chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt rough for a few hours; had cold chills; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious social media case. This case involved a patient with unknown demographics who had cold chills (Chills) and felt rough for a few hours (Feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (Influenza) and sick for over a week (Illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for both the events, at the time of reporting.  There will be no information available on the batch number for this case.
PFIZER-BIONTECH COVID-19 EUA:  RESIDENT WITH POSITIVE COVID TEST ON 7/21/21.  RESIDENT SENT TO HOSPITAL ON 7/22/21 FOR EVALUATION OF HYPOXEMIA.  HOSPITAL REPORTED TO FACILITY THAT RESIDENT ADMITTED TO ICU ON VENTILATOR ON 7/23/21 AT 2AM.
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
In the days following the shot, I had the typical symptoms (fever of 101.5, migraine, chills, fatigue, injection site soreness). However, I also had shortness of breath and heart palpitations. My normal 2 mile fast dog walk each night was no longer possible. Even talking on the phone created SOB. This was sudden and unexpected. I went my primary care provider.
Losing vision; Less mobility; Joints were inflamed; COVID vaccines reaction/sore arm after covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Losing vision), MOBILITY DECREASED (Less mobility), ARTHRITIS (Joints were inflamed) and VACCINATION SITE PAIN (COVID vaccines reaction/sore arm after covid vaccines) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (COVID vaccines reaction/sore arm after covid vaccines). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Losing vision), MOBILITY DECREASED (Less mobility) and ARTHRITIS (Joints were inflamed). In 2021, VACCINATION SITE PAIN (COVID vaccines reaction/sore arm after covid vaccines) had resolved. At the time of the report, VISUAL IMPAIRMENT (Losing vision) had not resolved and MOBILITY DECREASED (Less mobility) and ARTHRITIS (Joints were inflamed) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of COVID vaccines reaction/sore arm after COVID vaccines and losing vision with Humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of less mobiltiy was not provided. The reporter's causality for the events of joints were inflamed with Humira(adalimumab) was a reasonable possibility.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was fine until about 13 minutes after the shot. She passed out in chair breifly. She came to quickly. EMS came and checked pt vitals and she declined going to the ER.
Systemic: Hypertension-Severe, Additional Details: Patient presented to pharmacy on 12/31 and wanted to report a side effect he though was related to his first dose of pfizer. Patient had previously had Covid twice before being vaccinated on 12/21. He said about 2 hours after vaccination he was not feeling well and had is BP checked and in came out to 250/125. He was rechecked 5 hours after this and everything had normalized.
Patient received the first dose of pediatric Pfizer on 11/19/2021. He started feeling sick on 11/21/2021, and then diagnosed COVID-19 positive on 11/23/2021.
This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (excursion from the freezer) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19  immunization. No medical history reported. On Nov 8, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 8, 2021, patient experienced product temperature excursion issue (excursion from the freezer). On Nov 8, 2021, product temperature excursion issue (excursion from the freezer): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. There was an excursion from their freezer on Oct 1, 2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not know how to do the analysis. She stated her team already knew the recommended temperatures and needed to know if the vials were still okay to be used because they were administered to 118 patients.
EXTREME NIGHT LEG CRAMPS; SEVERE INFLAMMATION OF CONNECTIVE TISSUE OF BOTH FEET, KNEES, RIGHT HAND; ARTHRITIS: MODERATE INFLAMMATION OF RIGHT WRIST;  MILD INFLAMMATION OF LEFT SHOULDER AND LEFT SIDE OF NECK; LEFT WRIST;  WEAK ELBOWS; TOXIC LIVER
"Moderna COVID-19 Vaccine EUA"  Hospitalization for abdominal pain and vomiting (pancreatitis)
This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 [lot # L013429, Expiry date: 21-JUL-2017]. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Heart Attack, LAD artery 100% blocked, Stent placed to open up artery.
pt devel chills, fever 102, body aches, just a gen rotten feeling;s/s now beginning to subside, but still feels pretty poor;
SOB, sweating profusely, needed oxygen mask, dizzy, lightheaded. We had pt lie down due to symptoms, we were going to get an EKG but decided to call 991 was more appropriate. We administered oxygen at 2 liters. Paramedics showed up and gave Epi and check pt vitals again and was taken to hospital.
