chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash is itchy; Rash on stomach, both arms, and back; Headache; sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itchy), RASH (Rash on stomach, both arms, and back), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, HYDROCHLOROTHIAZIDE, TICAGRELOR (BRILINTA), FEBUXOSTAT (ULORIC), ACETYLSALICYLIC ACID (BABY ASPIRIN), HETASTARCH (HYDRAEL 130), OLMESARTAN and TAMSULOSIN for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash is itchy), RASH (Rash on stomach, both arms, and back), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, RASH PRURITIC (Rash is itchy), RASH (Rash on stomach, both arms, and back), HEADACHE (Headache) and VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.       Treatment medication included Triamcinolone.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
late second dose/ the first dose was given on Jan2020; expiration date was/ 23May2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 23rd May 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on unknown date in January 2020.).   On 1st June 2021, the patient received the 2nd dose of Shingrix. On 1st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the outcome of the drug dose administration interval too long and expired vaccine used were unknown.  Additional details were provided as follows: The age at vaccination not reported.  The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lenghtening of vaccination schedule. The patient received 2nd dose, which was also expired on 23rd May 2021. The reporter did not had specific date. The reporter consented to follow up.
This spontaneous report as received from a pharmacist via patient's wife refers to a male patient of unknown age. Current condition was not reported. Historical medication was not reported. On 31-AUG-2014 the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported). No concomitant medication was reported. Approximately in 2014, as reported patient received ZOSTAVAX on 31-AUG-2014, immediately began to experience an itchy rash at the injection site following the administration. It was reported that the itchy rash did not spread anywhere else on body. The outcome of an itchy rash at injection site was unknown. Additional information has been requested.
Presented to ED 1 month after flu shot administered. Admitted to 3AM, then ICU, then to 3BM. Transferred to another facility for inpatient neurology then back to this medical center (2 week admission). Guillain-Barre Syndrome was not ruled out. His sxs are resolved according to last outpt neurology f/u note. Neurology recommended that pt not have another flu shot again. pt had the flu shot at this facility 4 other times without any problem. Leg weakness; paralysis.
My son has had a fever since the second shot. His fever comes and goes throughout the day varies from no temperature around 98- 101 with no fever reducing medication. He has no other symptoms. He does normally run temperatures.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP7534), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Known allergies: Nickel (metal)" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: Apr2021, stop date: Feb2023; OMEPRAZOLE, start date: Apr2021, stop date: Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid from 14Feb2023 to 18Feb2023.
about an hour was rough; chills / shivering; turned into shaking that wouldn't stop; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that 12 hours after the shot, for about an hour was rough. The patient had chills (but not feverish), shivering and turned into shaking that wouldn't stop. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Major pain in muscles and joints, especially lower back, hips and legs. Severe chills, but with no apparent rise in temperature. Severe headache.
Female patient who originally presented to the hospital on 4/8/2021 due to weakness.   She was found to have COVID-19 pneumonia treated under mild pathway.  The completed remdesivir treatment.  She did not require antibiotic.   She improved significantly and felt back to baseline.  She required enema for constipation and requested enema upon discharge.  For DVT prophylaxis she was treated with group C per protocol.
Patient was give flu vaccine 1/4/12 approx 445PM. Later that evening pt experienced headache, blurred vision, dizziness et nausea. He went to ER. All tests were normal. Pt has history of migraine.
Per patient; dose administered too high on arm and may have affected joint/tendon. Patient still experiences pain radiating down arm that she and physician think may have been caused by vaccine administered too high on arm.
Per store, pt was administered 1st dose of Moderna covid vaccine on 2/4/21. However at store clinic, patient supposedly was also administered another 1st dose of Moderna covid vaccine on 2/22/21--per vaccine consent form, patient also indicated that they had NOT received any vaccines in the past 30 days. In addition, at store clinic patient was administered the paired 2nd dose of Moderna covid vaccine on 3/22/21. Patient may have gotten a total of 3 doses of Moderna covid vaccine. Tried to call patient to verify; left message but patient has not called back to verify.
This spontaneous report as received from a physician refers to herself, a 60 year old female with drug allergy on ULTRAM and AUGMENTIN XR. Concomitant medication and no medical history were not reported. On 29-MAR-2014 the patient was vaccinated with ZOSTAVAX (batch/lot was not reported), single dose subcutaneous in the left arm. On 30-MAR-2014 the patient developed red, painful, hard lump at the injection site. Then she developed redness and swelling extending from the left shoulder down to the elbow. The patient contacted her physician's office but no treatment was prescribed. No lab diagnostics performed. The outcome of red, painful, hard lump at the injection site and redness and swelling extending from the left shoulder down to the elbow was reported as improving. Additional information has been requested.
