chrisvoncsefalvay/vaers-outcomes huggingface dataset:
58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose; 58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HAV (Havrix pediatric) (batch number 2Y534, expiry date 02-MAR-2025) for prophylaxis.   On 13-SEP-2023, the patient received Havrix pediatric (right deltoid) .5 ml. On 13-SEP-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: 58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose) and adult use of a child product (Verbatim: 58 year old patient received a 0.5 mL pediatric dose of Havrix instead of the full Adult dose).The outcome of the underdose and adult use of a child product 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: 13-SEP-2023 The reporter was clinic coordinator called to inquire that how to proceed. The reporter reported that a patient received a 0.5 mL pediatric dose of Havrix instead of the full adult dose, which led to underdose and adult use of a child product. The reporter did not consent to follow-up.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This was an unsolicited report of injection site reaction received via GSK employee. The reporter noted a 10 centimeter erythema at the injection site along with pain and difficulty raising the arm above the shoulder. The reporter was unsure of how long the symptoms lasted. This was the only information provided and the reporter did not wish to be contacted again about this event. The reporter wished to remain anonymous and would not provide any initials, date of birth, age or contact information.
Received Menactra and TDaP on 12/02/2010, approx. 6pm c/o very painful arm-gave childrens Tylenol. On 12/03/2010 c/o stiff neck, headache, sore muscles, had fever approx. 101 and hives-gave children's Tylenol and Benadryl. I called and spoke with Dr. to let her know, said to give Benadryl. Next 3-4 month symptoms came and went also then with swollen eyes, lips. Saw Dr. said to continue Benadryl at night and Claritin at day. Worked for 2-3wks then symptoms became worse. Saw Dr. again same symptoms also now swollen eyes, lips. rx'd prednisone-worked minimal. On 5/08/2011 was seen at urgent care for severe hives, itching, felt arm tingling and going numb. I called Dr. to let her know.  I insisted on patient being referred to specialist.  Saw Dr. approx mid 5/11. Ordered blood work and Rx'd Zyrtec & Atarax. Worked 2-3 wks then hives started up again with itching, burning, (stiff neck and muscle ache on and off). When rx wears off also has swelling throughout body (hands, feed, eyes, lips, groin). Patient continues with symptoms.
MD rpt pt recv vax 4/29/98 & 5/15 pt exp 18-20 lesions w/mild temp 101f for 1day, & desquamation.
Information has been received from a nurse, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the unspecified number of patients were vaccinated with an improperly stored doses of VARIVAX lot # reported as M100673, expiration date 09-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously excursions. This is one of several reports received from the same source. Lot number [M100673] is an invalid lot number for varicella virus vaccine live (oka/merck). Additional information is not expected because the reporter do not want to be contacted. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000351: US-009507513-1611USA013515.
Week after first shot my arm started hurting again then that night became warm red itching painful there is some swelling and a knot
same bleeding disorder; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC DISORDER (same bleeding disorder) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC DISORDER (same bleeding disorder) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGIC DISORDER (same bleeding disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient had a bleeding disorder after getting the vaccine. Her reaction happened one day after she got the vaccine.  No concomitant medications were reported. No corrective treatment was provided.  Very minimal information is available at this time and follow-up has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Very minimal information is available at this time and follow-up has been requested. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded.
Initially only local warmth, swelling and pain. This was followed 2 hours later by chills, fevers and severe body aches especially the digits but also widespread elsewhere. He also reports loss of appetite and severe fatigue. He had to leave work early because he felt so bad.
At 0400 woke up and notified heart skipping a beat and heart palpitations. Chest felt uncomfortable with palpitations. Went back to sleep and woke up at 0730 and still had heart palpitations and chest felt uncomfortable with palpitations. Heart palpitations continued to get worse and went to Urgent care where the physician said I had a heart murmur and PVCs were noted when listening to my chest. I was send to the ER where PVCs were noted on heart monitoring multiple times per minute with shortness of breath. I got a chest X-ray and lab work that came back normal and was told to follow up with cardiology and get an ECHO done. The heart palpitations continued until the following day where they only were occurring once an hour or so and by today 6/19 I am no longer having heart palpitations.
Patient c/o itching on torso, neck, arms with tightness of throat 15-20 min. after IM injection. BENADRYL liquid 12.5mg/5ml 20ml PO and Prednisone 20mg/tab 3 PO.
Hive on back on day 4 after, 2 more next day on belly and but, next day one week mark torso  became covered on right side and headed around side to back over next few days. Finally had a virtual doctor visit who prescribed cortisone. Never had hives before
1/29/2016 17:05 EST 16 YEARS OLD MALE PRESENT FOR REDNESS ON LEFT ARM AFTER BEEN GIVEN THE HPV SHOT GIVEN 12/11/15 AT 4:24PM. Culture Wound (Order): Cellulitis, Stat collect, *Est. Requested Draw Date and T 1/29/2016, Cellulitis of left upper extremity, To be done at Lab: Final - 01 February 2016 8:50 EST - No growth. Pre - 31 January 2016 9:56 EST - No growth. GS - 30 January 2016 5:21 EST -  No White Blood Cells. No organisms seen. No epithelial cells. TREATMENT: MUPIROCIN TOPICAL 3 TIMES DAILY FOR 10 DAYS. CLINDAMYCIN 300MG 1 CAP PO Q6HR FOR 10 DAYS. MOM TO BE NOTIFIED TO FOLLOW UP IN 1-2 WEEKS.
fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced PYREXIA (fever) and MYALGIA (body aches). On 09-Jan-2021, PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Itchy throat 10 minutes after injection. No shortness of breath, no breathing problem, no cough, no difficulty with swallowing. no facial swelling.  Client was evaluated by EMT. BP177/91  Pulse 91 O2 Sat 97% Client did not take all of her blood pressure medication today. She felt her symptoms resolved after drinking water and resting.  Client was observed for 30 minutes after injection.
pt recv vax; reported stridor & wheezing w/in 10-15 min of vax; dph given at home & returned to ofc 30 mins later p/ vax;reported nasal flaring, but no distress; exam in ofc nl;
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies, medical history or if received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Unknown if patient ever had COVID test or diagnosis.     On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 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 (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    It was reported that patient received 1st booster. Concomitant drugs were not reported. It was reported that patient received various doses. It was also reported that it was unknown if patient had patient experienced a similar event in the past, unknown if patient was hospitalized. It was also unknown if events improved or worsened. It was reported that 7 doses were administered. It was unknown if vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment medications were not provided.
Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 19-APR-2016 at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. On or about 06-APR-2017, the patient sought further treatment from another physician (Neurologist) for ongoing and worsening symptoms, which were diagnosed as thoracic post-herpetic neuralgia and depression fueled by zoster misery. The patient was prescribed VALTREX, Gabapentin, Lidocaine, LYRICA and LIPODERM for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
general aching and chilling with 100.4 temperature,lack of appetite, headache, no energy.  Minimal after 24 hours and only headache after 40 hours.  Dull headache for 3 or 4 days.
No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 67-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 31-OCT-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002426: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
after vax, same day, had very odd chemical taste in mouth while driving home. Call clinic to report her symptoms. About 5 hours later, extreme chills, shuttering and shaking. Had on a lot of clothes to keep from being so cold. Had aching in all muscles in body. Hands wouldn't move in middle of the night Became delirium and did not feel conscious, had more of an onset of a fever last night 11.18.20.  Was nauseous and couldn't eat. Had very bad headache, couldn't get up to use bathroom. Lasted 36-48 hours. When had first shingrix dose on 08.23.20 , it produced increased heart rate. Second dose, was not bad with heart rate.
LIP SWELLING; HIVES; SEAFOOD ALLERGY; BODY HOT; SORE LYMPH NODES; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, treatment medications included: oxycodone/paracetamol. On 07-MAR-2021 17:00, the subject experienced sore lymph nodes. On 10-MAR-2021, the subject experienced body hot. On APR-2021, treatment medications included: epinephrine. On 13-APR-2021, the subject experienced seafood allergy. On 13-APR-2021, the subject experienced hives. On 20-APR-2021, the subject experienced lip swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore lymph nodes on 09-MAR-2021, had not recovered from seafood allergy, and body hot, and the outcome of hives and lip swelling was not reported. This report was non-serious.
10 days after shot my upper arm below injection site started to itch really bad and by the 11th day the whole upper arm was swollen, hurt, itched real bad and was very hot.  That lasted about 3 days, i also had lumps travel down by arm to my elbow and swollen hot pain radiated around my whole upper arm.  17 days after injection I had a bad fever and extremely bad stomach ache and was very nauseous and sick for 4 days.
Patient had no reaction listed. Patient was given a vaccine that had expiration date of 12/30/2069 that was a place holder expiration date and this had expired. This is required to report
She got her vaccine, 2 hours later she started to have a headache that started on the left side near the temple that would come and go.  She then noticed that the headache moved to her forehead and shoot to the entire head.  Had some light headedness, and low grade fever of 99-100 range.  She then also began to feel tired or feeling drained around 5:30-7:00 that evening.  She also ended up getting arm pain around 3:00-4:00 and warmth.  She did not take anything for these symptoms.  The symptoms were off and on throughout the evening and the worst was the arm when she lied on her arm it was tender.  The next morning her arm was more tender, kind of painful to anything like an ice pack, sensitive to the touch.  She had the band-aid on at the time, and it was more swollen and stuck out.  Then they noticed around 2:30 when it looked red, shaped like a baseball, inflamed, warm.  She did still have a slight fever, body aches all over, felt like her bones were glass.  She did feel very exhausted/tired.  No nausea or diarrhea, but just felt bad and wiped out.  It felt like she had the flu.  She woke up this morning feeling a lot better.  Her arm is still slightly tender, not as sensitive as it was yesterday, but does still have the baseball size mark on her arm.  She had a slight headache this morning, but otherwise is feeling fine.  The arm also had some itching that started the first day, and does still have that as well.  She also has some shoulder pain in the same arm today.   It is only tender to touch if mild pressure is applied to it.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Tested negative twice after taking Paxlovid; (Mar2023) Negative, notes: Tested negative twice after taking Paxlovid; (Mar2023) Positive, notes: Positive again COVID rebounded. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Mar2023 to 17Mar2023. The known allergies were reported as none and other medical history was reported as none.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). This case will be reassessed should additional information become available.
Aortitis; Vision loss; Hearing loss; Wegener's granulomatosis; Third nerve palsy; Right ear fullness; Large vessel vasculitis; viral syndrome; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date, the pt was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (HCP) for the long-term prevention of shingles and zoster-related conditions. On or about 28-JAN-2014, the pt was administered (at 52 years old) the zoster vaccine live (ZOSTAVAX) vaccine (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) by a pharmacist. On unspecified dates, as a result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered the following injuries: right ear fullness, hearing loss and vision loss; and she was diagnosed with viral syndrome, aortitis, third nerve palsy, Wegener's granulomatosis and large vessel vasculitis. Outcome of the events was not provided; causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, 3rd nerve paralysis, Granulomatosis with polyangiitis, Deafness, Blindness and Aortitis were determined to be medically significant events.
Low grade fever 1 day post inject. Temp spiked to 105 which produced febrile sz. Post ictal state then appeared fine. Fever did not return.
Received 1st immunizations 3/13/09 - PEDIARIX left thigh, HIB left thigh and PCV7 right thigh and RV5 orally. Developed subjective temp few hours later then began to cry only when they moved her head from right side to vertical or left. She had begun to keep it tilted same day to right. Fever resolved but the head tilt and fussiness has not.
Numbness and tingling on left side of body that is persistent since seven days after first vaccination. Hive breakout on back and right arm an hour after second dose.