chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the vaccine, the mom brought in photos of the Child's arm.  It had a 'butterfly' shaped red area at the injection site.  The mom explained that roughly 10ish hours later, the arm was very tender, sore and the area around the injection sight was red and slightly warm.  She took a photo of the arm hours later.  She tried relieving the pain with cool and warm compresses, ibuprofen and acetaminophen.  Nothing helped besides soaking the warm in a warm Epsom salt bath.  She said the child complained of tenderness when she attempted to move the arm and it took a 'few' days for the pain to go away.  Other medical staff, the nurse and pediatrician review the photos, and screen for allergy .  By the position of the point of injection, it was determined that the muscle was missed and potentially the vaccine was given subcutaneous, indicative of vaccine administration errors observed before.  The child was petite and it was determined that it was safe to administer the second dose, using the thigh muscle.
After receiving 2 vaccine Menactra an Trumemba the pt sat for a few minutes and they left the exam room. Once in the hallway he passed out. Once on the ground he shakes for a 2 second an then came too within 30 seconds.  He remained in the office for 20 minutes, while his vital signs were checked by the provider.
Itchy Red Rash, roughly 2.5 inch diameter.  duration-in progress.
Erythema multiforme on 8/25/12. Treatment included Benadryl 12.5 mg/5ml oral liquid 1.5 tsp q 6h prn itching/rash and orapred ODT, 2 tabs dissolved by mouth qd x 3 days then 1 tab qd for 2 days.
102 degree fever for 2 days. Redness/soreness in left upper arm away from the injection site. Fever abated, soreness has not
Heart palpitations two weeks post vaccine and lasting for six to eight weeks.  Full cardiac work up done with no major findings.  EF at 65% and mild valve issues noted on 2D.  Symptoms have somewhat stabilized at this time but I still have irregular heart beats.
Pain at injection site followed by muscle ache at site with difficulty lifting my arm for 24 hours
hot red circle around flu shot area, warm to touch-swollen-ached for 1 1/2hr
This spontaneous report was received from a medical assistant concerning a 16 years old female patient. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 17-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. Later, on 05-OCT-2017, the patient received the second dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. No symptoms reported. There was no product quality complaint (PQC) involved.
Pt received DTP and experienced swollen leg-hot, red (left) high pitch cry "per" parents
pt devel severe h/a 2hr p/vax;APAP wont help;c/o muscle aches in lower back 1hr p/vax;
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celsius) for greater than 10 weeks.  Vaccine was stored for a total of 4 days past its beyond use date in the refrigerator.   Patient did not experience any adverse events.
HCP reporting a temperature excursion for PROQUAD and reports a dose of PROQUAD was administered to a patient; Caller reported no additional AE/PQC at time of call; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # T005401 (rHA) and expiration date 12-AUG-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 80 degree fahrenheit (°F) for 23 hours; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.
Knot size of ping pong ball formed at injection site noticed Sunday morning (36 hours post injection). Heat and redness at site of injection along with the knot. Starting at 8 pm Friday evening, lasting thru Sunday morning patient experienced excessive sleepiness and fatigue.
p/vax pt didn't cry;pt was put on floor standing;while sibling getting inj;began to drop;mom caught pt;pt was pale 7 unconscious & diaphoretic;pt was unconscious for 1-2min;not blue;no resp distress;no jerking;dec activity for 15min;
I received the Janssen COVID-19 Vaccine EAU at 1:45 PM. I was very tired around 8:30 PM, so I went to bed. I never fell fully asleep and began feeling worse at 11:00 PM. I had a fever of 101.5 F, chills, muscle spasms, anxiety, shortness of breath, and could not stop crying. This lasted until approx. 4 AM when I finally fell asleep. The next morning I woke up feeling much better. But, for the next 5 days, I have had on-and-off low-grade fevers between 99F and 100F.
Joint pain in both shoulders, both knees, both elbows, neck, both hands 24 hours every day, does not go away.  Lack of energy, easily fatigued, cannot focus or concentrate, brain fog, can?t remember simple things, diminished lung capacity. Lack of motivation due to physical symptoms.
Mother requested daughter received the Janssen vaccine.  Mother signed form on behalf of underaged daughter to confirm this was the vaccine she insisted on.
