chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I took notes during my wait time: -6 minutes in my throat felt weird, but different than normal allergic reactions to foods. I prepared my Epi-Pen so I have easier access at this time. -9 minutes in the sides of my tongue were slightly itchy. -11 minutes in and I felt as though the saliva in the back of my throat was thicker and I needed to clear my throat a bit more often, similar to allergic reactions. -15 minutes in, I felt my heart pound once out of beat, but my heart rhythm returned to normal immediately. Tongue itchiness also became intermittent rather than constant. -18 minutes in, overall condition improved and I felt better. -22 minutes in, my throat felt scratchy like I would if I consumed legumes (chickpeas, green peas, soy beans, etc.) but also oddly warm, which was out of the norm.  No treatments needed given mild reactions. I went to work, but notified my co-workers of my reaction, so if my condition worsens they can help administer my Epi-Pen. I am reporting this at 9:21 am on 03/05/2021, roughly an hour after my first dose.
After six hours, fever, nausea, bodyaches. After two days, right foot right hand pain indicating arthritis That continues to L hand, wrists etc
15 MINUTES AFTER HER VACCINE SHE STARTED FEELING DIZZY AND LIGHTHEADED. ON SITE EMS RESPONDED. VITALS BELOW. SHE WAS OFFERED WATER AND GRAHAM CRACKERS. SHE FELT BETER AND WAS RELEASE TO HOME
redness, swelling 10x12cm on lt thigh were DTAP was injected 2 days ago;
Received DtaP, MMR AND IPOL on 4/2/08.  On 4/3/08 woke up with left arm warm, hot, and swollen.  Seen in our office on 4/3/08 and diagnosed with Early Cellulitis left arm s/p DtaP & IPOL immunization.
PAIN IN RIGHT HAND; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the patient experienced pain in right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right hand. This report was non-serious.
First pain at injection sight. Rash and profuse itching by next day. Rash scalp, ears, down back and buttocks, under breasts all over chest and arms.
Patient had smallpox vaccine approx. 10 days prior to presentation.  Complained of dull chest pain.  Evaluation revealed non-specific ECG changes and multiple positive troponin assays suspicious for myocarditis.
Patient received Pfizer vaccine first dose Lot EN6199 on 3/25/21. Patient had itching and hives on arms and neck- patient stated that usually have adverse reaction to vaccine- benadryl 25mg given po at 15:15. Patient was advised to wait an additional 15 minutes in clinic for monitoring. at 1530- patient had less hives, states still felt itchy- advised to wait and continue to be monitored- patient left at 1350.
for at-risk - cancer and congestive heart failure; for at-risk - cancer and congestive heart failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Congestive Heart Failure" (ongoing); "Cancer" (ongoing). The patient took concomitant medications. The following information was reported: CARDIAC FAILURE CONGESTIVE (medically significant), NEOPLASM MALIGNANT (medically significant), outcome "unknown" and all described as "for at-risk - cancer and congestive heart failure". Clinical course: Other medications in two weeks has at-risk conditions that may take medication. Unsure exact age but either adult or elderly probably 50s or 60s. Yesterday he had a dentist appointment to put a bridge in. They had to shave down a tooth, and his mouth was numb when he talked to us at around 17:45. Not sure when this procedure became necessary, but just an information. Believe he was likely at least fully vaccinated, but unsure which vaccine and when exactly got vaccinated. Probably sometime by 2021, may have had earlier access to vaccine due to pre-existing conditions. It was unknown if had covid prior vaccination and if had covid tested post vaccination. It was unknown if patient had any allergies.  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 information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Systemic: Headache-Medium, Additional Details: Patient made an appt online with her daughter on 10/1/21. Daughter checked in 1st, and recieved vaccine. Afterwards, mother decided to check in for her premade online appt & received vaccine. Patient came into pharmacy on October 16,2021 and states that once the needle was in her muscle she had changed her mind and did not want to recieve the vaccine but it was too late because she had already been injected. Patient now states that she has had a headache and anxious ever since.
Feet tingling, achy joints, ringing in the ears, headaches, blurry vision, rash over entire body.
8/4/10 Fever, chills, myalgia, blisters on fingers, some swelling x 6 days; woke up Sunday with abd. pain in middle of the night, felt like was going to pass out. Red, painful lines on left upper ext.
The patient's medical history and concomitant medications were not reported. The patient reported that she was sick everyday after she took the first dose and experienced all of the symptoms like colds, fever, chills and diarrhea. The outcome of the events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I started having fever, chills and muscle weakness within 24 hours of receiving the vaccine. For the next few days, these symptoms persisted. When the symptoms subsided (although not completely gone) around 9/15, I started getting headaches. One or more a day for the next few days. On 9/20/21, I began having dull, right breast tenderness and right armpit pain. That persisted for a week and then on 9/27, I noticed I had a rash on my back and noticed that it had been in a line around my armpit and to the right breast. Wherever there was a rash, there was intermittent shooting pain. This is the symptom state I have now.  Shooting pain that persists throughout the day and a rash.
Aches/pains; dull headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/pains) and HEADACHE (dull headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (Aches/pains) and HEADACHE (dull headache). At the time of the report, PAIN (Aches/pains) and HEADACHE (dull headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment  medication was provided by the reporter.   This case was linked to MOD-2021-219851, MOD-2021-219851 (Patient Link).
Within approximately 5 minutes of injection had numbness and tingling from left upper arm all the way down to fingertips. Told the nurse about it and she said oh, that has happened to some people.  When I asked how long it lasts she said it should go away but not within the 15 minutes. The nurse asked if I wanted to stay longer. Then the nurse said if it doesn't go away to call and let your Doctor know. Then she sent me on my way like it was no big deal.
For the first three day I had fever, vomit, diharrea, chills and severe headache.   On October 11th, 2021 my left arm started to become itchy, on Tuesday October 12th, 2021 a rash presented on the arm, these is the arm where the vacine was placed. Went to clinic due to severe pain on the arm. Was prescribed antibiotics and esteroids. The rash continued to grow and spread (right eyelid and right thigh), went back to the urgent care, was given a shoot of esteroids, and higher dose of esteroids for home. I was also refered to a dermatologist, but I can't affort the insurance deductible for the specialist. The rash is still active althought it has decrease, it has not disaperear.
pain in hands/leg pain; pain at knee joints/pain in ankle; swollen hands/swollen legs from the  knee down to the feet; swell and  pain at the knee joint; struggles to walk; muscle cramps/spasm; Not able to sleep; Unable to wear their shoes; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen hands/swollen legs from the  knee down to the feet), JOINT SWELLING (swell and  pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps/spasm) and INSOMNIA (Not able to sleep) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C2114 and 028A211(4 or A)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen hands/swollen legs from the  knee down to the feet), JOINT SWELLING (swell and  pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps/spasm), INSOMNIA (Not able to sleep), HYPOKINESIA (Unable to wear their shoes) and ARTHRALGIA (pain at knee joints/pain in ankle). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in hands/leg pain). The patient was treated with PREDNISONE at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen hands/swollen legs from the  knee down to the feet), JOINT SWELLING (swell and  pain at the knee joint), GAIT DISTURBANCE (struggles to walk), MUSCLE SPASMS (muscle cramps/spasm), INSOMNIA (Not able to sleep), HYPOKINESIA (Unable to wear their shoes), PAIN IN EXTREMITY (pain in hands/leg pain) and ARTHRALGIA (pain at knee joints/pain in ankle) outcome was unknown.            No concomitants were reported.
Shivers; Nausea; This case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shivering and nausea. On 23rd November 2020, the outcome of the shivering and nausea were recovered/resolved.   It was unknown if the reporter considered the shivering and nausea to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient experienced some shivers and nausea with the first dose but it resolved quickly.  The patient followed up with disease control and prevention guidelines.  The reporter did not consent to follow-up and declined to provide HCP information. For tolerance of 2nd dose of Shingrix, refer case US2020232824.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020232824:Same reporter. 2nd dose
Headache; Myalgia; Chills; Lymphadenopathy; Brain fog; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ek9231) via intramuscular in left arm on 02Jan2021 18:00 at single dose for COVID 19 immunization. The patient received the vaccine in hospital. Medical history included asthma, migraine. Known allergies included Latex allergy. Concomitant medication included oral contraceptive pill (OCP), ergocalciferol (VIT D), melatonin, ubidecarenone (COQ10) and fexofenadine hydrochloride (ALLEGRA). No other vaccine was received in four weeks. The patient didn't have COVID prior vaccination.  The patient experienced headache, brain fog, myalgia, chills, lymphadenopathy on 03Jan2021. Therapeutic measures were taken as a result of events including ibuprofen (MOTRIN). The events did not require Emergency Room Visit or Physician Office Visit. No COVID was test post vaccination. The outcome of events was recovered in Jan2021.
