chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, red large; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red, red large) and PRURITUS (Itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red, red large) and PRURITUS (Itchy). At the time of the report, ERYTHEMA (Red, red large) and PRURITUS (Itchy) 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 assessment.  No concomitant medications were reported.  Treatment information was not provided.
The pt received the first dose at age 13, and the second dose at age 17; no additional AE reported; Information has been received from a registered nurse, concerning a 17-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient was 13-year old when she received the first dose.  At the time of the report, on 16-OCT-2020, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), Lot # S023475, expiration date on 26-MAR-2022, 0.5 milliliter, (route of administration, and anatomical location was not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S023475; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 47 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: EL1283), on 20Sep2021 as dose 3 (booster), single (Lot number: EW0167) and on 30Mar2022 as dose 4 (booster), single (Lot number: FL9729) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: Other medication in 2 weeks product was Carvedilol. The patient received completed treatment for tongue cancer in January 2022 (radiation/chemotherapy).; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events and suspect drug(s) cannot be excluded.
Information has been received from a registered nurse (R.N) concerning a 9-year-old male with no pertinent medical history or allergies, who on 28-AUG-2006 was vaccinated subcutaneously with one dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Secondary suspect vaccination given on the same day included a dose of poliovirus vaccine (manufacturer unknown). On 28-AUG-2006 the patient experienced vomiting and diarrhea shortly after administration. Unspecified medical attention was sought. Subsequently, it was reported that the patient recovered from vomiting and diarrhea on 29-AUG-2006. No product quality complaint was involved. Additional information has been received on 19-OCT-2006 reporting that it was determined that the adverse experiences were unrelated tot he vaccine. It was also reported that the patient received a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and there were no signs or symptoms of any adverse reactions.
She developed fever for 1 day and rash on left deltoid that spread to her left forearm the next day. The rash continued to spread to left arm until 10/27/18. Still with residual rash on left forearm and upper arm on 10/29/18 when I saw her but resolving.
Vaccines administered 10/03/2002 am, by evening feeling warm to touch. Motrin given every 6-8 hrs, mother didn't take temp, feeling warm stopped 10/05/2002, but cries and is jumping in his sleep at night only. Referred for MD evaluation. I2 site OK
My daughter went to the clinic and received her flu vaccine on 10-21-19. It was given right by the bony prominence of her shoulder instead of in the deltoid muscle. She is having shoulder and arm pain. I have contacted the clinic about improper vaccine administration techniques as I am a nurse myself.
patient stated her head was pounding, she was disoriented Gave patient IM diphenhydramine then she left in the ambulance
I received my Pfizer booster shot in my right arm around 10:50 am on 12/10/21.  By the evening the area under my arm pit hurt a little, but I didn't think that much about it.  Unfortunately, the pain continued on 12/11 and got worse.  At times it hurt to move my arm.  I thought I strained a muscle .  I was tired that day and didn't actually look at my armpit in a mirror.  However, on 12/12/21 I noticed a very swollen area near my right arm pit.  It was about the size of a standard egg.  I immediately had my husband look at it and then I called my doctor's office.  I spoke with personal and she said several people had experienced similar side effects with the booster. She said it would most likely go away in a few days and I could apply compresses.  She also said I could go in for a visit, but I decided to see if it got worse.  Fortunately, the swelling went down within a few days.  A representative with the smartphone-based tool program said I should complete this form.
Itching, burning, swelling, and tenderness at injection site. Symptoms first noticed 12 hrs post injection.
Tired day after vaccine. In the afternoon had chills, fever 103, headache. Called hospital and increased cold fluids.
pt recvd single dose of vax on 17oct94 as a prophylaxis; pt died 20oct94; cause of death unk; pt was receiving many oth meds;
No adverse reactions noted at clinic visit 8/9/17. Patient found unresponsive; deceased on 8/11/17.
Patient had syncope episode after vaccine. Paramedics were called, patient was not transported to ER as Paramedics reported to patient and dad that vitals were stable. Provider encouraged dad to take patient to ER for further evaluation
8/31/2011 9:21:01 AM > seen for WCC and received shots on 8/29.  Mom states that he has been having "runny diarrhea stools" since yest.  Mom states that "stooling about q 2 hrs" - total of 7-8 all day yest, he did spit up yest - which is not normal for him & wasn't his normal "cooing" self . 100.7 (ax w/ degree added) yest.  voiding well.