Localized erythema at site of vaccination. Discussed monitoring closely. Apply cool compress PRN. May use Benadryl q8h for the next several days. Advised to follow-up if area becomes increasingly red, swollen or hard, or if other symptoms of concern develop (including but not limited to persistent fever, urticaria).
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adolescent female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO vaccine on an unknown arm. The age at vaccination was not reported. The patient experienced arm pain on the injected arm. Limited information was provided by the sale representative from the nurse practitioner.
Tingling in arms and hands of right arm, dizziness, pale, feeling faint, symptoms began approx 10 minutes after being vaccinated. Symptoms got progressively worse until she took Benadryl about 1 hour later. She began to feel better after the Benadryl.
Arm was sore and slightly red immediately after injection, but 6 days later redness had increased, arm was more sore and warm to touch - developing cellulitis and treated with cephalexin.
EE states she developed an achy arm/shoulder the same day of the shot and it is still present of 12/02/2013. States she believes the shot "got close to a nerve".
Initial report received from a consumer's parent on 05 November 2010. A 17-year-old female patient received on 04 October 2010 a left deltoid intramuscular (IM) injection of MENACTRA, lot number U3356BA and a right deltoid IM injection of FLUVIRIN, manufacturer Novartis lot number UH180AC. The patient's medical history was not reported but the patient was taking multiple vitamins. She had no adverse events following prior vaccinations and she had no vaccinations within 4 weeks prior to receiving MENACTRA and FLUVIRIN. On 29 October 2010, the patient developed a fever of 103. The next day on 30 October 2010, she developed a loss of feeling/sensation in her mouth and was not able to taste. By Saturday 30 October 2010, the fever cleared. The loss of sensation progressed to the arms, hands and fingers. By Tuesday 02 November 2010, the patient's legs and feet became affected. The patient could walk and had control over movement but the sensation was dulled. She could not feel her extremities. The patient's range of motion (ROM) was normal. The patient was seen by a doctor and had blood work which included sedimentation rate (sed rate), complete blood count with differential (CBC with diff), metabolic, "THS", and vitamin B12. The results of the testing were not reported. The outcome was reported as not recovered. Documents held by sender: None.
5/16  Weakness and fatigue in early day followed by fever (100.6 F) with chills that evening and 4-6 small red spots.  5/17  Fever continued (101.0 F) and red spots increased; approx. 30 by evening and were itchy. That night chills continued and a burning sensation in lungs with deep breaths.  Fever was treated with acetaminophen and ibuprofen throughout the day. 5/18 Fever continued and number of red lesions increased to >70 in number and increased discomfort and itching.  Visited urgent care facility and was diagnosed with fever of 100.6 and chickenpox virus.  Given a prescription of Valacyclovir HCl.
Systemic itching, systemic tingling, Hypotension, syncope, Bradycardia, injection site swelling
Soreness started in Left arm at injection site 3 hours after injection; then 9 hours after injection, began experiencing pronounced achiness, headache, nausea, and chills.
Sore arm at injection site; felt jittery; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 08Mar2021 01:45 (Lot number: EL3247) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hay fever" (unspecified if ongoing). Concomitant medications included: FLONASE; ZYRTEC. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Mar2021 06:30, outcome "recovering", described as "Sore arm at injection site"; FEELING JITTERY (non-serious) with onset 09Mar2021 06:30, outcome "recovering", described as "felt jittery". Therapeutic measures were not taken as a result of vaccination site pain, feeling jittery. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are needed. No further information is expected.
I had the shot on the 8th,  The first 24 hours I was tired and had some injection site soreness.  Day 2 until now I have had numbness in legs and feet. A huge lump appeared a few inches from injection site.  My whole body feels swollen and tender.  My eyes are swollen and my vision is blurry.  It feels like someone is poking my internal organs. I am tired all the time and I have pain in back.   I am scheduled for second shot  in a week and now I am very afraid that the side effects will be worst after the second shot or possibly permanent.
