chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Sinus issues; Fullness and pulsing in / left ear; Puffy Lips; Vision changes; Palpitations; Pain in teeth; Arm pain; Not feeling good / All / symptoms have resolved / except for not feeling good; Cold sore; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th December 2020, 12 days after receiving Shingrix, the patient experienced cold sores. On an unknown date, the patient experienced headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache, pain in arm and feeling unwell. The patient was treated with acyclovir and medication unknown (Otc Medicines (Medication Unknown)). In December 2020, the outcome of the cold sores was recovered/resolved. On an unknown date, the outcome of the headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache and pain in arm were recovered/resolved and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the cold sores, headache, sinus disorder, ear feels clogged, lip swelling, visual disturbance, palpitation, toothache, pain in arm and feeling unwell to be related to Shingrix.  Additional details were reported as follows: On 16th December 2020, the patient recieved Acyclovir.  The patient reported that the cold sore returned in January 2021 and she again treated with Acyclovir and it resolved (unknown date).  The patient also had headache, sinus issues, fullness and pulsing in her left ear, puffy lips, arm pain, pain in teeth vision changes, palpitations and she was not feeling good. No Lot number or expiration date for vaccine was provided.  The reporter did not consent to follow-up.
temp elevated to 104-105 x 3 days, sz (possibly 2), irritable for several days;inconsolable  consulted MD sz related to temp;mom feels poss life threatening if vax again w/vax;
Headache, Myalgia, inj site soreness/tight, headache, muscle aches, swollen glands Narrative:  Dasy 1-2 inj site soreness/tightness; day3-4 mild headache; Day 7-8 Muscle aches and swollen glands
Found in bed seizing with fever, apneic - taken to ER, intubated and transferred to a tertiary medical center.  60 day follow up states that followed by neurology with nl EEg and dx with febrile seizures.   Nurse follow up on 06/30/04 states: "none." Nurse follow up on 06/30/04 states: "ADD: bilateral otitis media, anemia, disseminated intra-vascular coagulation."
expired dose of Menactra was inadvertently administered to patient, no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a 14 years old female patient who was inadvertently administered with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported, expiry date: 30-Jun-2019), via unknown route in an unknown site on 15-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had no 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sore shoulder where shot was administered. Achy joints, sensitive nerves, headache.
Mom called clinic today. Reports child's left arm is swollen from shoulder to elbow. Also reports redness and fever in arm. Mom reports is seeing doctor today for illness NOT related to vaccine.
4-5 hrs p/vax pt dec responsiveness, shallow breathing, no cyanosis, pale-appeared apneic to parents;
Breakthrough case of COVID-19, I had a minor headache, a fever of about 100.5, I was tired and a lot of coughing and bringing up mucus. I took PAXLOVID on the 8th for 5 days, and on Tuesday the 12th, my at home test was negative.
Information has been received from a 71 year old female who on 3 weeks ago was vaccinated with a 1 time dose of ZOSTAVAX (Merck). Concomitant therapy included LIPITOR and alcohol. The patient experienced joint pain on her wrist and ankles after the vaccination, and soreness at the injection site that "passed away in a few days". The patient was still experiencing the joint pain and had not spoken with her doctor yet. At the time of the reporting, the patient was recovering. Additional information has been requested.
Pt developed a large red, warm, area surrounding vaccine site w/advancing erythematous boarder.
Arm was very sore, had a red welt on the injection site the size of a tennis ball, injection site was very hard, and warm to touch.  Could hardly touch site, or move arm that vaccine was given days afterwards.
massive seizure/small stroke symptoms - no explanation. Left me unconscious and unresponsive for over 2 hours only to come to unable to speak or open my mouth. Seizure symptoms and blackouts have continued with no diagnosis over the last 4 months with doctors unable to determine a cause or treatment. Therapy was suggested as last resort- this also did not work, psychiatrist and therapist both do not think that these are related to my mental state (though I have other issues that are).
This vaccine caused me to have a pretty bad hashimoto flare up. Severe tiredness. Achy all over and even tho I took eye drops as directed they were dry and Sandy feeling for a couple of days. I never stopped my meds prior to vaccine. My immunodeficiency did not require me to as it may in some other cases. Even today my left shoulder still has pain at site of injection.
20 minutes after staff received his flu vaccine, he returned back stating he was itching and noticed a rash on his face. staff denied being lethargic or diaphoretic , i informed staff that i am going to assist him to family practice clinic , i then assisted him to family practice clinic, and the nurse in charge at that time took vital signs and notified the physician immediately.
