chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning sensation; itching sensation; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation) and PRURITUS (itching sensation) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BURNING SENSATION (burning sensation) and PRURITUS (itching sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning sensation) and PRURITUS (itching sensation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication reported. Patient started feeling burning and itching sensation all over 3 weeks after the 1st Shot. Patient has only taken Benadryl the last two days. Benadryl helps but the reaction comes back.
This was the booster (1/2 dose).  The morning after the injection I experience two episodes of syncopy - passed out on the floor and periodic vomiting all day.  Could not eat or drink for the entire day.   Previously, after my 2nd Moderna injection, I passed out for over 25 minutes and was transported by EMS to the ER.
Red rash around site of injection, approximately size of my arm covered was 2" x 3" in size.  I did not notice it on the first day after injection, but on the second morning, I saw the rash on my arm.  Extremely red, slightly raised bumps, warm to the touch.  (I have pictures of my arm).   It is still visible today (3rd day after injection) but the redness has decreased and the area covered has also decreased.  The area is still slightly itchy and sensitive to the touch. This rash is in addition to having extreme fatigue, sore arm, pain when raising arm - which lasted about 24 hrs and now is gone.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:55 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.69 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degree Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-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).
Rash/hives 10 days after booster shot. So far I?ve had it for a week and it?s still  itching.
Employee received mandatory TDaP (Adacel) vaccine at 1100. Experienced severe arm soreness, rash on neck and chest, headache, and lightheadedness at 1430.
cerebrovascular accident/right leg weakness, numbness, trouble ambulating and confusion/concomitant weakness related to his cerebrovascular accident; meningoencephalitis; dementia; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or around 29-DEC-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered right leg weakness, numbness, trouble ambulating and confusion. The pt was diagnosed with having a cerebrovascular accident, meningoencephalitis and dementia with concomitant weakness related to his cerebrovascular accident. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events of cerebrovascular accident, encephalitis, and dementia to be disabling.
VERY SICK AFTER THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included Cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 12-APR-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 experienced very sick after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick after the vaccine was not reported. This report was non-serious.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received ustekinumab (solution for injection in pre-filled syringe, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The outcome of unspecified adverse event was not reported. This report was non-serious.
Information has been received from a registered nurse concerning a 34 year-old female patient with a history of Hepatitis A and Psoriasis who on 21-May-2003 at approximately 15:00 was vaccinated subcutaneously in the right upper arm with a first dose of varicella virus vaccine live (lot number 642877/0416M). There was no illness at the time of vaccination. On 21-May-2003, the patient developed "some swelling at injection site". On 29-May-2003, the patient developed a "very mild rash" described as a rash at the injection site on her back and abdomen and a duration of 4 days. No treatment was required. There was no relevant diagnostic laboratory data. Unspecified medical attention was sought. Subsequently, the patient recovered from the rash at the injection site. There was no product quality complaint involved. No other information was provided. Additional information is expected.
Pain at the injection site in muscle that radiates down the arm just above the elbow. Hurts when I raise my arm.
Headache, Myalgia, Fever, Fatigue, sore throat Narrative:
No reports of joint or muscle pain, no fever at home. Was a small lesion (nickel sized) approximately 24 hours after vaccine administered, and then enlarged to about baseball sized by 72 hours after at provider visit. Rash: From Shingles Vaccine (SHINGRIX). History of Present Illness: Duration of rash: since Friday, 5/18; Location of rash: left deltoid; Color of rash: bright pink; Any crusting or oozing from rash?: no; -Treatments tried for rash: triple antibiotic ointment; Pruritus (itching)?: no; Personal history of a chronic skin condition?: no; Any mouth sores?: no; Recent respiratory tract infection?: no; Fever or recent fever? no; Change in soap, laundry detergent or hygiene products?: no; New or unusual foods?: no; New pets?: no; Recent travel out of state or camping?: no; Recent insect bites?: no; Targeted Review of Systems: Pain?: tender to the touch. Vaccine reaction plan: Provider drew a border in indelible ink and instructed patient to notify office if redness extends beyond ink border. D/C NEOSPORIN ointment, use soap and water to clean skin and moisturize using her usual product. If no expansion beyond border, no further action needed.
