chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the author of a literature, title as stated below. The patient was a 3-year-old girl who presented at 4 months of age with annular migratory erythema and persistent urticaria. Additional clinical manifestations included atopic dermatitis with alopecia totalis by 18 months, angioedema to avocado, almonds, and wasp sting, 1- to 2-day episodes of abdominal distension and diarrhea every 6 to 8 weeks beginning at age 18 months with development of dysphagia and odynophagia despite normal upper and lower gastrointestinal endoscopies. Infections were limited to pneumonia at age 1 year. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis. On an unknown date (10 days after receiving the vaccine), the patient experienced a measles-like illness. The outcome of measles was unknown. The reporter considered measles to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). Upon internal review, measles-like illness was determined to be medically significant. Additional information has been requested.
Angioedema; Hives all over body; crazy itching; skin peeling; difficulty swelling; red spots around injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21A, 033B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), URTICARIA (Hives all over body), PRURITUS (crazy itching), SKIN EXFOLIATION (skin peeling), SWELLING (difficulty swelling) and VACCINATION SITE RASH (red spots around injection site). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Angioedema), URTICARIA (Hives all over body), PRURITUS (crazy itching), SKIN EXFOLIATION (skin peeling) and VACCINATION SITE RASH (red spots around injection site) outcome was unknown and SWELLING (difficulty swelling) had resolved.            Concomitant medication was not reported. No pre-existing condition or allergy was reported.  A week later after receiving booster dose patient experienced AE. Patient was on Prednisone and taking Benadryl which did not helped. Patient experienced difficulty swelling but it improved later.  Company comment:  This case concerns a male patient with no reported medical history who experienced serious unexpected event of angioedema, that occurred after the booster dose of the mRNA-1273. The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 3rd dose however, the reporter noted that the patient experienced ''similar symptoms'' after the 2nd dose but they were not specified.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-460663 (Patient Link).; Sender's Comments: This case concerns a male patient with no reported medical history who experienced serious unexpected event of angioedema, that occurred after the booster dose of the mRNA-1273. The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 3rd dose however, the reporter noted that the patient experienced ''similar symptoms'' after the 2nd dose but they were not specified.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
She almost passed away; She got depressed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) 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: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "She almost passed away"; DEPRESSION (non-serious), outcome "unknown", described as "She got depressed". The consumer reported that there was a death in family, and she got depressed. The patient never took any vaccine before. Reporter further stated, she took this vaccine and was hospitalized for a week. She almost passed away.  The reporter considered "she got depressed" not related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the event of Depression is assessed as unrelated to bnt162b2 and more likely due to death in family as reported in narrative .
Day after vaccination-- At 3:45:Whole-body fatigue/soreness. Before 4pm, chills. At around 5:30pm: Fever (101.2-102.6F).   Drank plenty of fluids and stayed in bed with multiple blankets for over 14 hours - in and out of sleep (mostly sleep).
Pink spotting; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Pink spotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Intrauterine contraception (The patient said that has an IUD and that never had any vaginal bleeding. ) in 2017.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced VAGINAL HAEMORRHAGE (Pink spotting). At the time of the report, VAGINAL HAEMORRHAGE (Pink spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported by reporter. Treatment information was not reported.
Pt recvd vax & 3 days later tested ps for HBSAG; pt was tested because nurse got needlestick from pt;
He had a low grade fever for the first couple of days and was very fussy when he was normally a very laid back baby. He stopped babbling and stopped saying Muma and Dada, which he had been for a couple of months. He stopped looking us in the eye, and then started banging his hand on the high chair for an hour to two hours if we let him. He was no longer interested in his rattles and teethers and started rocking back and forth for hours. We thought it might be a long term problem but were assured by the clinic staff that those are not symptoms of a problem, but we NEVER had those symptoms before these last vaccines. He slowly came out of it, as we refused any more vaccinations, and kept talking to him. We will no longer vaccinate for fear of a more long term reaction.
I got shingles as a side effect of the vaccine. It lasted about a week and a half with treatment.
I broke out in small bumps first on my hands, then face, then neck and torso. It itched a bit.
PT STATES APPROX 1 HR AFTER RECEIVING VACCINATION, SHE EXPERIENCED PAIN IN UPPER LT ARM THAT, WITHIN THE NEXT FEW HOURS, WENT UP THE BACK OF HER NECK AND THEN INTO HER RT ARM.  SAYS RT ARM WAS MORE UNCOMFORTABLE THAN LT.  STATES RT SIDE AND RT LOWER BACK ALSO UNCOMFORTABLE THAT NIGHT, SIMILAR TO DISCOMFORT SHE EXPERIENCED LAST YEAR WHICH SHE BLAMES ON EATING E. COLI TAINTED PEANUT BUTTER (NO MEDICAL TX SOUGHT OR OFFICIAL DX OF E. COLI).  C/O ACHINESS ALL OVER.  DENIES FEVER, WEAKNESS, OR LOSS OF SENSATION.  ALL S/S SUBSIDED IN LESS THAN 24 HOURS.  NO MEDICAL TX SOUGHT.  REPORTS SHE HAS GOT FLU SHOT ANNUALLY X SEVERAL YEARS WITHOUT REACTION.  SAYS SHE DID NOT EVEN FEEL THE SHOT WHEN NURSE ADMINISTERED IT.
red welt of approximately 6 cm, at the injection site; at the injection site and it hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (red welt of approximately 6 cm, at the injection site) and VACCINATION SITE PAIN (at the injection site and it hurts a lot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Blood pressure.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (red welt of approximately 6 cm, at the injection site) and VACCINATION SITE PAIN (at the injection site and it hurts a lot). At the time of the report, VACCINATION SITE URTICARIA (red welt of approximately 6 cm, at the injection site) and VACCINATION SITE PAIN (at the injection site and it hurts a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown   This case was linked to MOD21-076388 (E2B Linked Report).; Sender's Comments:  MOD21-076388:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "gluten allergy" (unspecified if ongoing); "celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 01Jun2022, for Covid-19 Immunization; bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), administration date: 21Sep2022, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 30Oct2023 to 04Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362775 same patient, different drug, different event;
Pt. brought to our attention that she was diagnosed w/ Cellulitis according to her MD office. Rash/ swelling, other misc. symptoms.
First dose: within a few minutes heart racing, felt faint & strange, very cold teeth chattering, dry mouth.
Information has been received from a registered nurse concerning a 9 year old female who on 05-OCT-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck), and a second dose on 08 FEB 2007. There was no concomitant medication. Approximately one year after the second dose of varicella virus vaccine live (Oka/Merck), on 06-FEB-2008, the patient developed 8-10 chickenpox lesions, on her chest and 3-4 on her back. The lesions were described as small and raised with yellow fluid. It was also reported that the patient developed 8-10 watery pimples on her back and a couple on her chest on 05 FEB 2008. The patient had some itching, and was afebrile, with a normal appetite and activity. The patient was seen at the doctors office at 11:45 (date unspecified), and chickenpox was confirmed. Unspecified medical attention was sought. The lot number was not available. There was no product quality complaint. At the time of reporting the patient was recovered.  Additional information is not expected.
Achy; sore arm; low grade fever; On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients; Received booster from expired vial; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever), UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Influenza (Manufacturer is Sanofi Pasteur.  Lot number: U77383JA route given has intramuscular and anatomical site is left arm.) on 11-Oct-2021. Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Sleep apnea and Impaired fasting glucose.    On 29-Oct-2021 at 12:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial). On an unknown date, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever). On 29-Oct-2021, UNDERDOSE (On 29Oct2021 they administered 15 Moderna COVID-19 booster half doses to patients) and EXPIRED PRODUCT ADMINISTERED (Received booster from expired vial) had resolved. At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (sore arm) and PYREXIA (low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment medications are provided.   This case was linked to MOD-2021-370301 (Patient Link).
Pt vaccinated with Hepatitis B 24JAN90, Feb90 developed pain after sitting, primarily in base of coccyx which still persists.  2nd vax given 4MAR90 on 5APR90 worse exacerbation of ms ever experienced. Given Prednisone. See WORM for details.
Received DTaP, IPV in left arm 8/5/09. Was brought to office on 8/7/09, noted redness 10 cmx8 cm in left upper arm with warmth and tenderness in area. Diagnosed with early cellulitis started on KEFLEX T.I.D x 7 days; advised to treat area with ice.
Had normal symptoms such as aches, headache, fever BUT my adverse ( or what I considered adverse) was swelling. I had to even take off my wedding ring which I never do.  It lasted about 2 days . I took Benadryl and Tylenol during that time.
Tiny vesicle rash on both arms. Then some on hands. Area around lesions pink. No itch.
