chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Frozen shoulder on the injection side; A lot of pain in the left arm; Inability to move the upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder on the injection side), PAIN IN EXTREMITY (A lot of pain in the left arm) and MOBILITY DECREASED (Inability to move the upper arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced PERIARTHRITIS (Frozen shoulder on the injection side), PAIN IN EXTREMITY (A lot of pain in the left arm) and MOBILITY DECREASED (Inability to move the upper arm). At the time of the report, PERIARTHRITIS (Frozen shoulder on the injection side), PAIN IN EXTREMITY (A lot of pain in the left arm) and MOBILITY DECREASED (Inability to move the upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications was provided by reporter.
Rash- face and arms Flushing of face -cheeks increased pulse 97-100bpm tingling in hand
Sore injection site ?very mild?onset about 3pm day of injection Red, swollen injection site and painful to slightest touch?onset about 8am day after injection, unresolved at this time Extreme dizziness?onset 1pm day after injection, lasted approx 4 hours General unwell feeling?onset 1pm day after injection, resolved around 10pm that day
No additional AE; expired dose of VAQTA administered to a patient; Date of excursion: 20-JAN-2021; Temperature 46.2F; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 05-MAY-2021, the patient was vaccinated with an expired and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 50U/1ml, lot # reported as T014590, with expiration date 15-APR-2021 (both confirmed to be valid), 1 dose form for prophylaxis. The temperature excursion was 46.2 degrees Fahrenheit (F) for 10 minutes which occurred on 20-JAN-2021. There were no previous excursions reported. The digital data logger was not involved. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Still Payne in left arm when I move it certain ways. There's a hard knot in my arm there.
Pt reports experiencing increased heart rate, dizziness, weakness and feverish. also felt short of breath at first.
Injection site is hard, warm, itchy and getting bigger in size as days go by.  Started the size of a nickel then a quarter then a silver dollar and now, day 5 about 2 inches in diameter.  Its painful when I touch it otherwise I feel no pain and no fever.
was really bad, very bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1), for COVID-19 immunisation, reaction(s): "no adverse event". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "was really bad, very bad".  Additional information: The reporter's first sister-in-law (patient) gotten the COVID vaccine and with the first they did okay but not with the second. The reporter's first sister-in-law was really bad and the caller was not even going to venture into what to say but her first sister-in-law was very bad.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administration of Adult dose to pediatric patient; Patient 19 years of age received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th February 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 6th February 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, a 19 year old patient received an adult dose of Engerix B, which led to overdose and adult product administered to child. The Healthcare professional was not at the facility to provide lot number and expiration date. The Vaccine administration facility was the same as Primary Reporter. The reporter did not consent to follow up. Note: The suspect 'Engerix-B adult' was coded as PFS as per the source document as clarification was raised regarding the formulation and no specific response was received.
Immediately following injection patient began to have localized swelling, redness, and warmth measuring 8x10cm on the right thigh where the MMR was placed. Patient also has the same immediate reaction to VARIVAX which was placed in the right arm. That localized reaction was measured at 5x6cm. Markers were placed on each localized reaction sites so we could watch for continual spreading. Patient was kept in office for observation an additional hour to ensure no further reaction symptoms presented themselves. An ice pack was provided for both sites and patient was given Tylenol for pain. Mother was advised to watch for additional localized reaction. She voiced understanding and we have scheduled a follow up appointment so we may continue to monitor this patients outcome.
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician in the concerning a 36-month-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and dose not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to included all their concomitant medications).  There were no adverse events associated with these medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. 02/05/09 Follow-up received 31-Mar-2009: added product complaint investigation results.
This is a spontaneous report from a contactable physician assistant (PA) via Pfizer-sponsored program. A 16/17 year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA along with MENACTRA, on an unspecified date. The patient medical history and concomitant medications were not reported. Previously at age 11, she received a dose of MENACTRA. On an unspecified date, the patient experienced numbness of arms, shortness of breath and sort of a panic attack: she was seen in emergency room and due to the events she was admitted to the hospital. The outcome of the events was unknown.
Pain in left arm after Tdap vaccination-worsened by next morning. Diagnosed at pmd with brachial neuritis on 08/22/2016 seen pmd 09/06/2016 with continue to have pain and weakness in left arm. Pt states she is unable to fully extend left arm. Has had 3 physical therapy sessions.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Fluid buildup/retention started early in the year, January 2021. In May 2021, it got excessive bilateral fluid buildup (Pitting Edema). I went to hospital for medical tests.
My PCP advised I take benedryl and tylenol after the vaccine because of the AE I experienced to the 1st vaccine so I am unsure if because I was extra tired is d/t all of the vaccine or if the benedryl played a part in it.  But about 2hr after I begin getting a headache but had already taken tylenol so I didnt take anything.  I got a little dizzy and super sleepy but nothing else on the first day.  The next morning I was so tired, drained feeling and very fatigued.  I got up for a while but had to lay back down because I was feeling foggy, tired and very fatigued causing me to miss work.  About 4pm I felt a little better.  The next day I had a mild headache and still felt a little tired but was able to go to work and nothing else since.
