chrisvoncsefalvay/vaers-outcomes huggingface dataset:
18NOV93 shot given; approx 23NOV93 red rash upper body; 30NOV93 red rash worse & some joint ache; 3DEC92 rash, most joints swollen, knees swelled to double their size, unable to walk stright, back pain;
Information has been received from a nurse practitioner referring to unknown number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date, the patients were vaccinated improperly stored VARIVAX (lot # L050560, expiration date: 14-DEC-2017; lot# M034584, expiration date: 27-JUL-2018; lot# M036292, expiration date: 17-AUG-2018; lot# M038858, expiration date: 14-SEP-2018; lot# reported as " M040137", expiration date: 28-SEP-2018; lot# reported as " M041081",  expiration date: 05-OCT-2018; lot# reported as " M038857", expiration date: 14-SEP-2018; lot# M038226, expiration date: 07-SEP-2018; lot# M037643, expiration date: 01-SEP-2018; lot# M027885, expiration date: 30-JUN-2018; dose and route unknown) for prophylaxis. The VARIVAX was stored at 10 Fahrenheit for 3024 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012126:
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medication and past drug history was unknown. On an unspecified date in 2015 (reported as either 30-JUN-2014 or 01-JUL-2015), the patient was administered (Oka/Merck) VARIVAX, 1 vaccine lot # L002214 expiration date 21-JAN-2017 (dose, frequency and route of administration were not provided), after it had a temperature excursion (incorrect product storage). Concomitant medication was not reported. It was unknown if there was any relevant laboratory data. At the time of reporting, it was unknown if the patient ever received (Oka/Merck) VARIVAX again and the outcome of the event, incorrect product storage was unknown. This is one of the six reports received from the same reporter. Additional information has been requested.
Joint pain; Temperature of 100.7F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Temperature of 100.7F) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Temperature of 100.7F) and NAUSEA (Nausea). At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Temperature of 100.7F) and NAUSEA (Nausea) outcome was unknown. Not Provided                   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Patient fainted in lobby 1 minute or so after receiving vaccines, she responded quickly. Laid in exam room for 10 minutes. Was feeling better and left clinic with no complaints.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfate" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300098063 same patient, different drug/event;
02/16/2021 Vaccination. Shortly thereafter started to experience tremors in my head and my hands. I went down for appt. They did a bunch of tests but couldn't say it was from the vaccine, wouldn't say it wasn't. I didn't have this before the vaccine. Also, my memory, it affected it a lot. Still experiencing symptoms. 1st vaccination 01/18/2021 Moderna. Booster 12/27/2021 Pfizer/pharmacy.
Patient states he took bandaid off vaccine next am and there was a rash. It is scabbed up, approximately 2x2 inch circle on upper left arm at vax injection site. Patient reports no itching, no hotness, just scabs.
I got the shots 2 years ago and STILL got shingles/Suspected Vaccination Failure; I got the shots 2 years ago and STILL got shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingle shots 2 years prior to the reporting and still got the shingles on his/her freaking face. This case was considered as suspected vaccination failure as details regarding completion of laboratory confirmation were unknown at the time of reporting.
Diarrhea, swollen joints in my hands, the joints were purple, shivering, fatigue, and fever of 105.
41-year-old patient received her first dose of Gardasil 9 on 01-FEB-2019; No adverse effect reported; This spontaneous report was received from a pharmacist, concerning a 41-years-old female patient. The patient's medical history, concomitant medications, concurrent conditions and drug  allergies were not reported.   On 03-JUL-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), one dosage form for prophylaxis (anatomical site of injection, route of administration was not reported) (lot # N020352 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), with expiration date on 10-APR-2020) (product use issue).  It was reported that the patient would received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(G ARDASIL 9) on 03-JUL-2019. No adverse effects reported.
Varivax given in left arm. Injection site became red, blotchy. Face became red, reaction occured within five minutes of injection. Child stabilized and sent home.
did not feel well; Cough; Sore throat; Low-grade fever; Little stuffy/runny nose; Little stuffy/runny nose; This is a spontaneous report from contactable consumer or other non-healthcare professional (patient).A 40-years-old female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on 12Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date of Mar2021 patient experienced cough, sore throat, low-grade fever and little stuffy/runny nose. The patient did not feel well and is not sure if these are side effects to vaccine or covid symptoms. The reported stated that, may have been exposed to COVID prior to getting vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive on unknown date. The outcome for the all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Seizure like activity. Began having convulsions that worsened as they progressed. Was completely alert and oriented during convulsions. These convulsions lasted a total of 5-6 hours. Remedied on their own; no treatment obtained.
Rash all over her torso, legs, arms, and back, and spreading on to face.
SkinRash Narrative: ITCHY SKIN RASH AT THE SITE OF THE INJECTION
Vomiting the night of vaccine Fever following morning Nausea Developed a cough
Throat swelling within 1 hour of 1st dose; advised by ED to see PCP prior to receiving 2nd dose and should be only scheduled if PCP has cleared her.
Pt was in office for a visit,   was given a flu vaccine and a Covid vaccine, but received the pediatric dose of the covid instead of the 12 yr and up
administered with an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        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 provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-378221 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non Significant Follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-378221:MOD21-162338 (Crosslinked)
Diarrhea; Fever; Chills; Vomiting; sore arm again; very sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PAIN IN EXTREMITY (sore arm again), DIARRHOEA (Diarrhea), PYREXIA (Fever) and CHILLS (Chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) and MELOXICAM (MOBIC) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm again). On 18-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). On 09-Jan-2021, PAIN IN EXTREMITY (very sore arm) had resolved with sequelae. At the time of the report, PAIN IN EXTREMITY (sore arm again), DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting) 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.   No treatment medications were reported.
