chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion; doses 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 (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.17 for dose administered on 12 Feb 2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 12 Feb 2021. This vial was moved to fridge on 09 Feb 2021 and beyond use date for the vial was reported as 10 Mar 2021. Product moved to clinic on 12 Feb 2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period 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.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
SUDDEN ONSET BODY ACHES, HEADACHE, CHILLS, SKIN PAIN, DIAPHORESIS, DIZZINESS. TREATMENT INCLUDED IBUPROFEN, ANACIN, FLEXORIL, VICODIN, FIORICET, REST AND FLUIDS
dehydration; dizziness; body aches; rash at site of vaccination; fever; nausea; vomiting; indication: a history of diabetes; This spontaneous report was received from a nurse regarding a 53 year old male patient. The patient's medical history was not reported. The patient did not have any drug reactions or allergies. The patient's concurrent condition included diabetes. The patient's concomitant therapies included atorvastatin, sitagliptin phosphate (JANUVIA), empagliflozin (JARDIANCE) and zolpidem. On 25-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R033079, expiration date: 06-JUN-2020, subcutaneously for a history of diabetes (product use in unapproved indication). Beginning on 26-SEP-2019 through 27-SEP-2019, the patient experienced fever, body aches, dizziness, dehydration, vomiting, nausea and rash at the site of vaccination. The patient called the physician who instructed the patient to go to the emergency department on 29-SEP-2019. The patient was seen the emergency department with a three day history of those events. Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC) and urinalysis were done with unknown results. The patient was given one liter of Normal Saline intravenously (IV) and ondansetron (ZOFRAN) and sent home with oral ondansetron (ZOFRAN). There were no interventions to prevent seriousness criteria. The patient recovered between 30-SEP-2019 and 01-OCT-2019. The reporter's causality assessment was not reported. No product quality complaints were involved.
pt was diagnosed as having a "take reaction on 27 Feb 03 and since that time has noticed off and on myalgias and fever. but the last 3 days she has noted a non itchy rash over the trunk and neck. on exam there are 20-25 1-2 mm erythematous pustules scattered over the neck and trunk.  her fever is gone today.  i diangosed her today with erythema multiforme secondary to smallpox immunization
Grandmother noted that patient has been fussy since Valentines day, felt a little warm but temperature not taken.  Patient given Tylenol. Child woke up this morning with a maculopapular rash noted by nurse from hairline to waistline.  Family treated skin with Aveeno lotion from first sign of rash.  Instructed to continue to monitor and treat symptoms, report any changes to the health department staff.  Explained that a rash can occur up to 12 days post vaccination in a small percentage of vaccinated and virus cannot reproduce so no precautions are needed. Grandmother voiced understanding and will report any further concerns.
Pt had anaphylaxis reaction 10 minutes after administration.  Sensation of light headed, could not talk, sensation of tongue swelling and throat closing.  Pt was immediately given one dose of epi using standard adult epi pen, IVF, and 25mg benadryl IV.  Pts vitals were always wnl, including oxygen.  Pt stabilized and in 60 minutes was ready to go home wo any adverse outcome.
I woke up gasping for breath at 3:30 AM the morning following the shot. My blood oxygen reading was 83 and my pulse was 88. (normal is 95 and 66). I had gone to bed at 7:00 PM feeling sore and exhausted.  I was unable to get my blood oxygen level above 88, or my pulse below 88. By 9:00 AM, my pulse and Blood Oxygen were normal.  I was achy and tired for the next 2 days.
not given in the deltoid muscle but just below; Redness; Pain; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On 2nd July 2021, the patient received Shingrix (intramuscular). On 2nd July 2021, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema, pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by pharmacy intern. The reporter stated that, Shingrix vaccine was not given in the deltoid muscle but just below, which led to vaccine administered at inappropriate site. The patient developed redness and pain after a dose of Shingrix. The reporter consented to follow up. No additional information was provided.
Mild vaccine reaction - redness around site, advised observe, return to office for antibiotic if worsens (seen by Dr).
Dermal fillers swollen and painful after second dose.; Dermal fillers swollen and painful after second dose.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0179) via an unspecified route of administration in the left arm on 06May2021 at 14:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), dermal fillers and botulinum toxin type a (BOTOX). The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 06May2021, the patient experienced, dermal fillers swollen and painful after second dose. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of swelling and pain and included treatment with Benadryl, MD may rx prednisone. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dermal fillers swollen and painful after second dose was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Anaphylaxis - chest pain, shortness of breath, tingling in throat, lightheadedness  Responsive to Epipen x 2.  Given IM solumerol  EMS took her stable to ER
1st Moderna vaccine 1/12, area is swollen, egg sized, with small hard bumps above it. Red, warm, yesterday temp 99.2, today swelling has slightly improved
Right after the vaccine, my arm was sore and swollen for a couple of days. That went away. But about 10 days later, I noticed my vaccine site has a large red area and feels warm. It has been like this for 3 days. I have never felt bad or run a fever. Should I seek medical attention, or should I have concerns about getting the second vaccine?
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 15-APR-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Continual crying after injections with apnea? 1st NOC x 2, no fever. Hives next day with small pea size red area RL (no lump) still crying with another apnea? episode. Pt taken to hospital on 4/14. Admitted and observed for 24 hrs. No apnea noted during hospital stay, vitals wnl and blood work neg according to hospital records.
Patient complained about swelling of arm that was hot to the touch. They tried to go to urgent care but insurance did not cover so they went to the emergency room. The doctor gave the patient 2 different antibiotics and advised the patient how to decrease the swelling. The swelling did subside and the patient said they no longer have any more symptoms
Information has been received from a physician concerning a 9 month old male patient with no pertinent medical history and no drug reactions/allergies, who on 18-NOV-2010 was vaccinated with the initial dose of ROTATEQ (Lot # not reported) orally. There was no concomitant medication. There were no Lab diagnosis/studies performed. No adverse event was reported. Additional information has been requested.
Narrative:  88 yo male with PMH of A.fib, HTN, DM, presented to the ED on 2/21/22 c/o fatigue, coughing. Of note, patient was just discharged from hospital after gall bladder removal. Found to be COVID+ in ED. Treated with remdesivir 02/22-02/24. Condition improved and discharged on 02/27/22 to home.
8pm started to feel dizzy, naesuous, and fever. 9pm chills, fever 2am severe body aches, chills, fever 6am headache Anytime I didn?t take tynonel I had a fever, chills and extreme body aches for 24 hours
This spontaneous report was received from a licensed nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA (lot number, expiry date was unknown). Concomitant medications were not reported. No adverse effects reported. The outcome of the events were unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a pharmacist who heard the information from another pharmacist via a sales representative concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot# and route were not provided). Concomitant medication was not reported. In approximately November 2011 (reported as two years ago), the patient developed herpes zoster ophthalmicus after receiving ZOSTAVAX. The outcome of the adverse events was unknown. Additional information is not expected.
Patient had irritation and swelling at surgical incision site of liposuction surgery from January.  Also swelling of the surgical incision and itchiness.
This spontaneous report as received from a Registered Nurse refers to patients of unknown age and gender. It was reported that on unknown dates, doses of GARDASIL 9 (lot number reported as M011840, expiration date 01-FEB-2018) which were exposed to temperatures outside of the recommended range, were administered to the patients. No adverse experience had been reported. Temperature and time frame were: 1.2 degrees Celsius (C) for 22 minutes; 1.3C for 1 hour and 57 minutes; 1.4C for 2 hours and 15 minutes; 0.9C for 36 minutes; 1.3C for 21 minutes (duration: 331min). There were no previous temperature excursions. This was reported because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA009624: US-009507513-1611USA009626: US-009507513-1611USA009623: US-009507513-1611USA008904.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX (batch number 32ZG4, expiry date 29th February 2020) for prophylaxis. On 14th July 2018, the patient received the 1st dose of SHINGRIX. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain (serious criteria hospitalization), injection site erythema (serious criteria hospitalization), injection site swelling (serious criteria hospitalization) and pain in arm. In February 2019, the patient experienced obstruction (serious criteria hospitalization) and aneurysm (serious criteria hospitalization). On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and pain in arm were recovered/resolved and the outcome of the obstruction, aneurysm and product supply issue were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, obstruction, aneurysm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Two days after receiving SHINGRIX, the patient had redness, pain and swelling at the injection site. Her arm hurt for 3 to 4 weeks. In February 2019, less than a year after receiving SHINGRIX, the patient saw a cardiologist and was diagnosed with a 99 percent blockage in her heart, as well as an aneurysm. Her blood pressure was also very high. She had surgery on 8th February 2019 to place a stent. Between the shortage and her surgery she was unable to get the 2nd dose until the date of reporting. The reporter did not consent to follow-up.
