chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Armpit hurts; hot flashes; Her whole body was shaking; massive migraine; felt tired, tired all daynext day; Headache; Her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt), AXILLARY PAIN (Armpit hurts), HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking) and MIGRAINE (massive migraine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management, Fibromyalgia, Diabetes, Acid reflux (oesophageal) and Allergy NOS.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt), FATIGUE (felt tired, tired all daynext day) and HEADACHE (Headache). On 06-Apr-2021, the patient experienced HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking) and MIGRAINE (massive migraine). On 07-Apr-2021, the patient experienced AXILLARY PAIN (Armpit hurts). At the time of the report, PAIN IN EXTREMITY (Her arm hurt) and AXILLARY PAIN (Armpit hurts) had not resolved and HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking), MIGRAINE (massive migraine), FATIGUE (felt tired, tired all daynext day) and HEADACHE (Headache) outcome was unknown. Not Provided          The patient reported that her arm hurts more than first dose. On 06-Apr-2021, she was tired all day.  The patient received unspecified medication for migraine.   This case was linked to MOD-2021-069627 (Patient Link).
A few hours after the vaccine I developed a fever, dizziness, chills, severe headache and had night sweats.  It was if my whole body was swollen and just to move had me in tears because my body was so sore. The arm pain was there but not as bad as from the first vaccine.  I developed SOB and have had to start using my asthma pump which I hadnt had to use in over 3 years.  I have been off work since 1/3 from the AE experienced to both vaccinations and to date I am still experiencing breathing issues. I have been developing intermitten fevers off and on throughout this  whole time. An the fatigue has been awful.   I havent been able to stay awake long and as of yesterday was the first day I have been able to stay awake for an extended period of time.
At the dentist today it was brought to my attention that my daughter tonsils are very swollen. She has no fever, no soar throat, and no difficulty breathing or swallowing. I dont know if her swollen tonsils were present before her vaccine or if they developed as a side effect of the vaccine or are an unrelated development within the last 2 days.
7 days following booster, high blood pressure 200/90plus.   Unaware of surroundings.  Hospital admission stroke suspected.  No stroke.  Head MRI normal.  blood pressure normalized, admitted to hospital.  Next day increasing paranoia, halucinations, short term memory loss.   Spinal tap not conclusive.  EEG not conclusive.  Anti seizure medication no improvment.  Deteriation of condition until iv steroids day 3 in hospital.  Immediate improvment of symptoms.  oral steroids for 5 days improved symptoms.  2 weeks later apparent full recovery.  being monitored by cardiologist. Never fever.Encephalitis and encephalomyelitis following immunization procedure (Discharge Diagnosis) - 1/23/22 NSTEMI (non-ST elevated myocardia
This spontaneous report was from a register nurse via company representative, refers to a male patient of unknown age. Co-suspect and concomitant therapies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, lot number, expiration date, strength and route were not reported. Co-suspect and concomitant therapies were not reported. The patient's father stated that on an unknown date, the patient experienced warts after receiving GARDASIL. At the time of the report the outcome was unknown. The patient's mother stated that the warts were caused by GARDASIL. This case is one (1) of two (2) reports from the same reporter (1405USA003843). Additional information is not expected.
This is a spontaneous report from a contactable nurse practitioner. A 17-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA Lot# M77282 Expiry Date Jun2017, intramuscular in the left arm on 16Aug2016 at 09:00 am at single dose. The patient medical history and concomitant medications were not reported. The patient turned pale, had chills, severe headache, abdominal pain, nausea, vomiting and stomach ache on 16Aug2016 at 10 am, within an hour after vaccination. The nurse advised the patient to take fluids and take Ibuprofen. No emergency room or physician visit was needed. All the symptoms improved in 8 hours and resolved within 24 hours. The reporter considered the events as associated to the vaccine administration and she would likely not get the 2nd and the 3rd dose of vaccine due to severity of reaction. Follow-up (07Sep2016): New information reported from the same contactable nurse includes: suspect vaccine details (route, anatomical location and time of administration, dose number), reaction data (new events nausea, vomiting, stomach ache were added, time of events onset, updated outcome), no visit, causality assessment. Follow-up attempts are completed. No further information is expected.
Patient had fever 101.2F on Feb 19th. Patient developed pox all over body on Feb 20th. Fever broke on Feb 21st. Pox cleared up on Feb 23rd.
Patient reported rash to right ring finger four days after Shingrex vaccine administration. Nurse practitioner diagnosed lesion as herpetic whitlow.
Shingles; Inappropriate Schedule of Vaccine; Circumstance or information capable of leading to medication error; This case was reported by a physician via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, drug dose administration interval too long and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the shingles, drug dose administration interval too long and circumstance or information capable of leading to medication error were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The patient had a mild case of shingles. The patient also planned to delay the 2nd dose by more than 6 months, which led to lengthening of vaccination schedule and circumstance or information capable of leading to medication error.  The reporter consented to follow up. This case has been linked with case US2020000362, reported by the same reporter.
Initially uncomfortable red area warm to the touch which developed into cellulitis per ED at local hospital by that evening/night.
Pt rec'd Engerix-B as 4th dose following 3 doses of Recombivax-HB (nonresponse) & still did not respond.
This spontaneous report as received from a 73 year old nurse refers to herself. The patient current condition included granulomatous changes in right mid lung which was diagnosed in August 2002 and reaction to Computerised axial tomography (CAT) scan dye (unspecified). On 31-DEC-2008 the patient was vaccinated with ZOSTAVAX (strength reported as 19400 PFU, dose, route of administration, anatomical location and lot numbers were unspecified by reporter) because physician told her she needed it. Concomitant medications included cholesterol medication (unspecified product) prescribed for a couple of months in 2012. On 19-JAN-2009, the patient had been experiencing unspecified number of rashes diagnosed as shingles on her perineum, abdomen, waist area, lower legs and right arm. The shingles were described as blisters and redness. The patient sought medical treatment from an unspecified physicians on an unspecified dates. On an unknown date in September 2012 Herpes simplex 1 was 1.51 (units not provided) and Herpes simplex 2 was 5 (units not provided). Treatment included unspecified number of courses of treatment with acyclovir and VALTREX. The patient was also treated with prednisone on 01-JAN2012 and gabapentin on 05-SEP-2013. The patient's shingles was resolved and again returned many times after several treatments with acyclovir and VALTREX and also with prednisone and gabapentin. The patient reported that her last episode of shingles began on 09-SEP-2014. The outcome of shingles was reported as not recovered/resolved. The causality was unknown. Additional information has been requested.
Redness, tenderness, swelling, warmth, and pain where the shot was given.
Patient received 2nd dose of Pfizer 14 days after 1st dose of Pfizer vaccine.
-Fever of 100.4 at max -Headache -Muscle aches -Fatigue -Nausea
Sever joint pain in both hips, knees and ankle.  Pain lasted 5-6 hours.  Ibuprofin provided mild relief.   This occurred 3 days after dose.  The pain eventually went away.  Had a relapse of pain 3 months later.
Brachial neuritis developed. Started with shoulder/neck problem 11/15 and then left calf at home. Appointment here 1/7/04.
Pt called on 9/25 to report that on the evening of 9/22, she was experiencing allergic reaction: rash on arm and torso, fever, tingling lips. Went to the local ER for treatment.
itching; burning; rash all over his back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), SKIN BURNING SENSATION (burning) and RASH (rash all over his back) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02920A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), SKIN BURNING SENSATION (burning) and RASH (rash all over his back). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching) and SKIN BURNING SENSATION (burning) outcome was unknown and RASH (rash all over his back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included Pain cream.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event outcome updated to recovered for rash.
gave a partial dose to the patient because the syringe leaked/ no adverse event; there was some leaking from the syringe; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 74 years old female patient who received a partial dose (underdose) of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] because the syringe leaked (syringe issue).   The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   On 07-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ282AA and expiry date: 23-May-2020 via unknown route in the right deltoid.  It was a case of actual medication error due to vaccine underdose.  It was also a case of syringe leak.  It was unknown if the patient had any adverse event.  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 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.  List of documents held by sender: none.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with a 0.5 ml dose of GARDASIL (dose and lot # not reported) intramuscularly that was improperly stored. The nurse stated that GARDASIL had multiple excursions (48 F for 2 days, 34 F for 16 hours, 34 F for 2 days, 49 F for 1 day, 34 F for 8 hours, 47 F for 4 days 34 F for 2 days. No adverse effects were reported. This is one of serveral reports received from the same source. Additional information has been requested.
Large (3"x3") red injection site irritation day 1-2. On day 3, site was growing hot and sensitive to touch. It was growing/spreading approx 1"/hour. Ended approx 6"x9", very hot, and excruciating to touch.
This case was reported by a healthcare professional and described the occurrence of arm soreness in a 15-year-old female subject who was vaccinated with (Boostrix, GlaxoSmithKline) for prophylaxis. Concurrent vaccination included Menactra (.5ml) given intramuscularly in the right deltoid on 3 April 2007. On 3 April 2007 the subject received booster dose of Boostrix (.5ml, unknown) in the left deltoid. At an unspecified time after vaccination with Boostrix, the subject experienced arm soreness and inappropriate schedule of drug administration as Boostrix was given "nine months apart." At the time of reporting the outcome of the events were unspecified. Follow-up information received on 03 August 2007 indicated that the event onset was 04 April 2007. The day following vaccination with Boostrix. The arm soreness did not last more than a week. Soreness resolved and no other symptoms were reported as of 08 June 2007. The subject reportedly received Tdap vaccine at the doctor's office in July 2006. In the reporter's opinion, the event was possibly related to treatment with Boostrix.
patient here for first dose of Pfizer pediatric vaccine after shot complained of dizzy and was lethargic.  lowered to floor  oxygen sat 98 pulse inthe 80s  had juice felt better and  had a second episode similar .  she took more juice and crackers and gradually improved .  she sat up and then ambulated in hall with no adverse vital signs or symptoms.  Mom states she has had this before related to emotions or hypoglycemia,.
Dry cough, 130 am for about an hour Sore arm at injection site still ongoing
inc fever 103.2, listless, tachycardic (P156) w/crying inconsolably;
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (she knows of 4 other people who were vaccinated and got COVID-19) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 4, 2021, patient experienced COVID-19 (she knows of 4 other people who were vaccinated and got COVID-19). Patient treated with remdesivir for the adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (she knows of 4 other people who were vaccinated and got COVID-19) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications not provided. Reporter did not allow further contact. Sender's comments: This spontaneous report concerns four female patients, of unknown age, who experienced COVID-19. The event occurred after unknown duration following vaccination with mRNA-1273. The reporter stated the patients contracted COVID-19 after vaccination. The re-challenge: unknown as there is no information on the vaccine doses. The benefit-risk relationship of mRNA-1273 not affected by this report.
This spontaneous report as received from a physician concerning an 85 year old male patient who on 31-JAN-2013 was vaccinated with a dose of PNEUMOVAX 23 (lot # H014196, Exp 29-MAR-2014) (Dose not provided). The physician stated that in approximately 2013 the patient experienced swelling of her arm at the injection site after receiving PNEUMOVAX 23. The patient was seen back in the physician's office on 04-FEB-2013 and was noted to have a mild local reaction. The outcome of swelling of her arm at the injection site and mild local reaction was reported as recovering. The relatedness of PNEUMOVAX and the events mentioned above was not provided. Additional information has been requested.
NAUSEA, VOMITING, FEVER, HIGH HEART RATE AND BLOOD PULSE AND REDNESS AT INJECTION SITE.
