chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) had resolved. Not Provided          No concomitant product use was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: TCR- event outcome updated
Vaccine was injected into my left shoulder joint instead of deltoid muscle. Now having severe joint pain and decreased mobility. Have had labs, x-rays, MD appointments and now seeing orthopedics.
The pt developed a severe local reaction. Entire upper arm edema, induration, heat, erythema and pain. Her husband had the identical reaction from the same vial. Also, she had a systemic fever X 24 hours.
Patient received 2nd dose and ambulated over to the observation area about 7 minutes later the patient reported chest pain that was 7/10 and the patient stated it felt like someone sawing into her chest. EMS was activated and pt transported to the local emergency room
experiencing body pains after the first dose; she was sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "experiencing body pains after the first dose"; ILLNESS (non-serious), outcome "unknown", described as "she was sick".  Additional information: The patient was experiencing body pains after the first dose. She was sick and had the body pain from being sick, needs to know if she should reschedule her second dose. She also clarifies that her body pains did not occur after her first dose. She just got sick this past weekend after she had her first dose about 3 weeks ago. So this is her second dose she will be getting three weeks after the first dose. Her body pains were not a result of her first COVID vaccine, it was from being sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine afternoon of 1/7/2013. Patient experienced redness, swelling and pain in arm later that night. Patient called pharmacy morning of 1/8/2013 stating these symptoms and saying the pain is so bad she cannot move her arm.
vaccinated on 20Jan2021 and didn't know she was pregnant at the time; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccinated on 20Jan2021 and didn't know she was pregnant at the time) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccinated on 20Jan2021 and didn't know she was pregnant at the time). On 20-Jan-2021, EXPOSURE DURING PREGNANCY (vaccinated on 20Jan2021 and didn't know she was pregnant at the time) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Internal review on 24-Jun-21 resulted in updates to pregnancy details.
This case was reported by a consumer via call center representative and described the occurrence of burning sensation in face in a 74-year-old female patient who received SHINGRIX (batch number 2453L, expiry date unknown) for prophylaxis. The patient's past medical history included dizzy spells (experienced a dizzy episode on 6th August 2018 prior to getting the injection). On 15th August 2018 16:00, the patient received the 1st dose of SHINGRIX. On 15th August 2018, 1 hr after receiving SHINGRIX, the patient experienced burning sensation in face. On 16th August 2018, the patient experienced heart racing and dizziness. The patient was treated with BENADRYL. On an unknown date, the outcome of the burning sensation in face, heart racing and dizziness were recovered/resolved. It was unknown if the reporter considered the burning sensation in face, heart racing and dizziness to be related to SHINGRIX. Additional details were provided as follows: The lot number listed in this report was the lot number provided by the patient. The patient had asked the pharmacy for the lot number but she did not get the expiry date. An hour after receiving SHINGRIX, the patient experienced burning on a small portion of her face near her mouth. The patient received BENADRYL and it was resolved. Next day after receiving SHINGRIX, the patient experienced dizziness and her heart was racing, which was resolved. A day before the date of reporting, the patient had dizziness again but no heart racing. The patient estimated experiencing 10 dizzy episodes with 2 hours yesterday. The patient had denied permission to contact their physician.
