chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a male consumer who on 26OCT2010 was vaccinated with a dose of PNEUMOVAX 23 into the right arm by a pharmacist and "the next couple days" "felt miserable," had flu-like symptoms, chills, and a fever of 101.9. It was reported that the patient had an adverse reaction to the vaccine. On Friday (29NOV2010), the patient's blood pressure dropped and he sought medical treatment at the doctor's and was diagnosed with cellulitis and found out he was dehydrated. The consumer missed a couple days of work because of this incident. At the time of reporting the patient's outcome was not provided. Additional information is expected.
Erythematous macular rash over abdomen and bilaterally over upper extremities x 1 hour
PREVNAR 13 joint, muscle pain (ongoing) right arm. FLUZONE High Dose: Joint, muscle, nerve pain. Shoulder to wrist (left arm). Last few weeks (injection site) pain also.
pt recv vax 26JAN96 & 15MAR96 pt exp tightness or heaviness in throat near thyroid for weeks to months;14APR96 pt exp nausea;pt exp of tightness in throat & nausea had begun as subtle then worsened & then had lessened in severity;
patient fell down but was unaware of doing so, he almost immediately was conscious again and went and sat down, he was sweating all over for about 15 minutes as well; he was given a bottle of water and was observed until the EMS arrived: after they arrived and checked him out he left without the EMS
Increased wheezing and cough during the night, no fever. This was after child saw doctor for well check in the am when he had no wheezing.
Patient had Chills, Fever, Bad headache @ back of head, Body Aches, Legs weakened, joint pain.
SORE THROAT,NASAL CONGESTION, SORENESS AT INJECTION SITE Narrative:
Loose stools; Injected arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stools) and VACCINATION SITE PAIN (Injected arm became sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injected arm became sore). On 27-Mar-2021, the patient experienced DIARRHOEA (Loose stools). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Loose stools) outcome was unknown and VACCINATION SITE PAIN (Injected arm became sore) had resolved.            The patient's concomitant medications included heart medications and blood thinner medications (unspecified).     Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Followup added on 19-JUL-2021,AE Details and outcome updated
Disease recurrence; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Positive, notes: Day1- Wednesday 17Aug -tested positive; (21Aug2022) Positive, notes: Day Rapid antigen 5- Sunday 21Aug pm. faintly positive; (24Aug2022) Positive, notes: Day 8- 24Aug adverse event antigen faintly positive; (24Aug2022) Negative, notes: Day 8 24Aug Wednesday- Felt better- rapid antigen Negative; (27Aug2022) Positive, notes: Rapid antigen test brightly positive instantly. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: It was reported that the patient was not received other medication in 2 weeks. Day 0- Tuesday 16Aug - Symptom onset. Day1- Wednesday 17Aug -tested positive am -started Paxlovid pm 18Aug-23: severe light-headedness/dizziness. Took only 4 days Paxlovid. Stopped early due to dizziness. Last dose was day 5 on 21Aug Sunday morning. Day 5- Sunday 21Aug pm. Rapid antigen faintly positive. Day 8- 24Aug adverse event antigen faintly positive. Day 8 24Aug Wednesday- Felt better- rapid antigen Negative. Day10- pm hugged family without mask. Day 11-woke with rhinorrhea. Sneezing. Feeling of head cold. Spell of profound blurred vision/scotoma at work lasting 15 min. Upon return home- Rapid antigen test brightly positive instantly. Day 12-28Aug headache weak sinusitis dizzy fatigued.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE), COVID-19,disease recurrence cannot be ruled out.
Area of redness with increased local temp about 6 cm x 4 cm diameter l(L) mid thigh where KINRIX vaccine given IM - 0.5ml.
liquid portion of the DTap-IPV was administered alone and not mixed with the ActHib portion/No AE; Initial information was received on 31-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 35 months old female patient who on 14-Jul-2020 received 0.5 ml dose of only the liquid portion of the Dtap-IPV alone of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Box: lot U6218AA and DTAP-IPV Vial lot: UJ016AAA and expiry date for both was 26-Oct-2020) via intramuscular route in the right deltoid for prophylactic vaccination and it was not mixed with the ActHib portion (product preparation issue)   The patient's medical history, past  medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was a case of an actual medication error case due to inappropriate reconstitution technique.  Case details: A medical office reporting a medication error with Pentacel described as the liquid portion of the DTap-IPV was administered alone and not mixed with the ActHib portion. The office reported that the error was found because they have a remaining dose of ActHIB that has not been administered.   At the time of reporting no adverse event 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.
Fever 102 degrees 8 days after injection. Following fever was a red rash on shoulders that blanches when touched and hot to touch. A day later no longer a fever and now a red pimple like rash all over body including face and groin areas.
Muscle aches: entire body. Fever 102+ within -18 degrees of injection (Hep A)
No additional AE/ PQC reported; HCP called in to reporta temperature excursion; MMR II had been administered to two patients; This spontaneous report was received from a physician, concerning a 12-month-old patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 16-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot number reported and validated as T001211 with expiration date on 12-JAN-2022) (dose, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).  The administered vaccine experienced a temperature excursion above 46 grades Fahrenheit (F) (47.5 F) during a time frame of 0 hours, 6 minutes and 0 seconds; that vaccine also had two previous temperature excursions as follows: 46 F (46.8 F) during a time frame of 0 hours, 3 minutes and 0 seconds, and, 46 F (47.8 F) during a time frame of 0 hours, 5 minutes and 0 seconds. The data logger was not involved in the call. No additional adverse events (AE).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA006983:
Immediate rash and swelling.  Was given 50ml Benadryl  I he injection in same arm.   Rash continues to spread.  Very itchy. All over.  Legs back stomach neck chest arms hips buttocks.    Still spreading and uncontrollably itchy.  Have seen PCP and was given steroid ointment.  Doesn?t help at all.  Seeing doctor again next Monday
High Fever, Diarrhea, Seizure, Hard to wake up.  Called on line nurse.  Was told to give cold bath to get his fever down and to give Tylenol. Was almost 24 hours before symptoms began.  06/25/2008 Consultant records received from psychiatrist dated 5/1/2006-5/31/2007 with DX:  Autism. Exams report decreased eye contact, pacing c/w PDD.  In OT and Speech Tx. On Risperdal and doing well.
This non-serious spontaneous case, was initially received on 27-Sep-2017 from other health professional (pharmacist), concerning a 20-year-old, adult, female pregnant patient. On 27-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: XF31007, expiry date: 30-Jun-2018, route of administration, anatomical location: not reported). The patient was administered with vaccine which was stored at 53F, approximately less than 23 hours, instead of storing at 36-46F which was considered as drug administration error. This vaccine was administered when the patient was pregnant which was considered as vaccine exposure during pregnancy. The outcome of the events was not reported. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 27-Sep-2017: Batch number (XF31007) was added on the screen. The narrative was amended accordingly.
Unconsolable crying for around 4 hours. Calmed with Tylenol 15mg/kg and bath.
Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 37-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 01-Oct-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ?No treatment information was provided. ? The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Internal review on 19-Jul-2021 resulted in updates to the pregnancy details.
sz, drowsy for hr p/vax; dec appetite, eyes crossed, arching, fever overnoc 22JAN-23JAN;fever late PM 23JAN;2 more sz rt focal 39.4;
Itching on upper back started 6pm sat evening. Woke up sunday morning 9am with inflamed upper back and hives. tremendous itching.
pt had gen sz witnessed by mom 345PM;mom reports arms shaking, legs shaking, drooling, eyes roll back x 5min;pt sleepy afterward
mom states lt thigh swollen; screaming for 4 hrs; no fever; taken to MD; ice pack applied; relief obtained p/ice pack & lt leg elevated w/pillow; also given APAP drops;
Mild neuritis in left upper extremity from elbow to fingers. Evaluated by our Occ. Med Clinic, no signs of anaphylaxis reaction. Prescribed ibuprofen. Reevaluated 10/2/09 and released. Neuritis resolved.
