion.  I have had no injuries or trauma to my leg. I am a physician and have had psoriasis and PsA for about 25 years--have on and off medical care (topical steriods, creams and NSAIDS).  Due to my +BRCA2 gene I have not taken stronger immuno-suppressive therapies.
Redness, swelling, itchy, hot, lump at injection site 8 days after the injection. Started out small, next day got bigger, and today is the biggest.
administered ActHIB that was mixed with sterile water/no AE; Initial information received on 09-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 16 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] that was mixed with sterile water.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Apr-2020, the patient received a 0.5 ml second dose of suspect HIB (PRP/T) VACCINE lot UJ099AA, U6376AA via unknown route.  It was also a case of actual medication error due to Inappropriate reconstitution technique.  It was unknown if adverse event was noted.  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 Directiveand Module VI of the 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.
Site: Pain at Injection Site-Medium, Additional Details: Patient experienced pain at injection site. Has seen doctor and is trying different therapies
Received Menactra in left deltoid in early afternoon. That evening he developed a rash at the site of injection which spread up left arm and to left trunk. Appeared pale, gray and c/o nausea and dizziness. Given Benadryl which resulted in resolution of rash. Taken to ER, vital signs normal, left without being seen. Pt's rash had resolved.
sore arm; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Approximately 3 weeks post vaccine, I was awakened by severe R sided neck and upper trapezius pain.  Prior to this event, I noticed episodes of tingling that traveled from the R deltoid area to just above my elbow.  Pain improved significantly after being prescribed a shout course of methylprednisolone, but 5 days later I noticed a loss of strength in my R deltoid.  I still experience episodes of R sided neck and upper trapezius pain during the night and first thing in the morning.   R deltoid weakness continues to be a problem.
Off label use; Booster; Breakthrough COVID-19 infection; Breakthrough COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovered" (Jan2022) and all described as "Breakthrough COVID-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
One week after 2nd Moderna vaccine dose, I experienced a psoriasis flare-up.  Patches of Rash is largely on the upper and lower back.  The rash also occurs on the abdomen, calves and neck.  Now, four months later, the rash is still in the described areas.
On 10/27/2022, the provider ordered a 4th Prevnar vaccine because the patient had only received 3 Prevnar doses. However the fourth dose of the Prevnar was not necessary because the patient had already received one dose after the age of 1.
Throat swelled-pus came out of her eyes. Took Benadryl.
Very sore left arm, About 9 hours after injection began to feel cold, shaky, leg muscle ache and increasing temperature.
1st dose on Jul2021, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose of Shingrix on July 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment:  The pharmacist reported that a patient did not received the 2nd dose of shingrix. The reporter gave consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked to the case US2022187389 reported by the same reporter.; Sender's Comments:  US-GSK-US2022187389:Same reporter
Its a skin condition I've never had before around my eyes. It was red lesions and spots around my eyes, that were slightly itchy and began to spread from my left eye to my right eye. It could be Periorificial / Periorbital, it had gotten up to my lash line. I was prescribed metronidazole topical cream, I was told to put it on the affected areas around my eyes twice a day for four to six weeks. I didn't follow the directions exactly and the reaction seems to go away and came back. I followed the directions exactly the second time around and I'm into my sixth week and seems to be getting better but I'm having side effects. I'm developing a sty, I'm going to contact my doctor next week to see the next steps.
Client received an additional dose of Tdap and was observed for 15 minutes post administration with no adverse effects noted.
Pt experienced tingling around injection site on left deltoid, beginning 15 min after injection with reduction in tingling over subsequent 15 minutes.
I called and left 2 messages for mother to call back and never received a phone call. Although I did see the patient on 5/30/03 and appeared without symptoms.
