chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 4-year-old female patient who received INFANRIX (batch number AC14B157CA, expiry date 13th September 2014. On 11 November 2014, the patient received INFANTIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Patient received expired dose vaccine.
Chills, fever, body aches,  raised red rash around injection site (about 2" in height and 6-7" wide that becomes itchy on the 3rd day of having it. Painful when touched on injection site and warm to the touch on rash)
opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me; could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me) and LIMB DISCOMFORT (could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work) 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 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PAIN IN EXTREMITY (opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me) and LIMB DISCOMFORT (could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work). At the time of the report, PAIN IN EXTREMITY (opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me) and LIMB DISCOMFORT (could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
2nd round of (Shingles). And I've been vaccinated/Suspected vaccination failure; Recovering from (Shingles) second round; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she had been vaccinated and he/she was recovering from his/her second round of shingles. The patient stated that you do not want this. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Several years ago developed wrist pain 3-4 days after flu vaccine.  Had a couple of years w/ no reaction.  Last year developed wrist, ankle, elbow pains w/o fever, malaise or other flu like symptoms, aches persisted for 2-4 days.  This year again had no constitutional symptoms except aches in wrist (particularly L), elbows and ankles, and aches lasted longer then 2-4 days but were treated well w/ anti inflam meds.  vaccinated as part of employee health program at the hospital.
severe h/a, body aches, red, swollen shoulder w/temp of 3 1/2 days;
Redness, pain, and significant swelling at injection site. Systemic swelling with 15lbs fluid gain. Bloody stool. Fever persisting >48 hours.
Information has been received from a consumer concerning her daughter who on 02-NOV-2006 was vaccinated with her first dose of Gardasil. There was no concomitant medication. The patient's mother indicated that the shot her daughter received was extremely painful. She did not say if her daughter experienced the same pain when she got the second shot on 22-APR-2007 which was more than two months later. No product quality complaint was involved. Additional information has been requested.
Mom noticed bruising on left arm at about 7 pm yesterday. As per child warm to touch. Had fever of 101.3 on Wednesday 2-3 pm at school throughout the night.
painful urination; urinary incontinence; pain at the injection site / still having tenderness at the injection site currently; I am tired; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of DYSURIA (painful urination), URINARY INCONTINENCE (urinary incontinence), VACCINATION SITE PAIN (pain at the injection site / still having tenderness at the injection site currently) and FATIGUE (I am tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced DYSURIA (painful urination), URINARY INCONTINENCE (urinary incontinence), VACCINATION SITE PAIN (pain at the injection site / still having tenderness at the injection site currently) and FATIGUE (I am tired). At the time of the report, DYSURIA (painful urination), URINARY INCONTINENCE (urinary incontinence), VACCINATION SITE PAIN (pain at the injection site / still having tenderness at the injection site currently) and FATIGUE (I am tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications information was not reported. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-Significant follow up appended
fever; The patient had chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and CHILLS (The patient had chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had continuous pain in her esophagus.  The patient's past medical history included Pounding in head in November 2020 and Fever (felt like she had a fever however her temperature was normal). Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Anxiety.    On 30-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (The patient had chills). At the time of the report, PYREXIA (fever) and CHILLS (The patient had chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: Positive. In November 2021, SARS-CoV-2 test: Positive. In January 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. It was reported that patient received Pfizer for primary series. Patient received the vaccine in her right arm shoulder deltoid. No treatment medication reported by reporter.   Reporter did not allow further contact
Local site reaction, erythema, fever, swelling at injection site. Dr gave patient 8 mg Dexamethasone, antihistamines and antibiotic.
Extreme pain at the injection site; Difficulty raising arm  and lifting objects.; Sirva; Vaccine administered at inappropriate site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 26-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number E975Y, expiry date 25th June 2019) for prophylaxis.   On 17th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season. On 17th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain, injected limb mobility decreased, shoulder injury related to vaccine administration and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were recovering/resolving and the outcome of the shoulder injury related to vaccine administration was unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and shoulder injury related to vaccine administration to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported extreme pain at the injection site which remain till the time of reporting. The patient has difficulty raising his arm and lifting objects. The patient was administered the vaccine the same day and was given by the same nurse. The reporter suspects the vaccine was administered too high on the deltoid resulting in symptoms that occur with sirva, that was the shoulder injury which was related to vaccine administration. The reporter consented to follow up. This case was one of the 9 case reported by the same reporter.
Breakthrough case admission after 3 vaccines  Moderna 2/9/21 Lot# 007M20A;  Moderna 3/11/21 Lot# 023M20A;  Moderna 11/22/21 Lot# 93990
approx 5min p/inj pt became red, edematous & several vesicles appeared;
This case was reported by a physician and described the occurrence of hives in a 70-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis. The subject has no history of allergies and does not consume alcohol or tobacco. On 17 August 2005, the subject received a dose of Twinrix (dose number and lot number not provided). At an unspecified time after vaccination with Twinrix, on 17 August 2005, the subject experienced hives, diarrhea, chills, wheezing, and vomiting. The subject went to the emergency room on 18 August 2005 and received unspecified treatment for the events. The events resolved on 18 August 2005. The physician considered the events to possibly be related to vaccination with Twinrix.
