chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse (LPN) referring to a 28 year old female patient. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unknown date the patient was vaccinated with the first dose of GARDASIL injection (dose and route were not provided). On an unknown date the patient was administered the second dose of GARDASIL series one month too early. This was outside the labeled recommendations in the GARDASIL prescribing information. No adverse effect was reported. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
Elevated, hive-like rash noted on right arm - approx. 6-7 cm in size. Itchy.  No treatment given, improved by the time evaluated here in the office again on 10/24/16 but viewed from picture taken that day.
Information has been received from a licensed practical nurse concerning an approximately 8 year old patient who on 01-MAR-2000 was vaccinated with a dose of VARIVAX (Merck). On approximately 08-MAR-2007, the patient experienced 25 vesicles. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
Red area, warm 5?-3?... flu like symptoms and a migraine. Feb 11 feeling much better
Pt. received MCV4 vaccine at 0830 AM on 7/25/17, at 0832 I was completing vaccine record paperwork and heard a loud thump and turned around to find patient laying on the floor. Pt. stated 2 pain to back of head, no visible deformities, BP 100/62 at that time. Pt. helped to a chair and given ice pack for her head. BP at 0842 128/82, BP at 0848 122/82 and pt. denies pain at this time. Pt. advised to go to urgent care if anything changes.
This case was reported by a physician via sales rep and described the occurrence of headache in a male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache, general body pain and pain in arm. On an unknown date, the outcome of the headache, general body pain and pain in arm were unknown.  It was unknown if the reporter considered the headache, general body pain and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided follows: The age at vaccination was not reported. The physician stated that patient experience side effects with Bexsero including body aches, sore arm, and headache. The reporter was referring to her son.
Prominent ringing and muted sound in the left ear, sudden onset 6 days since vaccination.
Localized, erythematous swelling of left arm approximately 5 cm, posteriorly. Pt. returned 11/13/13 for follow-up.
Approx 3 weeks after Covid 19 Booster - shock to Pancreas causing blood sugar spike
About one hour after the vaccine he started experiencing intermittent sharp pain down the left side of his hear near the ear; Also had some dizziness present; sharp pains going down the left side of his head; This is a spontaneous report from a contactable consumer (patient reported for himself). The report was not related to a study or programme. An 88-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 18Jun2021 at 11:00AM, as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received his fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as single for covid-19 immunisation. On 18Jun2021, about one hour after the vaccine, the patient started experiencing intermittent sharp pain down the left side of his hear near the ear, also had some dizziness present and sharp pains going down the left side of his head. The clinical course of the event as follows: patient stated that he took the second Pfizer Covid shot at 11am in the morning on 18Jun2021. Around one hour after the shot he began to have sharp pains going down the left side of his head that comes and goes. He was reading from the list and it says about having headaches, but what he had are not headaches and reported that they occur every 10 to 15 minutes and it comes down the head and is a little dizzy. The outcome of the events was unknown.   Declines to provide an address but provides an email address. Declines to provide further report details and wants to ask about the side effect.
Localized swelling LUE red with edema. Some puffiness and edema under L eye.
Was confused by the 'VAX' at the beginning of both products; No additional AEs or PQC reported; Caller reported VARIVAX inadvertently administered to a 9 month old.; Caller reports child should have received VAXELIS and VARIVAX was administered/was confused by the 'VAX' at the beginning of both products; This spontaneous report was received from other health professional and referred to a 9-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-SEP-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, administered intramuscularly for prophylaxis (lot number X006982 has been verified to be a valid lot number, expiration date reported and validated as 07-MAR-2025) (anatomical location was not provided) instead of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) (VAXELIS) injection for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age) (wrong product administered). The health care provider (HCP) was confused by the "VAX" at the beginning of both products (product name confusion). No additional adverse events were reported.
Near constant ringing in my ears. It is causing me psychological distress. I do not recall this ever being an issue in my life until some time after I received the second vaccine, and I am unaware to any exposure to sound that may have caused this. Not sure if this is relevant, but my body responded strongly in the day or so after the 2nd vaccine with shivers, headaches, and fevers.
Got my 2nd dose of Pfizer covid vaccine on Thursday May 6,2021 on Sunday May 9, 2021 while in the car (parked) waiting on my family I felt a pop on the left side of my face near my left eye. I did have pain and swelling on the left side of my face near the eye socket. I visited urgent care that afternoon and the MD consulted with severe other MDs and eye doctors- no one had an explanation. I followed up the next day with my eye doctor who said it was possible that I had pulled an eye muscle. After high doses of Anti-inflammatory medication, ice, and rest for about 3-4 weeks and at home eye exercises it did resolve. I do wonder if it wasn't inflamed due o the vaccine as that was the only "new " thing that happened.
Patient came into pharmacy today to report pain in her left arm that she believes is still from her flu shot, recieved on 8/4/18. After asking a series of questions, the patient does not have any pain in her shoulder, no pain upon raising her arms or lifting her arms up from her sides, no constant pain, never experienced any sharp pain during injection, however she states that when she tries to move her arm across her body (from left to right) she experiences pain in the area she recieved her flu shot. She has Spoken with her Primary care provider about the pain, and he suggested giving her a cortisone shot in the arm to alleivate the pain, to which she declined. Patient also states that she plays tennis regularly and doesnt believe that she pulled any mucles while playing. Again, after multiple questions, patient does not appear to be experiencing any nerve pain, no constant pain, is not reporting symptoms of bursitis, but believes maybe a tendon was "hit" during injection. I informed her that I would complete an adverse event report, and suggested that she followed the advice of her primary care physician, to which she again declined. She is just hoping that there is something she can do to alleviate the pain because she "doesnt want to be in pain the rest of her life".
No adverse effects reported.; she was administered dose one of GARDASIL 9 in 2/2018, and dose two of GARDASIL 9 on 7/6/2020.; This spontaneous report was received from a 25 years old female patient referring to herself. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  In Feburay 2018, the patient was vaccinated with dose one of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and on 06-JUL-2020, the patient was vaccinated with dose two of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (both strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported), both for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
* 17th May 2022 -  I had an appointment to take the Pfizer 1st dose of the Covid vaccination at 9.30 pm at the  Pharmacy. I had the injection on my art arm.  * 18th May 2022 - Arm hurts but I read online  that it was normal to be sore, that means it is working. * 19th May 2022 - Every once in a while I felt like my chest hurts and had dry cough, then it goes away and comes again. * 20th May 2022 - Morning my chest was hurting again, with a dry cough too. Eventually it went away....but in the afternoon I had a sudden itching and burning under arms back of my thighs and pubic area. I noticed  had big welts and very itchy.... got worse. It was all over my chest and back too, and under my arms, and on my wrists and hands too. Went to ER at Hosp and they prescribed me allergy meds . Got better and then it got worse again. *21st May 2022 - The welts/urticaria /hives spread all over my body, up my neck down to my toes. They got really worse and went back to the ER at hospital. I took photos too of all the allergic reaction from day 1? up until to where it got worse. Even the nurse said she has never seen anything this bad. They gave me iv fluids and administered some medicine through the iv and it calmed me down and seemed to help. In fact all night I didn?t have any itches and by morning, the welts seems to be gone, I only had the few occasional itch on my wrists and hands and under arms this morning.  I know for a fact I am not allergic to anything,  like food or medications. I eat EVERYTHING. I am really sure that this was a delayed allergic reaction to the vaccine. I never had an allergic reaction before. This is  the first time.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Experienced site redness and rash in L deltoid area within 24 hours of injection which resolved 1/5/2020 1/3/2020 Experienced pain in L axillae radiating down the arm. Arm feels numb. 1/5/2020 Temp 98.5 normal temp 97.0 . Axillary pain and tenderness remain present during conversation 1/6/2020.
I contracted COVID-19 on 06/14/2022 and was asymptomatic throughout my contagious period. I was not prescribed any medication, because I did not develop any symptoms.
Extreme pain while being injected. Same day and next, lethargy, joint pain, pain behind eyes, exhaustion, upset stomach. All three days, and contouring, swelling, heat, pain in shoulder. Square red rash about two inches square surrounding injection site. Too painful to lie on that shoulder in bed.
HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for an unknown indication.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (HEADACHE). At the time of the report, HEADACHE (HEADACHE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Fever (101.8), chills, and terrible aches.  Her arm was extremely sore even to touch and it hurt to move it.  There was a large, red, hot, raised circle of about 4" in diameter that sort of even went under my arm pit.  The fever lasted till Monday, 9/2/13; by 9/2/13 was fine except the red circle is still there and arm is 'somewhat' sore (nothing like before though).
ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21/SEP/2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958806 and 20210958405.
c/o chest tightness 5min post moderna injection which lasted for about 3min. denies hx of same symptom with previous dose, denies SOB, chest pain, lightheaded, dizziness, headache, palpitation. Report history of anxiety. BP: 130/75 HR: 91 Sp02: 97% RA Seen and cleared by EMS, patient refused to go to the hospital, states she's fine now.
Nothing initially...The patient's mom just now told us.  She said he was having sore gums and went to his provider and she could not see anything but had heard that sore gums is a side effect of  moderna.  Recently, he started having issues with his chin and front part of his neck being sore and tender and felt nodules. He went back to his provider and was told that she didn't see any problems, so it must be the vaccine and she instructed her to let us know so we could fill out this report.
Pt returned two days later with redness around site. Pt was going out of town, warned pt that redness is possible, but if worsens could be infection. She went in to MD & was given antibiotic to treat infection. Pt has improved.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Dec-2011. On 05-Dec-2011, the patient received expired product. There was no adverse event associated with medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pt tried getting up after 5 mins of vaccine admin. Felt dizziness and vomiting. Subsided after 15 mins.
Reported to employee health on 9/24/18 with a 31/4" fading bruise with a hard bump which she stated was hot to touch on 09/21/18.
The morning after the vaccine, I woke up with a generalized rash across my abdomen, evenly dispersed across my torso. Nonpruritic.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL9261), intramuscular in the left arm on 25Jan2021 14:00 (at the age of 35-years-old) at single dose for COVID-19 immunization in a hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) and birth control pills. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination. On 26Jan2021 at 06:00 AM, the morning after the vaccine, the patient woke up with a generalized rash across her abdomen, evenly dispersed across her torso. It was nonpruritic. The patient received BENADRYL and CLARITIN as treatment for the event. The patient was not tested for COVID post vaccination. The outcome of the event was recovering.
I had major chest pain, and was gasping for air to; I had major chest pain, and was gasping for air to; was in Afib; i struggle getting out of bed to feed myself; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0612), via an unspecified route of administration, administered in arm right on 17Apr2021 (at the age of 58-year-old) at dose number unknown as a single dose for COVID-19 immunisation. Medical history included high blood pressure (other medications the patient received within 2 weeks of vaccination: High blood pressure medication). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 17Apr2021 the patient experienced major chest pain, and was gasping for air to, was in afib, the patient struggled to get out of bed to feed himself. Re-ported Event: patient received the vaccine early morning of 17Apr, and carried on his day, that night is when the symptoms came. The 2 symptoms that later sent patient to the hospital a few days later as patient explained. Patient had major chest pain and was gasping for air to breath. It was getting worse then out of nowhere, it stopped. And about 10 minutes later it hit patient again. This was a never-ending cycle all night long back and forth symptoms of intense chest pain and gasping for any air at all. By morning the symptoms had faded away. Carried on patient day when night came, they symptoms where back, not near intense as the night before, but still severe. This happened for a few more days and then patient went to his Dr, because the breathing was a major problem. Patient went to the Dr and she sent patient to the ER instantly. They ER said patient was in Afib and never had this or any history in the family. This has changed patient life, patient carrier. To this day patient struggle getting out of bed to feed himself. Adverse event result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient was hospitalised for one day. The clinical outcome of the events was not resolved.  Follow up attempts are possible. Further information is expected.
Arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient received Shingrix near the end of October and reports his arm was sore for around 6 weeks. The reporter did not consented to follow up.
patient vaccinated one month early for her booster dose. 2nd dose was administered on 10/11/21, therefore her booster should have been administered approximately on  3/11/2022
muscle pain left arm , site of injection and surrounding; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th October 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain. The patient was treated with nsaid's (Nsaid). On an unknown date, the outcome of the injection site muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.   Additional details were reported as follows: This case was reported by patient himself. The patient received Shingrix in left deltiod and reported muscle pain in left arm, at the site of injection and surrounding. Till the time of reporting, the event was not resolved. The healthcare professional recommended NSAID cream which provided temporary relief. The reporter given consented to follow up with healthcare professional. The reporter consented to follow up.
Information has been received from a pharmacist student concerning an "school aged" patient who was vaccinated with two doses of MMR II and still had negative titers to MMR II.  The patient was also given one dose of MERUVAX II a few months ago, but still had negative titers to rubella.  Additional information has been requested.
Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 (Lot number: EN6203) at the age of 37 years as dose 2, single and administered in arm right, administration date 01Feb2021 (Lot number: EL9265) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines (one and off)" (unspecified if ongoing), notes: other medical history: Migraines (one and off). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no.
AREA SWOLLEN- QUARTER SIZED. WARM TO TOUCH, HARD TO TOUCH. NO RASH, NO ITCH.