Information has been received from a physician via a company representative concerning to an 18 year old female patient. The patient had not medical history, drug reactions nor concomitant medications. On an unknown date, the patient completed the 3 dose GARDASIL (lot numbers and expiration date not reported), intramuscular vaccination series for prophylaxis. On an unknown date, after completion of GARDASIL, the patient was diagnosed with leukemia. In 2013, the patient completed an unspecified chemotherapy regimen and recovered from leukemia. No lab diagnostic test were performed. The reporter considered leukemia to be life threatening. Upon internal review, leukemia was considered medically significant.
Patient stated that she had a little bit of tingling in her tongue at 11:30AM. She stated that she did not report due to thinking that it was not a big deal. She left the vaccine clinic and went home. Patient's condition became worse. At 18:00 PM, she had lip, eye and facial drooping on the left side. She stated that the left side of her tongue is now slightly swollen. She also stated that her left arm was swollen at the injection site. She denied any trouble breathing or swallowing. Spoke to caller at Poision Control. Patient advised to get checked out in the ER setting to rule out a stroke. Patient refused. Explained risks of not going to ER to patient.
Case number PHEH2014US020669, is an initial spontaneous report received from a pharmacist on 10 OCT 2014. This report refers to a 25 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413301) intramuscular on 10 OCT 2014. Pharmacist reported that unopened and opened multi dose vials of FLUVIRIN reached 33-35.9 F overnight and this is the second temperature excursion. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided.
Already received 1st and 2nd dose of Moderna. No issues with either. Received booster shot. Extreme sweating, dizzy, not coherent. Went to ER. Son took him. Received fluids. Thought he was dehydrated. EKG done. Came back normal. All vital signs were normal, except sugar levels.
numbness in fingers on left hand, primarily thumb and pinky; felt a little light headed / "woozy" when initially walking after sitting 20 min after shot.
Fever 103 - seizure. ER visit 11/14/11. Left ear red. 11/18/11 physician visit. Follow up both ears inflamed.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. ON 16-NOV-016 the patients were vaccinated with improperly stored dose of ROTATEQ (lot # L028645 and expiry date: 25-MAY-2017, lot # M031802 and expiry date: 09-NOV-2017, lot# M007301 and 19-NOV-201, lot # M004885 and expiry date: 23-OCT-2017). The vaccine was exposed to a temperature of 53 Fahrenheit for 1 hour and 45 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
rash; blister; This case was reported by a nurse via sales rep and described the occurrence of rash peripheral in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) and (batch number 44N5L, expiry date unknown) for prophylaxis.   Co-suspect products included bupropion hydrochloride (Wellbutrin) unknown for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 4th June 2019, the patient started Wellbutrin at an unknown dose and frequency. On 6th June 2019, 2 days after receiving Shingrix and Wellbutrin, the patient experienced rash peripheral and blister. The patient was treated with steroids nos (Steroid Injection) and steroids nos (Oral Steroids). Wellbutrin was discontinued. On an unknown date, the outcome of the rash peripheral and blister were unknown.   It was unknown if the reporter considered the rash peripheral and blister to be related to Shingrix and Wellbutrin.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced rash and blisters on trunk and extremities. The clinic advised to the patient to discontinue in case reaction to that medicine. On 12th June 2019, the patient came back to office with complaint of rash worsening. The patient refered to dermatologist. The patient appointment was on 13th June 2019.
Rash; This spontaneous case was received on 08-Jan-2021 from physician via Med Communications (reference number: SEQW21-00113) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.   On 25-Oct-2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, indication and anatomical location: not reported). The batch number reported was 252659 and expiry date was 31-May-2019.  On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed rash.  The outcome of the event was not reported.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  This case is linked with cases 202100472 and 202100473 (the same patient).  Company comment: The event of 'rash' is considered as related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'rash' is considered as related to Flucelvax Quadrivalent.
Eye hemorrhage left eye 3-15-21 Eye hemorrhage right eye  3-27-21 Right eye much worst then left eye. Pressure on eye and itching. Still dealing with issue on right eye.
Became hot; indurated (left) shoulder; Really swollen (left) shoulder; Fever; Chills/Rigors; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Jan-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Jan-2021, FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors) had resolved.        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.   Other treatment medications include Motrin. All listed adverse events developed within 12 hours of vaccinations and had resolved within 12 hours of taking Motrin and Tylenol. No concomitant medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Injection site pain and some swelling   pain in muscle has spread and continues until today 12/18/22