chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored doses of GARDASIL9, MMRII, and VARlVAX may have been administered; no adverse effects reported; This spontaneous report was received from an office manager concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient were vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot# R020200 expiration date 05-MAY-2021, lot# R024259 expiration date 30-MAY-2021 and lot# 1614898 expiration date 15-NOV-2021; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# R030810 expiration date 24-OCT-2020, lot# S005251 expiration date 20-FEB-2021 and lot# S014807 expiration date 13-MAY-2021; and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot# S019583 expiration date 25-JUN-2021 and lot# reported as S0006018 expiration date 27-FEB-2021 (dose and route of administration were not provided) for prophylaxis             Digital data logger registered a temperature excursion of 12.3 Celsius degrees and -1 Celsius degree (for varicella virus vaccine live (Oka/Merck) (VARIVAX)), along 2 hours 25 minutes in refrigerator, and 2 hours 15 minutes in the freezer.  Lot Number S0006018 is NOT valid for varicella virus vaccine live (Oka/Merck) (VARIVAX). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; evaluationvalue - Patient / Device: N/A / 2993
Leg pain, fart disturbance, losing appetite, losing weight soon after H1N1 lost 50 lbs WT. Gosinoptilia, le  lymphodeuopathy; spleen.
Shingrix given instead of Varivax; Shingrix given to a 25 y/o patient; This case was reported by a nurse via other manufacturer and described the occurrence of wrong vaccine administered in a 25-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2022, the patient received Shingrix. On 9th February 2022, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received a dose of Shingrix instead of Varivax at the age of 25 years, which led to wrong vaccine administered and inappropriate age at vaccine administration. Lot number, expiry date, dose and frequency of Shingrix were unknown. No additional adverse events and product quality complaint were reported.
This spontaneous report was received from a licensed practical nurse and refers to 26 patients of unknown age and gender. The patients' concurrent conditions or medical history were not reported. On unspecified dates since 11-JAN-2017, improperly stored doses of ROTATEQ oral liquid (lot # M031650, expiry date 16-MAR-2018, or lot # M033338, expiry date 15-APR-2018; exact dose was not reported) were administered to the patients. The vaccine was stored over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 6 minutes. There was previous temperature excursion of over 46 degrees Fahrenheit but under 77 degrees Fahrenheit for 1 hour and 30 minutes. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007854: US-009507513-1701USA007856: US-009507513-1701USA007855.
Bells Palsy. Paralysis of the left side of the face Steroids prescribed Symptoms started to clear up after two weeks
Approx 10 days p/vax developed an acneiform rash & myalgia; No further details were provided;
42 years old female, came for Moderna booster dose, screened by vaccinator RN and qualified for additional dose. RN thought additional dose was only 0.25mL and administered Moderna (lot # 089J21A) 0.25mL  at 1219 on 1/13/22 on right arm. Client also received influenza vaccine on left arm. PHN noticed when looking at participant forms that client was under dosed for additional dose and educated  RN regarding additional dose being a full dose of 0.5mL. PHN sent medical consult to project clinical lead, per MD approved to administer another Moderna booster dose 0.25 ml to obtain full dose for an additional dose. PHN  called client and left message at 1545. Client called  PHN back at 1552 and agreed to get second half today by 1800.
