chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered vaccine which had undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; Dose/volume:0.25; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), ACCIDENTAL UNDERDOSE (Dose/volume:0.25) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Sep-2022 at 4:02 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and ACCIDENTAL UNDERDOSE (Dose/volume:0.25). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), ACCIDENTAL UNDERDOSE (Dose/volume:0.25) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and ACCIDENTAL UNDERDOSE (Dose/volume:0.25).    No concomitant medication was provided.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  Date vial was moved from freezer to refrigerator on 7-Sep-2022.   It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
Scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced THROAT IRRITATION (Scratchy throat). At the time of the report, THROAT IRRITATION (Scratchy throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine stored in the refrigerator for 31 days was administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine stored in the refrigerator for 31 days was administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in the refrigerator for 31 days was administered). On 07-May-2021, PRODUCT STORAGE ERROR (Vaccine stored in the refrigerator for 31 days was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medicines was not reported by reporter  treatment information was not provided
2/6/2023 I woke up , I had a headache and below my eyes it was tender and felt bad and sides of my nose. I sneezed a lot and thought it was allergies . I never had headaches before. I tested positive the next day. I did telehealth the following. The doctor prescribed Paxlovid. I was feeling tired.
redness, swelling, warmth, pain left upper arm with swollen supraclavicular lymphadenopathy, treating with Antibiotics for possible cellulitis and ice/NSAIDS for local vaccine reaction
I had a sore arm for a couple of days. I have a history of tinnitus and the noise is a constant and annoying. It has affected my sleep and my overall life. I experience spikes where the symptoms are worse. My doctor prescribed a sleep aid and an anti-depressant which is helping a little. I talked to my doctor recently and he recommended to double the dosage and see if that helps.
HEAVY IRREGULAR MENSTRUAL PERIODS; HORRIBLE HUNGER (COULD EAT AN ENTIRE BIG MEAL); FELT DRUNK; BODY ACHES; MUSCLE PAIN; HORRIBLE ARM PAIN (PAIN AT INJECTION SITE); FEVER OF 103 TO 105 DEGREE; DIZZINESS; DROWSINESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 137 pounds, and height was 63 inches. The patient's concurrent conditions included: gluten intolerance, exercising, perimenopausal, non-smoker, non-alcoholic,  drug allergy  (esomeprazole), acetomycin (penicillin) allergy, and allergy to oral steroids. Patient was not on any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: Unknown) dose was not reported, 1 in total, administered on 06-APR-2021 for prophylactic vaccination on her right arm (dose number in series 1). No concomitant medications were reported.  On 06-APR-2021, the patient experienced dizziness, drowsiness, body aches, muscle pain, horrible hunger (could eat an entire big meal), felt drunk which lasted for 3 days, fever of 103 to 105 degree which lasted for few days and horrible arm pain (pain at injection site) relived by putting ice and lasted for 1 week. Laboratory data included: Body temperature (NR: not provided) fever of 103 to105 degree. On an unspecified date, the patient experienced heavy irregular menstrual periods (got period twice a month for 3 months after receiving the vaccine then it went back to normal) (dose number in series 1). The patient did not take any medication for all her symptoms, the only measure she took was having chamomile drinks and getting a lot of sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, drowsiness, horrible hunger (could eat an entire big meal), felt drunk, body aches, and muscle pain on 09-APR-2021, heavy irregular menstrual periods, horrible arm pain (pain at injection site) on 13-APR-2021, and fever of 103 to 105 degree on APR-2021. This report was non-serious. This case, involving the same patient is linked to 20211219942.
I had a sore throat, hard time sleeping, sinuses were sore and coughing, this is how it started out in the evening on the 3rd. I took a test on the 4th and it was negative. Symptoms got worse and I took a test on the 6th and it was positive. Symptoms lasted until the 9/10th but I still have a cough. I took the antiviral medication for 5 days 2x day.
Case number PHEH2015US000687, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 38 years old male patient. Medical history and concomitant medications were not reported. On 31 Oct 2014, the patient received FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLUVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed as non-serious. No adverse event was reported following this medication error.
Patient developed a rash on 3/4 of her body, and gradually disappeared over 3 days.
About 30 minutes after vaccination, after returning to class, the student had complaints of being jittery and lightheaded. Patient stated Left arm was numb and twitchy and Left leg was numb also.  10:58 am BP =104/78, P = 80, R = 17, Temp = 99. Had banana to eat and drank 16 oz of water. Patient instructed to lie down on cot in nurses office. neuro checks were normal. 11:15 patient was recovered and spoke with parent over the phone.
Moderate erythema to LD muscles 5-6" round.  No fever or other symptoms.  Mom did not administer any TYLENOL or ibuprofen.  Developed over course of 24 hours.  Recommended ice & TYLENOL & to contact primary M.D. if symptoms worsen.  TC on 5/7/08 to f/u message left.  Mother called back, swelling gone lasted another 2-3 days.  TYLENOL worked well.
Fever, chills, significant aches in lower back and lower body, weakness, and worst of all, intense headache that dulled after about 24 hours, but has persisted for 4 + days at this point.  It is now day 5, and I still feel quite weak and my headache, though getting better, persists.  I experienced dizziness on days 1 and 2 that has also dulled, but has not quite fully resolved.  Frequent urination on days 1, 2,  and 3.
Began to feel extremely dizzy and tired. The dizziness lasted until the early evening hours. Was unable to rest. Symptoms were gone the next morning at 6:00 AM when I arose.
Breakthrough bleeding, 3 weeks out from placebo pills on birth control. No cramping before the bleeding.
- As expected high fever, -  Increased arthritis pain for the following 24 hours.  - Unexpected effect, in the week following she has developed boils in her skin: forearm close to wrist, legs close to ankles. Nothing else has changed, other than the COVID vaccine being 2nd shot that week. Applying Triamcinolone Acetonide topically to help control the itch.