Shingles - lasted for 3 weeks. Fatigue, brain fog, acne has lasted for 3 months.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB) (lot # reported as M036058 and expiration date 19-MAY-2019; dose and route of administration were not reported), for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced a temperature excursion greater than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit for 30minutes and another temperature excursion greater than 32 degrees Fahrenheit and less than 36 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was involved. Additional information has been requested.
Patient received measles-mumps-rubella vaccine 0.5 mL SQ, after 10 minutes passes started complaining of itching on arms and chest area with some rashes noted
Pain at injection site and entire upper arm, moderate back pain, throbbing finger joint pain and fatigue. Mild headache. Ibuprofen 600 mg, heating pad on back, ice pack on arm. Moderate discomfort and pain throughout the day until sleep. Awoke at 3 am and the pain was milder. Slight arm pain in the AM. All discomfort and pain gone by noon on 1/22/21, the second day post vaccination.
shortness of breath; over 42 days since first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD and Leukemia.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine). At the time of the report, DYSPNOEA (shortness of breath) and PRODUCT DOSE OMISSION ISSUE (over 42 days since first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After getting first shot of Moderna COVID-19 Vaccine patient experienced shortness of breathe and the pulomonologist put her on nebulizer.  Concomitant medication includes IgA transfusions, Blood Pressure medicines, Thyroid medicine, Nebulizer.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Event information is updated
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild
wait until they were vaccinated for Covid before getting their second vaccination; This case was reported by a pharmacist and described the occurrence of social problem in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix over one year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix over one year ago. The patient did not receive the 2nd dose of Shingrix till the time of reporting and was told to wait until he was vaccinated for Covid before getting the second Shingrix vaccination.  The pharmacist reported inappropriate schedule of vaccine and inquired if Shingrix series should be restarted. The patient received the full Covid vaccinations over 14 days before the day of reporting.  The reporter did not know exact dates of Shingrix or Covid immunizations. The reporter did not consent to follow up. This case is linked to case US2021AMR189788 reported by same reporter for another patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR189788:Same reporter
33 year old female nurse with hypothalamic hypothyroidism who in approximately 1990 in the AM was vaccinated in the deltoid with a first dose of Hepatitis B virus vaccine.  There was no illness at the time of vaccination.  In approximately 1990, within 30 minutes of receiving the vaccine, the patient broke out in hives.  At the time, she was told that it was probably a reaction to the preservative used in the vaccine which she thought was thimerosal.  Medical attention was sought and she was treated with antihistamines at that time and the hives resolved that same day.  The reaction was caused her not to complete the recommended series of vaccination.  A product quality complaint was not involved.  Follow up information was received from the registered nurse who reported that she had a reaction to the vaccine in approximately 1990 which consisted of itching and hives.  She had no adverse events following prior vaccination.  No further information is expected.
I received my second injection on April 15.  I did have side effects after this vaccine.  I had major dizzy spells and vomiting.  I never tested positive for the virus.  I was tested.   So current symptoms:   Constant headaches, feeling of anxiety, pulse rate elevated stays around 120-126.  Short term memory loss.  Hard to concentrate and stay focused. I feel like my skin is burning off and am hot to the touch with the exception of my hands and feet are like ice.
Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2017, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) was resolving.            No concomitant medication information provided. It was unknown if patient was enrolled in clinical trial.  No treatment medication information provided.  Causality for Humira: the reporter's causality for the event of ongoing pain was not provided.
Felt lousy from head to toe, no energy, chills, temperature 100.1, nausea no vomiting, extremely sore arm for 5 days, felt awful.  Had to leave work & come home & lie down all day & night.
Blood shot eyes, swollen throat, change in voice, elevated pulse, all within 10 min of coughing episode. 50 mg Benadryl po, 60 mg Prednisone po, Transport to ER.
biceps tendinitis, diagnosed 6/9/21, started after receiving Pfizer vaccine in the deltoid of the same side
High Fever (104.1), vomiting, lethargy  Treated at home.
5 hours after receiving the vaccine, I began having chills, then fever, nausea, and I threw up once.  The chills subsided after awhile, but the fever and nausea continued until about 10 a.m. the next day.  The fever was not higher than 102.2, and in the morning hours, it was 99-100.(varied).  Gone by the afternoon.  I had fatigue throughout the day after the shot, and still have a little today.  I didn't feel I needed to contact a doctor at this point.
(L) deltoid with area of induration ~3.5cm diameter somewhat tender and visible compared to contralateral shoulder. Patient also describes numbness over lateral aspect of left arm but neurovascular exam intact. Area of inflammation not fluctuant MCV4/MenB in (L) deltoid.