chrisvoncsefalvay/vaers-outcomes huggingface dataset:
big red bum; fever; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (big red bum) and PYREXIA (fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced ERYTHEMA (big red bum) and PYREXIA (fever). At the time of the report, ERYTHEMA (big red bum) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.    Reporter did not allow further contact
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 22-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T033166 expiration date 29-SEP-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006597: US-009507513-2109USA006537:
After the first shot iexperience slight dizziness,  was told to sit for 15 minutes, which I did.  Once the time lapsed I was told to report my info to the CDC and they would monitor it, which I did.  After the second shot given on February 19, 2021, about a week later it's when I experience this sore pain in my neck, which felt like a lump, so I called my Dr to get in to see him asap, he requested the ultrasound then the CT scan.
Nausea, joint aches, severe fatigue, headache, muscle tension and pain.
Hives on my arm; A spontaneous report was received from a consumer concerning a 55-year-old, male, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on his arm.  The patients' medical history included diabetes, hypertension and cholesterol and takes medications for these. However, the list of concomitant medications was not provided.  On 26 Dec 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 (BATCH: -026L20A) for the prophylaxis of COVID -19 infection. On 26 Dec 2020 he experienced hives on his arm.  Treatment for the hives on his arm was not provided.   Action taken with planned second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, hives on arm was not provided.; Reporter's Comments: This case concerns a 55-year-old male, patient, who experienced an unexpected non-serious event of Urticaria. The event occurred on the same day  after receiving the first dose of mRNA-1273, lot # 026L20A. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
herpetic sore on chin on 11/2,  followed by symptoms on 11/5 strange sense of smell (smoke), nausea, diarrhea, gas, urinary frequency, heart palpitation, shortness of breath, dizziness, brain fog, temp regulation (fever, chills) numbness and tingling on left side, neck stiffness on left side/
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, 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 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 24th patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow-up information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Patient was given a 0.3ml dose of pediatric bivalent vaccine instead of the adult bivalent. Patient reported no issues.
Headache, dizziness, nauseousness began immediately and did not subside.  About a week- 2 weeks later I be an having sciatica pain.
Per mom: 6/24/03 child received vaccines, did well, woke at 7 PM that evening shaking and with fever. Started having seizure. Mom called EMS. They took child to hospital and child was intubated, D/T, erratic breathing. Flown to another hospital's PICU. Child did better next day and was extubated.
31 yo female complained of adverse effect to moderna Covid 19 vaccination> She reports feeling "itchy" with elevated BP, elevated HR and rash on back of neck. Patient then began to complain that her throat was feeling dry and scratchy. Rash spread from back of neck to patients face. Patient received 0.3mg im epinephrine at 11:42am. ambulance was called and the patient was transported to emergency dept. for further evaluation.
FAINTED DURING ADMINISTRATION; This spontaneous report received from a pharmacist 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, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fainting during an administration of a dose of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fainted during administration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220109514 -COVID-19 VACCINE AD26.COV2.S-  Fainted during administration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
administered a Flublok vaccine to a 9 year-old child with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 12-Oct-2020.  This case involved a 9-year-old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2049, Expiration date- 30-Jun-2021) via intramuscular route in the left arm (Product administered to patient of inappropriate age) for prophylactic vaccination on 10-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No other vaccines were given.  This was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: Same day).  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe headache, chills through the night. First episode occurred second night following the shot. Second episode, same symptoms, occurred on the 8th night following the shot. Symptoms lasted until 6am.
Headache; Fever 100.5; body aches; staying focused on thoughts; swelling in Left leg/ankle; swelling in Left leg/ankle; Third dose administered on 23sep2021; Third dose administered on 23sep2021; Third dose administered on 23sep2021; This is a spontaneous report from a contactable consumer (patient).   A 65-Year-old non pregnant female patient received her third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3592) administered in left arm via an unspecified route of administration on 23Sep2021 as DOSE 3, SINGLE for COVID-19 immunization (age at vaccination 65 years). The patients past medical history included Obesity, heart murmur and the patient took fluconazole on 12Mar2021, lot number: UJ733AC, vaccine location on Right arm. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5204) administered in left arm via an unspecified route of administration on 12Mar2021 01:15 PM as DOSE 1, SINGLE for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734) administered in left arm via an unspecified route of administration on 02Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. On 24Sep2021 at 06:00 AM, the patient experienced Headache, Fever 100.5, body aches, staying focused on thoughts, swelling in Left leg/ankle. Treatment received for the adverse events are home massage, rest, sleep. The patient underwent lab tests and procedures which included body temperature was 100.5 on 24Sep2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
I started getting symptoms of sore throat, runny nose, headache, tiredness and fatigue, stuffy head, chills but no fever. The next day I did an at home COVID-19 test which was positive. I went to my doctors office and did PCR COVID-19 test which was positive as well. I received PAXLOVID and was told to take TYLENOL as well. My symptoms lasted for at least one week. I still have lingering headaches. I did have a negative antigen test on 6/3/2022.
No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant female patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.  This is one of several reports received from the same reporter.
Vomiting, hyperactive bowel sounds. Pt later went to ER for worsening condition the next day. Pt then went to different hospital and was given an enema, which caused pt to have syncopal episode. Pt then diagnosed with intussusception.
Pt reports cellulitis of R arm 4"x3" induration. Pt was treated with Doxyccline.
hearing loss; shingles; other zoster related injuries; Information has been received from a lawyer referring to a currently 66 years old patient of unknown gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or about November 2016 (at 61 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a healthcare provider at a pharmacyfor the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by healthcare providers and a doctor at healthcare facilities for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles, hearing loss and other zoster related injuries(Ill-defined disorder). The outcome of these events was unknown.
My daughter seemed to faint and fell to the floor, , seemed to seize slightly for about one minute  Then woke and seemed pale but fine  This morning she threw up
Hives on extremities, trunk, worse when heat or pressure applied to skin. No other symptoms or signs.
soreness since 3NOV98 & bruising none now 9NOV98;6NOV98 twitching of lt arm;pain radiating under arm pit;weakness of lt arm;
She had a sore arm. Per MD direction, she will hold the next Cosentyx dose for a week. With the increase in dose from last month (150 to 300mg), she has noticed the plaque has cleared up but has been coming back since she is due for her next dose.
rosacea; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority Support. This is a spontaneous report from a contactable other HCP (patient)/nurse. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rosacea on an unspecified date. Therapeutic measures were taken as a result of rosacea and doxycyline was used as a treatment drug. Outcome of the event was unknown.  Follow-up (12Feb2021): The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 12Feb2021, this case now contains all required information to be considered valid.  Follow-up (23Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
received booster of monovalent vaccine; Tongue numbness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 48-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received booster of monovalent vaccine"; HYPOAESTHESIA ORAL (non-serious), outcome "recovered", described as "Tongue numbness".  Additional information: Description of Event: 48-year-old female received booster of monovalent vaccine and developed tongue numbness immediately after that last for 12 hours. No hospital, ER or physician visit needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient recieved her  3rd series of Gardisil May 27 @ her MD office, approx felt dizzy for 2 week duration aftr ( she felt that she had to hold on to the walls when she walked). On friday she made an appt with her Md to be checked.  She was given an appt for June 10th. She was having a hard tiime focusing andwas unable to work because just sitting at her desk made her feel like she was going to faint...  She saw her Pcpand after eval felt she should see a ENTspecialist. Allher blood work was normal but patient was unable to drive or sit up because of the feeling she was going to pass out.  Unable to get an appt promptly with and ENT specialist.  We Wemt to another office for an eval.  She was cleared by ENT.  Patient proceed to feel worse and the stared c/o of arm heaviness that proceeded toleg heavisness.   In discussion with her NOP SHE SUGGEST TO SEE A NEUROLOGIST.  Agin extreme difficult getting appt with specialist.    MRI was ored secondary to dizziness, nausea arm and leg weakness.  MRI negative.  Relieved but still no answer Why a 21 year old active girl is physically debilitated  unable to drive or work etc.  lab work normal ..  After concern and discussion that symptoms are not improving .  NP decied to tx for lyme disease. no improve however now sever joint discomfort     Very scary to see a 21 yr old girl unable to get out of bed . np fevers etc 8/15/08-records received for DOS 6/17/08-C/O dizzy, nausea, headache, feels off balance, intermittent episodes of dizziness followed by nausea. Dizziness occurs primarily when standing. Fatigued, some weakness in arms on and off. Returned from foreign travel one month ago.  Impression: vertigo and nausea.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were inadvertently vaccinated with oral, ROTATEQ (lot#, strength, dosage, frequency and route unspecified), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dose #6: Pfizer/ Dose #7: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 at 13:15 as dose 6 (booster), single (Lot number: GJ6796), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Sep2023 at 15:15 as dose 7 (booster), single (Lot number: AU3832B), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type II Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Allergy: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Sep2023 at 15:15, outcome "unknown", described as "Dose #6: Pfizer/ Dose #7: Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID 19 treatment, from 17Oct2023 to 21Oct2023.
pt recv vax & joint pain & inflam, fatigue & diarrhea, lessened but never went away;episodes worsened last yr (occurring more frequently) & CNS sx, cardio/neuro syncope, visual disturbance, weakness rt side;dx post viral inflam arthritis;
Extreme itchiness all over my body within 12 hours.  Psoriasis rash flare on both elbows.  Treated with a topical cream (did not help), Zyrtec (did not help), and Benadryl (did help, but after 4 hours symptoms of extreme itchiness came back).
He came into mother's room, sat down on couch. He was flopping his arm, 1 minute his arm got stiff, then his hand became claw. Went to ER. Fainting seizure.
Pt became cyanotic and floppy. Per doc 204152, 60 day follow up, patient has been diagnosed with diffuse cutaneous mastocytosis. Either of the vaccines may have caused mastocyte release, with subsequent drop in blood pressure and cyanosis.
13 year old received the adult dose of Havrix; 13 year old received the adult dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's Comments: The reporter stated that a 13 year old patient received the adult dose of Havrix. No reactions were reported. The reporter consented to follow up via email.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The 13 year old patient received the adult dose of Havrix, which led to adult product administered to child and overdose.