chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with herpes zoster; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Patient presented with herpes zoster".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax JAN96 & 24JAN96 pt had one lesion in the diaper area which disappeared by 25JAN96;no further details were provided
Low grade fever, headache, muscle spasms, fatigue, aches and stiff muscles
pt recv vax 9OCT95 & was exposed to chicken pox;8FEB96 pt devel a chicken-pox like vesicular rash all over body & itching;
patient experienced a sore left deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (patient experienced a sore left deltoid muscle) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (patient experienced a sore left deltoid muscle). At the time of the report, VACCINATION SITE PAIN (patient experienced a sore left deltoid muscle) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-461983, MOD-2022-461987 (Patient Link).
I tested positive for Covid-19 on February 17, 2023 I experienced sneezing, sinus congestion, mucus, headaches, dizziness, fatigue, blockage in my ears. I was prescribed PAXLOVID for my symptoms.
The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 031L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy, Fruit allergy (Banana), Scleroderma on 15-Jan-2004, Palpitations on 15-Jan-2004 and Intermediate coronary syndrome (Intermed coronary syndrome) on 15-Jan-2004.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) PCR.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter   This case was linked to MOD-2022-472140, MOD-2022-460301 (Patient Link).
Patient woke on 10/14/21 with severe redness, swelling pain and area was warm to touch.  MD note: Extensive erythema, warmth of upper left arm from shoulder to elbow and extending about 50% around circumference of arm.  Small cluster of clear fluid filled vesicles in the center of erythematous area. Patient was given Keflex for 7 days.
Seen in ER 12/24/16 for S/P febrile seizure after getting 1 y/o vaccines which given 12/21/16. Pt developed fever the following day after getting vaccines and had febrile seizure on 12/23/16. No history of febrile seizure prior to this episode.
Pain, redness and swelling of the left arm where the Pneumovax and flu shots were given.
pt recvd vax & fainted; red area on back of head;aroused easily /w ammonia
osteoarthritis; health concerns; hands hurt; swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (osteoarthritis), GENERAL PHYSICAL HEALTH DETERIORATION (health concerns), LYMPHADENOPATHY (swollen lymph node) and PAIN IN EXTREMITY (hands hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. In December 2021, the patient experienced LYMPHADENOPATHY (swollen lymph node). On an unknown date, the patient experienced OSTEOARTHRITIS (osteoarthritis), GENERAL PHYSICAL HEALTH DETERIORATION (health concerns) and PAIN IN EXTREMITY (hands hurt). At the time of the report, OSTEOARTHRITIS (osteoarthritis) and LYMPHADENOPATHY (swollen lymph node) had not resolved and GENERAL PHYSICAL HEALTH DETERIORATION (health concerns) and PAIN IN EXTREMITY (hands hurt) outcome was unknown.            Concomitant medication of the patient was not reported.  Formulation of Humira (Adalimumab) was specified as Solution for injection in pre-filled pen.  No treatment information was provided by the reporter.  It was unknown if the patient was enrolled in a COVID-19 Vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of swollen lymph node with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of osteoarthritis, health concerns and hands hurt with Humira (Adalimumab) was not provided.
Has not yet received the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 05th November 2020).   On an unknown date, the patient 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not yet received the second dose of Shingrix, which led to incomplete course of vaccination. The patient requested information regarding the recommendation for receiving the second dose after the suggested 2 to 6 months. No additional details were provided by the reporter. The reporter consented to follow up and provided permission to contact healthcare professional.
Patient reports arm pain which began when he had the vaccination. He states that the pain sometimes travels up towards his neck or down toward his hand and hurts when he raises his arm above a certain level. He also sometimes experiences what he described like crawling feelings on his arm.
No adverse event; patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that the vaccine was delivered to the hospital on 20-Sep-2022. The vaccine was administered to 5 patients on 14-Nov-2022, 2 patients on 15-Nov-2022 and 2 patients on 22-Dec-2022. Treatment medications were not provided. This case was reported for patient 6th of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-725025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725025:Master case
headache, back ache, racking chills/shivering, sweats, frequent urination between 10pm-8am.  I think this was from the flu vaccine. I also had severe pain, swelling, redness on right arm (pneumococcus).
Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were possibly vaccinated with one dose of improperly stored GARDASIL (lot # J010668, expiration date 29-APR-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
redness at injection site, swelling at injection site, numbness and tingling in hand of arm which vaccine was given.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an 11 years old, female patient with no pertinent medical history reported. On 16-NOV-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 15-APR-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source.
Angioedema, swelling in lower lip and left cheek, face.  Etremely painful as lip was stretched so huge. Started 9:30 in evening and lasted 2 days. Went to asthma and allergy center the next afternoon to my treating doctor.   Confirmed reaction to vaccine due to my under lying autoimmune disorder
With 2 days I started having light and sound sensitivity and worsening anxiety that cause cold sweats. Also lower left abdominal pains that are sharp/stabbing that come and go.  Also It has made it more difficult to eat and hold onto the food in my body as my bowels move constantly as soon as I eat yet the stools are not loose.
Day after receiving meningococcal vaccine, had swelling and stiffness in hands, knees, and feet.
Individual received flu shot at 2:07pm on 12/2/04, at approximately 5:05pm noticed burning sensation in both legs: from upper (inner and outer) thigh areas down to calves. Areas were reddened and sensitive to touch. After 24 hours, burning/ redness subsided, however, legs were still sensitive  to touch.
