chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received the Bivalent vaccination after a temperature excursion; Patients received the Bivalent vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion).    Concomitant product use was not provided by the reporter.  The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in unbroken cartons with vial size of 2.5 ml and 5.5 ml.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.  The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  The patient had received the booster dose of Moderna COVID-19 vaccine, Bivalent.  Treatment information was not provided.
I waited after shot was given and when it was time I went home. Next morning my arm was swollen about size of golf ball, red and hard - went this way for 3 1/2 wks.
Double mastectomy with reconstruction; sentinel node was taken out; This spontaneous case was reported by a consumer and describes the occurrence of MASTECTOMY (Double mastectomy with reconstruction) and LYMPHADENECTOMY (sentinel node was taken out) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MASTECTOMY (Double mastectomy with reconstruction) and LYMPHADENECTOMY (sentinel node was taken out). At the time of the report, MASTECTOMY (Double mastectomy with reconstruction) and LYMPHADENECTOMY (sentinel node was taken out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was due to receive second dose on 15 Feb 2021.  No concomitant medications were reported. No treatment information were reported.
Information has been received from a physician concerning a 14 year old white female with no pertinent medical history or drug reactions/allergies who on 04-JUN-2007 was vaccinated with first dose of Gardasil ( lot # 656050/0245U) IM at 11AM.  Concomitant therapy included Vaqta (manufacturer unknown).  On 04-JUN-2007, the physician reported that the patient experienced passed out after receiving Gardasil.  The patient sought unspecified medical attention.  On 04-JUN-2007, the patient recovered from having passed out.  Additional information was received from a health professional. The patient had no illness at the time of vaccination. The patient experienced syncope on 04-JUN-207 at 11:10AM. Further information is not available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 15Dec2022 to 19Dec2022 for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182 use by 05/22/21 at 10:20) at 1342. Client reported feeling an "itchy" sensation in her throat to EMT at 1356. EMT, immediately notified the Co-lead, RN. RN and other nurse immediately went to assess the client. Patient was allergic to Benadryl so Benadryl was not given.  The patient was in no apparent distress, speaking in full sentences, skin was warm, dry, and intact. Vital signs were taken at 1357, BP- 145/80 (Left arm, sitting upright), HR-81, RR- 17, and oxygen saturation- 99%. Client denied difficulty swallowing, chest pain, shortness of breath, dizziness, lightheadedness, or generalized flushing. Observed the patient's oral mucosa and no swelling, edema, or angioedema was present. The patient stated, " It just feels like phlegm is in my throat, like my saliva is just thicker than normal, and my throat is just a little itchy." The patient was offered Epinephrine, but the patient stated, " No I will hold of on that for now." The patient was also given a bottle of water. Vital signs were taken at 1402, BP- 150/82 (Left arm, sitting upright), HR- 70, RR-17, and oxygen saturation at 100%. The patient was alert and oriented to person, time, place, and situation. The oral cavity was repeatedly observed, no edema or facial swelling was observed. Vitals were retaken at 1407, BP- 150/80 (Left arm, sitting upright), HR- 83, RR- 16, oxygen saturation at 99%. The client denied shortness of breath, chest pain, difficulty breathing. The patient was speaking in full sentences with staff. Vitals were retaken at 1412, BP- 152/ 80 (Left arm, sitting upright), HR- 80, RR- 16, oxygen saturation- 99%.  The patient continued to deny shortness of breath, difficulty swallowing, facial flushing, or chest pain. Vitals were retaken at 1422, BP- 152/70 (Left arm, sitting upright), HR-67, RR-16, oxygen saturation at 100%. The patient stated, " My throat is not as itchy and it just feels like I have thicker phlegm, it feels like what happens when I eat shrimp." RN, offered to call 911 but the client stated, " No I really don't think that is necessary." A final set of vitals was taken at 1427, BP- 150/72 (Left arm, sitting upright), HR- 72, RR- 16, oxygen saturation at 99%. The client had a history of allergic reactions to shrimp, dust, pollen, grass, and codeine. Patient did report being prescribed a Epi-pen in the past but was never able to pick it up from the pharmacy. Client reported going to an allergist in the past for intermittent hives that developed in various regions of her body. Client reported taking Zyrtec every morning, and is diagnosed Bipolar Type II Disorder. The patient reported having a history of anxiety. RN educated the patient about V-Safe and to follow-up with her primary care provider. RN educated the patient about Emergency Room precautions, such as if she experienced shortness of breath, difficulty breathing, chest pain, facial swelling, or altered mental status. The patient had an even and symmetrical gait when leaving the site at 1427.
No additional AE's; The nurse reported an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report has been received from a nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, or allergies, and concomitant medications were not provided.  On 13-MAY-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, vial (valid lot number U024220 [expiration date 04-AUG-2023]) for prophylaxis, after a temperature excursion of 32.9 degrees Fahrenheit (F) for 24 hours (h) 30 minutes (min) and 0 seconds (sec) (product storage error) (dose, dose number, vaccination scheme frequency, route, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
Client, following vaccination had crushing pain in Retroperitoneum region the following evening, joint pain in elbows and hands and lethargy. 6 months later gallbladder pain started despite having no risk factors. Joint pain and gallbladder issues continue to this day.
Began getting chills around 6PM. Went to sleep but was shaking so bad/teeth chattering. Around 11PM my heart began pounding and beating rapidly. When I stood up to call the DR. I became dizzy and felt like I was going to pass out. I laid back down and my heart continued to pound for several hours.
1/2 hr p/vax sx of pruritus lightheadedness, tightness in chest on exam, BP went down; pt given DPH & Epi;
At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident.  This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department.  At ER, CT scan and X-ray was performed.  Per report from  ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21.  Primary caregiver received a call from Castle RN at 0700, resident expired at 0615.
suspected vaccination failure; got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles shot, the patient got shingles. After that, the patient got new shot of two. The patient stated that, hope he/she would not get them again. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
Parents stated the child broke into a rash with bumps all over the torso. front & back area. also had a little on the face. They also stated they had applied calamine lo the areas, which seemed to calm the area. there was no fever detected with in the time of him breaking into a rash. duration of the rash 24-31 hr.  Cleared on 7/14/2023 . seen by dr. in office
Reporting a temperature excursion and stated that doses have been administered; Spontaneous information has been received from a Medical Assistance referring to patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not provided.   On 16-JUN-2021, the patient was vaccinated with improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter (route, site and indication were not reported; lot # T030479, expiration date 07-MAR-2022, were found valid). The administered dose of the vaccine experienced a temperature of -7.2° Celsius for 2 hour and 21 minutes.  The vaccines had had previous temperature excursions of -5.9° C for 2 hour and 31 minutes.  Information was called because of data logger. No product quality complaint was involved.
After about four hours, sore arm started, a little while after that I had chills and muscle aches. The next day (today 2/4) I had a fever of 100.5 and muscle aches.
Exhaustion and weakness.  On Wednesday, 9/15/2010, I began to get red and itchy dots on body. Have applied antihistamine to dots.
Received 3 doses of Moderna. A month after the 3rd dose I started with symptoms of Covid-19.
After getting the first covid pfizer shot, pre existing tinnitus symptoms increased. Prior to vaccination ringing in the ears was mild. Could tune out after 30min in the morning. After vaccination symptoms progressed to be louder ringing and feeling of lack of balance in the mornings. Harder to tune out until after 45min - 1 hour after waking up. After a mild case of Omicron infection symptoms increased further. Now even harder to tune out and get over nausea between 1-2 hours after waking up.  Ringing has increased dramatically.
