chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines were administered after temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HAV (Havrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2021, the patient received Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Havrix, Menveo, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Havrix, Menveo, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, had a freezing temperature excursion for their vaccines back in September 2021. These vaccines were administered after this excursion but they had no details at the moment about the patients or the vaccines. The reporter consented to follow up.
7 days post vaccine, developed a fever of 104, difficulty swallowing and generalized rash over the upper body. Seen in Emergency Room at  without a dx.
I noticed a light rash anywhere there was medal on my body, the next day there was heat to the rash, swollen and it had a very bad itch.
On the day of the vaccine, April 29, which I got in the morning, I experienced headache, malaise, pain in arm.  On the sixth day after the vaccine, May 5,  my left eyelid began to swell and continued to worsen each day.  The swelling was in the eyelid and above the eyelid.  The swelling was the most extreme first thing in the morning.  My eye itself was unaffected.  The swelling is extreme enough to interfere with vision and is noticeable to anyone looking at me from at least six feet away.  On the third day of swelling, I noticed that the area about a third of an inch under my left eye had begun to swell.  This swelling under the eye did not physically connect to the swelling of the eyelid and area above the eyelid.  On May 7, I went to see the doctor first thing in the morning.  She said it was an infection in the eyelid and prescribed an antibiotic.  I took an antibiotic right away and then again in the evening.  On May 8, the same day I am submitting this report, my eye was worse.  The swelling first thing in the  morning was the worst it has been and now the eye had some sort of "gunk" coming out - not badly, just overnight but this was a new symptom.  I took another antibiotic but now think it might not be helpful.  Also on May 8, the area around the injection site was inflamed and red and slightly itchy.  I put hydrocortisone cream on it.
Redness (4 inch diameter), swelling, pain, muscle ache, elevated temperature around injection site. Pt was given KEFLEX 500mg -> DC due side effects. MD changed to BACTRIM DS.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 22-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular (strength, dose, lot # and expiration date were not provided). On 30-DEC-2015, the patient was vaccinated with the second dose of GARDASIL 9 intramuscular (strength, dose, lot # and expiration date were not provided). On 14-MAR-2016, the patient was vaccinated with the third dose of GARDASIL 9 intramuscular (strength, dose, lot # and expiration date were not provided). No known adverse effects were reported. The dates of vaccinations were reconfirmed with the reporter. Additional information has been requested.
On 10/09/2021 I experienced sharp R arm pain while sedentary and sitting on my sofa which became increasingly excruciating requiring me to go the ED and found to have an unprovoked R shoulder dislocation.
Approximately 1 week post-vax the patient complained of tiredness and a headache. The patient's mother states he felt feverish, but did not check his temperature. The patient's mother also states that his skin has a yellowish tinge. The patient was seen by 2 different doctors, one of which felt the symptoms were vaccine related. The parents chose to not have patient complete the Hepatitis A or B series.
Coughing; Sore and stuff lungs; Entire body aches; Entire body shivers; Exhaustion; Dizzy; Pain in groin when urinating; Pain in groin when urinating; Increased pain in shoulder from previous impairment; Increased pain in head from previous impairment; Now every time I blow or clean my nose there is blood in it; Sore and stuff lungs; This is a spontaneous report received from a contactable consumer (patient) or other non hcp. A 31-years-old male patient received bnt162b2 (BNT162B2, Formulations: solution for injection), via an unspecified route of administration on 25May2021 11:45 (at the age of 31-years-old) (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. The patient previously took compazine [prochlorperazine edisylate] and experienced drug allergy. Prior to the vaccination, the patient was not 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 26May2021 at 04:00, the patient experienced coughing, sore and stuff lungs, entire body aches and shivers, exhaustion, dizzy, pain in groin when urinated, increased pain in shoulder and head from previous impairment. Most of the events subsided within 24 hours except cough, achey lungs and every time, when the patient blow or clean the nose there is blood in it. No therapeutic measures were taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of events coughing, sore and stuff lungs, now every time i blow or clean my nose there is blood in it was resolving and other events was resolved on 27May2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
The lymph nodes in the left side of my neck became enlarged and painful for about 1.5 weeks after the injection, the pain resolved within a couple of weeks and the swelling reduced significantly aby week 3.  The lymph nodes on the left side of my neck are still slightly larger and non-painful even now 6+ months after the injection.  It is unknown if they were slightly enlarged prior because the pain is what drew attention and made them noticeable.
pt recvd 2nd dose of vax & on 5FEB93 devel generalized hives; pt was treated w/unspecified antihistamines & recovered;
pt recv vax & devel severe tenderness, redness & warm @ inj site;MD dx cellulitis & prescribed an ATB;
noticed the nausea significantly today; had ice cream yesterday and had upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (had ice cream yesterday and had upset stomach) and NAUSEA (noticed the nausea significantly today) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A214) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (had ice cream yesterday and had upset stomach). On 03-Mar-2021, the patient experienced NAUSEA (noticed the nausea significantly today). At the time of the report, ABDOMINAL DISCOMFORT (had ice cream yesterday and had upset stomach) and NAUSEA (noticed the nausea significantly today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's medical history included HIV and underlying conditions.  Treatment medications was not provided by the reporter
Midnight--chills, nausea, diarrhea for 2 hours. In Morning--headache, fever.
Tinnitus in both ears/ not improved or worse as of 04/06/22 Increase in thyroid tsh numbers after being stable for 10 years with no increase
After getting 2 doses AND a booster, I was admitted to the hospital on May 1. 2022 with Acute Appendicitis & a Pulmonary Embolism (blood clot). 2nd dose was 3/30/21 and booster was 12/16/21.
Client has arthritis. Pain in LD where shot was given up side of neck on L side. Having more pain than usual. Has not seen PCP. Aches in muscles as well as his joints.
Injection site red and shoulder VERY sore when moving the arm. Around 10:00 PM I developed chills that lasted most of the night, and all day Sunday 12/6 had muscle aches, fatigue, and alternated chills and fever (100-102.3).
She got the vaccine, she is special needs, she was vomiting, throwing up, high fever (not taken), high blood pressure 120/90, chills, a lot of pain.   She is still having the same reactions, sleeping a lot, upset stomach.  Her mother gave her a Tylenol as she got her  period as well, but nothing other than that.  It is hard to give her stuff as she has kidney disease, also has an appointment to see an Oncologist next week.   Mother called the PCP but they do not have any openings to be seen.
Information has been received from a physician concerning an 18 year old female with no medical history who on 30-DEC-2008 was vaccinated with the third 0.5 ml dose of GARDASIL vaccine (lot# unspecified). There was no concomitant medication. On 04-JAN-2009 the patient experienced hives all over the body, itching and burning. The patient recovered on 13-JAN-2009. The first  dose was administered on 19-JUN-2008 and second dose on 19-AUG-2009. The patient sought unspecified medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/13/2009. Follow up information was received from a registered nurse (R.N.) concerning the 18 year old female patient with seasonal allergies who on 30-DEC-2008 at 2:30 PM was vaccinated in the left deltoid with her third dose of GARDASIL vaccine (lot# 661530/0575x). There was no illness at the time of vaccination and adverse event following prior vaccination. On 04-JAN-2009 at 3:00 AM the patient experienced hives on the whole body which burned and were pruritus. The patient saw an allergist who felt it was related to GARDASIL vaccine. Hives lasted through 13-JAN-2009 and finally disappeared. The patient was recovered on 13-JAN-2009. No relelvant diagnostic tests or laboratory data was collected. The patient sought unspecified medical attention. No further information is available.
Fever; chills; severe muscle pains; runny nose; severe migraine; fatigue; sore throat; burning; insomnia; coughing; burning eyes; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 16:30 (Lot number: EW0179) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe muscle pains"; RHINORRHOEA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "runny nose"; MIGRAINE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "severe migraine"; FATIGUE (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "fatigue"; OROPHARYNGEAL PAIN (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "sore throat"; BURNING SENSATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning"; INSOMNIA (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "insomnia"; COUGH (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "coughing"; EYE IRRITATION (non-serious) with onset 04May2021 01:00, outcome "not recovered", described as "burning eyes". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, rhinorrhoea, migraine, fatigue, oropharyngeal pain, burning sensation, insomnia, cough, eye irritation.  Additional information: Most recent dose details: Product= COVID 19, brand= Pfizer, lot number=EW0170, administration date=24 May2021, administration time= 04:30 PM, dose number=2, vaccine location= Right arm. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: Unknown. If Covid tested post vaccination: Unknown.  Follow-up attempts are completed. No further information is expected.
Severe body aches, headache started about 2am, about 10 hours after administration.   Fatigue.  Fever started about 24 hours after administration, highest reading 101.3.  All resolved about 48 hours after administration.
Initial non-serious case received from a health care professional on 09 October 2009. A female patient (age not reported) had a possible reaction (not otherwise specified) to FLUZONE (lot number U1881AA) in 2005. No further information was provided. Documents held by sender: None.
Expired booster dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter wanted to know what if a patient received a booster dose from an expired vial that was out of the fridge for 20 hours and asked if the vaccine would still be effective.  No treatment information was provided.
Patient may have received a deteriorated vaccine beyond recommended use and thus overly diluted beyond manufacturer recommended dilution because it was thought to have been a new vial.
