chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Mar-2021 at 9:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.71 for dose administered on 31-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported
The morning after receiving the vaccine the patient reported rash over arms, chest, back and legs. He denied having any swelling of the face, throat or tongue or difficulty breathing
Atypical bursitis in the shoulder; The arm but it is painful; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BURSITIS (Atypical bursitis in the shoulder) and PAIN IN EXTREMITY (The arm but it is painful) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURSITIS (Atypical bursitis in the shoulder) and PAIN IN EXTREMITY (The arm but it is painful). At the time of the report, BURSITIS (Atypical bursitis in the shoulder) and PAIN IN EXTREMITY (The arm but it is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Tinnitus started on the third evening following the vaccine. It's so loud that it's preventing me from sleeping.
This spontaneous report as received from a medical assistant via a Poison and Drug Center (PDC) refers to a 14 year old male patient. The patient's relevant medical history and past drug history were unknown. On 01-APR-2015, the patient was vaccinated with a dose of GARDASIL (0.5ml, once, intramuscularly, lot # K006960, expiration date 19-FEB-2017), that had been stored outside of labeled storage range at 52.5 degrees Fahrenheit for two hours. The patient's concomitant medications were unknown. The patient had had no relevant laboratory data performed. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to an unspecified patients of unknown age and gender. On an unknown date, an unspecified number of unspecified patients received a second dose of ZOSTAVAX (frequency, route and lot# were not reported). No adverse experiences reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Fever, chills, nausea, worst headache I have ever had, body aches, fatigue
experienced varying episodes of arrhythmia; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (experienced varying episodes of arrhythmia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 047A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia. Concomitant products included APIXABAN (ELIQUIS), VALSARTAN, AMLODIPINE, CHLORTALIDONE (CHLORTHALIDONE), DEXLANSOPRAZOLE (DEXILANT), ATORVASTATIN, ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (experienced varying episodes of arrhythmia) (seriousness criterion medically significant) and ILLNESS (felt sick). At the time of the report, ARRHYTHMIA (experienced varying episodes of arrhythmia) and ILLNESS (felt sick) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: high (High) 145 bpm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter. The patients heart rate went to 145, getting rapid heart beat occurred on April 2021. Patient has ECG device continuously attached.  Company comment: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-385656 (Patient Link).; Sender's Comments: This case concerns a 63-year-old male patient with no relevant medical history, who experienced the unexpected event of Arrhythmia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
It started off with finger pain in my ring finger of my left hand. Finger and hand pain. It progressed to kind of a migrating pain from my hand and my other joints. My elbows, knees, shoulders, neck, and back. A different joint was in pain on each different day. It was every day and it was intense pain. From a scale from 1-10 it was between an 8 and a 10. I went to the doctor on 04/13/2021 and they took some blood work and rheumatoid factor and everything came back normal. She put me on some prednisone. I did have the blood work repeated in May with another doctor and it did show inflammation increased member on the C reactive protein and the ANA. He prescribed hydroxychloroquine and I have been in that since August. My doctor said I have rheumatoid arthritis.
Patient received the vaccine at the pharmacy on 12/22/2021, at about 2:45 pm. On 12/23/2021 mother reported patient had an anaphylactic reaction at about 3:25 pm, 12/22/2021, after she already left the pharmacy. Patient had hives, tongue swelling, fatigue, nausea and racing pulse. Mother recognized this as anaphylaxis and injected EpiPen 0.3mg per her doctor's instructions. Patient fully recovered at home as of 12/23/2021. No history of allergic reactions.
Mid January, pt developed "curling" of the three middle fingers associated with the ulnar nerve (ring, small and middle). The fingers can't be opened straight on exam must be held open. MRIs 3/28/08. Neurologist told pt that based on the blood work, it was a viral infection of the ulnar nerve related to the flu vaccine.