Left arm - red, non raised rash approx 20mm x 30 mm, itchy, hydrocortisone applied.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 8/14/2022 Discharge Date: Aug 17, 2022   PRESENTING PROBLEM: Shock [R57.9]   HOSPITAL COURSE: 62-year-old male with a past medical history significant for chronic systolic congestive heart failure with CardioMEMS in place in the setting of ischemic cardiomyopathy as well as history of VT status post pacemaker placed in addition to paroxysmal AFib presents in a state of shock.   Patient reports that he has been getting more swollen and gaining weight the outpatient setting.  Because of this, he had gone from taking 60 mg in the morning and 40 mg in the afternoon of torsemide to 80 mg in the morning 80 mg the afternoon of torsemide approximately 10 days prior to his admission to the hospital.  In addition to this, he states that maybe 1-2 days prior to his admission to the hospital he was also started on metolazone 2.5 mg orally daily.  He notes that he began to feel more fatigued and tired and he also noted he began to feel more dizzy.  When he had some notable confusion with his dizziness, he presented to the emergency department.   In the emergency department the patient was hypotensive with systolic blood pressures in the 70s and diastolic pressures in the 40s.  White count was elevated at 16000. Labs remarkable for elevated creatinine at 2.8.  High sensitivity troponin I was found to be 26 with repeat checked trending down at 19. Chest x-ray was remarkable for some pulmonary vascular congestion.  Patient was given a 250 mL fluid bolus and despite this, required norepinephrine and transfer to the intensive care unit.     Patient is able to quickly wean off of vasopressors in the intensive care unit.  Although he had been empirically placed on antibiotics, strong suspicion was had for hypovolemic shock.  Once blood cultures came back negative, broad-spectrum antibiotics were discontinued.   Patient had overall improvement in his renal function and eventual normalization of his renal function.  Noting that his chloride and sodium were still low and with positive orthostatic vital signs, he was started on slow infusion of IV fluids afternoon 8/16 at 50 mL/hour normal saline.  By morning 8/17, patient had significant clinical improvement with normalization of all labs.   Case was discussed with Cardiology.  Plan was for discharge home 08/17/2022 with outpatient follow-up with Cardiology and further evaluation of the patient's CardioMEMS device.  He was advised to continue his beta-blocker but hold off on his Entresto for now as well as his spironolactone and metolazone.  He was advised to utilize torsemide 40 mg once daily starting 08/18/2022 with up titration in the outpatient setting as needed.  Patient discharged in stable condition.  Throughout the patient's hospital course, he had no issues related to COVID-19.
M-M-R- II that underwent temperature excursions ABOVE 9°C was administered; No addittional adverse effect reported; This spontaneous report was received from an unspecified reporter from the physician's office referring to an unreported age and gender patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medication were not reported.   On an unspecified date, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) (lot number T033814, expiration date 05-OCT-2022) underwent temperature excursions above 9 degrees Celsius (C) as follows: 12.4 C for 54 minutes (min), 9.6 C for 34 min, 9.5 C for 23 min, and 8.5 C for 9 min (product storage error temperature too high). There was no previous temperature excursion.   On 23-NOV-2021, the patient was administered the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) that underwent temperature excursions for prophylaxis (formulation, concentration, dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported).         No additional adverse effect was reported (no adverse event).  This is one of several reports of patients who were administered the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) that underwent temperature excursions and were received from the same reporter.; Sender's Comments:  US-009507513-2112USA006870:
Medication error.   Patient was given an adult dose of Pfizer COVID vaccine 0.3mL by mistake.   Monitored for 15 minutes no reaction during that time.   Patients mother notified same day by PA.
pt recv vax & devel induration @ inj site;no further details known as of the reporting date;this is 1 of 3 patients from this site who exp above reaction
Without warning/hint got feeling of going to pass out, went blind, without any warning vomited, got shakes/shivers, got headache. Note that I felt fine until the first notion that I was going to pass out. I didn't feel dizzy or lightheaded, but felt something that I never experienced before. Was not sick to my stomach prior to vomiting (haven't vomited in 30, 40 or more years)Sight came back after vomiting. The next day I felt fine, i.e,, I was back to "normal."
Within six hours of immunization, rash developed at site and spread all over body. Lasted 24 hrs, no itching or fever. Pt did not seem uncomfortable.
Symptoms were mild: congestion, sneezing, cough, runny nose. Prescribed Paxlovid.
One week after influenza vaccination, developed headache, flu-like symptoms and double vision. Seen by op
Patient states that starting the day after the vaccine was administered, she experienced muscle aches and pains in her whole body, which lasted for approximately 48 hours.
No adverse effect reported; The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from a physician assistant, referring to a patient of unknown age and gender. There was no information provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.   On 23-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous, lot # R023513, expiration date on 16-AUG-2020 (dose and anatomical localization were not reported). The physician assistant reported that the patient was inadvertently administered a dose of with varicella virus vaccine live (Oka/Merck) (VARIVAX), that had been improperly stored. The lot of with varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored DILUENT MRK (unknown Lot# and expiration date). No adverse effect reported.  On unspecified dates, the doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent temperature excursions of -9 °C to 8 °C (1.7 °C)  for a time frame of 4 hours, which was called by the digital data logger. There were no previous temperature excursions reported.; Sender's Comments:  US-009507513-1906USA000538: US-009507513-1905USA012089:
I first noticed an increase in my Heart-Rate about 15 seconds after the injection. I also felt an unusual pain in my lower back area, down to the end of my spine. During my 30-minute waiting period after the injection the symptoms did not subside.  Since I am allergic to Insect Stings, I had 25 mg Diphenhydramine Tablets and my Epinephrine Injector with me at the clinic. I took one 25 mg Diphenhydramine Tablet orally with water.  My symptoms subsided after about 30 minutes. I waited an  additional 30 minutes at the clinic.  My  wife and I left after that time period. I presently feel normal at this time.
