chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 2:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 2:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.72 years.  Concomitant products were not provided.  On 08-Jan-2021, the vaccine with batch number 041L20A was moved to fridge. On 11-Jan-2021, 9 vials were moved to the clinic. On the same day at 09 AM and 02 PM, vials underwent temperature excursion with temperature of 34 and 35 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 07-Feb-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
red spot close under arm and swollen; Sore arm; arm is red; red spot close under arm and swollen; A spontaneous report was received from a consumer concerning a 79-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm is red, red spot close under arm and swollen.  The patient's medical history was provided blood pressure and cholesterol . Concomitant medications reported were blood pressure meds, cholesterol med, potassium, Metformin for drug use for unknown indication.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events arm is red, red spot close under arm and swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm is red, red spot close under arm and swollen was unknown.
Loud Tinnitus, I have went to several ENT doctors, also another Clinic, Prednisone Treatment did not help since the ringing started ,  also lot number ER 8730
Vasovagal reaction - hypotension, brief syncope, thready pulse, nausea and dizziness. Place on oxygen at 2L/min vic NC. Pulse ox = 98-100% Sat. Improved with rest. 09:50 Sat = 99% on RA, BP 110/82, P 60.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "medical condition with the lungs", start date: 2017 (ongoing), notes: has oxygen for that and that was stable; "paralyzed lung" (unspecified if ongoing), notes: stable; "Wheelchair" (ongoing); "has oxygen" (unspecified if ongoing), notes: the lungs that he had already in 2017 and has oxygen for that and that was stable. There were no concomitant medications. Past drug history included: Sertraline, start date: Jun2021, for depression; Hydroxizine, notes: low dose. Vaccination history included: BNT162b2 (Dose: 2, Lot number: lot EW01), administration date: 14Jun2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "sore arm"; BNT162b2 (Dose: 1, Lot number: ER8737), administration date: 24May2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The previous other three covid vaccine didn't do anything to him. He always gets his blood drawn and they check everything especially with him going to the (name withheld) and he was fine with the other vaccines and had three other covid vaccines that were Pfizer as caller states later in the call and he had no symptoms with those and only had a sore arm for all four doses of the vaccine but the sore arm only lasted for the first 24 hours with the first three vaccines and then he was good.
I suffered itching on my arm around and below the site of the injection. The area was approximately   two inches wide and four inches long. The itch at times was intense and lasted approximately eight   days. I applied a 1% Hydrocortisone cream topically for approximately four of the worst days. On a scale   of 1-10, I would rate the itch as a 7 to 8. I did not seek medical attention as I felt this was not a serious   threat to my health and just monitored this symptom closely. I also felt it was evidence of the vaccine   actually working and expected. The itch never prevented sleep or itched intently enough that my   scratching lead to bleeding or any more than moderate discomfort.
accidentally gave a expired Menactra four days after the expiration date with no reported adverse event; Initial information received on 25-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 35 years old female patient who experienced accidentally gave a expired menactra four days after the expiration date with no reported adverse event while receiving vaccine Meningococcal a-c-y-w135 (D Conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 22-Feb-2022, the patient received a suspect Meningococcal a-c-y-w135 (D Conj) vaccine at a dose of 0.5 mg (strength; not reported) lot U6827BD via intramuscular route in unknown administration site for immunization.  On 22-FEB-2022 the patient developed a non-serious accidentally gave a expired menactra four days after the expiration date with no reported adverse event (latency :same day) (expired product administered).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (accidentally gave a expired Menactra four days after the expiration date with no reported adverse event).  At time of reporting, the outcome was Unknown for the event accidentally gave a expired menactra four days after the expiration date with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
pt slept 10 1/2hr (from 2AM on 29APR until 1230PM);pt was somnolent & difficult to arms;refused to eat p/waking;sepsis w/u (blood, urine & CSF ox);pt adm to hosp;
Information has been received from a registered nurse concerning a 62 year old female pacemaker user with mild pulmonary hypertension and tachycardia after taking antihistamines and a history of lateral mastectomy with chemo completed on October 2006 who on 10-SEP-2008 was vaccinated with ZOSTAVAX (Merck) (lot # reported as 659326/1824U) subcutaneously in right arm.  Concomitant therapy included RYTHMOL, CARDIOL, LASIX, K-LOR, ATACAND, MSD, CELEXA, FEMARA, and ZITHROMAX.  On 14-SEP-2008.  The patient experienced urinary urgency with itching and then found a patch of blisters in the buttock and vaginal regions (also reported by the patient as shingles or chickenpox).  The patient was taking ZITHROMAX for a sinus infection and thought the itching was related to antibiotic use.  The patient contacted the physician on 17-SEP-2008 and a culture of the lesions was performed.  Then she returned to the physician on 19-Sep-2008 and was placed on FAMCICLOVIR 500 mg three times a day.  The patient is reporting continued zoster at the original location and blisters in the mouth at the time of the report.  Follow-up information was received from the nurse who reported that she was not interested in VZV analysis by polymerase chain reaction (PCR), but the physician may be interested.  The nurse was going to provide information to the physician about the VZV program.  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
rt sided parotid gland inflammation, swelling, tenderness to palpation occurring p/initiation of vax;
Tightness in abdomen, violent vomiting, diarreha, fainting, weakness, fatigue  11/03/09 Vaccine record received. 11/05/09 Medical records received for DOS 10/30/09. Patient developed nausea, diar and vomiting several hours s/p vaccine.  Hot and cold flashes. ED visit. All bld wrk WNL. Fluid replacement and antiemetics. Felt better. D/c to home.