Atrial Fibrillation developed in early April, resting heart rate jumped 20-30 beats per minute, diagnosed June 11 with EKG; stress test and echocardiogram in July; cardioversion and angiogram in August
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patients were vaccinated with a dose of improperly stored PEDVAXHIB (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. It was reported that the temperatures had reached below recommended temperatures. Specified temperature excursion details were unavailable at the time. This case is linked to case number 1610USA009568 and 1610USA011174 via same reporter link. Additional information has been requested.
Covid-19 type symptoms of headache; fever, eye ache; fatigue, body ache plus pain in injection site. I went to clinic to get tested for covid19 as I thought I was getting the virus again. I felt very much like I did in November when I tested positive & had Covid symptoms for 2 weeks. I was sick but no breathing issues so did not go to hospital.
Varicella-type rash on buttock. Fewer than 50 lesions present.
tremor in legs, constant screaming begining @ 7PM on day of immun; high fever to 103 clearing mostly on 13JUL;
I developed injection site pain and a metallic taste in my mouth after receiving my first dose of Moderna vaccine.
I was having trouble moving my head and arms without pain that makes you want to cry; scratchy throat; tired; muscle pain not too bad but not great; severe headache /  having trouble moving my head / without pain that makes you want to cry; pain in both arms / trouble moving my/ arms / without pain that makes you want to cry; neck and pain; upset stomach; shaking; This case was reported by a consumer and described the occurrence of throat irritation in a 55-year-old female patient who received Herpes zoster SHINGRIX. Concurrent medical conditions included thyroid hormones decreased and multiple allergies. On 6th November 2020, the patient received the 1st dose of SHINGRIX .5 ug. On 14th November 2020, 8 days after receiving SHINGRIX, the patient experienced mobility decreased. In November 2020, the patient experienced throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach and tremor. On an unknown date, the outcome of the throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach, tremor and mobility decreased were recovered/resolved. The reporter considered the throat irritation, tiredness, muscle pain, headache, pain in arm, neck pain, upset stomach, tremor and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had multiple allergies and take medicines for low thyroid. Age at vaccination was not reported. Age group was captured as adult as per product indication. The patient received SHINGRIX on right arm. Reaction started with scratchy throat, tired and muscle pain not too bad but not great. It escalated during the week with severe headache, neck and pain in both arms, upset stomach. By Saturday night on 14th November 2021 the patient had trouble moving head and arms without pain that makes want to cry. It started to ease up Monday the 16th but the patient did call doctor. The patient continued to feel milder symptoms until the next Sunday.
No adverse event. 23-year-old patient (pregnant) with asthma received a 2nd booster of Moderna.
had them in spite of having had 3 shots/suspected vaccination failure; had them 3 times; had 3 shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 3 Shingles shot, which led to extra dose administered. The patient had 3 times shingles already in spite of having had 3 Shingles shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
VACCINE ADMINISTRATION ERROR DUE TO AGE. NO ADVERSE EVENT IN CLINIC OR IN FOLLOW UP.
Lyme disease; Paraesthesia of limbs; Drug effect incomplete; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4375216-00 (Company).  A 37-year-old female patient received BNT162b2 (BNT162B2), on 10May2021 as dose 1, single (Batch/Lot number: unknown), on 01Jun2021 as dose 2, single (Batch/Lot number: unknown), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Jan2022 (Lot number: 1159933), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious) with onset 2022, outcome "not recovered", described as "Drug effect incomplete"; LYME DISEASE (medically significant) with onset 2022, outcome "not recovered"; PARAESTHESIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "Paraesthesia of limbs". The patient underwent the following laboratory tests and procedures: Lab Test: (2022) Positive, notes: Positive for lyme disease. The action taken for adalimumab was unknown. In 2022, the patient experienced tingling in all four extremities/vaccine caused paresthesia in hands and feet for about seven days, tested positive for lyme disease and not had great results yet with humira. In 2022, the tingling in all four extremities/vaccine caused paresthesia in hands and feet for about seven days resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of tingling in all four extremities/vaccine caused paresthesia in hands and feet for about seven days, tested positive for lyme disease and not had great results yet with Humira was not provided. For the events Paraesthesia of limbs (Paraesthesia),Causality as per reporter (Drug/Vaccine) was Possible. For Lyme disease (Lyme disease), Causality as per reporter (Drug/Vaccine) was not Reported. For Drug effect incomplete (Therapeutic product effect incomplete), Causality as per reporter (Drug/Vaccine) was not Reported.  The reporter's assessment of the causal relationship of "lyme disease" and "drug effect incomplete" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "paraesthesia of limbs" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information in the case the report events  "lyme disease" and "drug effect incomplete" and "paraesthesia of limbs" assessed as Related to suspect drug BNT162b2.
