chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red, raised, itchy patch around injection site.  Patient said began evening after vaccine administration and was worse in the morning.  Patch today is about 3 inches in diameter.  She states she took Atarax and applied hydrocortisone cream to the area and it is getting better now.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
PAIN IN SHOULDER; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was not reported and height was 51.5 inches. The patient's concurrent conditions included hypertension, obesity, arthritis, panic attacks, borderline diabetes, mold allergy, tree allergy, cat allergy, dog allergy, cipro allergy, and non smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced pain in shoulder. On 29-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pain in shoulder on 09-APR-2021. This report was non-serious.
Fever 103, crying, fussy, red rash over entire body - Maculopapular rash.
This case was reported by a pharmacist via call center representative and described the occurrence of mass in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX. On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced mass and myalgia. On an unknown date, the patient experienced feeling unwell. The patient was treated with TYLENOL and ibuprofen. On an unknown date, the outcome of the mass and myalgia were recovered/resolved and the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the mass, myalgia and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The health care professional reported developing a lump that lasted a week and myalgia that started the day after receiving the dose of the SHINGRIX series. The health care professional stated she felt like she was getting sick. The health care professional was taking TYLENOL and Ibuprofen for the adverse effects. She did not have lot number and expiration date of vaccine.
she was giving the pentacel vaccine and realized that she only gave the diluent; Initial information received on 16-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who received only gave the diluent portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without ActHIb portion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccines were Prevnar 13 and Rotavirus.   On 10-Apr-2019, the patient received a 0.5 ml second primary dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5576AB via intramuscular route in the left thigh.  It was of actual medication error due to inappropriate reconstitution technique.  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.  List of documents held by sender: none.
Constant vertigo since 2nd vaccine on Feb 10, 2021.  Have seen several different types of doctors and cause has not yet been determined.
Pt reported initial reaction of uncontrolled bilateral shaking/tremor of arms. Tremor abated, but patient reported next three days had nausea, loss of apettite and fatigue. Pt reported 10/18/2014 - states complete resolution.
Noticed nausea without vomiting's, decreased appetite, upper GI upset including burning. I made an appointment with GI dr. who is recommending ultrasound of upper ab, a colonoscopy to look at the GI track, and an ultrasound to rule out celiac disease. My side effects began just this month, about 6 months after the vaccine.
tested COVID positive with at home test on 09-May-2022; tested COVID positive with at home test on 09-May-2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 52 years, in left arm at workplace clinic for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Patient do not have any known allergy. Concomitant medication(s) included: ATORVASTATIN; VENLAFAXINE HYDROCHLORIDE. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF8841, Location of injection: Arm Left), administration date: 18Nov2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 51-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 51-year-old, for COVID-19 immunization. There were no other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "tested COVID positive with at home test on 09-May-2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (09May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Fever started in the afternoon, clear runny nose, Fever up to 103, Resp rate up to 70 per min No retractions, fever down to 100.  11/20 + 11/21, vomited X2, Some lethargy.
Pt recvd vax 1030AM about 12noon c/o entire arm & hand being painful; denies discoloration or warm areas; dad states c/o aching & applying ice bag; will consult pt's MD:
Swollen really bad, sore, and red. About the size of a top on a jar. Itchy.
Child given vaccine on 5 July. Parents returned to clinic with him on 13 July and reported that after about 4 days, he developed an intense local reaction- redness and swelling around the injection site. Mom had photos on her phone of the reaction. Over the past few days, the redness and swelling have gotten better. Mom used home remedy salve on the site. No medications given. At visit on 13 July, there was still slight swelling in area of vaccine and mild erythema. There was no tenderness at site. Parents deny any symptoms of the child having difficulty breathing, nausea or vomiting, syncope, or any other symptoms besides the local reaction. Mom requested VAERS report be submitted. At the visit on July 13, she also noted that the child had not received a vaccine since he was 2 months old.