Redness at injection site; Hardness at injection site/Being a 2 inch circle around the injection site; Tenderness at injection site/ a continual ache; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site induration, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration, injection site pain and injection site swelling to be related to Shingrix.     Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: The case was reported by patient. The patient received 1st dose of Shingrix in the left arm and experienced redness, hardness, tenderness, a continual ache, and swelling at the injection site. The patient said there being a 2  inch circle around the injection site. The patient said all symptoms were ongoing.  The reporter did not consent to follow-up.
Information has been received from a nurse prescriber via a company representative referring to a 15 year old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was vaccine with GARDASIL 9 (lot number, strength, and dose were not reported) for prevention of human papillomavirus (HPV). On approximately 19-JUL-2017 (reported as 3 weeks ago) recently the patient was seen in the office and had 1cm by 1cm nodule on his arm near the injection site. The reporter believed it was "an insect bite and not related to the vaccine". The outcome of the events was unknown. Action taken with GARDASIL 9 was not applicable. The reporter considered the events to be not related to the vaccine.
forced me to take my ONLY flu shot EVER in 1990 right there at that facility/never have I been so sick as I was directly after; Initial information was received on 29-Sep-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who forced me to take my only flu shot ever in 1990 right there at that facility/never have i been so sick as i was directly after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Influenza immunisation. The information on batch number was requested.  On an unknown date the patient reported that forced me to take my only flu shot ever in 1990 right there at that facility/never have i been so sick as i was directly after (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (forced me to take my ONLY flu shot EVER in 1990 right there at that facility/never have I been so sick as I was directly after).  At time of reporting, the outcome was Unknown for the event forced me to take my only flu shot ever in 1990 right there at that facility/never have i been so sick as i was directly after.
Myalgia; Sinus pressure; low grade fever, 99.9 -100.4; This case was reported by a physician via call center representative and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included covid-19 vaccine (Covid 19 Vaccine).   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced myalgia, sinus pressure and fever. On an unknown date, the outcome of the myalgia, sinus pressure and fever were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, sinus pressure and fever to be related to Shingrix.   Additional details were reported as follows: This case was reported by the physician for himself. The age at vaccination was not reported. The physician stated that the patient received Shingrix vaccine and experienced myalgia, sinus pressure, low grade fever that ranged from 99.9 to 100.4 degree F for the past 3 days (exact date of onset not given). The physician reported he was currently taking cholesterol medication (medication name not given). The physician reported that he received the 3rd dose of the COIVD-19 Vaccine1 month ago (Manufacturer not provided). The physician wanted to know how long after receiving SHINGRIX do people experience side effects. The reporter did not consent to follow-up.
Had grand mal seizure while driving on 3/8/21. Taken to emergency room and released. Phenobarbital levels were therapeutic.  Saw family doctor  3/18/21.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/02/21Lot# 2nd dose01/30/21 ,lot# Diagnosed covid positive:08/06/21 Symptom onset:08/02/21 Exposure: Symptoms:fever, cough, fatigue,muscle aches, loss of smell
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX lot # N031002, expiration date 03-NOV-2019, subcutaneously for prophylaxis. Concomitant therapy included sterile diluent which was used to reconstitute Oka/Merck VARIVAX and was properly stored. The doses of Oka/Merck VARIVAX experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-2.7 degrees Celsius) for 3 hours 45 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger. No adverse effects were reported. This is one of two reports received form the same reporter. Sender's Comments: US-009507513-1808USA004034.
