chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's been almost three weeks and I'm still having patches that won't go away. It's 98% gone with just annoying lingering itchiness; Hives across entire body within ten minutes. Hives lasted eight days; Also had slight throat swelling; heart pounding; dizziness; headache; fever; chill; general ugh; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318), via an unspecified route of administration on 27Jan2021 at 09:00 (at the age of 47-year-old) as UNKNOWN, SINGLE in the left arm for covid-19 immunisation. The patient medical history included diabetes, thyroid. The patient had Known allergic to seabass and grouper (seafood), sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications in two weeks included Levothyroxine Sodium, Glyburide, Ergocalciferol (Vitamin D), Atorvastatin all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021 at 09:15, the patient experienced hives across entire body within ten minutes. Hives lasted eight days. Also had slight throat swelling, heart pounding, dizziness, headache, fever, chills, and general ugh. It's been almost three weeks and patient still having patches that would not go away. It was 98% gone with just annoying lingering itchiness. The patient did not receive any treatment for the events. The outcome of the events was recovering.  On 13May2021 Follow-up attempts completed. No further information expected.
pt recv vax;exp gen rash on abd&dx w chicken pox;also devel a low grade fever&malaise;
Narrative: 60yo female with colon cancer. Died on 06/15/2021. She received covid vaccinations on 03/09/21 and 03/30/21 from facility. Appears patient died of colon cancer and death is not related to the covid vaccinations.
Patient states he was having hearing complications the following day after the vaccine. Sounded like the wind or a tornado was coming through he stated.  Lasted for 20 minutes.
pt discovered blurry vision/vision loss 1 hour after getting the immunization. Has not resolved as of 04-9-21
c/o abdominal pain, cramping, nausea, diarrhea, vomited after one dose several hours later s/s happened with dose 2 and dose 4.
Pt received vaccine and approximately 5 minutes later pt got light headed fainted and hit head on the floor of the waiting room. Pt begun to seize for approximately 30 seconds then regained consciousness. Pt was stabilized and monitored. 9-1-1 contacted immediately and handled pt care once they arrived.
R leg erythema et edema-severe local rxn. Monitor, Motrin x 2 d, Benadryl x 2d, f/u prn.
Redness @ site of vaccine post 15 minutes. After 2 hrs, redness and skin hot to touch plus swelling severe-leg 1 inch larger than opposite limb. Mother contacted HD on 5/9/02. Was advised to contact physician. Client was seen by doctor  5/9/02 and again 5/10/02. Mother reports left leg measured 1 inch larger than right leg @ physician's office. Physician gave Duracef for possible skin infection and Benadryl. On 5/13/02, mother states leg looks better- mottled appearance now. Is to rerturn to physician on 5/16/02 for follow up visit.
w/in 15min p/vax c/o feeling nauseous;w/in 20min n/v onset;w/in 45min c/o n/v & pain in back of head;states this is the aura prior to onset or sz;reported 2 day later that 1st sz occurred approx 1hr p/vax & cont for remainder of day;
I started to develop a very bad headache. I took one of my medications and it did not help my headache. I started to develop a sore throat. My headache did not go away so I took a COVID-19 test and it came back negative. A couple days later my symptoms did not improve so I took another COVID-19 test and it came back positive. My headache was so bad that I went to urgent care. They prescribed me Paxlovid. After the first dose I got relief from my headache. Two days later my symptoms were gone.
Myalgia & Rash Narrative:  Localized swelling with myalgia and fatigue
9-15-13: Spiked high fever, severe chills and fatigue. 9-16-13: fatigue, fever, chills. 9-17-13: Patient developed facial swelling, hives, chest pains, difficulty breathing. Went to ER.
This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, myalgia, fatigue, chills and influenza-like symptoms. On an unknown date, the outcome of the fever, myalgia, fatigue, chills and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, myalgia, fatigue, chills and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 101 degrees F. The reporter did not agree to be contacted for follow up. No additional information was provided. Lab Comments: Lab test was done on an unknown date.
autoimmune disorder; Lung pain; stomach pain; underskin rash; vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune disorder) in a patient of an unknown age and gender 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.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune disorder) (seriousness criterion medically significant), PULMONARY PAIN (Lung pain), ABDOMINAL PAIN UPPER (stomach pain), RASH (underskin rash) and VOMITING (vomiting). At the time of the report, AUTOIMMUNE DISORDER (autoimmune disorder), PULMONARY PAIN (Lung pain), ABDOMINAL PAIN UPPER (stomach pain), RASH (underskin rash) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Company Comment  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.
