chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sharp pain in my heart; ribs on my left side became sore in front and back; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: FA7484), via an unspecified route of administration, administered in right arm on 02Aug2021 15:00 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included lupus, breast cancer on left side from 2014, high blood pressure, and known allergies to sulfa titanium. Prior to vaccination, the patient was not pregnant, did not have COVID and did not receive any other vaccines within 4 weeks. The patient had unspecified concomitant medication within 2 weeks of vaccination. On 03Aug2021 13:00, the patient reported sharp pain in her heart. Her ribs on the left side became sore in the front and back. No treatment was received for the events. Post-vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in Aug2021.   Follow-up attempts are completed. No further information is expected.
Large area of discoloration and induration and warm 90x110 cm over L deltoid.
Uncomfortable; Pain in my left armpit; Puffy and kind of painful; Pain in my left armpit; Puffy and kind of painful; Sore arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Apr2021 (2 clock, unknown if AM or PM) (lot number: unknown) at single dose for COVID-19 immunisation. Medical history included Covid diagnosed on 31Dec2020. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date in Apr2021, uncomfortable on 03Apr2021, pain in left armpit / puffy and kind of painful on 03Apr2021. Clinical course as reported: I got my first shot on Thursday at 2 clock and the only reaction that I had up until now is just a sore arm. I was actually diagnosed with Covid on 31Dec2020, so three months ago. I woke up this morning with a pain in my left armpit. I was uncomfortable and then I went to the bathroom and I looked at, it is in the armpit like where the armpit hair is. It is puffy and kind of painful. Any idea what that is? The outcome of the events was unknown. The reporter considered the report was non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I have a sort of rash that is spread around my entire torso, under both armpits, and is partially on my neck and upper legs.  I noticed it about three days after I received the vaccine, and then went to the doctor's office the next day to have it looked at. They addressed it as dermatitis, and I recieved doxycycline and predniSONE to take/use for the following 12 days, which I have been using since the morning of the 6th.
I began having a sore/swollen lymph node on my right side of my neck on 1/17. It has progressively gotten more tender and is making it hard to sleep as of the past day or two. I have an appointment with my GP tomorrow.
Pt had reddened, warm area quarter size to site on RL upper aspect of leg at injection site of DTAP and Hib immunization. Given on 8/23/04.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a female patient who received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Nov-2018, the patient received a dose of suspect TYPHIM VI lot N1K811M via intramuscular route in unknown administration site. It was a case of actual medication error due to vaccine underdose. The syringe leaked between the hub, (in which the needle was attached) and the syringe itself (Syringe issue). It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 10-Dec-2018 from a nurse. Lot number updated in field and narrative. Documents held by sender: none.
Stiffness in right thumb; sore arm with covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in right thumb) and VACCINATION SITE PAIN (sore arm with covid-19 vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in right thumb) and VACCINATION SITE PAIN (sore arm with covid-19 vaccine). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in right thumb) and VACCINATION SITE PAIN (sore arm with covid-19 vaccine) outcome was unknown.            Relevant concomitant medications were not reported. On unknown date, the patient experienced sore arm with COVID-19 vaccine, Stiffness in right thumb. Treatment information was not provided.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Moderna COVID-19 vaccine (Elasomeran) was Not Provided. AbbVie's opinion was that the causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Adalimumab Solution for Injection was Not Provided. AbbVie's opinion was that the causality for the event(s) of Stiffness in right thumb and sore arm with covid-19 vaccine with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.
Taking tylonla  1000mg, Trazodone 50mg, Tizanidine 1mg, Celecoxid 400mg, Venlafaxine-er 37.5mg. Has had to go to a chiropractor to try to numb arm, and got body adjusted. After getting the shot 2 weeks later her left side of her arm and neck has had pins and needles sharp pains going down arm and around the left side.
Soreness at injection, chills, hot and sweaty, nauseau, and loss of appetite.
