chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was suppose to be administered daptacel, but received adacel, no AE; Patient was suppose to be administered daptacel, but received adacel, no AE; Initial information was received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 15 months old male patient who received 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6602AA, expiry date 25-Feb-2022 via intramuscular route in left upper leg) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) for prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided. Patient had recieved 3 Pentacel (DIPHTHERIA VACCINE TOXOID HIB VACCINE CONJ (TET TOX) PERTUSSIS VACCINE ACELLULAR 2-COMPONENT POLIO VACCINE INACT 3V (VERO) TETANUS VACCINE TOXOID).  Concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported (symptoms none 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.
Migraine that will not go away. NOT a headache. Migraine with nausea that has lasted so far 4 days and counting. Treated with numerous doses of ibuprofen, Aleve, acetaminophen, and Dayquil. Drank lots of water and ate healthy. No relief of pain whatsoever. At the very least if I ever have a naturally occurring migraine one of the drugs will work to alleviate a little bit. Nothing has worked. Migraine has been moving from left side to right side numerous times throughout the day. I cannot function because it is very debilitating.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 83-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 02-OCT-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Developed a bad unknown rash (looked like shingles rash) in area under my breast and on sides. Also developed hives from my waist down to upper thighs.
Severe muscle and joint pain, headache, sore throat, nausea, puffy eyes, fatigue
BACK WAS SORE; ARM WAS A LITTLE SORE; CHILLS; ARM FELT TIRED  (WHERE PATIENT GOT THE SHOT OF VACCINE); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced back was sore. On 30-MAY-2021, the subject experienced arm was a little sore. On 30-MAY-2021, the subject experienced chills. On 30-MAY-2021, the subject experienced arm felt tired (where subject got the shot of vaccine). The action taken with covid-19 vaccine was not applicable. The outcome of the arm was a little sore, arm felt tired (where patient got the shot of vaccine), back was sore and chills was not reported. This report was non-serious.
dental abscess; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH ABSCESS (dental abscess) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced TOOTH ABSCESS (dental abscess). The patient was treated with AMOXICILLIN from December 2021 to 15-Dec-2021 for Dental abscess, at a dose of 500 mg. At the time of the report, TOOTH ABSCESS (dental abscess) outcome was unknown.            Dental abscess which was shown in the Xray.  No Concomitant medication was reported.
On the 23 of December, I had a pain on the Rt side between spine and shoulder blade it went down my arm and I developed numbness on my 2 fingers, pinky finger and 3rd digit. I saw 2 weeks after 12/23/2020. He did a MRI of my neck. The doctor thought  it was inconclusive, he did not think it was related to the C-Spine. The doctor did an Electro impedance that resulted there were no abnormality but that it was related to the carpal tunnel. No loss of muscle strength. The doctor felt it was related to the vaccine because both of the test were inconclusive. I still have numbness from the middle of my forearm to the middle of my upper arm. It's worse with cool air blowing on me.
Hard lump formed at exact site of injection, within the week, as patient could still see injection's red dot right above hard lump.
reported liquid DTaP-IPV portion of PENTACEL given without the Hib component with no reported adverse event; reported liquid DTaP-IPV portion of PENTACEL given without the Hib component with no reported adverse event; Initial information received on 18-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old male patient to whom liquid dtap-ipv portion of pentacel given without the hib component with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) and rotavirus vaccine live reassort oral 5V (Rotateq) both for Prophylactic vaccination.  On 01-Aug-2022, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot U7198AA, expiry date: 28-Jan-2023) via intramuscular route in the left thigh for immunisation.  On 01-Aug-2022 liquid dtap-ipv portion of pentacel given without the hib component with no reported adverse event (single component of a two-component product administered, Product preparation error) same day latency following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: Not applicable.  Outcome: Unknown.   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.
Redness in injection are, numbness in arm, cold hands and blisters in site of injection.
The single dose vial is labeled 0.25 mL, a pediatric dose is 0.25 mL, but the vial contains 0.5 mL of vaccine. The whole vial was drawn and administered to the patient. Patient had an onset of fever on 10/18/23, temp up to 102.5. He was seen in clinic on 10/20/23 for fever, fussiness, acute suppurative otitis media of both ears.
after one day on the thirtieth of nov i had swelling under the armpit of my arm right arm with the injection was given swelling under the armpit; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose 2, single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset 30Nov2021, outcome "unknown", described as "after one day on the thirtieth of nov i had swelling under the armpit of my arm right arm with the injection was given swelling under the armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchiness; Arm numbness and pain; Arm numbness and pain that raises to the neck; body pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), HYPOAESTHESIA (Arm numbness and pain), PAIN IN EXTREMITY (Arm numbness and pain that raises to the neck), MYALGIA (body pain) and CHILLS (Chills) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPOAESTHESIA (Arm numbness and pain), PAIN IN EXTREMITY (Arm numbness and pain that raises to the neck), MYALGIA (body pain) and CHILLS (Chills). On an unknown date, the patient experienced PRURITUS (Itchiness). At the time of the report, PRURITUS (Itchiness), HYPOAESTHESIA (Arm numbness and pain), PAIN IN EXTREMITY (Arm numbness and pain that raises to the neck), MYALGIA (body pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided. Patient was scheduled for second dose but cancelled it because of persisting events.
Patient fully vaccinated and hospitalized due to COVID-19. Patient stated her symptoms are a fever, congestion, fatigue, and headaches.
Information has been received from a physician concerning an 18 year old female with mild hypertension and a history of mildly elevated aspartate aminotransferase and increased cholesterol who on approximately 21-MAY-2008 was vaccinated intramuscularly with GARDASIL vaccine (lot # and dose not reported). Secondary suspect therapy included lisinopril (manufacturer unknown). Two weeks ago approximately 21-MAY-2008 when she received the vaccine, the patient experienced quick fainting episode. She was well for one week. The physician reported that for the past week, the patient has had a persistent frontal headache, dizziness and fatigue that seems worsening. The physician noted that the patient was not previously being treated for the hypertension and that the patient's primary care physician thought that the headache might be due to her hypertension. The patient underwent a head CT and CT angiogram, and labs including thyroid test and CBC for which the results were reported as all being normal. On 03-JUN-2008, the reporting physician started the patient on lisinopril (manufacturer unknown). The patient's headache and dizziness did not change after she was started on lisinopril (manufacturer unknown). Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 14:30 as dose 4 (booster), single (Lot number: GH0937) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment was Paxlovid which received from 28Oct2022 to 01Nov2022.
(I had same reactions after my #2 vaccine as well but  more severe after 3rd - booster)  Had vaccine @ 11am, felt fine until 7pm, with sudden onset of severe shakiness and fever 37.7,  Soon afterwards, I started having severe random shooting nerve pain in specific areas of my body: head behind ear, clavicle, medial area above knees, biceps both arms, shoulders, across lower ribs, L abdomen. These pains occurred every  30 sec- 2 mins, very sharp for only a few seconds. I took hot baths, Ibuprofen, and later Vicodin 1/2 tab so I could sleep. Did not work. Symptoms lasted until morning of 10/17.  I am still have shooting pans, but not as frequent and mainly in the head, thigh, and shoulder area Symptoms after my 2nd booster were the same but lasted only 12 hours.
Seizure-like reaction; This case was reported by a other health professional via sales rep and described the occurrence of seizure like phenomena in a 2-year-old male patient who received Flu Seasonal QIV  (FluLaval Quadrivalent 2022-2023 season) (batch number AJ3JX, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) for prophylaxis.   On 6th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device and PREVNAR 13. In October 2022, 30 hrs after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced seizure like phenomena (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure like phenomena was unknown.   It was unknown if the reporter considered the seizure like phenomena to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: The patient received doses of Flulaval and Prevnar 13 at the same visit into 2 different thighs (Flulaval in left thigh). The patient had a seizure-like reaction the following day, approximately 30 hours later.  The office that administered the vaccine was notified 5 days after the event by the patient's mother. They had not sought any face to face healthcare. It was unknown if the reporter considered the seizure to be related to Prevnar 13. The reporter consented to follow-up via postal.
Patient was administered HIB vaccine instead of the ordered HPV vaccine from PCP.  Patient's family reported no side effects, no abnormal s/s following the administration
developed an Auto Immune Disease; still having blurred vision; hypertension; aches; joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of AUTOIMMUNE DISORDER (developed an Auto Immune Disease) and VISION BLURRED (still having blurred vision) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (developed an Auto Immune Disease) (seriousness criterion medically significant), VISION BLURRED (still having blurred vision) (seriousness criterion medically significant), HYPERTENSION (hypertension), PAIN (aches) and ARTHRALGIA (joint pain). At the time of the report, AUTOIMMUNE DISORDER (developed an Auto Immune Disease), HYPERTENSION (hypertension), PAIN (aches) and ARTHRALGIA (joint pain) outcome was unknown and VISION BLURRED (still having blurred vision) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient looks like having to retire from  job. The COVID vaccines were not part of the Countermeasure Program where the patient reported adverse effect day one. It was unknown if the patient experienced any additional symptoms/events. No treatment medication were provided.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (medically significant) events of autoimmune disorder and vision blurred an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown for autoimmune disorder and not resolved for vision blurred. The benefit-risk relationship of mRNA-1273 is not affected by this report.
It started with an upper respiratory infection in Feb 2022.  Then I developed an itchy slightly bumpy rash on back. Then it progressed everywhere. That ended up going away after a few days. I then developed a common cold on 4/13. It started with a sore throat, extreme sneezing. coughing, nasal congestion, sinus pressure. 2 days ago 5/4, The rash came back. It started on my back, left leg, collar bone etc. I am still experiencing the rash. I've been taking antibiotics, cortisone and prednisone.
Patient developed a rash 24 hours after the injection. It began behind her ears and spread to her face and down her chest and back over the course of 24-48 hours.  The rash consisted of small bumps that were shiny and looked liquid-filled, though none ruptured. The rash cleared after 5 days. No other symptoms were present.
Hives on arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on arms and legs) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced URTICARIA (Hives on arms and legs). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 15-Jan-2021, URTICARIA (Hives on arms and legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported.
Patient requested a pneumonia vaccine as she had received one 1 year ago and the pharmacy tech input pneumovax 23 as the one she needed this year but handed the pharmacist prevnar 13 as she thought she handed her pneumovax 23. Patient was told she had received the same vaccine last year and was observed after and counseled and she was fine.
105-120 resting heart rate (normally low 70s); Shortness of breath; fever of 101.5 degrees Fahrenheit  (reached 103.5 highest); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 2022 (Batch/Lot number: unknown) at the age of 23 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2. single, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 01Feb2022, outcome "unknown", described as "105-120 resting heart rate (normally low 70s)"; DYSPNOEA (non-serious) with onset 01Feb2022, outcome "unknown", described as "Shortness of breath"; PYREXIA (non-serious) with onset 01Feb2022, outcome "unknown", described as "fever of 101.5 degrees Fahrenheit  (reached 103.5 highest)". The events "105-120 resting heart rate (normally low 70s)", "shortness of breath" and "fever of 101.5 degrees Fahrenheit  (reached 103.5 highest)" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient experienced Shortness of breath, 105-120 resting heart rate (normally low 70s), fever of 101.5 (reached 103.5 highest), at 21 hours post-booster shot. Patient was diagnosed with COVID-19 Prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.