chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of discomfort in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (vaccine for the shingles virus a few years ago). On 29th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced discomfort and product supply issue. On an unknown date, the outcome of the discomfort was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was counseled that it was a two part process that required a follow up vaccine within a certain time window within six months from part 1 to ensure effectiveness. After 1st dose the patient caused, local discomfort for several days and have stayed in touch with Pharmacy ever since only to be told literally each month to check back because no additional supplies have been available. It was six months later and the patient was annoyed. The patient asked, what's the matter and when would be able to secure a follow up shot? Would have to start over if this didn't happen soon.
Patient had a mild chest pain; After the bivalent booster, patient had a high fever 101 F; Patient right arm injection site was swollen and achy; Patient right arm injection site was swollen and achy; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Patient had a mild chest pain), PYREXIA (After the bivalent booster, patient had a high fever 101 F), VACCINATION SITE SWELLING (Patient right arm injection site was swollen and achy) and VACCINATION SITE PAIN (Patient right arm injection site was swollen and achy) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced CHEST PAIN (Patient had a mild chest pain), PYREXIA (After the bivalent booster, patient had a high fever 101 F), VACCINATION SITE SWELLING (Patient right arm injection site was swollen and achy) and VACCINATION SITE PAIN (Patient right arm injection site was swollen and achy). On 04-Nov-2022, CHEST PAIN (Patient had a mild chest pain), PYREXIA (After the bivalent booster, patient had a high fever 101 F), VACCINATION SITE SWELLING (Patient right arm injection site was swollen and achy) and VACCINATION SITE PAIN (Patient right arm injection site was swollen and achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 F (high).     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received fifth vaccine as bivalent booster dose. No concomitant medication information was provided. After the bivalent booster, she had a high Fever 101 F, and her right arm injection site was swollen and achy. She also had mild chest pain, but she monitored herself. She did not think that it was necessary to go to the ER and she did not inform the cardiologist. All symptoms went away, 48 hours after the Bivalent vaccine. No treatment medication were provided.   This case was linked to MOD-2021-039119, MOD-2022-670597 (Patient Link).
The patient was to receive Flucelvax and instead received Fluad 65+. Information was looked up and evidence by research and manufacturers the patient experimented stronger local side effects due to the vaccine. Patient's estimated date of delivery is unknown.
She got her vaccine, the only original sensation was the vaccine site.  Then as the day went on she got a headache.  Then at night she was in a lot of pain head to toe.  She could not sleep, her legs had a terrible sensation.  Her right leg had a knee replacement about 5 years ago, and that leg throughout the night felt like it was going to explode.  Her left leg has also had surgery, and that also was in a lot of pain.  She took Tylenol for her pain which helped minimally.  Her teeth started to hurt and she had pain in her ears as well.  The following morning which would be 24 hours later the vaccine she got very nauseous, started vomiting, and she had a throbbing belly, could see it moving up and down.  The pain was a major issue for her.  Throughout the day yesterday the symptoms and pain eased off.  Today, she is almost normal, still has a headache, but all the other pain seems to have subsided.  She did not call her doctor, she did call the pharmacist and asked if she should call the FDA and they told her yes.  She called them and they gave her VAERS phone #.   The pulsations in her stomach did go away within a minute or two.
Triggered autoimmune condition response to gadolinium. Then I had a blood clot one month after hip surgery. Since then, I have had 4 autoimmune flare ups.
