chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face dry; arm hurt a little; face stiff/ tight; face tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (face tingling), DRY SKIN (face dry), MYALGIA (arm hurt a little) and MUSCULOSKELETAL STIFFNESS (face stiff/ tight) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FOLIC ACID, LEVOTHYROXINE, DIGOXIN, RIVAROXABAN (XARELTO) and METHOTREXATE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced PARAESTHESIA (face tingling) and MUSCULOSKELETAL STIFFNESS (face stiff/ tight). On an unknown date, the patient experienced DRY SKIN (face dry) and MYALGIA (arm hurt a little). At the time of the report, PARAESTHESIA (face tingling), DRY SKIN (face dry), MYALGIA (arm hurt a little) and MUSCULOSKELETAL STIFFNESS (face stiff/ tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient reported an event hair/ back of head feels funny outcome was unknown.
Breakthrough case after 4 vaccines Moderna 1/28/21 Lot# 037K20A;  Moderna 2/27/21 Lot# 027L20A;  Moderna 10/25/21 Lot# 939903;  Moderna 4/15/22 Lot# 033K21-2A
Headache; Can't sleep; 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 female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pertussis", start date: 2016 (unspecified if ongoing), notes: she and her other 2 sons got the pertussis back 5 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; INSOMNIA (non-serious), outcome "unknown", described as "Can't sleep".  Additional Information: The patient had a headache since her second vaccine of the BioTech. The clinic people told her to give another 2 weeks before she gets worried. If it's not better by then she will go back. It's just a bad headache and bad enough to where she could not sleep. If this was all she gets to save her life than that's okay. She was totally an anti-vaxxer and questions vaccines because she and her other 2 sons got the pertussis back 5 years ago and was very upset about that. She reported that she was in quarantine right now. Reporter did not specify the seriousness for headache. Investigation Assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101432469 same reporter, differet patient
Loss of consciousness; Muscle aches; Headache; Nausea; Vomiting; Dose1 26Dec2020, dose 2 12Jan2021; Dose1 26Dec2020, dose 2 12Jan2021; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the right arm second dose on 12Jan2021 12:15 at a single dose (lot number: EK4176) and intramuscular on the right arm first dose on 26Dec2020 10:15 at a single dose (lot number: EL1284) for COVID-19 immunisation. Medical history included asthma. Concomitant medication included Women's multivitamin within two weeks of vaccination. The patient had no allergies to medications, food, or other products; was not diagnosed with COVID-19 prior to vaccination, did not receive any other vaccines within four weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered at a hospital facility. On 13Jan2021 03:30, the patient experienced muscle aches, headache, nausea, vomiting and loss of consciousness. Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
4 hours after shot pt reported swelling, eyes redness, chest tightness. Received steroids, Cephalexin and VICODIN from Emergency Room. Feeling better 24 hours later.
face flushed; body was mixed up; dull headache; sore arm for four days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face flushed), FEELING ABNORMAL (body was mixed up), HEADACHE (dull headache) and MYALGIA (sore arm for four days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02or7B? 0r8? L7OA and 031orIL70A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur, Cardiac valve leak, Chronic sinusitis, Bronchitis and Carotid artery atheroma. Concomitant products included ATORVASTATIN, VITAMINS NOS, FLUTICASONE PROPIONATE, SODIUM FLUORIDE (FLUORIDE [SODIUM FLUORIDE]) and VITAMIN D3 for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 experienced FLUSHING (face flushed), FEELING ABNORMAL (body was mixed up), HEADACHE (dull headache) and MYALGIA (sore arm for four days). At the time of the report, FLUSHING (face flushed), HEADACHE (dull headache) and MYALGIA (sore arm for four days) had resolved and FEELING ABNORMAL (body was mixed up) outcome was unknown.            Patient is not sure of the Lot Numbers of the vaccines. No treatment information is provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137883, MODERNATX, INC.-MOD-2021-137848 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR Received. Event outcome updated as recovered.; Sender's Comments:  MODERNATX, INC.-MOD-2021-137883:husband case MODERNATX, INC.-MOD-2021-137848:family member case
Severe headache,  abdominal pain and chills, vomiting, diarrhea, and fever (101.7)?temp taken after 800mg ibuprofen
She got her vaccine, 1/2 an hour after that she got shortness of breath and chest pain.  Her chest was very very heavy.  She went home and around 5:00 AM she could not move, half of her body was paralyzed.  She still has the chest pain and shortness of breath.  She was not able to speak at that time, and could not call out for help.  The numbness went away the day after, but continues with the other symptoms.  On top of that at the same time she got the vaccine she stopped getting her  periods.  She went to see her doctor, they did blood work which indicated that she was in menopause.  Right after 6 months passed she got her period back and now has been having it normally again.  She does not know if this was induced by the vaccine or really menopause.  She is not on any medication due to the shortness of breath or chest pain.   All of her blood work was related and nothing is related to her deficiency.    Her PCP told her not to get a Moderna booster in the future, stick with Pfizer.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Negative; (15Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received antiviral treatment (paxlovid) from 06Mar2023 to 10Mar2023. Other medication in 2weeks: No.  No follow-up attempts are possible. No further information is expected.
