chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication was not reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.   Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:case
24 to 48hr p/vax pt devel a rash w/papules on abd & bilat antecubital & popliteal areas;pt saw MD & was treated w/Valisone lotion;addtl info recv 17DEC96 indicated that pt recovered;
Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Chills; Achy; Fever ; Tired; Headache; Nausea.
Information has been received from a consumer concerning herself (a 72 year old female) with fibromyalgia, short gut syndrome, history of diarrhea, rotator cuff surgery and shingles as well as allergies to penicillin, sulfa, neomycin, codeine, (PERCODAN) and (CIPRO) who on 26-JAN-2009 was vaccinated intramuscularly in her left deltoid with the first dose of PNEUMOVAX vaccine. Since receiving the vaccine (on 26-JAN-2009) the patient had experienced an injection site reaction including muscle pain, decreased mobility, chills and fever of 100F. She had taken TYLENOL and hydrocodone to relieve the pain. She stated she had a small stature and small muscle mass. At the time of reporting the patient was not recovered. The patient called to the physician's office for medical attention. Additional information has been requested.
Received H1N1 11-16-09, on 11-17-09 woke up with tattoos raised & itchy. Started taking Benadryl, did not help. Saw HC provider 11-23-09, inspection revealed 12 cm hyperpigmented annular area on left L.E 1, 1 cm hyperpigmented annular area over sternum. Few discrete 3-5 mm hyperpigmented patches on left UE rash remains with itching.
Client got light headed and clammy after vaccine, known fear of needles. 99% on RA, BP 104/64 sitting, 104/68 laying down.  Felt better after 20 minutes and left with husband.
Diarrhea; intense cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and MUSCLE SPASMS (intense cramping) 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 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and MUSCLE SPASMS (intense cramping). At the time of the report, DIARRHOEA (Diarrhea) and MUSCLE SPASMS (intense cramping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant details provided
I exp low grade fever 100.5 on Saturday, diarrhea and severe joint pain.On Wed/Thurs I had to miss work due symptoms.
Severe swelling on upper cheeks, under eyes; not feeling to good; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING FACE (Severe swelling on upper cheeks, under eyes), MALAISE (not feeling to good) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020 and Dermal filler injection (dermatological fillers in her) since an unknown date. Concomitant products included ESTRADIOL (ESTROGEN) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SWELLING FACE (Severe swelling on upper cheeks, under eyes), MALAISE (not feeling to good) and FATIGUE (fatigue). The patient was treated with PREDNISONE (oral) for Swelling, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) for Swelling, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) (oral) for Swelling, at an unspecified dose and frequency. On 05-Jan-2021, MALAISE (not feeling to good) and FATIGUE (fatigue) had resolved. On 28-Jan-2021, SWELLING FACE (Severe swelling on upper cheeks, under eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Swelling returned after tapering off steroid, and as a result patient resumed treatment with Zyrtec and pepsid. Symptoms resolved days later and have remained suppressed.
Case number PHEH2012US003901 is an initial spontaneous report received from a physician on 14 Feb 2012 and a follow up received on 27 Feb 2012. This case refers to a 20-year-old male patient. He was vaccinated with MENVEO vaccine (batch number: X10047) intramuscularly on 30 Jan 2012. It was reported that this patient received only the MenCYW-135 liquid conjugate component of MENVEO vaccine; did not received the MenA lyophilized conjugate component of MENVEO vaccine. No adverse event was reported following this drug administration error. The patient was subsequently vaccinated with both the components. No other information was available at the time of this report. Follow up information received from the physician on 27 Feb 2012: update patient demographics and revaccinations with MENVEO.
her daughter got a bug bite and much longer than normal to heal; bug bite; complaining of pain; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 1 dose of the Pfizer COVID 19 vaccine but her mother cancelled the second appointment and states that they would not receiving it. Patient got a bug bite and it took much longer than normal to heal. She did hours of meditation for healing. She was in pain from a bug bite and reporter relays that patient was complaining of pain that she never had before. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
BROKE OUT INTO HIVES, WAS ADMINISTERED 50MG OG BENADRYL
Developed localized rashes on my left arm, left hand and left leg 2 days after the shot. Benadryl and tylenol took care of the discomfort.
PT states he is still experiencing sharp pain in the left arm, with numbness since the day after receiving the vaccine.  He is experiencing reduced range of motion. any pressure on the area such as lying on that side increase the pain. Pain is getting worse and range of motion is decreasing.
This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergie was specified. On an unkonwn date in September 2014 over the past 3 to 4 weeks, the patients were vaccinated with GARDASIL (lot#, dose, route not reported). No concomitant medications were reported. No symptoms reported. There was no product quality complaint. The outcome is unknown. This is one of the three reports received from the same reporter (MARRS # 1410USA005091 and MARRS # 1410USA005092). Additional information has been requested.
Pt developed arthritis in knees, hips, shoulders and neck. She was diagnosed with polyarthritis or polymyalgia rheumatica by Clinic. She took Lodine and Celebrex without effect. She has had arthroscopic surgery on both knees.
pt stated that she was at work and she started getting dizzy and collapsed.  She was sent home and has been weak, had chills and nauseated.  On 3/21/2021 she was feeling some better  Today 3/22/2021 she woke up with fatigue and nausea.
An under age client came to the vaccination clinic site. Client was vaccinated, but no symptoms or side effects were reported post vaccination. Client was able to go through registration with a note indicating client birthdate was incorrect with the vaccination system against the passport. It was later noted that client was 17 years old and should have not gotten his vaccine because he did not meet the age requirements for the Moderna vaccine.
moderate pain in middle-upper back muscles; headache; moderate pain in middle-upper back muscles; chills; Injection site was sore; Felt tired; mild fever; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 44-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: ER 8729, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 16:15 as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store (at the age of 44-year-old). The patient medical history was not provided. The patient did not have any known allergies. The patient concomitant medications included zinc (ZINC); calcium (CALCIUM); magnesium (MAGNESIUM) all taken for an unspecified indication, start and stop date were not reported. The patient also received vitamin C, D and B. The patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On an unspecified date, the patient had moderate pain in middle-upper back muscles, chills, and a headache. On 24Apr2021 at 09:00 the patient had events reported as injection site was sore, felt tired and mild fever. The patient did not receive any treatment for the reported events. The reporter reported the seriousness of the case as non-serious. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Patient received flu vaccine in the right arm and HPV vaccine in left arm.  A few minutes afterwards, patient directed to the restroom.  Patient comes out of bathroom stating she felt dizzy and had ringing in her ears.  Patient immediately sat down in chair with nurse assistance.  Patient's head then slumped over and passed out.  Nurse called for assistance while transferring patient to the floor to lay in a supine position.  Once on the floor, patient arouses and nurse explains to patient that she had passed out and we were helping her.  APRN assists in assessing patient.  BP taken, wet towels applied to patient's forehead.  After several minutes, patient assisted back into a chair. She remained there for approximately 20 more minutes for continued observance and given crackers and water to snack on.  Patient reports that she gets light-headed easily and that she had no breakfast this morning prior to appointment.   Patient alert and oriented x4 upon departure.
Case previously recorded as MA2009-4550. Initial case report received from a nurse on 18 NOV 2009. A patient below 4-year-old was accidentally vaccinated with 0.5 mL of FLUVIRIN 2009/2010 intramuscular, (batch no. 102126P1A, expiration date 31 MAR 2010) on 17 NOV 2009. NO adverse events was reported. NA09-008426.
Woke up next morning feeling like my throat was going to close, worst migraine had in 20 years, nausea and vommitting started and wouldn't stop.  Had to call doctor for a perscription to settle my stomach - ondansetron
More than 36 days after the first dose without receiving the second dose; Went to emergency Room for diabetes; Covid-19 positive but not experiencing symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIABETIC COMPLICATION (Went to emergency Room for diabetes), ASYMPTOMATIC COVID-19 (Covid-19 positive but not experiencing symptoms) and INTENTIONAL DOSE OMISSION (More than 36 days after the first dose without receiving the second dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure, CLOPIDOGREL for Blood thrombin, MAGNESIUM, ASA, VITAMIN D [VITAMIN D NOS], AMLODIPINE BESILATE, METFORMIN, GLIPIZIDE, VENLAFAXINE, TAMSULOSIN, MULTIVITAMINS [VITAMINS NOS] and CYANOCOBALAMIN (B12 1000 SR) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIABETIC COMPLICATION (Went to emergency Room for diabetes) and ASYMPTOMATIC COVID-19 (Covid-19 positive but not experiencing symptoms). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (More than 36 days after the first dose without receiving the second dose). At the time of the report, DIABETIC COMPLICATION (Went to emergency Room for diabetes), ASYMPTOMATIC COVID-19 (Covid-19 positive but not experiencing symptoms) and INTENTIONAL DOSE OMISSION (More than 36 days after the first dose without receiving the second dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported.   Reporter did not allow further contact
Mother states is red rash that started on abdomen. States very sparse type rash that does not appear to itch child. Denies any fluid filled blisters.