A Pharmacist was supposed to give Fluarix, however accidentally grabbed and administered Fluzone High Dose Quadrivalent to 13 separate patients on different days with no adverse event; Initial information received on 15-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional (pharmacy manager) via call center.  This case is linked to cases 2020SA323787, 2020SA323795, 2020SA323899, 2020SA323872, 2020SA323616 and 2020SA323597 (same reporter).  This case involves a 38 year old female patent for whom it was reported that a pharmacist was supposed to give fluarix, however accidentally grabbed and administered influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] to 13 separate patients on different days (wrong product administered) on 13-Nov-2020 (batch number: UJ552AA and expiration date: 30-Jun-2021) at a dose of 0.7 ml once via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong vaccine administered (latency: 7 days).  At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: 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.
dysgeusia / altered taste sensation; diminished smell sensation. symptoms developed during 15-minute post-vaccine observation period, ongoing to present / time of submission of this report.
received a partial injection of fluzone states that the baby jumped, and the needle got pulled out with no reported adverse event; Initial information was received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who received a partial injection of  influenza quadrival a-b vaccine [Fluzone QIV] states that the baby jumped, and the needle got pulled out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization and received a partial injection of fluzone states that the baby jumped, and the needle got pulled out with no reported adverse event (incorrect dose administered) (latency: same day) following the administration of influenza quadrival a-b vaccine. The information on batch number was requested.  Reportedly "The nurse was asked the reason for the partial injection, and she states that the baby jumped, and the needle got pulled out. She states that she wanted to know if the 2-year-old needs to be rescheduled for a full dose. This situation is reported as a medication error due to the baby jumping and the needle got pulled out. "  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event received a partial injection of fluzone states that the baby jumped, and the needle got pulled out 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.
Night after injection continuing until 10AM: shaking, chills, vomiting, fainting, dizzy, "giddy", stomach cramping, muscle aches throughout especially neck, migraine.
Pt. called 10/27/14 reported c/o sore throat, congestion, coughing, and tiredness. Stated no fever or nausea/vomiting. Started day after shot with sore throat and progressed to all other s/s. Reports can't afford to go to doctor. Inst. To go to ER for condition or worsens.
Pt recvd 1st dose of Hep B vax on 9MAY91 & 6 hrs post vax exp nausea, vomiting & vertigo which persisted x 12 hrs; pt recovered;
Symptoms of 2nd dose  Day 1:  None  Day 2:  Chills & fever, Sweating, headache, dizziness, nauseas, bodyache  Day 3: fatigue and lightheaded  Day 4: diarrhea and vomiting slight headache and bodyache
Complained  of tingling in left finger tips and aching in left elbow.  Vaccine admin in left deltoid.  Released to f/u with PCP if needed
Facial Paralysis Shingles Nerve pain right side of head, ear, face and neck Weakness in extremities Depression Fatigue
The injection was given too high and infiltrated the bursa sack around the shoulder joint.  The left shoulder became very painful on the evening of 12/31/2020.  The patient placed heating pad on the joint intermittently, exercised her arm and took ibuprofen for 48 hours.  It was resolved in 48 hours.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
had a history of sinusitis that "keeps cycling and he can't seem to get rid of it, however it does go away"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 08Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing); "sinusitis" (unspecified if ongoing). The patient's medical history, reported also as family history included: "parkinsons" (unspecified if ongoing), notes: his wife has Parkinson's and severe scoliosis of 28 years; "severe scoliosis" (unspecified if ongoing), notes: his wife has Parkinson's and severe scoliosis of 28 years. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: AWO173), administration date: 03Aug2021, for COVID-19 immunization, reaction(s): "Unexpected therapeutic effect". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had a history of sinusitis that "keeps cycling and he can't seem to get rid of it, however it does go away"".  Additional information: Caller provided that his wife (withheld) and himself had two primary, Pfizer Covid-19 shots in 2021 within 3 weeks a part. Caller provided per their vaccination card they received "AWO173 on 03Aug2021 and the second vaccine on 08Sep2021." Caller provided that they never received a booster. Caller is asking if his wife and himself are able eligible to receive the Pfizer Covid-19 bivalent booster?. Caller provided that they are going to be traveling this month and decided that they feel they should get vaccinated. Caller stated that his wife has Parkinson's and severe scoliosis of 28 years. Caller provided that he has afib and has a history of sinusitis that "keeps cycling and he can't seem to get rid of it, however it does go away."   Follow-up attempts are completed. No further information is expected.