2 days after received flu shot, symptoms hit suddenly. Hard to breathe, choking, drainage in lungs, solid chunks of phlegm. Blocked passageway. Couldn't breathe. Did not go to Dr. Feverish-felt like she was on fire, Coughed so hard that her chest and ribs hurt. Symptoms lasted 3 weeks. She was drinking lots of water and lost weight.
severe, rash when I work out on my arms, legs and trunk / light rash on my arms; I am not active; rapid worsening of my vision in the past week; my heart rate is now faster than it has previously been / resting pulse in 72 / my pulse is 85; sedentary all morning; This case was reported by a consumer and described the occurrence of itchy rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included menopause. Previously administered products included Shingrix with an associated reaction of burning sensation (received 1st dose in October 2020, refer case US2021AMR025898). Concurrent medical conditions included allergy to antibiotic (allergies are vibramiacin and gantrin).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary. The patient was treated with loratadine (Claritine). On an unknown date, the outcome of the itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary were unknown.   It was unknown if the reporter considered the itchy rash, feeling unwell, abnormal vision, heart rate increased and sedentary to be related to Shingrix.  Additional details were provided as follows: The patient had no other underlying health issues other than menopause muffin top. The patient received Shingrix in pharmacy and get a severe rash when work out on patient's arms, legs and trunk.  The patient was not active and had light rash on arms. The reporter started on Claritin for the rash and was on one pill and increased the dosage to two pills with the advent of the rash for no reason. The patient experienced a rapid worsening of vision in the past week. The patient heart rate was faster than it had previously been. The patient normal resting pulse in 72 and patient pulse was 85 and had been sedentary almost all with only one cup of tea as a stimulant. The reporter asked how long these effects would last. The patient reported doomed to a lifetime of itchy rash when try to did any exercise that makes perspire or when go into a hot environment. The patient work with a caterer doing events in non-COVID years and cannot imagine anyone wanting around covered head to toe in rash.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025898:same reporter
POST VACCINATION AS PT WAS LEAVING SAID HE STARTED TO FEEL WARM IN FACE, AND THEN HAD SHARP LOWER BACK PAINS. PT WAS SEATED BACK PAINS CONTINUED FOR APPROXIMATELY 3-5 MIN. EMS SERVICES WERE CALLED AND PATIENT WAS EVALUATED
p/vax mom reports pt had a fever that noc;w/in several weeks devel weakness;dx of myasthenia gravis made 10/96;Annual follow-up received on 12/22/00 states provides no additional data.
Dizziness, Headache & Myalgia  Narrative:  Received vaccine at 0900 on 1/22/21, woke up in middle of night with migraine, had taken 2 otc excedrin migraine lasted 24 hours and has has  subsided. Also c/o arm soreness, body fatigue which has subsided . Still Feels  lightheadednes with excertion lasts 10 sec and then clears up, never has had a  reaction to a vaccine before.
I slept 15 to 20 hours a day from Tuesday until Friday.  I also had suffered severe brain zaps.
Incision where knee surgery done has reopened and become infected.   Started spreading opening Sunday 4/4, was placed on antibiotics 4/5 and the wound has progressively gotten more open and deeper since
Arm swollen days later. Painful. Unable to lift with arm. Plan to go to doctor today.
very bad headache; nausea; muscle aches; fatigue; vomited; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 20Jan2021 at 12:15 at a single dose in the right arm for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications  included bupropion hydrochloride (BUPROPION HCL XL) and topiramate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 08:00, the patient experienced very bad headache, nausea, muscle aches, and fatigue. The patient also vomited on 21Jan2021 at 08:00. The patient took Tylenol as instructed by her doctor and rested. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
client complained of dizziness after receiving 1st Pfizer Covid Vaccine (lot#EW0161 Exp. 4/17/21). Client alerted EMT he was feeling dizzy, nauseous, and sweaty. Other medical staff joined EMT. Upon arrival client was sitting on chair, pale, diaphoretic, holding emesis bag. Alert and oriented. Client stated had been sitting approximately 13 mins when he started feeling tingling sensation to both arms below elbow, dizziness, nausea, and chills. Client denied chest pain, shortness of breath, headache or blurry vision. Vitals 1515: blood pressure: 132/90, pulse 60. Client transfered to gravity chair and given water. 1521 client stated tingling sensation was improving, chills were improving, and nausea had resolved. Medical history: sleep apnea. Medications: for gastritis, name not available, per client has not taken in a couple weeks. Vitals 1523: blood pressure: 130/84, pulse 68. Skin color improving, per client dizziness, chills, nausea all resolved. 1530 client stated tingling sensation had resolved. Medical staff slowly began to reposition client back to a straight chair position. Vitals 1532: blood pressure 132/85, pulse 60. No complaints, everything resolved. Client back in straight sitting position without complaints. Client advised to speak to provider prior to second dose. Last vitals at 1543: blood pressure 130/84, pulse 60. Per client feeling fine, ready to leave. Able to stand up with no dizziness. ER precautions given. Client left facility with steady gait at 1546
A non-serious spontaneous report of sore throat, headache and weakness has been received from a registered nurse concerning an unreported number of Public Health Nurses, subsequent to administering FLUMIST. No concomitant medications or medical history was provided. The patients did not receive FLUMIST. The patients experienced the events of sore throat, headache and weakness after administering 50 to 70 doses of FLUMIST over a four to six hour period. The reporter stated wearing a surgical mask while administering FLUMIST immunizations seems to prevent the symptoms. The sore throat, headache and weakness lasted for 24 hours and then resolved.
