chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse event; 5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (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 (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions).    No concomitant product reported by reporter.  5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions. It was unknown if patient received any other vaccine in the 4 prior to COVID-19 vaccine.  No treatment medication reported by reporter.  Case included information of patient 2 of 5 patients.
reports approx 8" red, swollen, sore, warm to the touch area on left upper arm
Patient tested positive 11/13/21 at CVS (nasal swab). Symptoms started 11/11/21; fever >100 on day #1 (resolved 11/16/21), nasal congestion, runny nose, coughing, headaches (main concern), body aches, sore throat (started initially - has now resolved), fatigue, loss of smell, and vomited the first day (has not vomited since). Patient had cancer and chemo 1 year ago (completed chemo 8 months ago).
sore arm; chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs; chest pain/muscle pain in the rib in the chest ribs; teeth pain; teeth sensitivity; anxiety; When I take a death breathe it hurts and sometimes it doesn't; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 58-year) on 07Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Advil 12 hours back for arthralgia. The patient stated, she received the first dose of her Pfizer vaccine that morning at 9:45am or 10am. she was fine. she just had a sore arm. About 2 and 1/2 hours later experienced: chest area feels like gas; chest pain/muscle pain in the rib in the chest ribs. Minor issue: teeth pain/sensitivity there. she talked to her PCP and he said she had anxiety, so took CBD oil. She stated "When I lie down the pain wakes me up because of the pain. When I take a death breathe it hurts and sometimes it doesn't. It's been almost 8 hours, there's no gas that I'm passing. I'm eating very light food (it's not due to the food I'm eating). It's a unique experience. Something new. not very severe. Question asked whether to take Advil or pain medicine. I was taking Advil for my joint pain, yesterday last night around 10:30 I took the last dose. Today I didn't take anything. Question asked if I should monitor for anything else." On 07Mar2021 the patient experienced sore arm, chest area feels like gas, chest pain/muscle pain in the rib in the chest ribs, teeth pain, teeth sensitivity, anxiety and when I take a death breathe it hurts and sometimes it doesn't. Therapeutic measures were taken as a result of anxiety. The clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Significant menstrual bleeding, 24 hrs a day, still lasting as of the date of this report (so far, a total of 6 straight days). I, the patient, have been through menopause and have not had a period in over 17 months.
One hour after receiving flu vaccine employee broke out in hives on arms, followed by stomach and then legs. No other symptoms. Took 40 mg Benadryl at bedtime. Hives were gone in the morning.
Information has been sent from a consumer concerning her daughter who on unspecified date was vaccinated with the second dose of GARDASIL (lot number, route and site not reported). It was reported that the patient was only able to receive two out of the three GARDASIL vaccinations. After the second vaccine she was diagnosed with Lyme's disease and was told that it was not good idea to give her any type of vaccination with an immune type disease such as Lyme. Therapy with human papilomavirus vaccine was discontinued. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
vaccine adm at 2:33, , 2:40pm pt had fainting episode vs:129/67, P44-54, T96.2, R18, O2 sat 98%, EMS called R/T syncope and bradycardia. 2:44 vs:116/72, T96.2, R18, O2 97%, in and out of consciousness. lowered to ground by clinical staff, turned on side. 2:50 vs: P70, 112/64, R18. 2:53 EMS onsite, 126/79, P66, R18 3pm EMS cleared pt, declined to go to hospital. 3:10 VS 126/79, P66, R 18, A/O x 4, friend present. Medical director informed, ok to leave. Left in no acute distress.
