chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Refridgeration excursions identified; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Aug-2022 at 11:47 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Sep-2022 at 1:18 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Aug-2022 at 11:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    No concomitant medications were reported.  Patient received the dose 1 and dose 2 of vaccine in deltoid muscle.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions had been reported for the patient as per the reporter's knowledge.  No treatment medications were reported.
administered subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in an unknown number of patients who received Herpes zoster (Shingrix) (batch number J7J4X, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that Shingrix was administered subcutaneously for unknown total of patients by a new employee, which led to intramuscular formulation administered by other route.  The reporter consented to follow up. This case has been linked with the case US2021209477 and US2021209480.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209477:Same reporter US-GLAXOSMITHKLINE-US2021209480:Same reporter
Patient received the influenza vaccine a few months prior to event in December. Patient recently recovered from bronchitis. One day after the first SHINGRIX dose, symptoms began.
09/07/06am fever, nausea and vomiting, upper arm rash, upper arm and elbow pain.
experienced an aura while she was driving, in which she had to pull over until it passed; Migraine/had a complicated migraine/very unusual migraines; Started getting the migraines with an aura; Headache/Severe headache/ throbbing headache/bad headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Diagnosed in the 1970s. Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis. The following information was reported: AURA (non-serious), outcome "unknown", described as "experienced an aura while she was driving, in which she had to pull over until it passed"; HEADACHE (non-serious) with onset 02Apr2021, outcome "recovered" (2021), described as "Headache/Severe headache/ throbbing headache/bad headache"; MIGRAINE (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Migraine/had a complicated migraine/very unusual migraines"; MIGRAINE WITH AURA (non-serious) with onset 06Apr2021, outcome "unknown", described as "Started getting the migraines with an aura".  Additional information: On 02Apr2021, patient experienced a throbbing headache that continued into half of the day on Sunday. Patient reported the headache then went away. Two days later, she started experiencing migraines and had 6 migraines in two weeks. Patient stated during one of the incidences, she had a complicated migraine, in which she has not had since her 40s. Patient stated that she was not able to respond or tell anyone her name. Patient stated that they were very unusual migraines and sometimes she would have an aura then a migraine, but other times she would experience the headache and no aura. Patient stated that she experienced an aura while she was driving, in which she had to pull over until it passed. Patient stated that she had medicine for bad headaches, but she rarely had to use it. The patient got iron infusions from her hematologist.  No follow-up attempts are possible. No further information is expected.
HPI   86-year-old male with history of coronary artery disease, G-tube dependent, chronic renal insufficiency, hypertension presenting today with altered mental status.  Per facility patient's baseline is ANO x1-2 and quite combative/agitated.  Today he was harder to arouse and was only responding to painful stimuli.  Here today in the ED patient is unable to verbally respond, lethargic, and slightly tachypneic with shallow breaths. Spoke to patient's son who is also his POA who states he made the decision to send patient in after nursing facility called him and explained that patient was heavily breathing and not as responsive as normal.      Patient's son tells me that yesterday he got his 2nd covid vaccine just yesterday.   patient  was admitted to hospital -Acute metabolic/toxic encephalopathy - poa  prob sepsis from UTI - poa
Chills with fever, headache, body ache fever every 6 hours for over 2 weeks.
No additional adverse events reported; Medical Assistant reports the administration of PROQUAD to 16 year old patient; This spontaneous report was received from a medical assitant referring to a 16-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 14-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T036562, expiration date 26-APR-2022 (route of administration was not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse events were reported.
a knot underneath my  collar bone and in the muscle of my neck; was throbbing all day; I was unable to go to sleep; This is a spontaneous report from a contactable female consumer (patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in left arm on 28Apr2021 (Batch/Lot Number: ER, unknow what that is U, V, 0175) as single dose at an unspecified age for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ER8729) as single dose at an unspecified age for COVID-19 immunisation.  The patient experienced a knot underneath her collar bone and in the muscle of my neck, it was throbbing all day, she was unable to go to sleep on an unspecified date. The outcome of events was unknown.   Reporter seriousness for events was unspecified.  No follow-up attempts are needed. No further information is expected.
pt recvd vax 2NOV93 & w/in 24 hrs devel erythema & swelling from inject site to wlbow; erythematous area also extended into axilla; fever to 101; seen by MD 4NOV93; being treated w/ice packs & APAP;
About 18 hours following the vaccine, I woke up with blurred vision. As the day has progressed, my vision is still blurred. (24 hours after vaccine.