My COVID-19 symptoms started on 02/27/2023. I had red swollen sore throat, no fever, productive cough, body aches, and severe headaches. I went to the urgent care on 02/28/2023 I still had headaches, cough, body aches, headaches, loss of appetite, and sore throat. At the urgent care they tested me for RSV, COVID-19, Flu. I was positive for COVID-19. They test results came in at 09:30PM through my portal. At that time they gave me doxycycline and advised me to take MUCINEX. On 03/01/2023 I called and asked to prescribe PAXLOVID. They prescribed me PAXLOVID 5 days. I was also taking doxycycline. I still have minor cough with phlegm which has no color and sore throat.
Localized reaction noted to bilateral anterior thighs.  Redness and itching.  Benadryl 6ml po given in office.  Monitored pt for add'l 20 minutes.
bilateral numbness, tingling Narrative:  Pt had received Moderna Lot 029L20A on 1/28/21. Pt endorses that he began to feel tingling in his hands, bilaterally on 2/2/2021. Pt presented to hospital on 2/4/2021 w/ CC that his arms and legs were weak and he has been having difficulties going up stairs and getting out of bed and these symptoms are not normal for patient. Pt also noticed double vision in horizontal plane lasting up to 30min and resolves spontaneously and then returns a few hours later. Pt is currently being worked up to rule out GBS
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ lot # M002252, expiry date: 28-FEB-2017 and lot# L033694, expiry date: 16-JUN-2017, orally. Temperature was 0.8 Celsius degrees for 4 hours and 20 minutes. Data logger was involved. No adverse effects were reported. This is one of three reports from the same reporter. Additional information has been requested.
why her HPV vaccine from 2006 "did not work"; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 31-year-old female patient with a history of MDD.  On an unknown date in 2006, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (exact dose, dose #, route, anatomical location, lot # and expiration date were not reported).  On an unknown date, at the time of the report, she presented to clinic to discuss her pap smear/HPV results. She had a normal pap smear but tested positive for HPV, with her genotype negative for 16, 18, 45  the most high-risk variants. It was determined that the patient should have a repeat HPV/pap in one year based on a 5 year CIN3+ risk of 4.8%. The patient was distraught when she received her results  she felt shame, was concerned about cancer, confused why her HPV vaccine from 2006 "did not work," (vaccination failure) and felt unsure about how to discuss these results with her new heterosexual male partner. She experienced reassurance with education about the transient, common nature of HPV infection and the knowledge that higher risk strains are responsible for the majority of HPV-associated cancers. The outcome of the event was not reported.  The author considered the event of vaccination failure to be related to suspect vaccine.   Literature report.  A copy of the published article is attached as further documentation of the patient's experience.
PT REPORTS HE STARTED WITH ITCHING AND RASH ON HIS ARMS, TRUNK, FOREHEAD AND LEGS THE NIGHT OF THE VACCINES.
Given vaccine 10-23-09 pm. 2 days later (10-25-09) started to develop rash on L deltoid (where shot was given) and down onto forearm scattered macular papular rash. Itchy. Still has rash 10-26-09
Sorry arm; sore throat; red, itchy eyes; fever and chills; headache; cough; itchy; stuffy head and fatigue. So far I have treated with Saline spray, ibuprophen and Sinus Medication. Tonight will be 48 hours post injection and reaction started 27 hours ago.
Client called and notified me of events below 3-2-15 Client states went to ER 12 days after receiving vaccines for "vertigo and vomiting." States ER Doctor diagnosed her with "vestibular neuritis." States he told her it was probably caused by "either the vaccines or exposure to the Herpes virus from her husband's cold sores" was hospitalized x 2days.
Moderna COVID-19 Vaccine EUA  Symptoms: horrible headache, fever, muscle aches, fatigue. Onset was 8 hours after injection and lasted up to 30 hours. This occurred during both first and second dose. Second dose had higher fever (104 degrees)
Painful and extreme weakness in left hand. Specifically, the palm. I cannot make a tight fist or grip anything for long.  I took sleeve to help with the pain for 10 days but it has not gone away.
facial paralysis; rt side of face, drooping mouth & eye w/numbnesss in mouth & rt side of tongue; ?Bell's palsy;
Pt states itching surrounding injection site approximately 2 inches and more below injection site. Warm to touch her doctor recommended ALLEGRA since pt said she could not have BENADRYL. Pt did not take ALLEGRA but did compresses to area and redness and itching has gone away within one day.
