chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 100.1 degree for 26 hrs; Fatigue which stayed for 3 days; Muscle pain; Joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.1 degree for 26 hrs), FATIGUE (Fatigue which stayed for 3 days), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Cardiac disorder, HYDROXYCHLOROQUINE for Sjogren's syndrome.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 100.1 degree for 26 hrs), FATIGUE (Fatigue which stayed for 3 days), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 100.1 degree for 26 hrs), FATIGUE (Fatigue which stayed for 3 days), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) 100.1.     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.
I became extremely tired and went to sleep. I was awakened by the feeling of something traveling up my esophagus toward my throat. It was unlike anything I?ve ever felt. As it reached my throat I began to cough. It was intense electrical energy like something wanted to get out. I have not stopped having daily coughing since that day. It is not extreme coughing and the feeling is less intense but it?s occurring daily.
Approximately 12 hours after vaccine I developed a fever, aches, chills and migraine headache. It was like this for approximately 24 hours. It is starting to go away today, just aches and chills today.
This is a medication error.  Directed by Health Clinic to fill out Report. Patient came in for second dose of moderna, accidently gave pfiser (EW0179, exp 8/2021)
Patient scheduled for second dose of Moderna vaccine. Patient received booster dose (0.25ml.) instead of (0.5ml) dose which was the appropriate dose by RN. Phone call was made to the patient at 1205pm  and voicemail message was left. Patient has not returned call as of this report.
1st Vax: 03/01/2021 Allergic reactions, Angioedema , Facial swelling, arm and leg swelling, Covid Arm, Injection Site Swelling, fever, chills, crusty lesion behind left knee, 2 types of rashes on legs- pinpoint red and a bumpy, itchy contact dermatitis.  2nd Vax: 03/31/2021 Same as above plus severe non- migraine headache, low fever, throwing blood clots and greenish brown mucus from sinuses and sputum,  a Wheezing, given albuterol at ER, stomache and back/leg pain worse than usual.
Patient given an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) had resolved.        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.   No concomitant products were reported.  No treatment information was provided.   This case was linked to MOD21-088351, MOD21-088359, MOD21-088361, MOD21-088363, US-MODERNATX, INC.-MOD-2021-114456, US-MODERNATX, INC.-MOD-2021-114834 (E2B Linked Report).; Sender's Comments:  MOD21-088351: MOD21-088359: MOD21-088361: MOD21-088363: US-MODERNATX, INC.-MOD-2021-114456: US-MODERNATX, INC.-MOD-2021-114834:
Head ache; Body pain; Little fever; 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 HEADACHE (Head ache), MYALGIA (Body pain) and PYREXIA (Little fever) 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 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Head ache), MYALGIA (Body pain) and PYREXIA (Little fever). At the time of the report, HEADACHE (Head ache), MYALGIA (Body pain) and PYREXIA (Little fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Reporter did not allow further contact
Most likely they did get the flu; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient with unknown demographics who experienced the flu (influenza), while he/she received influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  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 developed a non-serious flu (influenza) it was reported that, but not the statins that were in the flu shot. Its guess every year which statins of the flu will hit. Also the  virus  was constantly changing by the time of flu season (Unknown latency)following the administration of influenza vaccine.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as Unknown for flu.  No further information was reported.
I experienced hot flashes for a number of months. I entered menopause ten years ago, and have not experienced any hot flashes until I took the Johnson and Johnson COVID shot. Also, the site of injection remained painful for several months.
None reported Narrative:  An 86yo male with history of Arthralgia of Pelvic region and Hip, Aortic Valve Insufficiency, Hyperlipidemia, Hypertension, GERD, Chronic A-Fib, Mild Cognitive Impairment, BPH, Cardiorenal Syndrome and Allergic Rhinitis Per Nursing documentation he received first Covid- 19 vaccine on January 14, 2021 and the second shot on February 4, 2021 without complications and per policy /protocol He had bladder issues and was scheduled for a procedure on February16, 2021 but prior to that on February 8, 2021 His daughter reported he developed Hematuria and pain, was seen at medical facility, she picked him up upon discharge, he got home, stepped into the house with difficulty and collapsed. He was take to Hospital with EMS, got admitted to ICU, was on a ventilator and passed away on February 17, 2021
Pt developed painful endurated edema of left upper at site on injection persisting for more than 5 days after injection.
pt says she woke up w/ a horrific headache.  She got up vomiting, SOB, lung pain, 101.3 fever, chills, sweats.  These symptoms lasted for a couple of days.  She says she has diarhea now, feels like she has a fever but does not.  She has tingling in both hands and has a very hot swollen left arm around the injection site.  The knot is about the size of the palm of her hand.  Patient says she feels a little better but still has the symptoms.