Got the shot and the worse flu ever and 2 weeks later the worse flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the shot and the worse flu ever and 2 weeks later the worse flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient  got the shot and the worse flu ever and 2 weeks later the worse flu (influenza) (latency : 2 weeks ) following the administration of INFLUENZA VACCINE.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
had shot, got a mild case/Suspected vaccination failure; got a mild case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shot, got a mild case/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got a mild case). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Mar-2023 The case was received from the patient via interactive digital media. The patient had shot and got a mild case. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 11Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid Disease" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dilantin, reaction(s): "Known allergies: Dilantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Sep2023 to 25Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300311955 Same patient, different drug, different event;
fever; chills; lethargy; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (shingrix) for prophylaxis. On an unknown date, the patient received shingrix. On an unknown date, unknown after receiving shingrix, the patient experienced fever, chills and lethargy. On an unknown date, the outcome of the fever, chills and lethargy were unknown. It was unknown if the reporter considered the fever, chills and lethargy to be related to shingrix. Additional details were provided as follows: The reporter was known to the patient. The age at vaccination was not reported. The reporter stated that, she heard about individual (patient) that experienced fever, chills and lethargy after dose of shingrix (dose number was unknown). The reporter did not have any patient identifiers. The reporter did not consent to follow-up. The case had been linked with US2021265875, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021265875:Same reporter
On and off headaches since vaccine. 4/28 right calf pain/ cramping, 4/29 11am quick onset severe pressure headache followed by left side face, arm, and leg numbness/tingling/weakness. Within 1 or 2 minutes heart felt like it was racing combined with body shaking/shivering. Ambulance to the hospital by 11:45am, and she was treated with tPA Alteplese after a CATscan came back negative. Symptoms improved over a few hours. I am writing this 23 hours after the ambulance transport and patient continues to have outside and inside mouth numbness and throat numbness all on left side. Blood work hass been normal except low potassium, leg ultrasounds negative. MRI results pending. Patient is still hospitalized as of 10am on 4/30.
Hives, Itchy, Light headed. Patient received 10 mg of Zyrtec and Adult Epi from Auto Injector 0.3mg  x1
Adverse reactions were much stronger with the 3 vaccine. Large swollen underarm glands, increased fatigue-over & above normal MS symptoms, vomiting, body aches .  This vaccine seemed to irritate my current body impact  of my MS. Increased twitching, left leg-foot numbest, high level of mid-back and caused my to have flu like symptoms.
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 60 years old female patient with chronic lymphocytic leukaemia. She received 2 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with fludarabine (+) rituximab (+) lenalidomide.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 0. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 7. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
red patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red patch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (no adverse event).    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (red patch). At the time of the report, VACCINATION SITE RASH (red patch) outcome was unknown.            no concomitant medication and treatment provided
administration of improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On 27-AUG-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml, lot # T002848, expiration date: 23-JAN-2022 (route of administration was not reported) for prophylaxis. Vaccine was reconstituted with sterile diluent (STERILE DILUENT).  It was reported that the dose of the product administered to the patient was not stored properly for the time frame of 50 minutes in the temperature between 6 degrees Fahrenheit (F) and 14 degrees Fahrenheit (10.56 F) with a previous temperature excursion between 6 F and 14 F (8.47 F) for 30 minutes. Digital Data Logger was involved.  The outcome of medication error was unknown.
Patient came to pharmacy complaining of a rash on her left arm after getting the COVID shot. On their left arm near the injection site her skin was swollen and red. Per the patient, it was warm to the touch, and hurt a little when she touches it. Patient did not report any other symptoms. Informed patient to see their primary care provider.
Sore and painful legs and shoulders. Possible mini stroke ,  slurred speech, headaches and right sided weakness. Hands loss of sensesation.
Large local reaction to IZ given on 1/22/02 to left thigh. TriHibit and Hep-B (Recombivax) were given. Redness and swelling spread to include entire anterior thigh. Seen on 1/28/02 due to persistent swelling. No infection, no abscess and no loss of function.