chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain/pain/entire arm and entire body; Tingling; Shoulder pain; pain at injection site/entire arm; Inappropriate schedule of vaccine; Headache; Flu Like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included chicken pox.   In November 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 10 and 11 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain, tingling sensation, headache, influenza-like symptoms, shoulder pain and incomplete course of vaccination. On an unknown date, the outcome of the general body pain, tingling sensation, headache, influenza-like symptoms, shoulder pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the general body pain, tingling sensation, headache, influenza-like symptoms and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient states he received the first dose of Shingrix vaccine in early November of 2018.  It had been over 6 months and he has not yet received his second dose of the Shingrix vaccine.  The patient experienced headache and flu like symptoms that lasted for about 3 days.  The patient also experienced pain at injection site, entire arm and entire body.  Now the pain was still present only at the shoulder.  The patient also had soreness present near the upper shoulder, and sometimes he gets a tingling sensation radiating from shoulder down.  The patient mentioned he has had chicken pox as a young boy. The reporter did not give consent to follow up. No further details were provided.
hospitalized with eye shingles; first dose on 2019, in 2022 received second; This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number A4D72, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2019, the patient received the 1st dose of Shingrix. In January 2022, the patient received the 2nd dose of Shingrix. In January 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced ophthalmic herpes zoster (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that the patient received a dose of Shingrix and on an unknown date the patient was hospitalized with eye shingles. In January 2022, after reporting eye shingles, the patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow-up.
I had lymph nodes in my left arm were swollen from the 28th to 31st of October. I had a fever; I didn't check it on Thursday, but I did have it on the 29th and 30th. I had a headache from the 28th the 29th. From the 28th to 30 of Oct, I had aches and nausea on the 29th. I had chest pain and shortness of breath. I also had fatigue. I still have shortness of breath. It mainly occurs when I had to step out of the apartment. I had a COVID-19 test done on Friday and it came back negative. I took Tylenol to help with the pain and the complications.
I developed a fever of 100 or so a couple of days after the shot.  IO think the fever caused the mild seizure. In the past I have had Grand Mal seizures which were very severe. I have not had one of those for over 15 years. I went to the Clinic and saw Dr. (Privacy) who prescribed medicine for my headaches. Because the headaches continued, I visited my neurologist and had a CAT Scan to see if there was any change in my condition since my previous scan that was done years ago. The scan found no change.  Eventually the headaches subsided but I still have them occasionally. Since then I have also had a number of days of fatigue   I feel that the seizure was caused by the fever which was reaction to the vaccine. But I do not know what is causing the headaches.
ON 2/5/22 PT WAS GIVEN THE PEDIATRIC DOSE WHEN THE ADULT DOSE WAS INDICATED.  PT WAS UNDER THE AGE OF 12 WHEN SHE RECEIVED HER 1ST DOSE  ON 12/7/21 HOWEVER RETURNED ON 2/5/22 FOR HER 2ND DOSE AND WAS 12 YEARS OLD.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date (dates) those patients were vaccinated with ROTATEQ (dose, units, route of administration, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Patient experienced pain and burning that radiated from left arm to neck. She stated she became short of breath, dizzy, rash, and loss of function in the left arm. Patient's husband contacted 911 and administered EPIPEN at direction of EMS.
inconsolable crying for 5 hrs approx 36 hrs p/vax given; mom gave APAP for 1st 24 hrs;
My top lip felt funny like when you get novocaine or a fat lip, it felt numb then 30 minutes later it went away. But as it started to go away my lip was tingly and prickly.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication was reported. No treatment medication was reported.  This case pertains to the 8th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
On 9/25/10 patient received both Flu & Pneumo on right. On Sunday he noticed a bump on right arm & has fever & runny nose. Feels bad & tired. He said his wife put some pain ointment on it.