A non-serious spontaneous report of upper respiratory tract symptoms was received from a physician concerning her five-year-old daughter, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications was reported for this patient. On 24-Oct-2009, the patient received H1N1, Intranasal for an unknown indication. On 25-Oct-2009, the patient experienced fever and upper respiratory tract symptoms which lasted for four days. The outcome of the event was resolved.
Bullous Pemigoid/blistering itching skin reaction/rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization. The following information was reported: PEMPHIGOID (medically significant), outcome "recovered", described as "Bullous Pemigoid/blistering itching skin reaction/rash". The event "bullous pemigoid/blistering itching skin reaction/rash" required physician office visit. Therapeutic measures were taken as a result of pemphigoid. Clinical details: Patient's first Pfizer shot for Covid was fine. After second shot and got a blistering itching skin reaction about two months after the shot. After visiting several Dermatologist, patient was referred to (withheld) and was diagnosed with Bullous Pemigoid. It took a few months of dupixant treatment for the rash and itching to go away. Patient never had it prior to Covid shot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Case number PHEH2012US024261 is an initial spontaneous report from a consumer on 07 Dec 2012. This report refers to a male patient of unknown age. The patient was vaccinated with a seasonal influenza vaccine (manufacture and batch number: unknown) on an undetermined date. After vaccination, the patient experienced Guillain Barre Syndrome on an unspecified date. Seriousness and outcome of the event were not reported.
He returned from the hospital through a PEG tube, he was stable. On 7/3/2021, caregivers give a round of vitals at 7:30 am, he was stable, when he was going to receive food he was without vital signs. Cause of death respiratory cardiac arrest.
Swollen lymph node under left armpit starting about 24 hrs after vaccines and lasting 3-4 days.
Information has been received from a Certified Medical Assistant concerning a 78 year old female patient with no known drug allergies/drug reactions who on 11-MAY-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 657143/0380U) subcutaneously into her left arm. It was reported that on 11-MAY-2009 the patient experienced soreness, redness and swelling of her arm at the injection site after receiving PNEUMOVAX. The patient sought medical attention with an office visit. There were no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of report. Additional information has been requested.
sites of subcutaneous injections (live virus immunizations) developed welts within minutes of administration-pt was given antihistamines as ordered per provider and observed for 20 minutes prior to discharge
Presents with cough, shortness of breath, leg edema and anorexia.  The patient developed her shortness of breath with associated leg swelling at approximately the beginning of the month.  COVID testing on 1/4/2022 was negative.  The patient was provided with a course of steroids and Lasix by her oncologist, and scheduled to see cardiology as an outpatient.  On approximately 1/11 the patient states she experienced decreased appetite, worsening cough and shortness of breath.  She has not eaten well since that time and states food has no taste and she has a poor sense of smell now.  Today her cough worsened, and her daughter who is a nurse noted oxygen saturations in the 80s at home on room air.
Patient was given Pfizer for dose 2 instead of Moderna. No side effects reported.
I got just one hive on my arm and it itches and hurts; I got just one hive on my arm and it itches and hurts; I got just one hive on my arm and it itches and hurts; This is a spontaneous report from a contactable consumer (patient). A 43-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0182, Expiration Date: 31Aug2021), via an unspecified route of administration in the left arm on 10Jun2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced just one hive on arm, and it itches and hurts on 11Jun2021. He wanted to know if he can take Benadryl or Claritin as treatment. The patient's second dose vaccine shot due date on 03Jul2021. The outcome of the events was unknown.
approx 1yr p/vax pt devel varicella zoster rash. addl info requested
No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) 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 EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    No concomitant drug was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment drug was reported.   This case was linked to MOD-2022-690931 (Patient Link).
Swelling and extreme soreness in entire right upper arm, much greater than any previous injection. On day of injection and day after. Today, day 3, extreme fatigue and full body aches, headache, nausea, nasal congestion, and low grade fever. TYLENOL taken right after injection as done with every previous flu vaccination in the past.
Patient came in on 9/1/18 and said that she is having a reaction to a pneumonia shot she received on 8/30/18. Her warm is red, painful, and warm. The site seems to be spreading. She is currently taking benadryl and zantac for it, as well as using an ice pack, which I told her to continue to do. I also called her primary care physician, but had to leave a message. She said she will call me if the area worsens or changes and will see her doctor about it next week.
2-3 days after vaccine, experienced decreased appetite, fatigue, fever (Tmax 106 per pt), and headache.  Received workup for meningitis, and after lumbar puncture had onset of conjunctivitis, and cranial nerve palsy with double vision.  Treatments have included supportive care and treatment of pain/discomfort.
Case number PHEH2012US011418 is an initial spontaneous report received from a nurse on 05 Jun 2012: This case refers to 11-years-old female patient. She was vaccinated with MENVEO (batch number: M11053) at dose of 0.5 ml intramuscularly on 05 Jun 2012. But vaccine came out of the vaccination site during the injection resulting in less than 0.5 ml entering to the patient's deltoid muscle. No adverse event was reported following this administration error.
