chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful; red; swollen; warm; itchy; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain, erythema, swelling, feeling of warmth and pruritus. On an unknown date, the outcome of the pain, erythema, swelling, feeling of warmth and pruritus were unknown.   It was unknown if the reporter considered the pain, erythema, swelling, feeling of warmth and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. GSK employee reports that he received an email communication where someone shared that they were having a prolonged reaction to the dose of Shingrix they received last week.  The reaction was described as painful, red, swollen, warm, and itchy. The reporter did not give consent to follow up. No additional details are available for this adverse event, the person report their reaction declined follow up.
At 3:10 pm,upon arrival at the event pt was laying on cot,she was pale and c/o of dizzy. the vs .water was given,pt stable At 3:20 pm,pt was assisted out.
Sore Left Arm; Pain at the lower right abdominal; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 08Apr2021 at 16:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included fibroids. The patient was allergic to amoxicillin. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 16:00, the patient experienced pain at the lower right abdominal and at 17:15 she experienced sore left arm. The patient also reported that she never had any pain or discomfort at the right abdominal area even though she had fibroid not after she took the 1st dose Pfizer vaccine. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events sore left arm and pain at the lower right abdominal was not resolved.   No follow-up attempts are needed. No further information is expected.
No additional AE/no PQC.; HCP reported patient received PROQUAD and VARIVAX concomitantly in error.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-OCT-2023, the patient received measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, 1 dose, valid lot #X011982, expiration date: 22-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, 1 dose, valid lot #X017483, expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided) concomitantly in error (Accidental overdose). No additional adverse event was reported (No adverse event).
Complained of left arm pain after flu shot; was admitted to hospital due to questionable stroke. Received cardiac/pacemaker work-up (negative). Then saw doctor in pain clinic and was referred to neurologist. Rx for PT, Trileptol and Darvocet. Still having pain. Thinks shot was given too high. The 60 day follow up residual weakness, numbness with occasional flare-ups of pain related to certain positions. Pt feels that flu shot was given "too high" in her deltoid muscle. Neurology report shows encapsulitis.  Follow up 9/10/04: Pt doing so well, just had battery replaced on pacemaker. No longer a volunteer at this hospital. Discharge summary states TIA, facial paralysis, urinary tract infection, degenerative joint disease, abdomenial pain. msv
On June 1st 2021 I got the j&j covid vaccine. 2 weeks later I got severe cramps in my calves and ever since have not been able to walk more than a few steps without pain. Since that time I have received a CT with contrast and have been told I have blood flow issues.
Had a relative that past away due to getting her booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DEATH (death), outcome "fatal", described as "Had a relative that past away due to getting her booster shot". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The causality between the event and BNT162b2, BNT162b2 omi ba.4-5 was reported as not known.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Had a relative that past away due to getting her booster shot
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-SEP-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 which had lot # K007825 with expiry date 13-JAN-2016 (dose and route not reported). No adverse effects reported. No further information provided. Additional information is not expected as the reporter did wish to be contacted.
Information has been received from a licensed practical nurse from the health department concerning a 78 year old female who on 13-DEC-2006 was vaccinated with a dose of Varivax for the prevention of shingles instead of Zostavax. There was no adverse experience related to this event. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Twelve days ago infant was seen for 4 mo well check, and immunizations. The next day he developed a rash on his legs. These lesions would come and go. It spread to his trunk and upper extremities and face. He is still having new lesions daily. Mom has not given any medicine for this. He also has a runny nose. No fever. Acting well. Drinking less than normal. ZYRTEC 1 mg/mL 2.5 mL qid x 1 wk, tid x 1 wk, bid x 1 wk then a day for 1 wk (per immunologist). Pt is to RTC in 10-14 days for recheck.
On 2/2 received 1 st dose of vaccine. On 2/14 developed nausea, vomiting and diarrhea. Admitted to hospital and found to have a troponin of 72 and coronary angiogram done. Endomyocardial biopsy revealed myocyte damage and mixed inflammatory infiltrate concerning for myocarditis. Patient ultimately has started to recover with treatment of methylpred 1 gram x 3 days.
Hives for 6 days moving to different parts of the body, on the 3rd day hands, feet and face were swollen, including tongue. On my doctor's advice I went to the hospital ER
Started noticing some left leg weakness-felt like I have to drag my left leg even while walking short distance. I ignored it thinking it was nothing! But after the 3rd and 4th boooster doses, my left leg weakness worsened and started having weakness in left upper extremity and my balance was poor.
I got shot at 7 am Thursday morning. I had sore arm around 130 pm. And was all day.   At 130 am Friday morning. I woke with chills.  I took my temp. It was 100.8. And he lot as high as 101.2.  Between 130-430.  I woke up again at 630 and it was 100.3.  I have been warm all day now.  I do not feel I need attention o am sweating it out.
profound exhaustion, unable to stay awake even with stimulation,  severe anorexia - unwilling to eat pleural effusion +4 leg edema UTI felt like she was shaking internally (found it painful) felt hot (not common) body aches outcome=death
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated either with GARDASIL (dose and Lot# were not reported), oral ROTATEQ (dose and Lot# were not reported) or PEDVAXHIB (dose and Lot# were not reported) which were improperly stored. No adverse effects were reported. Additional information has been requested.