Got pfizer 3rd dose on 13Sep2021; Got pfizer 3rd dose on 13Sep2021; Doesn't know if pain in her hips/right back is because of shot or because of side effects; Doesn't know if pain in her hips/right back is because of shot or because of side effects; This is a spontaneous report from a contactable other healthcare professional. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Sep2021 (at the age of 55-year-old) as dose 3, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 and dose 2 via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient reported she has not had side effects but got Pfizer 3rd dose on 13Sep2021. She does not know if pain in her hips/right back was because of shot or because of side effects in Sep2021. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021
flu like symptoms; Headache; fever; Joint pain; chills; 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: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced flu like symptoms, headache, chills fever and joint pain. 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, and emergency room/department or urgent care. The clinical outcomes of the events flu like symptoms, headache, chills fever and joint pain was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
broke out in severe, diffuse vesicular, erythematous rash;15SEP97 extends in large patches over arms, trunk, mostly persists 25SEP97 w/secondary infect;
Tinnitus in right ear, which is progressively getting worse. Whooshing sound in head, especially when laying down. Pressure behind eyes, intermittent swelling on upper cheek and eyelids. Vision problems, especially when changing position from laying down to getting up, sitting to standing, where there is a gray curtain that moves slowly across the field of vision. Head constantly feels pressured and almost as though there is fluid build up.
Pfizer vaccine booster.  Patient claims worsening shortness of breath and body aches for past several aches since having pfizer booster in March.  She did have a relatively severe case of coronavirus in December 2021.
Pt presented to ER via EMS with cpr in progress; per ems, they were called for sob, pt was awake and talking when ems arrived but collapsed and quit breathing upon being placed inside the ambulance; pt was intubated and had 7 epi?s and bicarb w/ brief returns of palpable pulse followed by bradycardic pea; coded for approx. 40 min pta; arrest occurred at home; defibrillation was not performed; external pacer not used; pt was COVID positive PMH: Cancer-breast, diabetes 2, htn Medications: hydrocodone acet 10-325 q6h prn, lantus solostar u-100 (3ml), losartan 50 mg qd, oxybutynin chlor 5 mg bid, Prilosec 20mg oral cpdr 1 cap daily, rosuvastatin 10mg qd, zolpidem 10mg qd
02/22/2021  My joint getting steeper, I have pain in my whole body, my doctor told me that my remit Arthritis was triggered after a week of vaccine. My remit factor went from low to high. My doctor gave me a steroid 40mg for 3 days since it didn't work my doctor game me a steroid 60mg to control my pain. I took it for 3 weeks. Prednisone to help it better. The patient has blood work before vaccine and blood work was also done after the vaccine.
Feels like a swelled Lymph node under my right armpit , the same arm I received the injection , it?s about the size of a half golf ball
runny nose; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and SNEEZING (sneezing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was provided.
Patient complains of feeling shaky - not feeling herself - getting hot and then chilled. Very dry mouth with trouble swallowing.
Diarrhea; Nausea; Stomach cramping; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 28Feb2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and carpal tunnel. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), gabapentin (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN) and 8-Tetrahydrocannabinol (THC) (MANUFACTURER UNKNOWN), all for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Mar2021 at 02:00, the patient experienced diarrhea, nausea and stomach cramping. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events diarrhea, nausea and stomach cramping were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Large, red, hard, raised area with fever and 2 streaks leading towards armpit and breast. Swollen lymph nodes under armpit. Fever & chills. Tachycardic heartrate. Nausea. Severe headache. Dizziness.
2 1/2 wks p/vax pt devel Gianotti-Crosti synd; seen by dermatolgist; no treatment given; condition resolving;
07/07/22 transfer to Inpatient Rehabiliation Unit from medical unit "after a fall". PMHx " atrial fibrillation on Eliquis" "sick sinus syndrome s/p pacemaker and frequent falls"
I was feeling sick the night before. I awoke the next morning with headache body ache and stomach pain. I took two COVID test on that day that came back as negative. On the 3rd day I tested it was positive. I started to have cough, upset stomach, headache and diarrhea. This lasted about 8 days. I was still testing positive 10 days after my symptoms had cleared. I still have a cough that does not hurt but it is annoying.
Muscular weakness; fatigue, all over body but mainly in lowerextremities; This is a spontaneous report received from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route administration in the right arm on 05Feb2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 12Feb2021, the patient experienced muscular weakness and fatigue all over the body but mainly in lower extremities. On an unknown date, the patient had undergone the COVID-19 test which included nasal swab and the results were unknown. The patient did not receive any treatment for the reported events. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of muscular weakness and fatigue was not recovered at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
10/4/10 Right thigh with red raised reaction approximately 1 1/4" x 1", slightly warm to touch and firm. Mom states was worse 2 days ago. Tx - ice, TYLENOL and hydrocortisone cream.
