chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided; temperature excursion; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 09-FEB-2022, the patient was administered with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U024221 was verified to be valid, expiration date reported and established as 04-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided).   The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) previously experienced a temperature excursion of 6 to 14 Fahrenheit (F) degrees (6.4F) for 15 minutes. No other information was available at this time. The vaccine had no previous temperature excursions. The patient did not experience any other adverse events.; Sender's Comments:  2202USA004245:
large red area on her arm; itching; joint aching; muscle joint aching; arm felt burned; This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema, pruritus, joint pain, muscle pain and burning sensation. On an unknown date, the outcome of the erythema, pruritus, joint pain, muscle pain and burning sensation were recovered/resolved.   It was unknown if the reporter considered the erythema, pruritus, joint pain, muscle pain and burning sensation to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix in the right arm. The patient experienced a very large red area on her arm with intense itching and then very significant muscle joint aching and her arm felt burned. For tolerance of 2nd dose, refer case US2020123365. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020123365:same patient
Information has been received from a physician concerning an adult male who was vaccinated with one dose of Hepatitis A virus vaccine inactivated. Thirteen days post-vaccination the patient developed a headache so severe he had to be hospitalized. An MRI was performed to r/o an aneurysm, however, at the time of reporting no results were available. The headache "has lasted for about one week now". Additional information has been requested.
Patient suddenly had a fever of 103.3 degrees, rectally, when she woke up from nap time. I gave her 1 tsp. of Advil. Fever lowered after medicine was given.
Patient received covid vaccine and developed an allergic reaction. She got hives all over her body, coughing, an increased respiratory rate of 66, heart rate of 134, blood pressure 130/84.  She had the reaction shortly after, about 2 minutes later. Epipen was given, Benadryl and albuterol. About 35 mins later she complained her throat was hurting and started shaking but felt hot. She was sent to the Emergency Department.
Fever started 1/12/17 (TYLENOL/ibuprofen for Tx). Rash started 1/15/17. Less active.
Starting the week after the first vaccine I had drastically fluctuating high blood pressures that had previously been controlled and steady, chest pain, nose break out left side, felt something was in my left eye, loss of high-pitched hearing and tinnitus in left eye, POTS symptoms, dizziness. I have experience the POTS, fluctuating blood pressures, headaches and tinnitus over the last year since my vaccine. They are all somewhat better at this point. I have asked two doctors to report this but I doubt that they have due to lack of staffing.
This spontaneous report as received from a medical assistant via a company representative refers to a 2 month old patient of unknown gender. On an unknown date in 2009, the patient was vaccinated with ROTATEQ, orally (dose, lot # and expiration date were not provided). On an unknown date, the patient experienced diarrhoea and vomiting. The outcome of diarrhoea and vomiting was reported as recovered/resolved. The relatedness between the adverse events and ROTATEQ was not reported. Additional information has been requested.
no other adverse events; nurse called to report a temperature excursion on Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 16-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) 1 time dose, lot # T035408, expiration date 14-APR-2022 for prophylaxis (exact dose, dose #, route and anatomical location were not provided). The temperature excursion was 8.258 degrees Fahrenheit (F) for 15 minutes. There were no previous excursions reported. The digital data logger was involved. No signs or symptoms were reported. No other adverse events reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2107USA002799:
Muscle pain in the scapula; Feeling a little fatigue; Shoulder joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling a little fatigue), ARTHRALGIA (Shoulder joint pain) and MYALGIA (Muscle pain in the scapula) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (Feeling a little fatigue) and ARTHRALGIA (Shoulder joint pain). On 18-Jan-2021, the patient experienced MYALGIA (Muscle pain in the scapula). On 17-Jan-2021, FATIGUE (Feeling a little fatigue) had resolved. On 18-Jan-2021, ARTHRALGIA (Shoulder joint pain) had resolved. At the time of the report, MYALGIA (Muscle pain in the scapula) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Then I took my first pfizer shot 4 weeks ago and haven't used my nebulizer since/I took my 2nd shot last saturday and my wheezing stopped; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included I had chronic asthma, I had 3 attacks in past 6 months and I was suffocating from an unknown date and unknown if ongoing. The patient reported then i took my first pfizer shot 4 weeks ago and haven't used my nebulizer since/i took my 2nd shot last saturday and my wheezing stopped on an unspecified date. Patient had chronic asthma. had 3 attacks in past 6 months. During latest attack, nothing worked. Patient was suffocating, was already on medication for past 2 years, used my nebulizer every morning and night so can breath. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash on the injection site; Bump on the injection site; Fever; Had no energy immediately after the vaccine; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had no energy immediately after the vaccine), COUGH (Coughing), VACCINATION SITE RASH (Rash on the injection site), VACCINATION SITE SWELLING (Bump on the injection site) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced ASTHENIA (Had no energy immediately after the vaccine), COUGH (Coughing) and PYREXIA (Fever). On 28-Aug-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE SWELLING (Bump on the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Had no energy immediately after the vaccine), COUGH (Coughing) and PYREXIA (Fever) outcome was unknown and VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE SWELLING (Bump on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient developed severe dyspnea on exertion, chest tightness, and palpitations
died after the third booster dose with a mRNA vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "dementia" (unspecified if ongoing), notes: Caller says he believes the contact mentioned her mom had dementia or Alzheimer's; "Alzheimer's" (unspecified if ongoing), notes: Caller says he believes the contact mentioned her mom had dementia or Alzheimer's. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant) with onset Apr2022, outcome "fatal", described as "died after the third booster dose with a mRNA vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Reporter said that the contact said her mom died after the third booster dose with a mRNA vaccine that she got with another vaccine, which he thinks was the flu vaccine. unspecified flu vaccine NDC/LOT/EXP: not provided as reporter was unsure if this was product patient had gotten. He said he waited to call in the adverse event since the reporter said she would let him know which vaccines it was if she could find out, and had said the mRNA vaccine could be Moderna. It was reported that date of patient death is unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died after the third booster dose with a mRNA vaccine
61 year old patient accidently given Fluad.  Patient reported no serious adverse reaction just mild malaise and possible slight fever.
evening of vax had 2 hrs temp of 103 & weakness; eye closure, drooling didn't recognize parents-shaking; no sz brought to ER;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:34 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 33 degrees Fahrenheit from 09:00 AM. 20 vials were moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 PM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4PM: 34 and 5 PM: 35.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 09:00 AM. 20 vials were moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a health professional concerning a 12 month old white female with club feet and a history of premature birth at 34 weeks and who was a twin, who on 27-FEB-2006 was vaccinated with a first subcutaneous dose of Varivax (Lot# 652455/1018R). Concomitant vaccine administered that day included a fourth intramuscular dose of COMVAX (Lot# 647098/0964N). Concomitant therapy included ZITHROMAX, beginning on 27-FEB-2006, for the treatment of an upper respiratory infection with right otitis media, which the patient was experiencing at the time of vaccination. On 10-MAR-2006 the patient was experiencing at the time of vaccination. On 10-MAR-2006 the patient was seen in the office with a vaccine site inflammation. The patient was started on CEFTIN, 125 mg, twice per day for 10 days. It was reported that the patient recovered on 17-MAR-2006. The patient's twin brother experienced vaccine site inflammation following vaccination with Varivax (WAES# 0605USA01854). Additional information is not expected.
mom rpt 10-14 days after vax pt irritable, fussy, had swollen bilat.neck glands, fever of 99-100. poss swollen leg.  seen by m.d. 5/20 @ regular check up was fine then.
*Orthostatic hypotension [I95.1]   Yes ? Generalized weakness [R53.1]   Yes ? Chronic diastolic heart failure (HCC) [I50.32]   Yes ? Sleep apnea in adult [G47.30]   Yes ? Type 2 diabetes mellitus with both eyes affected by mild nonproliferative retinopathy without macular edema, without long-term current use of insulin (HCC) [E11.3293]   Yes ? Essential hypertension, benign [I10]   Yes  Patient woke in middle of the nigh with confusion and tripped over furniture. Was having orthstatic S/S. Went to hospital for evaluation.
