chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID# 45536) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Within 15 minutes of the vaccine the recipient begin to vomit, developed a headache, chills and weakness.
COVID arm. Circular, red rash with lots of itching around 5 days after 1st dose was given.
ACUTE DVT, UNSPECIFIED VEIN ACUTE HYPOXEMIC RESPIRATORY FAILURE
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced flu-like symptoms. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms. This report was non-serious.
Day after vaccination  felt weak in morning, developed chills all afternoon,  fever of 99.4 started about noon.  Mild nausea, lightheaded feeling. Also had some abdominal cramping, which I often have due to colitis so probably unrelated to vaccine. Treated fever with acetaminophen at about 2 p.m., temperature went down to 98.7 but continued to have chills most of afternoon. Second morning after vaccination still have chills but milder. Temperature of 98.7 in morning. Not medicated.
Within 24 hours developed redness to right thigh, then increased. No fever. Did complain of soreness to site. Impressive red, indurated lesion to right thigh. No warm to touch. Lesion 16cm at longest point, 12 cm across. Pain on palpation - deep palpation. Localized reaction to DTaP immunization to cover for possible cellulitis. Started Cephalexin 500mg PO for 10 days.
Information has been received from a nurse concerning a female who was vaccinated with two doses of GARDASIL, dates not reported. The nurse reported that after receiving her second dose of GARDASIL in the morning, the patient woke up during the night and had broken out with hives. Additional information has been requested.
Came down with a 100.2 degree F fever the night I got it, which went away after one dose of tylenol. The following night I did have a low grade fever of 99.3, which also went away after one dose of tylenol. I have had muscular soreness, and am now developing a small, itchy, red patch at the injection site. I will fill out another adverse form if it gets worse.
Had cold chills the nite of flu shot with fever, headache and red blotches on arm. 5th day arm and body still sore. Got better and then got same symptoms back again in 10/27/08.
This spontaneous report was received from a grandmother regarding a 5 year old male patient (grandson). The patient had no pertinent medical history or drug allergies or reactions. On 29-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and route was not reported). No concomitant medications were reported. On 09-AUG-2013, the patient experienced chicken pox following administration of VARVIAX (Merck). There was no treatment rendered for the event. The outcome of chicken pox was reported as not recovered. The patient did not seek medical attention. Additional information has been requested.
Administered the DTaP, IPV, and Hib vaccines around 10:15am. Mom called back early to mid afternoon describing that patient had a fever, went limp, lips were dusky, then vomited and choked a bit. Came back to my office within an hour of this episode. Appeared fine. Sent to ER for acute life threatening.
Severe chills, fever, fatigue, headache, muscle ache, joint ache 4:00am onset 4/12 until 8:00pm 4/12
8 days p/MMR vax pt neck pain-elbow on same side as receiving vax; pain was constant for 2 wks;
It started the next day after the vaccine. I had fatigue, light headed, head ache, brain fog, nausea and dizziness. The doctor ran a lot of test and everything came back negative. I am now seeing the Chiropractor because the doctor don't know what else to do. I have been going to the Chiropractor for about 4 weeks now. I was referred to another Chiropractor because the first one didn't know what to do for me. I have an appointment today.
(R) thigh - outer _> 24-48 hrs noticed patch size of dollar bill- raised red and bumpy - small patches raised outside of this - on inner thigh and on penis. Warm- not itchy. Iced and BENADRYL - No progress with BENADRYL. Ice helped. Scab on spots 3-4 days later. Steroid cream Rx.
patient had no known side effects; An expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist referring to an adult under the age of 65 years old.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 31-OCT-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot #T030667, for prophylaxis (dose, route and site of administration were not reported)  which had expired on 28-SEP-2022 (expired product administered).  Administered vaccine had no known temperature excursions prior to administration and patient had no known side effects.   Lot number T030667 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). Lot number T030667 is a valid lot number for Rocuronium Bromide (ESMERON).
2 hours after injection.  Pain at injection site, sore throat, nuasea, headache, joint pain. Following day, headache, muscle pain at injection site, nausea and joint pain mostly in elbows and shoulders.