Chronic Regional Pain Syndrome - Intense pain in foot could not walk until January 2015. Multiday migraines, chronic fatigue, mononucleosis continuing. My healthy, athletic son can barely function any more.
HEMORRHOIDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 an unspecified date, the patient experienced hemorrhoids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hemorrhoids was not reported. This report was non-serious.
Approximately one hour after receiving the Pfizer vaccine in the left arm, I experienced left sided facial numbness that lasted all day. On the second day after receiving the vaccine, I noticed a rash on my chest.
ACUTE ONSET LIGHTHEADEDNESS, CHEST PRESSURE, ITCHING ON HANDS.
Starting having itching over entire body next day after taking flu vaccine, acompanied by fine rash. Lasted 5 days resolved with using bebnadryl around clock.  No history of allergic reaction to flu vaccine in the past.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored PROQUAD lot# reported as M004891 with expiration date: 25-JUL-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Rash started within 2-5 minutes after Pentacel given on right thigh. Rash was also up on trunk and spread to the rest of her body. Nurse was called to the room. Benadryl and steroids given. Rash went away within 30 minutes of meds being given. Patient went home with mom after rash went away.
Pt had a high-pitched and prolonged "different" cry, post vax. On 11/13/01, DT was given instead and no adverse reactions were noted by parent this time. This child has a twin sister.
This case was reported by a other health professional and described the occurrence of expired vaccine used in a male patient who received HAVRIX (batch number AHAVB566AN, expiry date 30th May 2014. On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored  VARIVAX subcutaneous injection (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA001984: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA009081:, MERCK 1610USA009083:Mfr number.
tested positive for covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for covid) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Type 1 diabetes mellitus, Sulfonamide allergy and Drug allergy (all stimulant-based drugs). Concomitant products included ISOTRETINOIN (ACCUTANE), IBUPROFEN, SPIRONOLACTONE and INSULIN ASPART (NOVOLOG) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 8:00 PM, the patient experienced COVID-19 (tested positive for covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient was taking unspecified birth control as concomitant drug .   Event COVID-19 stop date reported as JUN-2022.  Device date reported as 31MAY2022.  Company comment: This spontaneous case concerns a 36-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Details regarding primary doses and third dose of COVID 19 vaccination are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. Details regarding primary doses and third dose of COVID 19 vaccination are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Fluad comes in a prefilled syringe. When I twisted the tube into a BD needle, it felt a little off. I looked at the loaded dose and everything looked normal. I went to administer the shot in the patient's left arm, and all the fluid came out of the piece that connect the Fluad to the  BD needle. No liquid went into the patient. I told the patient what happened. I then re-administered in his right arm.
Case number PHEH2016US023372 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 44 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular into left arm on 01 Jul 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Pain and swelling of injection site at 9:00 pm on April 23, 2021 until 10:00 am on April 25, 2021.  Headache at 9:00 pm on April 23, 2021 until 10:00 pm on April 24, 2021.