Patient came back to office and received decadron, benadryl, toradol, and kenalog.
Rash. High fever 104. Splotchy purple face. Large red welt at site of shot.
This spontaneous report was received from a physician regarding a patient of unknown demographics. There was no information about concurrent conditions and historical medication. On 24-SEP-2010, the patient was vaccinated with VARIVAX dose 1, on 01-SEP-2015, dose 2 and 19-SEP-2016, dose 3. No adverse event was reported. No concomitant medication was involved. The outcome of the event was unknown. No PQC(product quality complaint) was involved. Additional information has been requested.
presented to the hospital with weakness, fatigue, decreased appetite. diagnosed with pneumonia which progressed to ARDS
First COVID-19 vaccine: hands were normal and she could form a fist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 11:30 (Lot number: EL9265, Expiration Date: 31May2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Surgery" (unspecified if ongoing); "Could not bend her fingers to make a fist because so stiff" (ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 06Feb2021 03:00, outcome "unknown", described as "First COVID-19 vaccine: hands were normal and she could form a fist".  Additional information: The patient was calling to report a good effect not a bad effect. The patient had hand surgery and could not bend her fingers to make a fist in her hand because it was so stiff. She had months and months of therapy and she still couldn't make a fist but after the vaccination her hands were normal and she could form a fist. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had no additional vaccines administered on same day of BNT162B2.   No follow-up attempts are possible. No further information is expected.
Almost immediate unbearable pain, a short break from the pain. Then several days later it returned and has not left 3 weeks later. Pain at raising arm, some passive arm movement pain, pain at weight bearing or completing daily required tasks (dressing, washing, driving).  Following a doctor's visit on 11/3/2014 with no x-rays completed the doctor stated that possibly a nerve or other sensitive area was hit by the injection. Muscle weakness was noted. Physical exam and range of motion was explored by my physician.
Headache; fever; chills; joint pain; muscle pain; fatigues; This is spontaneous report from a contactable other HCP. A 36-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient took the first dose on 23Dec2020 at arm left for covid-19 immunization. Medical history included asthma from an unknown date. Allergies to medications included Lamictal and Penicillin. There were no concomitant medications. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, fever, chills, joint pain, muscle pain, and fatigue on 11Jan2021 with outcome of not recovered. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. Information on the batch number and lot number has been requested.
large, red, warm, swollen area 9x8cm @ inject site; 18DEC92 no addtl info recvd on this report;
PATIENT REPORTED THEY HAD A RAISED RASH ON 8/21 THAT WAS AROUND THE INJECTION SITE.  THEY WENT TO URGENT CARE THE FOLLOWING DAY AND THE RED AREA WAS OUTLINED AND ABOUT THE SIZE OF A HALF DOLLAR BUT WASN'T RAISED ANYMORE.  PATIENT WAS ADVISED TO MONITOR AND IT SEEMED TO BE IMPROVING.
Pt had varicella vaccine right lateral thigh SQ on 10/19/2001. On 10/29/2001 Mom noticed a small reddened area on right lateral thigh, by 10/30/2001 rededned area about the size of a half dollar and is tender touch.
Site: Pain at Injection Site-Severe, Systemic: non localized arm pain, pain all over arm ranked 7 out 10 on pain score for 12 days after and still going-Severe, Systemic: Joint Pain-Severe, Additional Details: patient's whole arm is in pain for 12 days after taking shot and still going on. already called dr and left message for MA on vm
Patient has received DTAP & yearly Flu vaccine w/o adverse reaction in the past. 5 min after administration had hives on face without angioedema/wheezing/respiratory distress/stomach pain. Diphenhydramine administered and observed for 25 minutes
This spontaneous report as received from a physician assistant refers to a 85 years old female patient who in 2006 was vaccinated with the first dose of PNEUMOVAX23 (lot number, dose, route and indication were not reported). On 08-NOV-2012, the patient was vaccinated with a second dose of PNEUMOVAX23 intramuscular (IM) (lot number reported as H013399, expiration date: 07-MAR-2014) (dose and indication were not reported). No other co-suspects were reported. Concomitant medications included: influenza virus vaccine (unspecified). The physician assistant reported that the patient developed a localized injection site reaction which was beginning on day 2 (on 10-NOV-2012) after vaccination with his second dose of PNEUMOVAX23. It started at the injection site and "drifted" down to the elbow. The patient entire forearm was red, hot, swollen and painful. The patient was treated with BENADRYL and ice for the adverse event. The patient sought medical attention, she was seen in the office. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. This is one of the several reports from the same source. Additional information has been requested.