chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other adverse events reported; improperly stored dose of proquad was administered.; This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 21-JUN-2021, the patient was vaccinated with an improperly stored dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live ( recombinant human albumin (rHA) PROQUAD) 1 injection subcutaneously (lot number T034824 which was determined to be valid upon internal review with expiration date 11-APR-2022 but reported as 23-FEB-2022) (vaccination scheme frequency, route and anatomical location of administration were not reported) as prophylaxis (product storage error). The administered vaccine experienced a temperature excursion of 28 grades Fahrenheit (F) during a time frame of 4 hours, as recorded by data logger. There was not a previous temperature excursion. No other adverse events were reported.
vertigo; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and DIZZINESS (dizziness) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced VERTIGO (vertigo) and DIZZINESS (dizziness). At the time of the report, VERTIGO (vertigo) and DIZZINESS (dizziness) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.
Severe pain itching and Rt. arm swollen twice the size and very warm to the touch. Headache, nausea, and extreme weakness. Diarrhea, loss of appetite, numbness on rt. side and severe chills. Very sleepy all day and did not eat anything. Applied ice to arm at the advice of Pharmacist. Spent the entire day covered up with blankets shaking with chills. Did not take daily meds. Only had sips of water.
Exactly 12 hours after getting the shot he woke up with chills, fairly severe headache and bodyaches. He took two extra strength tylenol. The chills only lasted for about 20 minutes, but he was cold. All of that next day he was in a reclining chair, taking two extra strength tylenol every four hours for headaches and body aches.  Yesterday he stopped the tylenol because the head ache was resolving.
Since receiving the vaccine on 02/23/2021, my left arm muscle has been twitching.  I have been having tingling down my left arm with my hand and fingers going numb.
On 11.7.18 staff inadvertently administered Tdap instead of Dtap. Age of patient at time of event: 11 years 1 months.
Pt felt dizzy, light headed, hot flushes, very painful arm, vision changes (disturbance).
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: Have continued to test positive for 16 days on rapid test (home test). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No other medications in 2weeks. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 01Jun2022, treatment stop date: 05Jun2022, indication: treatment of COVID-19. Adverse event: Have continued to test positive for 16 days on rapid test (home test). Developed fever, body aches, headache, cough and runny nose 5 days post end of treatment of Paxlovid. Symptoms continue on day 10 post end of treatment. Adverse event start date: 10Jun2022 and patient recovered. Device timestamp: 15Jun2022.
Inflammation, swelling, redness around injection site. Large area, itching, extending down to elbow rash appeared 2nd day.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2022) Positive, notes: three days after completing the course of Paxlovid my Covid symptoms returned and I tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: No known allergies reported for patient. Reporter stated that three days after completing the course of Paxlovid patient's Covid symptoms returned and was tested positive for Covid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swollen clavicle lymph nodes left side, noticed about 5 days after 1st dose
Itching; Yes, the 1st shot I receive a small rash on my head yet same side on the arm that it was given on left side.; Yes, the 1st shot I receive a small rash on my head yet same side on the arm that it was given on left side.; little hive on her hip; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that,  A 72-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in arm left on 21Mar2021 as dose 1, single for covid 19 immunisation, (age at the vaccination 72 years old) and patient took ascorbic acid, lycopene, omega-3 fatty acids, tocopherol (EVION [ASCORBIC ACID;LYCOPENE;OMEGA-3 FATTY ACIDS;TOCOPHEROL]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart, insulin aspart protamine (NOVOLOG MIX) taken for an unspecified indication, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTON) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken for an unspecified indication, start and stop date were not reported; insulin detemir (LEVEMIR) taken for diabetes mellitus, start and stop date were not reported. It was reported that she received the first one in March 2021 and noticed a little hive on her hip, on the left side, the same side she received the needle. On an unspecified date in Mar2021, the patient experienced, little hive on her hip on the left side, the same side she received the needle and Yes, the 1st shot she receive a small rash on my head yet same side on the arm that it was given on left side, and on an unknown date patient experienced itching. When probed for the laboratory test, the patient stated, "she had laboratory test last week, she had at my doctor's office." The patient stated, she took, she did tried putting some cream on it some put it down cream (Captured as suspect) but that really didn't helped, made it worth and then she had Benadryl by mouth, she took Xyzal by mouth, she took Xyzal last night, she thought that would help she was mean itching, Evion Cream, Benadryl tablet 5mg, Xyzal tablet, 5mg. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Irregular menstrual cycle symptoms. From typical 5 day predictable monthly cycle to 12 days of fresh bleeding and more intense symptoms from what patient was used to experiencing: soreness and swollen glands in neck, sides, swelling in hands and feet, body aches and pains, cramps, headaches, poor concentration, and depression-like thought patterns, as well as the notable fresh blood for 12 days straight.  The timing has also been irregular and unpredictable each month since. Longer PMS windows as well.