Woke up in middle of night with body aches, especially in my legs.  Kept me awake for hours.  I was exhausted the next day. Aches and exhaustion subsided over 48 hours.  After 2nd injection I experienced the same but milder reaction on the tenth day after the injection. However, I have been tired for a longer period of time. About 3 days.
I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.; later I woke up to my entire face and lips swollen and had to go to the ER.; later I woke up to my entire face and lips swollen and had to go to the ER.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.), SWELLING FACE (later I woke up to my entire face and lips swollen and had to go to the ER.) and LIP SWELLING (later I woke up to my entire face and lips swollen and had to go to the ER.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced URTICARIA (I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.), SWELLING FACE (later I woke up to my entire face and lips swollen and had to go to the ER.) and LIP SWELLING (later I woke up to my entire face and lips swollen and had to go to the ER.). At the time of the report, URTICARIA (I got my first moderna shot February 1st and 5 days later broke out in hives for the first time in my life.), SWELLING FACE (later I woke up to my entire face and lips swollen and had to go to the ER.) and LIP SWELLING (later I woke up to my entire face and lips swollen and had to go to the ER.) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient went to an allergist and they told him that it wasn't caused by the vaccine because it would've happened immediately. Patient took antihistamines and it finally went way.   This case was linked to MOD-2022-461935 (Patient Link).
This spontaneous report as received from a consumer refers to is daughter, a currently 4 year old female patient with no pertinent medical history or drug reactions/allergies. On an unspecified date in 2011, the patient was vaccinated with M-M-R II INJ, subcutaneously (dose and lot number not provided). No co-suspect therapies were provided. There was no concomitant medication. The reporting consumer stated that approximately five months after receiving M-M-R II, the patient had a seizure (date not specified). The patient experienced a second seizure approximately three to four weeks after the first seizure. The patient had a Nuclear magnetic resonance imaging (MRI) scan (date not specified), which was determined to be normal. In a follow-up MRI (after an unspecified interval), the patient was diagnosed with Band Heterotopia. It was reported that the event caused hospitalization (dates not provided). At the time of the report, the outcome of the event was reported as not recovered/not resolved. Upon internal review, the event "the patient was diagnosed with Band Heterotopia" was considered as medically significant. Additional information has been requested.
08/09/2019 2:30pm presented for 4 month immunizations. I gave patient rotatec, Pneumonccal and Pentacel. When I came back to triage room I saw I did not mix the Hib powder with the Dtap and IPV liquid. I saw the powder in the vial as I was dropping the vials into the sharps container. I took the sharps container and showed it to lpn and lpn the vial Hib in the sharps container. lpn called Sanofi and lpn told me Sanofi said to give Hib vaccine. I gave patient Hib 0.5ml in the right thigh. APRN notified when this occurred.
Client in post vaccination waiting area. Approximately 6 minutes after arriving, a felt flushed, anxious feeling. Reports dizziness and lightheadedness. Patient requests to use nearby cot.  Staff escorted patient to cot to lie down. BP on palpation 100. At 10:20am, BP 108/76 HR68 R18.  Requests to stay lying down. At 10:38am, patient is ready to sit up. BP120/76 HR72 R 72. Patient reports "feeling normal." Continues to sit and drink offered water.  Reports did not eat breakfast this AM. Ready to depart at 1050. Final BP 110/76 HR 76, R18. No complaints
it wiped me out; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2022AMR140151   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she was wiped out. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR140151; Sender's Comments:  US-GSK-US2022AMR140151:Same reporter  2nd dose
Tested COVID positive  01/20/2022 at Doctore and home test was done on 01/18/2022.Medication /Molnupiravin 200 mg 4 capcuples every 12 hour for five prescibed for COVID.  Short supply at Phramacy.  Major sick feeling , tired, night sweats, head hurting, eyes noise pour water, whezzing and brocoli tubes. Was prescibed medication since she has ashma,  to alleviate conditions.  Mild symptoms coughing during the night and sinus pressure in face but still recovering.
7-10 papular lesions - scattered. Dx. Varicella, Tx: Acyclovir.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-AUG-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUL-2014, the patient was treated at a clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR and hydrocodone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Immediate & prolonged high pitched cry; Lt leg very red & raised several inches in diameter; To ER given DPH; Leg got better but later redness & raised appearance returned & was given more DPH;
Nothing at time of vaccine booster.  May 1, sore throat, May 2 positive antigen test; Paxlovid prescribed; fever, tiredness, runny nose, cough, metallic taste when eating sweet items.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-DEC-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
17NOV95 it was reported that pt was running a temp of 103-104 for 24hrs;APAP was givrn w/no relief;RN recommended consult w/PMD
after vaccine at 915a. around 230-330 I started with a splitting headache. I took Tylenol. By 5pm. I chills, muscle and joint ache and upset stomach. I took my temp and i was 99.7. I drank some fluids and Gatorade. I started getting dizzy and took 2 more Tylenol. I woke up at 5am and I had chills and a temp of 100.1. Took 2 more Tylenol. 730a my headache went away but I had tenderness at injection site stiff neck and joint pain. Headache came back around 2:30p. Around 3 I took some tylenol. I called the COVID hotline in the am and they called the team MD. Ordered a covid test and it waiting on results.. antibodies still remain positive from previous covid infection from June 2020.
Information has been received from a dentist concerning a 14 year old male patient (the dentist's grandson). The patient's medical history and concurrent condition were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (lot#, expiration date, dose and route not provided). It was unspecified if patient received GARDASIL or GARDASIL 9. Concomitant therapy was not provided. On 16-APR-2015 the patient experienced an unspecified reaction after receiving GARDASIL, resulting in the patient being hospitalized at an unspecified hospital. The outcome of the adverse event was unknown. Additional information has been requested.