The pt's leg became red and swollen after the injection, and a knot appeared after redness and swelling went away. The knot is still there (shot given 2 weeks ago). Also another knot in the groin area. Pt saw MD, no treatment. MD is watching this situation. No temp was noted.
After the second vaccine dose she reported not feeling well with unspecified symptoms for a few days. On February 18th, 2021 she visited her doctor with numbness in her hand. They thought it may be carpal tunnel and sent her home. The morning or March 18th , 2021 she had a severe stroke and was transferred to Hospital and then to other hospital. She was in the hospital until Tuesday March 23rd when she was transferred back to her home for hospice care. She died on March 26th, 2021.
FEVER TEMP 104, HEADACHE, FLU LIKE SYMPTOMS, LETHARGY, DIZZINESS
Four hours after shot, I lay face-down, for three days, horrifically ill, like I had the worst flu of my life.   Two months after shot, started developing never-before-experienced symptoms:  - Blood, both Upper and Lower GI 03/2022: BACTERIAL OVERGROWTH SYNDROME 9/13/21: CHRONIC DIARRHEA, WITH BLOOD 6/2021 - TOOK UNTIL 6/22 TO DIAGNOSE NARCOLEPSY: EXTREME fatigue, going from sleeping 6 - 7 hours a night, to REQUIRING 16-18 hours of sleep, per night. 7/22/2022: EXTREMELY RARE SKIN RASH - Reactive Perforating Collagenosis ???SEVERE NEUROPATHY UP TO KNEES ??? NEUROPATHY OF HANDS - GLOVED PATTERN 7/2/21: FIBROMATOSIS OF LEFT PLANTAR FASCIA 11/9/21: RIGHT ULNAR NEUROPATHY AT ELBOW 10/12/21: BILATERAL PSYUDOPHIA - ATHEROSCLOEROSIS OF AORTA 2/24/22: ANEMIA IRON DEFICIENCY 3/9/22: BONE PAIN 6/30/22: HYPERSOMNIA - LATER DIAGNOSED AS NARCOLEPSY (AT AGE 60?!) - SUPRAVENTRICULAR TACHYCARDIA
2 X 2 INCH BRUISE;  RED DOTTED RASH ON UPPER ARM, BACK, AND PART OF SHOULDER
received the Comiranty vaccine while breastfeeding; received the Comiranty vaccine while breastfeeding; felt tired; achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "received the Comiranty vaccine while breastfeeding"; FATIGUE (non-serious), outcome "unknown", described as "felt tired"; PAIN (non-serious), outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200955167 same drug, different patient and different event.;
A spontaneous report has been received from pharmacist via regulatory authority. The report concerns a male patient of Unknown ethnic origin (age 3 years, height 100 cm, weight 17 kg). No medical history was reported. No concomitant products were reported. The patient received FluMist Quadrivalent (intranasal) 0.2 ml once/single administration, via nasal route, for influenza immunisation on an unknown date. On an unknown date, the patient experienced chills. On an unknown date, the patient experienced cough. On an unknown date, the patient experienced decreased appetite. On an unknown date, the patient experienced pyrexia. On an unknown date, the patient experienced viral infection. On an unknown date, the patient experienced vomiting. On an unknown date, the patient experienced fatigue. On an unknown date, the patient experienced nasal congestion. The patient recovered from the event(s) of chills, cough, decreased appetite, pyrexia, viral infection, vomiting, fatigue and nasal congestion on an unspecified date. The events were considered serious (important medical event). Sender's Comments: Chills, Cough, Decreased appetite, Pyrexia, Viral infection and Vomiting are not listed events in the company core data sheet for Flumist Quadrivalent. Young age could be risk factor for viral infection which could contribute to pyrexia, cough, decreased appetite, chills and vomiting. Due to missing information on exact site of infection, onset date of all events, administration dates of suspect vaccine, risk factors for viral infection present (such as premature birth, contact with an infected person), underlying comorbidities, relevant history, concomitant medications, diagnostic and etiologic workup it is not possible to make a conclusive assessment of the causal relationship of events and Flumist Quadrivalent.
