chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered from a vial that was left 24 hours at room temperature after being punctured; Vial that was left 24 hours at room temperature after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was left 24 hours at room temperature after being punctured) and PRODUCT STORAGE ERROR (Vial that was left 24 hours at room temperature after being punctured) 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 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vial that was left 24 hours at room temperature after being punctured). On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was left 24 hours at room temperature after being punctured). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was left 24 hours at room temperature after being punctured) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial that was left 24 hours at room temperature after being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided. The vial was punctured on 05 Oct 2021 and was left by mistake overnight at room temperature.
My resting and walking heart rate doubled. My resting rate is usually 60 and it was well over 100. I had fluttering and a heavy feeling heart. I visited the ER and everything looked fine. They said to rest for the weekend which I did and my heart rate was back to normal by Tuesday, 11/16/21.
On 1APR92 small swollen area approx dime size noted on rt arm & rt arm sore; By 230PM the same day, swelling had inc to area below site of inject & extended to the elbow; area was raised & warm to touch rt arm sore reddness noted; t100.4;
p/vax pt devel 2in red area around typhoid vax given in rt forearm, warm to touch;has red streak starting towards bend of arm;able to move;advised to see MD
pt recv vax 24JUN96 & 29JUN96 pt was noted to have a sl amount of protein in urine p/a routine UA;no further details were provided;
Began feeling extreme fatigue and injection site soreness around 7:00PM on 1/13 and went to bed very early for me at 8:15 PM.  When I awoke at 5:00 AM my head felt foggy, I had chills, and headache.  I took extra strength Tylenol at 6:00 AM with relief of headache, but returned to bed from 9:00 AM to noon due to fatigue, muscle aches and chills.  I have continued to have fatigue, headache, muscle aches, and chills throughout the day (1/14/21). I also developed a fever of 100.6 at 5:00 PM.  Second dose of tylenol has reduced my temp to 99.5, but I continue to feel fatigued with headache.  The current time is 6:15 PM on 1/14.
Reddened area raised measuring 6.9 cm by 5 cm on upper left arm.
0910 - Patient was given Flucelvax to right arm, Patient initially stated 'it hurt more than usual'. 0925 - Patient started complaining of headache and nausea. 0945 - patient started complaining of tingling around her lips and dizziness. Provided was then notified. Patient was placed laid on exam table with feet elevated. 0953 - IV was started by provider to patient's right hand and provider gave patient Benadryl and solu-medrol. Patient started on 500ml of Normal Saline. VS BP 139/94 P 83 RR 20 T 97.7, patient complaining of dizziness and numbness/tingling to around lips. Denies pain. 1007 - VS BP 149/106 P 90 RR 20. Patient denied dizziness. Does report numbness to right hand. Patient is shaking, but states she does not feel cold and denies a blanket. Provider informed. 1019 - Normal saline completed. Patient ambulated to bathroom. Not complaining of dizziness or numbness. Denies pain. Ambulated with assistance. No concerns. 1025 - Returned from bathroom with no concerns. No dizziness. No numbness/tingling. 2nd bag of 500ml Normal Saline started. 1032 - VS BP 138/96 P 73 RR 18. Denies dizziness. Denies numbness/tingling. Denies pain. 1045 - Patient resting comfortably. 1100 - VS BP 130/80 P 69 . IV Discontinued. Patient released from clinic with assistance.
Pt recv vax on 4/23/99; 45 min post vax pt exp headaches &chills x 2hr; tx=bedrest, Advil
Severe muscle aches, vomiting, headaches, runny nose, general malaise which started abruptly the day after receiving her flu vaccine.
Information has been received from a physician concerning a 10 year old white female patient who on 5/23/95 was vaccinated with a dose of varicella virus vaccine live. On 8/22/03, it was reported that the child recently developed full blown chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the health care facility indicated that per mom, the patient developed chicken pox on 9/2/03. The patient recovered in 1 week. It was also reported that on 3/21/95 the patient was vaccinated IM with a fourth dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (TRIPEDIA). No further information is expected.
Patient states that her flu shot was painful upon administration and that her pain level over past 2 weeks has been a 7 out of 10 on pain scale. She states her doctor's office suggested ALEVE OTC and to make an appointment if pain persists. Patient also states that her left arm (flu-shot arm) has sharp pain shoots down to elbow and she cannot lift if more than half way and cannot unhook her bra. She never expressed this amount of pain at administration or previously.
