chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLEEPINESS 30 MINUTES AFTER VACCINATION; INJECTION SITE TENDERNESS; SLIGHT HEADACHE; STONED FEELING; DECREASED RINGING IN RIGHT EAR (UNEXPECTED THERAPEUTIC BENEFIT); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ringing in right ear only from approximately 15 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced sleepiness 30 minutes after vaccination. On 09-MAR-2021, the subject experienced injection site tenderness. On 09-MAR-2021, the subject experienced slight headache. On 09-MAR-2021, the subject experienced stoned feeling. On 09-MAR-2021, the subject experienced decreased ringing in right ear (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sleepiness 30 minutes after vaccination, stoned feeling, and slight headache, had not recovered from injection site tenderness, and the outcome of decreased ringing in right ear (unexpected therapeutic benefit) was not reported. This report was non-serious.
redness and itching at site.  slight pain at site.  no swelling.  advised oral diphenhydramine and monitoring for worsening symptoms.  advised to follow up the next day
Pt recvd 3rd dose of Hep B vax ID instead of IM; subsequently, pt devel a "local reaction";
Right armpit swollen to size of an orange. Nausea and headaches. Chest pain, excruciating chest pain when I cough. Fever. Light pain when breathing
Soreness; shivering/chills; felt like crap for a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date and it was good, no problem).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Soreness), shivering (Verbatim: shivering/chills) and sickness (Verbatim: felt like crap for a day). The outcome of the pain and shivering were not reported and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the pain, shivering and sickness to be related to Shingles vaccine.     It was unknown if the company considered the pain, shivering and sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 13-MAR-2023 The case was received from the patient interactive digital media. The patient stated that the second Shingles shot knocked him/her for a loop. The patient had soreness, chills and shivering, felt like crap for a day or so but, so glad as he/she got the jab.  The patient stated that now he/she did not had to worry about the real deal. The follow-up could not be possible as no contact details were available.
Had some hot flashes and a headache overnight and when I woke up in the morning. I took some Tylenol in the morning and felt better later that day.
Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist pave 7 doses on 01Jun2021 out of a vial,but does not know if vial was from 30May2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Additional information was received from initial reporter and does not contain new information On 30-Jun-2021: Telephonic follow up response was received from initial reporter: Event verbatim was updated
Pt arrived with increased shortness of breath and acute hypoxic respiratory failure. He was recently hospitalized and discharged on 7/26 for osteomyelitis status post bilateral toe amputation, and his hospital course was complicated by AKI. Pt was found to be tachypneic and required BIPAP and was COVID positive.
Patient complained of nausea and vomiting, headache, cold sweat but said he felt hot.  Improved in 20 minutes.  2 hours afterwards he said he felt normal.
Left arm pain  Fatigue/foggy Headache     Reason for reporting: Tinnitus (ear swooshing and ringing) developed in left ear,  slight hearing loss aabout 12 hours after vaccine
Heart pain/worsened; headaches after my 2nd dose which would not respond to Tylenol or ibuprofen/non-stop headaches; my vision was weird zigzag moving lines that formed a circle like shape.; ocular migraine; Heart pain; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy, Allergy to antibiotic (sulfamethoxazole and trimethoprim), Nickel sensitivity, Irritable bowel syndrome, Arthritis and Migraine.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant). 20-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 25-May-2021, the patient experienced OPHTHALMIC MIGRAINE (ocular migraine) and VISUAL IMPAIRMENT (my vision was weird zigzag moving lines that formed a circle like shape.). On an unknown date, the patient experienced CONDITION AGGRAVATED (Heart pain/worsened) and HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen/non-stop headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 25-May-2021, OPHTHALMIC MIGRAINE (ocular migraine) had resolved. At the time of the report, ANGINA PECTORIS (Heart pain) had not resolved and CONDITION AGGRAVATED (Heart pain/worsened), OROPHARYNGEAL PAIN (sore throat), VISUAL IMPAIRMENT (my vision was weird zigzag moving lines that formed a circle like shape.) and HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen/non-stop headaches) outcome was unknown.            Concomitant product use was not provided.  Patient reported she had a history of migraine but nothing like the events experienced.  She had consist headaches after her 2nd dose which would not respond to paracetamol or ibuprofen.  She emailed her physician but did not see in person.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-208995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Added allergies, medical history, vaccine information, and events; event outcomes updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient's mother contacted DSHS 2/8/16 to report that the patient had been taken to the ER the evening after receiving immunizations. Mom states patient was found unresponsive by an uncle. Per ER records, mother states patient remained breathing, but wouldn't respond, had a blank stare. Family called 911 & child was taken via EMS to the ER. Rectal temp in ER at approx. 7:30PM was 103.8. Mother states patient last had Tylenol around 3PM. Patient was discharged from the ER around 2AM after lab completed & patient's temp returned to normal.
no additional AE reported; AN EXPIRED DOSE OF M-M-R WAS ADMINISTERED TO A PATIENT; This spontaneous report was received from a registered nurse and refers to a patient with unknow age and gender.  The patient's pertinent medical history and concurrent conditions were not reported.  On 07-FEB-2022, an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (0.5 milliliter, lot #T001214, expiration date: 12-JAN-2022, administered for prophylaxis) and also sterile diluent (STERILE DILUENT) solution for injection/infusion was administered to the patient.  The reporter confirmed that the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) did not experienced a temperature excursion. No additional AE reported (no adverse event)
Full-body muscle ache began within a few hours.  Knee and wrist joint ache and elevated temperature followed within 24 hours.
Awoke the morning following the vaccination with ringing in my ears.  It has continued without abatement to the present time, two months later.  It is a constant high pitched "noise".
Symptoms of Tinnitus began within a few days after my 5th vaccine/booster. It is more prominent in the Right ear, and at night sleeping.
Light headed, blurred vision. BP/pulse: 139/92, 63; 145/82, 57. O2 sat 99%-100%. History of anxiety disorder. Stable, discharged to home.
NAUSEA; SEVERE FATIGUE; HEADACHE; SWOLLEN LYMPH NODES IN NECK; RUNNY NOSE; WATERY EYES; FLU LIKE/BAD COLD; SWOLLEN LIPS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included chf, asthma, and congestive heart failure, and concurrent conditions included seasonal allergy, penicillin allergy, alcoholic, no smoking, and nonsmoker, and other pre-existing medical conditions included the patient has no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clarithromycin, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lips. On 14-MAR-2021, the subject experienced swollen lymph nodes in neck. On 14-MAR-2021, the subject experienced runny nose. On 14-MAR-2021, the subject experienced watery eyes. On 14-MAR-2021, the subject experienced flu like/bad cold. On 14-MAR-2021, the subject experienced severe fatigue. On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from runny nose, and flu like/bad cold, and had not recovered from headache, swollen lymph nodes in neck, nausea, severe fatigue, watery eyes, and swollen lips. This report was non-serious.  Version created to amend the previously reported information on 15-MAR-2021. Upon review, following information was amended: Medically confirmed field was unchecked.
administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 77-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Expiry date was 07-APR-2022. Number of vials/doses: 173 doses.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Patient with known alcoholism, found down and out covered in blood for an unknown period of time.  Brought to Healthcare Facility by ambulance for treatment, and planned to transfer.  Suspected GI bleed; when flight crew arrived, decided to intubate.  Failed first attempt, and patient when into cardiac arrest.  Was revived with CPR and 2 doses of epinephrine.  Pt also received TXA and 1 unit PRBC, and fluids.  Successful second attempt, though BPs remained labile.  Pt transferred to ICU and was notified that additional evaluation found bleed had actually occurred proximal GI tract (oral mucosal bleed, not esophageal).  Pt also diagnosed prior to transfer with multilobar pneumonitis, ascites secondary to alcohol cirrhosis, hematemesis/meme positive stool, leukocytosis and pancreatitis.  Was notified by ICU less than 24 hours later that pt was on vent and stable.
Developed backache & headache, 100.6, no appetite. Wife & son had aches-pains mostly bronchial.
This spontaneous report as received from a physician refers to a 52 year old male patient with multiple sclerosis. On 04-AUG-2017 the immunosuppressed patient was vaccinated with a dose of ZOSTAVAX lot # N015628 with expiration date 30-JUL-2018, for prophylaxis. Concomitant therapies included fingolimod hydrochloride, losartan potassium (manufacturer unknown), methylphenidate, and BACTRIM. On 04-AUG-2017, 1 day after onset of therapy the patient experienced product use issue. The outcome of product use issue is unknown. The reporter considered product use issue to be not related to ZOSTAVAX.
This spontaneous report as received from a nurse refers to an approximately 18 year old female patient. No information regarding the patient's medical history was provided. On 13-JAN-2011 the patient was vaccinated with the first dose of GARDASIL injection. On 20-AUG-2012 the patient received the second dose. No concomitant medication was reported. It was reported that the patient received GARDASIL off schedule. The patient asked to receive the third dose in the near future. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Information has been received from a physician concerning a 36 year old female with no drug allergies who "last week", on approximately 21-FEB-2011 was vaccinated subcutaneously with a 1.5 ml dose of MMR II (lot # not provided). There was no concomitant medication. It was reported that the patient experienced left sided facial numbness about 6 hour after the MMR II injection and increased fatigue. No lab diagnostics studies performed. Patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Follow-up information was received, which stated that the patient's symptoms were fully recovered. No further information is available.
LEFT DELTOID SWELLING, TENDERNESS, REDNESS EXTENDING DOWN TO ELBOW REGION, WAS TREATED WITH BENADRYL AND ICE.
Narrative:  Patient was hospitalized on a COVID unit and initiated on dexamethasone and Remdesivir 5 day course each. He had O2 supplementation via nasal cannula as well as inhaled bronchodilators and supportive care with expectorants and mucolytics. Patient improved with the above regimen and by 9/7/2021 was feeling good spirits. He was tolerated by mouth and ambulating in his room with oxygen supplementation at 3-4 L/m. He was deemed stable for discharge home with close outpatient follow-up for posthospitalization reevaluation as well as oxygen weaning.
fever 100.5 (for 1 day), body aches (for 3 days), muscle pains (3 days) chills (1 day) , headache (4 days), severe pain in left arm to (3 days), joint pain (3 days). fever resolved with advil and aleve.
patient claims to have self diagnosed pancreatitis after developing a burning sensation in her stomach. diagnosed via online research.
1 of 4 pts vax w/Td exp inject site react of erythema & induration; pt had redness/induration 2 xs 4 cm 6 days p/vax;
pt irritable,very fussy,high pitched scream MD was called primary provider stated placed on ibuprofen alternated w/APAP drops;to call hosp if sx persist beyond 6-8hrs;
30 mins after receiving vaccine, child c/o stomach cramping. At 8:30 pm she again c/o stomach pain and stated she couldn't move her left side (side of injection) Grandmother pinched her and she felt it, says she could move left arm and leg, she just didn't want to move it. Grandmother called MD, who told her to 'watch' the child.  The child slept all night, cont. to c/o stomach ache the next day, and finally vomited after eating a sandwich in the afternoon of the 2nd day.  Grandmother states she has been fine since.
Throat swelling, racing heart, head throbbing, chest tightness, slight dizziness, and face flushing. These symptoms came in waves and is a normal reaction I get with medication I am sensitive to. However because I not having a normal reaction, I was told to go to an emergency room for a EKG. I knew this wasn?t a heart event, but a reaction to the vaccine. It is a normal reaction for me. I?ve dealt with it most of my life.
Severe Headache Rash starting on neck and chest Chills Fever Vomiting
Fix weeks after the vaccine I started to have severe abdominal pain, fever and blood in the Urine. It started with abdominal pain and the next day I had a fever.  I went to the ER it was discovered that I had elevated Liver Function tests and Eosinophilia.  There was Bilirubin in my Urine.  I was discharged the next day. The fever persisted and I returned to the ER. My levels were much worse and my Eosinophil levels were climbing. I also developed a rash on my hands and feet. After extensive testing nothing definitive was found. I have not had any problems like this before.
Child received immunizations at regular check up. Went to ER same day c/o something being in throat, voice change, throat & tongue swollen. Got IV fluids, Benadryl 7.5 mg, Solu medrol 30 mg IV. Epinephrine 1:1,000 0.15 ml SQ, Benadryl 7.5 IV. Sent home with Orapred 15 mg/5 ml 10 ml QD x 5 days.
Pt recv vax on 2/18/98; on the same day pt exp a swollen thigh from knee, crying unrelieved by Tylenol, and hot to touch.
My normal temperature is 97.3 degrees. Since my first vaccine, my temperature fluctuates daily between 97.3 and 99.3.  I received my second vaccine on 02/08/2021. I haven't discussed this issue with my primary care as I have an appointment scheduled for 03/08/2021.
Rash at site of injection spreading around to inside of upper arm.  Light headed and dizziness.
Hives. No anaphylaxis or difficulty breathing. Evaluated in clinic on 12/13/11. Benadryl given for symptoms.
pt recv vax 13SEP96 & 1hr post vax pt reportedly devel a fever of 101 & muscle aches;
Lack of efficacy; break through COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (break through COVID) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (break through COVID). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (break through COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19.         No concomitant medications were taken by the patient.  No treatment medications were taken by the patient.  The patient had to undergo a surgery for the shoulder.  The patient had undergone rapid COVID test and the patient was not sick at all and has self-quarantined rom the family members.  This is a case of drug ineffective of this 59-year-old, male patient, with no known medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  7 months after second dose of Moderna vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of drug ineffective of this 59-year-old, male patient, with no known medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  7 months after second dose of Moderna vaccine. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
PT REPORTS FEELING INTENSE PAIN TRAVELING DOWN LEFT ARM, STARTING ABOUT 2 HOURS AFTER VACCINATION. ALSO REPORTS INTENSE ABDOMINAL DISCOMFORT AND TIGHTNESS AROUND NECK AND TORSO. HAS "CHILLS" RUNNING DOWN LEFT ARM. PT DENIES DIZZINESS, SHORTNESS OF BREATH, DIFFICULTY BREATHING OR DIFFICULTY SWALLOWING.
Mother was awaken my child's breathing, he sounded like he was trying to get air. Stated son informed her that it was hard for him to breathe. They called the paramedics they gave him oxygen but his levels kept dropping. His throat was closing and they gave him Alburtral and was taken to the ER.  He was given a steroid shot and he started to get better. He also tested positive for COVID at the ER.
vaccine vial punctured and administered and left in fridge overnight. next morning same vial was used to administer vaccine. rph phoned patient who said she was fine. rph phoned md who said they made note and will call if they have further questions.