pt recvd vax & walked aprox 20 feet &collapsed onfloor; picked pt up off of floor & noted eye deviating to the rt for approx 35 seconds; w/o verval response; shortly p/episode pt begin to respons appropriately; VS stable;
covid vaccine breakthrough  dose 1 Moderna 4/7/21  008B212A dose 2 Moderna 5/5/21  043B21A
fever; tired the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US072736_NS.  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; FATIGUE (non-serious), outcome "recovered", described as "tired the next day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of diagnosis of influenza after FLUMIST has been received from a physician concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 16-Sep-2010, the patient received FLUMIST. On 22-Feb-2011, a rapid Flu test was performed and the patient tested positive and diagnosed with influenza. The patient was presented with a congestive cough, a clear runny nose and a poor appetite. All the symptoms were resolved. The outcome of the event was resolved.
she turned hot, don't know how hot, she was very warm to the touch, hot to the touch/forehead was warm; she got a fever; not feeling well; Her forehead was warm and her foot was cold; This is a spontaneous report from a contactable consumer. This consumer reported information for two different patients. This is report first of two reports. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 24Mar2021 10:30 (at the age of 72-years-old), at dose 2, single for covid-19 immunization. Medical history included Huntington's disease and depression. Concomitant medications included ongoing tetrabenazine taken for Huntington's disease; donepezil hydrochloride (DONEPEZIL HCL); levothyroxine sodium (LEVOTHYROXIN); rosuvastatin; bupropion taken for depression. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 03Mar2021 at approximately 10:30 (at the age of 72-years-old), at dose 1, single for covid-19 immunization and not experienced any events. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No additional vaccines administered on same date of vaccination. On 25Mar2021, the patient turned hot, she was very warm to the touch, hot to the touch and she got a fever on morning, she was not feeling good; clarified as not feeling well, she also experienced her forehead was warm and her foot was cold on 25Mar2021. Therapeutic measures were taken included aspirin. There were no investigational assessments. The outcome of the events fever and cold feet was unknown, all the other events were recovering.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346113 Same reporter/ drug and different patient/events
Client called stating she may have had reaction to the Flu shot that she received on 9/21/09 at the Farmer's Mkt Outreach. - She developed severe joint pain ~ 4 hrs post vaccine & fever of 99-100 degrees. - On 9/22/09 she felt better but still had the joint pain & fever ~99 degrees. Also felt achey all over, took Motrin with Relief. By 9/23/2009 symptoms subsided. NKA's.
some light bleeding; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:30 (at the age of 55 years old) (Lot Number: ER8731; Expiration Date: 31Jul2021) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included ongoing ulcerative colitis, ongoing ulcerative proctitis, ongoing Crohn's disease, ongoing rosacea (in her 20s-30s) and menopause. The patient previously took metronidazole (METROGEL) for 30 years with no issue. Patient had no Prior Vaccinations within 4 weeks. On an unspecified day in 2021, patient reported some light bleeding after the first vaccination then after the second vaccination on 11May2021, patient experienced a full blown period after menopause. The event resulted in a physician office visit. The outcome of the event was unknown.
Information has been received from a nurse practitioner concerning a 17 year old female who on 16-MAY-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included Menactra. On 16-MAY-2007 the patient fainted. Subsequently, the patient recovered from fainted. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse practitioner concerning a 17 year old female who on 16-MAY-2007 was vaccinated with her first dose of GARDASIL (lot # unknown). Concomitant therapy included MENACTRA given on the same day. On 16-MAY-2007 the patient fainted after being vaccinated. Medical attention was sought. On 16-MAY-2007 the patient recovered. Therapy was discontinued. Further information is not available.
This serious literature case, initially received on 23-Jul-2018, reported by other health professional and concerns a 75-year-old, elderly, female patient. In past (reported as 5 months ago), the patient's Computerized Axial Tomography (CAT) scan of the chest was essentially unremarkable. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, 3 weeks after a flu vaccine, the patient presented with sudden onset fatigue and extreme dyspnoea with minimal exertion. Patient had no joint pain or rashes. On an unspecified date, the patient had different lab investigations. Complete blood count and renal function both were found to be un-remarkable. A CAT scan of the lung showed diffuse bilateral patchy consolidation with coalesced nodularity in the upper and mid lung fields. All respiratory cultures were negative. Vasculitis workup was found positive for cytoplasmic-ANCA (c-ANCA). Hence, the patient was diagnosed with Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis. The reporter stated that Systemic reactions to the flu vaccine are rare and include Guillain-Barre Syndrome (GBS), and hypersensitivity reactions. Reported autoimmune reactions include non-clinical antibody productions or flare ups or flare-existing conditions. ANCA (Anti-Neutrophilic Cytoplasmic Antibody) associated vasculitis (AAV) is rare with incidence of 1 in 20 million annually. Its association with flu vaccine reported only in few cases in the literature. AAV has been reported to occur within 2-4 weeks after flu vaccine only in 8 cases. There was an equal distribution of c-ANCA (cytoplasmic pattern) and perinuclear-ANCA (p-ANCA) in these cases. The kidneys and the lungs are the most affected organs. Cyclophosphamide and prednisone are effective treatments for most. The etiology of AAV in this case is presumed to be an auto-immune mediated response much like in the idiopathic AAV. However, it is unclear if there is a genetic predisposition for flu vaccine associated AAV. At the time of this report, the outcome of the events was not reported. The reporter assessed the event Anti-Neutrophilic Cytoplasmic Antibody (ANCA)-associated vasculitis as related to flu vaccine.
