chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY
swelling; rash; arm started itching pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), RASH (rash) and VACCINATION SITE PRURITUS (arm started itching pretty bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SWELLING (swelling) and RASH (rash). In April 2021, the patient experienced VACCINATION SITE PRURITUS (arm started itching pretty bad). At the time of the report, SWELLING (swelling), RASH (rash) and VACCINATION SITE PRURITUS (arm started itching pretty bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient came to pharmacy to show us itchy rash/bumps on deltoid area that developed after her flu shot.  I counseled her to apply hydrocortisone to relieve the itching.  I left a note, and they confirmed she used a 5/8" needle when administering the flu shot.
Severe pain and weakness in arm for 2 weeks, moderate pain continuing over 2 months
pt recvd vax 24JAN94 & w/in 24 hrs devel fever of 103 which persisted through 27JAn; office visit 26JAN; treated w/APAP; pt also devel sl cough & congestion following immun;
Redness on legs, swelling. Treated with Tylenol q 6 hr
received the 2 dose vaccine / 12/7/20 / just got the herpes infection this past week; This case was reported by a consumer via (Shingrix GSK and described the occurrence of herpes virus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingrix. In April 2021, between 4 and 5 months after receiving Shingrix, the patient experienced herpes virus infection. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient received the 2nd dose of Shingrix and just got the herpes infection this past week prior to the report. The patient used Valtrex to treat the herpes infection. The reporter inquired could we tell, what had happened or do the patient needed the booster dose.
rash on chest; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 63 years or 64 years. There were no adverse events associated with dose 1 of Shingrix. The patient had rash on the chest.  No other details were known.   The patient did not consent to follow-up.
throbbing pain from head to toe, gradual onset, continued to wane until 6a this morning.
No additional AEs; administration of expired PROQUAD vaccine to 2 patients on 9/20/22.; This spontaneous report has been received from a nurse concerning a 6-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 20-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), 0.5 milliliter (ml) (lot # U009260, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD], expiration date reported and upon internal validation established as 19-SEP-2022) (anatomical location and route of administration were not provided) for prophylaxis (Expired product administered).  No additional adverse event was reported.
Pt recv vax on 4/29/99; on 4/30/99 pt exp local allergic rxn of erythema, swelling, warmth
mild cough; I was told individual was not feeling well morning of 12Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization.   Relevant medical history included: "overweight (not sure how much)" (unspecified if ongoing), notes: overweight (not sure how much); "Allergies: potentially gluten" (unspecified if ongoing), notes: Known Allergies: potentially gluten. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, Primary Immunization series complete but unknown manufacturer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization.  The following information was reported: MALAISE (non-serious) with onset 12Dec2021, outcome "unknown", described as "I was told individual was not feeling well morning of 12Dec2021"; COUGH (non-serious), outcome "unknown", described as "mild cough".  Additional information: Do not know when he started developing a mild cough. was in early 20s - probably between 21 and 23-years-old. The lot number for bnt162b2 was not provided and will be requested during follow up.
Tested prior to hospital admission. Started with a cough on 7/17/21 and fell at home. Was brought to ER for evaluation. Per nurse on the floor, he was admitted for fall and COVID, and has no issues from fall so continued admission is due to COVID treatment.  Currently receiving plasma treatment and oxygen.
rash across top part of stomach with mild itching,rash across top part of hips with mild itching; sore stomach; body aches; fever (101.2°F); chills; fatigue; joint pain; This spontaneous case was reported by a health care professional and describes the occurrence of RASH PRURITIC (rash across top part of stomach with mild itching,rash across top part of hips with mild itching), ABDOMINAL PAIN UPPER (sore stomach), PAIN (body aches), PYREXIA (fever (101.2°F)) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash across top part of stomach with mild itching,rash across top part of hips with mild itching), ABDOMINAL PAIN UPPER (sore stomach), PAIN (body aches), PYREXIA (fever (101.2°F)), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, RASH PRURITIC (rash across top part of stomach with mild itching,rash across top part of hips with mild itching), ABDOMINAL PAIN UPPER (sore stomach), PAIN (body aches), PYREXIA (fever (101.2°F)), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 f.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants or treatment medications were reported.
she has a bleeding problem; she couldn't sleep; her arm was sore; she had shooting pains throughout her whole body, leg, arm, head jaw ("the pain moved"), until 4AM the pain continued; she also felt tired; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's other medical history and concomitant medications were not reported. Patient received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. On an unspecified date, she has a bleeding problem and she has heard about ITP reactions to the vaccine. She also said that there are many people who couldn't sleep after receiving the second dose of the Pfizer or Moderna vaccines. And last Friday (UNSPECIFIED DATE), at night she had a "weird side-effect", she couldn't sleep, her arm was sore and she had shooting pains throughout her whole body, leg, arm, head jaw ("the pain moved"), until 4AM the pain continued, then she was able to sleep for a few hours, she also felt tired. She would like to know if this has been reported with the vaccine. The outcome of events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Lymphadenopathy in right arm with intense pain, also intense pain on the back from shoulders to the waist. Arthralgia, specifically on both ankles, fever , dizziness, and nausea. treated with acetaminophen and rest.
chest stuff [Respiratory tract congestion]; chills; fever; aches in joints ankles and knees; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest stuff [Respiratory tract congestion]), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (aches in joints ankles and knees) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782591) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 30-Jan-2023, the patient started UPADACITINIB (RINVOQ) (Oral use) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 11-Oct-2023, the patient experienced RESPIRATORY TRACT CONGESTION (chest stuff [Respiratory tract congestion]), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (aches in joints ankles and knees). At the time of the report, RESPIRATORY TRACT CONGESTION (chest stuff [Respiratory tract congestion]), CHILLS (chills), PYREXIA (fever) and ARTHRALGIA (aches in joints ankles and knees) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No Concomitant and treatment medications were reported.
raised area @ inject site, red rash blotchy @ inject site extending to elbow; 12AUG92 extremely swollen, warm & tender; 13AUG92 sx worse; seen in ER 13AUG;
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2016 ("between 09-FEB-2016 and 03-MAR-2016"), the patients were vaccinated with doses of improper stored VARIVAX (Merck) (lot # L007225, expiration date 03-MAR-2017; lot # L017142, expiration date 13-MAY-2017; lot # L021211, expiration date 10-JUN-2017) (dose and route were not reported). The vaccine was exposed to temperature 35F for 15 hours 45 minutes. There was no previous temperature. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Appears much of the dose leaked down patient's arm; Undetermined amount of 2nd Moderna Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Appears much of the dose leaked down patient's arm) and DEVICE CONNECTION ISSUE (Undetermined amount of 2nd Moderna Vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced UNDERDOSE (Appears much of the dose leaked down patient's arm) and DEVICE CONNECTION ISSUE (Undetermined amount of 2nd Moderna Vaccine). On 11-May-2021, UNDERDOSE (Appears much of the dose leaked down patient's arm) and DEVICE CONNECTION ISSUE (Undetermined amount of 2nd Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
please above, pt is diagnosed with zoster outbreak 9 days after receiving the vaccine.  Course, currently 15 days with increasing dermatome involvement.
A report was received from a health professional on 25Oct02, concerning seven pt who experienced red, burning, hard nodules at the site of injection, after receiving Fluvirin on 22Oct02. On 22Oct02, seven out of 68 employees who received Fluvirin at a community hospital experienced red, burning, hard nodules at the site of injection within a few hours. The pt's were seen in the ER. The vaccine was administered using a TB syringe with a prefixed needle. It was unk if the pt's recovered. The reporter provided no information on pt specific details. The reporter suspects that these adverse experiences are probably associated with this particular batch of Fluvirin. The following day, additional employees received Fluvirin from a different batch and no adverse experiences were noted. Update 1 20Feb03: A report was received from a health care professional concerning a 60 year old male vaccinee who experienced raised red induration at the injection site 15 minutes after receiving Fluvirin on 20Oct02. The vaccinee was observed in the ER and recovered on 23Oct02. Three other vaccinees had the same reaction to the same batch. See ref: PJP200300088, PJP200300089, PJP200300090.