I experienced muscle weakness in lower extremities, chills, headaches, facial weakness, vision disturbances (blurry vision), diagnosed with guillain-barre syndrome.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. No information has been reported regarding the patient's medical history, current conditions and concomitant medications. On an unknown date in 2016 (also reported as starting on or after 24-MAR-2016) unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dosing details were not reported) (lot # L023387, with expiry date 22-JUN-2017, lot # L033343 with expiry date of 13-SEP-2017 and lot # L044694 with an expiry date of 04-FEB-2018. the RECOMBIVAX HB vaccine was stored at a temperature of 34 F (Fahrenheit) for a time frame of 20 minutes. There was no previous temperature excursions reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a male patient who on 13-APR-2007 was vaccinated with a dose of Proquad (Lot # 656312/0297U). It was reported that the patient developed redness, swelling, tenderness and induration at injection site on an unspecified date after vaccination, approximately April 2007. Additional information has been requested. This is one of several reports received from the same source.
This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On July 2015, reported as "3 years ago", the patient was vaccinated with his first dose of GARDASIL for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not reported). At the time of reporting, the patient was currently in the office to receive the second dose in the series with GARDASIL 9. No adverse effects were reported.
Soreness at injection site, Extreme chills and fatigue, beginning about 8am Feb 5, chills continued until evening but were not as bad in afternoon. Low grade fever, migraine and nausea began around 2:00. Woke up with migraine at 6:30 am on February 6 which has subsided since taking sumatritam. Some fatigue and lethargy this morning but ok otherwise
No additional AE reported; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients.; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (dose and dose number were not reported) and an improperly stored dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event).  On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.; Sender's Comments:  US-009507513-2210USA006289:2210USA006289 US-009507513-2210USA006287:2210USA006287 US-009507513-2210USA006288:2210USA006288
Sore arm; Not felt normal for a week; Fatigue; Strong head ache in first few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Not felt normal for a week), FATIGUE (Fatigue) and HEADACHE (Strong head ache in first few days) in a 39-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Feb-2021, the adult was diagnosed with PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Not felt normal for a week), FATIGUE (Fatigue) and HEADACHE (Strong head ache in first few days). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The adult was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Not felt normal for a week), FATIGUE (Fatigue) and HEADACHE (Strong head ache in first few days) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-049952, MOD-2021-050069, MOD-2021-050206, MOD-2021-049952 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Non-significant follow-up, contact information added.
No adverse event; One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 22-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (One of our staff gave a Blue cap Moderna vaccine today that shows an expiration date of 20-May-2023).    No concomitant medications were provided. No treatment medication was provided.
Redness, swelling and itchiness at injection site. It is resolving redness started 12/2/13 swelling and itchiness started 12/3/13.
Patient is a 70 y.o. male who woke around 0200 with slurred speech, left facial droop and left upper and lower extremity weakness.  Head CT shows a right frontoparietal hemorrhage with surrounding edema.  He has history of metastatic renal cell cancer, with mets to bone, lung and pancreas.  He is under the care of Oncology at Facility.  Recent note from Dr. in Facility detailing his care. He was diagnosed with renal cell carcinoma in 2019.  Note states he has widespread bone metastasis to spine, femur, scapula, ribs.  He is on Xarelto for cardiac history.  K-Centra given in ER.   He presents with GCS 15.  Speech is slurred but understandable.  Answering all questions appropriately.  Right gaze preference but will cross midline.  Left hemiparesis involving upper and lower extremities, sensory intact.
On the evening of vaccination, the client experienced chills and fever. The following morning, her right arm was swollen and erythema was noted 6" in diameter. The client called the health dept and was instructed to see MD. Per telephone call on 12/7/01, the client's husband reports that she saw MD on 12/6/01 who prescribed an antibiotic, and elevation of arm. Swelling is somewhat reduced today. Per telephone call on 12/12/01, she reports that right arm itches but no other problems.
Chills, nasal congestion, aches within 1 of injection, followed by puffy eyes in 12 hours, tightness in chest, hoarseness.
APPEARANCE OF SPLINTER HEMORRHAGE UNDER NAIL OF LEFT ANNULAR FINGER, ASSOCIATED WITH PAINFUL BLENCHING PULP OF SAME FINGER, WITH PUNCTATED HEMORRHAGES. PAIN LASTED 6 HOURS, WAS PULSATILE AND 7/10
Patient stated she had hives soon after vaccination. She went home and had flu like symptoms including headache, nausea, and fever. When I spoke to her this morning, 10/31 she stated fever has since resolved and had taken MOTIRN to help relieve symptoms.
Approximately 5 to 10 minutes after vaccine, mild headache, slight neck stiffness, felt as if waiting are was warm. At 30 minutes post vaccination, felt burning on face.. Skin was flushed dark red on face, ears and tops of hands. Mild itching on legs, no rash. Slight throat discomfort. Took 25 mg of Benadryl with relief. Approximately 2 hours later, burning sensation returned, noted tingling sensation in lower lip with slight swelling. Notified personal physician. Ordered prednisone in event of worsening symptoms. I then noticed a sensation of slight throat tightening/swelling and increased tingling sensation in lower lip. Began 6-day course of prednisone. Headache returned that evening along with itching of arms, legs and back with no rash. Noted high-pitched ringing in ears, which has recently decreased from constant to (now) intermittent. Itching sensation continued to persist.
At 1:30am I woke up with the chills and body aches, I had to bundle up with my jacket, over my pajamas and add a second blanket. I also felt wide awake and I'm not a morning person. My entire body aches every for my head. My joints and muscles hurt from my toes up to my shoulders