chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Sharp pain in her head; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Sharp pain in her head) and DIZZINESS (Dizziness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Sharp pain in her head) and DIZZINESS (Dizziness). At the time of the report, HEADACHE (Sharp pain in her head) and DIZZINESS (Dizziness) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Completed ADR form received.
This case was reported by a physician and described the occurrence of seizure in a adult female patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine. On an unknown date, less than a week after receiving DTPa vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to DTPa vaccine. Additional details were provided as follows: The patient experienced seizure within one week after vaccination with DTPa. This case was linked to case US2015GSK133554, as it concerned with the subsequent vaccination.
leg pain, hematuria, petechia, thrombocytopenia, ITP; anemia; viral flu-like sx; petechial rash, bruising, confusion; cough productive; BP 150/90, pulse 110, cramping in lower legs; had systolic flow murmur on cardiovascular exam,to ICU
06/08/21 My arm was hurting doctor wanted to check and see if I don?t have a black cloth he sent me to do x-rays but he said he can?t see I need to have a CT scan to see my nervousness damage because I can?t move my arm it hurts
Had a Seizure 2 wks after vaccine. No family or previous  history of seizures. Had to be taken to emergency room by ambulance.
Soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 09:15 (Lot number: EL3247) at the age of 60 years as dose 1, single and administered in arm right (Lot number: EP6955) as dose 2, single for covid-19 immunization.   The patient's relevant medical history was not reported. Concomitant medication(s) included: atorvastatin.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021 17:00, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient qualified for full (0.5 mL) third dose of Moderna, they instead initially received the half-dose (0.25 mL) booster. Once the mistake was noticed, the patient then received and additional half-dose after confirmation with Moderna
rash all over the upper body and upper leg, its very itchy; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN 6293) via an unspecified route of administration on 02Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunization. Medical history included blood pressure and cholesterol. Concomitant medications included losartan for blood pressure and atorvastatin for cholesterol. On an unspecified date in Mar2021, about a week after the second vaccination, the patient experienced a rash all over the upper body and upper leg, which was very itchy. The patient went to four doctors and a dermatologist and nobody knew what it was. The patient was treated for the event with a steroid, prednisone, for a month and a steroid cream, mometasone. The event was not getting better, not going away. The patient had blood work "last week", with pending results. The clinical outcome of "rash all over the upper body and upper leg, its very itchy" was not resolved.
Headache, Myalgia, Arthralgia, Injection site swelling, chills, fatigue Narrative:
pt recvd vax 22JUL & w/in 24hrs inj sit became red/swollen/tender 3 days later, area on arm 9"x6" (from armpit to elbow) is red & swollen;pt did not report any systemic rxn, fever, arthralgias, myalgias, itching or hives;
Debilitating fever, chills, extreme aches, headache, fatigue, nausea lasting 48 hours. Headache lasted about 5 daysand fatigue and brain fog has been ongoing for over a week. Originally took Tylenol, but it didn't touch the headache so switched to Aspirin, which helped briefly.
The morning after the vaccine, I felt light-headed all day. That evening, I fainted for over a minute. My wife called an ambulance and they ran some tests on-site but didn't go to the hospital. My wife took me to the hospital which I stayed over night.
I have a red rash and some swelling on my left arm. It occurred after the second dose. I did not have a reaction after the first dose.
Received 2nd vaccine 20 days after the first shot; A spontaneous report was received from a healthcare professional concerning a 45-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) twenty days after the first dose, which was outside of the guidelines.  The patient's medical history was not provided. No relevant concomitant medication was reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 026L20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 038K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 05 Feb 2021, after the vaccination, the reporter analyzed the Agency document and found that the patient had already received the first dose twenty days ago, which was outside of the guidelines.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, vaccination taken twenty days after the first dose, which was outside of the guidelines, was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 026L20A for first dose and lot # 038K20A for second dose) with no associated AEs reported.
funny feeling; muscle cramping, muscle spasms; paresthesia; 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), administered in arm right, administration date 28Feb2021 (Batch/Lot number: unknown) 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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "funny feeling"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "not recovered", described as "muscle cramping, muscle spasms"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "paresthesia". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient received the 1st dose last Sunday, 28Feb2021. Patient got a funny feeling, tingling in her leg and then it shoots up to her arm and she clenched her fist. It only lasted about 15-20 seconds. Patient then went to the hospital on Sunday. They ran tests and everything came back good. But, it happened again to her today. She reported that this was happening on the left side of her body. She stated that she got the vaccine in her right arm. MD put down muscle cramping, muscle spasm and paresthesia as a diagnosis. Patient also reported that she have to keep stretching out her muscles. She stated that a few friends of hers have had different side effects from the vaccine. She then asked if this was a side effect associated with the vaccine and if she should get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID-19 Vaccine  Evening of vaccination #1, felt very ill, hot, stomach bloated feeling, diarrhea a several times till 1am
received 2nd Pfizer dose on 2/3/21.  Tested positive for COVID 19 by PCR on 4/7/21 w/ symptoms of cough, anosmia, sore throat.
Antibodies were extremely low; This spontaneous case was reported by a consumer and describes the occurrence of DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ) for Psoriatic arthritis.    No medical history is provided by the reporter.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ) (unknown route) 11 mg. On an unknown date, the patient experienced DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low). At the time of the report, DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Her antibodies are extremely low.         No treatment medications provided by the reporter.   Patient had the Moderna covid (corona virus disease ) vaccines 2 doses and recently had an antibody test and her doctor thinks she should get the Pfizer covid vaccine but wants her to be off the Xeljanz before she takes it and wait two weeks before she starts  it again. she is asking how long does it take to get out of her system.   This case was linked to MOD-2021-187585.
Box of Dtap placed with Tdap. Pt given Dtap instead of Tdap, No adverse reactions.
Information has been received from a women in a physician office concerning a 7 year old. caucasian male pt with no medical history and NKDA who on 10/02/96  was vaccinated SC with the first dose of varicella virus vaccine live. On 04/25/01, the pt developed a rash describred as red flat lesions with a few blistered. Subsequently, the pt recovered from the rash on an unknown date. It was not reported if the pt sought medical attention . No further details were provided.
Tingling sensation in mouth approximately 8-10 hours after receiving dose. Became full cold sore by 24 hours after receiving dose. Never previously had cold sores. Chicken pox as child. No current covid infection.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, a few months ago, the patient was vaccinated with ZOSTAVAX, 1 injection, (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. On an unknown date, a few months ago, the patient "had come down with a bad case of shingles". An unknown topical cream and antiviral medication was given for the adverse event. The outcome of "had come down with a bad case of shingles" was unknown. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
Nausea, "crawling skin", achy muscles/joints, only lasted until 1/24 at around 8:00pm.
Patient was seen for her annual exam 2 days ago. She was given PNEUMOVAX at that visit. The following day she developed redness, warmth, and swelling of her left upper arm. She also had a low grade fever yesterday morning. She has been taking acetaminophen.
That night in the middle of the night I woke up with my right arm that my shot was given in was very sore and I could barely lift it up. The next morning 12/22/20 I woke up with a fever of 100.0 and feeling achy, and a Headache. By that same evening my fever spiked up to 102.9, migraine, body aches, and my arm still very sore. Fever not relieved by ibuprophen or Tylenol. The next am 12/23/20, my fever still 102.5 and same symptoms as day before. My fever did not go down until midnight that night and it broke and my temp was 99.1 throughout that day (12/24/20) until that late afternoon when it finally went to 98.6. Symptoms resolved and migraine gone.
feeling some discomfort; Slight itchiness; redness around the site of injection and getting bigger; Pain at site of injection/burning sensation; A spontaneous report was received from other health care professional concerning a 76- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced Pain at site of injection/slight burn sensation(injection site pain), redness (Injection site erythema) and slight itchiness (Injection site pruritus) and feeling some discomfort (Injection site discomfort).  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 4-jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  He had pain at the site of injection for 2 days from the day he received it. On 9-jan-2021 he started noticing redness around the site of injection and it seems to be getting bigger. Over the weekend around 16 or 17 of January 2021 he started feeling some discomfort which includes slight burning sensation and itchiness. He had used Benadryl ointment for the affected area since last week, but he still had the symptoms.  No laboratory data was provided.  No treatment drugs were provided.  Action taken with mRNA-1273 in response to the events Pain at site of injection/slight burn sensation (injection site pain), redness (Injection site erythema) and slight itchiness (Injection site pruritus) and feeling some discomfort (Injection site discomfort) was unknown.   On an unknown date, the outcome of the event Pain at site of injection/slight burn sensation(injection site pain) was recovered/resolved and the outcome of the events redness (Injection site erythema) and slight itchiness (Injection site pruritus) and feeling some discomfort (Injection site discomfort) was not recovered/not resolved.
inadvertently given Kinrix instead of Infanrix; 18 MO received Kinrix; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date unknown) for prophylaxis.   On 24th February 2023, the patient received Kinrix. On 24th February 2023, unknown after receiving Kinrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 24-FEB-2023 Reporter's comment: The patient was inadvertently given Kinrix instead of Infanrix. The reporter needs to know what needs to be done to make sure there was no harm and also that he was covered. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received Kinrix instead of Infanrix, which led to wrong vaccine administered. 13 months old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration.
Fever, headache, vomiting, body aches, coughing.  12/30/08 MR received for DOS 11/14-17/2008 with D/C DX:  Fever, Vomiting with dehydration, Bronchitis, Bilateral OM, anemia. Pt presented with 4 day hx of fever, vomiting. Had been seen for cough 4 days prior and given Flumist.  PE (+) for TM infection, dry mouth and throat, rhonchi, tachycardia. Tx IV abx and nebs.
Fever, Chills, Weakness.  Taking Tylenol for fever reduction.  Lots of fluids.
Her arm was sore and really hurt; This is a spontaneous report from a Pfizer-sponsored program via a contactable female consumer (patient reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 05Feb2021, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced her arm was sore and really hurt on 05Feb2021.It was reported that she received Pfizer COVID-19 vaccine first dose 'today' on (05Feb2021) and her arm was sore, and it hurts really bad. She wanted to know if she can safely take any pain relievers. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.  Follow-up attempts have been completed and no further information is expected.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a consumer concerned a male 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: 1821286, and expiry: 21-OCT-2021) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 11-JAN-2022, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121658.
On Oct 11, 2021 I had extreme 24 hour symptoms of chills, drowsiness, confusion, and muscle pains and aches. I had major chest pain accompanied with the muscle aches. No treatment was necessary. The pain lasted throughout the weekend.
Muscle aches & brain fog starting 3-4 days after vaccine. Right arm pain/tenderness starting then also.  Heart palpitations starting 4 days after, also slightly elevated blood pressure. 5 days after injection severe blood pressure spike 177/86.  Calls to primary care doctor . Emailed cardiologist who suggested this was reaction to Shingrix.  Neither recommended ER visit (!?!)  Only alternative - self treat with V8 low sodium (high potassium) juice, & lots of beet juice, magnesium supplement, shower.  BP fell to 160/80  Took  .125mg Klonopin that night in order to sleep. Follwing day, BP tracked from 160/80 to 148/80.  By next day BP almost normal. Saw primary care doctor that day (already had routine physical scheduled).  Blood tests at his office.
Pfizer Bivalent booster dose was inadvertently administered instead of the second monoclonal Pfizer 2nd dose due for the resident.
Moderate to severe itching at all prior scar sites, some decades old.  Severe itching/discomfort surrounding Nexplanon implant.  Previously broken/fractured bones, and site of 20 year old rotator cuff tear, all throb with dull pain as if they are new injuries.  General feeling of malaise, lack of appetite, and mental fogginess.  All symptoms continue to persist still 48 hours after vaccination.  Also experienced fever of approx. 102 degrees for roughly 24 hours.
5 x 7 cm erythema showed inj. site (L) post. Patient placed on Cephalexin and F/U with PCP recommended.
Sore throat; Fever; This case was reported by a consumer via other manufacturer and described the occurrence of sore throat in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra at an unknown dose. On an unknown date, unknown after receiving Fluarix Tetra, the patient experienced sore throat and fever. On an unknown date, the outcome of the sore throat and fever were unknown.   It was unknown if the reporter considered the sore throat and fever to be related to Fluarix Tetra.  Additional details were provided as follows:  The age at vaccination was not reported. No further details were provided.
Ever since having the injection I have been having 2-3 Migraines a month. I have never had Headaches such as these.  Extremely sensitive to light, sound, and movement
approx 5 seconds p/vax pt was unable to see & immed had an asthmatic/allergic react; pt was treated in office w/Epi, Ventolin, 02; pt recovered w/in 20 mins;
temp up to 102 R x 2 days; up @ noc, very fussy;
Given 11 yr old immunizations on 3/18 noted swelling & redness on right arm 3/19.  Also c/o fainting feeling with h/a 3/19 for several hrs that subsided.  Return to office on 3/20 & 3/21.  2 cm erythemic patches on both arms, 4 inch oval area on right arm with swelling & erythema BENADRYL q6 x recheck 3/21 - Better, less swelling & redness noted ? allergy to band aid
Tingling sensation in my lips and the tip of my tongue about 20 minutes after I got the vaccine.  I was given a dose of 25 mg of benedryl and asked to remain in the observation area for an hour.  The tingling stopped within the hour and I went home.  I was fine the rest of the day but experienced fatigue and a sore throat on Days 2 and 3 after vaccination.  I was told to get a COVID test and it came back negative.  I am fine now.  I will get my second dose on Feb 13th.
Per mother since vaccination, pt started to lose weight & was diagnosed with Type I DM 4/12/12, concerned because pt was given CERVARIX in error.
Received pneumonia shot Wednesday 10/9. One hour after shot, arm started hurting. By bedtime left arm started swelling from shoulder to elbow, red. Client went to ER.
Patient presented to the emergency department on 10/23/2021 with cough and confusion. He was found to be COVID-19 positive and was treated with monoclonal antibodies during this visit. Patient was discharged. Patient presented to emergency room again on 10/28/2021 with chest pain and shortness of breath. Patient was admitted and treated for symptomatic COVID-19 infection. He was treated with dexamethasone, remdesivir, and supplemental oxygen. He was discharged home on 11/1/2021.
Pt exp rash, hives & constant itching 9 days p/recvd TD inject; rxn still persists as of 26MAR92;