chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy rashes; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number PF454, expiry date 26th January 2022) for prophylaxis.   On 16th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 1 week after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and about 1 week after getting the vaccine the patient developed itchy rashes on different areas of her body. She still has the rashes.
Two months post 2nd vax, the pt's hip joints started to ache and muscles were tight in the spine. Shoulder pain was experienced also.
Rash onset for 2 days. Erythematous and itchy. Denies aggravating and relieving factors. No SOB. T: 97.5 on 8/24/16.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-OCT-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster with complications. During 2016, the patient was treated at a family health center for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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. Additional information has been requested.
1st shot of Gardisil   Patient became ill with headache stomache ache (cramping) & mother told her it was probably just the flu & it lasted 3 days. The second time she got the shot 3 months later patient was dizzy & nauseated within 10 to 15 minutes after shot & other symptoms included achey all over blisters on skin & low blood pressure & headache & low grade fever.
Bad pain after getting the vaccine; This spontaneous case was reported by an other and describes the occurrence of PAIN (Bad pain after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Bad pain after getting the vaccine). At the time of the report, PAIN (Bad pain after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
This spontaneous report as received from nurse refers to a Human Immunodeficiency Virus (HIV)-positive patient of unknown age and gender. On unspecified date in September 2007 the patient was vaccinated with first dose GARDASIL, on unspecified date in November 2007 patient was administered with second dose of GARDASIL and on unspecified date in January 2009 with third dose, subsequently (doses, lot # and expiration dates for each vaccination not reported). No adverse effect reported. Additional information is not expected.
Dizziness within 24 hours, extreme vertigo needing medical treatment within 48 hours. Extreme fatigue beginning immediately after injection.
was vaccinated and got them again/suspected vaccination failure; got them; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine and got them again 2 years after vaccination. The follow up would not be possible as no contact details were available. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My lower back is killing me), FEELING ABNORMAL (Not feeling great), PAIN (Achiness), URTICARIA (Hives on arm, trunk and rest of the body) and MYALGIA (Muscle pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 017B21A and 010A21A) for COVID-19 vaccination. No Medical History information was reported.On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (My lower back is killing me), FEELING ABNORMAL (Not feeling great), PAIN (Achiness), URTICARIA (Hives on arm, trunk and rest of the body) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (My lower back is killing me), FEELING ABNORMAL (Not feeling great), PAIN (Achiness), URTICARIA (Hives on arm, trunk and rest of the body) and MYALGIA (Muscle pain) had not resolved. No concomitant medication was reported.
patients have been administered doses while the temperature excursion assessment was ongoing; patients have been administered doses while the temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022.   The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
got Covid; got Covid; Covid vaccine booster shot; This is a spontaneous report from a contactable consumer or other non hcp.  A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for Injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. On an unspecified date, the patient had COVID vaccine booster shot (immunization) and afterward the patient got COVID (COVID-19) and drug ineffective even though the patient was vaccinated. The reporter did not want follow-up regarding this matter as she had nothing else to share regarding this event. The outcome of the events was unknown.  No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.
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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021, 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, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported  64.30 for dose administered on 30-Mar-2021. No concomitant product reported by reporter.  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.  Batch number 014M20A underwent multiple temperature excursion on 02-Mar-2021 from 27 to 36 degrees Fahrenheit from 09AM to 03 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. No treatment medication were provided.
This spontaneous report was received from an 81 year old female patient (health professional), with drug hypersensitivity to penicillin, regarding herself. The patient's pertinent medical history was not reported. Approximately in May 2013, reported as "2 years ago", the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration date were not provided). No concomitant  therapies were reported. On an unknown date in January 2015, the patient was diagnosed with shingles in her left eye by the dermatologist who she works with, who referred the patient to an ophthalmologist, for the treatment of the shingles in her eye. The reporting healthcare worker stated that almost 5 months had past since diagnosis was made, and she was still having itching her head (left side) and her left eye's vision was still blurry, and she was still experiencing pain on her left side of the nose. The patient also stated that she did not have blisters from shingles anymore. The patient was treated with many different types of eye drops, one of which was prednisolone eye drops, and VALTREX tablets. It was also reported that the patient had a routine blood work made on an unspecified date (no results provided). The outcome of herpes zoster was reported as not recovered. The reporter did not provide a causality assessment for the adverse event. Additional information has been requested.
Information has been received from a physician concerning a 68 year old male who on June 03 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. On June 05 2004 the patient developed pain and swelling of most joints. At the time of the report, the patient was considered as not recovered. Medical attention was sought. the patient was treated with celecoxib (Celebrex) for pain. No product quality complaint involved. Additional information has been requested.
LEFT Leg swollen, pink area over swelling about 150 mm diameter, warm to touch. No pain or tenderness, but parents report there there had been pain and tenderness. Now improving 48 hours after injection
Within a month after receiving the Shingles Vaccine (ZOSTAVAX), I experienced and am still experiencing a rash with severe pain in my feet up to my knees in both legs. I have tried everything, creams, witch hazel to relieve the pain and rash. It occurs without warning and I have to submerge my legs in a tub of ice cold water and it helps the pain and itching. The palms of my hands also itch but no pain. I have tried to determine if it was food but that was not the case since eliminating foods and replacing did not make a difference. Will this get better? This rash and pain has been going on over a year now and the occurrence is more frequently now.
PT came to pharmacy for 2nd pfizer vaccine. Upon receiving vaccine, patient was alert and sat down for post observation. Within 5 minutes, pt started to feel faint and hot. Did not complain of SOB.  We continued to monitor her, and had her take off her sweater and tried to lay her down but patient refused to move. She was pale but able to answer questions. Within a second, patient lips turned blue, teeth clenched and foaming at the mouth.  An epi pen was administered and patient awoke. Paramedics then arrived 3 minuntes later and took over.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with chronic leukemia, rheumatoid arthritis, depression, thyroid disorder, allergy to sulfa and codeine. The patient's medical history included herpes. On 18-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # reported as J012661, Exp date: 10-JAN-2015), 0.65 ml, subcutaneous. Concomitant therapies included piroxicam. On 18-APR-2014, "within a day", the patient developed an unspecified blister at the injection site after receiving ZOSTAVAX. No treatment was given for the events. No lab diagnostic studies performed. The patient called the pharmacist on 21-APR-2014 for medical attention. The events outcome was reported as not recovered/not resolved. Additional information has been requested.
1131 received 2nd dose moderna vaccine 1140 pt noticed 'heaviness' on left side of face especially eye 1155 pt notified nurse of sx 1157 pt brought to the AR triage area. VS: BP 158/93, 98.1F, HR 84, 98%. Left facial droop, left eyelid swelling and decreased sensation. A&Ox4 speaking clearly in full sentences. Husband at the bedside verified left sided facial  droop not baseline for patient.  1209 pt assessed by Doctor and EMS called 1225 pt transported to ED via medic
BRIEF OVERVIEW: Admission Date: 9/10/2023 Discharge Date: Sep 22, 2023 Discharge Disposition:  skilled nursing facility        ?  No future appointments.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Asthenia [R53.1] Generalized weakness [R53.1] Acute cough [R05.1]   HOSPITAL COURSE: The patient is a 79-year-old lady was presented to the hospital from assisted living due to generalized weakness and fatigue, cough and shortness of breath.  Her past medical is significant for lewy body dementia. Symptoms had been present and worsening for a few days prior to admission.   Initial workup revealed that she was positive for COVID 19. She did not require oxygen. She was seen by PT / OT who recommended sar. She had some confusion and emotional lability worse from baseline dementia. She had CTH which was unremarkable. MRI brain was also unremarkable.  Unfortunately, the patient had to wait until she was out of COVID precautions before being able to be discharged to SAR.  Eventually, she was cleared on 09/22 and was discharged to SAR in medically stable condition.
Immediately following the vaccine he had severe arm swelling x 3 days, which resolved and was followed by reactive lymph nodes in the axilla x 3 days. This was followed by weakness and buckling of the knees (bilaterally). This is improving but it fluctuates up and down. No numbness, tingling, or incontinence. No treatment given.
Pt was inadvertently given the monovalent. He is scheduled to return for the Bivalent. No reaction reported.
Approximately 30 min follow immunizations the mother of child reports she had bilateral mildly red eyes and bilateral moderately swollen eyelids & below eyes.
pt recv vax & on the third day post vax pt exp dizziness on & off or one day;sx resolved w/o tx;
Covid arm ( red, swelling,hot, tender, pain). Chills, fever, nausea,  lethargic, headache
Pt reports with the 1st dose he had little bit of pain in his arm which went away the next day. With 2nd dose the symptoms did not occur until March sometimes, pt. experienced pain the in right shoulder which then travels to the left shoulder, down his legs and groin area. Pt reports he cannot turn in bed bc everything was hurting especially his hip and arms. Pt reports it was hard to lift his arms "feels like someone was pulling out my arms", had difficulty tying his shoes or picking anything up. The pain run down his spine and radiate to his right leg "hurt to even talk about it". Currently he is experiencing very little muscle pain in his left shoulder.  Pt reports he had tried Tylenol and Ibuprofen but that did not provide him with any relief. Pt had been seen by PCP
I received an anthrax shot at 0830 on 01AUG09.  As lunch time drew near, I began getting a terrible headache.  I ate lunch and the headache persisted.  I then started to have stomach pain and broke into a cold sweat.  At 1530, I drove home and vomited violently.  I noticed blood in the vomit.  After vomiting again, my wife drove me to the hospital.  I vomited again 3 hours later.  I spent the night in the hospital on an I.V.  I was not able to attend my drill on Sunday due to doctor's orders.  I was also extremely weak from the vomiting and lack of sleep.  I was in drill status on 01AUG09 when the incident occurred.  I am still quite weak today, 04AUG09.  In addition, on 01AUG09, I had a physical fitness test immediately before receiving the anthrax shot.  I was still hot and sweating. 8/25/09-ED records received for DOS 8/1/09-DX-Headache, vomiting. C/O headache, vomiting, feeling dizzy. 9/28/09 ICD9 codes received: 784.0, 787.03, E948.8
MD reported no other adverse events other than the pt was last seen on 8JAN92 @ 6AM alive & was found on 8JAN92 1130AM dead by mom;
My right leg and foot went completely mumb and cold for about 30 secs., also there has been some  pain in back of right knee.  I don't know if that experience had anything to do with the vaccine I received or not.  I just never had that experience before and I thought it may be important to note and submit.  I didn't call the doctor nor did I go to get medical attention.  I rubbed and worked my leg and foot until it began to warm and feel normal again.
After 10 minutes, patient got up took 2 steps and had to sit down. He then passed out, stiffened up and appeared to be seizure like (eyes in back of head, shaking, stiff). After reaching out to him, he responded to me within 30 seconds. He was pale, sweating, clammy, and hot. We gave him water, damp paper towel, and then seemed to do better. Paramedics were called and they treated him further. After he was responsive, he told me he has a phobia of needles, but did not mark anything on VAR form to let us know.
Red swollen area just below where vaccine administered. Hard to touch and warm. Continued to expand over 2 days.
Intense crying/screaming followed by loss of consciousness (eyes rolled back, went limp in my arms). After a while I was able to rouse him, but he passed out off and on for about 3 minutes.
maculo-papular rash, sudden onset of chest pain, substernal, radiating to back, pain lasted approx 3hrs relieved with Toradol dose in ED, sx's improved w/leaning forward
Patient is 17 years old and received a Janssen COVID vaccine, which is not currently approved by the FDA in this age group.
Information has been received from a physician concerning a 15 year old female who on 26-JUN-2007 was vaccinated with a first dose of GARDASIL (lot# 656050/0245U) IM and on 22-SEP-2007 was vaccinated with a second dose of GARDASIL (lot# 657006/0188U) IM while being pregnant. The patient came into the physician's office on 27-FEB-2008 the patient experienced complaints of abdominal pain, felt weak, feeling hot and a poor appetite. The patient was sent home and delivered a full term 6 pound baby in the bathroom on 27-FEB-2008. The patient and the baby are currently in the hospital on 28-FEB-2008. (It was unknown when the patient admitted to the hospital). The baby was a little anemic otherwise healthy. No additional information was provided. The reporter felt that complaints of abdominal pain, felt weak, feeling hot and a poor appetite required hospitalization. Additional information has been requested.
Tinnitus in both ears beginning about 12-14 hours after vaccination.  Still ongoing at the time of this submission.
PATIENT REFERS: BACK AND CHEST PAIN, HEADACHE, CHILLS, RESPIRATORY PROBLEMS.