chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and swelling 4 inches around injection site of (L) deltoid. Warm to the touch per pt. Denies fever and chills. Advised to apply ice, PO TYLENOL and Ibuprofen for pain/swelling. Monitor area for increased size. ER if SOB.
Injured her left arm; Left arm is in pain; This case was reported by a consumer via call center representative and described the occurrence of limb injury in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included myeloma, malignant (and also had lymph node biopsy done during which her rotator cuff was injured.).   On 15th March 2020, the patient received the 1st dose of Shingrix. On 24th April 2020, 40 days after receiving Shingrix, the patient experienced limb injury and pain in arm. On an unknown date, the outcome of the limb injury and pain in arm were unknown.   It was unknown if the reporter considered the limb injury and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and she injured her left arm when she was checking her blood pressure.  Her left arm was in pain. About a week later she went to see her physician. She was having a MRI done later. She has had malignant myeloma of upper left arm in 2016, and had lymph node biopsy done during which her rotator cuff was injured. The reporter consented to follow up. No other details were provided. The caller did not know complete name and address for her physician.      Lab Comments: had lymph node biopsy done during which her rotator cuff was injured.
FLU; This spontaneous report received from a patient concerned a 6 decade 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 (suspension for injection, route of admin not reported, batch number were not reported) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination.  The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced flu. The action taken with covid-19 vaccine was not applicable. The patient recovered from flu on JUN-2021. This report was non-serious. This case, from the same reporter is linked to 20210623078.
Headache, Fever, LEFT SORE ARM; FEELS LIKE SOMEONE IS "POLING" RIBCAGE NEAR SHOULDER BUT DOES NOT FEEL CARDIAC RELATED Narrative:
I had natural infection with Covide 3/2020.  First vaccine 2/2021 and second dose 3/2021.  Booster shot with PFizer receivered 10/25/21.  I premedicated with tylenol and was fine.  Next day Tuesday also medicated with  tylenol as I had low grade fever after the second shot.   Tuesday evening I was a little tired and noted mild could which I had with first 2 vaccines also.  Next day We 10/27 I was progressively tired.  Thursday about midday I noted feeling warm  and started having shaking/teeth chattering chills off and on but I was able to make it through the day.   Thursday night/Friday am I awoke about 3-4am  with pounding headache, shaking chills and 7/10 Left pelvic pain which I assumed was my left ovary ( history of cyst and endometriosis) and temperature starting to increase to 99.6.  I took tylenol and 1 hour later Ibuprofen  and was able to go to sleep.  about 720 am I awoke with nausea,  headache about 4/10, pelvic pain 3-4/10.  Later that day I had shaking chills and fever off and on up to 100.3 until 7pm my temp was 103.  AT that point I went to ER for eval and to rule out infection.  Temp improved with multiple rounds of tylenol and I was discharged home.  HOwever fevers and chills continued the next days up and down from 97.9 to 102.9, cough worsened each day, headache worse with fever and pelvic pain off and on untill 11/3 when I saw infectious disease Dr.  He felt given I had natural infection and on review on labs and tests I has a severe immune response to the booster shot and should take prednisone 20mg x 5 days.  I took prednisone 20 mg yesters 11/3 and have not had any fever or headache since but still have some cough
I contacted my primary care office after experiencing a tender knot on my calf for a couple of days that also became reddened on the skin surface.  It was determined by ultrasound that I had a small, superficial blood clot in my lower right calf on June 3rd. We treated the blood clot at home with a compression stocking, elevation and heat, and I had a follow-up ultrasound on June 10th that indicated no change in clot location or size. I continued with home treatment and did not have any further complications. The pain and redness have resolved since that time. Prior to this pregnancy I have had two healthy pregnancies and one miscarriage at 8 weeks between those two. I delivered my third child on June 14, 2021 via C-section without complications. Baby weight was 6 lbs 15.5 oz.
Pt received 0.5 mL instead of 0.25 mL that she should have received for her booster dose (4th dose). Pt reported no adverse side effects besides her arm was sore temporarily.
(NB: He doesn't remember if the 2nd dose was in the right or left arm -- the first dose was definitely the right arm.) Sunday, April 4 awoke with severe facial pain. The next day, Monday April 5, a small rash on the left side of the neck, above the collar-line was visible. It was obvious it wasn't a bug bite, nor a burn. It looked like possibly contact dermatitis, though there was no known cause.  Pt had a trip planned and left for out of town that morning (April 5); the place where he was staying in out of town provided Hydrocortisone cream + Zyrtec. Over the next several days the pain continued & the rash spread down his neck and up his neck, to his left cheek & ear.  Pt went to urgent care on Thursday, April 8 and was diagnosed with herpes zoster. He was Rx: Valacyclovir He is still taking Valacyclovir -- the herpes vesicles are crusted over / healing
This spontaneous report as received from a female physician via a Company Representative, reporting on herself, a patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Patient stated that she received ZOSTAVAX and experienced unspecified an injection site reaction. The outcome of the event was not reported. Additional information has been requested.
Shoulder injury. Unable to lift arm - not due completely to pain. Severely decreased abduction and adduction after 2 days.
Vaccine administered on 06/25/07 and pain developed at injection site that evening. Left shoulder pain. Aching pain, worse with movement. No constitutional symptoms.
on day 2 extreme tiredness and joint pains, Day 3 and 4 added by dry heaving. stomach ache, diarreah general malaise including some brain fog ( inability to focus on work tasks) Day 5 cold sweats on exertion,  symptoms subsided on day 7.  on day 9 started with light dry cough,  it has progressed to the point of bronchitis now. Dr. prescribed course of prednisone, and Zithromaycin and recommends not taking second dose of this vaccine which is due on Fri, April 9th 2021
Patient's spouse calling to state that his wife, who was 7 months pregnant, was administered GARDASIL-9 instead of TDAP.; Patient's spouse calling to state that his wife, who was 7 months pregnant, was administered GARDASIL-9 instead of TDAP.; No AE; This spontaneous report was received from patient's spouse and refers to a 7-month pregnant female of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, anatomical location, and route of administration were not provided) instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (Exposure during pregnancy) (Wrong product administered). No additional adverse events were reported.
Influenza vaccine administered - c/o itching at injection site only. Band aid removed (non-latex) due to history of tape sensitivity, area red at site. Redness decreased after band aid off. Itching onset was immediate. Personal doctor contacted. Benadryl 50mg PO taken.
Very painful during pain administration, continuation of pain to date, limited range of motion to date, painful upon palpation to date, inability to lift normally to date.
arm was red, like a rash and warm to the touch; arm was red, like a rash and warm to the touch; arm was red, like a rash and warm to the touch/rash appeared to be spreading and swelling; arm was red, like a rash and warm to the touch/rash appeared to be spreading and swelling; arm was painful to move; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the parent.  A female patient received meningococcal group b Rlp2086 (TRUMENBA), on 30May2023 as dose 1, single (batch/lot number: GF4142, Expiration Date: Aug2025) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "arm was painful to move"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2023, outcome "not recovered", VACCINATION SITE WARMTH (non-serious) with onset 2023, outcome "unknown" and all described as "arm was red, like a rash and warm to the touch"; VACCINATION SITE RASH (non-serious) with onset 2023, outcome "not recovered", VACCINATION SITE SWELLING (non-serious) with onset 2023, outcome "unknown" and all described as "arm was red, like a rash and warm to the touch/rash appeared to be spreading and swelling". Therapeutic measures were taken as a result of vaccination site rash, vaccination site swelling.  Additional information: The nurse informed that her daughter received her first dose of Trumenba on Tuesday and had a significant reaction to it. She confirmed she became aware this morning on 01Jun2023. The patient was 16 (unit unspecified), she was getting her second dose of the other meningococcal ACWY, unsure which brand and her first dose of Trumenba. The nurse informed that the reaction was that her arm was red, like a rash and warm to the touch. The rash appeared to be spreading and swelling. The arm was painful to move, unknown which arm. The patient received the dose of Trumenba Tuesday afternoon (unspecified). The reporter informed worsening, sounds like it was continuing to spread even after administering Benadryl. The reporter informed that the mother plans to have her daughter seen tomorrow morning by the doctor.
Patient had itchiness of the eyes shortly after receiving Flumist until the time the patient took some Benadryl at around 9PM the same day.
PROGRESSION OF RHEUMATOID ARTHRITIS; MEMORY IMPAIRMENT; POOR CONCENTRATION; GASTROINTESTINAL DISORDER; WATERING EYES; EYE PAIN; TREMOR OF HANDS; GENERALIZED SPASM; BACK PAIN; SHOULDER PAIN; PAIN IN EXTREMITY; URTICARIA AGGRAVATED/BREAKOUT IN HIVES; This spontaneous report received from a patient via other manufacturer concerned an adult female with unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, Humira was wearing off two days before injection (wearing off effect) due/experiences eye watering pain a few days before Humira shot (watering eyes, eye pain). Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe rheumatoid arthritis.  On an unspecified date, the patient experienced progression of rheumatoid arthritis, memory impairment, poor concentration, gastrointestinal disorder, tremor of hands, generalized spasm, back pain, shoulder pain, pain in extremity, and urticaria aggravated/breakout in hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from gastrointestinal disorder, and urticaria aggravated/breakout in hives, and had not recovered from memory impairment, poor concentration, watering eyes, eye pain, shoulder pain, pain in extremity, back pain, progression of rheumatoid arthritis, tremor of hands, and generalized spasm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220918276-covid-19 vaccine ad26.cov2.s- Progression of rheumatoid arthritis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY( Rheumatoid arthritis) . Therefore, this event(s) is considered not related.
Two weeks after second moderne shot, any joint that had any previous arthritis aches, magnified 50 times to the point that my hands, neck, and right elbow are unusable. My hands were the worst affected. To the point I have not been able to use them without severe pain. A steroid shot and drugs helps. Very debilitating.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses. Dates of administration of vaccine were reported as 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non-significant follow-up received contains: Reporter details updated.
Information has been received from a registered nurse concerning a 75 year old female who on 10-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy on same date included a dose of yellow fever virus vaccine.  On approximately 10-APR-2007 the patient experienced genital burning, redness, pain, blisters.  It was reported that the patient also experienced pain, redness, swelling and canker sores in her mouth.  The patient was seen at an urgent care facility.  At the time of report, the patient was not recovered.  A product quality complaint was not involved.  No further information is expected.
Vaccine administered post excursion with no reported adverse event; Temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who was administered post temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022 the suspect INFLUENZA QUADRIVAL A-B VACCINE was exposed to a temperature excursion at 29.0 Fahrenheit for 45 minutes with no reported adverse event (product storage error).  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (strength and dose not reported; lot UT7689LA) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC 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.; Sender's Comments:  US-SANOFI-01296467: SAD20220927002156:
I felt dizzy and I had a metallic taste in my mouth right after the shot, and then about 7 pm I fell asleep when I got home around 4 pm. I woke up at 07:00 pm and had a sore arm and I had a mild headache. It felt like my throat felt swollen like there was a lump in the back of my throat (that started immediately after the shot). I was fatigued. It felt like my body was warm, but I didn't have a temp. I took some Tylenol. For the next four days, my throat had that feeling of having a lump in the back of it and so I went to urgent care. They said my throat was red and irritated and they told me to take one Zyrtec a day for a week and then my throat symptoms went away. My other symptoms lasted for about four or five days with the first shot.
Client states that pain in arm began approximately 4-5 hours she received both PPSV23 and Tetanus vaccine (not sure of the brand). By the next evening, client noticed a red, hot rash that started a few inches lower than site of vaccine on right arm. Rash did not extend to forearm. Red was raised but not itchy. Today (4/30), rash is still visible but not as red, still raised, and warm to the touch. States had a fever from 4/26 until possibly 4/28 but does not know how high because didn't take temp.
Vertigo lasting 5 weeks, Tinnitus persistent , and worsening, Brain Fog, lasting 4 weeks
Information has been received from a nurse concerning a 23 year old female with no known allergies and a concurrent condition of diabetes with elevated lipids who on 8/25/04 was vaccinated in her right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647029/0460P). Concomitant therapy included insulin, simvastatin, and irbesartan. On 8/26/04, the patient called the office to report injection site soreness, hot and cold flashes which progressed to whole body aching and sweats. She also had a fever. The physician prescribed acetaminophen and ibuprofen. On 8/27/04, she went to the ER and was admitted to ICU. She improved after unknown treatment and was scheduled for discharge today or late last night. The outcome was reported as recovering. Injection site soreness, hot and cold flashes, whole body aching, sweats and fever were considered to be immediately life-threatening. No further information has been requested.
Fever 102 for 3 days, muscle aches, migraine headache, nasal congestion and feet swelling. Took Advil 500mg BID, drank plenty fluids.
SINCE VACCINE WAS ADMINISTERED PATIENT HAS HAD PROBLEMS WITH ITCHY SKIN.  PATIENT HAS SEEN NUMEROUS DOCTORS AND ALL HAVE DETERMINED IT TO BE "CONTACT DERMATITIS" PATIENT DID NOT RESPOND TO TOPICAL CREAMS/ANTIHISTAMINES.  PATIENT TOLD EACH PRACTICIONER THAT THE PROBLEM STARTED AFTER ANTHRAX/SMALLPOX VACCINATIONS WERE ADMINISTERED.
C/o temp 102 on 9/2/16. C/o severe muscle and joint aches. C/o chills. Loss of appetite. Nausea. Site of injection was reddened and swollen. Unable to move left arm.
When I took first shot on aug 9th 2021 I started getting heart palpitations and I went to doctor and I was miss diagnosed of having anxiety in which the doctor prescribed me anxiety pills buspirone 5mg twice a day and a heart palpitations pill metoprolol succ 25mg once a day take as needed at that time about a 3days after I my palpitations were gone so i discontinued pills but then when I went to take the second shot on August 31 on the second day after which was on Thursday September  2nd 2021 I was driving and my heart started beating real fast I started shaking I thought I was having a heart attack and I went to the emergency  and the doctor there also misdiagnosed me and said it was anxiety and that I had a panic attack and to go back to my doctor and to see what she says. I went back to her and she put me on the same pills for 3mths but that this time for me not to stop taking them even if I started to feel better.   but three weeks later my lip swells up and my tongue I go see doctor but when I go see her the swelling has gone down and she just recommend for me to put salt water and drink a Zyrtec  well the next day at night my lip is swollen and my tongue like it gets worst so I contact a virtual general Doctor Who who referrals referred me to a dermatologist and that dermatologist was the one that diagnosed me that she had seen this before and it was a late reaction to the Pfizer shot  which that help me to go back in my history and to dig and find out that I have been misdiagnosed since day one from my heart palpitation it was not that I had anxiety it was the Pfizer shot that caused from my heart to heart palpitations
pt stated her left arm was itching, swollen, red and feverish after receiving the vax.  Later in the day it was red and swollen but the itching had subsided.  Pt said the next day the she could not move her arm since it was still swollen and painful. The following day the swelling had moved into the elbow and stayed swollen until the following.  Pt stated she no longer has the symptoms.