Pt recvd vax & the same day exp dragging lt leg & semi paralysis on lt side; movement on lt side better but still dragging leg; pt is currently seeing a MD for treatment & on workmans compensation;
Racing heart.  Painful urination. Backache. Headache. Chills. Fever   Lethargy
Information has been received from a 77 year old female consumer with no allergies and no pertinent medical history, who in August 2011 was administered the ZOSTAVAX "one shot once" (lot number and route of administration not provided) as a vaccination against shingles. Concomitant medications included: atorvastatin, levothyroxine, and citalopram. In approximately 2011 (reported as "a few months after she got the vaccination"), she got the shingles. The patient called her doctor when she woke up with the rash and the physician told her he needed to see her immediately. The patient stated she assumed the physician did a test and did not just look at her and say she had shingles, but she didn't remember what tests were done (no results were provided). She was prescribed gabapentin (four 300 mg pills every 4 hours). The patient has continued therapy with gabapentin and stated that if she doesn't take the gabapentin, "my whole body starts to scream." The patient stated she was miserable and in constant pain. The outcome of the shingles was reported as not recovered. Additional information has been requested.
I felt light headedness, some mild nausea and I had been diagnosed with ventricular tachycardia. I am also at the tale end of covid. The symptoms sometimes last for about 20 minutes some last for a couple hours. I am still experiencing these symptoms.
Very serious reaction to the first / dose / she was sick; Very serious reaction to the first / dose / she was / with flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (on an unknown dates, patient had shingles twice in her lifetime when she was younger). Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received live shingles vaccine on an uknown date and did not have any side effects). Concurrent medical conditions included drug hypersensitivity and chemical sensitivity. Concomitant products included benadryl (nos) (Benadryl).   In August 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced sickness (serious criteria other: Serious as per reporter ) and influenza-like symptoms (serious criteria other: Serious as per reporter). Shingrix was discontinued. On an unknown date, the outcome of the sickness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient had both the shingles incidents before she received the Shingrix vaccine. The patient received the live shingles vaccine before she had ever received the first Shingrix dose. The patient reported that she has had a medication/chemical sensitivity condition before she received the first Shingrix dose. It was not a full-blown allergic reaction, but it did have an effect on her. She expanded on this sensitivity by stating that she had a delayed reaction to allergy shots which include flu-like symptoms in the morning and which used to get worse at night.  The patient stated that this sick feeling with flu-like symptoms did not start right after the first Shingrix dose but that it was a delayed reaction. She did not have any anaphylactic shock or hives.  The patient never received her 2nd Shingrix dose because she had a very serious reaction to the 1st dose.  The patient further described this reaction by stating that she was sick with flu-like symptoms for three weeks.  The patient declined to provide her date of birth or her full address and was unable to provide the dosage, lot number or expiration date of the Shingrix dose she received, and the full address, email address, or fax number of her physician.  The reporter consented to follow up.
Child reported to parent on Saturday, 11/15/2008, two days after immunization, a sore left arm, with redness, swelling in uupper arm.  Seen by this nurse on 11/18/2006 with redness, induration, and tenderness of upper left arm size of palm (3x4 inches).  Child wss alert, active, "out for dinner" with parents.   Mother reports that in one week child was showing now symptoms.
14-year-old patient was given the menactra injection today with no reported adverse event; Initial information received on 13-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 14-year-old female patient (last menstrual period: 12-Apr-2022) who was given the meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] today with no reported adverse event.      The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hpv Vaccine VLP RL1 4V (Yeast) (Gardasil) for Prophylactic vaccination.   On 25-Apr-2019, the patient received Dose-1 for meningococcal a-c-y-w135 (d conj) vaccine via intramuscular route in the left deltoid once (Strength: standard, frequency: once) (dose, lot/batch number and expiry date: unknown) and on 13-Apr-2022 received Dose:2 at a dose of 0.5 mL total via intramuscular route in the left deltoid total  (Strength: standard, frequency: once) (lot: U7211AB, expiry date: 14-Mar-2023) for immunization.  On 13-Apr-2022 the patient received menactra injection with no reported adverse event (Product administered to patient of inappropriate age) (Latency was 2 years 11 months 19 days from Dose:1 and same day from Dose:2) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.   It was reported that "Educator from a MD office called to advise that a 14-year-old patient was given the menactra injection today. The patient was given the first injection of menactra three years ago on 25-Apr-2019. Caller asked if the dose needs to be repeated at age 16. This was reported as a potential adverse event because of use against local labelling (underage for booster)."    Action taken was not applicable.  Corrective treatment was not reported  At time of reporting, the outcome was Unknown.     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 the guidelines. 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.
Arthralgia, skin rash, nausea, vomiting and chills; Injection site reaction (warm, red, tender).