1st dose Nov2019, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 and 23-Sept-2022 Reporter's comment: The caller wanted to know how to proceed with vaccination. Since the caller was not an health care professional information could not be provided and the caller finished the call before collecting patient´s data and consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Client was given the three vaccines at 0835. At 0836 client stated she was feeling "dizzy" and  "lightheaded". Client could not hold head up on her own, would not open eyes, and would not respond to her name. Client was breathing. Cold pack placed on neck and fan placed in front of client. Client stated she felt "nauseas." Client was then transferred to laying position on cot with knees in bent position around 0840. Blood pressure reading taken at 0845 measuring 110/74. Pulse measured at 74 bpm. Client oriented to person, place, disoriented to time. Around 0855 client able to stand from cot  and transfer self to sit in chair with out dizziness. Able to drink juice. At 0858 client walked out of clinic room without assistance to sit in waiting room. Advised to sit for ten more minutes Client walked out of building at 0905.
Patients under the age of 18 were administered a COVID vaccine; A spontaneous report was received from a pharmacist concerning a 17 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced patients under the age of 18 were administered a COVID vaccine.   The patient's medical history was not provided. No concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026-20A).   On 29 Dec 2020, the vaccine was administered to a 17-year-old patient.   The action taken with mRNA-1273 in response to the event was unknown.  The outcome for the event, patients under the age of 18 were administered a COVID vaccine, was considered recovered on 29 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 (Lot number: 026-20A). There were no reported AEs associated with this case.
04/21/2022  The area I got my shot was a little swollen, red and warm to the touch.  I felt a little funny, not real sick, just a little nauseous.  It hurt a little bit where I could not lay on that side. This lasted for a couple of days. It began to go down after a couple of days. I noticed I noticed I was having a little shortness of breath in the morning, then it would go away. It became more regular around the middle of May, I began getting a cough and my throat was getting sore.  I took some allergy medicine. I noticed after coughing; I was having trouble inhaling.  I went to the Emergency Room and told me to see my PCP. I went to my PCP and they did a CT scan of my lungs. I had pneumonia in both lungs. I was prescribed an antibiotic which I took for seven days. I still had shortness of breath and sweating, and I could feel my heart beating in my neck. I went back to the doctor. They did bloodwork and an x-ray of my lungs.  My bloodwork did not look good and they wanted to check for blood clots. I went to the Emergency Room and they did another CT. They saw a Pulmonary Embolism and I was admitted. I was placed on a Heparin Drip. I was released after 3 days and prescribed a blood thinner for 9 months, they were unable to see where the clot came from.   The Heparin did help.   .   I do, however, still have shortness of breath , sweat and my heart rate goes up. My Blood Pressure also goes up. It just is not as regular
Fever; aches; chills; headache; This is a spontaneous report from a contactable consumer (patient himself). A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration at the left arm on 05Jan2021 13:30 at a single dose for COVID-19 immunization. The patient's medical history included COVID-19 from an unknown date. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, 07:00 PM, the patient experienced fever, aches, chills, and headache. No treatment was received for the events. Outcome of the events at the time of last observation was reported as recovering. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  Information about lot/batch number has been requested.
Muscoskeletal Stiffness; Swelling; Mobility Decreased; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscoskeletal Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Mobility Decreased) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscoskeletal Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Mobility Decreased). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscoskeletal Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Mobility Decreased) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 79-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 28-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING.  1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE
Myalgia, muscle joint pain, fatigue, nausea.  States reaction 4-5 days post vaccine x 5 years.  Onset within hours after flu vaccine.
Had a normal morning, ate a protein breakfast and went shopping at about 10 am.  After entering the grocery store, I had a sudden onset of dizziness and my vision became erratic.  I could not focus my eyes properly - it was almost as if one of my contacts was out of the eye but that wasn't the case.  Fortunately, I was near the furniture section of the store and found a place to sit.  I stayed sitting for several minutes while I fought the dizziness and thankfully my vision came back into focus.  Within a couple of hours, I developed a migraine headache that lasted off and on for 5 days.  I do have migraines occasionally (the last one was July 2020 - I keep a log), however I have never had this type of precursor or warning sign of a migraine.
STOMACH PAIN; BACK DISCOMFORT; NAUSEA; MALAISE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced malaise. On 12-JUN-2021, the subject experienced stomach pain. On 12-JUN-2021, the subject experienced back discomfort. On 12-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, stomach pain, and back discomfort, and the outcome of malaise was not reported. This report was non-serious.
felt warm, his temperature was 99F; eyes feel a little heavy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (felt warm, his temperature was 99F) and ASTHENOPIA (eyes feel a little heavy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced SKIN WARM (felt warm, his temperature was 99F) and ASTHENOPIA (eyes feel a little heavy). At the time of the report, SKIN WARM (felt warm, his temperature was 99F) and ASTHENOPIA (eyes feel a little heavy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99f (High) 99F. On an unknown date, Body temperature: 99 and 100 (High) 99 and 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded
Intense, persistent dizziness, nausea, vomiting, T102.  Seen by allergy MD on 12/02 who withheld usual allergy shot and stated he thought the patient had a sinus infection.  Vomiting & dizziness persisted and seen by PMD 12/3:  Given "shot for nausea"; able to hold down fluids thereafter but dizziness persisted until 12/6.  Mother states the child (who normally weight ~80 lbs.)had lost 6 lbs. when weighed at PMD.  Child unable to take his migraine meds (Periactin) since 12/1 due to nausea; PMD stated he believes the dizziness was result of not taking the Periactin as usual.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX (batch number LL552, expiry date 8th June 2021) for prophylaxis. The patient's past medical history included shingles (the patient had shingles about one month prior to receiving SHINGRIX vaccination). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The patient's age at vaccination was not reported. The patient had shingles about one month prior to receiving SHINGRIX vaccination. After the patient had the SHINGRIX vaccination, the patient's shingles returned within 2 or 3 days.
PATIENT REPORTED SUPRACLAVICULAR LYMPH NODE SWELLING ABOUT 1+1/2INCH BY 3/4INCH ABOUT 2 DAYS AFTER RECEIVING MODERNA BOOSTER.  PATIENT ALSO HAD SOME MALAISE AND CHILLS FOR THE FIRST DAY BUT THAT HAS PASSED.  PATIENT DID NOT RECIEVE ANY MEDICAL ATTENTION.
Pt recv vax on 11/12/98; on 11/13/98 pt exp problems w/ concentration, thinking, leg cramps, nausea, stomach cramps, cold & clammy
Patient received dose 1 of COVID vaccine on 1/4/2021.  On 1/18/2021 developed body aches, nasal congestion, and nasuea/vomiting.  Tested positive for COVID.
Lt inject site hard, red, painful 2" in size; 18JUN91 fa says all right now; no residual swelling, redness or tenderness;
Rt arm pain especially painful with certain movements. Painful lying on it. Instructed to use heat, ibuprofen. It has been 3 wks & has not gotten any better.
Information has been received concerning a pt who post vaccination, experienced excruciating arm pain within 10 hours of vaccination. The pt told nurse the pain was so severe that she soaked in the tub and could not sleep all night. The pt also experienced nausea. Unspecified medical attention was sought. The intervention for this pt was hot compresses and anti-inflamatory.
Vasovagal reaction immediately following vaccine administration. Patient lost consciousness for approximately 10 seconds after receiving vaccines and regained consciousness. Patient was sitting in chair while having shots administered and did not obtain any secondary injuries. Patient was monitored in clinic for 30 minutes with vital signs being taken. Patient recovered well and did not report any pain, dizziness or lightheadedness.
Achy; sleep apnea; Fever; Very very tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achy), SLEEP APNOEA SYNDROME (sleep apnea), PYREXIA (Fever) and FATIGUE (Very very tired) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergies: Advil, and Ibuprofen, Codeine, Definity (Perflutren Lipid Microsphere) , Latex sensitive, Nexium, Sulfa and Esomeprazole magnesium.  Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Latex allergy, Drug allergy, Sulfonamide allergy and Drug allergy.    On 24-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 24-Oct-2023, the patient experienced PAIN (Achy), SLEEP APNOEA SYNDROME (sleep apnea), PYREXIA (Fever) and FATIGUE (Very very tired). The patient was treated with PARACETAMOL (TYLENOL) on 24-Oct-2023 for Fever, at a dose of took 2 tylenol. At the time of the report, PAIN (Achy) and FATIGUE (Very very tired) outcome was unknown and SLEEP APNOEA SYNDROME (sleep apnea) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2023, Body temperature: 9.7. On 25-Oct-2023, Body temperature: Temp was 99.5.         Concomitant medication was not reported.  The patient had no problems with first two Moderna dose.  The patient took fluids.