Had onset of angioedema throat swelling. seen and treated 2 times in ER. 10-16-07. Admitted 10-16-07 x 48 hr Readmitted x 1 to ER again 11-2-07.  12/11/07 Received hospital medical records of 11/2-11/3/2007 patient experienced recurrence of angioedema, tongue swelling, maculopapular rash & blistering of lips when steroids were tapered.  Tx w/IV steroids & admitted overnight for observation after switching to oral steroids. FINAL DX: Allergic reaction.  1/8/08 Received additional hospital medical records for 2 different admissions. 10/16-10/18/2007 patient experienced angioedema w/airway compromise & swelling of tongue & floor of mouth, trouble swallowing, speech difficulty & rash x 4 days.  Seen by pcp earlier on 10/16 & tx w/epi & benadryl.  Sent to ER, treated w/IV steroids & antibiotics & d/c to home.  Returned to ER later same day with same s/s & SOB & difficulty handling oral secretions. Admitted for observation.  Oral surgery consult done.  Laryngeal scoping done & was WNL as swelling resolved.  D/C to home on tapering steroids FINAL DX: angioedema w/airway compromise & swelling of tongue & floor of mouth.  10/19-10/28/2007  patient experienced progressibly worsening SOB, tongue swelling, perioral numbness & paretic erythematous macular papular rash on chest & back angioedema x 1 day.  Tx w/IV steroids, benadryl & admitted.  Exam revealed facial flushing & periorbital edema.  Improved & d/c to home on slow tapering steroids. FINAL DX: angioedema secondary to flu shot, resolved. Annual Follow-up Information 12-DEC-2008: Still residual pain and discomfort in joints. 60 Day Follow-up Information 30-JAN-2008: Still recovering from side effects. Steroid Tx for angioedema/significant myalgias.
Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of unknown demographics who received a 0.5ml second dose of IPOL, lot N1K921M, expiry date- 14-Nov-2019 via intramuscular route in the left thigh on 22-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to poor quality vaccine administered. Black speck the size of a pen mark on a piece of paper floating in the vial and the vial was opened 06-Mar-2019. It was also a case of Particle present in liquid product. No adverse event reported. Global PTC Number- 100004070. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Follow-up information was received on 25-MAR-2019 from a nurse. Global PTC Number updated. List of documents held by sender: none.
10/1/2021 - Pfizer booster #3 Covid-19; 10/2/2021 left arm swollen red, huge circle look like bee sting; 10/5-7/2021 hard time breathing; 10/8/2021 called urgent care & was referred to  Hospital for tests. 10/8-10/2021 Emergency checked in for testing and stayed three days.
Subject received immunization IM, left deltoid approximately 11:30 AM on 9/11/2018; noticed a raised red area after work on 9/12/2018, approx 4:00 PM, works stocking shelves in retail store; presented arm to pharmacy today 9/12/2018 around 3:00 PM, saying it had gotten a little better yesterday evening, but it has become aggravated at work today; the area is red, raised, and trapezoidal in shape, approximately 3-inch high and 4-inch wide; the mark from the injection is in the upper right quadrant of the reddened area. pt takes ibuprofen for chronic osteoarthritis, which may help with swelling and inflammation, discussed using ice pack or cold compress to help reduce swelling, pt marked the borders of the area to see if it becomes larger with next work day. Will continue to monitor the reaction site.
intermittent vaginal bleeding about 2 weeks to 2 months after vaccination. Since I have been menopausal for 5 years, this was certainly unusual. I had an ultrasound in June and a uterine biopsy later that month. Follow up pelvic ultrasound in September. My uterine lining is judged to be quite thicker than is normal for a person my age. But no cancerous tissue was detected.
Clinic nurse administered COVID-19 vaccine during visit on 4/15/2022; beyond use date was 4/12/2022.
This is a spontaneous report by a contactable nurse reporting for herself. A 49-year-old female nurse received PREVNAR 13 on 22Jul2013 at 9 AM, intramuscular injection on left deltoid muscle. Relevant medical history and concomitant medications were none. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 22Jul2013 she had swelling at the site of injection and redness extending from injection site. On 25Jul2013 she developed three spots of rash on her left arm. Relevant sibling information was unknown. Relevant sibling information was unknown. Relevant lab data was none. At the time of the report she had not recovered from above mentioned events. The nurse considered that there was a reasonable possibility that the events were related to PREVNAR 13. Follow-up (29-AUG-2013) Follow-up attempts completed. No further information expected.
Shortly after vaccination Patient complained of itching.  Patient was evaluated by EMS, vitals stable and Hives found on back of legs and back. 50 mg of Benadryl given. EMS observed for 45 minutes, hives resolved.  Patient released to care of spouse.
Excruciating pain in right arm starting approx. 3 hrs after vaccination. Could not sleep that night. No relief from any position. Arm still cannot be raised w/o pain after 5 weeks (11/15/05). Concerned about long-term effects.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 4 decade old female of unknown race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included multiple medical issues.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a negative antibody test, suspected immunological vaccination failure. It was reported that patient felt that the medical personnel during the vaccine clinic might have administered a partial dose to the patient possibly due to a drop of liquid coming out during administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with PQC number: 90000182451 The suspected product quality complaint has been confirmed to be void does not apply to this PQC error based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210622043-covid-19 vaccine ad26.cov2.s-suspected immunological vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS