chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Feb-2021, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-027049, MOD-2021-026665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up document received  included no new information. NNI for daughter case
9AUG93 vax administered 330PM; 10AUG93 930AM nausea/vomiting; 10AM temp inc & h/a then n/v x 4 hrs; 7PM chills & sleepy-delerious; poss viral illness;
Information has been received from a 20 year old female patient reported herself who completed the vaccination schedule for GARADSIL. After that, in June 2009 she experienced abnormal PAP Smears. No lot number provided. The patient sought unknown medical attention. At the time of report the patient's status was not recovered. No further information is available.
My arm was sore and hard to move immediately after the shot for about five days, however pain seemed to be decreasing.  Then pain came back a week later, and now it is sharp and stabbing whenever I lift my arm up and across my body (the motion used to remove my shirt).  Does not seem to be getting better.  Research online indicates this can happen when the shot is given high up on the shoulder, which mine was.
four patients received expired Moderna COVID-19 doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (four patients received expired Moderna COVID-19 doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Flu like symptom 24 hours after second shot then, not steady balance. Now, constant hissing sound.
MASSIVE BRAIN BLEED; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. 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: Unknown, expiry date: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that "my mother had a massive brain bleed 2 weeks after the you know what". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive brain bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211139481 -covid-19 vaccine ad26.cov2.s- massive brain bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient presented to the ED and was subsequently hospitalized for DVT on 4/7/21. She also presented to the ED and was subsequently hospitalized for pulmonary embolism on 5/7/21. These visits are within 6 weeks of receiving COVID vaccination.
Pt rec'd DTP instead of TD as a booster; Developed t102 & felt dizzy & shaky; lt arm hurt x 1wk & for past 1wk; Has had arm pain & chest hurts across & goes down lt leg; Discomfort comes & goes last up to an hr;
I did not have a reaction to the vaccine. I tested positive for COVID-19 with a home test on 12/12/2022. I went to an urgent care to be tested and it was confirmed positive. I did not have any symptoms prior to 12/12/2022. I was given the prescription for Paxlovid.
I noticed maybe 2 months after vaccine that it was taking me longer to do normal job functions like reading and doing reports and those kind of functions, and that's when it became obvious to me and thinking it was going to do away and it didn't , so it was just taking a long time to do job functions. In addition to that, I'm not sharp cognitively, I have malaise a little. I can still do my job but I'm just not as sharp. I'm scheduled to talk to Doctor over phone today. I did have blood work done a couple of months ago but it didn't show anything alarming.
Post vax, the pt developed cellulitis of right leg. Treated with Keflex for 10 days.
Patient states her arm was red, hot, swollen, and hard around the site of injection the evening that she received the vaccination. She went to urgent care and received a prescription for prednisone and an antibiotic. She then went to see her family practitioner about the incident. After receiving treatment it took one week for symptoms to resolve.
Information has been received from a registered pharmacist concerning nine patients of unknown age and gender. On unspecified dates, the patients were vaccinated subcutaneously with a 0.65 ml ZOSTAVAX (frequency was not reported) (Lot #: H011427; Expiration date: 12-SEP-2013), that had been improperly stored, exposed to 40 F for 30 days. There were no adverse effects. Follow up information has been received form pharmacist considering a 63 years old patient of unknown gender, who on 29-NOV-2012, was vaccinated with a dose of improperly stored ZOSTAVAX. Pharmacist reported that the vaccine excursion began on 26-SEP-2012, excursion was not discovered until 29-NOV-2012. This is one of several reports received from the same source (related MARRS numbers: 1212USA00449, 1212USA005678, 1212USA005677, 1212USA005679, 1212USA005681, 1212USA005680). Pharmacist reported that in the interim seven (not nine) patients were vaccinated with ZOSTAVAX that was improperly stored. Additional information is not expected.
Red, inflamed circle around injection site with swelling.  Patient described it as having a knot under the skin that was itchy and warm to the touch.  Patient went to her family physician and was prescribed Cephalexin and Naproxen.
Symptoms began with feeling hot, flushed, and itchy on neck and scalp. At 9:00PM small red marks could be seen below the breasts, across the abdomen, and on the should blades. By 6:30 AM hives were all over my body with rings of red under the breasts and around the back, around my lower abdomen across the hips and around my lower back, along the backside, shoulders and shoulderblades. My hands were red, hot, and itchy. My ears were red, hot, and swollen. There were red marks all over my body in various sizes and visual patterns. I felt very hot and incredibly itchy. I managed the impulse to avoid scratching uncontrollably. At 7:15 AM I took 50mg of Benadyll and again at 1:30 PM. My hives subsided gradually and were visible through Sunday morning.
mom notified office about pt's condition about 18 hrs p/onset diarrhea; pt seen immed appeared to be in shock due to severe dehydration; mild jerking of extremities w/eyes fixed, skin dry & fontanel sunken;
Multi-organ inflammatory reaction:  -Inflammation of the heart: skip beats, speed up, slow down, chest pain,  out of breathe -Enlarged lymph nodes  -Inflammation in the mesentery: severe gut pain and constant nausea for over 4months! Could hardly eat.  Very sick.  Persistent enlarged lymph nodes in the mesentery: not lymphoma. Biopsy showed necrosis! (Death) and granuloma inflammation.  -Entire esophagus & stomach lining Red & inflammed  -Tiny blood clots coming from GI tract exactly 2 weeks and 1 day after 1st and 2nd doses.  -Liver pain and raised ALP -Enlarged spleen & spleen pain  -Lung nodules  Enlarged lymph nodes persist past 8 months and continue.  Nausea improved but persistent.   Heart improved after 4 months
Client developed fever, HA, exhaustion secondary to > vaccine & lasting x 24 hours - 30 hours.
Pt got 2 shot in same arm, flu and ppsv 23 on 10/17/2017. Pt and her husband stop by us today (10/19/17) and husband told me that his wife has reaction (swollen arm) after ppsv 23. He show me the pictures of swollen arm which look big and red. They went to urgent care (ER) and pt was prescribed doxycycline by doctor. Pt is in slight pain due to swelling but husband says she is ok and safe now.
Started around 12:30am, convulsions, chills, rapid heart rate and high blood pressure, took 2 Advil  104 fever, profuse sweating Given 2 Tylenol at hospital
Began vomiting during the night, about 12+ hours after vaccination. Vomiting stopped by the next morning.
Breakthrough case admission after 3 vaccines Pfizer 3/11/21 lot# En6207;  Pfizer 4/1/21 lot# ER8732;  12/14/21 Pfizer lot#33130BA
Palpitations began 24 hours after the Pfizer booster vaccine in Nov 2021  and have continued daily. Now under care of cardiologist. No previous heart problems.  Prior 2 dose vaccines were Moderna administered Jan & Feb 2021 with no cardiac effects.
pt woke up @ 4AM on 9OCT92 pt was very hot, temp not taken; pt was hallucinating; temp was 101 @ 8AM, nl by evening;
Arm pain for a few days; fever 103; on and off low grade few; headache; chest congestion in the morning; coughing yellowish mucus.
Patient phoned pharmacy to report adverse reaction to ADACEL vaccine. Patient stated that an area the size of her palm appeared the day after the vaccine was administered. The area is red and elevated. Pharmacist spoke with ordering physician, and scheduled a follow up for the patient to see the physician the day of the reported adverse reaction (4/27/2018 @ 04:15 pm).
She had shingles in the past after a trial of shots in her knees, thought it was pimples on her face, went to her PCP and found out that it was from the knee injections, which they had stopped and forgot to tell her that it was due to shingles that they discontinued it.  Her father also had a history of shingles, bad case.     She got her vaccine and within a few minutes of getting it she started itching.  By the time she got home it was welling up.  She called the pharmacy back who told her that it was some of the reaction other people have.  The next day it got worse, she called her PCP and she went on line and read about it, and it said that more people have reaction to the 2nd one than the first.  It started with itching, and turned into the size of a donut ring of flat rash.  It did itch, did not scratch it, was terribly hot and did swell.  Right in the middle of the injection site is about the size of a quarter turned black and blue and turned black last night.  Today it is starting to go down and not bothering her nearly as much.  She also had a sore throat, felt nauseated and felt that she was coming down with COVID.   She does use gloves and a mask when she goes out and uses the N95 mask.  She took a COVID test and it was negative.   Saturday was the worst day.  She was instructed to go to the ER on Saturday, which she did not.  She was not given any recommendations.  She takes Zyrtec, as well as Singulair and Meclizine and those three combined did help her itching.  She did try putting some ice on it one night to reduce the swelling.   She did not take her fever as she is on heavy pain medicine for her severe arthritis and did not feel that it would register.  She did feel she had a fever though, but still has the rash, but much improved.  It is still bruised and some rash around it.
8/20: 6 hours after injection began feeling sluggish with mild headache; afebrile ; left arm exquisitely tender 8/21: 12 hrs after injection (5:30am) full blown and extensive myalgias & arthralgias, headache, and fever up to 101.5; by 6pm I could no longer tolerate the aches/pains and took acetaminophen 1g po - repeated again at 10:30pm.  8/22: much improved, but extreme fatigue, febrile @ 100.0, down to 99.0 by bedtime; arm tender only to direct contact 8/23-25: residual fatigue, afebrile
400 mg aleeve@10:00am Vaccine at 11:45am Temperature 96F @ 2pm 400 mg acetaminophen @2:30 96.5F @ 6pm 98.3F @ 11pm 101.1 @ 3am  Fever, chills, body aches, general malaise, exhaustion yet restlessness/inability to sleep
Pt. reported incident via pc on 1-28-13. She came into clinic on 1-29-13 for the nurse to complete the VAERS form and evaluate the pt. She reports that she noticed redness and itching at the site on 1-23-13. The redness spread to the size of her hand with firmness. She also reports fever at the site. On 1-26-13 she reports that it began to improve. On 1-29-13, RN observed that the area is normal color, no fever at site, there is firmness measuring 3 inches x 2.5 inches. Discomfort has resolved. Advised her if she had any problem to notify the clinic and to see her PMD.
Fever and URI on 11/10; fever 101-102.4. Red, raised areas started on 11/13 on shoulder, knee, thigh and face. Seen in office on 11/16.
Tinnitus in both ears on and off SINCE 2nd Covid19 Vaccination dosed on 3/25/21...IMPROVED in March of 2022.  Went for my 4th booster on 6/21/22 and 2 days after experiencing full Tinnitus in both ears, HEADACHE, and Jaw Pain!  I know the Tinnitus issue is specifically from the vaccine because I've NEVER experienced Tinnitus prior to it.  After my initial 2nd shot (from the series) 36 hrs. after I heard "Crickets" thinking it was coming from outside my window BUT the Cricket sound followed me for a few hours.  Shortly after both my ears began to ring and buzz annoyingly and constantly.  I went to see an ENT Specialist in May of 2021 who examined me and said there was nothing that could be done!
FATIGUE FAST HEART BEAT DiZZiNESS  Side Effects lasted off + oN for 24 HOURS
pt felt very dizzy and hot flashes, perspiration, we made her lay dowm and kept talking to her to se was okay, took BP 1st reading 110/85, 2nd reading after 15 min, 110/90. gave some water and she ended up eating a banana,  made followed up call around 05:30 pm 04/27/2021 pt was okay at home normal BP and she was normal
Received injection on 1/30/03. Called office on 1/31 c/o redness from inject site left arm to shoulder, swelling, warmth, and vomiting. Went to ER told to give PT Tylenol. T.C. to PT on 2/3/03. Mom states PT is fine now.