Information has been received from a 71-year-old female with a history of anal carcinoma in 1990, a history of "broken bones" and no known allergies who on 06-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 658605/1089U). Concomitant therapy included alendronate sodium (MSD), calcium (unspecified) and multi-vitamins (unspecified). On 06-NOV-2007 the patient experienced "soreness on my right arm where I had ZOSTAVAX (Oka/Merck)". "It has now moved into the shoulder and sometimes up to my neck". "It is hard for me to reach". "It is not excruciating, and I am not on any medications for it". The patient sought medical attention via a phone call to the pharmacist. No diagnostic labs were performed. At the time of reporting the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Left Lateral thigh. With Extensive red hot indurated skin, slightly purple in center but NONTENDER. Treatment - cool compress, ibuprophen *Reaction to DTAP
vial placed into refrigerator 11/01/2021. used beyond 31 days.
One day post vax, pt's leg was red. Two days post vax, pt's leg started swelling and became warm to touch. Three days post vax, pt diagnosed with cellulitis and given Keflex.
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines which underwent a temperature excursion in the freezer were viable).    No concomitant medications were provided.  Temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. The patient received the booster dose.  No treatment medications were provided.
Actually caught Shingles 9 days after being vaccinated for Shingles.  Facial Rash, Ear Rash,  Mouth Rash.  Shooting pain.
Sore throat, sensation of swelling on tongue and throat, scratchy eyes and became mucous, and chills - no fever - took Benadryl at 10:00pm and next morning no symptoms.
I had previously had COVID during the first week of January 2021 and recovered.  During that time, I had lost about 80% of my sense of smell which I still have not regained.  But at time, I never has any loss of taste.  However, immediately after receiving the vaccination I noticed an altered sense of taste.  I would describe it as almost all of my sense of taste is gone but actually everything I eat has a rancid taste.  Some foods cause the bad taste more than others.  Some foods I used to love now bring out the worst after taste such as peanut butter.  The more bland the food usually results in less "bad" taste.  But overall I can't really taste the actual taste of any food.  And to make it worse, before when I couldn?t smell, it was bearable, but now most of the same foods that taste bad also have the same rancid odor I smell also.  So to summarize, I now can?t really taste or smell anything except for the rancid taste and odor the food has.  It is amazingly challenging as people don?t understand when I describe it to them that almost all food smells and tastes bad since that isn?t just loss of taste.  As of today, it has now been over 3 weeks since my vaccination and I don't see any improvement yet.  I did recently (about 2 week ago) have full lab work done as part of an annual checkup and all results came back normal.  So now I have reduced smell from COVID and loss of taste from the vaccine.  I don?t see any other explanation than that the vaccine caused this new phenomenon.  It could has something to do with the fact that I previously had COVID.  I am hesitant to even go to the doctor since I am certain they will have no idea what to do.
Itchy; Odd sensation; Breast pain; Twingy; Armpit pain; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain), PAIN (Twingy) and AXILLARY PAIN (Armpit pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disorder. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Cardiovascular disorder.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain) and PAIN (Twingy). 07-Feb-2021, the patient experienced AXILLARY PAIN (Armpit pain). At the time of the report, PRURITUS (Itchy), ANXIETY (Odd sensation), BREAST PAIN (Breast pain), PAIN (Twingy) and AXILLARY PAIN (Armpit pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (normal) No abnormalities found.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Patient experienced the same symptoms as of the first dose," itchy odd sensation" under her right armpit and the right side of her breast. Nurse reports symptoms are still present as of 12 May 2021 and that the pain "comes and goes". She reported that the pain was worse on the left side than the right side.   This case was linked to INC.-MOD-2021-123238 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-123238:dose 1
pt stated the morning she after she got the 2nd dose of covid vax she was light headed.  She laid down later that night, when she got up she was dizzy and very light headed and she fell.  Her husband helped her back to bed.  She got up next morning and was still dizzy and light headed but she also felt weak in the chest, maybe SOB.  These symptoms would come and go all day.  Today 3/1/2021 she has tightness in chest along w/ a cough.  Pt will see her PCP later today on 3/1/2021.
Diabetic foot infection - Patient was admitted 3 days ago for gas gangrene in the right foot and was taken directly to the operating room for surgery where Irrigation and debridement and partial first ray amputation was performed. Patient was kept in house until cultures and sensitivity came back and patient was then discharged home on appropriate antibiotics per cultures. Medical management was handled by the hospitalist team while the patient was in house. Patient was discharged home with oral antibiotics and instructions to remain non-weight bearing on the right foot. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
11 y/o pt received first dose 1 of Pfizer vaccine.  Pt was observed. No rxn noted.
Autoimmune disorder; Bone pain; Food allergy; Lung disorder; Lethargic; Fatigue; Penicillin allergy; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disorder) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and PENICILLIN NOS for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and PENICILLIN NOS (unknown route) at an unspecified dose. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disorder) (seriousness criterion medically significant), BONE PAIN (Bone pain), FOOD ALLERGY (Food allergy), LUNG DISORDER (Lung disorder), LETHARGY (Lethargic), FATIGUE (Fatigue) and DRUG HYPERSENSITIVITY (Penicillin allergy). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disorder), FOOD ALLERGY (Food allergy) and LUNG DISORDER (Lung disorder) had not resolved, BONE PAIN (Bone pain) outcome was unknown and LETHARGY (Lethargic), FATIGUE (Fatigue) and DRUG HYPERSENSITIVITY (Penicillin allergy) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment: This is a spontaneous case concerning an adult female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Autoimmune disorder, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Autoimmune disorder, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I received my 2nd Pfizer dose on 4/23 at 2:40 pm at the Essex fair grounds  24 hrs later my joints were on fire  and I have a massive swelling  in my left arm pit same arm i received the injection it is very sore and swollen