chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-DEC-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician's office from a physician/MD, as recommended for routine adult health maintenance and for the long-term 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 02-SEP-2016, the patient was treated by a certified nurse practitioner (NP-C) at a healthcare facility for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
PAIN ON ARM WITH THE FIRST SHOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hpa (secondary-hypothalamic- pituitary-adrenal insufficiency) (since she was a kid). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 063A21A expiry: UNKNOWN) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced pain on arm with the first shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain on arm with the first shot was not reported. This report was non-serious. This case, involving the same patient is linked to 20221022922.
itching at site of injection; tierdness; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching at site of injection), FATIGUE (tierdness) and PYREXIA (fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at site of injection) and FATIGUE (tierdness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (itching at site of injection), FATIGUE (tierdness) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 98.7 (High) 98.7 Fahrenheit. On 15-Mar-2021, Body temperature: 99.0 (High) 99.0 Fahrenheit. On 16-Mar-2021, Body temperature: 99.9 (High) 99.9 Fahrenheit.         No relevant concomitant medications were reported.
Swollen, red rash at injection site, fever, chills, headache, body ache.
Pt has knot on right arm. Tender to touch. Not red or warm to touch. No signs of infection. Local reaction. MD saw in Clinic today. MD instructed to do symptomatic treatment only.
Red circle around injection site. several itchy red bumps on both legs not sure if bug bites or related to arm reaction.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot # M001200 (dose, expiration date, route and site of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
13:40 #2 Hep A given IM RVL Lot # 0368AAV - Received 15:00 call from mom reports client has rash on truck front & back, red raised macular papular. Spoke with Dr's nurse on phone informed mom to give client BENADRYL and observe for further sx. 17:00 client return to clinic T 99 R 20 HR 100 denied difficulty swallowing, c/o (L) earache, unable to examine. Mom encourage to watch closely, go to ER if sx worsen.
Itching at injection site on and off; Rash in area of injection/ Pinkish in color rash; Some heat coming out when I touch it at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site on and off), VACCINATION SITE RASH (Rash in area of injection/ Pinkish in color rash) and VACCINATION SITE PAIN (Some heat coming out when I touch it at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O29620A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site on and off), VACCINATION SITE RASH (Rash in area of injection/ Pinkish in color rash) and VACCINATION SITE PAIN (Some heat coming out when I touch it at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site on and off) was resolving and VACCINATION SITE RASH (Rash in area of injection/ Pinkish in color rash) and VACCINATION SITE PAIN (Some heat coming out when I touch it at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient put cold compressor to relieve the symptoms.
Muscle soreness at injection site progressed to joint pain and decreased range of motion. There was also some nerve pain around 11PM. Pain was a 4 without movement and a 7 with.
Severe nausea and vomiting, fever, lethargy, stomach ache, headache, sore arm muscle at injection site
first dose in 2018, not received dose two; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The nurse practitioner reported that a patient had not received dose two. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Pale, listless, lazy eye, severe projectile vomiting for 1.5 hours
provided booster dose 1 day prior to approved 6 month wait period; client last 2nd dose 4/13/2021 and was scheduled for 10/13/2021 but came to clinic 1 day early( today 10/12/2021).  waited 15 minutes after dose; left on own accord with no reported side effects.
pt recv vax & w/in 1hr of vax pt exp tiredness & facial hot flashes;the events resolved w/in 48hr w/o treatment;
dizziness and nausea. Brain fog. High temperature. Chills. Pins & needles. Diarrhea.
Sweating, nausea, paralysis from neck down sensation of loss of bowel lasting 60-minutes   Residual effects sore left arm bicep to wrist into middle finger (currently)
Information has been received from an employee in a physicians' office concerning a 15 year old female student with a penicillin allergy who on 04-DEC-2007 at 15:30 was vaccinated SC with her second dose of varicella virus vaccine live (Oka/Merck) (lot# 658999/1490U) in the right tricep. There was no illness at the time of vaccination. On 04-DEC-2007 at approximately 20:00, the patient contacted a physician to report that she developed redness and pain with a 4 inch circular, firm rash that was tender to touch at the injection site of varicella virus vaccine live (Oka/Merck) given 7 hours ago. The patient was afebrile with no streaking up the arm. On 06-DEC-2007, the patient was seen by the physician who noted the painful rash was worsening at the vaccination site. The rash was approximately 11 X 12.5cm and erythematous, warm and tender with no streaking. On that same day the patient was treated with Keflex. On 12-DEC-2007 was recovered. Additional information has been requested.
Tickling both hands left and right. Left hand is more than the right hand. This tickling  I felt it on my first dose which was on 7/12/2021 on my left arm and hand but in 2 hours was gone but today 8/10/2021 at 1am my left hand started the tickling and also my right hand. Moreover as of now 12:30 pm on 8/10/2021 I still feel the tickling.
GOT EXTREME CHILLS, FEVER AND BODY ACHES FOR A GOOD 30 HOURS AFTER THE VACCINE.
Gave .50ml dose (should have had .25ml dose as booster to J&J)
1 day p/vax pt exp pain & numbness from shoulder joint to fingers of the lt arm;pt is under the care of a MD & physical therapist;pt claims to be unable to work because of this;
No adverse effects; unspecified patients received improperly stored doses of PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a 66-year-old patient of unknown gender. No information regarding the patient's pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies.  It was reported that on 09-OCT-2019, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was exposed to a temperature excursion with a lowest temperature below 36 Fahrenheit (F) degrees (30.5 F degrees) for 10 hours. There was no previous temperature excursions.  On 30-OCT-2019, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265, expiration date 31-MAR-2021 (dose, dose number, route of administration and anatomical injection site were not reported) for prophylaxis. The call was placed because of the Digital Data logger report. No adverse effects reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1911USA001801: US-009507513-2005USA002452: US-009507513-2005USA002453: US-009507513-2005USA002454: US-009507513-2005USA002455: US-009507513-2005USA002456: US-009507513-2005USA002457:
A patient received a dose Daptacel vaccine that reached at 1.7 degree Celsius for 30 minutes due to temperature excursion on July 30 in refrigerator due an unknown reason/No AE; Based on information received on 06-SEP-2019, the report previously considered as non-valid became valid: [patient identifier updated].  Initial information received on 09-Aug-2019 regarding an unsolicited non-valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Lot: C55118A, Expiry date: 30-Aug-2020 and Lot: C53668A, Expiry date: 07-Feb-2020), which had a temperature excursion for reasons not known. Nurse stated on July 30 the refrigeratore reached a temperature of 1.7 degree Celsius for 30 minutes.  It was as actual medication error due to incorrect product storage.  The patient did not experience any averse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.  Follow up information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  Case became valid and the patient experienced no adverse event.  List of documents held by sender: none.
Atrial Fibrillation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation) in a 58-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications reported.  Description: The patient had a racing heart beat and was seen by a cardiologist. The patient wore a heart monitor and was then diagnosed with atrial fibrillation (medically significant).  The patient was recently prescribed a blood thinner.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Itchy lips, tongue swelling, given epinephrine she had at home and called ambulance. Went to local ER, treated and released 9/23/15. 9/24/15 presented to ER again w/ trouble swallowing, admitted overnight. Sent home w/ 7 day rx methylprednisone and Benadryl prn.
This spontaneous report as received from a 73 year old female patient concerning herself. The patient had no pertinent medical history. The patient had allergic to penicillin with reaction of hives and allergic to codeine with reaction of hives. The patient's medical history included hives. On 11-APR-2011 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and strength were not reported). There was no concomitant medication. On 23-SEP-2013 the patient developed the shingles after receiving ZOSTAVAX. The patient was given B12 (dosage and manufacturer unspecified) and ZOVIRAX (dose unspecified) as treatment. There was no lab diagnostics study performed. Action taken was not provided. The outcome of shingles was reported as not recovered/not resolved. The patient had sought unspecified medical attention. Additional information is not expected.
drowsy effects; all over body itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (all over body itch) and SOMNOLENCE (drowsy effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AZATHIOPRINE, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and GABAPENTIN for an unknown indication.    On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PRURITUS (all over body itch). On an unknown date, the patient experienced SOMNOLENCE (drowsy effects). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (all over body itch) and SOMNOLENCE (drowsy effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller would like to know: if immunosuppressant meds will prevent body from making antibodies after the Moderna COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow up received on 01-oct-2021 and contains mail address.
Patient deceased 6/18/05 3 AM (found dead in bed). 7/29/05 D/C summary from ER received which revealed child arrived in full arrest & unable to resuscitate. 9/20/05 Received Autopsy Report which revealed COD to aspiration of stomach contents.
Received 4 yo immunizations on 3-4-11 KINRIX (DTAP, IPV), PCV 13, Varicella, MMR. Fever up to 103.5 degrees F began on 3-5-11, lasted 2 days. Hives started 3-6-11, BENADRYL per mom seemed to help. No hives in office & well-appearing.
Syncopal episode 10 min after vaccination which lasted 1-2 min.  Regained consciousness when laid flat on the floor without any complications.  VS 10:12 122/70, HR 88, RR 16, Temp 98.6, O2 sat 99% RA, BG 100, PERRL, EOMI.                   Recheck at 10:38 110/66, HR 86, RR 16, Temp 98.2, O2sat 98% RA Denied any complications.
Woke up on Monday night with muscle pain in left shoulder, neck. Continues through Tuesday off and on.
This is a spontaneous report from a contactable pharmacist, who reported the same event for 2 patients. This is the second of two reports. A male patient of unspecified age and ethnicity received a single dose of PREVNAR 13 (Lot L625074, Expiry date 30Nov2016) in the arm on 26Oct2015. Medical history and concomitant medications were not reported. The patient had a cellulitis type of reaction on the same day. The outcome of the event was unknown. The pharmacist believed that the cellulitis occurred after having shot of PREVNAR 13 as it was at same arm as the injection site.
was positive for covid/vaccinated 100%; was positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "was positive for covid/vaccinated 100%"; COVID-19 (medically significant), outcome "unknown", described as "was positive for covid". It was further reported that the person the caller was working with. The patient had the Pfizer covid vaccine. The patient had the same symptoms the caller had. The patient does not have any medicine that she was taking and the caller told her she needs to be seen by a doctor. The patient is vaccinated 100% because they had to get vaccinated for work. The patient was positive at work. They have 10 flight attendants and only 2 got positive. The patient was working with the caller and the customers did not have their masks on someone was sick on that plane. The patient was positive for covid too. The patient had the Pfizer covid vaccine. The patient is vaccinated 100% because they had to get vaccinated for work. The patient was positive at work. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: she was positive for covid. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
1st dose: moderate pain in left arm after approximately 4 hours 2nd dose:  Day 1: moderate pain felt within two hours. Overnight developed moderate to severe pain near injection site and of bicep  Day 2: low fever 99.6F,  chills, fatigue, brain fog, swelling/bruising of injection site the size of a silver dollar- deep red/purple in color, very painful to the touch Day 3: injection site swollen the size of a silver dollar with moderate redness/tenderness. Lessened moderate brain fog and fatigue Day 4- present: injection site mildly swollen the size of a silver dollar, mild to moderate redness, purple bruising appearing around the site, and mild itchiness
This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a adult female patient who received FLUARIX QUADRIVALENT (batch number LM55C, expiry date 23rd June 2015). In October 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced injection site induration and injection site warmth. On an unknown date, the outcome of the injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site induration to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site warmth to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was in her 40s, at the time of reporting. The patient experienced and induration at the injection site (deltoid) after receiving last year's FLUARIX vaccine. The injection site induration was about 14 cm which was warm to touch. The reaction resolved after 4 days from the onset. The patient would be receiving her FLUARIX vaccine this year. The reported lot number (4M7GD) corresponds to FLUARIX QIV and not to FLUARIX TIV as per the sales data sheet. Therefore, the suspect vaccine was updated to FLUARIX QIV. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133984, US2015GSK133985, US2015GSK133986 and US2015GSK134910).
Did not develop antibodies after 2 doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included immunocompromised.  On 06-FEB-2020, the patient received the 2nd dose of Shingrix. On 18-NOV-2019, the patient received the 1st dose of Shingrix. On 01-MAY-2023, 1180 days after receiving Shingrix and 1260 days after receiving Shingrix, the patient experienced therapy non-responder (Verbatim: Did not develop antibodies after 2 doses). The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 04-MAY-2023 Pharmacist reported a potential revaccination with Shingrix in an immunocompromised patient who does not developed serum antibodies after the 2 dose series. The serological testing completed on 1 May 2023. Patient was about to start medication that had a high risk of varicella re-activation, so antibody testing was recommended prior to starting therapy. Unable to provide any patient demographics due to hospital policy. The reporter had consented to follow up. The patient received the complete schedule of Shingrix vaccine and does not developed serum antibodies, which had led to therapy non-responder.