@20min myalgias progressive;40min shaking, chill, some peripheral vasoconstriction; SPO2 <- 97%;
upon leaving clinic p/vax pt fell to floor w/body convulsing;pt was not incontinent;pt was incoherent for approx 2-3sec & was then able to adequately answer questions;sick to stomach;sensitive cardiovascular system;dx vasovagal syncope;
The pt developed an injection site reactions characterized by redness, swelling and muscle pain radiating down the arm.
Information has been received from a consumer, who was the guardian of the patient, for the Pregnancy Registry for GARDASIL, concerning a 14 year old female with no pertinent medical history or drug reactions or allergies who on 08-APR-2008 was vaccinated with a 0.5 ml dose of GARDASIL. On the same day, the patient was also vaccinated with VARIVAX (Merck), tetanus toxoid vaccine, diphtheria toxoid vaccine, meningococcal conj vaccine (unspecified), hepatitis A virus vaccine (unspecified) (manufacturer unknown) and "ACHD". Concomitant therapy included calcium (unspecified), iron (unspecified) and prenatal vitamins. It was reported that the patient would be delivering next week. There were no lab tests performed. It was reported that the patient had no ill effects from this. The patient sought unspecified medical attention via the physician. Follow-up information was received from a staff member in the physician's office via phone call. It was reported that the patient delivered a healthy and normal baby boy on 05-OCT-2008 via C-section. The C-section was performed because the baby was "like 12 lbs". The reporter did not have any additional information to provide. Upon internal review, the baby was "like 12 lbs" that required C-section was considered to be other important medical event. Additional information is not expected.
rash on fash  and I believe on scalp that is itchy, tried taking benedryl but it did not make a difference. shoulders and back also itchy but rash does not appear to have spread there. hands are trembling.
TINGLING IN THE FACE, EAR, HAND AND FOOT RING AND PINKY TOE ON THE LEFT SIDE.. ON 3/14/21 LEFT SIDE RIBS TINGLING PAIN NUMB FEELING. ON 3/15/21 RIGHT HAND STARTED TINGLING.
I feel awful; can hardly get out of bed; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling bad and bedridden. On an unknown date, the outcome of the feeling bad and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the feeling bad and bedridden to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination not reported. The patient feel awful and can hardly get out of bed.  The patient have all of the side effects. The patient asked how long do the side effects of the Shingrix vaccine last.
Pt recv vax on 1/27/99; on 1/28/99 pt exp fever (105) &lethargy; dx= allergic rxn to vax;  tx="shot in the leg"
Pt was nauseous, diaphoretic, and pale. Pt denies eating anything all day. Juice and crackers offered. stated he felt better about 5 minutes later.
2/12/03, T-97 P 68, BP 12422. Injection site indurated warm to touch. Node upper L chest enlargement painful when touched.
Five days following the vaccination I broke out in hives throughout my body. They would go and come and I am still experiencing some hives here and there.
Pfizer on 3/15 and 4/5. Positive on 9/5 admitted 9/5 to current
Went to the doctor extreme diarrhea. He went to ICU for a couple of days.
feeling sick; 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 MALAISE (feeling sick) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feeling sick). At the time of the report, MALAISE (feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported. Concomitant medication were not reported
A non-serious report of administration of expired FLUMIST has been received from a nurse concerning a four-year-old male. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 14-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received. Neither as of 18-Apr-2008 when the office was contacted for follow-up information. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from the same reporter:  MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006659; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Onset 12-16 hours after injection: extremely sore arm at site of injection, chills and body aches & pains. No fever. Treatment- 800mg Ibprofen/rest/fluids. Symptoms lasted about 12-14 after onset.
injection given 1/14/10 next day experienced pain and tenderness to the touch. Pt also experienced limited range of motion in arm, unable to raise arm beyond chest level without shooting pain. Also experiencing pain in axillary area.