chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-health care professional (patient's daughter) on 21 September 2015. This case involves a 53 years old female patient who was vaccinated with a dose of FLUZONE QIV (batch number, dose, route and site of administration was not reported) on 18 September 2015. Illness at time of vaccination was not reported. The patient did not have any known allergy, and did not have any medical history. Concomitant medications were not reported. On 18 September 2015, same day at evening following the vaccination, the patient experienced itching, burning, "welt" at injection site and following day's area was enlarged toward her underarm. It was also reported that the patient continued to have swelling or "welt" that was itching, burning, painful area, size of 5 to 6 inches and located toward her underarm. Lab data and corrective treatments were not reported. The patient was recovered from injection site swelling, itching or burning and patient was not recovered from other events. Follow-up information received from a physician on 29 October 2015. The patient had received 0.5 ml of FLUZONE QIV intramuscularly in left deltoid. On an unknown date, following the vaccination, the patient had developed cellulitis at injection site. The patient was seen at physician office on 22 September 2015. The patient was treated with Keflex 500 mg for one week. List of documents held by sender: none.
I woke up early in the morning to use the restroom and my heart rate was very high and I had heart palpitations- I could feel it in my chest, hear it in my ears and it remained high even after sitting down to try and get it be lower.
Severe case of shingles (Herpes Zoster) started 3/26/2021 just cleared up but severe pain from neuropathy. (I know of another case where I work of someone in their 20's).
Second day having flu like symptoms. Body aches and pains. Sore at the injection site. Headache.
A consumer reported that a 4 month old male received Prevnar, Hib-Titer, Tripedia, and IPV vaccines on 4/28/00. Immediately, the infant became quieter, and became less focal. (Talked less baby talk), and smiled less than usual. The reduction in vocalization and smiling persisted as of 5/4/00. A copy of this report has been forwarded to Aventis Pasteur.
Extreme pain I right arm from the shoulder, over the shoulder to the front of the right arm. I can't move arm at all. I had a fever of 100 and fatigue. I have taken Ibuprofen and Tylenol.
Patient presented to office 12/17/18 with 1 day h/o rash. No fever. +/- painful/tender. On exam had TNTC papulovesicles arranged in clusters and distributed along dermatome from mid abdomen extending around on left side/flank and stopping at spine.
Pt recvd Hep B vax & w/in 24 hrs of vax pt exp fever, nausea, vomiting, h/a, lethargy;@ the time of report pt had recovered;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer hypertension" (unspecified if ongoing); "Hypertension" (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 Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID-19 Treatment with Paxlovid orally from 09Jan2023 to 14Jan2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
30 minutes after the injection she started having a headache, dizziness and fever. The next day she noticed 2 cold sores on her lips and mouth sores throughout her mouth. She was unable to eat for several days. Symptoms resolved by 1/22.
Patient became unconscious shortly after receiving the vaccine for about 2 seconds. She was diaphoretic and her b/p was elevated 151/74 and after 5 minutes decreased to 126/81 and stated she felt dizzy. She was diaphoretic for about 15 minutes. An ice pack was applied to the back of the neck and she was monitored. After 20 minutes she stood up from a sitting position and denied feeling dizzy or lightheaded.
fatigue, sinus migraine headache, muscle pain, chills, nausea, low grade fever
Fever of 103 axcillary with 2 minutes of stiffening, erythimical jerking of arms, legs during sleep without respiratory problems. Seizures with fever. Fever contiued June 18- June 27.
3 1/2 hrs cont high pitched crying yesterday evening p/vax; no problems today
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 02-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC).
Rash - Sat 3/24. Rash all over body. Fever started 24 hours after vaccines (100) lasted 4 days. Generalized med sized papules and macules - All over including  palms and soles, no weeping, no warm to touch.
Body ache; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) and PYREXIA (pyrexia) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. C0S9860 and AS7180B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (lasted 6 days, very mild, no symptoms) on 15-Apr-2022.   On 06-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Apr-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache) and PYREXIA (pyrexia). At the time of the report, PAIN (Body ache) and PYREXIA (pyrexia) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. With all the subsequent booster shots, patient had body aches. When he had gotten fever previously, it came with the other symptoms. Reporter said that some of the lot numbers might be incorrect as he was unable to read what was written in the card. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742282:New varient 2023-24
Heavy sensation feeling in arm; sharp achy pains left side of chest pectoral region; sharp pinch pain while taking breath; Fever; Achiness and soreness; Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever) and VACCINATION SITE PAIN (Achiness and soreness) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism and COVID-19 virus test positive on 15-Sep-2020. Concomitant products included LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever), VACCINATION SITE PAIN (Achiness and soreness) and LYMPHADENOPATHY (Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Heavy sensation feeling in arm), NON-CARDIAC CHEST PAIN (sharp achy pains left side of chest pectoral region), PAINFUL RESPIRATION (sharp pinch pain while taking breath), PYREXIA (Fever), VACCINATION SITE PAIN (Achiness and soreness) and LYMPHADENOPATHY (Severe swelling in axillary lymphnodes the size of a baseball on the same side of the injection site) had not resolved.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3 weeks post vaccine I developed tinnitus in both ears. It got progressively worse over the next few months. I saw an ENT who said there was no explanation for the tinnitus. After many hearing tests, exams, a course of steroids and finally a brain MRI, I still have no answer and am suffering terribly.
Fainted; headache; tired; chills; blood pressure was low; area was sore; This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (on an unknown date received 1st dose and experienced headache, sore arm, tired, and felt out of sorts, refer case US2019AMR116527).   On 22nd June 2019, the patient received the 2nd dose of Shingrix. On 22nd June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 23rd June 2019, the patient experienced fainting (serious criteria GSK medically significant), headache, tiredness, chills and low blood pressure. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fainting, headache, injection site pain, chills and low blood pressure were unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the fainting, headache, injection site pain, tiredness, chills and low blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Less than a day after receiving Shingrix vaccine, at evening, the patient experienced soreness in area of injection.  The patient also experienced chills, headache, tiredness, fainted on the morning of reporting date and had low blood pressure. This case has been linked with the case US2019AMR116527 for the same patient reported by the same reporter.
Left arm around shot was very swollen, hot to the touch, hard and itchy. I gave him Benadryl and I called the on call doctor and was advised to take my son to the E.R. I was told that he had the beginnings of cellulitis and he was prescribed Cephalexin.
patient is unable to lift their arm above their head.  patient experiences severe muscle pain when laying or sleeping on the arm. Patient experiences numbness and tingling in the arm.
pt c/o pressure behind her eyes and slightly light headed. Pt consumed one bottle of water. Pt reported not having anything to eat since noon. Pt asked by EMS if she had checked her BS, pt stated, "No she had not". Pt encouraged to stay with AC blowing on her and to dringk some more water. Pt unerstood. No S/S of respiratory distress noted, no swelling at injection site. pt denied itching or difficult breathing or swallowing. Pt verbalized understanding. Pt stated, "I feel better". Pt left site at 1907
Pneumovax given 11/30/07. Next AM arm red, hot, swollen, sore to touch. Pt had vomiting with hot and cold chills. Pt to ER 12/11/07. Called ER 12/2 area still sore was told to take Claritin and Ibuprofen. Phoned office 12/10 - still sore and itching. Pt taking Claritin - improving now.
waited 30 minutes before leaving per instructions, by the 40 minute mark I began to itch all over.  No rash/hives/trouble breathing, just itching.   Called dr office and they said to try OTC allergy medicine (ie alegra) and if that didn't work within an hour to try benedryl.   that did not really help, still itching all over just not as severe.  Friday 4/23/2021 had a dr appt already set up and was prescribed hydroxyzine to help with itching.  Has controlled severity of itching but not relieved.  Still itching as of today.
Left arm EXTREMELY sore, almost totally unusable for 24-36 hours, Uvula swollen to approx twice normal size-3 days to fully return to normal
10/2018 Malaise setting in, some days worse than others. By the end of the month having trouble with LT knee being weak, walking with slight limp. 11/2018 Both knees are weak, more fatigue. By end of the month difficult to climb stairs, knees buckle at times. Difficulty lifting/raising legs, requires a lot of energy to move and is exhausting to walk. 12/9/18 Fell inside home, LT knee buckled. 12/11/18 LT leg goes numb/tingles from knee down. 12/12/2018 positive MRI thoracic spine, signal in cord and surface cord enhancement of lumbar nerve roots. 12/20/18 spinal tap-elevated proteins and white cells. 12/21/18 EMG-NCV absent peroneal F responses and tibial H reflexes. 12/21-12/23/2018 admitted to hospital for IV steroids-no help. 12/21/2018 MRI lumbar spine finding consistent with Guillain-Barre syndrome. 12/24/2018-1-10-19 oral steroid taper down. 12/24/2018 tingling is now waist down to toes, numbness in vagina and rectum-difficult to move bowels, cold feet, horrible balance, unsteady gait. 1/1/2019 RT calf tightness. 1/2/2019 bilateral calf tightness when walking, tingling sensation feels like light vibrations from waist down to toes. Declining balance. 1/8-1/12/2019 IV immunoglobulin therapy. Current day 1/13/19 waiting to see how I respond to IVIG therapy. I will begin aqua physical therapy 1/14/2019 to help with abdominal/lower leg weakness. Balance is slightly improved, tingling sensation is slightly less at rest but very much present when walking. Bowel movements have improved. Feet are still cold.
still feels like she has a fever that is in and out; left upper arm is red; Left upper arm is swollen; Feels very dizzy; has some chest pains; felt like she got real influenza flu; was very sick; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like she got real influenza flu), ILLNESS (was very sick), PYREXIA (still feels like she has a fever that is in and out) and ERYTHEMA (left upper arm is red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood disorder. Concomitant products included MORPHINE, ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]), NORTRIPTYLINE, ZONISAMIDE, FOLIC ACID, METOCLOPRAMIDE, GLYCERYL TRINITRATE (NITROGLYCERIN LINGUAL), CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE + D3), SIMETHICONE, CLONAZEPAM, VITAMIN B COMPLEX, DOCUSATE SODIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and LEVETIRACETAM (KEPPRA) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she got real influenza flu) and ILLNESS (was very sick). On 01-Mar-2021, the patient experienced PYREXIA (still feels like she has a fever that is in and out), ERYTHEMA (left upper arm is red), PERIPHERAL SWELLING (Left upper arm is swollen), DIZZINESS (Feels very dizzy) and CHEST PAIN (has some chest pains). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like she got real influenza flu), ILLNESS (was very sick), PYREXIA (still feels like she has a fever that is in and out), ERYTHEMA (left upper arm is red), PERIPHERAL SWELLING (Left upper arm is swollen), DIZZINESS (Feels very dizzy) and CHEST PAIN (has some chest pains) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
the night and next morning patient experienced sore arm.  she said the vaccinator hit a muscle due to quickly giving her the vaccine.
Lethargy second and third day, but then felt fine afterwards; Dizziness during evening of vaccination and next day; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN6201 and expiration date was not reported), via an unspecified route of administration, administered in arm left on 18Feb2021 at 09:30 (at the age of 79-year-old) as single dose for COVID-19 immunization. The patient other medical history and concomitant medications were not reported. The patient previously took quinolones and had allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not COVID tested post vaccination. On 18Feb2021 at 20:15, the patient experienced dizziness during evening of vaccination and next day and lethargy on second and third day, but then felt fine afterwards. The patient did not receive treatment for the events. The outcome of the events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Patient was given the vaccine but it had not been diluent per the instructions. Patient was given a concentrated amount of the vaccine at 0.2mL.
Patient presented with the complaint of a bitter taste in his mouth following the Shingrix vaccine.  He is generally in good health and takes no medications regularly.  After his routine physical exam, he received his first Shingrix immunization.  He had not previously received Zostavax.  Within about 5-10 minutes he noted a bitter, not metallic, taste in his mouth localized in the area of his right buccal mucosa.  It did not involve his tongue or oropharynx. There may have been an associated numbness/funny feeling in the same area.  There was no increased salivation, difficulty speaking, throat tightness, change in his sense of smell, or other local or systemic symptoms noted. The bitter taste/numbness resolved spontaneously within 5 minutes.  He has had no recurrence over the past 72 hrs. He has never experienced anything similar associated with vaccine or otherwise.  His annual physical exam a few hours earlier documented nasal stuffiness, but otherwise a normal exam.  He is being followed for borderline hypertension, but has not yet been prescribed medication. He has no history of acid reflux, dry or burning mouth, or facial or cervical nerve damage although did have cervical myelopathy relieved by C2-T2 fusion about 5 years ago.  Is an ex-smoker.
pins and needles on side of the jab; mild pressure when lying on that shoulder; Unable to raise myself from bed; trouble getting up and could not raise his body; shakiness; flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of TREMOR (shakiness), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT INABILITY (trouble getting up and could not raise his body), PARAESTHESIA (pins and needles on side of the jab) and LIMB DISCOMFORT (mild pressure when lying on that shoulder) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TREMOR (shakiness) and INFLUENZA LIKE ILLNESS (flu like symptoms). On 09-Feb-2021, the patient experienced GAIT INABILITY (trouble getting up and could not raise his body). On 10-Feb-2021, the patient experienced GAIT INABILITY (Unable to raise myself from bed). On an unknown date, the patient experienced PARAESTHESIA (pins and needles on side of the jab) and LIMB DISCOMFORT (mild pressure when lying on that shoulder). On 10-Feb-2021, GAIT INABILITY (Unable to raise myself from bed) had resolved. At the time of the report, TREMOR (shakiness), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT INABILITY (trouble getting up and could not raise his body) and LIMB DISCOMFORT (mild pressure when lying on that shoulder) outcome was unknown and PARAESTHESIA (pins and needles on side of the jab) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Concomitant medication A-RED  per day was started from 2016 via eye route .  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received with Updated Patient demographics. Added Concomitant Drug, Added events and outcome of the events.