chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vials straight from refrigerator and immediately administered; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and mentioned that she believed the pharmacist removed vial from refrigerator and immediately filled syringe allowing no time for vaccination to thaw.(PT  The consumer's medical history was not provided. Concomitant product use was not provided by the reporter.  On 24 Feb 2021, prior to the onset of the events, the patient received dose of mRNA-1273 (Batch no: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  She reported that she watched the pharmacist administer the vaccine and believed the pharmacist removed the vial from refrigerator and immediately filled syringe allowing no time for vaccination to thaw.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, vials straight from refrigerator and immediately administered was recovered on 24 Feb 2021.; Reporter's Comments: This report refers to a case of "wrong technique in product usage process".for mRNA-1273 (lot # unknown) with no associated AEs reported.
November 2000 first shot, December 2000 second shot within a couple of days after second shot patient broke out with pitariasis itching. She saw doctor for this who then referred her to dermatology. After almost a year of fight with the rash she was about clear. She again had the flu shot October 2001 again within a couple of days was coated with the rash from head to toe. Went almost another year all clear again. On October 22/23, 2002 had a flu shot and in 2 days has broke out again from head to toe with pitariasis.
Right arm became red and painful at injection site. The inflamed area is warm to the touch. The erythema is 2? wide x 4?long Patient is taking ibuprofen 600mg PRN up to 4x/d Cetirazine 10mg, 2 tabs once daily  Famotidine 20mg, 2 tabs once daily  Ice pack
Initially, she was placed on high-flow oxygen.  She was offered BiPAP at night which she sometimes refused.  She was continued on steroids initially and we ordered completion of Baracitinib which she had started at the referring facility.  We also started some diuresis with oral Lasix.  Initially, her respiratory status seemed to improve, but she developed evidence of acute renal failure.  We stop potentially offending drugs and started IV fluid without improvement.  Ultimately, I consulted Nephrology and she started on dialysis with improvement in her laboratory numbers.  However, her respiratory status again declined.  She required very high flow oxygen.  She spiked a fever and started broad-spectrum antibiotics, though cultures remain negative.  She was much worse on 08/01.  I discussed at length with her husband including potential advanced directives for no intubation / CPR.  Ultimately, her family arrived at the hospital and in conjunction with the patient decided that she had had enough.  They did not want further antibiotics, steroids, high-flow oxygen or BiPAP (which the patient found uncomfortable).  We transitioned to comfort care, and she passed away peacefully with family in attendance.
COVID rebound; COVID rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "shiitake mushrooms" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 16Sep2023, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID rebound". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 cannot be fully excluded.
vaccine administrated beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had ever diagnosed positive with Covid-19.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before. It was unknown if patient had any chronic or long-standing health conditions.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 44 years 9 months. No concomitant drug reported. It was reported vaccine administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines. No treatment information was provided by the reporter.
pt recvd vax; screaming, non stop 4 hrs after vax; lasted 2 hrs; resumed screaming 17nov94 & lasted 2 1/2 hrs; rx tempra every 4 hrs;
received an early second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 22nd September 2021, the patient received the 2nd dose of Havrix and hepatitis A vaccine pre-filled syringe device. On 22nd September 2021, unknown after receiving Havrix and hepatitis A vaccine pre-filled syringe device and an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient inadvertently received an early second dose of Havrix, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Patient is a 42 y/o  male residing. At approximately 4: 40PM  received a Johnson and Johnson Janssen vaccine in the left  from . Client approached this nurse at 5:37PM complaining of pain in his left arm. Client described pain as ?pressure? in his left upper and lower arm and the pain radiated to the left side of his neck and left jaw. Client was alert and oriented; client was had no diaphoresis and client color was within normal limited; reparations deep even and unlabored; heart rate 70 bmp and pulse were strong and regular.  Explained to client the need to call 911 and client refused.5:40PM Client remained alert and oriented without change in physical appearance; heart rate 80 bmp and pulse remained strong and regular. Resident denies any routine medications. Reports he had ibuprofen twice during the day from the staff. Client reports he had been clean from cocaine use for the last 6 weeks. 5:40PM Had  Program Assistant/Counselor summoned to the room and explained to Patient client's refusal for 911 assistance. Patient was able to get client to agree to a 911 call. At 5:45PM 911 was called. 5:55PM Paramedics arrived and assessed client. According to paramedics? EKG and vital signs ?looked good?. Paramedics suggested client go to the emergency room for further evaluation; client declined. Paramedics explained to client the risk involved in refusing additional assessment by the emergency room. Client verbalized he understood the risks he was taking by refusing transportation to the emergency room. 5/21/2021 approximately 11AM Called to follow up with client; was not in but spoke with Manager. According to  has no residual effects and was ?up and about? as usual.
Initial health care professional report received on 09 Dec 2009: This child was inadvertently received 0.5 mL IM dose of FLUVIRIN (batch no: 102128P1) on 08 Dec 2009. No adverse event was reported. No more information was available.
pressure on top of his cerebral cortex; Broke out in sweats; Some memory issues; Temperature of 102; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (pressure on top of his cerebral cortex), HYPERHIDROSIS (Broke out in sweats), MEMORY IMPAIRMENT (Some memory issues) and PYREXIA (Temperature of 102) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OXYCODONE, DIAZEPAM, MULTIVITAMIN [VITAMINS NOS], FOLIC ACID and ZOLPIDEM for an unknown indication.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HEAD DISCOMFORT (pressure on top of his cerebral cortex), HYPERHIDROSIS (Broke out in sweats), MEMORY IMPAIRMENT (Some memory issues) and PYREXIA (Temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (pressure on top of his cerebral cortex), HYPERHIDROSIS (Broke out in sweats), MEMORY IMPAIRMENT (Some memory issues) and PYREXIA (Temperature of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Body temperature: 102 (High) 102.         Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Severe headache, 9-14-21 around 7am Sinus Inflammation, 9-15 Muscle stiffness in Neck
A report was received from a health care professional on 11/19/03 concerning a 51 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown demographics. No information about the patients' pertinent medical history, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX, lot # M027347 with expiration date on 01-JUN-2018 (dose and route of administration were not reported) reconstituted with properly stored concomitant of sterile diluent (MERCK). The vaccine underwent a temperature excursion of -14 to -10 degree Celsius for 204 hours. Digital data logger was not involved. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001280: US-009507513-1706USA001284: US-009507513-1706USA001282: US-009507513-1705USA011819: US-009507513-1706USA001279: US-009507513-1706USA001281:
no adverse event; VAQTA administered after a temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a 12-month-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, intramuscular injection, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly in the left thigh for prophylaxis (strength and exact dose were not provided).  The vaccine underwent temperature excursion of 47.9 degrees Fahrenheit for 47 min (incorrect product storage) in clinical Practice on 01-DEC-2022. Digital Data Logger was involved. No additional adverse event (AE) was reported. There was no product quality complaint (PQC).
Patient called primary care physician, Dr. and reported generalized weakness and hypotension BP @ 112/60 mmHg (normally 124/80) 4 hours after receiving 2nd Shingrix shot. No syncope reported by office
1 of 4 pts exp an inject site react which began 1 wk following vax; no other clinical info available
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Weakness-Medium, Additional Details: Temp 98.6 and BP normal
Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old female patient who experienced a non-tender injection site reaction of 5 cm, red and raised.  The patient received the fourth dose on 05-Nov-2007, the third dose on 08-May-2007, a dose on 07-Mar-2007 and the first dose on 05-Jan-2007.  The patient also received the first dose of Varicella Virus Vaccine, Live (manufacturer unknown) and the first dose of MMR (manufacturer unknown) on 05-Nov-2007.  The patient has a past history of no reaction on previous exposure to vaccine (no reaction following vaccination on 05-Jan-2007, or 07-Mar-2007, or 08-May-2007).  Concomitant therapy included MMR and Varicella Virus Vaccine.  The patient experienced non-tender injection site reaction of 5 cm, which was red and raised on 05-Nov-2007.  The patient was treated with oral BENADRYL.  The injection site swelling and erythema resolved on an unknown date in Nov-2007.  No additional information was available at the time of this report.
pt devel fever of 103-105 according to mom; temp taken by ear; temp devel < 24hrs post vax; pt seen in ofc next day w/no temp & dx sinusitis rx APAP & Motrin during temp
fever; Nausea; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), NAUSEA (Nausea) and CHILLS (chills) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), NAUSEA (Nausea) and CHILLS (chills). At the time of the report, PYREXIA (fever), NAUSEA (Nausea) and CHILLS (chills) outcome was unknown. Not Provided          No Concomitant Medications were reported.
Information has been received from a physician's assistant concerning a male patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided). The medical assistant reported that the patient passed out shortly after receiving the GARDASIL injection. The patient was given a chance to rest and he recovered. It was unspecified if the patient sought medical attention. Follow-up information was received from a medical assistant who reported that the 13 year old male student patient on 16-JUL-2010 at 8 a.m. was vaccinated into the right deltoid with a dose of GARDASIL (Lot # 662518/0087Y). No illness at time of vaccination. Child passed out after shot given on 16-JUL-2010. He quickly recovered with no problems on the same day. No further information is available.
Swelling around both eyes, itching around eyes, progressing to general facial itching. Swelling worsening over the 5 days after injection leading to Urgent Care visit.
p/vax pt had 3-4inch diameter area of redness & swelling;no fever;area warm to touch on lt leg @ site of redness & swelling;
10 day progression of ascending paralysis leading to admission. Neurological evaluation is Guillain Barre and responded well to IVIG.Annual followup 01/4/2010 Full recovery with inceptin of mild sensory neural hearing loss possibly related to GBS after Menactra. 60 day Follow-up Information 16-OCT-2006: Being evaluated for a mild sensioneural hearing deficit, Etiol ? / noted after event
Red rash at injection site 3hrs. after injxn. Spread to elbow and is itchy. Persists for 3-4 days.
Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) 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 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.            Concomitant medications were not provided.
I developed an abscess at injection site which has been drained 4 times and was cultured and it was determined to be a staph infection.
vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08B22A NDC:80777-273-10) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022).    No concomitant medication information was provided.  Caller said that there were informed 14 days later that it expired. Caller said that vaccine expired after the 30 days it was unfrozen on 11-Sep-2022. Patients received vaccine on 21Sep2022 and 22Sep2022.  Vial size was 5.5 mL.  Vial did not undergo any temperature excursion.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660237 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660237:same reporter
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection.  Currently still symptomatic.
Local: induration: 3.5 x 5.25 cm. No secondary infection noted. Has F.U. 1 week.
acute onset of loss of taste occurring within days of receiving Prevnar that lasted for several weeks then slowly resolved over weeks to months.
6/3 66y.o. female with PMH of CLL (last chemo around 2013), Non Hodkins lymphoma, GERD and  hypothyroidism presented to EC with c/o worsening symptoms for COVID.
Pharmacist found expired doses of covid-19 vaccine from previous day in immunization room; shots were removed and placed in a vial labeled in red ink "EXPIRED-DO NOT USE".   vial was placed with used vials of vaccine and diluent for disposal.  Immunizing technician  took this vial and gave two (2) patients shots of this expired vaccine.
Patient got the first moderna dose on 04-01-21. He came to pharmacy today (04-25-21) stating his arm still hurts. He says it is not swollen and no rash.  He states it just hurts to move it up and down. I advised him to see his doctor.
This case was reported by a healthcare professional via sales representative and described the occurrence of decreased therapeutic response in a 25-year-old female subject of unspecified age who was vaccinated with ENERGIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown) and experienced decreased therapeutic response. This healthcare professional reported two employees may have completed Hep B series years ago but are not sure. Titers were drawn within the last year and were found to be low. This is the second of two employees. For the first employee case see A0892888A. Follow-up information received via the reporter on 10 December 2010 indicated that there was little to no information on this report. Remark was made that the subject was not even sure that she was immunized. No additional information is available.
Pt started with J&J as primary covid series and pharmacist Administered Moderna Booster at dose of 0.5 ml instead of 0.25 ml on 12-3-21  Pt stated she was immunocompromised/hashimotos disease.   Spoke to pt on 12-4-21 and she was having chills/body aches and low grade fevers
SORE ARM AT INJECTION SITE AND CHILLS SIX HOURS LATER Narrative: