chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of an expired Havrix dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30-SEP-2022) for prophylaxis.   On 07-JUN-2023, the patient received Havrix. On 07-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Havrix dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter was a nurse manager. The healthcare professional asked if they had to repeat the dose. The reporter consented to follow up. The patient received Havrix beyond the expiration date, which led to expired vaccine used.
Iodiopathic Transverse myelitis; Patient with Multiple Sclerosis; This is a literature report.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 22Feb2021, outcome "unknown", described as "Iodiopathic Transverse myelitis"; MULTIPLE SCLEROSIS (medically significant) with onset 22Feb2021, outcome "unknown", described as "Patient with Multiple Sclerosis". Therapeutic measures were taken as a result of myelitis transverse, multiple sclerosis.  Clinical course: Patient with Multiple Sclerosis. Developed pain in the right arm after 2nd COVID-19 vaccination, which steadily intensified and spread quickly to upper torso. Severe back pain. Ascending numbness and paresthesias in her legs to lower abdomen. Unable to stand. Received 1 gram IV solumedrol and high dose oral prednisone taper. Some improvement in right leg function improved but still unable to stand.; Sender's Comments: Based on the available information in the case, an association between the reported events MYELITIS TRANSVERSE , MULTIPLE SCLEROSIS and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Patient reported having red spots and some swelling a few days after having shots. She said that this started on arm of shingles shot and spread through most of body (appears to be arms, torso, face/neck). Patient reported to urgent care for treatment.
A nurse was giving vaccines on 11/6.  She had a dose of pfizer covid in the vaccination room for a patient, but realized the patient requested moderna instead of pfizer, so she returned to the pharmacy to get a dose of moderna, but left the dose of pfizer in the room, intending to use it for a later patient who requested pfizer.  The next patient who came in was receiving Arexvy, which needs to be reconstituted.  The nurse inadvertently used the syringe containing the pfizer dose to mix and then inject the Arexvy, so the patient received a dose of Arexvy and pfizer at the same time.  She realized it later as she was looking for the dose of pfizer she knew she had saved back and couldn't find it.  The patient was reporting no adverse effects as of about 6 hours after receiving the vaccine.  I told him to expect slightly more general vaccine side effects (fatigue, headache, etc), but he had not sought medical attention as of the time of this report.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with neomycin allergy. On 08-JUN-2012 the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneously (LOT and batch numbers were not provided). Concomitant therapies included SINGULAIR, estradiol (manufacturer unknown), unspecified allergy and antibiotics eye drops, unspecified nasal sprays and unspecified antibiotics. In approximately December 2013 (reported as: 6 months later) the patient began experiencing unspecified eye symptoms. The patient had recently, on an unspecified date, allergy testing completed that has shown neomycin allergy. The patient was treated with unspecified steroids at the moment of this report. The patient sought medical attention via contacting the physician's and was under physician's treatment. The outcome of unspecified eye symptoms was reported as not recovered/not resolved. The relatedness between unspecified eye symptoms and ZOSTAVAX was not reported. Additional information has been requested.
The vaccines were administered on 9/23. On 9/25, pt came in with a rash on his arm.
Pt presented to center with c/o redness, soreness (R) deltoid/arm.
headache; tiredness; get palpitations; chest pain; arm weakness when standing too long; Anxiety; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as 5730, pending clarification), via an unspecified route of administration on 18Dec2020 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 45 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included asthma and known allergies to epinephrine, latex, sulfa. Concomitant medications included amoxicillin (AMOXICILLIN), ibuprofen (MOTRIN). On 19Dec2020 at 01:00 PM the patient had headache and tiredness ever since get palpitations, chest pain, arm weakness when standing too long or when first get up. Heart doctor thinks it's due to vaccine or anxiety but never had this before shot. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment for the events included anti anxiety medication, metoprolol. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination the patient was tested for COVID-19 (nasal swab) on 18Jan2021 which resulted negative.  Information about lot/batch number has been requested.
Received 3rd Moderna vaccination at approx 1250.  12:54- Notified patient in the lobby having a reaction. Wheeled back to room with assist of RN. Complaints of dizziness, hot, diaphoresis, faint, diff breathing, tongue swelling. Able to speak and breath freely at this time.  12:56- BP 148/90  P 88 L arm Manual- Cool washcloth on head, laying down, given sip of water 12:58- Complaint of "throat tightening, itchy mouth, tongue swelling to point she cannot close mouth" Observed able to speak and breath freely throughout duration of visit. 1:00- 0.3 mg Epi IM to Left thigh via autoinjector, Ambulance called by RN, BSN Observed able to speak and breath freely throughout duration of visit.  1:01- 160/102 L arm Manual Observed able to speak and breath freely throughout duration of visit. 1:03- 140/102 P 92. L arm Manual- states not worsening, Observed able to speak and breath freely throughout duration of visit. 1:05-  Ambulance arrives BP 140/90, P 90, L arm Manual O2 Sat 95, RR even and unlabored 1:06- Tremors present- informed patient this is the epinepherine. Continues to state that s/s are not worsening. When prompted, stated that 2nd Moderna caused tightness in Jaw 1:08- 140/102 P 92. L arm Manual O2 sat 96 RR even and unlabored. Observed able to speak and breath freely throughout duration of visit. Patient declined further treatment by EMS and did not appear in distress.  1:11- Ambulance left. Encouraged follow up if patient is continuing to have any difficulty. Observed able to speak and breath freely throughout duration of visit. 1:16- Given 1 MG IM Benadryl to R arm for itching. Tremors starting to improve. Observed able to speak and breath freely throughout duration of visit. 1:22- BP 130/90 P 88. Observed able to speak and breath freely throughout duration of visit. 1:34 Continuing to improve.  1:41- assisted to bathroom, able to ambulate without difficulty. Feeling much better after the Benadryl 2:02- BP 130/88 P 86. Ambulating fine, RR unlabored, all S/S resolved 2:05- Left with spouse to private vehicle. given education to seek medical attention for difficulty breathing, swelling, or any other adverse reactions.
persistent redness + arm pain to L arm after 2nd moderna shot. Symptoms started 2 days after injection on 2/28 or 2/29. Aching pain will spread down the arm distally + redness/warmth changed in intensity.
sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) 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 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.            No treatment information provided.   This case was linked to (Patient Link).
has a little bump on the injection site and it's been itchy for the last six weeks; has a little bump on the injection site and it's been itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "has a little bump on the injection site and it's been itchy for the last six weeks"; VACCINATION SITE MASS (non-serious), outcome "unknown", described as "has a little bump on the injection site and it's been itchy". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Swelling, redness, hard knot, hot (the size of an apple, 2nd time) but 1st reaction smaller. Treated with ice.
- Moderate arm tenderness beginning about four hours after injection and last for about 48 hours. - Extreme fatigue beginning about four hours after injection and lasting about 24 hours before decreasing to moderate fatigue for another 24 hours. - Metallic taste in mouth beginning about half an hour after the vaccine and lasting about two hours. - Skin striations on the arm that received the injection beginning about 4 hours after the injection and lasting about 3 hours.
1) Soreness at site of injection; 2) fatigue, slight headache, slight body ache
Received shot at approximately noon and within a few hours, began not feeling well and by that night developed fever 102 with loss of appetite, chills, weakness, unable to stand - her legs developed spasms and jerking. The next day, temp continued to climb up to 102.6 with continued issues with spasms and jerking to lower extremities. Did not seek medical care but did take natural herbs and nutritional supplements to treat. Symptoms have lessened each day but were persistent for 10 days post vaccination. Has a hx of CLL diagnosed in 2008 and WBC runs persistently high.
Pt was having flu like symptoms on 10-5-10. Pt stated to pharmacist on 10-13-10 that he went to ER on 10-09-10 and had a-fib for 5 hours and was given breathing treatments, was diagnosed with bronchitis. Pt finish last dose on Z-pak on 10-13.
This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored vaccine for children stock (reported as VFC stock) VAQTA (lot# M022924, expiration date 24-JAN-2018) (dose, frequency and route were unknown) for prophylaxis. At the time of report, the storage temperature and time frame were not determined. There was previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007537.
Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medication were provided.   This case was linked to MOD-2022-568302, MOD-2022-568300 (Patient Link).
Patient became dizzy about 15-20 minutes after receiving vaccination. Also c/o nausea. Sat outside in the cooler air for 5 minutes and started to feel better so left the facility. Patient states got vaccine at 9:10 in the am and then s/o arm beginning to itch at injection site in the afternoon. Patient states on Saturday 1/9/21 she noticed a red band around her arm about 1 inch below the injection site. The band had very defined margins. Today 1/12/21 upon patient presenting the clinic for VAERS report the redness is not defined to a line and is spidering down the arm more.  Arm is warm to touch.
Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via intramuscular route. It was a case of actual medication error due to Product storage error as the vaccines were improperly stored and was vaccinated later on. It was unknown if patient experienced any 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 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.
PT REPORTED TO MEDICAL WITH COMPLAINTS OF CHEST AND SHORTNESS OF BREATH. REFERRED TO ER WITH RESULTING REFERRAL TO HOSPITAL FOR ADMISSION TO ICU. ELEVATED CKMB AND TROPONIN.
Patient called to report a side effect from her 3/11/21 Moderna vaccine. She stated she started getting ringing in her ears a month later and it is still there, and sometimes sounds like a hissing. She stated she reported this to her provider, but wanted to report this as well to Moderna. RN stated will send this infromation to the CDC.
Information has been received from a physician concerning a 17 year old male patient who on 25-OCT-1993 and 14-OCT-1994 was vaccinated with the first and second doses of MMR II (lot numbers were not provided).  On 26-NOV-2009 the patient experienced left parotitis.  The patient did not have a fever.  It was noted that the patient had exposure to others with mumps.  The patient had blood work performed on 22-DEC-2009.  The serum immunoglobulin M test results was <1:10.  The serum immunoglobulin G was 5.46 and the serum amylase was 86.  On 22-DEC-2009, the patient was diagnosed with mumps.  On 27-NOV-2009, the patient was vaccinated with a third dose of MMR II (lot # 664886/0776Y).  At the time of the report, the patient's outcome was unknown.  Follow-up information has been received which reported that on 30-NOV-2009 the patient experienced both side of parotitis.  On 01-DEC-2009, the patient had blood work performed and was diagnosed with mumps.  At the time of the report, the patient's outcome was unknown.  No further information is available.
Patient complained of soreness/tenderness in arm that lasted for 6 days. No pain at time of injection.
Regression in fine and gross motor skills. Further regression in speech. Regression in social skills and communication.
Redness at site (and soreness, although I expected the soreness) but even more, itching in various parts of my body!
pt. recvd. 1st dose of Engerix-B 08NOV89,2nd vax 08DEC89 & 3rd on 08MAY90.Titer indicated pt. non-responder,p/ booster seroconverted.
The evening of receiving the vaccine my only side effect was a sore arm for a couple of days. After about 8 day after vaccine, I noticed a large red circle around the vaccination site, that was slightly hot and itchy. It was approx 2.5 in large. I put on an aloe/tea tree lotion and over 2 days it faded. Just today 1/23, my arm began itching and the redness is back.
extreme muscle soreness, entire cervical & thoracic vertebrae area; pain even trying to lift arm to bursh teeth; lt leg had numbness; pain woke pt 4AM next morning lasted 7 days exactly; no temp
extreme body aches (mostly neck/spine); Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.; heart palpitations; occasional chest pain; extreme fatigue; headache; fever; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain) and FATIGUE (extreme fatigue) in a 32-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic asthma (Allergy induced asthma).  On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain), FATIGUE (extreme fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain), FATIGUE (extreme fatigue), HEADACHE (headache) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102° F.  The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.  Concomitant product use was not provided by the reporter.  The patient experienced extreme fatigue, headache, fever (102° F), extreme body aches (mostly neck/spine), bee stinging sensations that wake her from sleep (normally in hand or leg), hands, fingers, and toes felt very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain. The patient did not experience any additional symptoms/events.  The patient did not have any additional medical history, concomitant disease or risk factor.  There were no lab data/results available.  Treatment information was not provided.
- nauseous -vomiting - sore throat - migraine - arm pain - very fatigue
with shot itself, shooting pain down the length of arm with extreme pain per pt.  Then soreness resolved 2-3days later. Then 3 weeks later with edema and pain at same location with inability to use arm well ( can't abduct shoulder due to pain not weakness) with no reduction in response 1 week after hte start of the increase pain.  also with scar like skin changes overlying area of injection that was not there at time of injection or post the injection that pt noted, no scabbing.
Dx-Alopecia Areata post 1 month of HPV inj.