chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL). At the time of the report, MYALGIA (muscle aches) and ACCIDENTAL OVERDOSE (0.5mL 2nd booster instead of 0.25mL) outcome was unknown. Concomitant medications was not provided by the reporter. Patient got 0.5 mL as a 2nd booster dose instead of 0.25 mL. Stated that she and her husband both had a 0.5mL 2nd booster. Patient wife stated that she and her husband both had a primary series Jan2021 and booster in August. Treatment information was not provided. This case was linked to MOD-2022-536473 (Patient Link). Reporter did not allow further contact.
No additional AE.; Improperly Stored VAQTA was administered to patient.; This spontaneous report was received from a nurse and refers to a 18-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 06-JAN-2021 between 9:30 AM and 12:00 PM, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date 03-DEC-2021 (exact dose, anatomical location and route of administration were not reported) for prophylaxis.    Digital Data logger was involved. The temperature excursion occurred on 06-JAN-2021 at 1:30AM. The vaccine was stored at the temperature that was reported as 35.2 degrees of Fahrenheit for 45 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I encountered two adverse events. The first was after my first shot on 8/20. Eight days after the initial dose I had two enlarged lymph nodes in my left armpit. They were painful, sore and tender to the touch. It lasted for 4 days. After my second shot I on 9/20 I got COVID arm, large red inflamed area about the side of a grapefruit around the injection site. It was painful, tender and hot to the touch. I could not use my arm to its full range of motion. This has not yet resolved.
lost use of his left arm; This case was reported by a consumer and described the occurrence of mobility decreased in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (wife had shingles and no shot and had pain for over 4 years, but pass on the shot.). Previously administered products included Shingles vaccine with an associated reaction of mobility decreased (1st shot received on an unknown date, for tolerance, refer case US2021AMR202714).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had a shot and lost use of his left arm. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202714:same reporter same patient
Diarrhea; Gas; Intestinal distress; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (Intestinal distress), DIARRHOEA (Diarrhea) and FLATULENCE (Gas) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE (EPIPEN) for Bee sting, TESTOSTERONE, MONTELUKAST and HYDROCHLOROTHIAZIDE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Intestinal distress) and FLATULENCE (Gas). On 13-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (Intestinal distress), DIARRHOEA (Diarrhea) and FLATULENCE (Gas) outcome was unknown.        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.   Treatment information was not provided.   This case was linked to MOD-2021-242170 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Added Reporter Email address and concomitant medication EpiPen was added
After hours of non stop crying- baby went silent for a second all four limbs rapidly/jerkingly pulled into her body about 3 times, non voluntarily, like a seizure, then she kept crying hysterically for the next 4 hours.
A week after my son had his MMR and Varicella vaccines he developed cold like symptoms and on the 8th day after the vaccination his tempeture went up to 104 F and he had a seizure.  911 had to be called and he was transported to the emergency room.
Initial misuse report received on 04 September 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) which expired on 19-Aug but was given on 03-Sep. As of 04 September 2013, the patient did not have any adverse events. List of documents held by sender: none.
Lt arm soreness 1 wk after H1N1 vaccination, last for 2 wks and still sore. Limited range of motion at Lt. arm and shoulder with pain. No pain, no redness no swelling at injection site noted after vaccination. (* Pt. has been traveling with luggages for several months.)
Chills; Light-headed/Dizzy; This is a spontaneous report received from a contactable consumer (patient's spouse). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267, expiry date: unknown), via an unspecified route of administration, on 13Feb2021, as single dose, for COVID-19 immunization. Medical history included hypertension, blood pressure abnormal (reported as blood pressure) and prostatic disorder (reported as prostate). Concomitant medication included amlodipine taken for blood pressure abnormal; benazepril; metoprolol; apixaban (ELIQUIS); tamsulosin; omeprazole; venlafaxine taken for prostatic disorder; and succinate sodium, all start and stop dates were not reported. The patient experienced chills and was light-headed and dizzy in Feb2021. No treatment was given for the events. The reporter wanted to know if they have to go the emergency room and asked for the treatment. The outcome of the events was unknown.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age. The nurse noted, that she heard from other health care professionals, that on multiple unspecified dates the patients were vaccinated with GARDASIL 9 (batch #; lot #, dose and route of administration were not reported) on an administration schedule outside of the labeled administration schedule. There was no adverse event reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Fever, headache, stomach cramps, rectal bleeding when I tried to go to bathroom.  Bleeding lasted 3 days
This spontaneous report as received from a medical assistant refers to a 25 year old patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 24-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 (Strength, dose, anatomical location, lot # and expiry date were not reported) intramuscularly for prophylaxis. On 14-OCT-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly for prophylaxis (Inappropriate schedule of product administration). On 15-NOV-2018, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly for prophylaxis. There were no adverse reactions reported. There was no product quality complaint associated with this report.
