chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose administered too early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications unknown.  Nurse would like to know when the next dose can be given or if it should be given at all.  no treatment information was provided.   This case was linked to MOD21-090279, US-MODERNATX, INC.-MOD-2021-128426, US-MODERNATX, INC.-MOD-2021-138320 (E2B Linked Report).; Sender's Comments:  MOD21-090279:cross link US-MODERNATX, INC.-MOD-2021-128426:cross link US-MODERNATX, INC.-MOD-2021-138320:Crosslinked case of reporter- Different patient
Merck sterile water dilutent used to reconstitute HIB instead of manufacturer dilutent for HIB which is 0.4% sodium chloride.
Had body aches and chills for 3 days  after receiving vaccines. June 1st went ER w/ shortness of breath thinking had pneumonia. Admitted for 1 day. They did CT scan and discovered I had pulmonary embolism, was put on lovenox 2 injections daily, now eloquis. Was referred to hematologist to check for blood clotting disorders none found.
This spontaneous report has been received from a nurse practitioner and referred to a 17-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions drug, reactions/allergies, and concomitant therapies were not reported. On an unknown (at the age of 17), the patient was vaccinated with a dose of PROQUAD subcutaneously (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis that was reconstituted with a sterile diluent (MRK). There were no side effects reported and no product quality complaints. Additional information has been requested.
pt stated that a couple of days after the vax he was headed to get lab work done at the hospital for a upcoming  procedure when he started having shortness of breath.  He was only able to walk about 20-30 yards and was gasping for air.  He had the procedure and went home but was not able to sleep without sitting up.   He has a C-PAP machine but has not been able to use due to having excessive mucus.  He also had some body aches and pains that have since subsided.  Pt went to the Hospital on 2/16/2021.  He was given a chest XRAY,  took blood work and was given O2.   Pt was discharged and told to FU w/ PCP and Cardiologist ASAP.  Pt took Covid Test on 2/19/2021 and is waiting for results. Pt has an appt w/ his Cardiologist on 3/17/2021 where they will and echo cardio- gram and he has also has an order to take a chest XRAY due to his SOB symptoms.  Pt starts radiation on 3/1/2021 for prostrate cancer.
The patient had a reaction on the right arm.  The site had a knot (hard) and it scabbed over for a month now.  On the 24th of Nov, she started getting a rash on her foot, then below the clavicle on both sides of her back.  She had to take a 7 day therapy of steroids of 60 mg per day.  She did take Valtrex for two days when she first noticed the rash.
MIGRAINE; DIARRHEA; UPSET STOMACH; TIRED; POUNDING HEADACHE; SORE THROAT; INJECTION SITE PAIN; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced pounding headache. On 04-MAY-2021, the subject experienced diarrhea. On 04-MAY-2021, the subject experienced upset stomach. On 05-MAY-2021, the subject experienced migraine. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore throat, tired, and pounding headache on 10-APR-2021, chills on 09-APR-2021, and injection site pain on 12-APR-2021, and had not recovered from migraine, diarrhea, and upset stomach. This report was non-serious.
low grade squamous intraepithelial lesion; This spontaneous case was reported by a consumer and describes the occurrence of CERVICAL DYSPLASIA (low grade squamous intraepithelial lesion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 prophylaxis.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 prophylaxis.    The patient's past medical history included Body mass index high.   On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced CERVICAL DYSPLASIA (low grade squamous intraepithelial lesion). At the time of the report, CERVICAL DYSPLASIA (low grade squamous intraepithelial lesion) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Human papilloma virus test: Positive. On 18-Jun-2021, Smear cervix abnormal: abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was provided by reporter.  No Treatment drug was provided by reporter.
pt recvd vax 1FEB93 & devel very sore swollen arm in shoulder joint about 8FEB93; very reluctant to move arm; seen by MD on 9FEB93 for dx of immun react to DTP; to have DT only from now on;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/07/21pfizer,Lot#EL3248 2nd dose: 01/28/21Pfizer,Lot# EL9262 Diagnosed covid positive: Exposure:Home Symptoms:Fatigue, chills
pt recvd vax; devel fever & local rxn of soreness, swelling & rash at inject site
As stated before...pt experienced more tremors than usual and more intense tremors than she usually experiences.
12 hours post vax, the pt developed areas of local irritation, redness at the vax site which occurred on both upper thighs. The left thigh was 3 x 2 inches, and the right thigh was 1 inch. No cellulitis was noted.
This spontaneous report was received from a registered nurse refers to an unknown number of patients with unknown demographics. On unspecified dates, beginning in July 2016, the patients were vaccinated with improperly stored GARDASIL 9 lot # M041990, expiration date: 28-JUN-2019, lot # K011325, expiration date: 08-APR-2017 and lot # M032650, expiration date: 31-MAR-2019 for prophylaxis. No symptoms reported. It was confirmed that no doses were administered past the expiration date. The GARDASIL 9 was exposed to temperature of 29F for time frame of 5292.5 hours. There was no previous temperature excursion involved. No data logger. No product quality complaint. No further information provided. There was consent to follow up. Sender's Comments: US-009507513-1707USA011447.
Adverse event: Extreme severe headache lasting over 6 hours. Led to ER visit after advise from nurse on-call. Treatment attempted at home: 1000mg of Tylenol. Treatment at ER: Toradol (ketorolac), Reglan (metoclopramide). Dosage unknown. [Administered via IV, I am the patient] Outcome: Pain subsided.
CHILD'S DATE OF BIRTH WRITTEN AS  AND AGE WRITTEN AS 13 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS STEP FATHER. CHILD IDENTIFIED IN (#149053018) WITH DATE OF BIRTH AND TOO YOUNG FOR FIRST DOSE.
Information has been received from a health professional concerning a 20 month old male patient who on 24-FEB-2009 was vaccinated in the right leg with the first dose of VARIVAX (Merck) (lot number 660663/1534X). The same day was vaccinated in the left leg with the fourth dose of PREVNAR (lot number C27703) and in the left leg with the second dose of FLUZONE (lot number UT2788HA). On 15-NOV-2009 the patient experienced fever (100-103) that resolved for 2 days and papule vesicle lesion trunk, head and lower leg. On 24-Nov-2009 the patient recovered. No further information is available.
The wrong dose of 0.5mL given in place of the 0.25mL booster dosage due to smaller syringe size.
1600; Swollen and red like a rectangular 4in flag patch. 1800; Stiff and sore shoulder. Saturday 7 december, more of the same. sunday, red reduced to 1" circular bruise.
6 days, post vax, pt had 2 similar 'grand mal' seizures. Over the course of 6-8 months, he lost speech and became unrelated. Now has been dx'd with PDD/ASD.
Information has been received from a healthcare facility concerning a 69 year old male pt who on 7/19/00 was vaccinated. On 7/19/00, the pt developed redness and swelling at the injection site. On approximately 7/22/00, the pt experienced shortness of breath and was admitted to the hospital on 7/24/2000 with a dx of pneumonia. Additional information has been requested.
I have been on a birth control pill since February 2021 and have not had my period since then. However, about a week after I had my COVID vaccine, I started experiencing brown spotting. This was continuous, and about three weeks later I started to have my full on period which was very heavy. All of this is going on while I am still taking my birth control pills that, prior to the COVID vaccine, had stopped my period completely.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-MAY-2014 the patient was vaccinated with a dose of VARIRAX that was exposed to temperatures outside of the recommended range (dose, route, indication and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
09/27/2021- The evening of the vaccination, the arm that the vaccination site was on started to hurt, by dinner I could barely lift my arm. I had to have my husband help me lift my shirt. I felt like my shoulder was broken. I felt I needed to be in a sling. It was very extreme. I started getting small fever, extremely exhausted, uncomfortable. I was down for the count for at least 36 hours. I was not able to do my normal routines for 36 hours. For the past 2 weeks, the last 3 afternoons, I have felt extreme fatigue I have been dizzy, I have brain fog, headaches, certain things set me off like a strong smell, decomposing leaves, anything that has set me off before. I felt like my CIRS was under control prior to the vaccine, after the vaccine. I felt like I went backwards. Even in my own store, a general store, has caused me problems. I have to wear a mask and can only be in there for a short period of time. I took an older medication-WelChol 625 mg, I took 1 today,  I was on prior, because it helps get rid of toxins. I saw a message therapist, she recommended her chiropractor to me.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/15/21 and 2/5/21. Covid + 1/26/22, Presented to ED 1/26/22 with hematemesis. In ED found to have SBP in the 90s and was given 1 uPRBC and 1L fluid. He had EGD on 1/26/22 s/p banding x5. On 1/27/22 RRT was called due to hematemesis and hypoxia. Went into cardiac arrest and ROSC was achieved before ICU transfer. Emergent EGD was attempted but pt became unstable with worsening hemorrhagic shock despite 3 vasopressors and 2 massive transfusion trays. Code status changed to DNAR. Patient expired on 1/28/22.
Hives around face, back, arms- started in the car after getting shot. Of note, latex glove was used and h/o latex allergy but glove did not touch back or face.
Thigh muscle issues causing muscle fatigue after the first two doses, balance issues after the third dose, and an inability to walk independently after the fourth dose
Fever, body aches all over, Swelling at injection sites, sick feeling for 3 days, headache that advil won't help.  Injection sites hurt a lot.  Won't go away.  Can't sleep very well.
I had my Shingrex (2nd one) vaccine and developed a fever of 101 with some arm soreness and muscle aches. It's worth it to avoid a Shingles outbreak but I felt this should be reported for better accuracy in how many people experience these side-effects.
PATIENT EXPERIENCED CRAMPING IN LEGS AND HAND OF LEFT SIDE OF THE BODY ON FRIDAY NIGHT. SYMPTOMS RESOLVED FOLLOWING DRINKING WATER AND RESTING AND OCCURED FOR ABOUT 24 HOURS. HAD CALF MUSCLE CRAMPING THAT WENT INTO GROIN
FEELING VERY SICK; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. On 15-APR-2021, the subject experienced feeling very sick. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) no infection, Chest X-ray (NR: not provided) no infection, and Urine analysis (NR: not provided) no infection. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, feeling very sick, and headache on 25-APR-2021. This report was non-serious.
