chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (no adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #AR9237B) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (no adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses). Concomitant products were not reported. The patient received lower than authorized doses and received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml dose. The reporter had an issue and they incorrectly drawled up the doses. Treatment medications were not reported.
As needle was withdrawn, patient put her head back and tensed up for approximately 10 seconds.  Appeared pale and clammy.  Stated she felt tired and didn't feel well.  Remained seated for approximately 15 minutes before she felt well enough to leave.  We gave her cold water and a wet washcloth to apply to forehead before she stood up.  Was able to walk out of the store with the escort of her partner.  Per partner, patient hit her head very hard the previous day - was experiencing nausea prior to receiving her vaccination.
A report received from a health care professional on 11/11/02, concerning an 85 year old male vaccinee who inadvertently received expired Fluvirin vaccine on an unknown date. No adverse events were experienced by the vaccinee. There was insufficient information to determine the reporter's causality assessment. See ref: PJP200200727
Small localized reaction started day after. Increase to redness, swelling. Spreading down R arm hot to touch.
Fever of 103 even with Tylenol, chills, body aches, headache, nausea for 48 hours. Finally on the third day i am do not have the fever or chills, but headache and stomach pain still.
Child presented to ED following 2 febrile seizures starting at 4 am 5/5/2021. His second seizure was at 1 pm 5/5/2021. He had a 3rd seizure while in the E.D. He ran fever throughout the day and had a fever with his first seizure as well. He received an oral dose of diazepam after his 3rd seizure. He is being monitored in the hospital overnight and will follow-up with a Peds Neurologist after discharge.
Information has been received from a pharmacist concerning a female who in August 2007, was vaccinated with Gardasil.  The patient received the second dose of Gardasil in October 2007 and the third dose in February 2008.  Subsequently the patient experienced pruritus after the second dose of Gardasil.  The pruritus was described as severe enough to require treatment with an unspecified prescription of prednisone for an unspecified duration.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/7/2008. Follow up information received on 24-MAR-2008 stated that the patient's rash was found to be due to scabies. No further information was available.
At my annual dermatologist appointment on 4/5/2017, he saw 2 areas of rash on my abdomen and 1 on each breast. He took a biopsy. On 4/20/2017, the report showed mycosis fungoides, a rare non-Hodgkin's lymphoma also known as cutaneous T cell lymphoma, or cancer. It is incurable, treatable, and chronic. I am stage 1A. I went to the Hospital clinic on 10/30/17. I have flare ups of painful rashes on my waist and upper legs, cherry angiomas rash under jewelry. I am on clobetasol cream, next is nitrogen mustard ointment. Treatments for cancer tests and doctor visits are very expensive! There is no cure, the rashes come and go forever, get thicker, more percentage of skin, and possibly tumors, and death. The rash is usually itchy, but mine is painful to the touch, similar to shingles. I hope no one else gets or has gotten this cancerous rash after a ZOSTAVAX vaccination.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 2:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 2:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 21.02.  Concomitant medication of the patient was not reported.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature of 35 degrees Fahrenheit at 09:00 AM and 10:00 AM respectively. These vials were moved to fridge on 23-Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. The vaccines moved to clinic on 27-Mar-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
Vaccine was administered the Moderna COVID vaccine.  He explained that he was nervous/anxious about receiving the vaccine.  I waited until he was ready, and explained that I could perform a countdown to immunization (3-2-1 and on 1 I would inject).  He agreed.  I also mentioned that he should not look while the immunization was occuring.  He also agreed and looked away.  Once the immunization was complete, he said he felt great and requested that I give him his second shot when it was time.  I advised him that it is recommended to wait for 15 minutes after vaccine administration for monitoring of side effects, and he declined stating that he felt fine and ready to leave.  Shortly after leaving, he crashed his motor vehicle and totaled his car.  The patient was left with no injuries.
My menstrual cycle has changed. I currently have the paraguard iud implanted and I was due for my period the weekend after I got the 1st shot. I have yet to get my period but I am spotting lightly as; I have yet to get my period but I am spotting lightly; This is a spontaneous report from a contactable Consumer (Patient). A 29-year-old non-pregnant female Patient received first dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: ew0202 and expiry date was not reported), via an unspecified route of administration into left arm on 19Jul2021 at 13:15 (01:15 PM) (at the age of 29 year) as dose 1, single for COVID-19 immunization. Patient did not receive prior vaccinations within 4 weeks of covid-19 vaccine. Medical history was none, and concomitant medications were not reported. The patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for Covid-19 since the post vaccination. On 24Jul2021, the patient stated that her menstrual cycle was changed. She currently has Para guard IUD implanted and due to her period, the weekend after she got the first shot. She was yet to get her period but spotting lightly as if it was her period, but it has lasted about a week now and she was not sure yet if my period will come or not. Laboratory test on 21Jul2021 included Nasal Swab (Rapid AG) resulted Negative. Patient did not receive any treatment for adverse events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
About 7 days after my vaccine was done, I noticed my arm was swollen and had a hard bump and hurt very badly every time it was touched, it showed up days after never before.
I Have been very tired; I have to nap several times a day; I also have periodic headaches; This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fatigue, somnolence and headache. On an unknown date, the outcome of the fatigue, somnolence and headache were unknown.   It was unknown if the reporter considered the fatigue, somnolence and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the the patient was not reported but selected as an adult as per vaccine indication. The patient received dose of Shingrix in 1st week of February 2020 and had very tired, had to nap several times a day, and periodic headaches.
Started 04/15/2003:  Mild case of chicken pox (10 lesions) after receiving varicella on 04/30/1999.
pt was given both varicella and mmr intramuscular, supposed to be given subcutaneous. we called manf after discovering error, they said shots do not have to be redone, pt notified.
Arm was a little sore shortly after having received the shot, but soreness increased over time. As of 12/18/18, her arm was still sore and couldn't raise her left arm as high as she used to. She refused to get the second shot due to the soreness.
After 7 years without menstruation due to Mirena IUD, patient experienced regular menstrual spotting and a 2 day period in the months following the second vaccination
Cold feeling comes and goes; Can't get up and go; Felt "punky"; Felt like she had no strength" in her legs and felt "punky/ felt weak in her legs; Balance was off; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt like she had no strength" in her legs and felt "punky/ felt weak in her legs), BALANCE DISORDER (Balance was off), FEELING COLD (Cold feeling comes and goes), GAIT INABILITY (Can't get up and go) and FATIGUE (Felt "punky") in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Reflux esophagitis, High cholesterol and Allergy to antibiotic (Allergic to antibiotic (name unspecified)). Concomitant products included PRAVASTATIN, FAMOTIDINE and DILTIAZEM for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Felt like she had no strength" in her legs and felt "punky/ felt weak in her legs), BALANCE DISORDER (Balance was off), GAIT INABILITY (Can't get up and go) and FATIGUE (Felt "punky"). On 11-Mar-2021, the patient experienced FEELING COLD (Cold feeling comes and goes). At the time of the report, ASTHENIA (Felt like she had no strength" in her legs and felt "punky/ felt weak in her legs), BALANCE DISORDER (Balance was off), FEELING COLD (Cold feeling comes and goes), GAIT INABILITY (Can't get up and go) and FATIGUE (Felt "punky") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
pt recv vax 8JAN98 & 9JAN98 pt exp fever, swelling, chills & cellulitis spreading down the entire leg;
Back pain; Back and hip problem; she is in pain; Feeling wiped out; feeling bad in the morning; Loss of appetite during lunch and dinner; Achy feeling in the body and always wanted to go to bed and sleep; Achy feeling in the body and always wanted to go to bed and sleep; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCCINE; Batch/Lot number was not reported), via an unspecified route of administration on 09Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. In Mar2021, the patient experienced back pain, back and hip problem; she was in pain was feeling wiped out; feeling bad in the morning and then loss of appetite during lunch and dinner and had achy feeling in the body and always wanted to go to bed and sleep. She was supposed to receive a medication and injection for her pain but her doctor advised her that after second vaccination only the doctor will give that medication because he was concerned whether that would have an effect of the vaccine to. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever (101.7)- 24hrs Increased resting heart rate (125BPM)- 24hrs, took about 2 weeks to reduce back to baseline around 70s Headache Chills
Thirty minutes post vaccine client developed a red rash "from red to toe" and stated her body felt hot "like a sunburn" and her legs "felt like they fell asleep". No difficulty breathing. In formed Mom to go directly to ER and take Benadryl PO if available. Mom did go to ER where child received Benadryl and Zantac PO. Dischrged same afternoon Fl RN called mother next day and child has fully recovered. Fl RN.
Chills, fever, swelling in face where facial filler had been - this is the worst and most continuous adverse effect now three full days later
Next morning, I woke up with severe positional headache (headache with standing or sitting up, resolved completely with ibuprofen and tylenol within 20 minutes). The next morning I also had a sore left deltoid, and soreness extending into my left chest and shoulder, which diminished throughout the day after ibuprofen and tylenol. I also had a left swollen armpit, which I interpreted as swollen lymph nodes. My left armpit was sore and was visibly swollen compared to the right. The left lymph node is still visibly swollen as I report this (approximatley 36 hours after vaccine administration), and is sore but less sore than initially.   Of note, when I received the first vaccine in this series, my left deltoid was more sore than with the second administration, but soreness was limited to the deltoid and resolved within 3 days.
arm bothering her, cant lift arm, went to orhto, he ran xrays and all was clear. pt is going to start physical therapy and now taking antiinflammatory
Always had extremely regular periods of 6-7 days, never had any breakthrough bleeding, since vaccine period was two weeks late twice and have had very long periods of up to 12 days. and breakthrough bleeding, still ongoing as of Oct 2021, I do not take any birth control or other medications containing hormones
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/16/2021. Patient presented to ED on 9/25/2021 and found to have pneumonia secondary to COVID-19. He began to develop symptoms around 9/14/21 and was diagnosed on 9/15/21. He was started on ceftriaxone, azithromycin, dexamethasone and baricitinib.  He also was managed with LABA and SABA.  Despite this, he continued to deteriorate and required increasing oxygen support and was brought to the ICU on 10/5/21 in respiratory distress and he was intubated. Post intubation CXR revealed a large right sided pneumothorax which was managed with chest tube.  He required additional pressor support due to deep sedation.  Patient developed AKI on 10/7/21 and started on CRRT. On 10/9/21 the patient experienced acute desaturation and epoprostenol was started. Patient continued to deteriorate and expired on 10/15/2021.
12-10-08 approx 10 pm pain R shoulder, fever up to 104. Pain, redness and swelling increased during next 4 days. 12-14-08 Admitted to hosp from IC. Fever, headache, photophobia, nuchal rigidity. R deltoid area red warm, tender. Treated with IV fluids, warm compress, NSAIDS. D/C 12/16/08 no follow-up.   1/7/09 MR received for DOS 12/14-16/2008 with D/C DX: Adverse reaction to pneumococcal vaccine.  Aseptic Meningitis.  Local Reaction at site of injection. Pt presented to ER with fever of 104.9'F, progressive shoulder pain and frontal H/A x 3 days since receiving pneumonia vax.  ROS (+) for fever, chills, malaise, fatigue, diaphoresis, H/A, photophobia, eye pain and redness, cough, nausea & diarrhea, neck pain, dizziness, tingling. PE (+) for bilateral injected conjunctiva, photophobia, limited ROM of the neck, wheezing and crackles R lung, erythema R deltoid, dilated veins of R chest. Initially tx with abx which were d/c with CSF results.  Improvement noted with IVF and NSAIDS.
a lump that formed under a finger length size away from injection site; the first 3 days I was running high fevers; had terrible head aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump that formed under a finger length size away from injection site), PYREXIA (the first 3 days I was running high fevers), HEADACHE (had terrible head aches) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (a lump that formed under a finger length size away from injection site), PYREXIA (the first 3 days I was running high fevers), HEADACHE (had terrible head aches) and CHILLS (Chills). At the time of the report, VACCINATION SITE MASS (a lump that formed under a finger length size away from injection site), PYREXIA (the first 3 days I was running high fevers), HEADACHE (had terrible head aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a nurse practitioner concerning a 52 year old female with COPD, HTN and GERD who on Oct 14 2004 was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 647657/0947N). Concomitant vaccine therapy given intramuscularly in the left deltoid included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1410BA). There was no illness at the time of vaccination. That same day the patient developed shortness of breath, and erythema, induration and diffuse edema in the right upper arm. That night the patient visited the ER after developing a fever. After several days, the patient recovered. the patient did not have any adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected.
migraine - intensified every two hours overnight waking me up each time. I took 600mg of ibuprofen to help reduce intensity body aches- head/neck/arm chills sweating sore arm including swelling at injection site the shape of the bandage
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The reporter was patient wife stated that she and her husband were fine after the first dose, they both just had a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
woke up with her legs burning on fire; fatigue; body aches; Chills; went to bed and slept through the night; 1.5 hours of sleep a night because of the constant pain around the clock; The burning turned to pins and needles feeling that started at the top of; could not wal; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (went to bed and slept through the night), BURNING SENSATION (woke up with her legs burning on fire), PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of) and GAIT INABILITY (could not wal) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21a and 004M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced SOMNOLENCE (went to bed and slept through the night), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (Chills). On 04-Mar-2021, the patient experienced BURNING SENSATION (woke up with her legs burning on fire). In March 2021, the patient experienced PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of) and GAIT INABILITY (could not wal). At the time of the report, SOMNOLENCE (went to bed and slept through the night), BURNING SENSATION (woke up with her legs burning on fire), PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (Chills) outcome was unknown and GAIT INABILITY (could not wal) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-051146 (Patient Link).
devel lt upper arm deep muscles & shoulder (sick pain) 3 days p/vax;