chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's and no PQC's were reported; A physician stated that an improperly stored dose of MMR II pursuant to a temperature excursion was administered to a patient.          ?; This spontaneous report was received from a physician referring to a patient of unreported age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-AUG-2022, the patient was vaccinated with an improperly stored dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) rHA, U014656 (also reported as: W014656), expiration date: 07-MAY-2023, to prevent measles, mumps and rubella infection (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of 13.8F and 51F for 25 hours and 100 hours respectively (product storage error). The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.     Lot Number W014656 is NOT valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), and does not match any company product.
received only the adjuvant portion; received only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Shingrix. On 14th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment:  The office manager stated that the four patients received only the adjuvant portion of Shingrix.  The reporter did not have the demographics of the patients at the time of the call but would have if follow up were made.  These were the first dose for all four patients.  The reporter consented to follow up. This case is 1 out of 4 cases reported by the same reporter. Additional Supportive Information: The patients received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022AMR169910:same reporter US-GSK-US2022AMR169909:same reporter US-GSK-US2022168220:same reporter
Moderna COVID-19 Vaccine EUA High temperature  of 104.4, fatigue, chills, body aches. Symptoms lasted approximately 30 hours
high risk pregnancy due to maternal age, 36, but otherwise normal healthy pregnancy without any complications-  8/4/2021 history of tachycardia and palpitations that had been well controlled on bystolic since at least 2016 1 day post pfizer vaccination began to experience frequent episodes of palpitations throughout the day, sometimes accompanied by chest tightness and SOB, which has persisted intermittently since
45 second generalized tonic-clonic seizure with low grade fever (37.8) 1 day after vaccination.
Pt had possible rxn. approx. 12 hrs. after the vaccines. Multiple spells of tonic arm flexure with facial grimacing. No LOC. No emesis. No incontinence. No postictal events. Pt had temp 101+ degrees 12 hr. after vaccines.
Pt started having a sore leg hours after the injections. And over the course of the next few days it started to get worse, she was complaining about itching on the wound, the area was hot, to the touch, bright red, and bruising in the center of the effected area. The top half of her thigh was swollen, and the was a hard knot over the area. I took her back to the Dr and they looked her over, and I was told to get her benadryl, and Tylenol.
Information has been received from a 27 year old female medical assistant who in approximately April 2007, got Zostavax (Oka/Merck) (Lot #656606/0033U) on her fingers while reconstituting it.  Concomitant therapy included ibuprofen.  In approximately April 2007, the patient experienced white, clear fluid filled blisters on her index and middle finger of her right hand, in the area where she was exposed to the vaccine.  The blisters come and go, and are tender to the touch.  As of 09-JUL-2007, the patient had not recovered.  Medical attention was sought.  Additional information has been requested.
Red swollen lump at injection site (R arm).  Benadryl given by mother (day after injection)
feeling unwell; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 16:45 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 18Nov2021 12:00, outcome "recovered" (2021), described as "feeling unwell"; NAUSEA (non-serious) with onset 18Nov2021 12:00, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 18Nov2021 12:00, outcome "recovered" (2021), described as "vomiting". Therapeutic measures were not taken as a result of malaise, nausea, vomiting.  Additional information: Facility type vaccine: Doctor's office/urgent care. The patient did not received any other vaccine in four weeks. The patient did not had covid prior to vaccination and not tested covid post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
She was found unresponsive by her husband on 4/11/2021 and pronounced dead at the scene. She had been to the emergency room for recurrent syncope several weeks prior to any vaccinations. No cause was determined.
The pt developed redness, pain and swelling at the injection site (right leg) 24 hrs post vaccination. Seen on 04/18/2002 and treated with Keflex.
Pt called on 9/27/18 stating that starting within a few hours of  receiving the vaccinations she felt very nauseous and lightheaded. Over the next few hours she experienced chills, sweating, headache, and vomited multiple times. She had to call into work on 9/27/18. She stated that she felt much better after about 24 hours receiving the vaccines.
Sore arm; Headache; Fever; Chills; Muscle joint aches; Fatigue; Nausea; Hoarseness of voice; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle joint aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Aortic stenosis, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, LISINOPRIL for Hypertension, Aderol for focus, MULTIVITAMINS [VITAMINS NOS] and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for immunity.    On 25-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle joint aches), FATIGUE (Fatigue), NAUSEA (Nausea) and DYSPHONIA (Hoarseness of voice). On 04-Jan-2021, VACCINATION SITE PAIN (Sore arm), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle joint aches), FATIGUE (Fatigue), NAUSEA (Nausea) and DYSPHONIA (Hoarseness of voice) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment activities for event was reported as none.
