chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 22 min post MMR/Hepatitis B vaccine. Pt was light headed, near syncopal episode, pale, weak. This vaccines was pt's. #2 MMR and #2 of #3 Hepatitis B series. Pt. stated he done great with the first MMR and Hep B.
5 days p/vax parents noticed a rash around inject site; rash approx 3" x 4" raised papular rash-sl reddened; parents did take pt to ER to check it then office visit next day;
Information has been received from a physician concerning a patient who was vaccinated with all three doses of Rotateq and subsequently experienced a rotavirus infection.  The patient was seen by the physician for medical attention.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
Itchy rash developed at the vaccination site on my arm ten days after receiving vaccination.  Rash and itchiness gradually disappeared after three to four days.
Resident experienced flash pulmonary edema at 2300 on 01/25/2021  with SOA, Overt coarse crackles to all lung fields, hypoxia on room air requiring 5LPM via NC, Hypertension (190/102). Resident was sent to Hospital where she was admitted for pulmonary edema.
No adverse event; Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No relevant medical history/conditions, allergy, concomitant diseases and risk factor were reported.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 1 and batch/lot number: Unknown); for COVID-19 prophylaxis: Spikevax (Dose 2 monovalent, batch/lot number: Unknown and administered 4 months ago). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and Spikevax.    On 08-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023) 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 (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023).    No concomitant medications were reported. No treatment medications were reported.
Bilateral arm pain below elbows and hand tingling, throat swelling within 12 hrs of vaccine.
I contracted COVID-19 around 10 months after receiving the COVID-19 vaccine I had breathing issues and fatigue.
Pt received Engerix-B & experienced numbness in lt leg, lt deltoid soreness, bilateral arthralgias, tingling in lt leg, minimal burning at injection site.
mistakenly got 4 vaccinations of Shingrix, got extra doses; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 4th dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-Apr-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. What if the reporter had mistakenly got 4 vaccinations of Shingrix. Additional Supportive Information:  The case was self-reported by the patient. The patient received 4 doses of Shingrix, which led to extra dose administered. The follow-up would not possible as no contact details were available.
Injection site stinging, soreness, red, hard, and hot. Area of redness/swelling is continuing to grow.
A vial of Moderna was transported from one vaccine event to another and did not use Qualified Container and Packout for the initial vaccine transfer of 10 doses of Moderna. The transport timeframe was 15 mins total.
Myalgia, Fever, NauseaVomiting, chills, welt on arm Narrative:   Other Relevant History:
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. the concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, either lot number L044526 with expiration date of 09-NOV-2017, lot number M004328 with expiration date of 26-JAN-2018 or lot number M009765 with expiration date of 23-FEB-2018 (strength, route of administration and dose were not reported). No concomitant therapies not adverse effect were reported. This is one of two cases from the same reporter. Additional information has been requested.
Around 8:30PM started to feel bloated and the feeling of something out of the norm.  Around 8:45PM-diarrhea.  Then, nausea followed quickly.  Stood up, felt light-headed, and vomited several times.  Went to bed around 9:30PM.  Got up 3 times during the night with diarrhea.  Got up in the morning and felt fine.  No headache or fever.  But was feeling chilled when I went to bed.
I had my 2nd Moderna Covid vaccination on Monday at 11. By the time I got home Monday night, I was having rigors and severe pain throughout my body. Tuesday, I continued having the pain, extreme fatigue and started having itching, burning and hypersensitive skin everywhere.  Finally took Benadryl around 2000 Tuesday evening when my lips and tongue started getting numb and tingling. 5/4/2021- The pain subsided, but I continue to have the itching and hypersensitivity.
pt was feeling lower back pain 5-10 minutes after the vaccine was given.pt complained of sharp lower back pain but it got better after 15 minutes she was able to get up move strech
Fatigue, Violent Diarrhea and Vomiting that lasted 2 1/2 days for the diarrhea and overnight for the vomiting.  Caused hemorroids.