6/30 fatigue in the evening. 7/1 mild sore throat and headache. 2 negative COVID tests, 1 at home and 1 PCR. 7/2 tested positive with at home test. Symptoms were worse on 7/2, still mild, but worse than 7/1. Migraine started on 7/2. Started PAXLOVID on 7/2 after tele visit with doctor. Marked improvement after PAXLOVID.
face flushing; redness/It's like jawline, ear, redness in the face and comes and go throughout the day; itchiness; Covid arm with the rash at the sight of the injection; This spontaneous case was reported by a patient and describes the occurrence of FLUSHING (face flushing), ERYTHEMA (redness/It's like jawline, ear, redness in the face and comes and go throughout the day), PRURITUS (itchiness) and VACCINATION SITE RASH (Covid arm with the rash at the sight of the injection) in a 49-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031914) for COVID-19 prophylaxis.     Patient had no relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna (Lot 051D22A) on 28-Oct-2022; for Product used for unknown indication: Flu shot the week before (shot the week before) in October 2023, Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Flu shot the week before, Moderna, Pfizer and Pfizer.    On 30-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 02-Nov-2023, the patient experienced FLUSHING (face flushing), ERYTHEMA (redness/It's like jawline, ear, redness in the face and comes and go throughout the day), PRURITUS (itchiness) and VACCINATION SITE RASH (Covid arm with the rash at the sight of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FLUSHING (face flushing), ERYTHEMA (redness/It's like jawline, ear, redness in the face and comes and go throughout the day) and VACCINATION SITE RASH (Covid arm with the rash at the sight of the injection) was resolving and PRURITUS (itchiness) outcome was unknown.            No concomitant medication was reported. It was reported that patient tried lotions as well but nothing seems to help. Patient did not had any side effects with the first Moderna Booster they received.
UNCONTROLLABLE HIGH FEVER. WENT INTO SHOCK, CONVULSED. CALLED 911 ABOUT 6PM. TYLENOL ADMINISTERED, COLD BATHS. 11/24/11/30 and 12/10/2009 MR, DC summary for 11/22-11/25/2009, DC Dx febrile seizure patient presents wih seizure activity, hx of fever. LP, Influenza A +,  Tx with Tamiflu
Patient is 2 years old. Should have gotten Dtap #4 however received Kinrix which contains dtap and ipv. No reaction.
Severe body aches, "worst headache ever", pain 10 on scale 1-10. Began mild, increased in intensity over 6 hours with the most intense pain lasting more than 1 hour, administered 800mg ibuprofen generic, 30 minutes later intensity subsided but is not gone.
Red swollen and painful 8/10/10. Patient went to clinic 8/8/10 - Received ROCEPHIN 1 gram IM and BACTRIM double strength 1 PO x 10 days.
Patient reported day of vaccination was unable to have any range of motion in arm for 3 weeks after.  Has improved but still unable to fully use arm.
4/10 - 4/11 -- chills throughout the evening 4/11 -- fever* of 102 4/12 -- fever* of 103 -- took 1 acetaminophen at 2 pm & 12 pm 4/13 -- fever* back to 103 by 6 pm, so started taking 1 acetaminphen every 6 hours until 11 pm 4/14 -- fever* of 100 at 5 pm, took last acetaminophen at 6 pm 4/15 -- no fever at 7 a.m. or 2 p.m.; very weak  * Fever accompanied by chills & cold sweats. Slight cough also developed & lasted a couple weeks (possibly allergies tho' I'm on allergy meds).
This spontaneous report as received from a registered nurse refers to a 89 year old female patient. The patient's medical history and current conditions are not reported. On 16-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 of dose 0.5 ml, intramuscular in the right arm (lot # J009827 and expiry date 10-AUG-2014). Concomitant therapies included INFLUENZA VIRUS VACCINE (Unspecified) in the left arm. It was reported that the patient was vaccinated with expired PNEUMOVAX 23. Product quality complaint was not reported. The outcome of expired vaccine administered is unknown. Additional information has been requested.
Received dT on 11/14/02. On 11/16/02 felt ill and achy. Erythema around site increased and was seen at urgent care 11/17/02 and again at our office 11/18/02. Dx large local rxn.
fever, chills for 3 days, headache, fatigue, body aches. Cellulitis to administration site requiring MD visit and treatment with antibiotic.
Information has been received from a physician concerning a 34 year old female with no known drug allergies and a history of rheumatoid arthritis who on approx. 2/5/01 was vaccinated with MMRII. On 2/19/01, the pt was hospitalized to be treated for Guillain-Barre Syndrome. The physician had no further information. Additional information has been requested.
Light menstral spotting after the vaccination. This also happened after my second vaccination and lasted about a month.
1.5 hours after receiving injection - throat tightened, itching everywhere, significant itching of head and scalp, some rash on chest and abdomen
10x10 cms of Erythema on L outer deltoid.  warmth, cellulitis reaction, mild tender induration