DIAGNOSED WITH ASEPTIC MENINGITIS DUE TO SMALLPOX VACCINATION.
Fever starting at 99 and going up to 102 by 2 am. Fever of 101 continuing next day 08/24/2014.
This is a spontaneous report from a contactable physician. A 70-year-old female patient of an unspecified ethnicity received PREVNAR 13, (Expiry Date Mar2018, NDC # 0005197102, UPC # 100009468481) intramuscular at 0.5 ml, single on 23Mar2017 for immunisation, PLAVIX via an unspecified route of administration at 75 mg, from an unspecified date to an unspecified date for an unspecified indication. Medical history included chronic obstructive pulmonary disease (COPD), Heart valve disorders, solitary pulmonary nodule, blood cholesterol. Concomitant medication included alendronate sodium, levothyroxine, metoprolol, oxybutynin, pravastatin, prednisone, sertraline, budesonide, SYMBICORT, trazodone, VENTOLIN HFA, zolpidem. On 24Mar2017 the patient experienced injection site was slightly hemorrhagic, whole arm was full red, slightly indurated. On an unspecified date the patient experienced burning sensation. Course of events: Physician stated that the patient came back with a huge hemorrhagic around the whole arm on the right hand side: injection site was slightly hemorrhagic but then her whole arm was full red, slightly indurated and she was also complaining of burning sensation. The patient started to develop all the symptoms on the following day. The patient is very agitated and angry. The physician told her it could be anything. Hemorrhagic was quite a lot, it went from arm to forearm. Skin of the patient was slightly indurated because she was older. Normally their skin is loose and handy so this particular area where the hemorrhage is indurated and burnt. The outcome of the events was unknown.
Red, raised, itchy area (6.5 cm x 6 cm) developed approximately 24 hours after vaccination was administered, at varicella administration site.
This case was considered medically important.  Information regarding PREVNAR was received from a consumer, the mother of a patient who experienced autism.  The patient received the fourth dose on an unspecified date.  Additional suspect medication included previous doses of PREVNAR.  On an unspecified date, the patient experienced autism.  The outcome was unknown.  The mother stated the child had received a total of 36 vaccines (dates and trade names not reported).  No additional information was available at the time of this report.
Adrenal gland tumor; Brain fog; Depression; Anxiety; Cough; Fatigue; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADRENAL GLAND CANCER (Adrenal gland tumor), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), ANXIETY (Anxiety), COUGH (Cough), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 27-May-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADRENAL GLAND CANCER (Adrenal gland tumor) (seriousness criteria medically significant and congenital anomaly), FEELING ABNORMAL (Brain fog) (seriousness criterion congenital anomaly), DEPRESSION (Depression) (seriousness criterion congenital anomaly), ANXIETY (Anxiety) (seriousness criterion congenital anomaly), COUGH (Cough) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), HEADACHE (Headache) (seriousness criterion congenital anomaly), NAUSEA (Nausea) (seriousness criterion congenital anomaly) and PYREXIA (Fever) (seriousness criterion congenital anomaly). At the time of the report, ADRENAL GLAND CANCER (Adrenal gland tumor), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), ANXIETY (Anxiety), COUGH (Cough), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.            Treatment  information was not provided by the reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment Nausea, Fatigue, Headache and pyrexia are consistent with the Known safety profile of the product. for the rest of the events: Very limited information has been provided at this time.   More information about medical history and seriousness of the events was requested.; Sender's Comments: Nausea, Fatiga, Headache and pyrexia are consistent with the Known safety profile of the product. for the rest of the events: Very limited information has been provided at this time.   More information about medical history and seriousness of the events was requested.
Right arm general neuropathy, weakness in arm, twitching in right hand and especially at site where immunoglobulin was injected at bite site. Pain in fingers, hand arm up to elbow then back of arm. Pain comes and goes depending on whatever aggravates the nerve in that arm. Now well over a year since the injection in that right arm pain persists in same manner. Appears to be permanent nerve damage in that arm rather than temporary.