Information was received regarding a case for ZOSTAVAX (Marrs#1509USA008590) from a consumer and a pharmacist who refers to her husband, of unspecified age. On 31-JUL-2015, the consumer was vaccinated with ZOSTAVAX, and reported that her husband has been diagnosed with "shingles" (secondary transmission) within the last week (date not provided). The consumer explained that her husband visited the local hospital emergency room with a red rash across his chest. Her husband was not admitted. The outcome of the event was not reported. No further information was provided. Additional information is not expected.
10 days post 1st vaccine, redness and swelling of arm at injection site. Slight fever. Mild fatigue.
pt recv vax & pt devel a fever of 102; the following day pt had recovered; reporting nurse felt that there was a problem w/this particular lot; No further details were provided;
Rapid heart rate and feeling of cold almost immediately after receiving vaccine.   Hands turned white and cold.   Left hand tingling.   Not reported to observer.  Unsure if this was related to anxiety or a true reaction.  Chills and anxiety throughout the rest of the day/night.  Insomnia.  Feeling of pressure in head, joint aches throughout the night following vaccine and the next day.  Sore arm.  All symptoms resolved by 01/09/2021.
This spontaneous report as received from a physician refers to a 21 year old female patient. The patient's medical history included thyroid history. On 01-MAR-2014 the patient was vaccinated with second dose of GARDASIL lot # H015863, expiration date 24-FEB-2015, 0.5 ml, intramuscular for family history of Cervical Cancer. There was no concomitant medication. On 04-MAR-2014 (Tuesday) the patient experienced body spasms. In March 2014 the patient's body was "hot to touch" and the patient also developed twitching in an unspecified eye in March 2014. The patient sought medical attention via informing the physician on an unspecified way. No lab diagnostics studies performed. There was no treatment given for the event. The outcome of the events was reported as not recovered. Additional information has been requested.
This spontaneous report as received from a certified medical assistant referring about a patient of unknown gender and age. Concurrent conditions and medical history were not provided. Certified medical assistant reported that a patient received GARDASIL (dose, route, indication and lot number were not provided) on 25-JUL-2013, 16-OCT-2013 and 29-NOV-2013. No adverse effect reported. Additional information has been requested.
Received 2nd dose of Moderna vaccine on L deltoid 01/28/2021 @ 1030. Remained in health clinic for observation for 15 minutes as instructed, no adverse reactions noted. Left observation area without S/S. Arrived back at work location upstairs, at 1050 started experiencing numbness of L arm, L side of neck and face until 1200. Was observed by charge nurse and another RN for any respiratory distress or shortness of breath, did not experience either. Charge nurse notified lead immunization nurse at walk-in clinic, as well as SCN. Both assessed me and symptoms were resolved by 1230.