Local swelling and itching over vaccine site - received Zoster Vaccine previous day. 2 inch x 3 inch area.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-month-old patient of unknown gender. On 05-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N020352 (expiration date: 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Three to four hours after the 1st dose of the Covid 19 Vaccine, administered on 2/16/21, I was wheezing heavily.  I wheezed for a couple of weeks, it dissipated somewhat until I saw the doctor on 3/4/21.  I was given a course of treatment of inhalers and a week on steroids to help . I received the 2nd dose of Covid 19 Vaccine on 3/16/21.  Three to four hours later that day, I again began to wheeze.   I continued with my inhalers.  After a week the wheezing disipated.  I went to see a pulmonologist at the end of March, and had a breathing test.  I was still wheezing and had difficulty breathing .  He prescribed an additional inhaler, and I am improving gradually.  I do have a history of asthma.
HEADACHE, Myalgia, NauseaVomiting, chills, hot Narrative:
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
patient experienced a massive brain stem stroke on the morning of Friday, April 2, 2021. He was found minimally responsive on the floor at home and rushed to  Medical Center which has a comprehensive stroke center. Imaging and testing determined there was no chance of recovery that would restore meaningful quality of life. The family removed life support on Saturday, April 3, 2021.  Of note ,Patients sister, also, similarly suffered  mild stroke shortly after receiving her 2nd Pfizer COVID-19 vaccine. Her recovery is ongoing and her family has been encourage to also report to VAERS.
Patient arrived to receive 2nd dose of Moderna on 5/5/2021 at 10:18. five minutes into the 15 minute post COVID vaccine administration monitoring, patient started experiencing side effects:  10:23:Patient reported dizziness, lightheadedness, became pale and clamy, with nausea. Patient request water and was given 16 oz water bottle. Patient reports that she did not eat breakfast, has no hx of allergies, and has hx of anemia. Patient currently taking Iron and B complex supplements. BP 52/33 P 53 o2 Sat 91% on RA. Patient took a bite of a brownie.  1025: medical response team arrived. Patient assisted to laying position with feet elevated.  10:28: Pulse 64, Pulse ox 91% on RA  10:30: Verbal order received to assess blood glucose. BS 79, BP 88/58 P 62. Denies nausea  10:33 Verbal order received to give Glucose 4g Tab by mouth on-time. Patient consented.  10/35: Patient denies nausea, denies dizziness, skin is dry and skin color is normal for ethnicity. BP 92/61 P 81 o2 Sat 98% on RA  1036: reassessed patient. Patient continues to improve.  monitor patient for 10 more minutes in flat position then assist patient to sitting position for an additional 15 minutes and continue to monitor.  10:40: BS 118  1041: 96/64 P 70 O2 sat 98% on RA  1046: Patient assisted to sitting position and reported light dizziness. BP 87/57 P 65, o2 sat 94% on RA. Patient drank 8 oz. of water.  1051: BP 86/58, P 70 o2 sat 93% on RA. Denies Dizziness  1052: reassessing patient. Patient denies dizziness, denies lightheadedness, denies nauseouosness, skin dry and skin color normal. Patient to be monitored for an additional 12 minutes. If continued progress patient is ok to go home. Patient has driver present at this time. Patient encouraged to change positions slowly, continue to hydrate, eat meals. If issues arise and continue patient encouraged to contact her PCP or visit closes urgent care or ER. Patient verbalized understanding.
BLOOD CLOT; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. 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 and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient died of a blood clot from the Johnson and Johnson vaccine. It was reported as reporter's pharmacist had a patient whose husband died of a blood clot from the Johnson and Johnson vaccine.  It was unknown if an autopsy performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220530466-Covid-19 vaccine ad26.cov2.s-blood clot . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Today (10/29/12) pt called stating that 3 months after a typhoid vaccine was given, she experienced severe pain and numbness & sensitivity in her (R) arm x 1 month. States has seen by 2 orthopedic physicians who could not find a reason for the pain. States today, "arm is no longer painful - only "sensitive". Pt was sent a recall letter last week regarding typhoid vaccine recall. Was advised no ill effects from vaccine only diminished vaccine protection.
admitted w/ intractable nv due to diverticulitis and soa d/t covid, requiring o2 tx w/ remdesivir and dexamethason
Patient notified us regarding rt. arm redness, swelling in upper arm 3x5 area, warm to touch. 8-10 hours after injection.  Took tylenol, took it easy.