chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot in left arm on Nov. 13th 2006; reactioncame as surprise I expected only a sore arm. Came home---- about 2 hours after shot felt like I had the flu -----muscles in whole body hurting----temperature went up about 1.5 degrees.  Called Doctor at pharmacy ---said to take tylenol and that I would feel better in about 2 days.   Severe muscle pain and fatigue-weakness like flu; congestion; cough; headache; had to go to bed  couldn't stay up.     Had no choice but to go to bed--------pushed all of the liquids I could to stay hydrated and cleanse my sytem.  Muscle pain was better on Wed. morning but not the congestion and coughing and the fatigue.   Literature says it takes 2 weeks for full immunity so don't know whether this reaction will last longer and to what extent.  Note the time of the vaccine I entered is approximate.  Was late afternoon about 5:00 p.m.
Patient received 0.5ml of the Covid Vaccine instead of the recommended 0.25ml for their age.
Headache, Myalgia, Arthralgia, Fever, pain injection site Narrative:
very sleepy; Tired all the time; Raised, red welt at site of the shot about the size of an egg; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), VACCINATION SITE URTICARIA (Raised, red welt at site of the shot about the size of an egg) and FATIGUE (Tired all the time) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Raised, red welt at site of the shot about the size of an egg). On an unknown date, the patient experienced SOMNOLENCE (very sleepy) and FATIGUE (Tired all the time). At the time of the report, SOMNOLENCE (very sleepy), VACCINATION SITE URTICARIA (Raised, red welt at site of the shot about the size of an egg) and FATIGUE (Tired all the time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood test: unknown (Inconclusive) blood labs drawn today 05MAY2021 for testing..         Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.    This case was linked to MOD-2021-044371 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: follow-up information include:Event updated(Fatigue)Lab data was added On 20-Jun-2021: event added
I have a large red spot/inflammation on my upper arm, next to the site of my vaccination.  It is about the size of the bottom of a soda can.  It is red, swollen, firm to the touch (like a lump under the skin), painful and started feeling itchy today.  I first noticed it 27 hours after the vaccination was injected.  I did not have this reaction after vaccination #1 in the series.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age. On 23-AUG-2013 the patient was vaccinated with M-M-R II (rHA, lot # 670080/0402AA, expiration date on 01-MAR-2013) (subcutaneous, 0.5 ml, strength not reported). No adverse effects were reported. It was unspecified whether the patient sought for medial attention. The outcome was unknown. Additional information has been requested.
covid arm; Itchy swelling at injection site; very hot; enormous rash 3 inches; burning; bright red; terrible itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (very hot), VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (terrible itch at injection site), VACCINATION SITE RASH (enormous rash 3 inches) and INJECTION SITE PAIN (burning) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (terrible itch at injection site). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (very hot), VACCINATION SITE RASH (enormous rash 3 inches), INJECTION SITE PAIN (burning) and VACCINATION SITE ERYTHEMA (bright red). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm) and VACCINATION SITE SWELLING (Itchy swelling at injection site). At the time of the report, VACCINATION SITE WARMTH (very hot), VACCINATION SITE REACTION (covid arm), VACCINATION SITE PRURITUS (terrible itch at injection site), VACCINATION SITE RASH (enormous rash 3 inches), INJECTION SITE PAIN (burning) and VACCINATION SITE ERYTHEMA (bright red) had resolved and VACCINATION SITE SWELLING (Itchy swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-261489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received included event outcome COVID arm was updated from unknown to recovered. On 20-Jul-2021: Follow up received included patient demographics, additional event(Itchy swelling at injection site) were updated.
pt felt slight tightening of chest and throat- injected epinephrine- pt felt better after about 15 minutes and was released to her mother.  After phone discussion on 6/13/21, mother said symptoms returned later in the day and she went to ER and received a steroid injection.  Per mother on 6/13/21. pt was feeling fine
This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was hospitalized after receiving a flu vaccine due to the egg protein in the vaccine. The pharmacist did not know when this occurred, or what flu vaccine it was, just that it was some time in the past. The patient did not tell the pharmacist what reaction she had that caused her to be hospitalized.
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING and NASOPHARYNGITIS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING, NASOPHARYNGITIS and FATIGUE. At the time of the report, OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING, NASOPHARYNGITIS and FATIGUE outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Before getting the vaccine tested twice for COVID-19- negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
The patient had syncopal episode, hit her head.  She was unconscious  for about 1 minute.  She suffered basilar skull fracture and intracranial bleed
Pfizer 1/29/21, 2/19/21, 8/26/21, 5/25/22. Positive on 7/19/22
Got a rash one week after first vaccine on chest, stomach, arms, buttocks and thigh area.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in the right arm on 13Mar2021 at 08:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included kidney transplant and high blood pressure. Concomitant medications included tacrolimus (PROGRAF), sulfamethoxazole; trimethoprim (BACTRIM), nifedipine (PROCARDIA) and metoprolol (MANUFACTURER UNKNOWN), all from unknown dates for unspecified indications. The patient was allergic to milk. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 19:00, one week after the first vaccine, the patient got a rash on chest, stomach, arms, buttocks and thigh area. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash and included treatment with Zyrtec 10 mg, 1 daily. The clinical outcome of the event rash was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
about 21 days after the first dose, she developed a rash that was itchy with hives over her chest.  it was getting better. then she got her second vaccine, rash improved. then about 4 weeks after, her rash spread from chest to all extremetis and was all over.
Significant pain in knees, with some pain in hips and shoulder joints. Pain continues at this time.
Arm pain at injection site, dizziness, weakness, nausea, fever, rapid pulse, tightness of chest and tightness of breathing. Treatment went home to rest, TYLENOL, took inhaler (VENTOLIN). Symptoms lasted over 3 days, and continued to not feel well for a couple of weeks. (Had adverse reaction with prior flu vax, but thought it was coincidental and not sure if caused by the injection. This time proved it was for sure the vaccination. )
Patient asked for a COVID vaccine. Pharmacy technician ran a Influenza vaccine. Pharmacist administered the influenza vaccine after confirming name, date of birth and vaccine to patient.  After it was given he asked the pharmacist to fill out the COVID vaccine card and the pharmacist stated that an influenza vaccine was given. He stated he had already gotten the influenza vaccine at his doctor's office a few weeks ago. We gave him the correct vaccine, notified his physician and completed this form. Patient is not likely to have any adverse effects but was counselled on what to look for and pharmacy will follow up with patient in 1 day.
Initial report received from a healthcare professional on 05-Nov-2013. A 11 year old male received FLUZONE QIV (batch number U4790AA, expiry date and route were unknown) on 01 November 2013. The patient's medical history and concomitant medications were not reported. On 01 November 2013, after the vaccination the patient experienced shaking, chills and a temperature of 103.0F which was highest to 103.5. At the time of this report the outcome of the events were not resolved. Documents held by sender: none.
Initial humming in ears about 6 hours after dose and odd joint pain.  Day 2 dull throbbing pain in my left foot regardless of weight-bearing.  The pain symptoms subsided after about 72 hours,  but the ear symptoms quickly evolved into persistent and loader ringing (tinnitus) in both ears that persists to this day.
I got so sick from this one, I though I was dying /horrible 2nd dose; Terrible aches 2nd dose/pains from head to toe 2nd dose; It doesn't make sense a vaccine can make you that sick; chills 2nd dose; Fever 2nd dose/ Burning up of fever 2nd dose; Body ache 2nd dose / pains form head to toe 2nd dose; got so sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got so sick), FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick) and CHILLS (chills 2nd dose) in a 51-year-old female 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 COVID-19 from February 2020 to 2020 and COVID-19 from April 2020 to 2020.    On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced ILLNESS (got so sick). On 19-Nov-2021, the patient experienced FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick), CHILLS (chills 2nd dose), PYREXIA (Fever 2nd dose/ Burning up of fever 2nd dose) and MYALGIA (Body ache 2nd dose / pains form head to toe 2nd dose). On 22-Nov-2021, FEAR OF DEATH (I got so sick from this one, I though I was dying /horrible 2nd dose), PAIN (Terrible aches 2nd dose/pains from head to toe 2nd dose), ILLNESS (It doesn't make sense a vaccine can make you that sick), CHILLS (chills 2nd dose), PYREXIA (Fever 2nd dose/ Burning up of fever 2nd dose) and MYALGIA (Body ache 2nd dose / pains form head to toe 2nd dose) had resolved. At the time of the report, ILLNESS (got so sick) outcome was unknown.            Symptoms included: fever, pains, chills, body ache, terrible aches, pains form head to toe and said it was worst than worst flu or a virus; was in bed for 3 days. Symptoms started at 1:00 am the day after getting the vaccine (19Nov2021) and subsided on 22Nov2021.  Also got sick but it seems it was more severe this time.   This case was linked to MOD-2021-402874 (Patient Link).
Tightening in chest & throat, palpitations, eventual wheezing began approximately 5 minutes after shot administered. Had taken prophylactic 25mg Benadryl 30 minutes before shot. Ambulance EMT administered 5-mg Benadryl intramuscular in right arm about 10 minutes later. Proceeded to ER, symptoms never worsened while under observation for 1 hour. Released after that
severe pain in both of his upper arms; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: er0734), via an unspecified route of administration, administered in arm left on 11Apr2021 11:30 AM (at the age of 68-years-old) as a single dose for covid-19 immunisation. The vaccine administered at the Pharmacy/drug store. The patient had known allergies with penicillin. Concomitant medications included benazepril; celecoxib; duloxetine; and hydrochlorothiazid; all were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ep7534), administered in left arm on 22Mar2021 12:00 AM (at the age of 68-years-old) for covid-19 immunization. On 13Apr2021 20:00 (08:00 PM) about 32 hours after his second shot, he started getting severe pain in both of his upper arms. It started in the middle of both of his humeri and radiated up to his shoulders. It was severe pain that lasted for about 30 minutes and then started to reduce in severity. Within a couple of hours the pain was mostly gone in his right arm and some pain remained in the left arm which was where he got the shot. The event resulted in disability or permanent damage. The patient did not received any treatment for the event. The outcome of the event was recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event of pain in extremity, a possible contribution of the drug to the event 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Mild Injection site pain, Moderate fatigue, light nausea, and moderate hot and cold flashes; onset about 5 hours after injection. The injection site pain and fatigue will hopefully be cured by getting a good sleep tonight; nausea was offset by Tums. The temperature flashes are still occurring 9 hours after injection and do not seem to be getting worse any more; hands and feet cannot warm up and neck and forehead are hot (no thermostat to look at temperature).
CHILD FAINTED AND HIT HER TOOTH AND MOUTH AND GOT A LACERATION ON LOWER LIP.
This spontaneous report as received from a nurse refers to an 11 months 3 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Two weeks after being vaccinated thumb got cold and called the family physician and I couldn't feel my thumb and I was told that I had to go the ER 10-20-21 and I was told at the ER all tests was normal after that visit 2 weeks later my thumb started to blister and was still told that nothing was wrong. ER visit.
At 8:35pm on 3/30, sudden onset severe vertigo while lying down - lasting only a minute - followed by severe nausea and cold sweat. Couldn't open eyes or move head for fear of repeating episode. A few hours later, a repeat episode lasted a few minutes and triggered vomiting.  Around 7am the next morning, a third episode violent enough to trigger vomiting again. The severe nausea and headache lasted around 12 hours, but the mild nausea and severe headache lasted 48 hours. At 5 days after vaccination, still feel lightly dizzy with a sense of confusion or fogginess.
A few hours after vaccine developed a itchy rash, itchy between my fingers and swelling of fingers. Since vaccine to present continues with rash, hives, swelling of eyes and lips, fingers remain itchy. Had 2 episode's of wheezing/ cough, needing to use Albuterol inhaler, which I have not used   for 4-5 years. Updated Dr (covering for APRN) Was told it was a delayed reaction. Updated.
BRUISE AT SITE OF INJECTION; WHOLE ARM ACHES/SHARP PAIN IN ARM/ARM ACHES ALL THE TIME; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced bruise at site of injection. On 03-APR-2021, the subject experienced whole arm aches/sharp pain in arm/arm aches all the time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from whole arm aches/sharp pain in arm/arm aches all the time, and bruise at site of injection. This report was non-serious.
No additional AE/none of these patients had any type of adverse reaction.; Vaccines had temperature excursion on 12/14/2021/who was given VARIVAX in the right arm on 22-DEC-2021.; This spontaneous report was received from a certified medical assistant and refers to a 5-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-DEC-2021, the vaccine experienced temperature excursion of 21 degrees Fahrenheit for 3 hours and 32 minutes. There was no previous excursion reported.  On 22-DEC-2021, the patient was administered a dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # U019908, expiration date: 24-JUN-2023, in the right arm for prophylaxis (strength, dose, formulation and route of administration were not provided) (Improper storage of product in use).  No additional adverse event was reported - it was reported that none of the patients had any type of adverse reaction (No adverse reaction). No further information is available.  This is one of several reports received from the same reporter.  Lot Number U019908 is valid for varicella virus vaccine live (oka/merck) (VARIVAX).; Sender's Comments:  US-009507513-2202USA000907: US-009507513-2112USA007215:
Upper arm muscle 7"x 3" area itching, reddish, warm like sunburn. Itching gone and color of area began fading after 2 days (took Claritin tablets 3 times and used Benadryl Cream). Redness almost gone after 8 days.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No relevant concomitant medications were reported.  No treatment information was provided.