Hep B vaccine. The second vaccine in the 1st series was given. Within 30 minutes pt developed one hive to the R cheek and one hive to the L thigh with redness and itchiness. Offered Benadryl which pt refused and monitored x 1 hr.
20JUL93 1145PM woke up w/ t103; 21JUL93 around 830AM started getting hives; fever off & on; took pt to MD 22JUL93 7AM hives are coverng pt neck down; very irritable constant crying; By 6PM was swelled & blue; throat & ear red, stopped cryin
t101 w/APAP-crying, pale, clammy, drooling, swollen leg, site red, chin quivering; saw MD that afternoon; shallow breathing; 25APR95 doing better but still sleepy;
small amount of the Shingrix leaked out onto the patients arm; small amount of the Shingrix leaked out onto the patients arm; small amount of the Shingrix leaked out onto the patients arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number cr3s5) for prophylaxis.   On 18-SEP-2023, the patient received Shingrix (intramuscular). On 18-SEP-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: small amount of the Shingrix leaked out onto the patients arm), inadvertent exposure to vaccine (Verbatim: small amount of the Shingrix leaked out onto the patients arm) and exposure via skin contact (Verbatim: small amount of the Shingrix leaked out onto the patients arm).The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter who stated while given the vaccine to the patient while withdrawing the needle small amount of the Shingrix leaked out onto the patients arm, which led to incomplete dose administered, inadvertent exposure to the vaccine and exposure via skin contact. No harm was done during this and pharmacist not complained of any other adverse event via the patient.  The reporter was warm transferred to the Vaccine Service Center for further questions.  The reporter consented to follow up.
Patient received a flu shot with intradermal route that is only approved for ages 18-64.
No additional AEs or PQC reported.; Caller reported expired dose of VARIVAX administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a physician and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number U029496 has been confirmed to be valid for varicella virus vaccine live (oka/merck) (VARIVAX)) expiration date reported as 21-SEP-2023) the expired vaccine was administered to the patient (Expired product administered) (strength, route of administration, and indication were not provided). At the time of reporting, the outcome of the event was not unknown.
Pt recvd MMR/DTP/OPV/HIB 7APR92 2PM & devel fever 102 R @ 8PM; fever up to 105 R next day 8APR92; also on exam by MD 8APR92 lt OM;
Increasing soreness and swelling in upper right arm, chills. The pain was acute and I could not sleep for hours. I awoke at 5 in pain and all of my other joints hurt-- it was hard to walk and my thumb joints were enlarged and swollen and painful. Excruciating pain in shoulder which had become hot and red and swollen, I couldn't move my arm without intense pain. My eyes were watering, nose running and coughing-- I did already have a cold, but it felt like an allergic attack on top of the cold. I called Dr office at 5:30 a.m., who works at the same practice, was on call and said I was having a reaction and to take NSAID and that I could take VICODIN which I have for ongoing shoulder pain and migraines. It is now day 2 and shoulder pain is persisting and intense.
Hives all over body, facial swelling, rapid heart rate, itching. Reaction lasted 20-30 minutes. Flu-like symptoms (fatigue, chills, runny nose) followed.
Pain, swelling, warm to touch, with red blotches extending down arm 6-7 inches from injection site.
Patient approached pharmacist to discuss adverse reaction she had several days after receiving TDaP. On 2/23 patient noticed swelling on her left deltoid. Patient showed arm to pharmacist who noticed pronounced swelling of the upper arm extending from shoulder to right above the elbow. Pharmacist referred patient to PCP. PCP later diagnosed cellulitis and patient was placed on oral antibiotic therapy.
Extreme fatigue; cold chills; fever; vomiting; abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date: not reported) on 17Dec2020 at 09:00 on the right arm then received the second dose on 07Jan2021 at 09:00 on the left arm both via an unspecified route of administration at a single dose for covid-19 immunisation. The patient medical history was reported as none. The patient was not pregnant. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 07Jan2021 17:00, the patient experienced extreme fatigue, cold chills, fever, vomiting and abdominal pain. No treatment was received for the reported events. The outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot number was already obtained.
Pfizer-BioNTech COVID-19 Vaccine EUA Red, itchy, watery eyes. It started when I woke up the next morning. It has gotten worse over the next few days. No other symptoms. Dr. prescribed prednisone, Benadryl, Claritin, eye drops.