I had a slightly sore arm for about a day after receiving the vaccine. I tested positive for COVID-19 in 01/2022. I took over the counter medication to help with my symptoms. It felt like a bad flu, and I stayed hydrated and slept as much as I could. In 01/2023 I had four strokes. Coming home from a trip was when I had my first stroke. My vision split where I had two visions but not together. Second one occurred in the hospital after my first stroke. At this time, I am checking in with my doctors and the lasted test indicate I am healing.
Area of induration and itching at vaccination site. Red day following immunization. Fine day 2.
Tiny pin point of blood in his arm after the administration; 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 male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Tiny pin point of blood in his arm after the administration"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Tiny pin point of blood in his arm after the administration"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "Tiny pin point of blood in his arm after the administration". The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "Tiny pin point of blood in his arm after the administration".  Additional information: Caller explained that, for the first four doses, he did not had any problem during the administration. The people administering the vaccine had a good technique and there was only a tiny pin point of blood in his arm after the administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201177784 same patient/drug/event, different dose number;
Expired vaccine used; Shingles like pain around left rib cage, no rash.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old adult male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 07Mar2021 (at the age 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included famotidine (PEPCID AC) and atenolol (MANUFACTURER UNKNOWN), all for unknown indications and from an unknown date and unknown if ongoing. The patient had not received any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not tested with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced shingles like pain on the left rib cage, no rash. The patient never had this type of pain before and expired vaccine was used. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the shingles like pain around the left rib cage which included treatment with unknown antiviral and pain medications. The clinical outcome of shingles like pain around the left rib cage was not recovered, outcome of expired vaccine used was unknown.  No follow-up attempts are needed. No further information is expected.
COUGHING; VERY SICK; SORE THROAT; NO ENERGY; FEVER OF 103.5; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had only been sick only 6 times in his life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 21-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Awaiting results. On 22-JUN-2021, the subject experienced coughing. On 22-JUN-2021, the subject experienced very sick. On 22-JUN-2021, the subject experienced sore throat. On 22-JUN-2021, the subject experienced no energy. On 22-JUN-2021, the subject experienced fever of 103.5. Laboratory data included: Body temperature (NR: not provided) 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 103.5, coughing, sore throat, no energy, and very sick. This report was non-serious.
This spontaneous report was received from a consumer regarding his son an 8 months male patient. Medical history and drug allergies were not reported. ON an unknown date, the patient was vaccinated with  M-M-R II (concentration, dose and lot number were not reported) when he was 8 months of age. No adverse events were reported at this time. Additional information is not expected.
Loss of consciousness; Syncope; Face injury; Tooth loss; Immediate post-injection reaction; Somnolence; This spontaneous report was received from the agency, referring to a 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 20-OCT-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly in the right arm (lot number S004578, expiration date 29-SEP-2021) as prophylaxis, the third dose of Japanese encephalitis vaccine inact (IXIARO), administered intramuscularly in the left arm (lot number reported as JEV18L97E, expiration date was not reported), and the second dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), administered intramuscularly in the left arm (lot number reported as U6691AB, expiration date was not reported).  On the same date, immediately after receiving final vaccine, patient fainted from treatment bed (loss of consciousness, syncope, and immediate post-injection reaction). Patient lost consciousness and hit face (face injury) on the floor knocking out two front right teeth (tooth loss). Patient took approximately 30 seconds to rouse but was still somnolent (somnolence). Patient oriented to person, place, and time. Vital signs taken BP 130/76 HR 81 PaO2 100% on room air and 14 breathes/min. Rapid response called, ER arrived to evaluate patient. Pt escorted onto gurney and brought to ER to be further evaluated.  The outcome of loss of consciousness, somnolence, immediate post-injection reaction, tooth loss, face injury and syncope, and the causal relationship between the events and the suspect therapies was not reported were not reported.  Upon internal review, the events loss of consciousness and syncope were determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S004578; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
79-year-old male presents emergency department by EMS in no acute distress.  He was febrile.  He was diagnosed with COVID about a week ago and when his nurse came in and found that he had a fever sent to the ER for evaluation.  He was on steroids and antibiotics.  He states he has been coughing.  He is nontoxic in appearance.  No vomiting but he is producing sputum.  He also has a history of hypertension MI with stents diabetes. Associated Symptoms: chills, cough, fatigue, fever, sputum, weakness
Swelling (hot dog sized area) then transitioned to itchy rash over a palm of hand sized area on 6/7/18 that remained irritated for 5 days.
Interchange of vaccine products; COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), on 14Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: other medical history: History of breast cancer. Concomitant medication(s) included: ANASTROZOLE, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Other medication in 2weeks brand. If treatment ae: No. Known allergies: No.  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.
pt stated that on 2/8/2021 that her lips became numb and both left and cheek are numb.  Pt is also dizzy and light headed.
Swelling on 10/1/11 alert to MD put on BENADRYL 150 mg/day (50 mg TID) x 1 week. MD indicated due to customer - should have used normal flu shot. Arm is ok as of 11/6/11.
mixing error occurred, patient may have been given just diluent. Patient was revaccinated 5/4.
Initial case was received from a healthcare professional on 06 November 2013. This case is cross linked with other cases 2013SA117345, 2014SA012989 and 2014SA012995 being a same reporter. A 60-yr-old female patient whose medical history and concomitant medication was not reported had received an intradermal FLUZONE (batch number: UT4726AA, dose and anatomical site of administration not reported) on an unspecified date. On an unknown date, the patient developed silver dollar size redness and swelling at the injection site. Corrective treatment of laboratory investigations were not reported. The outcome of the event was unknown. The list of documents held by sender: None. Follow-up information received from healthcare professional on 03 March 2014. It was reported that, the patient gender was male. At the time of this report, the outcome was recovered.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 25-APR-2018 the patient was vaccinated with improperly stored doses of ROTATEQ lot # N006285, expiration date 07-OCT-2018, for prophylaxis (strength, dose, route and frequency were not reported). The temperature excursion was of 47 Fahrenheit degrees (°F) to 77 (°F), during 36 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Patient states around 2 hours after receiving vaccine, he experienced fatigue, went home, called off of work the following day due to chills, febrile to 104 F, came into ER with similar complaints, fatigue, muscle aches, tenderness at site of injection and WBC count to 30K, few hours later was 27K, patient was admitted to hospital, LP performed, blood cultures obtained, all tests negative. White count the following day was down to 16K.
Patient slipped/tripped and fell in a familiar location resulting in pain requiring x-rays at ER. On returning to home, patient had chills and elevated temperature to 99.4F. Bed rest and TYLENOL. Ten days req to alleviate pain. Residual psychological timidity due to falling.
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer via other company manufacturer (Pfizer) concerned a 49 year old female. Initial information was processed along with the additional information received from department on 06-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, migraines, and skin cancer. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JAN-2022 for prophylactic vaccination. Age at time of vaccination 48 years old. Concomitant medications included benzonatate, sumatriptan, and valsartan. On 20-MAY-2022, the patient started non-company suspect drug Paxlovid for treatment of COVID-19. Paxlovid was discontinued on 24-MAY-2022. On 28-MAY-2022, the patient returned to positive rapid test after four negative days. (dose number in series 2). Laboratory data included: COVID-19 rapid POC test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000234203.
Patient had increased BP, felt flush, sweaty, and shaky about 15 minutes after receiving the vaccine.   Patient vitals taken every 10 minutes and monitored until she returned to her baseline. Patient also provided a water and snack. After about 20 minutes of additional observation the patient was fine and able to leave.