chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Permanent muscle damage; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE INJURY (Permanent muscle damage) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE INJURY (Permanent muscle damage). At the time of the report, MUSCLE INJURY (Permanent muscle damage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 16-MAY-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 240 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code is scanned.Date the vial placed in refrigerator was on 05 Nov 2021. There was no temperature excursion. The patient had no adverse event. No treatment information was reported.
Client reported feeling heart palpitations during the post vaccination observation period. Client evaluated by onsite EMS, who brought the patient to the observation area. Client denied chest pain or shortness of breath. Vitals 137/72, HR 94, SpO2 96% on RA. 12 lead ECG performed. Onsite EMS consulted with ER physician who reviewed ECG. Physician noted no acute changes on ECG. ED physician did not recommend transport or ED evaluation, and instructed the patient to follow up with her primary care physician. Client agreed to plan and was cleared to leave the observation area.
Severe arm pain, loss of use, swelling, pain score 7-9 on the 0-10 pain scale. Loss of sleep for two nights d/t pain. Pain on day three scores 4-7.  Can use arm, but very limited ROM.
This case was reported by a healthcare professional via another manufacturer and described the occurrence of grand mal seizure in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included hepatitis C and seizure disorder. On an unspecified date the subject received 1st and 2nd dose of ENGERIX B (unknown). At an unspecified time after each administration of ENGERIX B, the subject experienced grand mal seizure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. It was reported that the subject would be receiving the 3rd dose of ENGERIX B despite the seizures.
Noticing sudden tinnitus. Mild to moderate, does not seem to impact hearing. Reporting here first.
Got Corona virus vaccine and I came up positive; This is a spontaneous report from a contactable consumer reported for an unspecified age of female patient (mom) that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9265), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was no reported. Concomitant medications included dexamethasone and azithromycin. On 08Feb2021, she came up positive. The patient did not take treatment for the event. The outcome of the event was unknown.
Horrible myalgia. Fever 100.5 for about 14 rs. Headache
100.0 fever, rash at injection site the size of a dollar coin. The rash feels firm and warm.
She experienced pain.; This case was reported by a nurse via sales rep and described the occurrence of pain in a female 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK receipt date :14-July-2022 Reporters comment: The reporter did not consent for follow-up.  Additional Supportive information:. As per source document narrative mentioned as ''she'' so patient gender captured as female. .
woke up screaming 3PM, fretful, mouth foaming, lt eye red, refused to nurse advil given 425PM by pvt MD, loud high pitched cry, unable to calm;pvt MD states allergy to pertussis;
bled a lot after the injection/patient was concerned that the vaccine had not been well absorbed in her body because of bleeding; Initial information received on 29-Sep-2020 regarding an unsolicited valid serious case from a pharmacist.  This case involves a 71 years old female patient who bled a lot (Vaccination site haemorrhage), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient normally had a lot of pain, redness, and swelling after a flu shot.  Medical history, medical treatment(s) and family history were not provided.  The patient was on a blood thinner, but the reporter did not have the record of which blood thinner she takes. No other vaccine was given concomitantly.   On 28-Sep-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ480AB and expiration date:30-Jun-2021) once via unknown route in unknown site (reported as likely the left arm as that is usually the site used by pharmacy) for prophylactic vaccination.  On an unknown date, the patient has serious bleeding after the injection (Vaccination site haemorrhage) (Unknown latency) and stated that lacked the injection site symptoms that differed from her normal experience . The patient was concerned that the vaccine had not been well absorbed in her body because of bleeding. Also, she did not have any pain from the injection and wanted to know if the vaccine was working.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event Vaccination site haemorrhage.; Sender's Comments: This case concerns a 71 years old female patient who had bleeding at vaccination site, after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Patient was on an unspecified blood thinner which is an important confounding factor in this case. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report as received from a physician via field representative refers to a female patient of unknown age. No medical history reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection) (dose not provided). No concomitant therapy reported. On an unknown date, the patient passed out in the office moments after receiving the first dose of GARDASIL. She rested in the physician's office until she was strong enough to go home. She continued to feel tired and worn down for close to 24 hours. The patient called the physician's office but no medications were given to treat the events. PQC was not involved. The outcome of the event passed out was unknown. Additional information is not expected as the physician could not be contacted.
the day p/vax pt devel red sore arm;it was swollen, red & had a red streak going up arm;went to MD got ATB, told no further doses;
This pediatric patient was immunized with 0.2ml of pediatric vaccine that was not reconstituted.  There were no immediate adverse effects, and the parents were contacted and informed about the event and instructed to look out for local or systemic signs or symptoms of adverse effects.
Low grade fever, chills, lethargy, low level of nausea feeling lasted over a 16 hour period. Just didn't feel well. Slept for 14 hours.  First time having a reaction to any vaccine.  Shot injection site - still sore, as would be expected.    (Reporting for your statistics on my age group.)
Patient states he continues to have pain in his shoulder and has decreased range of motion after daily use.  His shoulder also throbs after daily use.
12/23/2020 10:00 am swollen , tender glands in my throat, left side, slight headache.
My daughter reported general achiness the night of the vaccine (May 4) and went to bed. The next morning (May 5) she passed out standing up from the toilet (about 5 minutes after getting out of bed).
7/24 Cellulitis over left arm at site of vaccination which was treated with Lovaqak. 7/26 Chest pain (S/P negative cardiac w/u) by cardiologist. No evidence of myocarditis 2 hours vaccinia.
Information has been received from a licensed practical nurse concerning a 62 year old female with hypothyroidism and pneumonia (01-JAN-2008), and no allergies, who on approximately 15-JAN-2008 (also reported as "February 2008" and "2 weeks later"), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 657145/1226U). Concomitant therapy included a thyroid medication and amlodipine besylate. That day the patient experienced a burning sensation with the injection. The following day, the patient's arm was painful and the pain spread across her shoulders, and to her hands, knees and foot. The patient's eyes were reportedly bloodshot. The patient saw an eye doctor who stated she had inflammation of the eyes. The patient was treated with ALREX ophthalmic drops. The patient's ocular symptoms worsened so she went to the emergency room, where she was treated with intravenous steroids. In the emergency room the patient had an elevation in blood pressure with the highest reading being 200/78. She also had an elevated sedimentation rate and an electrocardiogram revealed left ventricular hypertrophy. The emergency room physician diagnosed her with "reactive arthropathy." He noted that other than these symptoms the patient appears healthy. An eye doctor (unknown if this was the same original eye doctor or a new eye doctor) said that she does not have iritis but said the patient has eye pain from an unknown source. The patient currently was on oral prednisone and has decreased muscle tone. She still was not feeling well. The patient's new family physician has ordered an echocardiogram. She has also started the patient on blood pressure medication (unspecified manufacturer). At the time of this report the patient's outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
States 4 weeks after receiving vaccine she noticed a large red area (size of a baseball) with a marble size round lump inside.  Very tender to the touch.  Went to a provider 3 days after symptoms started, was dx with cellulitis put on an antibiotic, states has a reaction to that medication was only on it a few days and stopped it and then was never put back on an antibiotic as the swelling and redness went away.  Currently still has a small marble size lump with in her skin that she can feel.
lower blood pressure to the extent that he no longer needs blood pressure control medicine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.    On 24-May-2023, the patient received fifth 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 THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 THERAPEUTIC RESPONSE UNEXPECTED (lower blood pressure to the extent that he no longer needs blood pressure control medicine).    The patient was taking blood pressure medication. It was reported that since the last dose of the vaccine, the patient had experienced lower blood pressure to the extent that he no longer needs blood pressure control medicine. This has been going on for at least 2 months. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-736255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736255:Monovalent dose case
Fever 101, malaise, nausea and vomiting, sore arm starting the next morning, about 12 hours after administration, and lasting about 24 hours.
Information has been received from a 65-year-old female with an allergic reaction to the dye for an MRI and a history of shingles who on 31-JAN-2008 was vaccinated subcutaneous with 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included WELCHOL, ezetimibe (MSD), CEREFOLIN, ENABLEX, glipizide (+) metformin hydrochloride, alendronate sodium (MSD) and MICARDIS.  On 01-FEB-2008 the patient noticed a "hard lump" at the injection site which was "about the size of a fist", it had a "white circle around it", it felt "hot" and it had a "pink rash" in top.  "Now the swelling has gone down, it no longer feels hot, the white circle is gone and the rash is "spreading" on her arm.  The patient sought unspecified medical attention.  No diagnostic labs were performed.  At the time of the report the patient's status was recovering.  A product quality complaint was not involved.  No further information is available.
Patient describes  adverse effects as nausea, vomiting,  body aches, left arm pain, and headaches for two days following vaccine administration. No treatment has been provided so far. Patient has stated she is feeling better.