Severe migrating joint and muscle pain lasting approximately 10 days non stop Required cessation of daily activities including work Symptoms began to abate approximately  March 11
Exposed to other school children with chicken pox. Parents noticed small bumps over body on 04/26/2002.
Pfizer 4/13/21 and 5/4/2021. Positive 1/15/22
Patient developed swelling and tenderness at pneumovax site. No drainage or infection, fever or nodes. Resolved with locally applied ice pack.
Perivaginal ulcer - swelling started day after vaccination, and has gotten worse and more painful since then. Large - 1 cm diameter perivaginal ulcer noted on exam on 1/22/2022
Immediately following vaccine injection, injection site was sore. The injection site soreness eventually subsided, but the arm has continued to have muscular and shoulder pain since, and the pain has increased over time. It has become somewhat debilitating at this point and I believe I have SIRVA from the injection.
In 12/2022, I had distorted vision. I went to an eye doctor. They did cataract surgery and then they realized it was more than that. Then they sent me to a specialist. The specialist doctor had me come back and ran more test and diagnosed me with Wet Macular Degeneration in my left eye on 03/22/2023. The doctor said I needed shots in my eye. I had 2 now, they were a month apart.
I received my annual flu vaccine at hospital as an employee. I received it in my left arm. I had some pain which began a week or so after vaccination. It has now progressed to a frozen left shoulder for which I am now taking medication and physical therapy. The physical therapist says I'm the third patient he has gotten for this same thing in 3 months.
Administer expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 07-APR-2022. The vial did not undergo any temperature excursions. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 19th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, rash and injection site swelling. In May 2018, the outcome of the injection site erythema, rash and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On the next day of vaccination, the patient experienced redness and swelling at the site that resolved within 2 days. She also had a trunk rash that began the next day after the injection and resolved after 3 days. The pharmacist was referred to the patient's healthcare provider (HCP) to determine appropriateness of 2nd injection.
L arm pain at injection site (L deltiod ansd tricep muscle) and stiffness and reduced range of motion in L shoulder. It is slowly improving 3 months after injection but still present. I am seeing my doctor in April, 2022. This started about 3 weeks after the injection of the 3rd dose or the Pfizer booster shot.  I am a physcian and I put myself on a 10 day course of prednisone in February, 2022 and it did inmprove probably 75% after the course of prednisone.
Menstrual irregularities. Spotting, nirmal flow, cessation. Then spotting followed by heavy clotting(larger than a quarter) spotting for 4 days, followed by more heavy clotting.
doctor recommend a male patient get the Gardasil 9 vaccine who is out of the age range; no other issues or AE; This spontaneous report was received from an office manager and refers to a male patient of unknown age. The patient concurrent condition included immune compromised and break of warts in mouth and on tongue. His medical history, drug reactions, allergies and concomitant medication were not provided.   The physician recommended to the patient who was out of age range to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis. No other issues or adverse events were reported.
BREATHING ISSUES; UNCONTROLLABLE SHAKING; CAN NOT MOVE ARMS; CHILLS; MUSCLES HURT; This spontaneous report received from a consumer concerned a 22 year old female. 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: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced breathing issues. On 30-JUL-2021, the subject experienced uncontrollable shaking. On 30-JUL-2021, the subject experienced can not move arms. On 30-JUL-2021, the subject experienced chills. On 30-JUL-2021, the subject experienced muscles hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breathing issues, chills, uncontrollable shaking, can not move arms, and muscles hurt. This report was non-serious.
overnight woke up with arm pain, chills, cough, sore throat, joint pain, weak, cant eat
RECURRING  INTERMITTENT PAIN IN  LEFT ARM FROM 3 INCHES BELOW SHOULDER TO ELBOW  NOT CONSTANT PAIN..WORSE DURING SLEEP WHEN SHE LAYS ON ARM
Difficulty/labored breathing, chest tightness (feeling as if there were 1000 pounds on my chest), chest pain, vomitting, headaches. Symptoms lasted for 11 days.   I was hospitalized at Hospital for 3 days.
Dizziness & slight weakness about 10-15 mins after leaving site (had to wait 15 mins before they let us drive off the site) I stopped by a convenience store to pick up a bottle of water. Severe Headache -started about 30 mins later along with tiredness and chills. Headache subsided after a few hours and then experienced extreme muscle pain in my neck and shoulders along with a feeling of malaise.  Did not take any OTC drugs. Layed down in bed and tried to sleep.
I had like a cold. Runny nose. A fever of 100. Fatigue and I lost my taste and smell for one week. It did return. I feel I had a very light case. I felt a little fatigue and moved more slowly than I did. It was about two weeks I was fine. I am now monitoring my blood pressure because I have suffered Congestive Heart Failure in the past.
hot to the touch; red; itchy; arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE SWELLING (arm got swollen) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Patient is taking medicines for Blood Pressure.), Cholesterol (Patient is taking medicines for cholesterol.) and Kidney stone (Patient is taking medicines for Kidney Stone.).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE SWELLING (arm got swollen). At the time of the report, VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE SWELLING (arm got swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had a runny nose with fever and a fatigue. I also had a headache. I tested for COVID-19 on 02/11/2023 and the test was positive. I contacted my provider on the patient's portal and asked for PAXLOVID. I was taking over the counter TYLENOL and throat lozenges for my symptoms. I began to take the PAXLOVID and felt improvement within 1 day of taking it. I still had fatigue and a slight fever that lasted a few days. I am currently still experiencing the fatigue but the fever as well as other symptoms have gone away.
PATIENT HAD FIRST PFIZER VACCINE 11:58A. AFTER ABOUT 15 MINUTES  IN OBSERVATION, PATIENT STATED HIS THROAT WAS DRY. RN GAVE PATIENT WATER. MINUTES LATER,  PATEINT SAID HE FELT LIKE IT WAS HARD TO SWALLOW. RN CALLED (12:15P) AND:  12:17P - PROCEEDED TO TAKE BP AND SPO2. VITALS 120/86, 96%, HR 92.  12:20P - RT ARRIVED  12:20P - 130/83, 97%, HR 92 12:21P - Doctor arrived 12:25P - TRANSDERRED TO ER PER doctor
Pt recvd 2 doses of Engerix-B & the 1st dose was aproblematic; nausea, h/a, chills, fatigue, sweating & diarrhea devel 6 to 7 hrs p/2nd dose; red blotching p/eating especially cheeses appeared 48 hrs later;
9cmx6.5cm area of erythema left deltoid. Low grade fever 100.2.
sore arm; Chills; aches; malaise; This is a spontaneous report from a contactable physician reported for herself. A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899), via an unspecified route of administration in left arm on 19Dec2020 16:45 at single dose for COVID-19 immunization.  Medical history included pacemaker, insomnia and some preexisting hearing loss, no known allergies. Concomitant medications included unspecified medication received in two weeks. The patient was no pregnant. There was no other vaccine received at the same date of the product and in four weeks. The patient had no COVID prior vaccination. The patient experienced sore arm on an unspecified date, chills, aches and malaise in Dec2020. COVID test (Nasal Swab) post vaccination on 22Dec2020 due to chills, aches and malaise was negative. No treatment received for the events. The outcome of the events was unknown.
Information has been received from a male consumer regarding a case in litigation who in 11/1996, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dos of influenza virus vaccine (unspecified). Within 24 hours, the patient was in the ER with saucer size blotches on his torso, thighs, arms, and sides. Prednisone was prescribed (in descending amounts) along with clobetasol propionate (Temovate) and was ineffective. Two months later, it erupted again with the same results from treatment. The consumer stated he has been undergoing this cycle 4 to 5 times a year and dermatologist have been unable to stop the eruptions. The consumer noted that his quality of life has been damaged. At the time of this report, the patient has not recovered. Saucer sized blotches on his torso, thighs, arms, and sides was considered to be disabling. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 9th September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, injection site warmth and skin red. On an unknown date, the outcome of the pain in arm, injection site warmth and skin red were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site warmth and skin red to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At the time of reporting, the patient still had very sore arm, very warm near injection and red colored patches. The patient wanted to know of this was something to be worried about.
Day One 1.  Within 2 hours of taking shot, I started having pain when urinating and felt like I had to urinate all the time, but no release 2.  Am only able to urinate a few droplets at a time  Day Two 1.  Still struggled urinating  Day Three 3.  Went to see urgent care and was given antibiotic, still waiting to see outcome
Patient returned to pharmacy 8/3 and reported muscle pain occured day after receiving first dose shingrix, then started to break out in hive on right side of neck. Rash still appears on skin 8/3 that is now on back of scalp as well. Patient is going to urgent care to be assessed.
pt recv vax 20SEP96 & 23SEP96 devel CHF w/dyspnea on exertion;cardiomyopathy was confirmed by an echocardiogram;tx in MD office & improved;reported by MD;
Arm sore after injection.  Loss of appetite for dinner.  Woke up around 2:00 AM with chills.  Added more clothes and tried to go back to sleep.  Felt hot and took temperature and had a temperature of 100.  Body aches.  Took Tylonel around 3:30 AM.  Couldn't sleep.  Tylonel helped and I was able to fall back asleep.  Woke up at 6:00 AM for my day.  Fever gone, aches still a little there, tired from lack of sleep and a little bit of chills.  It was a rough night but overall feeling good today.
HIGH TEMP 100 THEN IT WENT UP TO 102  HEADACHE ACHY MUSCLES