This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. Hepatitis B vaccine COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effects was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Red sore area around administration site. Suggested Benadryl capsules and hydrocortisone cream.
OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced off label use, and inappropriate route of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate route of vaccination was not reported. This report was non-serious.
Severe headache and sinus pressure (like worst sinus infection I ever had), severe fatigue - first day. Second day was headache and severe sore throat (like the last day of bad strep throat), resulting in difficultly swallowing, and extreme fatigue.
LIGHTHEADED AND SORENESS AT INJECTION SITE Narrative:  SORENESS STARTED RIGHT AWAY. ADVIL WAS TAKEN FOR SORENESS
injection site pain and induration Narrative: She received her first dose of Moderna COVID-19 vaccine on Wednesday, 3 March 2021. Had mild soreness at the injection site in the left deltoid at first. Then on Monday, 8 March 2021, she noted pain in the right armpit and swelling and redness in the lower part of the deltoid muscle.
PT AWOKE ON 11/22 WITH REDNESS AND WARMTH AT INJECTION SITE, ON 11/23 AREA HAD GROWN AND WAS HARD, HOT AND PAINFUL. WENT TO URGENT CARE 11/23 PM AND WAS DIAGNOSED WITH CELLULITIS, RECEIVED IM ROCEPHIN 1 GM EACH HIP, ALONG WITH RX FOR ORAL AUGMENTIN 875MG BID X7DAYS WHICH WAS STARTED 11/24 AM. ALL SX HAD RESOLVED BY 11/25 PM.
This spontaneous report as received from a pharmacist refers to a 67 years old female patient with allergy to penicillin. The patient was vaccinated with PNEUMOVAX 23 (lot number reported as H011780, expired date 16-FEB-2014) (0.5 ml, intramuscular) on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient experienced severe swelling. Pharmacist followed up with patient today on 21-NOV-2012 and patient was still experiencing some pain and due to arm pain, patient missed some work. Patient told the pharmacist that she thought she received another dose of PNEUMOVAX 23 about two years ago in approximately November 2010. Treatment VOLTAREN and diclofenac were given for adverse event. The patient was still experiencing some pain and arm pain. The outcome of severe swelling was unknown. The reporter considered that the pain caused the disability as missed work. This is one of several reports received from the same source. Additional information has been requested.
Subsequent to receiving vax, the pt experienced a one inch loss of pigmentation at the injection site and brown induration at the site. No treatment was given. The most recent information received does not provide an outcome.
6 hour after shot;       Bloating, burping with foul taste, diarrhea, nausea     8 hours after shot;       Vomiting, diarrhea, nausea, weakness     8-30 hours; Discomfort, nausea, weakness     36 hour; Feeling fine again.        Fyi,
Both GARDASIL and GARDASIL 9 are being added as products to th.is case as the subject of the email states "GARDASIL/GARDASIL 9" however in the body of the email only GARDASIL is mentioned.; had reactions such as weight loss, weakness, and stomach issues.; had reactions such as weight loss, weakness, and stomach issues.; had reactions such as weight loss, weakness, and stomach issues.; This spontaneous report was received from an employee referring to a female patient of unknown age. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.   In 2006 (reported as 15 years ago), the patient started therapy with rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (also reported as Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis (product name confusion).   In 2006 (reported as 15 years ago), the patient had severe reactions such as weight loss, weakness, and stomach issues. The patient went to "many doctors" and "tried everything to resolve her issues." The patient has sought medical attention and received the treatment. It was unknown if any lab diagnostic/study was performed. The outcome of all the events was unknown. The causality assessments between the suspect vaccine and all the events were related by the reporter.