I have had ongoing chest pain since vaccination. I have done 12-leads as well as blood work with no indication of anything. However, since vaccination this has been an ongoing issue. Awaiting on getting an ECHO done on my heart.
curly haired child presented w/head lice @ 2wk post vax;mom reportedly tx child x5-6 w/OTC prescription & rx lindane;onset of alopecia early in SEP97 w/breaking hair & falling out in clumps & handfuls;
Muscle spasms in my back and left/right torso. Now, in my bladder too.
pt recv vax & 2wk post vax pt devel swelling in groin area which progressed to knees, neck, & behind ears;
Patient complains of being unable to raise left arm, complains of pain from elbow to shoulder region, denies any redness or swelling at injection site. Instructed to use warm compresses or heating pad and take Ibuprofen for inflammation
Abnormal clusters of lymph nodes in left of my brain and neck region; I could not not keep down water and medication; Extreme nausea; Headache; Neck pain; Extremely dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 006B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion hospitalization), DIZZINESS (Extremely dizzy) (seriousness criterion hospitalization), NAUSEA (Extreme nausea) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 14-May-2021, the patient experienced LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region) (seriousness criterion hospitalization) and VOMITING (I could not not keep down water and medication) (seriousness criterion hospitalization). The patient was hospitalized on 14-May-2021 due to HEADACHE, LYMPHADENOPATHY, NAUSEA and VOMITING. The patient was treated with BUTALBITAL ongoing since an unknown date for Headache, at an unspecified dose and frequency and ONDANSETRON ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), DIZZINESS (Extremely dizzy), LYMPHADENOPATHY (Abnormal clusters of lymph nodes in left of my brain and neck region), NAUSEA (Extreme nausea), HEADACHE (Headache) and VOMITING (I could not not keep down water and medication) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Computerised tomogram: (abnormal) Abnormal clusters of lymph nodes in left of my brain and neck region..         Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was reported by a consumer and described the occurrence of knee joint pain in a 55 year old male pt who received Lyme disease vaccine recombinant (Lymerix). The reporter is the pt. A physician or other health care professional has not verified this report. The pt's medical history was notable for no drug allergies. Concurrent medication at the time of immunization included Atorvastatin calcium (Lipitor). On an unspecified date in 2000, the pt received the third dose of Lymerix. Approx four years after the administration of Lymerix, on an unspecified date in late spring 2004, the pt experienced joint pain in the knee. The pt reported that he experienced so much pain that he limped. The pt was seen at a physicians office and underwent "multiple tests"; however, no tests or test results were reported. At the time of initial reporting, the knee pain was worsening.
Capsule had passed in the stool; A spontaneous report was received on 09NOV2023 from male patient of unknown age whose "capsule had passed in the stool" (PT: Product residue present). The patient took Vivotif (Typhoid vaccine live oral Ty21A; route: oral; lot number: unknown) for an immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient was prescribed typhoid medication and had doses properly. The patient took last dose of Vivotif and after 45 minutes, the capsule had passed in the stool. Further, the patient had no issues with the prior doses and wasn't experiencing any nausea or diarrhea or anything.  The outcome of the reported event was unknown.    The action taken with Vivotif with respect to the reported event not applicable.    No additional information was reported.  Company comment: It was reported that a patient took last dose of Vivotif and after 45 minutes capsule had passed in the stool (product residue present). Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took last dose of Vivotif and after 45 minutes capsule had passed in the stool (product residue present). Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.
pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2019, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid of arm. The patient stated that, after vaccination, the patient had pain in arm for 2 days which resolved. The patient consented to follow up. This case has been linked with case US2019AMR221727 andUS2019220403 reported by same reporter for same patient.
tinged blood urination; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (tinged blood urination) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Diabetes. Concomitant products included VITAMIN D3, MAGNESIUM, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]) and ZINC for an unknown indication.   On 15-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (tinged blood urination). At the time of the report, BLOOD URINE PRESENT (tinged blood urination) had resolved.            No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received provides no new information. On 29-Jun-2021: Follow-up received provided patient details, medical history, suspect dosage details and event outcome.