deathly migraine; vomiting; nauseas, I throw up 1 time a day; fatigue; body ache, body hurt; started feeling bad; flu like; Shaky; could not move arms or head; all possible side effects that everyone told; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head) and VACCINATION COMPLICATION (all possible side effects that everyone told) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head), VACCINATION COMPLICATION (all possible side effects that everyone told) and MYALGIA (body ache, body hurt). On 20-May-2021, the patient experienced MIGRAINE (deathly migraine), VOMITING (vomiting), NAUSEA (nauseas, I throw up 1 time a day) and FATIGUE (fatigue). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency; BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) for Migraine, at an unspecified dose and frequency and GABAPENTIN for Migraine, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head), VACCINATION COMPLICATION (all possible side effects that everyone told), MIGRAINE (deathly migraine), MYALGIA (body ache, body hurt), VOMITING (vomiting), NAUSEA (nauseas, I throw up 1 time a day) and FATIGUE (fatigue) outcome was unknown.            Patient reported every Blood test, Urine test and every test under the sun found nothing. Rheumatologist did not found anything and neurologist did MRI but found nothing and gave prescription for migraine. Concomitant medication was not provided
This spontaneous report as received from a registered nurse (R.N.) via a field representative refers to a male patient of an unknown age. The patient's medical history and drug allergies were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL (intramuscular, dose, lot# and expiration date were not reported). It was not confirmed if this was the first time the patient was vaccinated with GARDASIL. The patient's concomitant medication was not specified by the reporter. It was reported that in approximately 2015 (reported as a few weeks ago), the patient became "ill" after receiving GARDASIL and was admitted to an unspecified hospital (in the Intensive Care Unit) for about a week. While in the hospital the patient was diagnosed with Guillain-Barre syndrome. It was reported that unspecified diagnostic tests were performed and that an unspecified treatment was given for the adverse event. The outcome of Guillain-Barre syndrome was reported as recovering. Causality assessment between the event of Guillain-Barre syndrome and GARDASIL was not provided. The reporter considered the event of Guillain-Barre syndrome as medically significant, disabling and life threatening (based on the physician's diagnosis). Additional information has been requested.
Midnight (12/Feb/2021) she had diarrhea until Sunday.; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Midnight (12/Feb/2021) she had diarrhea until Sunday.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medication history was provided.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIARRHOEA (Midnight (12/Feb/2021) she had diarrhea until Sunday.). On 14-Feb-2021, DIARRHOEA (Midnight (12/Feb/2021) she had diarrhea until Sunday.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information includes Cipro 500 mg two times a day for 3 days.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: TCR  received on 25-apr-2021, patient declined follow up
Unconsoleable crying for 5 hrs following administration of vax; no inc temp noted;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 11Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BISOPROLOL FUMARATE, start date: 20Apr2022, stop date: 25Apr2022; IRBESARTAN, start date: 20Apr2022, stop date: 25Apr2022; ZIAC, start date: 20Apr2022, stop date: 25Apr2022; AVAPRO, start date: 20Apr2022, stop date: 25Apr2022. 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. The patient has administered other medication in 2 weeks. Paxlovid was given as a treatment for COVID 19. Treatment start date: 20Apr2022 and treatment stop date: 25Apr2022. The patient experienced Bad cold-like symptoms on day ten after having started medication. By day Five  the patient was feeling fine. There were no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Itching on front bend of elbow, last 24 hours feeling low on energy & wanting to sleep all the time.
neuropathy of the feet; sore arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the second of 2 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in Mar2021 as single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient previously took pregabalin (LYRICA) for neuropathy of feet. The reporter stated during inbound call, the patient received vaccine back in Mar2021 and it had worked great. The patient had a really sore arm on an unspecified date, reported "they stick with a big needle". It worked out great for the patient. The patient had neuropathy of the feet and he needed this medicine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829966 same reporter/drug/event, different patients