body ache that are worse at night; headache and body ache that are worse at night; patient received YF-VAX intramuscularly instead of subcutaneously; Initial information was received on 20-Aug-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a 29 year-old female patient who experienced body ache and headache that are worse at night (pain), (headache), after receiving vaccine YELLOW FEVER VACCINE [YF-VAX] (Incorrect route of product administration).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was given.  Reporter stated she was not pregnant   On 18-Aug-2021, the patient received (once) dose of suspect YELLOW FEVER VACCINE (Solution; lot UJ386AA and expiry date not reported) via an intramuscular route in the right deltoid for prophylactic vaccination.  On 18-Aug-2021, the patient developed non-serious body ache and headache that are worse at night (pain), (headache) on the same day following the administration of YELLOW FEVER VACCINE.  It was also a case of actual medication error due to in appropriate route of vaccination (latency was on same day).  It was reported "Caller states she received YF-VAX intramuscularly instead of subcutaneously. Caller asking for safety and efficacy information regarding YF-VAX given intramuscularly. Caller also asking for clinical studies of YF-VAX given intramuscularly vs. subcutaneously. States she received YF-VAX because she will be traveling soon.  Details of laboratory data were not reported.  Caller reported she had not taken anything or gone to doctor for headache and body aches.  At time of reporting, outcome of the events was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recvd vax & 15 1/2 hrs p/vax exp fever of 102, tingling & swelling snesation of lt arm; sx resolved;
dizzy; woke up at 3 AM sweating; woke up at 3 AM having a fast heartrate; weak; a headache; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, GABAPENTIN, MELATONIN (TRANSZONE), LISINOPRIL and PIOGLITAZONE for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Apr-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). On 09-Apr-2021, the patient experienced DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak) and HEADACHE (a headache). At the time of the report, DIZZINESS (dizzy), HYPERHIDROSIS (woke up at 3 AM sweating), HEART RATE INCREASED (woke up at 3 AM having a fast heartrate), ASTHENIA (weak), NAUSEA (nausea), VOMITING (vomiting) and HEADACHE (a headache) outcome was unknown.            No treatment information were reported.
Reaction to vaccine of fever chills vomiting and followed by rapid heart beat that is still ongoing of atrial flutter
I do not know which TDAP vaccine I received. Adverse effects include: fever, chills, sore joints and muscles, lethargic, increased heart rate. The symptoms that I experienced were severe. The worst of the symptoms last for 24 hours.
Friday 6/1/18 Woke with headache during the night about 1am. Took ALEVE and went back to sleep- arm hurting and not laying on this arm. Woke with really hurting arm at injection site and red swelling of injection site about 3" circle. Took BC Green Aspirin about 6am. At 8 am still with Bad Headache-Arm Hurting-Body just Sore- Upset stomach (maybe from severe headache). Took 2-ALEVE and within 45 minutes started to feel better. Continued to take 2 ALEVE every 12 hours for 2 days with the continuing injection site soreness and swelling/red. Monday went back to the Pharmacy where administered vaccine and talked with the Pharmacist. I was told that it is common for these reactions and as long as reactions not getting worse continue to take the over counter pain medicine. It was 14 days for the soreness and red swelling at injection site to completely stop. Even with this reaction I will still get the 2nd shot knowing the reaction I will probably have to keep from getting Shingles!
Hives. Red, bumps to back, chest, neck, arms, started 11:30 in AM today. Swelling, redness and itching to Left eyelid started 11/07/06 at 16:30. Diagnosed-stye to Left eye, possible allergic reaction
Immediate headache upon injection; Upon moving to observation (1-2 minutes), I had chest/throat tightness and shortness of breath. Within 15 minutes, I began to experience facial numbness; All of these adverse reactions continued for a few hours post-vaccine
sore arm; This is a spontaneous report from a contactable consumer. This case is for 1st dose. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in Arm Left on 17Feb2021 16:30 (at the age of 65-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cerebrovascular accident, blood cholesterol, blood pressure abnormal, pain. Concomitant medication(s) included warfarin (WARFARIN) 5mg; take once daily orally taken for Stroke from Oct2020 and ongoing; rosuvastatin calcium (ROSUVASTATIN CALCIUM) 40mg; take once daily orally taken for cholesterol from an unspecified start date and ongoing; amlodipine besilate (AMLODIPINE BESILATE) 2.5mg take once daily orally taken for Blood pressure from Jan2021 and ongoing; paracetamol (TYLENOL) 500mg; take as needed taken for pain from an unspecified start date and ongoing. The patient experienced sore arm on 18Feb2021. Prior Vaccinations (within 4 weeks) reported as no. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event was recovered after 20 days on 10Mar2021.  No follow-up attempts are possible. No further information is expected.
No adverse effects; inadvertently administered an expired dose of RECOMBIVAX; This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 21-JUN-2019, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) Thimerosal Free (RECOMBIVAX HB) intramuscularly, # M036156, expiration date 23-FEB-2019 (exact dose was not reported) for prophylaxis (Expired product administered).
Patient received pneumovax 23 vaccine on 12/7/21. Patient called pharmacy on 12/9/21 and stated she began feeling pain at injection site shortly after vaccine adminstration and went to emergency room later that night due to extreme pain. Patient stated the emegency room physican told her she was not having an allergic reaction and the pain was due to vaccine administration too high in the arm. Patient said she was given pain medication at the emergency room but is still having pain and cannot move her arm 2 days later. Patient will follow up with primary care physician if pain continues.
COVID-19 Positive; COVID-19 Positive; This is a spontaneous report from a contactable consumer. It was reported that a 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 (Lot unknown) as single dose for COVID-19 immunisation. No Known allergies. No covid prior vaccination. Medical hsitory was not reported. No other vaccine in four weeks. There was other medications in two weeks. The patient experienced COVID-19 Positive started from 11Aug2021. No treatment for AE. If covid tested post vaccination on 15Aug2021 with Positive result. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
bruise in left arm above elbow; This is a spontaneous report from a non-contactable pharmacist.   A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 02Oct2019, at single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine, received on an unspecified date, in 2019, for immunization. On an unspecified date, in 2019, the patient experienced bruise in left arm. It was specified that the patient an influenza shot in left arm, and on 02Oct2019 received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) in right arm. Has a large bruise in left arm above elbow.   No follow-up attempts are possible, information about lot number cannot be obtained.
dizzy, nausea, headache, myalgia, fatigue, arthralgia,  then on 1/14 fever 10.3 headache continued arm sore, did call out of work 1/14  took Tylenol and motrin
experiencing tingling in the hands, feet and arms/experiencing tingling in the lower part of her legs as well; itchiness; 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 56-year-old female patient received BNT162b2 (BNT162B2), on 21Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "experiencing tingling in the hands, feet and arms/experiencing tingling in the lower part of her legs as well"; PRURITUS (non-serious), outcome "unknown", described as "itchiness".  Additional information: Documenting possible duplicate AE (DOB withheld, Female) Decline to complete a report with safety. Caller had the adult vaccine second dose and is experiencing tingling in the hands, feet and arms. She wants to know if this is a side effect from the vaccine and if it is normal. Caller she mentioned experiencing tingling in the lower part of her legs as well. She also experiences itchiness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE; improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patients' medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On an unknown date, there was a temperature excursion registered for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) of -11.8 Celsius degrees for 1 hour 45 minutes and 0 seconds. There was no previous temperature excursion reported.  On 23-SEP-2022, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # W019623, expiration date 19-DEC-2023, (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error).   No additional adverse event was reported.
She had seven (out of 10) occipital face "pressure" of her right neck face .With 30 minutes of observation,  pressure improved to 3 (out of 10).  She had unlabored breathing and stable vital signs.
positive covid test; positive covid test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 04Jun2021 (Lot number: ew0187) at the age of 13 years as dose 2, single and administration date 13May2021 (Lot number: ew0183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 11Jan2022, outcome "unknown" and all described as "positive covid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course: Prior to vaccination, the patient had not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
pt called c/o staying up late all noc d/u DT inj site hurting;pt devel a red area w/swelling et heat;symptomatic ibuprofen et ice suggested;
Inflammation of the skin in the site of injection. Pain, after 3 days of vaccine BOOSTRIX and FLUZONE HD. She didn't use any care for the reaction, Not used of Ice or analgesics. The site is warmth.
acute syncope.  during 4 hr in er devel nausea, malaise and h/a, w/ arthralgia. rxiv hydration and inapsine.
Patient received vaccine, returned to playing cards, attempted to ambulate 10-15minutes later and fell to floor with seizure like contracting activity. duration of event 5-10 minutes. Medical attention received patient sent to hospital. Patient returned same day.
Headache on the right frontal area of head 15 minutes after injection.  Rated pain # 4 out of pain scale 0-10.
Dose provided 9am, then 9:25am pt developed bilateral eye swelling and slight shortness of breath. She has a history of severe allergy to medication/bees so she was already being closely monitored for the full 30 minutes. Her shortness of breath became better after 25mg Benadryl administered orally with water. Patient was monitored another 20 minutes, no other issues. Second dose for home provided. Pt was escorted to the car by RN where sister drover her home to continue to monitor. Nurse called pt to follow up at 2pm same day, no answer, voicemail left.
Flu-like symptoms; Fever; Diffuse body aches; Muscle aches; Feeling sick; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 29th July 2019, the patient received the 1st dose of Shingrix. On 29th July 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, general body pain, muscle pain and feeling unwell. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, fever, general body pain, muscle pain and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, general body pain, muscle pain and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: Within 24 hours the patient developed flu-like symptoms including a fever (maximum temperature reported as 101.8F), diffuse body aches, muscle aches, and feeling sick.  The patient was sent home from work by the physicians that she works with.  The patient took Ibuprofen and Tylenol for the symptoms, and symptoms resolved after approximately 48-72 hours. The reporter gave permission to follow up. This case had been linked to the case US2019142319, reported by same reporter. In the document onset date of events was reported as 30th July 2019, but as per narrative it was given as within 24 hrs. So onset date considered as 29 Jul 2019.
This spontaneous report as received from a nurse refers to a non pregnant 22 years old female patient. On 25-APR-2014 the patient was accidentally vaccinated with a dose of ZOSTAVAX (subcutaneous, dose 0.5ml, lot # J007209, expiry date 20-SEP-2014) instead of VARIVAX (Merck). Concomitant therapies included YAZ and clindamycin. No adverse effect reported. There was no treatment given for the events. Additional information has been requested.