Patient is a 84 y.o. Caucasian male who presents with weakness.  Patient started having coughs on Thursday, followed by weakness, excessive sleeping, no appetite, headache.  He had dialysis yesterday and felt extremely weak after to the point that he could not get out of bed today. He was found to be positive for COVID but not hypoxic in ER.  No chest pain, no nausea, no vomiting, no diarrhea, no shortness of breath.      Admitted to inpatient level of care
Tested positive for COVID-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (lack of efficacy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Diabetes.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (Tested positive for COVID-19) was resolving and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.         Concomitant medications included unspecified blood pressure medication and unspecified diabetes medication.  Patient had symptoms included cough, sore throat and sinus drainage. It was defined by patient like a normal cold. On 30-Sep-2021, patient lost taste and smell. Patient received monoclonal antibody infusion on 30-Sep-2021 for the treatment of symptoms. The only symptoms remaining were small cough and little bit of sinus drainage.; Sender's Comments: This report concerns a 65-year-old male patient with medical history of diabetes and abnormal blood pressure who experienced the unexpected non-serious event of COVID-19. Lack of efficacy was considered as an additional event. The patient had associated symptoms of cough, sore throat, rhinorrhea, loss of taste, smell and was tested positive for SARS-Cov-2. The patient was treated with monoclonal antibody infusion and the event was reported to be resolving. Re-challenge is not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 is not affected by this report.
PATIENT PASSED OUT AFEW MINUTES AFTER THE VACCINE. HAD INFORMED  ME THAT SHE PASSES OUT DUE TO FEAR OF NEEDLES COOLED HER DOWN WITH WET PAPER TOWEL AND SHE CLAIMED SHE HAD A LOW BLOOD SUGAR EPISODE,  GAVE HER A N OTC GLUCOSE TABLET THAT SHE TOOK & HAD HER REST FOR A WHILE AND SHE FELT BETTER
Red from injection site to slightly below elbow with edema, pt was informed to take Benadryl 4 times per day, Ibuprofen 3 times per day and to apply warm compresses to sight.
Several weeks after the vaccine I developed significant lethargy, fatigue, generalized muscle weakness. I dealt with it figuring it was caregiver fatigue as I work FT, care for my elderly father and have 2 toddlers. On an annual physical in July 2021 with my PCP we discovered my TSH levels were clinically 0. I have no family history of thyroid, endocrine or autoimmune diseases. I was referred to endocrinology and have been diagnosed with Graves Disease. Both clinicians feel the vaccine had an impact on this development due to my health history with no medical problems and no family link. I am undergoing routine care every 6 weeks, my condition is getting worse and I am coming in to considerable debt to pay for all of the labs and doctor visits.
achy; sick; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: achy) and sickness (Verbatim: sick).  The outcome of the pain and sickness were unknown.   It was unknown if the reporter considered the pain and sickness to be related to Shingrix.     It was unknown if the company considered the pain and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2023 The reporter reported that the patient received her 1st dose of Shingrix over 2 years ago, and never got the 2nd dose because it made her really sick and achy. The reporter did not have any further information to provide about this event. The reporter did not have any information about the Shingrix such as lot, expiry, route or location of administration, or patient information. The reporter consented to follow up.
Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:  Other Relevant History:
consumer tighten up his arm muscle, and some of the product run down his arm from his injection site/NO AE; consumer tighten up his arm muscle, and some of the product run down his arm from his injection site/NO AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 58 year old male patient who received dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED, out of which some ran down his arm from his injection site because of tightening up during the injection.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot UJ428AA, expiry date- 30-June-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose and Exposure via skin contact (latency same day).  Caller states she had a consumer, that was tightening up during the injection and when she finished some ran down his arm from his injection site. States she didn't notice anything wrong with the needle nor the syringe and the needle retracted the way it should have. States she had seen this before when a consumer tightens up during injection.  At the time of report, no adverse event was reported.  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 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.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling of jaw angle in a 60-year-old male patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX. On 13th July 2018, 3 days after receiving SHINGRIX, the patient experienced swelling of jaw angle. On an unknown date, the outcome of the swelling of jaw angle was unknown. It was unknown if the reporter considered the swelling of jaw angle to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced a swollen jaw on the same side as where the SHINGRIX injection was given in the left side. The date of 1st injection was not discussed.
Cap was not secure on on the vial. Patient did not get full dose of vaccine. Second dose was given
Left arm injection site: warm to the touch; elevated - raised area 7 cm x 5 cm with 105 cm (Length) x 2 cm (width) slightly red center. MD evaluation: Left arm erythematous & indurated. Treatment: NSAIDS; Motrin as needed & ice to area. Monitor for signs of infection.