Pt recvd MMR vax & 1 wk following vax devel a diffuse maculopapular rash, myalgia, arthralgia & malaise; sx lasted 3-4 days; no further details were provided;
Pt was given Flucelvax shot intended for a different patient instead of Fluzone HD. Technician noticed their error after setting up for the next shot for which that patient had the same first name.
Patient received second dose of Pfizer vaccine on 4/18/21 (left arm), with chills, body aches, left arm vaccination site soreness occurring that same day. 2 days ago, symptoms went away except for slight soreness at the injection site. Yesterday, +nausea, fatigue, chills - took nyquil cold and flu (also took it on Sunday and Monday night). Today, patient had dizzy spell for about 30 seconds to 1 minute. Still with nausea today, fatigue, lightheadedness. Injection site is still a little sore when pressing on it.
This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis. On 6th December 2021, the patient received Shingrix. On 6th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The patient received expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter asked should they repeat the dose. The reporter consented to follow up.
Patient was to  be vaccinated with Fluzone High-Dose Quadrivalent vaccine, but was administered with the Flublok Quadrivalent vaccine instead, no AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 84 years old female patient who was to be vaccinated with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot number UJ446AA and expiration date 18-Mar-2021) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiration date were not reported) via intramuscular route in the left deltoid for prophylactic vaccination on 23-Sep-2020 (PT: wrong vaccine administered).  Patient vaccination history included flu vaccines in the past, including high-dose flu vaccine and she had experienced local reaction of pain or soreness or puffiness at the injection site for a few days after the flu vaccine injection.  Medical history, medical treatment(s) and family history were not provided.  Patient received no concomitant vaccines on 23-Sep-2020.   It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  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.
feeling sick; aching; fever of 102.1; nauseous; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1), NAUSEA (nauseous) and INJECTION SITE ERYTHEMA (redness at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1), NAUSEA (nauseous) and INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 20-Apr-2021, NAUSEA (nauseous) had resolved. At the time of the report, MALAISE (feeling sick), PAIN (aching), PYREXIA (fever of 102.1) and INJECTION SITE ERYTHEMA (redness at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 102.1 (High) High.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Concomitant drug information was high blood pressure medication.
Information has been received from a Pharm. D. concerning a child (age and gender not reported) who was vaccinated on unspecified dates with 2 series, a total of 4 doses, at the appropriate schedule for each with hepatitis A virus vaccine inactivated (lot # not reported).  A titer done 4 weeks later was negative.  Unspecified medical attention was sought.  Additional information has been requested.
Patient has bilateral large red square like red marks a few inches underneath both injections sites and a smaller red spot in the area of the injection site on both arms . . . based on the position it could be a reaction to the the gloves used since on both arms.
Fatigue, vomiting, nausea, low grade fever at 99.5, body aches
Suspected vaccination failure; I'm suffering from singles; This case was reported by a contact via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself or herself. The age at vaccination was not reported. The patient got Shingles vaccine 4 years ago and on the day of reporting, he or she was suffering from shingles.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
ADMINISTRATION OF AN EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210959351, 20210959620, 20210958348, 20210958371, 20210958425, 20210958566, 20210958518, 20210958977, 20210958321, 20210958806 and 20210959909.
This spontaneous report as received from a pharmacist and also from a patient, refers to a 66 year old female patient. She did not have pertinent medical history, drug reactions or allergies and concomitant therapies. On 09-DEC-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscularly, lot # N024385, expiration date 18-MAY-2019 (dose and site of administration were not reported) for prophylaxis. On 09-DEC-2017, the patient was unable to raise her arm above her head, towards the end of that day, due to the pain in her arm. On unknown date in December 2017, the patient experienced redness around injection site. Furthermore, redness turned yellow. The outcome of pain in extremity was unknown. The outcome of vaccination site erythema and yellow skin was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was unknown. The patient did not seek medical attention. No treatment was given for the adverse events. There were no lab diagnostic studies performed. No product quality complaint (PQC) was involved.