Pt reporting headache, dizziness,  nausea, extreme fatigue, arm pain, body aches the day after receiving the vaccine. Seen on 9/21/2021 with continued symptoms
Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to  ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen)
Brief episode of SOB which resolved after removing mask. Resolved by the time of evaluation. Denied other symptoms.
Mom returned from the parking lot of our office to show me his right leg, 5 minutes after receiving vaccinations. Right lateral thigh found to be red, hot, firm for approximately a 4-inch circular area surrounding the site of Varicella. Child did not appear to be in discomfort and was not crying, agitated or favoring his right leg. Mom asked if this could be a hive. It did not seem to be a hive as evidenced by lack of a distinct area in the middle; it was a consistent large swollen, erythemic area. Instructed mom to administer Children's dose of Tylenol (by weight) and apply a cold compress to the area when they get home. She was to monitor him for signs of worsening of the leg and for fever or issues with breathing. If these occur she will call 911 or take him to the nearest ER or UCC. Mom acknowledged understanding and left about 1 minute later. I have left follow-up voicemail messages for mom on Monday, 8/6, and today, 8/8, with no return call. The child is scheduled to return to our clinic for a 4th dose Pentacel on 8/24/18.
Caller just got out of the hospital after having Covid along with her husband and they both got their 1st dose.; Caller just got out of the hospital after having Covid along with her husband and they both got their 1st dose.; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. This consumer reported same events for two patients (for herself and for her husband). This is the first of two reports.   A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient just got out of the hospital after having COVID along with her husband on an unspecified date and they both got their first dose of the vaccine. She wanted to know if they have to get their second dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412079 same reporter, drug, and event, different patient
Itchy, painful rash on arm that was vaccinated; Itchy, painful rash on arm that was vaccinated; Itchy, painful rash on arm that was vaccinated; Rash has clusters of raised, red bumps with puss that crusts over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EW0185) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergies: gluten, reaction(s): "Allergies: Gluten allergy", notes: Allergies: Gluten allergy. Vaccination history included: Bnt162b2 (lot number: EW0185, dose number: 1, vaccine location: Left arm), administration date: 14Jul2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE RASH (non-serious) all with onset 12Aug2021, outcome "recovering" and all described as "Itchy, painful rash on arm that was vaccinated"; RASH ERYTHEMATOUS (non-serious) with onset 12Aug2021, outcome "recovering", described as "Rash has clusters of raised, red bumps with puss that crusts over". The events "itchy, painful rash on arm that was vaccinated", "itchy, painful rash on arm that was vaccinated", "itchy, painful rash on arm that was vaccinated" and "rash has clusters of raised, red bumps with puss that crusts over" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site pain, vaccination site rash, rash erythematous.  Additional Information: Patient did not test positive prior to and post vaccination. Had no other vaccine in four weeks. Adverse events were treated with Steroid cream and resulted in Doctor or other healthcare professional office/clinic visit.  Follow-up attempts are completed. No further information is expected.
parents deny any reactions following vax administration; no signs of fever, irritability or neurologic problems; died 20APR95 w/preliminary dx of SIDS;
This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity started to receive a second dose of PREVNAR 13, at her arm via an unspecified route of administration on 20Oct2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) last year (2016). Her pharmacy administered another pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) this past Friday (20Oct2017). An intern injected the vaccine and it was so high up on her arm as to be almost up to the shoulder cap. She stated that the intern injected it far too deep and it caused her to have a shooting pain that radiated around to her neck. After leaving the pharmacy, her arm was very sore and she could not move it and almost passed out later. She also stated that her physician had administered multiple pneumonia vaccines (unknown name) to a "community of people" (number unspecified) in her area, who used to be chronically ill with sinus infections. After receiving the pneumonia injections she did not get sick again, "it even warded off regular colds". The outcome of the events was unknown. No follow up attempts are Possible. No further information is expected.
9/2/2023 - 9/11/2023 (9 days)  10/2/2021 30135BA  3/25/2021 ER8727  3/4/2021 EN6198   4/20/2022 FK9895