This spontaneous report has been received from the medical assistant refers to a 14 months old male patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the VARIVAX was properly stored. On 12-JUN-2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N031001 and expiration date 03-NOV-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 13:15 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 at 14:30 as dose 1, single (Lot number: EL9262), in left arm, on 15Feb2021 at 14:00 as dose 2, single (Lot number: EN6201), in left arm, on 18Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "basil cell carcinoma on skin - mose surgery" (unspecified if ongoing), notes: Other medical history: Fairly healthy basil cell carcinoma on skin - mose surgery; "basil cell carcinoma on skin - mose surgery" (unspecified if ongoing), notes: Other medical history: Fairly healthy basil cell carcinoma on skin - mose surgery. Concomitant medication(s) included: OMEGA 3 ACID ETHYL ESTERS, start date: 01Feb2016; VIT D3, start date: 01Mar2020; CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PHOSPHATE;CHROMIC CHLORIDE;COLECALCIFEROL;CUPRIC OXIDE;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;POTASSIUM CHLORIDE;POTA, start date: 01Apr2014; LOSARTAN, start date: 02Sep2016. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:The patient is treated with paxlovid for covid -19 from 02Feb2023, to 07Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a register nurse, refers to an unknown age and gender patient. Medical history was not reported. On an unknown date the patient was vaccinated with M-M-R II lot number, route and dosage were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patient had titers drawn on an unspecified date and the patient's titers for mumps came back "low" for mumps immunity. Additional information has been requested.
headache, feeling of spinning, side to side motion,nausea, imbalance gait. Diagnosed with vertigo, labyrinthitis till present(10-21-09) time with symptoms. Prescribed with meclizine and rest
2MAY96 945AM pt recv vax & mom noticed local rxn approx quarter size;pt c/o itching & area warm to touch;pt evaluated in our office & area size of ping pong ball;given DPH;
STOMACH IRRITATION; STOMACH CRAMPING; This spontaneous case report (PVX2019-2435) was received from a pharmacist on 25-Sep-2019. It described a 23-year-old adult female consumer who experienced stomach irritation (PT: Epigastric discomfort) and stomach cramping (PT: Abdominal pain upper), after administration of oral Vivotif capsule (took one dose every other day) for typhoid prophylaxis.  Case report: The consumer took the first two doses of Vivotif on 22-Sep-2019 and 24-Sep-2019, respectively and experienced stomach cramping and stomach irritation after taking it.  Action taken with Vivotif with respect to the event was unknown.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer experienced stomach irritation and stomach cramping after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, stomach irritation and stomach cramping are labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach irritation and stomach cramping after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, stomach irritation and stomach cramping are labelled as per CCDS.
Got vaccine 02/02/21 starting feeling fatigued immediately 11am, around 5pm started feeling fever, at 7pm started having chills, fever and pain and keep getting worse, by 11pm or 12am fever was 102.6 with lower back pain and all muscles felt weak even with tylenol continued, 3-4 am started getting headache and fever starting going down after tylenol and pain reduced and chills stopped.  Now pt contined tylenol and is feeling better tried eating breakfast almost passed out, does not have appetite
Pt recvd 3 vaxs on 1AUG89, 29AUG89, 25JAN90; Titer was neg; Given 4th dose of vax 13AUG90; Titer following neg;
10/15/99:Pt. rcvd 2nd dose of pneumo. vax.Few hrs. post-vax.,pt. exper. pain in his arm that radiated to his neck and deltoid was swollen.Next day pt. dvlped flu-like SX.10/17/99: dvlped red band around bicep.10/20/99:knee & face swelling.
Patient passed out for couple minutes after  getting the vaccination but regained  consciousness within couple minutes.  She was talking and felt fine. She said  it happened once before at doctors office  her spouse came & picked her up.
Chills, couldn?t get warm! Whole body couldn?t stop shaking,  Pounding headache, Fever, & Vomiting.
Pain - generalized (whole body). Treated with ketorolac and morphine without relief.
15 minutes after injection lips started tingling, short of breath, dizzy, nauseous, and rapid heart rate. Took Albuterol INH 2 puffs, BENADRYL 25 mg by mouth x 2. Symptoms relieved after 3.5 hours.  Had back pain when able to void at the end of 3.5 hours. Had shortness of breath again 3 hours later and took 10 mg CLARITIN and BENADRYL 25 mg x 1.
For 2 days he had arm pain and hot flashes. Day 3 he felt better but had some arm cramping. 84 hours after the vaccine he woke with tremors for several hours overnight; he then continue to experience muscle twitching but the tremor resolved the next morning. That day he noticed he felt very fatigued. The twitching and spasms lasted about 3 or 4 days. The legs will still spasm at nighttime and he still feels fatigued with less exercise tolerance. His baseline was 2-3 miles walking without difficulty prior to the vaccine, lately a mile will wipe him out. He also noticed intermittent midline pain around his breastbone that has improved. He hasn't had any shortness of breath. He had poor circulation to his hands and were cold and white but that resolved. He did not have sensory changes. His symptoms overall have been improving.