Patient got the first dose at the age of 16; A spontaneous report was received from a pharmacist concerning a 16-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got the first dose at the age of 16.   The patient's medical history was not provided. Concomitant product use was not provided by the pharmacist.  On 06 Feb 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 010M20A) for prophylaxis of COVID-19 infection.   On 06 Feb 2021, the patient got the first dose at the age of 16 (Inappropriate age at vaccine administration). The patient was fine and no symptoms at all. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event patient got the first dose at the age of 16 was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate age at vaccine administration  for mRNA-1273, lot # 010M20Awith no associated AEs.
On 10/3, malaise, headache, fever. On 10/05 pt developed a rash on face, spread to rest of body. Slightly itchy. Seen in office 10/06 RX Zyrtec for itchy.
Information has been received from a nurse referring to a 50 year old patient of unknown gender. On an unknown date, the patient was seen on a recent annual visit. Varicella titers were drawn and titers were negative. Subsequently on 08-JAN-2016 the patient was inadvertently vaccinated with ZOSTAVAX (lot # reported as K020761, expiration date 31-OCT-2016), 0.65 ml, subcutaneously instead of the first dose of VARIVAX (Merck) (wrong vaccine administered). No adverse effects were reported. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "a little chills and tiredness". Additional information: Caller stated that she does not want to file a report because her daughter and granddaughter are younger, 50 and 22, and it was just one day - a little chills and tiredness. Caller stated younger people seem to have more of an issue because people have immune system build up over the years. Both her daughter and granddaughter had similar side effects, but her daughter got the Pfizer vaccine. It was a day after or two days after, mild with no concern. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Onset of symptoms:  fever 3/8.  Tachycardia, episode of sleepwalking, feeling, "loopy," shortness of breath 3/12, Much worse 3/13.  Walking pneumonia diagnosed 3/13, negative Covid.  Started 10 day course of Omnicef 300 b.i.d. on 3/15/2021.
Employee received Flu vaccine a developed cellulitis extending from injection point and spreading up and around left upper arm.
This spontaneous case, was initially received from a Pharmacist on 09-Oct-2017, concerning a male patient of an unspecified age. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: less than full 0.5 ml, batch number: 195239, expiry date: 31-May 2018, route of administration: intramuscular, anatomical location: left deltoid) (explicitly coded to Incomplete dose administered). It was reported that the patient felt a mist from the vaccine, as though he wasn't getting the full dose. The reporter was wondering if/when he should be revaccinated (explicitly coded to drug administration error). The reporter assessed the report as non-serious. Follow-up received on 17-oct-2017: Route of administration and anatomical location was updated to Intramuscular and left deltoid respectively. Narrative was amended accordingly. Non-significant case correction received 09-Oct-2017: Batch number (195239) was captured in the case form and narrative was amended accordingly.
pt recvd vax & more than 1mo p/vax pt c/o stress & fatigue;pt was found to have atrial fibrillation;MD stated that Engerix-B may have caused this condition;no treatment so far;sx cont
Fever--101 oral, severe body aches, chills, nausea, vomiting, malaise. 48 hours
I had all three shots(old one too) and still got shingles; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included SHINGLES VACCINE (old vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had all three shots (old one too) and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided. The follow-up would not be possible as no contact details were available.
HIVES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included ciclosporin, omalizumab, and prednisone.  On 20-JUL-2021, the patient experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.
boil on the left side of vagina; Abscess; Boil on the rectum; itching in the vaccinated arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Boil on the rectum), FURUNCLE (boil on the left side of vagina), ABSCESS (Abscess) and VACCINATION SITE PRURITUS (itching in the vaccinated arm (left arm)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Hypercholesteraemia. Concomitant products included GLIMEPIRIDE, VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and EZETIMIBE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching in the vaccinated arm (left arm)). On 09-Feb-2021, the patient experienced FURUNCLE (Boil on the rectum) and ABSCESS (Abscess). On 23-Feb-2021, the patient experienced FURUNCLE (boil on the left side of vagina). The patient was treated with DOXYCYCLINE for Abscess, at an unspecified dose and frequency. At the time of the report, FURUNCLE (Boil on the rectum), FURUNCLE (boil on the left side of vagina), ABSCESS (Abscess) and VACCINATION SITE PRURITUS (itching in the vaccinated arm (left arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
C/O arm pain beginning after injection and continuing even now 2 1/2 months later.  Pain has moved from injection site to just below elbow. Has taken meds but no improvment.  Will see orthopedic MD this week. Pain constant, worse at night.
Information has been received from a physician concerning a 6-month-old male who in July 2007, was vaccinated PO with the third 2.0 mL dose of Rotateq (Lot #654794/0776F). The physician reported that on 24-JUL-2007, the patient experienced diarrhea. Unspecified medical attention was sought. After almost two weeks of diarrhea, the patient recovered. Additional information has been requested.
Information has been received through the Merck pregnancy registry from a licensed practical nurse at an OB/GYN office concerning a 13 year old female with asthma, sickle cell trait, cardiac murmur and no known allergies who in March 2008, was vaccinated with the third dose of GARDASIL at her primary health care provider's office.  The dates of the previous 2 doses of GARDASIL were unknown.  The patient was pregnant.  On 03-JUL-2008 the patient was seen in the office for her first obstetric visit.  The patient's last menstrual period was unknown.  Ultrasound confirmed the estimated delivery date is 24-AUG-2008.  Based on this, the patient's last menstrual period was estimated to be 15-NOV-2007.  The patient was anemic in the pregnancy.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up telephone information was received which reported that on 23-APR-2007, the patient received the first dose of GARDASIL, on 25-JUN-2007 received the second dose and on 29-OCT-2007 the third dose of GARDASIL. The patient conceived around 16-NOV-2007. The patient was induced on approximately 11-Aug-2008 at 37 weeks, 4 days for PIH (pregnancy-induced hypertension) /Pre-eclampsia-like symptoms. The baby was a little over 5 lbs, she couldn't remember exactly. She saw the baby last week, who was fine and well and has been given up for adoption to a relative of an office staff member. According to the nurse, the patient, seems to be doing well too. She had no further information to report. No further information is available.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 20-AUG-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions at the physician's office. Subsequent to patient's inoculation, the patient was treated by a healthcare provide for shingles.  As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Swelling and Pain in right Achilles.  Pain n right knee. Could  not bend knee. Pain in right shoulder....undergoing physical therapy for shoulder pain and to have physical therapy for Achilles pain and swelling.
Adverse reaction to flu shot: Pt stated that she has had pain in deltoid area from September after getting her flu shot until now (Jan. 14th). When she rolls over onto her arm, it's painful, it's painful to lift her arm, and she sometimes feels it in her back. She said the whole area feels inflamed. I suggested she talk with her doctor about the adverse reaction.
Fever (102.4), chills, headache, arm ache, feeling nauseated throughout the remaining Sat evening (10:30) into Sunday. Still treating fever closely as mom will rush to ER if it gets to 103.
18hrs of solid sleep commenced after approx 7hr or wakefulness following vaccination.  Ive been diagnosed with mild  tinnitus for about a decade. I mostly ignore it.  However, about 48hr after shot#1 the volume began increasing... somewhere between 5 and 6 days after it was an 11 out of 10 on volume... so loud I couldn't find words to answer the phone. It comes and goes in waves, I have moments of tolerable racket, and hours of piercing ringing.   Caffeine has no apparent effect for me. I eat a healthy diet, and exercise a couple days per week. I know aspirin can make it worse, but Excedrin has been the only OTC that's ever cut headaches for me, in my life.  Right now I waver between crushing head plain, and undecipherable ringing. Any constant hum like a fan or fluorescent lights is like nails on a chaulkboard to me. Today is day 7,  after a short night, i woke up to crushing head pain, showered and went back to bed, the head pain (without Excedrine) has subsided, giving way to fierce high pitched ringing.   My neck muscles are tired... i just realized Ive been holing the "shudder" pose, shoulders raised to my ears, like one does to protect from a sudden loud noise.