17 days letter was tested positive for Covid; 17 days letter was tested positive for Covid; This is a spontaneous report for initial and Follow-up 1 from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number-unknown, Expiration date unknown) via an unspecified route of administration on 24-JAN-2021 at SINGLE DOSE for COVID -19immunization. Patient medical history and concomitant medication were not reported. Patient received first dose of Covid vaccine 24Jan2020 and tested positive for Covid 17 days later. She had never took second dose of vaccine and is wondering if she can do that now. The outcome of the event was unknown  Follow-up (25Feb2021):This is a follow-up spontaneous report from a Pfizer Sponsored Program CEP 159558. Information about lot/batch number has been requested.  .
feel like i have a cold 2 days later; arm felt sore; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (feel like i have a cold 2 days later), MYALGIA (arm felt sore) and FATIGUE (felt tired) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (feel like i have a cold 2 days later), MYALGIA (arm felt sore) and FATIGUE (felt tired). At the time of the report, NASOPHARYNGITIS (feel like i have a cold 2 days later), MYALGIA (arm felt sore) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment drugs were not provided.
pt reported vertigo started approximately 2 weeks ago, on day shot was given, pt visited her physician regarding the dizziness
Tightness in throat right after I took shot. Treated myself Benadryl and inhaler  same day started itching rash on my chest pain at injection site pain moved to entire arm and under the breast happen with in 1 day Lympnodes enlarged  in the underarm area 3rd day stopped Benadryl and inhaler
pain and swelling of arm pit, hurts when she lifts her arm; pain and swelling of arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 16Mar2021 15:30 (Lot number: EN6206) at the age of 56 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY PAIN (non-serious) with onset 19Mar2021, outcome "not recovered", described as "pain and swelling of arm pit, hurts when she lifts her arm"; SWELLING (non-serious) with onset 19Mar2021, outcome "not recovered", described as "pain and swelling of arm pit". Therapeutic measures were not taken as a result of axillary pain, swelling. Additional information: Patient did not receive any other vaccines within 4 weeks or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Reporter was made aware of the side effects on 20Mar2021 10:11.  No follow-up attempts are possible. No further information is expected.
Patient reported dizziness, weakness, in and out of consciousness, palpitation and ataxia approximately 10 minutes after vaccination. Sent to ED and diagnosed with potential cerebral mass. Palpitations has occurred more frequently in the last 4 months when she ran out of metoprolol for the treatment of SVT since her PMH retired and she has not established new care yet. Dizziness, palpitations and ataxia resolved by next AM. Follow up with outpatient Neuro and cardiology. Given prescription for metoprolol XL 75 daily.
numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy; stuffiness comes and goes/ stuffy nose only in her left nostril; pain/pain when lifting or moving her left arm/pain comes and goes; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy), NASAL CONGESTION (stuffiness comes and goes/ stuffy nose only in her left nostril) and VACCINATION SITE PAIN (pain/pain when lifting or moving her left arm/pain comes and goes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (chronic) and Sinus disorder NOS.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HYPOAESTHESIA (numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy), NASAL CONGESTION (stuffiness comes and goes/ stuffy nose only in her left nostril) and VACCINATION SITE PAIN (pain/pain when lifting or moving her left arm/pain comes and goes). At the time of the report, HYPOAESTHESIA (numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy), NASAL CONGESTION (stuffiness comes and goes/ stuffy nose only in her left nostril) and VACCINATION SITE PAIN (pain/pain when lifting or moving her left arm/pain comes and goes) outcome was unknown. Not Provided      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 concomitant medications were reported No treatment drugs were reported
She got the vaccine on Monday and woke up Tuesday morning with some swelling, the worst of which was her eyes.  It did resolve itself as the day went on, and was back to normal when I talked to her on Wednesday.
Few days post vaccination = H1N1 noticed bruising on body for no reason; 8 days post injection woke up with large bloody area on inside mouth (left cheek). Bruising/itchy mark in areas noted later this evening over chest, abd, leg, face (petecheal rash).
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Severe, Systemic: Seizure-Medium, Additional Details: patient took tylenol every 4 hours afterwards. was completely fine after first shot and this shot she passed out twice and eyes rolled back, severe neck pain and unresponsive. following up with cardiac for EKG and further  testing.