(R) neuroretinitis. (R) upper extremity paresthesia. Multiple white matter lesions on MRI.
High fever, oxygen saturation levels dropped to low 90's, difficulty breathing, confusion, terrible headache, extreme body aches.  Lasted two days.
Wrong Route of Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 26-JUL-2023, the patient received Boostrix (subcutaneous). On 26-JUL-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong Route of Administration). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Jul-2023 The nurse manager stated that the patient received Boostrix via subcutaneously instead of intramuscularly, which led to Intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Diffuse maculopapular rash on all 4 extremities, no pustules initially.
Racing heart and chest pain. X ray shows hyperaeration symptomatic of mild copd. Absolutely new symptom post vaccine.
1st dose 12Oct2022, 2nd 06Mar2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old female patient who received HAV (Havrix) (batch number 3397T, expiry date 07-OCT-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 06-MAR-2023, the patient received the 2nd dose of Havrix. On 06-MAR-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 12Oct2022, 2nd 06Mar2023). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Mar-2023 The clinic supervisor reported that the patient received first dose at 13 months of age and then was given the second dose at her 18 month visit. Both doses were given from same lot number. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received second dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
13 yo M with a history of autoimmune hepatitis who presents with 1 day of fever, headache, altered mental status, and vomiting. He received his 2nd Pfizer Covid vaccine on 6/12 and began having symptoms the next night. He began taking ibuprofen for headache and fever. His symptoms worsened through the day until he had vomiting. He was saying strange things and behaving oddly. He became very hot and agitated at home, prompting mom to bring him into an outside hospital ED.  There, rectal temperature was 106F and he was noted to be combative.  A CMP was obtained, which was mostly normal. CT of his head was obtained, during which he had an episode of left upper extremity shaking concerning for seizure. He was reportedly alert throughout.   Patient is a 13 yo M with a history of autoimmune hepatitis who presents with 1 day of fever, headache, altered mental status, vomiting, found to have cerebral edema and elevated CRP. There is no acidosis, elevated lactate, or metabolic derangement, and utox is neg. The etiology could be related to the vaccine. Ingestions are also possible given the high fever and altered mental status - particularly serotonin syndrome. Infectious etiologies are also possible given the fever.   Treatments: hypertonic saline given x1 EEG started Tox screen negative Ceftriaxone and vanc given
Patient said shot was fine and no issues at pharmacy. Got home and some time in the next day, arm began to hurt very badly and could hardly lift/move without being in pain. Went to her MD on 10/22/19 and she told them she thought her vaccine was given too high on her arm based on where the bandaid was placed on her arm. They did not do any test/imaging to rule anything in/out but gave the patient a steroid and said to come back in a week after finishing steroid if not better. She came back and arm was still not better. Pain with movement and decreased mobility. They set up with physical therapy and she has been going every week. She came to our pharmacy on 1/21/20 and told us about this. Said her arm is back to 50% she would say. Telling us this is to see if our pharmacy would reimburse for her physical therapy expenses. This has been escalated to our corporate team to follow up with patient on this request. Interviewed pharmacist who gave vaccine and she said there were no complaints or issues from patient or herself at the time of administration. Said nothing out of the ordinary occurred during this vaccine administration.
Large red bumps (center chest). Herpes sores around groin. Hives on lower back. Psoriasis legs.
Possible incorrect dose was administered to the patient. The undiluted vial of Pfizer vaccine was mixed with possibly 1.3ml of diluent and only 5 doses were obtained from mixed vial. Patient was contacted immediately upon discovery of the possible mistake, and reported no side effects/adverse events(within 24 hours of administration). Patient was counseled on watching any further complications and will be followed up in next 48 hours and 72 hours.
This non-serious initial spontaneous case, was received on 06-Nov-2017, from a pharmacist, concerning a 36-year-old adult male patient. On 05-Nov-2017, the patient was administered with AFLURIA (TIV) (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that the AFLURIA was at a temperature of 57 F for a few hours (lasted for 4 hours). Hence, vaccine was outside the recommended range which was administered to the patient (explicitly coded as incorrect product storage and drug administration error). The reporter assessed the events as non-serious.
Bell's Palsy; voice was sort of ugly; A spontaneous report was received from a consumer who is a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and his voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis.  The patient's medical history included hypertension, triple bypass, operation in stomach and intestine and depression. No relevant concomitant medications were reported.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient stated he woke up at 0800 and noticed his voice sounded ugly. When he looked in the mirror his face looked crooked. The patient went to the hospital and was diagnosed with Bell's palsy. The patient stated he was discharged home the following day. He was given unspecified steroids.  Treatment information included unspecified steroids.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, voice was sort of ugly/dysphonia and Bell's palsy/facial paralysis, were considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.