Initial and follow-up information has been received from a registered nurse concerning a 36 year old male ER physician with no past medical history who in approx. the "1990's" was vaccinated wtih a series of hep b vaccine recombinant. Subsequently, the physician had a negative titer. In approximately the 1990's the physician was administered a booster dose of hep b vaccine recombinant. Subsequently, the physician had a positive titer. It was reported that in July 2001 the physician "was exposed to body fluids and a titer was negative." On 07/06/2001 the physician, at the age of 47 years old, was administered a second booster dose in the upper left deltoid of hep b vaccine recombinant. There were no illnesses at the time of vaccination. On 07/08/2001, two days after vaccination, the pt developed an ache in his left upper arm/shoulder and had difficulty raising his arm. It was noted that the shoulder pain lasted 3-4 weeks, and that the pt was improving and now had a full range of motion. Additional info has been requested.
Student immunized at 09:15 TDaP, MCV4, HPV. At 09:30 student returned to class at 10:05. Teacher called asking for assistance student pale, C/O dizziness, hand clammy to touch, eyes droopy. BP 112/80 awake looked sleepy, daze. Ammonia inhaler x1 used. Student reposition flat on her back feet elevated. Respirations 18 pulse 60. Redness hives presented to face at 10:19am. Diphenhydramine 50 mg given IM to Left deltoid. Temp 99.6 degrees F pulse 99 O2 Sat 94%. At 11:30am student mother picked her up. Student will resolved rash and no distress verbalized. Not: Returned to school the next day. Student reported she felt like fainting on her mensus and was feeling anxious about receiving vaccine all day.
pt recvd vax;exp urticaria over entire body 24 hrs p/ recving 2nd dose of vax for prophylaxis;unresolved
Finger tips always break out with spots; Vaccination site reaction; Several colds; Broke out peeling and red dots all over body after getting the second COVID vaccination; Broke out peeling and red dots all over body after getting the second COVID vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Finger tips always break out with spots), VACCINATION SITE REACTION (Vaccination site reaction), NASOPHARYNGITIS (Several colds), RASH MACULAR (Broke out peeling and red dots all over body after getting the second COVID vaccination) and SKIN EXFOLIATION (Broke out peeling and red dots all over body after getting the second COVID vaccination) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced SKIN DISORDER (Finger tips always break out with spots), VACCINATION SITE REACTION (Vaccination site reaction), NASOPHARYNGITIS (Several colds), RASH MACULAR (Broke out peeling and red dots all over body after getting the second COVID vaccination) and SKIN EXFOLIATION (Broke out peeling and red dots all over body after getting the second COVID vaccination). At the time of the report, SKIN DISORDER (Finger tips always break out with spots), VACCINATION SITE REACTION (Vaccination site reaction), NASOPHARYNGITIS (Several colds), RASH MACULAR (Broke out peeling and red dots all over body after getting the second COVID vaccination) and SKIN EXFOLIATION (Broke out peeling and red dots all over body after getting the second COVID vaccination) outcome was unknown. Not Provided          It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. The finger tips always break out with spots, broke out peeling and red dots all over body after getting the second COVID vaccination and several colds with Humira.  No treatment medication information was provided.
needle was inside the patient's body dose leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (needle was inside the patient's body dose leaked out) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2019, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 16-Apr-2021, the patient experienced UNDERDOSE (needle was inside the patient's body dose leaked out). At the time of the report, UNDERDOSE (needle was inside the patient's body dose leaked out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Little pain at the injection site; Felt flush afterwards; This is a spontaneous report from a non-contactable nurse.  This nurse reported similar events for two patients.  This is the first of two reports.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Dec2020, the patient experienced little pain at the injection site and felt flush afterwards. The outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020501389 same reporter/drug/event, different patient.
Left upper arm became very swollen, hot to touch.  Arm was difficult to move due to pain. (Tdap incorrectly given instead of Td)
Soreness at injection site; injection site rash; Small red rash on thigh; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced injection site pain, injection site rash and red rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site rash was unknown and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: Patient reported he received Shingrix dose in the right arm. He stated hours later he had soreness at injection site and noticed a small red, non-itchy rash on thigh (did not say if left or right). The patient suffered from skin rash at the application site. The patient asked if he could receive the second dose of Shingrix. The patient did not provide the information about the Shingrix dose that he received (lot number, expiration date). He stated he did go to HCP and they prescribed VALTREX for 1 week. His rash was almost subsided he said.  He asked if dose 2 would be worse. Medical disclaimer and medical information phone number was provided. Referred to HCP. Did not consent to follow-up. Additional supportive information:  The case US2022184469 was identified as duplicate of US2022184471. The case US2022184471would be voided, and all the future correspondence would be added in this case US2022184469 which stands as a case of record for this patient.
I experienced redness around my left eye, swollen reddened eyelid, and it was uncomfortable. After a nap the swelling had dramatically increased, my eyes were crusty, discharge, and the clinic recommended using a warm compress on my eye 3 times a day. The symptoms began to resolve after 3 days. I am still experiencing crusty feeling in my eye, but it is improved. I have an upcoming appointment 12/14/22.
Item #17 Flu, RSV & Pneumonia  Felt great the next day, lots of energy, no pain until 5pm. Arm started really hurting, I looked and it was a 10 x 10  inch swollen hot to touch lump. I put a liquid Benadryl on it which helped abit. Still swollen 9/30 at 4pm while reporting this.
Alopecia Areata, sudden appearance, no prior or family history. Continuing to lose hair rapidly since.
Started with chills, then dizziness, nausea and passed out until was found by another person. Had ringing in ears either right before passing out or when coming to consciousness.  Vomited after waking up. Chills returned, fever of 100.3, blue lips.  Headache came later
Presented with prolapsed ileostomy, compromise of ostomy perfusion, underwent reduction of ileostomy prolapse and ostomy revision.
PT EXPERIENCED TEMPORARY PARALYSIS IN LEFT LEG BEGINNING 01/17/2019, WAS TAKEN TO ER WITH 102.4 FEVER ON 01/18/2019. WAS ADMITTED TO HOSPITAL AND WAS DISCHARGED 01/20/2019.
Once I received the vaccine, I immediately felt a cough in my throat. About half an hour later my nose was runny. That night at 11pm I had the chills, a couple hours later I had a fever, nautious ness,  vomiting, belly cramps, joints and muscle pain especially in my back and legs, terrible headache. This lasted till around 3pm the following day.  I started with a headache BEFORE the vaccine as well.  Day 2 after the vaccine I was feeling much better.
very mild headache; mild fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (very mild headache) and FATIGUE (mild fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: flu vaccine (3 weeks ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Allergy to NSAIDs. Concomitant products included CLOPIDOGREL for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL), LOSARTAN, OMEPRAZOLE, ATORVASTATIN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and METFORMIN for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (very mild headache) and FATIGUE (mild fatigue). On 11-Nov-2021, HEADACHE (very mild headache) and FATIGUE (mild fatigue) had resolved.            Patient received second dose at the end of Apr-2021.  Patient stated only experienced very mild headache and mild fatigue during 24 hours after first dose, second dose and first booster. After first dose, events of very mild headache and mild fatigue, resolved on an unspecified date in Mar-2021 After second dose on an unspecified date in Apr-2021, patient developed very mild headache and mild fatigue, those resolved on an unspecified date in Apr-2021, after first booster on 10-Nov-2021, patient developed very mild headache and mild fatigue those resolved on 11-Nov-2021. No treatment was given.   This case was linked to MOD-2022-660018 (Patient Link).
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # K014826 with expiration date 28-MAY-2016). No adverse effects were reported. Additional information has been requested.
arm was sore where it had been injected; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore where it had been injected) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced INJECTION SITE PAIN (arm was sore where it had been injected) and HEADACHE (headache). At the time of the report, INJECTION SITE PAIN (arm was sore where it had been injected) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-098581 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098581: