chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3am sore arms, red around injection site, Chills, aching muscles and bones and joints, low grade fever which went up gradually over next few hours, by the next day I had 101.6 fever.  Only at 430pm on march 11th did I take advil. The fever went down. By the next morning I was feeling much better, like a new person. My arm was still red. However, on the 13th my arm is itchy and the red area radius has greatly increased. I also had many rounds of night sweats. Enought to keep changing my pajamas.
Possible secondary innoculation to genital area. Mutiple vesicles with crusting to penis.
cheeks really red, skin on cheeks very bumpy even p/APAP & fever was down;buttocks & pubic area red, swollen;rectal area blistered;
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot number L011846 and expiration date 16-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 17-year-old male patient who received BEXSERO for prophylaxis. On 13th August 2018, the patient received BEXSERO .5 ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced influenza-like symptoms, myalgia, arthralgia, malaise and nausea. On an unknown date, the outcome of the influenza-like symptoms, myalgia, arthralgia, malaise and nausea were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, myalgia, arthralgia, malaise and nausea to be related to BEXSERO. Follow up information received from nurse via licensee on 11th September 2018: For 24 hours the patient experienced flu like symptoms, myalgia, arthralgia, malaise and nausea. By 48 hours the symptoms were gone. The patient's mother was the reporting physician and stated no other vaccines were given at that visit. This case was linked to the case US2018GSK164091, reported by the same reporter.
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sharp muscle and joint pain after her first and second shot of the vaccine; it was more painful after her second shot, also developed rashes (about 3 inches in diameter) around the injection site on an unspecified date with outcome of unknown. No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
I was very fatigued. I started having major joint and muscle pain in my lower back down to my legs. I developed a pain in my hip that I could not stand. I had to use a walker to go to the bathroom. I passed out twice. I lost control of my bladder while I was passed out. I have to got see a neurologist for that. I went to the ortho specialist. I had a x-ray, that did not show nothing. I have several CT scans, it shows back and leg muscle issues. They said I demand in my tendons of my right hip joint. I had a surgical procedure for it. I said I have a panacea legion and renal access. Last week I had a endoscopy ultrasound biopsies on it.
Febrile - Temp 105 seizure 8 days after MMR, Varivax, Hib-Hep B, Hep A
Slight sore right arm.; tired; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Slight sore right arm.) and FATIGUE (tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 prophylaxis.     Concomitant products included SILDENAFIL and OMEPRAZOLE for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Slight sore right arm.) and FATIGUE (tired). At the time of the report, PAIN IN EXTREMITY (Slight sore right arm.) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2022-663256, MOD-2022-663266 (Patient Link).
Fever; Chills; Body ache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 17Mar2021 at 19:00(at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN) 40 milligram (mg) for an unknown indication from an unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5502) via an unspecified route of administration in the left arm on 24Feb2021 at 19:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021, at 12:00 (17hrs after the vaccination) the patient experienced fever, chills, body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events fever, chills, body ache and fatigue was resolved on 20Mar2021 at 12:00.   No follow-up attempts are needed. No further information is expected.
Rec'd call to observation area.  Rec'd client slumped down in chair complaining of lightheadedness and dizziness.  With the assistance of another nurse, client was lowered to the floor and 911 activated.  Lowered to floor and feet elevated using a chair.  Client was alert and responsive, no loss of consciousness, stated, "This happens all the time whenever I get a shot or medical procedure my nerves first give out."  EMT arrived and took over.  Vitals:  BP 122/74, pulse 94, resp. 26 and pulse Ox 97% on room air.  Pale complexion.  Client stated she has been for almost 24 hours.  Per EMT blood sugar was 106 and transferred to ambulance by EMTs for observation at 4:20 pm.  At 4:32 pm Rec'd follow report from EMT stated client was stable and cleared to go home.  No hospital transfer.
Additional symptoms presented themselves in both eyes roughly 2-4 weeks after the first shot (Moderna Lot#025J20-2A) and the initial 24-48 hour flu-like symptoms to the shot in Jan 2021. Second shot (Moderna Lot#042L20A ) was administered in Feb 2021 along with increased eye related symptoms. Initial symptoms included blurred vision, headaches/migraines, vertigo, and sensitivity to lights which included haloing and star-bursting. Initially sought care with optometrist, but was referred to Medical Center for additional assessment between Feb-April 2021. Ophthalmology initial assessment that symptoms were presenting as Fuchs Heterochromic cyclitis, bilateral (treatment recommended optical steroids and artificial tears). Symptoms stabilized, but failed to resolve during tapering treatments through July/Aug 2021. Referred to cornea specialist with an appointment of Nov 2021. Specialist assessment could not provide positive diagnosis, but did not believe symptoms were related to Fuchs Heterochromic cyclitis. Specialist could not confirm correlation with COVID virus or COVID vaccine, but recommended continue Ophthalmologist directed treatments. Third COVID shot (Moderna Lot#035C21A) was administered on Dec 2021, which presented increased eye related symptoms shortly after. Returned to Ophthalmology for 3 months checkups and referred back to Prof. Dr. in Feb and Sept 2022 for additional assessment. Symptoms again stabilized through spring/summer 2022 with suspected tie to COVID vaccine. Fourth shot (Pfizer Bivalent Lot#GJ5342) was administered October 2022, which again presented with increased eye related symptoms 2-3 weeks after the shot. Followed up with Ophthalmology who recommended not taking any additional COVID vaccines, submit CDC adverse affect report, and to seek military medical waiver from future COVID vaccines.
Itching all over body. Mild in nature. No airway swelling or itching. No swelling of lips or face. Improved without treatment. Had an additional episode of itching @ 24 hours after injection
Case number PHEH2014US020303 is an initial spontaneous report received from a pharmacist on 07 OCT 2014. This report refers to a 23 year old female patient. Her medical history and concomitant medications were not reported. On 07 OCT 2014, she was vaccinated  with a dose of FLUVIRIN 2014/2015 (batch number: 1413501) intramuscularly. The pharmacist was suspicious that the vaccine was frozen or stored below recommended temperature administration. No adverse event was reported following this administration error (incorrect storage of drug).
Hospitlized for AKI, hypoxia, COVID-19, encephalopathy, and respiratory failure. Pt expired at the hosptial.
SHORTNESS OF BREATHE WHILE DOING STRENUOUS WALKING; RUNNY NOSE; SLIGHT SORENESS IN LEFT ARM; SLIGHT SORENESS IN LEFT ARM DELTOID AND TRAPEZOID MUSCLE; INJECTION SITE SORENESS; EPISODES OF BOWEL MOVEMENT ACCOMPANIED BY BLOODY DISCHARGE FROM RECTUM; SLIGHT/MILD/DULL HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported,1 total administered on 07-JUL-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUL-2021 16:45 after 30 minutes to one hour after the injection patient experienced slight headache, after fifteen hours of injection on 08-JUL-2021 patient experienced slight soreness in left arm, deltoid and trapezoid muscle and runny nose. Patient also experienced first bowel movement accompanied by bloody discharge from rectum after fifteen hours of injection followed by second bowel movement accompanied by bloody discharge from rectum after eighteen hours of injection on 08-JUL-2021 and third bowel movement accompanied by bloody discharge from rectum after twenty hours of injection on 08-JUL-2021. After forty two hours of injection on 09-JUL-2021 bowel movement was normal and no bloody discharge from rectum was there, his left arm was still slightly sore and had occasional mild headache and experienced shortness of breath later that day on 09-JUL-2021  when doing strenuous walking. Patient reported that approximately after seventy two hours of the injection there was slight soreness at injection site and dull headache at times. Patient stated not to experience all of these symptoms before the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from episodes of bowel movement accompanied by bloody discharge from rectum on 09-JUL-2021, was recovering from slight/mild/dull headache, slight soreness in left arm deltoid and trapezoid muscle, slight soreness in left arm, and injection site soreness, and had not recovered from shortness of breathe while doing strenuous walking, and the outcome of runny nose was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210728244-Covid-19 vaccine ad26.cov2.s-Episodes of bowel movement accompanied by bloody discharge from rectum. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Received 3 vaccinations on 1-14-13, when Mom looked today, all three sites were red, with hardened bumps, very hot to the touch.
03/31/23 presents to ED for "shortness of breath". PMHx of "prostate CA, CKD, CAD s/p PCI to LAD, ischemic CM with ICD in 2016"
hives and itching within 15 minutes Tx: vitals, monitored, sent to ED- diphenhydramine  Allergy eval- Recommend 2nd dose Cetitizine pretreatment and 30 min eval  2/9/21 Received 2nd dose administered, No adverse Reaction
Developed Tinnitus 1 day after Moderna vaccine shot. Ringing in Left Ear began March 17, vaccinated on 16th.
Chest pain; Her chest hurts when she runs her fingers through her chest; Tightness in her chest; Slight coughing; Heavy breathing; Sweating; Body ache; Her arm pain is twice as bad; Fever only at night; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing) and HYPERVENTILATION (Heavy breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Joint pain. Concurrent medical conditions included Asthma and Depression.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing), HYPERVENTILATION (Heavy breathing), HYPERHIDROSIS (Sweating), PAIN (Body ache), PAIN IN EXTREMITY (Her arm pain is twice as bad) and PYREXIA (Fever only at night). At the time of the report, CHEST PAIN (Chest pain), CHEST DISCOMFORT (Her chest hurts when she runs her fingers through her chest), CHEST DISCOMFORT (Tightness in her chest), COUGH (Slight coughing), HYPERVENTILATION (Heavy breathing), HYPERHIDROSIS (Sweating), PAIN (Body ache), PAIN IN EXTREMITY (Her arm pain is twice as bad) and PYREXIA (Fever only at night) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medication included Antidepressant medication. No treatment medications were provided.
Patient presented 8 days post vaccination with mild symptoms of Erythema Multiforme distributing from vaccination site across left chest.  Patient spontaneously resolved without further complication or treatment within 4 days.
Patient reports receiving SHINGRIX around 11am. That afternoon the injection site was red. As time went on, it became swollen and now her wrist is hurting. She has a dr appointment this afternoon.
The day of the first shot, I developed soreness in my arm, headache, fatigue. The next day, my side effects continued and worsened.  On 4/4/21, my symptoms continued and I developed more fatigue, fever,  nausea, chills, early period, and abdominal pain.  On 4/5/21, these side effects continued and the abdominal pain increased.  On 4/6/21,   ER determined that I developed acute appendicitis.  My appendix ruptured and I had to have an appendectomy.
About 12 hours after my vaccination I experienced a low grade fever, chills, body aches, headache, diarrhea, loss of appetite, and very drowsy. This lasted from 8am until about 3pm. Later in the evening my only symptoms were headache and drowsy.
I had a rash on my stomach after first shot. After receiving second shot of Moderna, the same night, my throat and tongue swelled up and felt itchy and tingly. I also had bad abdominal cramps on my left side that I went to urgent care of  a week after second shot.
Pt was given the Moderna vaccine, 1st dose, on 07/06/2021 at a pharmacy.  She then developed an ARM RASH to the left delt (location of injection) and redness / swelling.  She presented to clinic and Urgent Care for evaluation on 07/15/2021.  This provider (NP) treated her with a short course of cephalexin and prednisone.  I advised her to get the second shot as scheduled. She had no hives, no airway effects.
No symptoms reported by patient.  Patient adversely given Pfizer vaccine as second dose, should have been a Moderna vaccine.
itchy 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comments:  The case was reported via interactive digital media. The patient experienced itchy four days after shingles vaccine. Additional Supportive Information: Follow up would not possible, as no contact details were available.
Entire deltoid inflammed 22 hours post injection. Benadryl administered to control itching
passed out twice; extreme hot flashes; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out twice) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: Pfizer on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high (The patient was taking regular medications.). Concomitant products included ATENOLOL and CHLORTALIDONE (CHLORTHALIDONE) for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out twice) (seriousness criterion medically significant), HOT FLUSH (extreme hot flashes) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, LOSS OF CONSCIOUSNESS (passed out twice), HOT FLUSH (extreme hot flashes) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            Treatment information was unknown.  Company comment: This is a case of Interchange of Vaccine Products that concerns a 51-year-old female patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred the same day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-386106 (Patient Link).; Sender's Comments: This is a case of Interchange of Vaccine Products that concerns a 51-year-old female patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred the same day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination; This is a literature report.  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 (FIRST DOSE), for covid-19 immunization. The following information was reported: THYROIDITIS ACUTE (medically significant), outcome "unknown", described as "Thyroiditis Related to mRNA-Based SARS-CoV-2 Vaccination". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of acute thyroiditis  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200710264 Same article/ Event/drug and different patient;US-PFIZER INC-202200710266 Same article/ Event/drug and different patient;US-PFIZER INC-202200710265 Same article/ Event/drug and different patient
This spontaneous case, initially received on 18-Oct-2016, was reported by a health professional and concerns a 60-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 18-OCT-2016 to 18-OCT-2016. Dose regimen: 0.5 ml single dose, Route of administration: Subcutaneous. Batch number: WT53306. No additional suspect drugs. Adverse event description: On 18-Oct-2016, a 5/8 inch needle was used to administer vaccine and may have been given subcutaneously (outcome: not reported, special circumstances: incorrect route of drug administration without adverse event). Reporter comments: The healthcare professional considered the event non-serious and classified it as a medication error.
Received Moderna Covid 19 vaccine on 1/16/21 still warm to touch, red and swollen.  She thinks the swelling and the pain, warmth has stayed about the same since last weekend, no better or worse.  denies  muscle pain, fatigue, fevers, or chills.    left deltoid has a circular 1.5in x 1.5in area of erythema, induration, pain to the touch.  It is quite warm on palpation.   This looks and feels the be cellulitis, although its not progressing.  It very well could be still be caused by the immunogenicity from the vaccine, but we will treat this as a cellulitis.  Call if any worsening please - cephalexin (KEFLEX) 500 MG capsule; Take 1 capsule (500 mg total) by mouth 2 times daily for 7 days  Dispense: 14 capsule; Refill: 0
Left upper arm redness, induration, and warmth of most of the upper arm. No apparent discomfort with direct palpation. No fever or pus. Is using the arm normally. Given TYLENOL at home.
7 days after injection my arm became red, itchy, sore, and hot. The symptoms are still present.
Swollen lymph nodes in left armpit. Lymph nodes are soft and tender to the touch. Patient understands that this can be a side effect of the vaccine, and just wanted to make sure it was reported as a side effect.