I was administered Hepatitis A Vaccine by shot in my right arm, momentarily afterward there were symptoms of nausea, fatigue, and fainting. I had to have immediate stitches given due to head injury. Nausea and fatigue symptoms lasted for a couple days.
Pt started vomiting @ 830PM on Thurs; Became limp, pale & lips turned purple; Took pt to hosp same evening; t100-101; Lab work was all neg x/white count sl elevated; pt vomited couple of times;
Anaphylaxis; Rash; urticaria; This is a spontaneous report from a contactable Physician. This Physician reported in response to other health professional letter [sent to physician] via follow-up.  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via intramuscular in the right deltoid on 12Apr2021 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included history of previous allergies to PNC (penicillin), codeine, amitriptyline and latex. Patient received antihistamine for the treatment of allergies. Concomitant medications included trazodone, vitamin C (ascorbic acid), calcium citrate, linum usitatissimum seed (FLAXSEED), topiramate (TOPAMAX), zolmitriptan (ZOMIG), norethindrone (norethisterone), ethestradiol (desogestrel, ethinylestradiol (ETHISTREL)), esomeprazole sodium (NEXIUM), valaciclovir hydrochloride (VALTREX), linaclotide (LINZESS), cyanocobalamin (VITAMIN B12), and colecalciferol (VITAMIN D) all taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534), via intramuscular in the left deltoid on 22Mar2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation and on an unknown date in Mar2021 patient had rash/hives. The patient did not receive any recent vaccines, for any other conditions and for SARS-CoV2 other than Pfizer-BioNTech Covid-19 Vaccine, prior to the event being reported. On 13Apr2021, the patient experienced anaphylaxis with signs and symptoms rash and urticaria. First saw patient on 13Apr2021, 1 day after 2nd dose, she reported rash/hives since 1st dose in Mar. The patient required medical intervention with corticosteroids and antihistamine. It was reported that Pfizer product had a causal effect to the adverse event. The outcome of all the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylaxis, rash, urticaria and the suspect drug BNT162B2.
Nausea, fever, weakness, body aches, headache, shortness of breath, upper abdominal pain,  calf muscle pain, brain fog, joint pain, cough.
Itching at injection site; Big red round circle at injection site; Injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Big red round circle at injection site) and VACCINATION SITE PAIN (Injection site arm hurt) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN, ALLOPURINOL, OMEPRAZOLE, FAMOTIDINE (PEPCID AC), DULOXETINE HYDROCHLORIDE (CYMBALTA), CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN), LABETALOL, SIMVASTATIN and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site arm hurt). On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Big red round circle at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Big red round circle at injection site) and VACCINATION SITE PAIN (Injection site arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's treatment details included Massages and Compresses.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: fallow up received contains no new information.
Swelling at injection site and axillary area. Muscle pain. Diphenhydramine, Hydrocodone/APAP 5/325, Cyclobenzaprine.
slept for days; fatigued; red and black spots on right side body; red and black spots on right side body; dose 1 back in 2017, refusing to get dose #2; bumps on left side of face; This case was reported by a consumer via call center representative and described the occurrence of sleep excessive in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the patient received 1st dose of Shingrix. In February 2022, not applicable after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced papular rash. On an unknown date, the patient experienced sleep excessive, fatigue, red spotty rash, skin discoloration and incomplete course of vaccination. On an unknown date, the outcome of the sleep excessive, fatigue, red spotty rash, skin discoloration and papular rash were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sleep excessive, fatigue, red spotty rash, skin discoloration and papular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The patient reported that she received Shingrix dose back in 2017.  She stated that minutes after she went home and slept for days after the vaccine. She was fatigued.  She did not remember the exact date but afterwards she noticed red and black spots on right side body.   She stated that 6 months ago of reporting date she experienced bumps on left side of face.  She was refusing to get dose 2. Additional Supportive Information: The patient was refusing to get dose 2 which led to incomplete course of vaccination. In 2017, the patient experienced sleep excessive, fatigue and incomplete course of vaccination. Time to onset for event sleep excessive and fatigue were several minutes with respect to 1st dose of Shingrix. Time to onset for events red spotty rash, skin discoloration and incomplete course of vaccination was unknown with respect to 1st dose of Shingrix. In 2022, the event papular rash was recovered. The reporter consented to follow up.
Patient developed a rash on the right lower back on February 22, two days after receiving his second hepatitis B injection.  The rash is consistent with herpes zoster (shingles).  Patient is a healthy university pathology department employee.  Employee given 1.0 milliliters of vaccine at the same time because vaccine is in a pediatric formulation.
Chills Severe sweating Headache Nausea  vomiting  Elevated blood sugar
Information has been received from an infectious disease physician concerning an approximately 13 year old female who was vaccinated with Gardasil. Subsequently the patient experienced genital ulcers 24 hours after the vaccination. The patient sought medical attention. Additional information has been requested.
Developed acute onset of chest pain and found to have elevated troponin consistent with post-vaccine myocarditis. This was his booster shot. He required admission mostly for pain control and monitoring of troponin values, which took two days to trend down.
Admission Diagnoses: Hypokalemia [E87.6] Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82]   Discharge Diagnoses:COVID-19 pneumonia resolved Hypercoagulability secondary to Covid infection Alzheimer's dementia Chronic systolic heart failure Diabetes mellitus controlled Obstructive sleep apnea   Hospital Course: She was admitted last week she had developed some hypoxia was tested positive for Covid on 24 August was started on remdesivir and Decadron has completed the course of remdesivir she is no longer needing supplemental oxygen will have her continue with 4 more days of Decadron will give her 15 units of NPH for 4 days with the Decadron to keep her blood sugars from going over 300.    Consults: IP CONSULT TO PHARMACY IP CONSULT TO DIETITIAN   Discharge Exam: Blood pressure (!) 155/74, pulse 73, temperature 98.7 °F (37.1 °C), temperature source Oral, resp. rate 16, height 5' (1.524 m), weight 64.3 kg (141 lb 12.1 oz), SpO2 94 %. She is alert oriented to herself in no distress not in any oxygen lungs are clear to auscultation   Disposition: Home or Self Care (Routine Discharge)
Joint pain, tiredness, weakness, chills, leg pain, aching muscles, stomach ache.
he started inconsolably crying around 12:30, showing severe inflammation, lasting many hours.  He had a horrible headache, nausea and vomitting, fever 105, soaked his christmas sweater with sweat to the point where I could wring the moisture out of it, listless at 1800.  Couldn't lift head or walk.  I had to carry him into the emergency room and the ER doctor agreed it could be an adverse reaction.
Started next day with headache, then progressed to achy & tired, then felt very cold & started taking temp. & saw temp go up to 104by late afternoon & then went down to 102 by bedtime.  Next AM started at 99 & then was gone by PM
Could not stand; Piercing pain in middle of spine to tailbone; Piercing pain in middle of spine to tailbone; Walking was very difficult; Left arm injection site sore; This is a spontaneous report from a contactable consumer(spouse). A 63-year-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ER8729), intramuscular at Arm Left on 06APR2021 10:45 at the 63 years old at single dose for COVID-19 immunization.  The medical history was none. The concomitant medications were none. The Historical Vaccine was BNT162B2 first dose on 16MAR2021 at 63 years old for COVID-19 immunization (Lot ER2613; Injected in left arm given in the muscle).The reporter was calling on behalf of her husband who had the second vaccine yesterday. He had an odd reaction and was not good. He had to go to work after getting the vaccine and was at work for an hour. He could not stand and he is a chef. She had to go pick him up. There was a piercing pain in the middle of his spine to his tailbone. The patient experienced Walking was very difficult and Left arm injection site sore. He has been on the Tylenol which is the protocol. All of the events happened on 06APR2021 12:30. This morning on Day 2, it was not much better. She would like to know if there have been any reports of this and what Pfizer recommends for this. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
racing & pounding heart - started within 30min after injection, lasted about 5 days (24/7).  Was not severe. Was able to perform normal daily activities.  No treatment was administered, just watched & waited.
88yo F with PMH of htn, HLD, hypothyroidism, GERD and recent kidney stones who presents with sob and sore throat x 2-3 days. SOB is at rest. worse with exertion. Associated with severe congestion. no fever or night sweats but did endorse some intermittent chills. Pt is vaccinated x 3 - March and April 2021. Vaccinated for the flu in September, 2021. pt lives in apartment by herself but has frequent visitors/friends who come by her apartment. Denies being around anyone who is frankly sick. Denies chest pain.
patient presented for 2nd dose Moderna, screener identified pt as not eligible due to age 17 years 11 months on 04 FEB 2021.  On same date we also Identified that pt had been vaccinated on 07 JAN 2021 in error  and manufacture guidance for not meeting minimum age of 18 y/o to receive Moderna COVID19 vaccine. Pt incurred minor S/S after initial dose per the parent, low grade fever, general fatigue and malaise for approximately 24 hours.  No other symptoms reported by parent.Health agency/CDC and manufacture contacted and advised for guidance.  Health agency provided guidance for 2nd dose administration now or at age 18 per parental authorization
Left thigh 3 1/2 x 3 1/2 redness, swelling and warmth present, DTaP site.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a drugstore as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Headache, Myalgia, BODY ACHES Narrative:  PT ENDORSED FEELING LIKE HE WAS HIT BY A CAR THE SAME DAY RECEIVING THE VACCINE. VOICED HAVING A 'BAD' HEADACHE.
Dizziness, Pale skin, pupils Dilated, Disorientation, cold hands