Client was leaving the building after her 15 min wait.  She became dizzy and got a headache.  She returned to the monitoring room.  B\P 142/80  Respirations even and unlabored.  Skin pink warm and dry.  Reported dizziness and a headache.  Client monitored an additional 15 min.  No further headache or dizziness.  B]P 138/78 pulse 60. Respirations even and unlabored.  Skin pink, warm and dry. Released informed to report to V-safe and to seek medical advise if in symptoms reoccurred.
It started on the third, 5:30AM, it woke me up, my heart racing so quick that I was so dizzy, I was trying to gather myself and I called an ambulance but then found out that the hospital was only 8 minutes away so I drove there myself. They said that they did not know for sure if it was pertaining to the vaccine or not. A few weeks later I went to another HCF. They said my potassium is low, which has never been a problem. I eat like two bananas every day I love bananas. They gave me potassium and sent me on my way. But the first time I went to the hospital I got labs and they came back good. I mean, I have frequent episodes of this and there is nothing to blame it on except the vaccine since it began right after that. I have an EKG scheduled for the 8th of July 2021 and I guess that's about it.
Patient received vaccine and was crying on table. Mom picked patient up immediately after vaccine was given and baby became limp, stopped crying, and eyes rolled back and began to close. Medical assistant that gave vaccine witnessed event, opened door and asked for help. Provider came into room immediately and patient was crying again. Event lasted approximately 10 seconds. Prevnar was the only vaccine patient was receiving this visit. Patient was examined by two providers after event and appeared pale but rest of exam was normal. Patient continued to cry but was comforted by mom. Mom and patient remained in office for observation. Color returned to normal prior to patient leaving office and left alert and smiling.
pt recvd 1 dose of Engerix-B & 3 wks later herpes/shingles appeared;
a week later she had it again, hotter than the first time; now it itches; a red spot on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a week later she had it again, hotter than the first time), VACCINATION SITE PRURITUS (now it itches) and VACCINATION SITE ERYTHEMA (a red spot on the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red spot on the injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (a week later she had it again, hotter than the first time) and VACCINATION SITE PRURITUS (now it itches). At the time of the report, VACCINATION SITE WARMTH (a week later she had it again, hotter than the first time), VACCINATION SITE PRURITUS (now it itches) and VACCINATION SITE ERYTHEMA (a red spot on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Her Husband also had the Pfizer COVID Vaccines and he got COVID/ his was like a bad cold; Her Husband also had the Pfizer COVID Vaccines and he got COVID/ his was like a bad cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient's spouse. A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Caller stated her husband also had the Pfizer COVID Vaccines and he got COVID but he didn't get PAXLOVID, his was like a bad cold.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her Husband also had the Pfizer COVID Vaccines and he got COVID/ his was like a bad cold". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a healthcare professional concerning a 2 month old female who was vaccinated PO with a dose of Rotateq. It was reported that the patient subsequently became constipated. Medical attention was not sought. At the time of this report, the patient's constipated persisted. Additional information has been requested.
Patient starting getting lightheaded and dizzy 10 mins after vaccination. Patient also had numbness in both legs from feet to knees. Patient was taken to ER and received Valcyclovir and Zofran.
Fever, Chills, Swelling at Injection Site; Stiffness and pain from injection site on left deltoid up to jaw; rash left arm below injection site; exhaustion, overall malaise.
Fever blister on lips; Fever 101degrees; Chills; This spontaneous case was reported by a nurse and describes the occurrence of LIP BLISTER (Fever blister on lips), PYREXIA (Fever 101degrees) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (Fever 101degrees) and CHILLS (Chills). On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP BLISTER (Fever blister on lips). At the time of the report, LIP BLISTER (Fever blister on lips), PYREXIA (Fever 101degrees) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever. On an unknown date, C-reactive protein: 11.6 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Concomitant medications include Hormone replacement therapy and Hydrochlorothiazide for a leg condition. Treatment medication included Tylenol and valacyclovir, to alleviate the symptoms of the fever blister