Light-headed; funny feeling in my throat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 03Mar2021 (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On 03Mar2021 the patient experienced light-headed, funny feeling in my throat. Reporter stated that When I had my first shot, they did report it. I had a reaction there. I had a funny feeling in my throat, and I was lightheaded and that lasted for an hour. So, my doctor told me I could take a Benadryl before I went for my second shot, and I am going on Wednesday. So, I just wanted to confirm if that was ok to go. Second dose scheduled date This coming up Wednesday, this 24th (Confirmed as 24Mar2021). Reporter confirmed it as the first dose of vaccine. Events occurred after taking the shot it was about 5 minutes. The clinical outcome of the events was reported was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Not feeling very well; Arm really sore / Could not lift it, hurt bad; Fever; Chills; Whole body aches; Can't breath well; Chest is really heavy; Doesn't have much energy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling very well), PAIN IN EXTREMITY (Arm really sore / Could not lift it, hurt bad), PYREXIA (Fever), CHILLS (Chills) and PAIN (Whole body aches) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MALAISE (Not feeling very well), PAIN IN EXTREMITY (Arm really sore / Could not lift it, hurt bad), PYREXIA (Fever), CHILLS (Chills), PAIN (Whole body aches), DYSPNOEA (Can't breath well), CHEST DISCOMFORT (Chest is really heavy) and ASTHENIA (Doesn't have much energy). On 13-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, MALAISE (Not feeling very well), PAIN IN EXTREMITY (Arm really sore / Could not lift it, hurt bad), CHILLS (Chills), PAIN (Whole body aches) and DYSPNOEA (Can't breath well) outcome was unknown and CHEST DISCOMFORT (Chest is really heavy) and ASTHENIA (Doesn't have much energy) had not resolved. Not Provided    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.   At the time of the report, the patient stated she feels better, but her chest was still heavy, she did not have much energy and arm is still sore. No fever at that time, but the night before it was really bad. She read that patients only have a sore arm after the first dose and other side effects after the second dose.  No event treatment specified.
Redness to the area and down my arm. Redness to other arm as well and itching on both limbs. My head also itched and my stomach became upset. These are the symptoms so far.
Felt itchy and was welted, started growing and growing..very painful and red.  Measured approx 4" X 1 1/2"....morning about a 1/4" bigger and very sore under my Left arm where shot was given...feel like I'm getting flu, headache, achy, took Benadryl 2 - 2x on 7/8/2011.
acute pericarditis, symptoms developed within 24 hours. have persisted for 10 days
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 15-OCT-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N029888 with expiration date in 28-AUG-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001849: US-009507513-1907USA001848: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001811: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000989: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988:
Fever with chills, migraine headache that changed locations from back of skull to behind eyes. Light and noise sensitive. Took  tylenol, advil fever went away next morning but still have a slight headache and light sensitive.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 31-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), as dose 1, single (lot number unknown) and as dose 2, single (lot number unknown) for covid-19 immunisation; and covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Dec2021 at 12:00 as dose 3 (booster), single (lot number unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) and SUSPECTED COVID-19 (medically significant), outcome "unknown" and described as "COVID-19". Therapeutic measures were taken as a result of the events which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Small red bump started developing. Was not painful immediately.  Evening became larger.  By morning and raised and large approx 2 inches in diameter. Dr. said draw line around in sharpie and give ice and Benadryl.  Gave repeatedly at prescribed hours, got larger. Went into doctor's office and they said continue.  Gradually diasappeared over the course of the week.
ARM SORE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore. This report was non-serious.
WHOLE FAMILY HAD HORRIBLE REACTIONS TO THE SHOT; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced whole family had horrible reactions to the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole family had horrible reactions to the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20211059062.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012713 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Raised welt at (R) thigh immediately following admin. of MMR vaccine. Also, localized redness at site of VZV vaccine (L) thigh (2.5 cm). (Redness on (R) thigh about 4 cm).
Pt recvd 3 Hep B vax given 26JUL89, 5SEP89, & 30JAN90; following these, titer was neg; Pt was given a 4th Engerix-B dose on 9AUG90; 4OCT90 titer was neg;
measles like rash all over body, minimally inj sclera;no febrile, itchy minimally;on med for tonsillitis 8SEP98;rash truncal face, cheeks proximal extremities;
Injury; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's wife) reported for a male patient (Husband) that: A male patient of an unspecified age started to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medication was unknown. On unspecified date, the caller mentioned that her husband had an injury after the first dose and will need to take Tylenol for pain. The caller would like to know when can her husband take pain medications after the first dose. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
When the pt awoke at 6:30 AM he complained of itching at injection site. Mom noted, redness, swelling, hardness at the site. The pt also experienced warmth and red bumps to injection site. After speaking to an MD, Benadryl was given. She was told to watch the pt and if symptoms worsened, or had problems breathing, to take the child to the ER.
Suspected vaccination Failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 3rd September 2021, less than 2 years 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine last year from the date of reporting. After receiving Shingles vaccine, the patient got diagnosed with shingles on the date of reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
8 hours after injection developed pain, swelling & warmth, inability to lift arm. Fever up to 100F. It lasted 3 days used ice pack and Tylenol.
Shooting pain up into her neck as well as tenderness, erythema, and induration of the site and below the injection site.
Area of erythema 3 1/2" x 3" on L thigh.
Child received Varivax vaccine SQ in right arm on May 7, 2007.  Mother states arm became swollen and hot to touch.  Brought into HD on Thursday, May 10, 2007 for nurse to evaluate injection site.  Injection site was noted to be slightly red, remained swollen and warm to touch.  Appearance of arm did not seem out of the normal range for possible reaction.  Mother states arm is much less warm than the day before.  Mother was asked what comfort measures she had tried (Tylenol, cool cloth, etc.).  Stated none,  she was "afraid to give Tylenol because she did not have a fever" and the mother feared the possible harm to her daughter's "kidneys".  Also stated the child said her arm did not hurt.  Nurse evaluated arm, explained that reaction of redness, swelling, warmth were within the normal range of expected reactions.  Instructed mother to apply comfort measure of cool cloth to arm and administer Tylenol per child's age and package instructions.  Also, informed that swelling and warmth in child's arm should resolve, but if it does not or if mother's notes increased swelling, redness, and/or pain to take child to physician for evaluation.
Information has been received from a consumer concerning her 5 year old grandson who was vaccinated with at least one dose of VARIVAX (Merck) on an unspecified date.  He has spent the last 2 weekends with his cousin who had bumps on the bottom of her left foot appeared on 07-APR-2008.  On 09-APR-2007 the same type of bumps his cousin had were noticed on him.  These bumps were on his back, bottom and a couple on the left leg.  The consumer thinks her grandson is on montelukast sodium (MSD) for asthma.  No outcome was reported.  The consumer also reported on her granddaughter and her grandson's father who had a similar problem (refer to WAES number 0804USA02505 and 0805USA04930).  No further information is available.
Redness and slight swelling and itching at injection site the evening of the shot. Cold compresses and benedryl used. 10-11 day after still have having some after effects.
Approx. 20 min. after pt. received immunizations, pt reported to dad that he "didn't feel good" and dad noted facial swelling. Upon exam, pt. noted to have swelling of eyelids, lips and hives on face, neck and trunk. Pt. given epinephrine 0.2 mg SQ, DECADRON 4 mg im and 1 tsp. BENADRYL with Rx for ATARAX to go home with. f/u call on 7/29/08, chlid with fever 102.5 and mild swelling and itching.
Multiple symptoms, including amenorrhea, dysmenorrhea, seizures, joint pain, blood in stool, HA's, N&V, lethargy, flu-like symptoms, syncope, heart palpitations, dx with chronic fatigue and fibromyalgia. Seen in ER multiple times and hospital admittance. Seen by cardiologists and neurologists. Pt remembers timeline.
SWELLING LIMB TO LIMB. HOT TO TOUCH. SWELLING IS WRAPPING AROUND THE APPENDAGE. PRESCRIBED FEXOFENADINE AND MOTRIN TO CONTROL SWELLING AND POSSIBILITY OF STEROIDS IF SWELLING CONTINUES OVER NIGHT.
No adverse event; Received expired first dose after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired first dose after manufacturer date of expiry).    No concomitant medications were reported. No treatment details were reported. Number of doses from vial was 1 dose from 1 vial. The vial was initially stored in the refrigerator on 08-Aug-2022 The vial did not undergo any temperature excursions.