Patient received Pfizer COVID vaccine on 1/11/21 and 2/1/21. Tested positive at her assisted living facility on 9/8/21 after another resident contracted COVID-19. Developed worsening generalized weakness on 9/8/21 but no other characteristic symptoms. Patient admitted to our facility for COVID-19 infection on 9/9/21 (status also positive upon admission) and received REGEN-COV. As of today 9/13/21, patient has been cleared for discharge but still waiting placement at living facility.
Within a few minutes I could feel the drug move across and in my body. Very strange feeling. Then I felt short of breath. I knew I was taking a breath but it felt as if my lungs were not getting air in the same volume as I'm used to feeling. I told my self to stay calm and keep breathing. Within a minute or two the feeling went away and breathing returned to the normal feeling. I did not feel light headed or pass out it was just that my lungs did not feel as if it was getting air in the normal way. When I returned to the facility for the second shot my body was going through a panic feeling. High heart rate and anxiety. I decided not to get the second shot
Vaccine that was given was aged for 4-6 year old, patient is 2 years 7 months. No treatment needed per HD, no signs or symptoms of reaction.
Initial report received from a health care professional on 20 Aug 2010: This patient was vaccinated with MENVEO (batch number unknown), on an unspecified date. Following administration with the vaccine, the patient developed local reaction where the arm "turned red all the way" on an unspecified date. The outcome of the event was not reported.
COVID-19/ After previously testing neg for COVID, tested positive again.; COVID-19/ After previously testing neg for COVID, tested positive again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Treated hypertension" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "treated elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; LEVOTHYROXINE; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19/ After previously testing neg for COVID, tested positive again.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment; Negative, notes: After previously testing neg for COVID, tested positive again; Positive, notes: After previously testing neg for COVID, tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter stated, Worsening of COVID symptoms, previously gone: cough, congestion, aches. After previously testing neg for COVID, tested positive again. The patient treated with anti-viral (Paxlovid) from 14Jun2022 to 19Jun2022.  No follow-up attempts are required. No further information is expected.
Employee presented to COVID Clinic for Moderna COVID 19 vaccination 1st dose. Given to left arm. Left clinic prior to completing 15 minute observation time and told an MA in waiting area that she felt ill ot her stomach and having trouble taking deep breaths.  Employee found in nearby Bathroom sitting on the floor, she had vomited, reported she was lightheaded, couldn't breath, shaking, abdominal discomfort sweating,  attempted to move employee to wheelchair, did respond well to transfer to Wheelchair, She reported symptoms worsening: HA, abdominal pain and developed blotchy skin, hyperventilating, and dizzy. CODE Blue called, patient given Epinephrine injection 0.5mg patient sent to ER
mom called 19FEB93 stating pt had vax 13JAN93; on 17FEB93 pt went to hosp was unable to move one side of body; poss polio immun rxn;
Excessive crying non stop, extreme tiredness, some pain in thighs ongoing for 2 weeks. When 4 months shots occurred bumps got bigger on thigh where the injection was received. It's very painful to the touch. The bumps are still hard and bigger then in inch in daiameter. You can see the needle point where the shot was injected.
Inadvertently gave a Moderna first dose to a 17-year-old. No immediate reactions were observed in the 15 minutes after the shot.
Patient complained of "anxiousness" and "nervousness" after receiving vaccine. Patient assessed by EMS on site. HR-99, SPO2 97% on RA, no rash or hives. Pt anxiety resolved after 25 minutes without treatment.
Headaches, vomiting, ?, weakness, falling. This 63 yr old female is here for (dem) dizzy, head pressure walked 5 k -"endorphin flow" yesterday felt good (had trouble walking to mailbox months ago). Yesterday-room tilting with walking. Pressure front to back head. Lists to left falls into walls. No spinning.
This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose, route and frequency unknown. On 04-MAY-2012, the patient was vaccinated with improperly stored dose of VARIVAX lot # 1273AA dose number 2. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Swollen lymph nodes in both arm pits, first in shot armpit (right),  a few days later in left armpit, recovered then return of lympadema in entire left arm. Mild but quite painful.
This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and blister. On an unknown date, the outcome of the erythema of extremities and blister were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and blister to be related to SHINGRIX. Additional information was received as follows: This case was reported by the pharmacy technician. The patient received SHINGRIX on the left arm. The patient presented with redness on the entire left arm, along with blisters right above her elbow on the left arm. This lasted for about a total of one week. No further details were provided by the pharmacy technician.