Diarrhea; 103.0 fever reduced to 100.9; Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (103.0 fever reduced to 100.9), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: abnormal (abnormal) 103.0 fever has come down to 100. 9..         Concomitant product use was not provided by the reporter. Lab details were not provided.
Swollen face, right sided Bells palsy. Positive EBV after shot ~ 2 weeks.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA227513 (same reporter). This case involves a 2 months old patient who was vaccinated with a once dose of PENTACEL (batch number:  C5551AA and expiry date: 10-Oct-2019) in the right thigh (dose, dose in series and route of administration were not reported) on 13-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were unpacked and storage of the vaccine may not have been within recommended temperatures which puts into question the viability of the vaccine. It was reported that on Monday, 13Aug2018, two patients were immunized with PENTACEL vaccines out of this shipment. On Monday night after business hours, an email was sent to the physician in this practice stating that this order of PENTACEL had taken too long in transfer/transit. Because of this, the storage of the vaccine may not have been within recommended temperatures which puts into question the viability of the vaccine. The vaccine took 3 days to get to the physician's office. It was unknown if any adverse event was occurred or not following the vaccination. 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 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.  Documents held by the sender: None.
This is a 25y.o. male who presents for one day of abdominal pain. On 1/1 he started having nausea and vomiting with some abdominal pain. He thought that he had the flu so he just rotated out. He states that he has had at least 15 episodes of emesis in the past 24 hours. Today his symptoms and abdominal pain have gotten significantly worse in which the pain is no longer in the right lower quadrant but it is all over the abdomen and radiating to the back. He has been having subjective fevers and chills at home.    In the emergency department he is tachycardic, white blood cell count 15.8, CRP 445. Sepsis bolus was started, Rocephin and Flagyl were ordered however this was changed to Zosyn. CT scan showing ruptured appendix with a small area of pneumoperitoneum.
Patient presented with diffuse edematous plaques on the trunk 2 weeks after receiving her first dose of the vaccine. Biopsy was performed and showed hypersensitivity reaction. Resolved with topical steroids.
Gave shots at 3:52 pm. Was told to stat 15 mins. in order to observe her for any reactions. After 15 mins at 4:07 pm she left us know she felt her throat was closing. We let doctor know right away. She immediately injected epinephrine on the patient. She stayed in the office until 8:45 and was continuously observed. Vital signs including O2 sats were monitored, sent home 5:45 pm
Lumps underneath her arm pit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lumps underneath her arm pit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Lumps underneath her arm pit). At the time of the report, AXILLARY MASS (Lumps underneath her arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
fever-one time highest at 100.3, dry cough, diarrhea, chills, headache on and off, sore throat, left swollen glands/sore, shortness of breath, body aches, fatigue, diarrhea, sinus congestion, nasal congestion. starting 1/8/2022
migraine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious), outcome "recovered". It was unknown if therapeutic measures were taken as a result of migraine. Additional information: Pharmacy Technician reported migraine following administration of second dose of original Comirnaty formulation (ca. early-2021). Serious was No. Seriousness criteria-Results in death was No. Seriousness criteria-Life threatening was No. Seriousness criteria-Caused/prolonged hospitalization was No. Seriousness criteria-Disabling/Incapacitating was No. Seriousness criteria-Congenital anomaly/birth defect was No. If COVID prior vaccination was Unknown. if COVID tested post vaccination was Unknown.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Experienced chills and shivering for about 5 hours and recurring chills on arms later in day for about an hour.
On 9/13/20 pt reported giant, swollen, red, hard bump on her arm that was hot to the touch. Low grade fever that started the day of vaccination (8/26/20) and rose to 99.9 overnight into the next day.  Whole upper left arm hurt that reduced to dull ache after about 5 days.  General malaise that lasted 5-6 days and nausea all day the day after shot.