Right Deltoid-warmth to touch, erythema 13cm x 10.5cm. patient reports itching. No pain. Swelling initially, now resolved
inconsolable crying 8 days p/vax followed by transient hypotonial/lethargy for 6 days;
It first started with fatigue and chills, I woke at 1 am with a slight fever and felt like bone aches in my big joints such as my legs and hips.  I had very mild soreness of the injection site.  I had a headache the next day. I had a canker sore as well that lasted over a week.  Most of the symptoms were gone with 24 hours.  I also got diagnosed with breast cancer but I am not sure it is linked with the vaccine.
2NOV pt recvd flu shot; reported 8DEC as following vax pt exp muscle aches, neck stiffness, back & shoulder; temple h/a, sinus, stomach, constipation, heartburn, fatigue constant, insomnia & nightmare;
Within four hours - arm was sore; fatigue Within 9 hours - Chills; severe bodyaches; headache; fever that fluctuated between 100.5 and 102 for 36 hours  Third day after injection experienced stomach ache and diarrhea during morning hours - this subsided by afternoon
Red Rash, hard at vaccination site, hot, itchy, loss of skin sensation at vaccination site .
shortness of breath; dizziness off and on; muscle spasms; cannot walk; can barely move; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history included spinal surgery. The patient's concomitant medications were not reported. On unspecified date patient experienced, shortness of breath, dizziness off and on, muscle spasms, cannot walk, can barely move. Patient reported that, reschedule his second covid vaccination which was schedule on 05May. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a different physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
PATIENT DEVELOPED SHINGLES AROUND INJECTION SITE ABOUT 1 MONTH AFTER 2ND SHINGRIX DOSE. HE FELT A TINGLING SENSATION AND SOME ITCHING AROUND THE SITE AND LATER OBSERVED A RASH WHICH HAS NOW LASTED ABOUT 3 WEEKS. HE DID NOT TAKE ANY MEDICATION FOR THE RASH AS HE WAS UNABLE TO SECURE AN APOINTMENT WITH HIS PHYSICIAN. HE DID NOT EXPERIENCE ANY PAIN, JUST MILD ITCHINESS. HE LATER SPOKE TO HIS PHYSICIAN WHO DID NOT PRECRIBE ANY MEDICATION SINCE PATIENT WAS GETTING BETTER.
During the evening after the shot the patient seemed more confused, disoriented, off balance and agitated.  In the middle of the night the patient fell and hit his head and was taken to Hospital.  Attending physician said he was very dehydrated and they gave him several liters of IV fluid.
Shivering, fever, headache, muscle and joint pain plus the usual injection site pain.
experienced  a severe allergic reaction to the first dose of the Pfizer vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "experienced a severe allergic reaction to the first dose of the Pfizer vaccine".  Additional information: On 19Aug2022, it was reported that, a patient started treatment on an unspecified date with the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site pain; This is a spontaneous report received from contactable other healthcare professional and a contactable consumer (patient). A 66-year-old female patient reported that patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 27Jul2021 (age at vaccination: 66-years) as dose 2, single for COVID-19 immunisation. The patient medical history included ongoing breast cancer from an unknown date. The patient's concomitant medications included (fulvestrant) FASLODEX for an unknown indication from 26Jul2021 and stop date was not reported and (denosumab) XGEVA for an unknown indication, start date and stop date was not reported. The patient received palbociclib (IBRANCE) via an oral route of administration from 28Jun2021 to current at dose of 100 mg daily for 14 days on and 14 days off for breast cancer (per md advise- prescription read 100 mg daily for 21 days and off 7 days with FASLODEX and XGEVA). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date in Jul2021, the patient experienced injection site pain. The patient underwent lab tests and procedures which included white blood cell count: 2.1 to 1.8 on an unspecified date in 2021 currently on break. The patient would have lab work on 05Aug2021 with XGEVA. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previously reported information: This case is updated to be reflected as spontaneous report; IBRANCE was added as concomitant medication. This report is also being submitted to allow appropriate submission to health authorities.
Left voicemail to see if there were any adverse reactions-none reported. Gave clinic extension.
pruritus; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose received on 27th March 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that patient was greater than 6 month since the 1st dose of Shingrix. This case was linked with case US2019097136 reported by the same reporter.   Follow up information was received from the other healthcare professional on 16th July 2019: The patient's demographic details were updated. On 27th March 2018, the patient received the 1st dose of Shingrix. On 27th March 2018, less than a day after vaccination, the patient experienced pruritus and declined 2nd dose. The reporter considered the pruritus to be unrelated to Shingrix. The VAERS details were updated.
soreness in left arm; tiredness and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (tiredness and fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included METOPROLOL for Blood pressure, ROSUVASTATIN for Cholesterol, METFORMIN for Diabetes, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (tiredness and fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in left arm) and FATIGUE (tiredness and fatigue) outcome was unknown.            Patient's Current Medical history includes Cholesterol.   This case was linked to MOD-2021-313910 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received on 14-Sep-2021 with no new infomation On 15-Sep-2021: Includes no new information.
Administration error. Patient was accidentally given an adult dose of the Covid Pfizer vaccine. The pharmacist thought they grabbed a PEDS vial but it was an adult vial. The adult vial was reconstituted as if it was a PEDS vial and then only 0.2ml (a normal peds amount) was drawn up from the incorrectly reconstituted vial. The dose the 11 year old received was approx that of a normal adult dose. The patient's parent was notified as well as the doctor. No extra adverse effects were reported.
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo temperature excursion. Manufactory code for the lot was MOD. Patient got half dose.  No treatment medication was reported by reporter.
Patient stated she has reactions all the time. Patient developed a rash at site and down to breast area the day after vaccination. Patient used allergy medication zyrtec and prednisone, which she had from a previous reaction. Patient reported all signs of rash were gone by 9/27/2020 (two days post-vaccination).
One week joint pain especially hip pain lasted 2 weeks( severe got cortisone injection) Swelling of lymph nodes in elbow area left arm golf ball sized lump this started at two and 1/2 weeks  and subsided after a few days. Then left shoulder and upper arm started hurting badly  swollen lymph nodes.  Overall joint aches have improved however.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after standing up to move to the observation area, she opened her eyes almost immediately after falling to the ground and was responsive, ems was alerted to check and make sure she did not hit her head. ems assessed and patient was stable, refused medical care or transport to the hospital. left with boyfriend (she was not driving herself).
break out in hives /  a week after that had the same reaction / 2 days ago she went in to the sun / broke out again in hives broke out in hives in sun again; sensitivity to sun; Rash; severe arm pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th February 2021, immediately after receiving Shingrix, the patient experienced injection site pain. On 24th February 2021, the patient experienced hives, sun sensitivity and rash. The patient was treated with benadryl (nos) (Benadryl). On 22nd February 2021, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the hives, sun sensitivity and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, hives, sun sensitivity and rash to be related to Shingrix.  Additional details were provided as follows: The patient had taken first dose of Shingrix on her left arm and experienced severe arm pain that eventually went away and lasted for 5 days. Also developed sensitivity to sun and break out in hives a week later on the inside of her elbows and after a week had same reaction then one week ago patient went outside in sun, broke out in hives in sun again.  The patient stated would be making an appointment to see an allergist. The reporter consented to follow up.
left knee is really swollen; Knee pain; This is a spontaneous report from a contactable consumer or other non health care professional (Patient's daughter). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269) via intramuscularly, administered in Arm Left on 05Feb2021 around noon (at the age of 89 years old) as dose 1, single for COVID-19 immunization at Church. No Patient's Medical History and no other products reported. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations were N/A. Caller explained she took her mom to get the vaccine on Friday, 05Feb2021 and explained her mother was fine on Friday when she received the vaccine. Probably the next day, Saturday, 06Feb2021, she stared experiencing really bad knee pains. Her left knee was really swollen. Caller was asking if patient could take an Advil or something to help with pain. Patient did not visit Emergency Room and Physician Office. The caller explains her mother was waiting it out because she knows she would have side effects. If the knee pains persist and goes on until tomorrow, maybe they will go somewhere. Relevant Tests were None. Investigation Assessment was reported as No. The clinical outcome of the event knee pain was not resolved, and left knee is really swollen was unknown.  Follow-up attempts completed. No further information expected.
Patient states that there was a swollen rash the next day, was seen by MD and sent home. 2 days later, patient came back and reported blisters, spread to stomach. MD treated patient for infection and asked them to notify us of the adverse event.