chrisvoncsefalvay/vaers-outcomes huggingface dataset:
negative titers; VZV Ab IgG V negative; Negative titer pneumococcal serotypes; This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 10-year-old male patient.  The patient's concurrent conditions included cough and asthma. Medical history included pneumococcal bacteremia. Concomitant therapies included salbutamol sulfate; montelukast sodium (manufacturer unknown); amoxicillin (+) clavulanate potassium; pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and Hemophilus influenza B vaccine (manufacturer unknown).  On 27-JUL-2018, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). On 19-OCT-2021, he was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown).   12-month post-pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (repeat) pneumococcal titers were unchanged or decreased (3/24 > 1.0 micrograms/mL). Varicella titers were all non-detectable (vaccination failure, antibody test negative).  The outcome of vaccination failure and antibody test negative was unknown.  The authors considered the events of vaccination failure and antibody test negative to be related to the suspect vaccines.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report
The patient received Pfizer's COVID vaccine at 12:22pm. They returned to the pharmacy at 1:20pm reporting she couldn't clear her throat and her tongue felt "tingly". They estimate this started around 12:55pm. EMS was contacted once the patient returned to the pharmacy. The patient was monitored. No medications were administered. EMS arrived at 1:29pm and the patient left with them.
Rashes across the whole body started appearing after 48 hours of the second dose. Rashes across both arms, legs, chest and back. Been 24 hours since noticed and hasnt subsided yet at the time of filling this information.
NauseaVomiting cold sweats, feeling very weak seen in person by occupational health NP due to few hours after vaccine administration had cold sweats, feeling weak and nauseous, then vomited. will continue to monitor.
during lunchtime were exposed to 15.8F for 30 minutes with no reported adverse event; FLUZONE was administered to two patients with no reported adverse event; Initial information was received on 23-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old female patient who experienced during lunchtime were exposed to 15.8f for 30 minutes with no reported adverse event and fluzone was administered to two patients with no reported adverse event while receiving vaccine influenza quadrival a-b vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Mar-2023, the patient received a 0.5 ml of  dose 1 of suspect influenza quadrival a-b vaccine lot UT7683NA expiry date: 30-JUN-2023 via intramuscular route in the deltoid not otherwise specified  for Immunization.  On 17-Mar-2023 the patient developed a non-serious event of during lunchtime were exposed to 15.8f for 30 minutes with no reported adverse event (product storage error) following the administration of influenza quadrival a-b vaccine.  On 17-MAR-2023 the patient developed a non-serious event of fluzone was administered to two patients with no reported adverse event (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the events (during lunchtime were exposed to 15.8F for 30 minutes with no reported adverse event, Fluzone was administered to two patients with no reported adverse event).  At time of reporting, the outcome was Unknown for the event during lunchtime were exposed to 15.8f for 30 minutes with no reported adverse event and was Unknown for the event fluzone was administered to two patients with no reported adverse event.  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 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.
patient that may have received 3 or 4 doses of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXTRA DOSE ADMINISTERED (patient that may have received 3 or 4 doses of the Moderna Covid-19 Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (patient that may have received 3 or 4 doses of the Moderna Covid-19 Vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (patient that may have received 3 or 4 doses of the Moderna Covid-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported; Sender's Comments: This report refers to a case of Extra dose administered for mRNA-1273 (Lot number: Unknown) with no associated AEs
ErythemaMultiform, UrticariaPruritus, painful and warm to touch Narrative:  employee took tylenol and with little efficacy; advised to visit ED for worsening of symptoms.
Dizziness; Hungry; Tingling lips; Shakiness/ trembling; Fast heartbeat; Easily irritated; Confusion; Slurred speech; Muscle weakness; Memory issues; Foggy brain; Exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in left arm on 20Mar2021 at 12:00 as a single dose for COVID-19 immunisation. The patients medical history included type 1 diabetes, celiac disease, asthma, vasovagal syncope, chiari malformation and major depressive disorder. The patient was allergic with naproxen, nonsteroidal anti-inflammatory drugs (NSAIDs), avocado and almonds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior vaccination. Concomitant medications included Humalog, Cymbalta and Remeron. On 21Mar2021 at 18:00, the patient experienced dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion. After vaccination on 21Mar2021, the patient underwent lab test for COVID-19 (nasal swab test; RT-PCR for SARS-CoV-2) and the result was pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for these events. The clinical outcome of the events dizziness, hungry, tingling lips, shakiness, trembling, fast heartbeat, easily irritated, foggy brain, confusion, slurred speech, muscle weakness, memory issues and exhaustion was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever T max 104 F on 7/27/17 at 10:00 am. Went to the emergency room and was admitted for observation.
uncontrolled blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included METOPROLOL, HYDRALAZINE and LOSARTAN for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure). At the time of the report, BLOOD PRESSURE ABNORMAL (uncontrolled blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Five minutes, post vax, the pt reported light-headedness. She was instructed to take deep breaths and elevate feet. A physician was notified and came to review the situation. She later reported numbness in both arms, nausea and increased pressure in the back of her head, neck and lower skull. In a matter of minutes, pt progressed to a state of semi-consciousness. Pt was transported to the ER.
Received the second dose of the Moderna vaccine two weeks after the first dose; A spontaneous report was received from other health professional concerning a 51-years-old female patient who received second dose of Moderna's (mRNA-1273) COVID-19 Vaccine two weeks after the first dose (inappropriate schedule at vaccine administered).  The patient's medical history included breast cancer, broken leg and was very stressed. No concomitant medications were provided.  The patient received their first of two planned doses of mRNA-1273 (Lot/batch number: unknown) on 22 Jan 2021. On 05 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: 012M20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received the second dose of the Moderna vaccine two weeks after the first dose (inappropriate schedule at vaccine administered). No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event the patient received the second dose of the Moderna vaccine two weeks after the first dose was considered recovered.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 012M20A with second dose) with no associated AEs reported.
This spontaneous report as received from a nurse prescriber concerning multiple patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M036056, exp 18-MAY-2019 and VARIVAX Lot# N017399, exp. 07-JUN-2019 for prophylaxis which had a temperature excursion of -9 C to 8 C for 59 hours. It was reported that the vaccines had a previous temperature excursion of -9 C to 8 C for 44 hours. The reported temperature excursion was because of a data logger. Concomitant therapies included sterile diluent (manufacturer unknown). No adverse event was reported.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006542: US-009507513-1712USA006543: US-009507513-1712USA006544:
On 12/01/00 mom called, child had fever yesterday and left leg had rash. Mom brought child in for MD to look at leg. Slight hard area, no redness but bruise noted. Able to stand on leg.
Rash upper body & upper arms; blemishes for 3 or 4 days; rxn started on 3rd capsule;
Pt received vaccinations on 6/9/09. He was up most of the night after vaccine with pain in his left thight. On 6/10/09, thigh was red & still painful. Also had emesis and may have had the chills.
Received a full third dose of the Moderna vaccine although they were not immunocompromised; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and ACCIDENTAL OVERDOSE (Received a full third dose of the Moderna vaccine although they were not immunocompromised) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (Tiredness). On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full third dose of the Moderna vaccine although they were not immunocompromised). On 01-Sep-2021, ACCIDENTAL OVERDOSE (Received a full third dose of the Moderna vaccine although they were not immunocompromised) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-434069 (Patient Link).
Nausea, Weakness, Overheated, Lightheaded, Body Aches, Fever, Rash, Dizziness
severe CFS (Chronic Fatigue Syndrome); This is a spontaneous report received from a contactable other healthcare professional (patient). A 79 years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration, in right arm on 24Feb2021 at 09:00 (at the age of 79-years-old) as a 2nd dose single dose for COVID-19 immunisation. Medical history included COPD (Chronic obstructive pulmonary disease), CFS (Chronic Fatigue Syndrome) and gluten intolerance (self-diagnosed for 35 years). Concomitant Medications received within 2 weeks of vaccination was just standard vitamins taken regularly. Past Drug history included sulfonamides (SULFA DRUGS) and one kind of benzylpenicillin (PENICILLINE). Patient had previously received the first dose of vaccine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient and was doing a lot better, the first shot was fine but the second dose put her back into a severe CFS (Chronic Fatigue Syndrome) condition on 28Feb2021,. Still not much better by June. The adverse event results in visit to doctor or other healthcare professional office/clinic. A study of COVID -showed patient have no antibodies. Patient has not been tested for COVID, since the vaccination. The outcome of event was not resolved.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 14-year-old patient of unknown gender. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
1.Swelling, redness, pain , rash about size of silver dollar. Did not start to appear until about the 7-8 day.  Reaction continued to get worse until day 12.  It is now day 15 and much improved but still present.  2. Noticed having some difficulty swallowing on the 3-4 day.  Did not have problems with swallowing foods,  only when trying to swallow small amounts of liquid , such as accumulated saliva.  I had to consciously engage muscles to gulp or get more liquid to get it down.   The problem is improved now at day 15.
11/23/2022 Vaccination; 05/16/2022 I started to get stomach cramps. The pain is pretty intense, bad. I didn't have a fever but was clammy. 05/17/2022 Symptoms were worse. Couldn't sit up as pain was worse. I remembered from 2007 to just drink liquids when had last flare-up of diverticulitis. I slowly can eat things like bread, bland things, very little things so not to shock my system. I emailed my NP. She said if I don't feel better soon to contact her to do a CT scan. I never had a fever.
This spontaneous report as received from a pharmacy technician refers to a male patient of unknown age. On 25-APR-2014 (also reported as today), the patient was vaccinated with expired dose ZOSTAVAX (lot number J001008, expiry date 24-APR-2014), 0.65 ml, subcutaneous. Patients concomitantn therapy was unspecified. The rerpoter was asking for potency information. Potency support as per solution. Patient did not seek medical attention. No adverse effect noted to patient. No product quality complaint was involved. The outcome of expired ZOSTAVAX was administered was unknown. No further information was available. Available information has been requested.
Fever, swelling (1/2 of leg, not just injection site), muscle tightness - hurt him to bend at waist and knee. Swelling took almost full week to go away, fever lasted 2 days, muscle tightness we are seeing a chiropractor about still.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 13-FEB-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 10-SEP-2016, the patient was treated at medical center for the onset of a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pt. states that after receiving the 3rd Booster of Phizer 11/16/2021, started experiencing symptoms 11/23/2021 of developing Shingles. (Previously 2nd dose of Phizer 05/13/2021 developed Shingles 05/20/2021). No noted Primary visit/communications.
Fever, aches, headaches, fatigue, sore throat, arm pain at injection site, diarrhea, nausea  Started same day and have lasted a week
Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022; No adverse Event; A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022), EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago) and NO ADVERSE EVENT (No adverse Event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044c22a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022) and NO ADVERSE EVENT (No adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022), EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022) and EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago).    No concomitant medications were provided. The patient had 1st dose of the primary series with monovalent product. Vial size was 5.5ml. The vial did not undergo any temperature excursions. No treatment medications were reported.