Admitted.  The primary encounter diagnosis was COVID-19. Diagnoses of Nausea and vomiting in adult, Weakness generalized, and Hypokalemia were also pertinent to this visit.
Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning an 18 year old female (previously reported as "older" female) who was vaccinated in December 2007 ("right before Christmas"), with the first dose of Gardasil (lot # not reported).  Concomitantly, the patient received influenza virus vaccine (unspecified).  It was reported the patient experienced "a whoosh/warm feeling going through her leg, the shot felt uncomfortable and the area was tender."  The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including body aches and malaise, as well as nausea.  It was reported that there were flu symptoms going around the town.  The nurse reported that the symptoms lasted for 1 1/2 days.  It was reported that another patient experienced symptoms after receiving Gardasil, (WAES # 0801USA02008).  Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow up information has been received from a registered nurse concerning an 18 year old caucasian female with no pertinent medical history, who was  vaccinated IM in the left thigh, on 18-DEC-2007 at 8:55 am, with the first dose of GARDASIL (lot # 656049/0187U). Concomitantly, the patient received the first dose, IM in the left arm, of influenza virus vaccine (SP, lot #02435AA). There was no illness at the time of vaccination. It was reported the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender." The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including headache and body aches and malaise, as well as nausea. She also reported fatigue and no appetite. It was reported that there were flu symptoms going around the town. The nurse reported that the symptoms lasted for 1 1/2 days, with recovery noted on 20-DEC-2007. It was reported that another patient experienced symptoms after receiving GARDASIL. (WAES # 0801USA02008). Additional information is not expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-APR-2016, the patient was treated by the same physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster. She was prescribed FAMVIR for management for her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Body aches, joint aches, fever, sweats, chills, nausea, extreme fatigue. Treated with Advil and rest. All symptoms continued until 12 PM 10/28/2010.
Approximately 15 hrs after injection and feeling no side effects all day. I woke up with sweats - used an ice pack to cool. 100.7 temp (normal temp is 97.7) then chills which required a heated blanket to get some comfort. I was dizzy and could not stand without support for any length of time during the next 5 hrs.  My sensecof taste was affected for almost a week- a weird "milk of magnesia " taste no matter what I ate.  12 hours later I was well enough to be on my feet, 24 hours after that I had very little recollection of the prior days activities or conversations. (Like a lost a day in my mind- that was scary- what's in this vaccine??) The next several days, did not have my normal energy level.  I am a healthy person, high energy person. I have never taken a flu vaccine, my body has a pretty great immune system, but I did this vaccine " mostly, for the good of the whole"- I will think long and hard before I would take this vaccine again or recommend doing so to anyone else. I have been told- those with the greatest immunity system will have the worst side effects- I am not sure that makes
Cough, wheeze & rash. Cephalexin 500 mg BID, Diphenhydramine 25 mg PRN.
He cant lift the arm because of the pain; Back is hurting; Can't use arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He cant lift the arm because of the pain), BACK PAIN (Back is hurting) and LIMB DISCOMFORT (Can't use arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 316139 Wasn't sure) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (He cant lift the arm because of the pain), BACK PAIN (Back is hurting) and LIMB DISCOMFORT (Can't use arm). At the time of the report, PAIN IN EXTREMITY (He cant lift the arm because of the pain), BACK PAIN (Back is hurting) and LIMB DISCOMFORT (Can't use arm) outcome was unknown.        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.   Treatment information was included vitamins.
Information has been received from a registered pharmacist concerning a 31 year old female who on 30-OCT-2008 was vaccinated with PNEUMOVAX (Lot # 662662/0979X) intramuscularly (total daily dose not reported). On 31-OCT-2008 the patient developed temp of 103-104 and shoulder induration, she can't lift arm above shoulder height". The patient went to doctor, the physician diagnosed her with "reaction to vaccine-cellulitis" and prescribed her antibiotics, DECADRON as well as alternate TYLENOL and ibuprofen. On 07-NOV-2008, the patient recovered and returned to work. This is one of several reports received from the same source. No further information is available.
Employee received 2nd dose of Pfizer vaccine. After about 13 minutes, patient returned to vaccination station with complaints of itching and mild hives noted to left forearm. Benadryl 50mg po dispensed at 1345.  Pulse Ox: 94%, HR: 70.  Pt stated Pulse ox normally runs at this level due to hx of asthma.  Itching continued to progress up left arm and down left leg. Denied any reaction after first dose.  Vaccine Clinic staff notified.  Pt escorted by staff to convenient care at 1353.