Within 5-10 minutes I began with a light cough.  I stayed for the 10-15 minutes but didn't think it was an issue so left the store.  On the ride home over the next1/2 hour the cough begain to increase in severity and frequency and then I lost my voice and was uable to speak.  My husband turned around and brought me to the urgent care located  near the pharmacy where I got my vaccination.  They gave me an epipen and several IV drugs including a steroid, antihistamine and a few others I don't remember and transported my to hospital for observation.  Within 3-4 hours my voice begain to return so I was sent home with more prescriptions.  My voice is better but has not fully returned.
Narrative: ADMISSION DATE: 08/21/2021 DISCHARGE DATE 0824/2021 DISCHARGE TYPE: Regular - has PCP f/u 09/2021 PRINCIPAL DIAGNOSIS (Reason for admission after study): 1). Acute bilateral epididymitis 2). E coli UTI 3). Acute COVID-19 syndrome 4). BPH HISTORY OF PRESENT ILLNESS: PATIENT3 yo male admitted 08/21/21 with acute bilateral epididymitis and possible R scrotal abcess pain in R testicle this morning. He also c/o constipation, but adds that the latter has been more of a chronic issue ROS negative for nausea/vomiting/abd pain/diarrhea/chest pain or dyspnea diagnosed with COVID, has had both vaccines, symptomatic but with reports fever/chills/body aches and negative ROS for pulmonary sx as above O2 sats normal on RA F/u exam GU exam with nurse chaperone present - bilateral scrotal edema and erythema improved Pleasant, no acute distress, alert and oriented x 3 CV: RRR s m/r/g Lungs: clear Abd: soft, nttp, pos BS Ext: no c/c/e GU: deferred, see GU (was female without chaperone - covid positive room) HOSPITAL COURSE: 1. Acute bilateral epididymitis/R scrotal abcess r/o - urine cx with growth of E coli - IV rocephin day 3/10 - d/c to home with additional 10 days oral vantin 400 mg bid - reviewed CT with contrast and discussed with urology - no discernable scrotal abcess present, so does not require surgical intervention - afebrile without leukocytosis at d/c 2. Acute COVID-19 syndrome - with systemic flu-like sx on admission, negative for any pulmonary sx, improved since admission - received both vaccines. 3. HL - continue atorvastatin and gemfibrizol 4. Chronic constipation - continue miralax at d/c - scheduled for routine colonoscopy/screening 10/21 has f/u PCP in 09/21 - d/c to home
Initial swelling, pain and redness at injection site starting on day 1.  Progressive pain (severe) and swelling down right arm, across upper chest and back, reaching neck by day 5 or 6.  Doctor prescribed 40mg Prednisone x 5 days and Tramadol pain medication in addition to the alternating 600mg 4x/day Ibuprofen and 1000mg 2x/dy  Acetaminophen.  Prednisone reduced swelling and had mild reduction of pain.  but pain, weakness and fine motor control increase of the days following completion and persist even 5 weeks post vaccine.  Right upper pectoral muscle and right triceps have significantly atrophied.  Pain, weakness, numbness/tingling, and loss of motor control persist.
pt presenting for 2nd dose Pfizer.  Complaining of numbness of nose and perioral tingling.  Patient had same reaction after first vaccination.  No SOB or swelling.  Exam negative.  HR 72, RR 18, 91% on RA.  No prior reactions to vaccinations or meds.  Given po benedryl to take home.
Itchy Sensation - Near Injection Site; Sore to Touch - Near Injection Site; Welts - Near Injection Site; Blisters - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Sore to Touch - Near Injection Site), URTICARIA (Welts - Near Injection Site) and VACCINATION SITE VESICLES (Blisters - Near Injection Site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical medical History Information was reported.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Sore to Touch - Near Injection Site), URTICARIA (Welts - Near Injection Site) and VACCINATION SITE VESICLES (Blisters - Near Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Sore to Touch - Near Injection Site), URTICARIA (Welts - Near Injection Site) and VACCINATION SITE VESICLES (Blisters - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to the company on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Sore to Touch - Near Injection Site), URTICARIA (Welts - Near Injection Site) and VACCINATION SITE VESICLES (Blisters - Near Injection Site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical medical History Information was reported.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Sore to Touch - Near Injection Site), URTICARIA (Welts - Near Injection Site) and VACCINATION SITE VESICLES (Blisters - Near Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE PAIN (Sore to Touch - Near Injection Site), URTICARIA (Welts - Near Injection Site) and VACCINATION SITE VESICLES (Blisters - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
dizziness, nausea, covid arm, red rash on the left arm surrounding my injection site
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M014318, expiration date 30-SEP-2017, dose unknown) orally for prophylaxis, which was exposed to temperature excursion of was 33.2 degrees Fahrenheit(F) for 12 hours and 43 minutes and 54.3 F for 1 hour and 23 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect had been reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004258: US-009507513-1612USA004370.
Per agency: Regarding The report for medical facility on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
This spontaneous report was received from a patient's mother via Pfizer, Inc. and refers to an 18 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, at the age of 18 months, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine and Hib conj vaccine (unspecified carrier), (for all administered vaccines, route and site of administration, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced brain swelling. The outcome of the brain swelling and the relatedness between this event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid vaccine and Hib conj vaccine (unspecified carrier) were not reported. Upon internal review, the event of brain swelling was determined to be medically significant. Additional information has been requested.
I had a sudden case of hearing loss (felt like my ear was suddenly full of water).  I got it around 1 or 2 days after vaccination. ENT specialist diagnosed it as a side effect of the vaccine due to seeing an uptick in similar cases after vaccination.  Side effect went away after around 4 days woth no treatment. Went to ER because I had a previous case of SSHL and was afraid this was the same thing.  Also had minor arm pain in both doses.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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 No adverse event (No reported medical history).    On 08-Jan-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 EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.