Pfizer / BioNTech 20Sep2021/ Treatment of COVID-19 6Jun2022; Pfizer / BioNTech 20Sep2021/ Treatment of COVID-19 6Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Lot number: 301358a) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergic Asthma" (unspecified if ongoing); "bandages adhesive" (unspecified if ongoing), notes: known allergies bandages adhesive; "Acid reflux" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Apr2003; SYMBICORT, start date: Apr2010; ALBUTEROL [SALBUTAMOL], start date: Apr2003; NEXIUM [ESOMEPRAZOLE MAGNESIUM], start date: Dec1999; ALLEGRA, start date: Mar2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech 20Sep2021/ Treatment of COVID-19 6Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: bandage as adhesive. Other medical history: Allergic Asthma, Acid reflux, Arthritis, Obesity.  No follow-up attempts are possible. No further information is expected.
I had vaccination on 06/13/2022. On 08/05/2022 I woke up at 03:30AM with a headache and shortness of breath. I called my primary doctor that morning they told me to call an ambulance and get into the hospital. I was sent home with medication. I still have a residual cough and I have to make a follow up with PCP as its not going away.
Delayed / doses / first doses in Nov 2019 / second doses yesterday, 4/22/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in November 2019).   On 22nd April 2021, the patient received the 2nd dose of Shingrix. On 22nd April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose later than the recommended interval, which lead to lengthening of vaccination schedule. The reporter did not consented to follow up. The case is linked with US2021090830, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090830:Same reporter. Husband's case.
Patient called and said the night after the shot was given she fainted for about 5 minutes. She is feeling better today (day of phone call next day) and I told her to stay hydrated and sit as much as possible. If she has another syncope episode to call me and/or go get herself checked out by MD. I told her she can come in and I can take a look at the shot or console her in any way possible. She said she will monitor.
Patient complained that several hours after Fluzone Quad vaccincation, he fell pain, tenderness, tightness, & ringing in the left ear.  Over the next several days, these symptoms intensified resulting in a consultation by ENT doctor.  ENT diagnosis was not significant and no treatment needed yet.  Patient symptoms did not improved after 1 week and patient ask immunizer if his symptoms is a result of the flu vaccination.
Within 24 hours brain fog , fatigue; After 24 hours 102 fever, COVID arm, headache, After 1 week itchy red bumps all over my torso; I have had to use my inhaler every day.
multiple bilateral pulmonary embolism; shortness of breath; elevated heart rate; elevated blood pressure; decreased oxygen saturation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Apr2021 at 10:30 (at age of 47 years old, no pregnant, Lot Number: EW0151) as a single dose for covid-19 immunization. Medical history included hypertension, known allergies Amoxicillin, sulfa, Keflex. Concomitant medications included losartan and omeprazole. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Apr2021 at 09:00, reported at 11 days post vaccine experienced shortness of breath, elevated heart rate, elevated blood pressure, decreased oxygen saturation. Diagnosed with multiple bilateral pulmonary embolism. No typical risk factors. Awaiting results of tests for protein s deficiency/factor 5/lupus. No family history of any. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care/ Life Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized from 26Apr2021 to 29Apr2021. The treatment received with IV heparin, now oral warfarin and Lovenox shots. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 test): negative on 28Apr2021, negative on 30Apr2021 and pending result on 02May2021. The outcome of the events was not recovered.
Report minor congestion in nasal passage, minor HA and body aches.  States it feels like I have a cold. Treatment: Tylenol. Outcome: Moderate improvement does interfere with ADLs continues to work.
pain in right side of hip and knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in right side of hip and knee) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ARTHRALGIA (pain in right side of hip and knee). At the time of the report, ARTHRALGIA (pain in right side of hip and knee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient fainted less than one minute after administration. Patient did no sustain any injuries and sat for 15 minutes until able to walk again. No other adverse effects reported.
Received the injection of HPV vaccine 9/5/17. Immediately a severe headache and fatigue occurred. A couple hours later the headache was so severe, crying in pain. Then vomiting severely. None stop. After that convulsions and loss of consciousness, seizure like symptoms. 911 was called and taken to the ER. Since that day, jerking, involuntary muscle movements, weak limbs, sensitivity to light which causes for constant use on sunglasses, swollen joints, purple splotches on the skin. Unable to stand because of leg pain and weakness. Unable to open things because of arm and hand weakness.