Hip pain; This case was reported by a consumer via call center representative and described the occurrence of pain in hip in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was unknown.   It was unknown if the reporter considered the pain in hip to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experinced hip pain after receiving her second shot of Shingrix on The reporter did not consent to follow-up. This case is one of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002009:Same reporter US-GLAXOSMITHKLINE-US2021AMR002842:same reporter
Pfizer vaccine was given as a first dose, Moderna as the second.  Vaccines were given 18 days apart.
Pain in left upper extremity near vaccine site.  And decreased ROM.  Pain began the day after 1st vaccine and never went away even with pain medication.  No pain or issues with rom  or shoulder injury prior to the vaccine.  Ultrasound found no blood clots.  X-rays taken.  An orthopedist finally diagnosed it as calcific tendonitis in my left shoulder.  Ultrasound aspiration guided left shoulder with injection.  PT treatments now.
This is one case out of a cumulative total of 217 cases solicited from the database during the surveillance period from 01 January 2010 to 23 October 2013. These 217 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 October 2013 from the investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a four year-old male subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject had received four doses of PENTACEL; dose one on 30 October 2009, dose two received on 12 January 2010, dose three received on 18 March 2010 and dose four on 08 March 2011 (lot numbers, routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 09 September 2013, approximately 30 months after the last dose. On 09 September 2013, the subject developed a cough and paroxysmal cough on 12 September 2013 without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 October 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 October 2013 for five days. The subject was not hospitalized. At the time of final contact on 21 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 42 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
DIZZY AND FLUSHED. PT WAS ATTENED BY EMS. PT THEN STATED SHE FELT FINE. PT WAITED AN ADDITIONAL 15 MINUTES. PT WAITED A TOTAL OF 30 MINUTES. EMS SAID PT COULD LEAVE. PT LEFT IN STABLE CONDITION.
Had a cold; Missed second dose appointment, more than 42 days have passed since first dose.; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Had a cold) and PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment, more than 42 days have passed since first dose.) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Had a cold) and PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment, more than 42 days have passed since first dose.). At the time of the report, NASOPHARYNGITIS (Had a cold) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment, more than 42 days have passed since first dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Treatment details was not reported
Pt developed itching hives apprx. 6 hours after 2 immunizations with increase next day. no SOB, no throat tightness, no reaction to previous injections.
HCP called to report an AE for GARDASIL 9.  Caller states the patient received GARDASIL 9 on  7/13/2023 and is pregnant and expecting to deliver on  08/17/2023.; No additional AE; This spontaneous report was received from an other health professional referring to a 41-year-old pregnant female patient. The patient is expecting to deliver on 17-AUG-2023 (date of last menstrual period (LMP) was 10-NOV-2022; pregnancy outcome was outcome pending; number of fetus was 1; fetus outcome was unknown).  The patient's pertinent medical history included attention deficit hyperactivity disorder (ADHD), and postpartum depression. Concomitant medications included prochlorperazine maleate (COMPAZINE), promethazine (PHENERGAN) and althaea officinalis (+) ascorbic acid (+) betacarotene (+) biotin (+) calcium carbonate (+) calcium citrate (+) calcium pantothenate (+) choline bitartrate (+) chromium nicotinate (+) colecalciferol (+) copper (+) ferrous bisglycinate (+) iodine (+) levomefolic acid (+) magnesium aspartate (+) manganese citrate (+) mecobalamin (+) molybdenum glycinate (+) nicotinamide (+) phytomenadione (+) prunus spp. (+) spirulina spp. (+) pyridoxine hydrochloride (+) riboflavin (+) selenium (+) thiamine mononitrate (+) tocopherol (+) zinc bis glycinate chelate (+) zingiber officinale rhizome (MULTI COMPLETE PRENATAL VITAMINS). The patient's drug reactions or allergies was reported as no known drug allergy (NKDA). The patient's concurrent conditions were not reported.   On 13-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered intramuscularly for prophylaxis (strength, dose, lot #, and expiry date were not provided) (Vaccine exposure during pregnancy). It was reported that treatment was given for the adverse event, but no more information was provided. Routine ultrasounds were performed but no result was reported. The patient had sought for medical attention. No additional adverse events or PQC was reported.
Information has been received from a nurse practitioner concerning a 4 year old female patient with no pertinent medical history who on 29-DEC-2006 was vaccinated with the first dose of MMR II. It was reported that the patient did not have any reactions after the first vaccination. On 14-DEC-2009, the patient was vaccianted subcutaneousy with the second 0.5 ml dose of MMR II (Lot # 663508/1726X) into her right thigh. There was no concomitant medication. Within less than 1 minute after the second vaccination, there appeared a wheal. The wheal 20 minutes later was 1 inch,hard  and warm area. The patient was given BENADRYL (the nurse practitioner felt this was intervention to prevent serious criteria). No laboratory diagnostics studies were performed. At the time of the report, the patient was still in the office and had not recovered. The nurse practitioner felt that patient being given BENADRYL for the wheal was an other important medical event. Follow-up information has been received from a nurse practitioner concerning a 4 year old child on 14-DEC-2009 was vaccinated with the second dose of MMR II at 9:00 AM. With 1 minute after receiving the MMR II in her right thigh (also reported 09:09AM), she developed a 5mm wheal about 1 cm from the injection site. BENADRYL was given immediately. Over the next half an hour it progressed to 1 inch diameter, warm, indurated area, encompassing injection site. On the same day, this event was resolved in 2 hours. There was no illness at the time of vaccination. In follow-up, the nurse practitioner did not feel that administration of BENADRYL for the wheal was an other important medical event. No additional information is available.
Patient called office at ~12:50 stating she was having a reaction to the pneumococcal vaccine, possibly an allergic reaction. She stated the arm where injection was given was swollen and itchy. She denied SOB or chest pain. At that time, she was instructed to take Benadryl and come in if desired. She came to the office this afternoon at about 14:00 with localized swelling around the injection site, approx. 6-7 inches in diameter. The skin is raised and has red edges. The swelling has increased in size since her initial call, but is limited to the injection site only. Patient was given cold compresses to apply to site and a dose of Diphenhydramine 25 mg PO liquid. She was also instructed to take OTC ibuprofen for discomfort. This is her second dose of the pneumococcal vaccine. Her first was in 2006; the manufacturer of that dose is unknown. She was given Pneumovax-23 subcutaneously today; that information is logged into the State Registry of Immunization Transactions and Services. The patient is to follow up with us later today.
Nondescript throat tightness/trouble breathing, body aches, dizziness that lasted 1/2 day on day after receiving vaccine.
Immediate feeling of light headedness. Figured it would pass and went home. I get migraines every few months, but that night was the worst one I've had in years, including an aura. Ever since that first shot, I have had a daily headache and the lightheadedness continues. It's been over 4 weeks and nothing has changed. I am too worried to get the 2nd one. It has messed with my equilibrium and ability to concentrate.
NO ADVERSE EVENT.  PATIENT RECEIVED SECOND DOSE AT 14 DAY INTERVAL VICE THE RECOMMENDED INTERVAL
Dizziness and blacking out for 5 minutes this morning at 8:30 am.
A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Sep-2013. The patient received given full dose of FLUMIST into one nostril on 16-Sep-2013. The outcome of the event of given full dose of FLUMIST into one nostril is unknown. The report was considered to be non-serious.
Employee received vaccination.  Within 10 minutes complained of burning at injection site and itching.  No redness, swelling and site not warm to touch.  Employee denied difficulty swallowing and dyspnea.  Employee given oral Benadryl 25 mg and observed for additional 30 minutes.  Employee continues to complain of itching but no redness, swelling of face/mouth, difficulty breathing noted.  No rash or hives noted and employee able to return to work.
Mild pain in the injection site.  Ovarian cramps and discomfort starting at 11 pm (vaccine administered around 3 pm the same day). Woke up the next morning with a vaginal bleeding resembling a period. I am in premature menopause and do not menstruate. I also take HRT for my menopausal symptoms. The bleeding lasted 6 days, just like my period would have.
Severe menstrual type cramps (EVERYDAY).  I haven't had a period since my thermal ablation 11/2008.  Significant breast tenderness.  Fatigue.
She received her flu vaccine in her left arm  on 10/19/22.  Yesterday she noted erythema at the injection site and it felt warm to touch.  Today, the site is red, about the size of a small orange and it is warm to touch.  Site is tender, per patient report.  Injection site appears to have been placed correctly.