I had this vaccine at my local pharmacy and was told the worst case side effect would be arm pain. The injection itself was painless. Within 12 hours I def had the arm pain which indicated below the actual injection site to my elbow, then I had tingling (creepy crawly) on bottom of feet and palms of hands, which spread to extremeties, severe flushing of the face, redness on arms, and very slight raspy breathing. Having dealt with allergies to antibiotics before I decided to take two benedryl immediately, which helped keep reaction controlled, but later the next day I spiked a high fever, headache and severe fatigue.  I had the injection on Friday at 4:30pm, today is Sunday at 1:30pm - still have some  of the "creepy crawly" itching on feet/hands,  still have arm pain , am controlling reaction and  fever with both benedryl and tylenol.
migraine-like headache; This is a spontaneous report from a contactable other health care professional, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) via an unspecified route of administration in the left arm on 08MAR2021 at 10:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient had unspecified past medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced migraine like headache within a few days after the shot on 11Mar2021 at 14:00. It was reported that the patient never gets headaches before. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient had not received any treatment for the event. The clinical outcome of the event migraine like headache was not recovered.   No follow-up attempts are needed. No further information is expected.
expired dose given to patient with no reported adverse event; Initial information received on 25-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 23 years old female patient and IPV (VERO) [IPOL] expired dose given to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine for Prophylactic vaccination.  On 25-May-2023, the patient received a dose 1 dose 0.5 ml of suspect IPV (VERO) Suspension for injection lot T1E871M expiry date: 10-oct-2022 via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 25-MAY-2023 the patient developed a non-serious expired dose given to patient with no reported adverse event (expired product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired dose given to patient with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Narrative: 66 y/o male with Hx of obesity, DM2, HLD and 2 out of 2 COVID vaccination who presents with fever, cough, fatigue. The patient states that he recently has been exposed to his granddaughter who tested positive on Aug 16th. Since that time the patient states he developed symptoms such as fever, dry cough, congestion, diarrhea, headache. In the next few days he himself tested positive outside the Facility on Aug 18th. He tried to quarantine at home but symptoms worsened and therefore presented to the ED. COVID positive. HR 85, BP 105/80, RR 18, On 3L nasal cannula. Labs showed, BUN 26, Cr 1.22, AST 97, ALT 71, CBC/INR normal, Trop neg, BNP normal. CPK 448, CRP 147, Procal 1.41, Ferritin >2000, LDH 538. Ddimer 1.21. CTA: negative for PE, moderate GGO's in bilateral lungs consistent for COVID pneumonia. He was admitted to the medicine service. HOSPITAL COURSE: The patient was admitted to the hospitalist service. Covid pneumonia with hypoxemia - Patient treated with course of dexamethasone/remdesevir. The patient did require supplemental oxygen (1-2L) for a few days but this was stopped several days prior to discharge. Discharged to home.
Red circular rash surrounding injection site, 2 inches in diameter. Does not itch or hurt.
"Moderna COVID-19Vaccine EUA" Running 103 temperature. Extreme Fatigue. Chills. Body Aches. Headache. Large knot/swelling on the injection site. Can barely lift my right arm.  Have been taking Benadryl and ibuprofen.
Redness, slight swelling at the time,warm to touch, T 98, P 74
Patient presented to the pharmacy with deltoid discomfort around previous injection site - redness, swelling, and erythyma. Patient stated previous injection site itched this morning and she started scratching it, patient was advised to go to urgen care for treatment.
Hospitalization 2/13/22-2/18/22 for COPD exacerbation, covid. Treated with zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
The patient is a 63 y.o. male with history of COPD, protein malnutrition presented to Hospital with shortness of breath.   Chronic respiratory failure Acute exacerbation of COPD/COVID infection Ventolin, Doxycycline Received doxycycline 100 IV twice daily Received dexamethasone 6 mg IV daily  Plan for DC home with home health   Covid-19 Virus Infection Date of onset of symptoms: 1/6/2023 Symptoms present on admission: Yes Date of covid positive test: 1/8/2023 Vaccination status: He is not sure Imaging: Chest x-ray Oxygen requirements on admission: Yes Current oxygen requirements: 2L (this is his home level) Medical therapy: remdesivir and steroids Consultants following: ID Anticipated special isolation end date: 1/17/2023   Severe malnutrition w/ cachexia, POA BMI-13.34 Supportive care Ensure booster if needed PT/OT eval  Care manager for DC planning
reddness & tenderness of lt upper arm; pain & is guarding the arm; swelling from near shoulder to elbow;
Pt spiked a temperature of 103.2, 24 hours after vaccines were administered. Fever lasted 20 hours. He was fatigued and drowsy for 3 days following administration. Approximately 8 days after vaccines he started with a eye blink tic, repeating his words, and acting confused with slurred speech. It is now 2 months post vaccine administration and his eye blinking tic is constant at all waking hours, his word repeating is every few sentences, but speech slurring is clear again.
Information has been received from a health professional concerning her 52 year old husband who was vaccinated into the abdomen with a dose pneumococcal 23v polysaccharide vaccine. She was not sure if the vaccine was given subcutaneously or intramuscularly. Subsequently, the patient developed injection site redness and the injection site was swollen and painful. The patient sought unspecified medical attention. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
bud 1/7/23, administered 1/9/23. Moderna analysis confirmed activity against COVID-19 on date of administration
arm pain; severe collar bone pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and BONE PAIN (severe collar bone pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced BONE PAIN (severe collar bone pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown and BONE PAIN (severe collar bone pain) had not resolved.        Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   No concomitant medications were reported. No treatment medications were reported
Started with mild nausea on the Wednesday morning. Lack of appetite throughout day & low energy. I?m the evening it went to exhaustion, no appetite, chills, & fever. Had a fever for nearly 6 days. Secondary flare up of esophagitis with chest pain as well.
Difficulty breathing, swelling in my throat, itchiness like I was getting hives but never appeared
The physician reported that the patient was vaccinated on 10/19/2000 and presented on approximately 11/01/2000 with erythema multiforme, ten red lesions and a low grade fever. Unspecified medical attention was sought. Additional information has been requested.
Influenza vaccination given on 10/21/2022. 70 year-old M with CAD s/p CABG x2, gallstones and Barrett's Esophagus presenting to ED after ~24 hours of burning epigastric pain with associated mid-back pain. Symptoms started on the morning of 10/26 while at work driving a school bus. He was able to complete work. He had a normal breakfast before symptom onset and reports his diet is fairly consistent. He didn't feel well when he returned home. He could eat and drink small amounts, but felt queasy. Anything he put in his stomach made the burning worse. He has not vomited. Pain continued on the day of admission and he felt generally exhausted. He went home and went to bed. Around 16:00, wife took his temperature and it was 100.4F. The pt preferred to wait it out but she convinced him to seek evaluation. In the ED, lipase was 250 and CT of the abdomen was c/w acute pancreatitis. He denies a history of the same. He doesn't drink alcohol and hasn't in 35 years. He doesn't smoke. He denies new medications.
TDAP 1/12/10 ~ 1/24 headache, right arm pain, some tingling and numbness. Then began to have pain in hips and thighs, lateral aspects, bilat. By 2/3 he also had chest pain, abd pain and R flank pain plus a metallic taste. Left eye and right hand got a little weak. Pretty much resolved by mid Febuary.
Erythema, swelling, warmth, beginning approx. 24 hours after administration of Varicella vaccine.
Altered Mental Status. Patient felt physically fine but mentally didn?t feel like himself.  He called it a ?psychedelic effect? He stated that his mind didn?t operate normally. He was more sleepy during this time as well.
24hr p/vax pt devel lt runny nose w/o cold sx;severe h/a, considered sinusitis;negative scan & unresponsive to sinus therapy;1wk later double vision;nerve paresis suggesting cavernous sinus synd likely for ischemic cranial neuropathy;
Patient was given 0.5ml of Moderna Monovalent.  He requested BI-VALENT Moderna.  There have been no physical adverse events or treatments given.
"Covid arm" ... swollen, red bump about 2 inches in diameter, which is a bit firm, slightly sore but mostly itchy and warm.
THE PATIENT REQUESTED A COVID VACCINE. THE PHARMACY ADMINISTERED ON 7/13/22. BUT THE PATIENT HAD JUST HAD A DOSE  ADMINISTERED AT THE SAME PHARMACY ON 5/4/22 FOR THE SAME VACCINE (PFIZER COVID ADULT)
Pt wife reported that pt fainted while driving home. Wife reported no serious injury to patient but was concerned what to do following. Pt was doing ok at time of reporting per wife. Advised to monitor heart rate/blood pressure, vision changes or headaches. advised following up with MD as soon as possible.
Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 1/26/2023 Discharge Date: 1/28/2023   PRESENTING PROBLEM: Hypokalemia  Thyroid nodule  Hypoglycemia Renal insufficiency  Fall, initial encounter  Pneumonia due to COVID-19 virus    HOSPITAL COURSE: The patient is a 87 y.o. male long term resident with a past medical history of anxiety, CKD, dementia, sleep disturbance, paroxysmal atrial fibrillation, coronary artery disease, hypertension, chronic obstructive pulmonary disease and left shoulder pain who presented to the emergency department after a ground level fall.  On presentation to emergency department he was noted to be hypoglycemic and hypothermic.  He had unknown COVID positive since 01/18/2023.  Urinalysis was consistent with infection and imaging showed a right lower lobe consolidation concerning for a superimposed bacterial pneumonia.  There was also an incidental finding of a thyroid nodule. He was admitted to the hospitalist service for COVID-19 pneumonia and urinary tract infection.   During hospitalization he initially required 2 L of nasal cannulated oxygen.  He was quickly weaned to room air.  He was placed on IV ceftriaxone and azithromycin for the treatment of superimposed bacterial pneumonia as well as Decadron for COVID-19.  Urinalysis did grow out Proteus and Aerococcus.  He was given a 1 time dose of fosfomycin for aerococcus coverage.  Thyroid nodule was discussed at length with patient and DPOA.  At this time they would do not want to pursue additional testing with thyroid ultrasound as he is not having any dysphagia or hoarse voice and they would most likely not pursue any type of treatment for malignancy.  TSH was normal on recent check.  He completed 3 days of ceftriaxone and 2 and half days of doxycycline.  He will be discharged on additional 2 half days of doxycycline and 2 days of Ceftin to complete antibiotic therapy for urinary tract infection and bacterial pneumonia.  He will also be prescribed additional 7 days of Decadron to complete 10 day course for COVID-19.  On the day of discharged in medically stable condition.  He denies any fever, chills,  shortness of breath, nausea, vomiting, or diarrhea.  He does continue to have a productive cough.  He does continue to have leukocytosis however with clinical improvement this is thought to be secondary to steroid use.  Recommend that he have a complete blood count in the next week or so after completing steroid therapy.  He will be discharged back to where he resides.
get a little red; flushing of his face; Heart racing a little inside; sore arm; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation. Medical history included patient occasionally drinks a glass of wine and also has a sensitivity to Tylenol with the same heart-racing response. The patient's concomitant medications were not reported. O 19Mar2021, patient experienced flushing of his face- get a little red only after having a few sips wine, usually starting with his nose, and his heart "feels a little race-y, inside". The reaction is not tolerable, and he cannot finish a glass of wine, regardless of if its white or red. No allergic reaction to wine/alcohol before getting the vaccine. Heart racing a little inside- do not take any Tylenol or stuff like that. Patient also had sore arm. Patient second dose of vaccine was due on 21Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected