chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad bruising at the injection site; pain at the injection site; episodes of grand mal seizure; Initial information received on 29-Jul-2019 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional (Patients mother).  This case involves a 11 years old female patient who experienced episodes of grand mal seizure, bad bruising at the injection site and pain at the injection site, while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 16-Apr-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration not reported).  On 26-Apr-2019, the patient experienced a serious grand mal seizure (generalised tonic-clonic seizure) 10 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.. It was reported that patient had two more episodes of the same event. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious bad bruising at the injection site (vaccination site bruising) and pain at the injection site (vaccination site pain) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was not confirmed that the vaccine was administered into the vein instead of deltoid muscle (the doctor thought that it might be).  No Lab data was reported.  Final diagnosis was episodes of grand mal seizure, pain at the injection site and bad bruising at the injection site.   An unknown corrective treatment was received (now on medication).  The event outcome was reported as Unknown for all the events.  Information on batch number was requested.  Documents held by the sender: none.; Sender's Comments: This case involves a 11 years old female patient who developed grand mal seizure 10 days after vaccination with MENACTRA and also presented with vaccination site bruising and vaccination site pain. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Administered 1st dose as error due to EUA for Moderna vaccine approved only for >18 years old.
Developed severe discomfort left arm within 3 hours following immunization. Range of motion left shoulder limited by pain, which increased in severity over subsequent days, Currently as of 8/7/06, range of motion is slowly improving although has not returned to full extent prior to vaccination.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 13-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
On Mon PM 11/11/02 child began with rash on left hand, then rash continued up arm to chest, then the rest of body-red bumps that itch. Mother has not noted any fever.
pt recvd vax; Lt upper arm w/ edema & swelling from axilla to 1cm above elbow;
redness; warm to touch; Flu like symptoms; low appetite; not feeling right; being a bit slow at work; bumpy spots on the arm; swelling at injection site; pain in the arm; aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE MASS (bumpy spots on the arm), ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch) and DECREASED APPETITE (low appetite) in a 53-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.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE MASS (bumpy spots on the arm). On 20-Apr-2021, the patient experienced DECREASED APPETITE (low appetite), FEELING ABNORMAL (not feeling right) and IMPAIRED WORK ABILITY (being a bit slow at work). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain in the arm) and MYALGIA (aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE PAIN (pain in the arm) and MYALGIA (aches) had resolved and VACCINATION SITE MASS (bumpy spots on the arm), ERYTHEMA (redness), VACCINATION SITE WARMTH (warm to touch), DECREASED APPETITE (low appetite), FEELING ABNORMAL (not feeling right) and IMPAIRED WORK ABILITY (being a bit slow at work) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
01/29/22 presents to ED for "Abdominal pain". PMHx of "Crohns disease s/p ileocolonic resection"
Round raised blotchy 2 inch spot on arm that is sore and itchy. Began two days after shot, and is still continuing.
Right sided jaw pain started 12/22/20 in the AM progressed through the evening. When I woke I had numbness and weakness on the right side of my tongue which I quickly realized included the lower portion of my right face.  An ER trip and a CT scan confirmed it was Bells Palsy. The upper portion of my face has is now included in the weakness and paralysis.
Received varicella vaccine on 11/3/15, presented with rash on 11/23/15. VZV DFA positive for VZV. Treated with valacyclovir, resolved. Prior to this, he was removed from all immunosuppression for a full years time, and CD4 count was >1000 prior to vaccination with live vaccine.
Headache, Rash swelling in neck, pain to touch of collar bone, swollen bumps on collarboan, swelling underneath armpit/sensitive Narrative:
2mo shot-no problem for 1wk then-shaking wide eye stare (scared look) for 20 sec.repeat next day;had 5mo shot w/same sx 2 times;
CONGESTION; RUNNY NOSE; COUGH; BODY ACHES; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight was 130 pounds, and height was 64 inches. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: Patient had No known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. Concomitant medications included carbamazepine for bipolar, and quetiapine fumarate for bipolar.  On an unspecified date, the patient experienced congestion, runny nose, cough, body aches, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, congestion, runny nose, cough, fatigue and body aches was not reported. This report was non-serious.
Pt. was observed having a syncope episode. Pt. slumped into husband. Pt. was assisted to lay on yoga mat once they felt that it was safe to do so. Pt. reported she had passed out in the past due to an injection, but she tolerated her last flu vaccine. Pt. stated she did not report to the vaccinating nurse that she had a history of passing out due to an injection. Pt. rested and vital signs within normal limits. Pt. felt better after some time and left home. Pt. agreed to follow up with her doctor and emergency room precautions reviewed.
SHE GOT HER 2ND SHOT ON THURSDAY AND NOTICED FRIDAY THAT SHE WAS GETTING SHINGLES. SHE CONTACTED THE PHARMACY TO REPORT ON MONDAY EVENING AND I ENCOURAGED HER TO CALL HER DR.
t103 x 2 days not relieved w/APAP; very irritable; projectile vomiting x 3-4 days; seen by MD tx APAP & fluids; MD felt pt should recvd ped DT;
Patient received Zoster vaccine on 8/2/12 in left arm subq. Came back in on 8/6/12 with blister size of quarter or better and red around. Called patient MD and set a visit for today for MD to check. Sore, redness, itching, blistered.
When I eat things they don't taste as they should its a metallic kind of taste. All soaps have a heavy metallic smell.
Immediately felt dizzy, elevated heart rate, extreme fatigue lasting about 10 minutes post shot instantaneously. Following day symptoms included headache, muscle aches, joint aches, loss of appetite and nausea, fatigue, inflamed hips, sore muscles.
Late in the evening on July 7 patient began having multiple seizures.  EMTs were called and patient was transferred to local hospital while seizing.  Patient stabilized in ER with injections.  But since patient was unconscious (postIcatal)  he was transferred to ICU until stabilized on oral medication. Patient in hospital for 36 hours.
It  has now been 8 days since my first dose of Pzifer vaccine (February 1, 2021) and I have been experiencing painful, aching quads in both legs and groin area.  Have taken Advil to relieve pain and still feel intense  throbing legs and especially the R groin area.  On a scale of 1-10 it is a 7-8.  Ten years ago I was diagonosed with Osetomyletics and the blood infection landed on my pelvic area and I was unable to walk .  Spent a week in the hospital and infectious disease doctors put a port in my chest an for 1 month was on heavy duty antibotics to rid the infection.  I am experiencing the pain in the same area of the groin, but now the quad muscles  are equally painfully.  I am concerned as it has now been 8 days and there is NO relief to my pain and I am assuming it is a side effect of the vaccine?  Please adivse.
I had itching at the injection site and a feeling of nausea for the first 3 days.  Yesterday I noticed that my left arm at the injection site had a "goose egg" that was raised and inflamed.  I had a very itchy rash which has lasted into today in spite of me putting triamcinolone on it this morning.  I also felt sleepy and off today.
Nurse notified NP she believes pt received air instead of vaccine. Discussed incident with caregiver and patient. Reviewed risks and benefit. recommended re-vaccinating after current incident. Pt and caregiver accepts being vaccinated. NP vaccinated pt in right arm (opposite of original injection) PT observed and left without incident. Reviewed/debriefed nursing's re: the incident with the patient.
Pt. became dizzy after receiving influenza vaccine. V.S. normal. Encouraged pt. to increase fluids. Heard no other c/o until 10/11/10 when pt. reported being dizzy for 3 days following the vaccine. No other s/s. Complete recovery.
recurring chills, coming and going about 1 or 2 per minute fatigue muscular discomfort throughout body, especially in upper arms, both sides
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 3:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.29.  Concomitant medication information was not provided by the reporter.  Excursion time was 9 AM, the temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  Vial was stored on cooler 1, on 28-Apr-2021, Excursion duration at 9 AM:33, 10 AM: 36, 11 AM: 40, 12 AM: 41, 1PM: 41, 2 PM : 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 26-SEP-2016, the patient was vaccinated with a dose of improperly stored PROQUAD lot # M010478 with expiration date 01-SEP-2017, therapy type HSA. It was reported that the vaccine was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
I had covid arm with swelling and rash it lasted about 4 weeks. I used hydrocortisone for rash swelling lasted approximately 4 weeks
Prior vaccination with Moderna Covid  on 2/9/21 and 3/9/21. Had onset of vertigo after her initial vaccinations which resolved over 1 month. No prior issue with balance or vertigo. The day after she had her Covid booster with Pfizer, she again had onset of vertigo.
Case number PHEH2012US010705 is an initial spontaneous report received from a consumer on 22 May 2012 with a follow-up received on 02 Jul 2012. This report refers to a 12-year-old male child. It was reported that on 10 Apr 2012, he was vaccinated with MenA lyophilized conjugate vaccine component of MENVEO (batch number: A10133) reconstituted with a sterile diluent intramuscularly on to unspecified site and did not receive the MenCYW-135 liquid conjugate. On 12 Apr 2012, he was revaccinated with a full dose of MENVEO. No adverse reaction was reported following the maladministration. Follow-up received from the consumer on 02 Jul 2012: Updated patient details.
3:30 am that night I got shaking fever/chills. I expected that but about 5 days after the shot the inside of my mouth was in a lot of pain. A fever blister formed on my lower lip (left) and the inside of my mouth felt raw.  It has been going on 2 days now- it?s hard to eat and hurts to talk. My gums are sore and I can feel raw spots on the roof of my mouth-like blisters.
I tested positive for COVID-19 on 12/10/22. I had a fever, scratchy throat, congestion, body aches and fatigue. I contacted my doctor, and I was prescribed 5 days' worth of Paxlovid. I am feeling better, but I still have some congestion.
Evening of 10/1 patient developed arm pain fever muscle aches.  Morning of 10/2 he woke with bilateral arm weakness and numbness. He continued to have fever and muscle pain. Fever continued until 10/5. On exam he had swelling at injection site but no redness, decreased sensation bilateral arms to elbows to fingertips. Strength in left arm decreased 4/5. Right arm strength 5/5. Full ROM. Recheck 1-2 weeks and Referral to Neurology.  Patient has no history of Neuropathy or carpal tunnel.  Symptome from vaccine could be neuropathy or maybe mild Guillain Barre. Patient also had COVID-19 in Nov. 2021 and completely recovered.
I started with itching my feet, my head, my back and there was some itching so; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613, Expiration date: Unknown) via an unspecified route of administration on 17Mar2021 as Dose 1, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Mar2021 (Friday), the patient experienced with itching in patient's feet, head, back and there was some itching/still get the itching but not as bad. Definitely not bad. It's improved. The patient received Benadryl as treatment medication for resulted event. The patient saw it was a minor side effect or a not serious side effect and wanted to make sure if that was okay to take Benadryl. The reporter queried if the patient just go ahead and get second shot, does that being with minor itching and how long the patient could expect the symptoms." Limited information was provided by the reporter. The outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information was expected.
Period started 13 days early. Severe cramping- do not usually have cramping with periods.
One week after receiving the injection I started having itching at the injection site. Within two days I had a large red swollen area surrounding the injection sight. This lasted for one week and then gradually resolved.
Pt received proquad, Kinrix and Hep A all in the (L) arm yesterday - today (L) deltoid and surrounding area is red - hot - swollen (+) cellulitis. Start on cephalexin today, will rev 2 days.
Symptoms started 2 days after injection. Reaction was initially itching at area of injection. After child itched area, arm had a localized reaction involving extreme swelling of injected arm, extending down to the elbow and up around site of administration. Wrapped around front of arm but did not wrap all the way around arm.  Reaction lasted approximately 2 to 2.5 days and then resolved. Patient is now doing well at time of reporting to pharmacist.
sore arms; Red swollen patch on the vaccination site; vacination  site pain; Bleeding upon injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms), VACCINATION SITE HAEMORRHAGE (Bleeding upon injection), VACCINATION SITE SWELLING (Red swollen patch on the vaccination site) and VACCINATION SITE PAIN (vacination  site pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding upon injection) and VACCINATION SITE PAIN (vacination  site pain). On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arms) and VACCINATION SITE SWELLING (Red swollen patch on the vaccination site). At the time of the report, PAIN IN EXTREMITY (sore arms), VACCINATION SITE HAEMORRHAGE (Bleeding upon injection), VACCINATION SITE SWELLING (Red swollen patch on the vaccination site) and VACCINATION SITE PAIN (vacination  site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever after 24 hrs, aches and pains after 6 hours, headache, naseua after 12 hrs
Information has been received from a physician concerning a female who on approximately 13-SEP-2007 was vaccinated with Gardasil.  On approximately 13-SEP-2007 the patient fainted and hit head after receiving the vaccination.  Subsequently, per the nurse, the patient is fine and recovered from fainting and hitting her head.  The patient sought unspecified medical attention.  Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left 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 had no relevant medical history. The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2014, stop date: 28Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 29Dec2022 to 02Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from an office manager concerning a 14 year old female who on 05-JUN-2008 was vaccinated with GARDASIL (dose and lot# not reported). On 05-JUN-2008, moments after vaccination, the patient felt nauseous lightheaded and fainted. No injuries were reported. Patient was monitored and taken by wheel chair to the car. The patient sought medical attention in the doctor's office. The patient outcome was not reported. Additional information has been requested.