Headache, Fever, Rash, NauseaVomiting, FATIGUE, BODY ACHES Narrative:  EMPLOYEE STATES SORA ARM, THEN 7PM ON 2/22 STARTED TO FATIGUE AND BODY ACHES. HIGH FEVER THROUGHOUT THE NIGHT 103.5 DOWN TO 101 F WITH TYLENOL; 6AM 2/23 VOMITING AND HEADACHES STARTED AND A TRUBK RASH WHICH RESOLVED WITH BENADRYL  Other Relevant History:
The adverse event is that the patient went into a coma state and was non responsive. Patient spent almost a month hospitalized and transferred into a nursing home. Trauma to the head caused severe orthostatic blood pressure problems, high fall risk, ongoing headaches, and caused patient to be exposed to covid, Be advised patient was tested the day before with a PCR 3 day covid test that resulted in zero antibodies.
Right side head and neck pain, buzzing, tingling, sensitive to sound right side. (Still experiencing these symptoms) Sudden flushing, sweating, nausea, weakness.  Severe upper arm pain, redness and hot to touch In hospital 1/2/23 - 1/3/23 treated with zofran, Tylenol, Benadryl  Initially was treated with heparin as it was thought that I had a venous sinus thrombosis
Chills, fatigue, body aches, left arm pain, was unable to sleep. Headaches. Symptoms lasted for about 24 hours.
SORENESS IN ARM. EXCESSIVE SWELLING IN LYMPH NODES, SAME ARM AS SHOT. LUMP UNDER ARMPIT, SIDE ARMS, CHEST. UN ABLE TO TOUCH WITHOUR PAIN
I developed a limited range of motion with my left arm; I found that there is a problem called SCAR; When reaching up for reaching back there is pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in Left arm on 30Mar2021 at 16:00 (at the age of 74-years-old) as dose 2, single dose for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, cervical disc 5 and 6 replace with a plate and screws in 1995 and panic attack from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in Left arm on an unspecified date for covid-19 immunisation and sulphur, cortisone, ultram [tramadol hydrochloride], codeine, penicillin and experienced drug allergy. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 12Jul2021. It was reported that after the second covid-19 Pfizer vaccine, On 30Mar2021 at 21:00, the patient developed a limited range of motion with her left arm. When reaching up for reaching back there was pain. This was not present before the vaccine. When questioning this event, she found that there was a problem called SCAR. Treatment for adverse events was unknown. Adverse events resulted in Disability or permanent damage. The reporter assessed events as Serious with seriousness criteria of resulting in Disabling/Incapacitating and no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Congenital anomaly or birth defect. As of 12July2021, she was still having this problem. The outcome of events was Not recovered.
Redness at injection site; Mild pain at injection site; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE PAIN (Mild pain at injection site) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Mild pain at injection site). In January 2021, VACCINATION SITE PAIN (Injection site pain) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Mild pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications include Aspercreme Spay. The event of vaccination site pain occurred on January 22, 2021 and resolved  in January 2021. It reoccurred on February 2, 2021 along with vaccination site erythema and outcome was unknown.
Sudden onset of fever, chills, rapid pulse and heart rate increased with muscle aches in shoulders and sudden cramping and spasms in feet. Dry eyes and mucus membranes came with the above symptoms including burning sensation in mouth, eyes, and nose. No illness prior to the onset of these symptoms. The symptoms came on rapidly and are very intense. Fever is 102.3. Symptoms are still present at this time and date.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Patient ID was reported as Unknown. Concomitant medications details were not reported by the reporter. It was reported that 51 doses received to several patient from Lot AS7140C. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details were not reported by the reporter.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. On 29-SEP-2014 the patient was inadvertently vaccinated with an expired dose of ROTATEQ oral, Lot # J004874, expiration date: 26-SEP-2014 (dose was not reported (also reported as "no dose administered")). No adverse effects were reported. Additional information has been requested.
24 hours post vaccine began to experience injection site reaction. Localized tissue reaction including swelling at site, 8cm redness (continues to grow 48 hours post vaccine administration)