pt recv vax & began to have pain below thumb & in the bottom of my hand later that day; went to ER 7 days later; dx irritated nerve my hand; same PMD tx w/aplint, Gelestone, Vicoden & Ansed; pain cont @ this time;
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 58 degrees Fahrenheit for 3 hours. Data logger was involved. There was previous excursion of 63 degrees Fahrenheit for 2.5 hours reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015042: US-009507513-1704USA015043: US-009507513-1704USA015044:
PATIENT RECEIVED AN EXPIRED DOSE OF PFIZER.  THEY EXPERIENCED A SORE ARM AND FATIGUE. RECOMMENDED TO REPEAT
Fully vaccinated with three doses of Pfizer. Admitted to the Medical Center on 01/14/2022. Tested positive for COVID 19 on 01/14/2022. Patient expired on 01/20/2022 while still admitted to the Medical Center.
Shot received 2:30pm. by midnight severe pain in left shoulder so got up to take 1 Aleve so I could sleep.  Wave of sweats and nausea/dizziness...lasted about 10 min.  Awake again 2:30 am by another nausea/dizzy wave---never actually vomited though, was able to breathe through it.  Awake again at 6:30 am by wave of nausea and headache, took 1 more Aleve and had a bowl of cereal to have some food in stomach. Multiple joints beginning to ache, including hips and both arms. Muscles tightening in arms and calves.  Back to bed.  Awake at 8am.  Headache and joints aching, however Aleve keeping it at bay enough to sleep. By 24 hour mark, nausea/dizzy spells were done.  By 48 hour mark the pain in joints done...except for minor pain and tightness at location of injection.
Severe brachial pain.  Burning pain, tingling, swelling, numbness in injection arm.  Very limited arm range of motion in shoulder.
Vaccines administered 1-7-14, mother reported fever 103 degrees evening of 1-8-14 no other symptoms, no local reactions at injection sites. Mother took infant to local ER. No significant findings. Administered TYLENOL and ibuprofen fever diminished.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000818: US-009507513-2112USA000713: US-009507513-2112USA000820: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825.
has a fever of 102; Caregiver tried to have him eat something but he took one bite said it did not taste quite right; slept most of the day/sleeping more than usual; This is a spontaneous report from a Pfizer Program. A contactable consumer reported that an 89-year-old male patient received first dose of bnt162b2 (Solution for injection) via unspecified route of administration on right arm at single dose on 23Jan2021, 14:00 (Saturday). The patient medical history included ongoing dementia (He has a little bit of dementia which has been ongoing since unknown date but at least 10 years) and Maybe some thyroid issues. The patient concomitant medication was not reported. On 27Jan2021, the patient slept most of the day/sleeping more than usual, caregiver tried to have him eat something, but he took one bite said it did not taste quite right and had a running fever of 102 degrees Fahrenheit. It was reported that patient usually wakes up around 9:00 to 9:30 and read his book but on 27Jan2021 he has been in his chair and slept most of the day, about 3-4 hours until around 14:00 to 14:30. The caregiver gave him some Tylenol and he was reading again with events ongoing and persistent. The reporter enquired whether these events were normal after vaccination because he would have had the symptoms onset closer to the date of vaccination. Therapeutic measures were taken for fever. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Pt reported increased flatulence for 1 and 1/2 days after 1st Moderna dose, he does not report diarrhea. Pt reported this when getting his 2nd dose at COVID VACCINE CLINIC
Client appeared to faint and vomited.  Client put in semi-reclining position in exam room.  Vitals assessed.  Clint given soda to drink and recovered completely.
Pt had no problems with site of Tdap in arm until 8 days after reaction she had a severe redness at site of inoculation. 5-6cm in diameter. Circular with central clearing. Cellulitis versus delayed hypersensitivity reaction.
Face hives broke out on Thursday, June 24th Eyes swole up on Friday, June 25th