Soreness and pain when extending arm out starting immediately after getting injection. First week I had trouble sleeping, woke up with extreme pain around left shoulder and left upper arm. The first two weeks, I felt soreness and pain while arm was at rest as well as when in motion. (Reaching, lifting, pushing). The third week, I am experiencing pain still in the mornings at its worst and while I do motions like lifting myself off the bed, while dressing, or even when I reach into my back jean pockets. I still have sharp pain in my arm/shoulder. I saw Doctor 10/06/2017 and he advised I take ADVIL 600mg every morning before I do any lifting at work. I've also bought Tiger Balm to rub on my arm 3x daily.
9-6-07 Pt called to complain about injection site pain. Stated he went to ER because of pain and inability to use arm. He stated he was obtaining ER records and would bring them to me; he has not done so. He felt that his problem was that the injection had been given to high with the joint. No specific dates given.
Pt's mid left thigh became warm to touch with slight edema measuring 9 x 12 cm round. Mother noticed this on 8/23/01 when child got up. She was treated with a cool cloth on leg throughout the day.
patient have never had the flu Untill patient got a flu shot; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a unknown demographics patient who have never had the flu untill patient got a flu shot (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient have never had the flu untill patient got a flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL9263), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: 301558A), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Oct2021; CITALOPRAM, start date: 01Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medications in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 25May2022 to 30May2022.The patient had no Known allergies.  No follow up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: After being administered the vaccine at 8:43 am, recipient developed lip tingle, slight edema on the lips, itchy and redness on the cheek at 8:58 am.  Patient refused to go to the emergency department.  Patient was given diphenhydramine and methylprednisolone. After 1 hour of observation - lips and cheeks improved. Patient no longer complained of itchy lips. At 10:50 am, patient stated they were fine and left the clinic.
This spontaneous report was received from a physician via a company representative referring to a 23 month old male patient with no drug reactions or allergies and no pertinent medical history. On 20-JUL-2015, the patient was vaccinated (by an unspecified physician) with a single dose of (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not provide). There were no concomitant medications. On an unspecified date in 2016 (reported as "sometime last week"), the patient presented to the physician's office with herpes zoster reported as "shingles rash" (exact onset date unknown). After seeking medication attention, the patient was prescribed with ACYCLOVIR and the shingles rash has cleared up. No laboratory diagnostics studies were performed. There was no product quality complaint (PQC) reported. The outcome of herpes zoster was reported as recovering. The primary reports did not provide the causality between (Oka/Merck) VARIVAX and herpes zoster. Additional information has been requested.
itchy redness in the area of the injection; itchy redness in the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (itchy redness in the area of the injection) and VACCINATION SITE PRURITUS (itchy redness in the area of the injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (itchy redness in the area of the injection) and VACCINATION SITE PRURITUS (itchy redness in the area of the injection). At the time of the report, VACCINATION SITE ERYTHEMA (itchy redness in the area of the injection) and VACCINATION SITE PRURITUS (itchy redness in the area of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided   This case was linked to MOD-2021-022839 (Patient Link).
Patient reported heart palpitations and mild chest pain in the week following the booster, so we went to our primary care doctor. They did an EKG in the office and told us that it showed signs of pericarditis. They told us that unless he felt additional pain, we did not need to treat but should monitor him for any shortness of breath. We do not yet know if it has resolved. We have an appointment 6 weeks out for a follow up EKG.
feeling pretty bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   The patient's past medical history included smoker (quit smoking about 2 years ago.). Concurrent medical conditions included chronic obstructive pulmonary disease (diagnosed with COPD about 8 years ago.).   On an unknown date, the patient received the 1st dose of Shingrix, the 1st dose of PNEUMONIA VACCINE and COVID-19 BOOSTER. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: feeling pretty bad).  The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR114355   Additional Information: GSK Receipt date: 21-AUG-2023 The patient reported that he received the 1st dose of Shingrix at the same time as a Covid booster and a pneumonia shot (unknown products) from his pharmacy, and was out of it for 2 to 3 days feeling pretty bad. The patient also reports that he was diagnosed with COPD about 8 years ago (pre existing Shingrix) and quit smoking about 2 years ago.  It was unknown if the reporter considered the feeling bad to be related to Covid booster and pneumonia vaccine. For tolerance of 2nd dose refer case US2023AMR114355  The reporter consent to follow up.; Sender's Comments:  US-GSK-US2023AMR114355:same patient
Pain in right shoulder and upper arm - Began after 3rd vaccine 7/29/2002. Have limited arm mobility. (Visited Chiropractor)  Severe local redness at site of injection 1/8/2003.
Arm pain at injection site on days 1-3 Sharp shooting  pain at lower left base of head along  toward  and in left inner ear  on days 2-4
5cm diameter warm, red, indurated patch right upper arm/deltoid. No systemic symptoms; improving through day. Take Benadryl, Tylenol PRN, use ice pack PM.