Got sick 5 days after the 1st dose; Coughing after the 1st dose; Sneezing after the 1st dose; Congestion after the 1st dose; Secondary sinus infection after the 1st dose; Fatigue after the 1st dose/very tired fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick 5 days after the 1st dose), COUGH (Coughing after the 1st dose), SNEEZING (Sneezing after the 1st dose), NASAL CONGESTION (Congestion after the 1st dose) and SINUSITIS (Secondary sinus infection after the 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinus infection. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE and ESTRADIOL (DIVIGEL) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ILLNESS (Got sick 5 days after the 1st dose), COUGH (Coughing after the 1st dose), SNEEZING (Sneezing after the 1st dose), NASAL CONGESTION (Congestion after the 1st dose), SINUSITIS (Secondary sinus infection after the 1st dose) and FATIGUE (Fatigue after the 1st dose/very tired fatigue). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal congestion, at a dose of UNK nasal spray; AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]) for Nasal congestion, at a dose of UNK nasal spray; CEPHALEXIN [CEFALEXIN] at an unspecified dose and frequency and CIPROFLOXACIN for Infection, at a dose of 500 mg twice a day. At the time of the report, ILLNESS (Got sick 5 days after the 1st dose), COUGH (Coughing after the 1st dose), SNEEZING (Sneezing after the 1st dose), NASAL CONGESTION (Congestion after the 1st dose), SINUSITIS (Secondary sinus infection after the 1st dose) and FATIGUE (Fatigue after the 1st dose/very tired fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On an unknown date, the patient visited an ENT as her symptoms were worsening. The ENT diagnosed the patient with a secondary sinus infection which they state was not related to COVID-19. On an unknown date, it was reported that the patient discontinued cephalexin after 4 days due to culture insensitivity.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received and reporter information and patient demographics updated, vaccine information, and concomitant/treatment medication information updated, event terms and onset updated and outcome updated to recovered/resolved.
The evening of the vaccine, she experienced profuse vomiting and diarrhea followed by chills. Several days later experienced "tightness" in chest and anxiety. She went to ER where they told her she was dehydrated and was experiencing some EKG changes. Since then 2 more ER visits with palpitations and anxiety.
Generally doesn't feel good; Achy/ hurts all over; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Generally doesn't feel good), PAIN (Achy/ hurts all over), FATIGUE (Fatigue) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included PAROXETINE, AJMALINE (CARDIA), LOSARTAN and EZETIMIBE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MALAISE (Generally doesn't feel good), PAIN (Achy/ hurts all over), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (Generally doesn't feel good), PAIN (Achy/ hurts all over), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        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 medications include eye drops, two inhalers.
9/15/09 Pt. had 0.5ml of FLUVIRIN in left deltoid. Pt had swelling at injection site. Pt had no asthma symptoms. Contacted Dr and follow up with patient. Pt had no further problems 3.5 hours after injection
Shortly after the vaccine I started having a migraine and extreme light sensitivity. Today I have gradually become nauseated, have a poor appetite, feel very lethargic, and have a mildly sore arm.
Baseball size knot with redness & warm to touch after receiving Fluv acc. @ school Base clinic. Seen & given Benadryl & Hydrocortison 1% topical cream
Bright red spot on cheek, chicken pox bumps all over body (3 weeks) lasted 2 days. Fever (after 6 weeks) 103 lasted two day 5/21 and 5/22.
This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6208), at the age of 38, via an unspecified route of administration, in the left arm, on Mar 12, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Mar 13, 2021, at 03:00, patient experienced insomnia and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has tested for COVID-19. On an unknown date (also reported as Dec 30, 2020), patient underwent SAR-COV 2-test, NAA via nasal swab and the result: negative. The clinical outcome of the event insomnia and fatigue not resolved (at the time of this report). No follow-up attempts needed. No further information expected.
issues with right eye impairing vision and requiring surgery; issues with right eye impairing vision and requiring surgery; herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 21-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions at approximately 64 years old. Subsequently, the patient was treated by health care providers (reported as providers) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) : herpes zoster and issue with right eye impairing vision and requiring surgery. The outcome of the events was unknown.
Positive COVID Test Post Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID Test Post Vaccination) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID Test Post Vaccination). On 19-Feb-2021, SARS-COV-2 TEST POSITIVE (Positive COVID Test Post Vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
FULL BODY PARALYSIS; IT WAS FRIGHTENING; This spontaneous report received from a patient concerned a 64 year old male of unspecified ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: nonsmoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies, no history of drug abuse or illicit drug usage. The patient was pretty healthy and was not on medicine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: unknown) dose was not reported, 1 total administered on 31-AUG-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021 in night, patient reported that he believed he had stroke, he was sitting down listening to music when his body stopped responding, mostly right arm was totally not responsive but did not affect heart, lungs or brain. He had this episode which did not last that long, only lasted a minute but it was frightening. According to patient after 30-40 second he began to have some animation on his right hand, he was able to take off his shirt to help cool off and eventually everything turned back to normal. He took acetylsalicylic acid (Aspirin) as it would eliminate or minimized "long term side" (sic) and did not seek medical attention as it was only lasted a few seconds and they were most likely going to give him aspirin anyways. The patient said he thought it was probably something autonomic in the cerebellum, might a bit like sleep paralysis and later stated he thought it was probably the vaccine as he had not done anything different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body paralysis, and it was frightening on 14-SEP-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210929008-COVID-19 VACCINE Ad26.COV2.S-Full Body Paralysis. This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Hospitalization for possible TIA, syncope, acute kidney injury, COVID-19, elevated LFT, elevated LFT, mild thrombocytopenia on dates 9/6/23- 9/7/23. Treated with no COVID-19 medications.
Since the next day from my vaccine, my skin has been super sensitive and feels like it is burning. My primary care doctor put me on two courses of prednisone, and it did help, but when I go off of it, it really bothers me. It feels tingly and like it still has a light burn.  I am still feeling this 3 months after the vaccine. It?s very annoying.
T102 ax, lethargy, vomiting, dec UA output;no other family members ill not exposed to illness;
Between first and second dose - had allergic reaction to nuts: peanuts, almonds,  cashews, pistachios - also showed reaction to coconut aminos - second shot received on 02/26/2021 in afternoon - lot #030M2oa
Narrative:  COVID infection following COVID vaccine series 04/16, Pfizer, dose #1 05/07, Pfizer, dose #2 05/07 QUANTIFERON-TB result: negative 08/02 COVID swab, result: not detected 08/11 pt cc: chills, cough, diarrhea, rhinorrhea exposure: unknown 08/12 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE B.1.617.2 08/12 ARS-COV-2 CLADE 21A DELTA clinically resolved
Patient started feeling a numbness/tingling sensation in her right pinky that slowly moved up her arm and to her elbow about 20 minutes after she received the vaccine. Her right eye started to droop as well and her right pupil was slow to react to light upon assessment by EMT. Patient usually feels dizzy at baseline but felt even more dizzy after the vaccine. The numbness and tingling sensation in the right arm started to subside at 1500 and was completely gone by 1520. Vital signs were taken by EMT, BP 110/70, O2 99%, and P 73 which is patient's baseline. Patient's side effects subsided and she was escorted out to the car by her mother and EMT and her mother drove her home. RN and EMT advised patient to call her primary care provider to explain the adverse effects of the vaccine.
Diarrhea; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ASTHENIA (No energy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (No reported medical history) and Blood pressure.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ASTHENIA (No energy). At the time of the report, DIARRHOEA (Diarrhea) and ASTHENIA (No energy) outcome was unknown.        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. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ASTHENIA (No energy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (No reported medical history) and Blood pressure.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ASTHENIA (No energy). At the time of the report, DIARRHOEA (Diarrhea) and ASTHENIA (No energy) outcome was unknown.        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 product use was not provided by the reporter.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Pt called on 4/30/01 and reported upper arm swelling and redness at injection site within 24 hours, post vax. Also complained of itching all over body with rash within 48 hours, post vax. Then 24 hours of nausea and vomiting, diarrhea and body aches. Symptoms gone by 4/30/01.