Redness on Injection Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on Injection Arm) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on Injection Arm). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on Injection Arm) had resolved.            Concomitant medications were not reported.   This case was linked to MOD21-039600, MOD21-056083 (E2B Linked Report).; Sender's Comments:  MOD21-039600:Cross linked cases with patient case MOD21-056083:Cross linked cases with patient case
Suspected vaccination failure; Have had shingles 7, yes SEVEN times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria GSK medically significant). 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 and Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had received all the various shots for shingles and since the last 2 shots, the latest ones, the patient had shingles 7 times. This shot does not prevent shingles. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown
Patient beganto have severe nausea and vomiting and headache about 3 hrs following vaccine. Same symptoms again today (11-2-14).
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); 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 (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 33-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 (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) 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, facility had not been able to download the digital data logger, they had been put on hold 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 did not have any questions and wanted to report this.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
Patient had SHINGRIX shot on 5/7/18. She came into the store on 5/16/18 to show us severe arthus reaction on her arm. She used topical steroid ointment and is resolving by 5/17/18. Pt does not feel need to see Dr.
At 5:15 AM child had a Grand mail seizure lasting 6 minutes. Temperature taken when convulsions stopped was recorded at 98.9 F. No history of seizures. Continued to twitch, moan, and have restless sleep for 4 hours (til 9:30am) afterwards. Took 12 hours to return to normal demeanor, energy and activity level.
Extremely ill.  Chills, diarrhea, nausea, extreme fatigue and fever.
My face was slightly swollen and right side inside cheek felt thick. My tongue also felt a little thick. No problems with breathing but because of swelling issue I chose not to try any foods that required a lot of chewing.
prescribed a dose of ACTHIB for a patient for IgA deficiency, with no reported adverse event; prescribed a dose of ACTHIB for patient for IgA deficiency, with no reported adverse event; Initial information received on 05-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 48 years old female patient who was prescribed a dose of acthib for a patient for iga deficiency, with no reported adverse event , while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported at an unknown dose via unknown route at an unknown administration site for immunization and  iga deficiency.  On an unknown date (latency: unknown), the patient developed a non-serious event of  prescribed a dose of acthib for a patient for iga deficiency, with no reported adverse event (product prescribing issue)(product use issue) following the administration of HIB (PRP/T) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events .   Outcome: unknown for both events   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 the guidelines. 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.
8.5cm round area of macular erythema, 1cm slightly raised satellite lesion at immunization site. mildly tender
My son received the vaccine and complained of a sore throat within 2 hours. Woke  me up six hours post vaccine, crying and struggling to breathe. He had inspiratory dyspnea and a harsh, raspiness to his breathing and voice. I calmed him down, and his forehead temperature was 102.6. I have him Ibuprofen and he was able to sleep. He had a sore left arm and stated his right axilla hurt. When touched, it felt slightly swollen. He was febrile for 24 hours. He had a soft nonproductive cough after the event - would only cough a couple times a day.
Woke up 48 hours after vaccination with pain, tenderness, and swelling on left side near collarbone/neck- subclavical lymph node? Approx 2" diameter.  Vaccination was in left arm , approx 1.5" below shoulder
COBICULAR ADINOPATHY REGRESSING SLIGHTLY AFTER 7 WEEKS BUT STILL PRESENT
Days 1-3 after injection intense soreness at injection site and full shoulder muscle. Day 6 - extreme headache all day ( don?t know if it?s relayed but not usual for me) Day 7- round, hard, red, and itchy spot appear at injection site
tired; This is a spontaneous report from a Pfizer sponsored. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 12:00 (Age at vaccination 37 years old) (Batch/Lot Number: ER8729) as DOSE1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations (within 4 weeks). On 09Apr2021 she stated she felt tired 24 hours after the first dose. Vaccination Facility. No Emergency Room and Physician Office visit. None relevant test. Outcome of event was recovered on 10Apr2021.  follow-up attempts are needed. further information is expected
11 year old patient received Men B vaccine dose instead of meningococcal conjugate (MenACWY) vaccine dose. There have been no known side effects or adverse reactions to the vaccines given on 1/24/23.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Shakiness-Mild
muscle pain; red, warmth, and puffiness of injection site; red, warmth, and puffiness of injection site; red, warmth, and puffiness of injection site; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included sulfa drug allergy and shellfish allergy from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that 1 week post vaccination, the patient experienced muscle pain and red, warmth, and puffiness of injection site in Jan2021. The outcome of the events was not recovered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.