INDIVIDUAL RECEIVED VACCINE PAST THE BEYOND USE DATE. MAY OR MAY NOT BE WITHIN THE 14 DAY STABILITY DATE (OFF LABEL). INDIVIDUAL MAY CHOOSE TO BE REVACCINATED.   NO ADVERSE EVENTS REPORTED.
patient felt lightheaded within 30 minutes after vaccine, then about 6 hours later she passed out and had to go to the hospital; she was treated with IV fluids, meclizine, and ativan
She presented with itching and rash a few hours after injection.  Relieved by ice and antihistamine oral medication.
Received the vaccine 7/22/21 at 1:00pm had a sore left arm, felt a bit dizzy & clammy but symptoms went away by Saturday 7/24/21.  Monday night 7/26/21 felt really tired & a bit achy.  7/27/21 I woke up with a stabbing knife feeling under my right shoulder blade up my spine & it ran thru front of chest & left leg started swelling a bit. Self medicated with tylenol, advil, ice & heat. 7/28/21 I went to store & bought ladocaine patches, creams to try to relieve the symptoms along with the other things I was doing.  7/29/21 I went to get a massage but I couldn't take my shirt off & it just hurt too much so it was short & sweet.  Friday 7/30/21 my leg was huge!  I couldn't take it any longer & went to the ER at 3:30, I was admitted at 5:00 with blood clots in my stomach & down my left leg.  Still not answers on back but it didn't show any clots with they did the CT's.  I was put on heporon blood thinner & had surgery on 8/2/21. I got to go home on 8/3/21 but started having chest pains & the back pain really bad so went back to ER on 8/6.  They did another CT to see if any clots were in back but there wasn't.  Sent home with oxy & fentanyl patches.
~ 9 hours after dose, had sudden onset of severe vertigo -- not positional. Occurred while lying still and persisted. Within ~ 10 minutes, sudden onset of SEVERE left occipital headache which persisted. Some nausea without vomiting. Vision disrupted with the vertigo. Head fog and profound weakness and myalgias. Initially seemed to improve with Tylenol and medicine. However, on the following Monday afternoon/evening and into Tue=sday AM became MUCH worse (headache and the vertigo. Contacted ny PCP who ordered MRI which was read as negative.  Started taking 1 gm Tylenol Q6 hours and 1 gm Naproxen BID with minimal relief. Seen in the ED the following Saturday. Got some IVF (slight relief) and routine lab tests were negative so sent home...
I was vaccinated/ Two years later I got Shingles / suspected vaccination failure; Two years later I got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient was vaccinated and insurance would not pay anything on it,. The patient went to drug store and paid for the shot. Two years later patient got Shingles, the doctor said it would of been a lot worse without the shot. The patient was glad that he or she had the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, and laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Event: Headache becoming persistent on different areas of the top of the head. Pain is tolerable to the patient although alarming as patient did not have this medical condition before vaccination.  Treatment: Self-treatment by patient by taking 240 mg of aspirin which alleviates the pain. Patient avoids fatty and salty food and does more exercise.  If condition remains for another week, patient will see his doctor.
Headache, Fever, BODY ACHES, MALAISE Narrative: EMPLOYEE STATES: SHE RECEIVED THE VACCINE ON 4/8/2021 AND STARTED RUNNING A FEVER THAT NIGHT. ON 4/9/21 SHE WENT TO A LOCAL ER WITH A TEMPERATURE OF 106.5 F. SHE STATES SHE SPENT THE NIGHT IN THE HOSPITAL. SHE HAD BODY ACHES, HEADACHES, MALAISE, AND FEVERS UNTIL MONDAY 4/12/2021
Fever of 102F for hours today. I've now taken total of 975 tylenol and 400 Ibuprofen today to combat. Fever is finally decreasing. Currently 99.9F.
Multiple Sclerosis relapse was notable a couple weeks after injection. MRIs confirmed advanve from only 10 lessions prior to vaccination to 16 lessions after vaccination. Worth noting for context, the 10 lessions came between 2008 and 2020 so my case of MS is extremely mild.
Pain at site of shot, temperature of 102, pounding headache, swollen lymph glands, chills, pain in neck, nausea, clammy sweats, badly infected throat.
She had 3 welts welt the day after. Now she has a bigger welt size of a quarter. Redness. Arm still a little swollen.
Evening of was sore shoulder muscle, lasting for 3 days.  Starting on 2nd day, soreness down into upper arm, almost to elbow.  3rd day sore and itching. Upper arm, just below shoulder muscle appears red like sunburn. Area about 3 inches, shaped like upside down heart. This area still sore and very itchy. No blisters or noticeable bumps, but slightly raised and harder than surrounding areas.  Still prominent on March 9th.
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were vaccinated with the improperly stored doses of GARDASIL (lot number K006960 and expiration date 19-FEB-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd 1st dose of Engerix-B 16APR91; 19APR91 pt exp abdominal cramps, nausea, diarrhea, facial rash, & flu-like sx; rash persists but pt is feeling better;
Arm red, swollen, warm to the touch, cellulitis. Slight itch. Seen Dr. Took CLARITIN and ZYRTEC for day duration.
D-dimer drawn 40 minutes after shot (for APLS unrelated to shot) was elevated at D dimer (value 0.62 mcg/ml feu); Had to extreme vertigo 17 minutes after vaccine that lasted 30 minutes.; This is a spontaneous report from a contactable other health professional (patient). A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Jul2021 at 16:00 (Lot Number: FA6780) (at the age of 37-year-old) as single dose for COVID-19 immunisation.  Medical history included antiphospholipid syndrome (APLS), blood pressure (BP) high, obesity, possible multiple sclerosis (MS), all from an unknown date and unknown if ongoing. No known allergies. The patient did not experienced COVID-19 prior or post vaccination. Concomitant medications included apixaban (ELIQUIS); metoprolol; gabapentin and omeprazole, all concomitants were taken for an unspecified indication, start and stop date were not reported.  On 28Jul2021, the patient experienced D-dimer drawn 40 minutes after shot (for APLS unrelated to shot) was elevated at D dimer (value 0.62 mcg/ml feu) and extreme vertigo 17 minutes after vaccine that lasted 30 minutes. The events were reported as serious, life threatening.  The patient underwent lab tests and procedures which included fibrin D dimer: 0.44 ug/ml on 08Jul2021 and 0.62 ug/ml on 28Jul2021 (Standard Range <0.50 mcg/mL FEU). No therapeutic measures were taken as a result of the events. The patient outcome of the events was recovering.; Sender's Comments: Based on possible temporal association and known safety profile,the causal role of BNT162B2 cannot be excluded for reported adverse events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
My symptoms were sore throat, coughing up phlegm. This lasted 2 or 3 days before I was texted for COVID-19. About the third day, I contacted my doctor, who prescribed me PAXLOVID. I have completed this. I still have sore throat a little and raspy feeling in my throat. I also experienced brain fog, fatigue and headache. These are a little better now.
UNDERDOSED; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced underdosed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of underdosed was not reported. This report was non-serious. This case is a duplicate of 20210406991.
Dizziness, Headache, Arthralgia, Fever, Site redness, discomfort, Chills Narrative:
She also seem not to stay awake, was noted to sleep all day long; Two hours after getting the vaccine  she experienced headache; She also has a knot on the injection site which is swollen; She also has a knot on the injection site which is swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (She also seem not to stay awake, was noted to sleep all day long), HEADACHE (Two hours after getting the vaccine  she experienced headache), VACCINATION SITE SWELLING (She also has a knot on the injection site which is swollen) and VACCINATION SITE ERYTHEMA (She also has a knot on the injection site which is swollen and red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced SOMNOLENCE (She also seem not to stay awake, was noted to sleep all day long), HEADACHE (Two hours after getting the vaccine  she experienced headache), VACCINATION SITE SWELLING (She also has a knot on the injection site which is swollen) and VACCINATION SITE ERYTHEMA (She also has a knot on the injection site which is swollen and red). At the time of the report, SOMNOLENCE (She also seem not to stay awake, was noted to sleep all day long), HEADACHE (Two hours after getting the vaccine  she experienced headache), VACCINATION SITE SWELLING (She also has a knot on the injection site which is swollen) and VACCINATION SITE ERYTHEMA (She also has a knot on the injection site which is swollen and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not reported.  Treatment information was not provided.
feeling fatigue; headache; vertigo; nausea; 1sr dose JAN-2022, 2nd on 26-AUG-2022; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in January 2022, refer case US2022128901).   On 26th August 2022, the patient received the 2nd dose of Shingrix. On 26th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 27th August 2022, the patient experienced headache, vertigo and nausea. On an unknown date, the patient experienced fatigue. The patient was treated with paracetamol (Tylenol) and antiemetics and antinauseants (Motion Sickness Medication). On an unknown date, the outcome of the headache, vertigo, nausea and fatigue were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, vertigo, nausea and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022128901   Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and next day after the vaccination she experienced extreme headache, vertigo, and nausea which required her to went to the ER (emergency room visit). The patient also stated that she had also been recently feeling fatigue. The patient's concomitant medication included Tylenol, OTC motion sickness medication. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2022128901:Same patient
On or about 10/12/2020, I developed a rash, middle of back, more painful than itchy. I thought it was an insect bite following yard work, so applied OTC hydrocortisone cream. Shortly thereafter, this rash grew, and a separate breakout occurred on my right front torso. I continue to use OTC hydrocortisone cream but it doesn't seem to help much. Currently, I have a series of painful rashes across my mid-section which appear to  be shingles breakout. None of the breakouts have cleared up; all are spreading slowly.  I had chicken pox as a child but have never had a previous shingles outbreak.  I will also note that I did experience typical side effects from the flu shot the day after vaccination: low-grade fever, body aches, mild diarrhea, nausea, mild soreness at injection site. Fever was gone in 1 day, other symptoms within 2 days.
On 1/25/21 after the first vaccination my thumb joints began to ache.  It is currently very painful to bend my left thumb and the joint at the base of the thumb is swollen. On day 10 after the second vaccination I broke out in a rash on my torso and legs.  It looked like a heat rash. It was not painful and has cleared up.
fever that peaked at 101.8F lasting 3 days, vomiting (through nose and mouth) after breastfeeding--multiple times per day lasting over 3 days. Lethargy, whining, Red bumps at site of injection.
Noticed crooked mouth and paralyzed on right side of face in the morning; Major headaches; Blistered tongue and blistered inside and outside of right ear (very painful).; Blistered tongue and blistered inside and outside of right ear (very painful).; This is a spontaneous report received from contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 10:00 AM (Batch/Lot Number: ER8735) at the age of 47 years as single dose for covid-19 immunisation. Patient had no medical history and no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Major headaches started 05Jul2021. Noticed crooked mouth and paralyzed on right side of face in the morning. Blistered tongue and blistered inside and outside of right ear (very painful). Admitted to Emergency room on 08Jul2021. Date of start of reaction/event was 05Jul2021 9:00. Treatment received included valacyclovir hcl and prednisone. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Outcome of events were not recovered.
Fatigue started 4/20, then fever and chills and shaking, cough 4/21-24 with runny nose, nausea and ice pick head aches, shortness of breath and wheezing. Rapid Covid test negative on 4/23. Continued coughing and after 4 days of ice pick head aches almost constantly, went to ER on 4/25 at 9:30 am.  IV pain meds stopped ice pick headaches after 40 minutes. Meds for cough and urinary tract infection. Discharged from ER after 5 hours. Continue to have fatigue, sleeping most of the day, low grade head ache, nausea, shaking, and one episode of vertical nystagmus.C
When I recieved my first shot in June of 2021, not only have I continued to have stomach cramping,  I have had little to no appetite. I have also missed periods, have had swollen breast tissue. ( yes, I have taken pregnancy tests all 3 were negative)
Temporary loss of vision in right eye. Joint pain for several weeks in injection arm. Menstrual cycle change! Longer than normal cycles.
Left arm swelling and redness. No fever. Recommended ice, motrin and benadryl.  Three patients within one week with reaction to Varivax.
Per admitting MD H&P: Cutaneous leukocytoclastic angiitis (6/10/2021)    Assessment: Sudden onset of leukocytoclastic small vessel lesions. Uncertain cause could be spontaneous. But she also she received a Covid vaccine 3 weeks prior either Pfizer or Madrona which brings up the possibility of a vaccine related vasculitis.  Also possibly is regulated, but the Only drug that is new for patient ciprofloxacin to take this on and off in the past though without issues. No other systemic lesions noted    Plan: Admit IV Solu-Medrol 40 mg now and daily Surgical consult for skin biopsy, notified. Hold ciprofloxacin for now Check an IgA, sed rate, ANA, complement level, ANCA, CRP