MUSCLE REFLEX WHICH CAUSED ARM TO MOVE; VACCINE PROVIDED A LITTLE HIGH ON ARM; PAIN IN ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfonamide allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle reflex which caused arm to move. On 06-APR-2021, the subject experienced vaccine provided a little high on arm. On 06-APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm on 06-APR-2021, and the outcome of muscle reflex which caused arm to move and vaccine provided a little high on arm was not reported. This report was non-serious.
Pt received second dose of Moderna vaccine at 0835. Pt reported tightness and itching of throat and face at 0853. Adverse event emergency protocol initiated. Oxygen saturation 90% on RA, Benadryl 25mg PO giiven, Pt transferred to in house Urgent care via wheelchair. was treated with 125mg solumedrol, benadrly 25mg IV, LR 500 ml IV, oxygen saturation up to 98% RA. patient monitored until patient stated improvement of symptoms.
My right eye is painful , itchy and slightly swollen.  Similar feeling like pink eye.  This started the morning after I received my 1st dose.
Generalized vaccinia - presenting as diffuse macular-papular vesicular rash on face/torso/chest/left shoulder. Worsened over next 5 days and admitted to isolation bed at medical center for supportive care.  Fevers, headache, nausea and vomiting upon admission.  Negative lumbar puncture and resolving symptoms now HD#4.  Case discussed with Vaccine Healthcare Network provider, medical center.
The patinet had titer done and she is still low immunity to chicken pox.; This spontaneous report was received from a physician and refers to a 35-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 08-DEC-2020, the patient finished her series with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously (lot #, expiration date, dose and site of administration were not reported), for immunity to chicken pox, (it was not reported when she started the vaccination series and how many doses she received) however it was reported that the patient had a titer done and she was still low immunity to chicken pox (antibody test negative). It was reported that no treatment was given. The outcome of the event was unknown.  The causality assessment between the aforementioned event and the suspect vaccine was not provided.
This spontaneous report as received from a 72 year old female patient refers to herself with severe chronic obstructive pulmonary disease. No information regarding drug reactions/allergies was provided. On an unspecified date of September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H011049, dose, route and frequency were unknown). Concomitant therapies included acyclovir, SPIRIVA, SYMBICORT, prednisone (manufacturer unknown) and antibiotic (unspecified). On 18-JUN-2014 the patient noticed a blistery rash that started around her scalp line and extended to her forehead and surrounded her eye. She was diagnosed with shingles around the second week of June 2014 (date unspecified). The patient claimed that her physician said this was one of the worst cases of shingles he had seen in quite some time. The patient went to the emergency room on Saturday 21-JUN-2014 because of the severe symptoms she was experiencing from her shingles. Lab diagnostics studies performed were reported as "bloodwork" (result unknown). The patient sought for medical attention but didn't receive any treatment for the adverse event. The outcome of the event was reported as not recovered. Causality assessment was not provided by the reporter. Additional information has been requested.
Left doctor: 3:30pm Noticed hives in throat: 6pm Swelling of mouth: 6:30pm Difficultly breathing/swallowing: 7pm Ate dinner assuming the air quality was bothering me.  Anaphylactic breathing problems, lips turn blue/purple: 8pm Start treating with Benadryl. Shaking involuntarily/Nauseous/feeling shock.  Drove to hospital: 8:45 Waited for symptoms to subside with medication until 10pm.  Not seen.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VAQTA (dose, strength, frequency, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002314: US-009507513-1706USA002916: US-009507513-1706USA002914: US-009507513-1706USA002915:
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: Age at vaccination was not reported. The pharmacist did not provide the batch number nor the expiration date of the vaccine. She did not know the year the patient was born, just the day and month, so she provided an incomplete date of birth. The reporter consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on 31st December 2018 and experienced muscle aches, refer linked case US2019045242). Concurrent medical conditions included herpes virus infection. On 11th March 2019, the patient received the 2nd dose of SHINGRIX. On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient had the SHINGRIX on the day before the reporting and so far all she had experienced was a sore arm, which began in evening of vaccination day and was worsen at the time of reporting. The reporter consented to follow up.
Information has been received from a health professional concerning a male with no known allegies who was vaccinated with a dose of hep b vaccine recombinant. Subsequently, after the dose, the pt experienced shortness of breath and dizziness. The pt was administered Benadryl and taken to the ER for observation. No other treatment was given. It was noted that another pediatrician administered the vaccine. Upon internal review, shortness of breath was determined to be an other important medical event. Additional info has been requested.
12-20-09 started w/ weakness in legs, numbness and tingling in tips of toes and soles. Paresthesia in hands at Christmas time. Problems climbing stairs, difficulty with balance, stumbles over objects. 1-7 back pain and diarrhea.
Induration at site of injection measuring 3.5" x 1.5" in size to right deltoid.
Shingles developed in left eye.Treatment was with antibotic drops and Acyclovir
Pt recv vax on 2/24/99; on 2/26/99 pt exp local rxn of warmth, redness & swelling