hives; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic to beef" (unspecified if ongoing), notes: She stated that she is allergic to beef, specifically beef gelatin or bovine gelatin. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Third dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives".  Additional information: Reporter was a MD (Doctor of medicine) calling on behalf of herself as a consumer. Reporter explained that she had some bad reactions after receiving the second booster dose of Pfizer-BioNTech COVID-19 Vaccine. She stated that she is allergic to beef, specifically beef gelatin or bovine gelatin. She said she experienced "hives, etc.". Reporter wanted to know if the vaccine contains gelatin and what is the exact source of this gelatin. Gelatin is not used during the manufacture of the vaccine. The vaccine does not contain gelatin. However, the vaccine is not specifically manufactured to be gelatin-free. We cannot guarantee that minute amounts of substances are not contained in raw materials obtained from our suppliers. Reporter wanted to know if the vaccine contains specifically bovine-derived products. Reporter stated that it took "a little while" to report the AE. She spent about 10-15 minutes on the phone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever; runny nose; headache; nausea; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old non-regnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) first dose  via an unspecified route of administration on 26Jan2021 12:00  as SINGLE DOSE for Covid-19 immunisation.Medical history included and concomitant medications were not reported. . Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Patient was not administered any other vaccines for 2 weeks and patient had no allergies. On 26Jan2021 the patient experienced fever, runny nose, headache, nausea, body aches. The outcome of the events were recovered.  Batch/Lot number was not reported at the time of report completion for an unknown reason.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received 1st dose and only had sore arm which was resolved on an unknown date. The patient did not consented to follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR066815.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066815:same patient (2nd dose)
Tinnitus in both ears. I originally noticed it on the day of the shot and it went away the next day. It came back on twelve days later and I still have the ringing in my ears. I never had this before.
pt recv 2nd dose of vax & 4 & 8 wk p/vax lab eval revealed that pt did not seroconvert;No further details were provided;
Pt was admitted on 5/10/21 c/o of rigor.  Patient complains of fatigue, weakness, intermittent fevers up to 100.8 °F.  EMS found patient to be hypotensive up to 84/52 and tachycardic up to 120s per minute. He woke up the morning of admission and then began to have shaking rigors at 10 AM and felt profoundly fatigued, dizzy and lightheaded.  Patient does have a history of COPD which is non-O2 nonsteroid dependent and has some chronic shortness of breath.  He does use inhalers and nebulizers and also continues to smoke.  He also has a history of melanoma who follows with provider.  In the ER he was found to have hypotension and was given 2 L of IV fluids.  He also had a 3 g drop in his hemoglobin over the past 5 days and there was concern for a possible upper GI bleed.  Because of the hypotension and drop in hemoglobin he was admitted to the ICU.  He was started on Protonix IV.  Chest x-ray, CT of the chest CT of the abdomen and pelvis were unremarkable for any acute process.  He was admitted for unspecified shock which was initially thought possibly due to sepsis but this was ultimately ruled out.  He was treated with 5 days of vancomycin and Zosyn and then antibiotics were discontinued.  Patient's troponin was elevated with an elevated delta.  He was seen In consultation by cardiology who felt that no further cardiology work-up was needed the cause for the patient's hypotension was unclear but his home lisinopril was discontinued.  he did require albumin but not pressor support.  As he was more stable he was transferred out of the ICU to the medical floor.  He was started on midodrine.  His blood pressure has improved he has remained afebrile throughout his hospital course he has remained stable off antibiotics.  At this time he is medically stable for discharge to home and will continue on midodrine for new autonomic failure/dysfunction. the cause for his fevers/rigors was not found
Headache, muscle pains, fatigue, hard hot section of upper arm well beyond injection site. Fever began on the morning of the 4th day. This has gone on for 4 days and symptoms have not decreased. I have taken allergy medication and anti-inflammatory when unable to sleep. I will go to my PCP tomorrow if symptoms have not dispersed.