This spontaneous report was received from a patient's mother and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VAQTA injection, 25/0.5 (units not provided) for prophylaxis (frequency, route of administration, lot #, expiration date were not reported). On an unknown date, the patient after administration of the vaccine began to experience headaches and stomachaches. The outcome of the events and causality relatedness was not reported.
It was discovered on 8/23 that the dose delivered to this patient may not have been diluted.  Patient's mother was contacted 8/24 and the patient is currently without symptoms/side effects.
Fever of 101°, sore muscles, exhaustion.  Started symptoms around 3 pm and grew worse over time.
area oblong shape 2 inches wide and 3 inches long that is bright red.; headache; mild chills; swelling at injection site-right arm; achy; soreness; tender arm; sore arm; felt like light flu; hard bumps; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm), INDURATION (hard bumps), INFLUENZA LIKE ILLNESS (felt like light flu) and ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INDURATION (hard bumps). On 24-Feb-2021, the patient experienced TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like light flu), HEADACHE (headache), CHILLS (mild chills), VACCINATION SITE SWELLING (swelling at injection site-right arm), MYALGIA (achy) and MYALGIA (soreness). On 01-Mar-2021, the patient experienced ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.). In February 2021, INDURATION (hard bumps) had resolved. On 25-Feb-2021, TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm) and INFLUENZA LIKE ILLNESS (felt like light flu) had resolved. At the time of the report, ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.), HEADACHE (headache), CHILLS (mild chills), VACCINATION SITE SWELLING (swelling at injection site-right arm), MYALGIA (achy) and MYALGIA (soreness) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter
PT HAD HIVES DAY AFTER THE 1 ST DOSE . THEY DID NOT MENTION ANYTHING TILL WHEN THEY CAME IN FOR SECOND DOSE . RECOMMNDED TO CHECK WITH PRIMARY CARE PHYSICIAN BEFORE GETTING SECOND DOSE AND TO GET IT AT THE DR'S OFFICE IF DR STILL DEEMS NECESSARY
patients received vaccine after temperature excursions; product storage error; Expired product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.
I awoke at 3 AM with shaking chill and muscle aches of moderate intensity (5 on a scale of 1 to 10).  I took 400 mg of ibuprofen and symptoms subsided substantially in 30 minutes.  Much milder symptoms persisted for 24 more hours and then almost completely resolved.
A few months after third dose of HPV/gardasil my daugther began to have severe pain bilateral low groin area., personality & mood changes occurred with abdominal pain, depression, crying, yelling, exhaustion stayed in bed 2 days twice a month followed by twice a month menses with heavy bleeding. My daughter described a popping sensation when abd. was in pain and cramps then there would be some relief. A few days after abdominal pain/cramps heavy menses would start. She has hair loss to head, hair develop on face and acne along chin.
an 11-year-old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a clinic employee. The reporter stated that the 11 year old patient received kinrix which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Tonic-clonic seizure for one minute then post-ictal. Awake upon arriving at ED in ambulance. Mom said whole body stiffened and she turned blue.
Tachycardia, enlarged atrial arch, decreased kidney function, constant headaches, fatigue,
Received Tdap (R) deltoid, IIV-3 Flu shot in (L) deltoid 10/16/15. Called provider on 10/19 to report reactions 2 days after shot, had redness and swelling, itching, and tenderness in upper (R) arm. Swelling was as large as a jumbo egg, painful to touch.
50 cent piece size redness, warm to touch on lt thigh;resolved on its own;
No additional AE/no PQC; Product experienced a temperature excursion and was administered before they were aware of TE; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender   The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 05-JUN-2023, the patient was vaccinated with a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection that had experienced a temperature excursion (product storage error) (lot number W027449 has been determined to be valid for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23); expiration date has been established as 25-SEP-2024) administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events were reported, the patient had not experienced any signs or symptoms of adverse events.  This is one of 2 reports from the same reporter. ; Sender's Comments:  US-009507513-2306USA004149: