chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy, redness, and "bumpy skin like a mosquito bite" at the site of injection; redness, and "bumpy skin like a mosquito bite" at the site of injection/redness is "an inch and a half around the two shots"; "bumpy skin like a mosquito bite" at the site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingle with an associated reaction of no adverse event. Concurrent medical conditions included autoimmune disorder and sensitive skin.   On 25th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of Influenza vaccine Quadrivalent 2020-2021 season. On 29th September 2020, 4 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site itching, injection site erythema and injection site rash. The patient was treated with hydrocortisone (Topical Hydrocortisone). On an unknown date, the outcome of the injection site itching, injection site erythema and injection site rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema and injection site rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced itchy, redness, and bumpy skin like a mosquito bite at the site of injection. The patient noticed the reaction on tuesday night and used a hydrocortisone topical which helped calm the itchiness (which was on and off).  Both vaccines were given on the right arm two to three inches apart.  The redness was an inch and a half around the two shots. The patient reports no fever, swelling, or diarrhea.  The reporter did not consent to follow-up.
Initial case received from a consumer, who is also the patient's uncle, on 13 August 2010. A male patient received an injection of MENACTRA (lot not reported) prior to entering college. A few days post-vaccination, he complained of severe headaches, and subsequently experienced a seizure. He was admitted to the hospital, where he experienced another seizure and also developed a rash. He was transferred to another hospital, and was diagnosed with viral meningitis. No additional information was reported.
Patient reported signs of an allergic reaction during the observation period after receiving the first dose of the Pfizer-BioNTech Covid-19 Vaccine.  Patient reported uneasiness, tongue swelling, and difficulty breathing.  Patient received an Epi-pen and symptoms mildly improved.  Patient remained stable until emergency services arrived.
light headed after injection; brain felt like it was vibrating; buzzing sensation in head.it was not painful but quite annoying.; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 06Feb2021 at 09:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoporosis and fibromyalgia. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the right arm on 06Feb2021 at 08:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the patient experienced light headed after injection. About 1 to 1-1/2 hours later brain felt like it was vibrating/ buzzing sensation in head which was not painful but quite annoying. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event brain felt like it was vibrating/ buzzing sensation in head was recovered on  07Feb2021; while that of light headed after injection was recovered on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
diff breathing, turning blue approx mins, but recurred x 2; hosp for observation, no further episodes;
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Follow-up information has been received from certified medical assistant who stated she did not have any further information available at that time. Additional information has been requested.
The day after I received the Moderna booster I started to have fatigue, feverishness, a hot flushed feeling and  more palpitations than usual. I also had increased fatigue and breathlessness with exertion. These symptoms lasted on and off for 6 weeks after my booster. Only now am I beginning to feel much better. My allergist/immunologist informed me I had a persistent inflammatory reaction to the booster.
The wrong dose for Moderna COVID Bivalent vaccine was given on 10/14/2022 at 0.25mL (As146B). Another 0.25mL dose was given on 10/28/2022  (061F22A).
Sudden onset of significant hair loss; Rapid significant onset of hair thinning; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 23Sep2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drugs and she also had been experiencing normal thinning with age and was genetically predisposed to gradual hair thinning with age. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021 the patient experienced sudden onset of significant hair loss within a few days of receiving the vaccine. Handful of hair were coming out. The patient had obvious bald patches on her scalp. There was no way that was coincidental. There were no other changes. she also had been experiencing normal thinning with age and was genetically predisposed to gradual hair thinning with age, but this was different. A rapid significant onset that lasted about a week or so. The events did not result in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 08Oct2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the events sudden onset of significant hair loss and rapid significant onset of hair thinning within a few days of receiving the vaccine was resolved with lasting effects on an unknown date in Oct2021.
inject site red, febrile, swollen & tender to touch lt deltoid; tx DPH, Decadron
Mom stated child's arm where varicella vaccine was given is swollen and warm to touch. States was worse yesterday (12/12/06) and better today (12/13/06).
RA flare"bonus" period; Inappropriate schedule of vaccine administered; product=COVID 19, lot =EN6202; other_vaccine_same_date_lot =ER8730, other_vaccine_same_date_dose =2; other_vaccine_same_date_lot =FC182, other_vaccine_same_date_dose =1; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FC182 and expiry date not reported), via an unspecified route of administration, on 12Sep2021, as dose 1, single, and then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number ER8730 and expiry date not reported) via an unspecified route of administration, on 12Sep2021, as dose 2, single and then third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6202 expiry date not reported) via an unspecified route of administration, administered in Arm Left, on 12Sep2021 11:00, as dose 3, single, all for covid-19 immunisation at the age of 51-year-old from Pharmacy or Drug Store. Medical history included ongoing rheumatoid arthritis (RA), penicillin allergy and sulfa allergy. Patient was not pregnant at the time of vaccination. Patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 was scheduled with inappropriate schedule of vaccine on 12Sep2021 11:00 and had overdose. The patient experienced RA flare "bonus" period on 14Sep2021. Patient received no treatment due to the event. The patient was not recovered from the event.
Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs  and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain.   At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks.   Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.
Mother called said baby woke up and vomited and had shortness of breath. I advised mother to call her physican and take baby to emergency room. She said baby had a mild fever and cough before vaccines. She did not know what baby's temp was now. She could not find thermometer. I again advised her if baby is SOB she need to go to ER and to call her doctor.
At 48 hours chills, low grade fever, nausea, fatigue, sleepiness, swelling and redness hotness @ injection site, positive reflex. Denies chest pain, wheezing, shortness of breath, rashes Positive dry cracked lips Today 4/26/21 1:30 PM phone conversation. Advised Tylenol, vaseline on lips, cold compress locally 10-15 minutes every 2-3 hours as needed. PRN nausea meds. Add Benadryl Q 6 hours Call back 24 hours. ER if cont of CP, SOB, wheezing, near syncope/syncope.
Had vaccine at approximately 5 pm - pt said arm was red around injection site shortly after. Around bedtime she noticed swelling and redness going to right armpit. She went to urgent care 8/31 because swelling, redness, and hot to touch was no better. They treated with KEFLEX and BACTRIM in case infected. She went to family Dr 9/2/15 because it was no longer red but still swollen. He put her on 5 day course of prednisone - still swollen - after that so she went back to doctor. He said that should have corrected any swelling/inflammation so he ordered an ultrasound. Ultrasound showed no reason for swelling around armpit/breast area. I talked to her 10/30/15 and she said there is no pain but there is still extra fluid under arm/armpit area. (Dr on 9/2 put on prednisone but stopped both antibiotics b/c he said it was not infected it was just a reaction to the vaccine).
No adverse event; Patient got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got vaccinated after BUD) 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 (Patient got vaccinated after BUD).    Patient registry ID was reported.  No concomitant medication information was provided.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medication was provided.
sore arm; Left sore arm when she wants to lift her arm up. It hurts from her elbow to her shoulder. This is; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (Left sore arm when she wants to lift her arm up. It hurts from her elbow to her shoulder. This is) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced ARTHRALGIA (Left sore arm when she wants to lift her arm up. It hurts from her elbow to her shoulder. This is). On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 24-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ARTHRALGIA (Left sore arm when she wants to lift her arm up. It hurts from her elbow to her shoulder. This is) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include Cold compress. Patient had a hip replacement surgery due to osteoarthritis in January 4th.
episode of repetitive momentary breath holding x 7 chest & stomach caved in;no change in color or tone;no rhythmic movements eyes/limbs;episode 30-60sec duration followed by screaming;adm to hosp for observation
At site of Hep A injection - red area approx 10cm in diameter noted at injection site (L thigh) area warm to touch noted on ED record.
REC'D VACCINE ON 1-19-21. ON 1-20-21 NOTICED NUMBNESS AND TINGLING TO LIPS AND TOUNGU, NO DIFFICULTIES SWALLOWING OR BREATHING. JUST SAW MD TODAY AT IMMEDIATE CARE. GIVEN STEROID SHOT AND ZPACK.PER MD, THIS WILL HELP. FEELING A LITTLE BETTER
Intussusception - open reduction on 12-22-09. Sx's assoc. were: V (bileous)/lethargy.
it was itchy; it was itchy, red; it was itchy, red and swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (it was itchy), RASH ERYTHEMATOUS (it was itchy, red), VACCINATION SITE SWELLING (it was itchy, red and swollen) and RASH (Rash) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included PRIMIDONE, BACLOFEN, PROPRANOLOL and TRAZODONE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced RASH PRURITIC (it was itchy), RASH ERYTHEMATOUS (it was itchy, red) and VACCINATION SITE SWELLING (it was itchy, red and swollen). At the time of the report, RASH PRURITIC (it was itchy), RASH ERYTHEMATOUS (it was itchy, red) and VACCINATION SITE SWELLING (it was itchy, red and swollen) outcome was unknown and RASH (Rash) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The rash was of the size of palm of his hand. It gradually faded but was still visible. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-048290 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up- Email id updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048290:Second dose case
Almost immediately I turned a bright shade of pink on both arms and my neck and chest area.  I was lightheaded and dizzy.  My blood pressure dropped to 87/57 (normally have high BP).  I had a hard time catching my breath.  These symptoms came in waves about every 15 minutes.  I was monitored for 2 hours until I felt well enough to go home.  I arrived at home a little after 5:00 pm and started having a very bad migraine.  I had fever, (101.8) chills, and trouble walking.  My legs felt like they weighed 100 pounds each.  Every joint in my body ached. I was extremely lethargic for the remainder of the evening.  The next day, 03/10/2021 I continued to suffer from the same symptoms as I had on the first day.  I was unable to return to work.  I could  not drive safely.  I attempted to be active and it resulted in being dizzy and very faint.  The migraines are incredibly painful  I have had migraines for years but these were the worst I have ever experienced.  I am now on day 3 (03/11/2021) and I am still unable to work. I have extreme fatigue and headaches. I am reporting this event to hopefully help in research of the vaccine.  I believe in science and will do whatever is asked of me to help this progress.
Employee states stared having bone and joint pain late Friday, 12/17/04, also has a light rash that worsens over the weekend.  On 12/20/04 she came to employee heath, with a large red rash noted on back, stomach and extremities. Sent to ER for evaluation. There she was treated with Decadron 8mg IM which was given at 9:45 am. She was sent home with a Rx for Prednisone 20mg and Atarax 25mg. Clinical impression: Hives, Urticaria
sneezing; feeling hot and cold; Not being able to keep anything down; fatigue; Nausea; A spontaneous report was received from a healthcare professional concerning a 22 year-old, female patient who received Moderna's COVID-19 vaccine and experienced  nausea, vomiting, fatigue, sneezing and fatigue, sneezing and feeling of hot and cold.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, 7 days after vaccination, the patient began to feel fatigue, sneezing a lot and feeling hot and cold with nausea and vomiting.  Treatment for the event included dimenhydrinate.     Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I HAD WHAT PEOPLE ARE CALLING "COVID ARM". BLOTCHY RED ITCHY
For three and half months, had constant pain, soreness, and lost strength in right arm. Went to doctor and was x-rayed. Needed to go to rehab for two and half months for twice a week treatments.
About 17 hours after the vaccine I woke up with chills, nausea and dizziness.  I threw up 4-5 times but felt better after taking ibuprofen.  Before the ibuprofen I felt very ill
swollen arm 2x shoulder to elbow;rash around arm, T102.5;
Chest pain, probably myocarditis, relived a bit by stretching but rather persistent. Started at 10:30pm and persisting to this time.
Resident had Johnson Vaccine on 6/25 at approximately 11:30am, had no initial symptoms on the day of vaccination.  On 6/26, resident was alert and verbal all day,  VS 98.1-93-18-119/77-95% on R/A , respositioned frequently in bed, at 5pm CNA was doing care and alerted nurse of res c/o not feeling well " I feel like im going to die" fingertips purple unable to obtain 02sat, color pale temp 98.3, pulse 110, RR 22, BP 87/53 res stating " please rush me to the hospital" , HCP and MD contacted, transfer orders given, resident left facility via ambulance at 5:20pm.  Per hospital on 6/27 at 7:00AM resident in the ICU at this time.
Pnuemovax Injection site, right deltoid noted to be red, tender, and warm on 10/25/2006 after receiving the injection on 10/23/2006.  No fever or chills.  Went to primary care provider who prescribed Keflex.
Mother called 1/13/2004 with questions re. further vaccinations. Reported that child had about 12 hour reaction from vaccinations 9/25/03 - fever (undocumented) shaking, jerking and high pitched scream or cry. Was fine in AM.
Started w/red spot @ point of injection, progressed next day to a larger red spot about 2.5" in diameter, swollen, sore, w/some itching.
There are no side effects. This child received Pedi Pfizer orange cap for ages 5to 11 years and he should have received Pedi Pfizer maroon cap for ages 6 months to 4 years. Parents will be notified today.
On 2/4 @ 0100 starting having fever, chills, body aches, joint pain,  headache.  On 2/5 @ 0900 all symptoms were gone.
Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 4 months old patient (gender not reported), who was vaccinated with a dose of MENACTRA (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a four-month old patient received MENACTRA. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.