chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ten Minutes after vaccination, patient complained of being lightheaded, and nauseous.  She was assessed by EMS and given benadryl.  Itching developed, vomiting and nausea continued, felt some restriction in throat.  Epi Pen (.3mg) and Pepcid administered.  Patient was transported by EMS to Emergency Room for further assessment.
Acute onset left supraclavicular lymphadenopathy/Swollen and painful lymph nodes above clavicle bone; swollen skin area about 3 inches around the lymph nodes; Dose 1: 29Apr2021 and Dose 2: 20Aug2021; This is a spontaneous report from a contactable consumer (reported for herself). A 63-years-old female non-pregnant patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FD8448/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 20Aug2021 at 16:30 (at the age of 63-years-old) as dose 2, single for covid-19 immunisation drug Store. Medical history included autoimmune disorder (Connective Tissue Autoimmune Disease), hypertension, hypothyroidism and spinal cord disorder, all from an unknown date and unknown if ongoing. Concomitant medication(s) included np thyroid (LEVOTHYROXINE, LIOTHYRONINE), estradiol (ESTRADIOL), cymbalta (DULOXETINE HYDROCHLORIDE) and verapamil hydrochloride (VERAPAMIL HYDROCHLORIDE), all the drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 29Apr2021 at 20:00 (at the age of 63-years-old) as dose 1, single for covid-19 immunisation drug Store. On 22Aug2021 at 06:00, the consumer reported that, acute onset left supraclavicular lymphadenopathy. Swollen and painful lymph nodes above clavicle bone and swollen skin area about 3 inches around the lymph nodes. No treatment was given for the events. The outcome of the events was not resolved and dose 1: 29apr2021 and dose 2: 20aug2021 was unknown.   Follow-up attempts are completed. No further information is expected.
PATIENT PRESENTED TO PHARMACY 8 DAYS POST IMMUNIZATION WITH REDNESS AND NOTICABLE SWELLING AT PREVNAR 13 INJECTION SITE. INSTRUCTED PT. TO USE COLD COMPRESS, DIPHENHYDRAMINE AND ACETAMINOPHEN IF NEEDED. INSTRUCTED PT. TO SEEK MEDICAL ATTENTION IF NO IMPROVEMENT OR WORSENING.
Patient had allergic reaction (itching, redness, some swelling) at the injection site.
The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022; doses administered after 30-day Use By Date and after expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and after expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     The patient had no known meds/food allergies. The patient had no chronic/acute illness.     On 06-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and after expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered after 30-day Use By Date and after expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient had not received any daily medications.  The vial was initially stored in the refrigerator on 25-Feb-2022. Expiration date for vaccine 25-Mar-2022. The vial did not undergo any temperature excursions. It was reported that the patient not experienced any side effect.  No treatment information was reported.  Patient had not tested COVID-19 within last month.
3/13-Noticable fussiness, crying; 3/18-significant crying and unable to calm, appeared to be ear pain; 3/19-took to doctor for ear pain, diagnosed acute upper respiratory infection. 3/22-Hitting himself, fear of play equipment, fear of swing, appeared to have overactive startle response.  3/23- continues to act as if ears hurt, crying often. 3/24-shortly after midnight mother wakes up and notices he had a high fever. He appears to be reaching out for mother. Upon mother picking him up appeared to be awake but limp. Mother noticed eyes moving back and forth quickly. Episode lasted less than five minutes. Mother gave him Motrin. Toddler calmed down and temperature taken, was 102. Toddler appeared to be very jerky with his movements and remained awake for 2 hours. Upon sleeping, Toddler was easily aroused and continued to have jerking movements. 3/24/14-Mother took patient to the doctor. On the way home he appeared to be extremely lethargic. At home appeared to be very confused and very irritable. Does not want to eat or drink, which is very unusual. Jerking and twitching in sleep was noted during that evening and caused severe sleep disturbance.  3/25-Symptoms and behavior remained the same-at approximately 3 pm began to break out in severe rash starting on bottom. By evening it was on bottom, face, stomach, a few on arms, hands and feet.  At approximately 1100 pm parents walked into room and noticed saliva on child's face and a circle of saliva on bedding. He was able to be awakened.  3/26-Upon awakening him, he cried for 2 hours straight. Mother took child to the Emergency room. Emergency room thought it looked like impetigo. Prescribed antibiotic ointment. Child went to sleep at 5 am. Jerky movements during sleep continued.  3/26-Took child to nurse practitioner at doctors office. Child has become increasingly irritable. He won't let others check ears, touch face, etc. NP thought it looked like strep. Prescribed antibiotics 3/28- Behavior did not improve. Returned to doctor due to continued jerking in sleep, inability to sleep, increased aggression, confusion, wanting to hang upside down, anxiety about separation from parent. Doctor referred to neurologist to have an EEG completed.  4/9/14-symptoms had improved with antibiotics as he had begun eating and drinking well again and sleeping better, but symptoms returned after antibiotics were completed. Went back to doctor. Dr's referred to Developmental Pediatrician, Geneticist, and Neurologist and EEG was moved up to occur at the end of the month.  4/14/14-Skin began to shed, especially on feet and hands. He complains of pain around toes. Toe appears to be irritated. Taken to walk-in clinic an hour away since it is Sunday. She gives more antibiotic ointment and tells us to keep it wrapped.  ****Generally there have been behavioral changes, differences in responsiveness at times, significant sleep difficulties due to limb jerk/tremors that occur throughout the night, separation anxiety, oversensitivity to sounds, aggressiveness towards others and excessive climbing/risk taking. We are continuing to look for diagnosis and treatment as it is unknown as to what caused his illness.
Narrative:  Patient went to a local clinic to have arm checked out where he had received the covid vaccine. He had swelling and redness around injection site. After about 10 days the symptoms subsided. Note, this was patients first dose of covid vaccine. Symptoms:  Rash, ErythemaMultiform & UrticariaPruritus Treatment:
Est. due date: 2/13/22. Side effects included 60 hours of body aches, extreme fatigue (14+ hours of sleep / day), fever, and loss of smell/taste around 48 hours. Smell returned within 24 hours of losing it. Symptoms were flu-like. No known adverse effects to pregnancy at this point. Negative COVID test following loss of taste / smell. Previous COVID infection in May 2020 (17 mos prior).
Mother calls reporting that where patient got her PCV-23 vaccination is very red and hard. She denies fever, or drainage at this time. Redness is not spreading. She denies extreme pain. As long as no fever or drainage, ok to continue to monitor. Use a warm compress and she can take ibuprofen or TYLENOL to help with the pain.
Cellulitis of left thigh. Benadryl PO q 4-6 hours. Keflex 250 mg TID for 7 days. Warm soaks.
Mother reports decreased eye contact, "not herself, "out of it", decreased feeding for 4 days after immunizations.
lump under my right arm about the size of a jelly bean; first dose > 35 days ago; lymph nodes swelled; hurts all the time; injection hurt like a flu shot; Lymph nodes hurt; headaches; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time) and VACCINATION SITE PAIN (injection hurt like a flu shot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: INFLUENZA VIRUS VACCINE.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time), VACCINATION SITE PAIN (injection hurt like a flu shot), LYMPH NODE PAIN (Lymph nodes hurt) and HEADACHE (headaches). At the time of the report, AXILLARY MASS (lump under my right arm about the size of a jelly bean), PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago), LYMPHADENOPATHY (lymph nodes swelled), AXILLARY PAIN (hurts all the time), VACCINATION SITE PAIN (injection hurt like a flu shot), LYMPH NODE PAIN (Lymph nodes hurt) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.
Post vaccination pt began s/s lightheaded ness, anxious and diaphoretic. RN and I transferred patient into cot, patient had syncopal episode of 2min, paramedics on site. Vital signs stable, patient states feeling, ? a lot better? after a few minutes. Patient and mother refuse going to the hospital. AMA was signed. Patient then transferred himself into wheelchair with minimal assistance. Patient waited in observation for 30min and left home with mom.
Swelling of the throat, white around the eyes sockets, beat red and flush with blotchy skin and visible redness, fiberglass under the skin feeling at injection site, extreme itching/redness.
Borderline seizures; Fever of 104 F; A spontaneous report was received from a consumer (patient), a 67 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced borderline seizures (seizure) and fever of 104 F (pyrexia).   The patient's medical history was not provided. Concomitant medication included tofacitinib citrate.  On an unknown date, about a month ago, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, the patient had a fever of 104 Fahrenheit (F) for 3 days and was very sick with  "borderline" seizures. The patient's blood work showed C-reactive protein (CRP) was 31 (unknown units), and white blood cell (WBC) count was low. The patient's physician was very concerned. No treatment medications were reported.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the event, borderline seizures was considered as unknown, and that of fever of 104 F was considered as recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Headache, soreness in upper body, cloudy thoughts, lucid dreams, fragmented thoughts, dizzy, drugged feeling, heaviness in whole left side, partial paralysis, impaired speech, impaired thinking, could not talk fast.
Information has been received from a pharmacy intern student concerning patient who on 10-NOV-2006 was vaccinated intramuscularly in the deltoid muscle with a 1 inch needle close to the elbow with a dose of Pneumovax 23. That same day the patient experienced a cellulitis-like reaction near the injection site that appeared red and swollen. Unspecified medical attention was sought and the patient was put on an unspecified antibiotic. At the time of report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Body aches, cramping throughout body, sensitive to touch, headache, fatigue  with insomnia, high blood glucose levels, sore throat, joint pain, muscle pain/weakness, extreme pain/throbbing at vaccine site, chills, hypersensitivity to anything touching me.
tinnitus developed in both ears (stronger in left ear); This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the arm left on 18Mar2021 at 08:00(at the age of 64-year-old) as a single dose for COVID-19 immunisation.  Medical history included mild hypertension. Concomitant medications included olmesartan medoxomil(MANUFACTURER UNKNOWN) and multivitamins (unspecified), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203) via an unspecified route of administration in the arm left on 25Feb2021 at 08:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient developed tinnitus in both ears (stronger in left ear). The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event tinnitus in both ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
as per patient she broke out in hives, diarrhea, body aches, nausea - Hives starting first on 8/19 and slowly going away with Benadryl. Diarrhea, Nausea, Body aches continuing until 8/26/20- she called her Dr and was told to take Tylenol, and Immodium.
Massive migraine, nausea, whole body aches, chills, inability to sleep, painful injection site, lower back pain, chest pain, sweats.  This was equal to or worse that when I had Covid during the winter.
This spontaneous report was received from a consumer concerning a 54 year old female patient with allergy (drug hypersensitivity) to sulfa and morphine. The patient's medical history included supraventricular tachycardia in 2008. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, dosage number, route of administration and expiration date were not reported). The concomitant therapies included: ZYRTEC-D, SINGULAIR, LEXAPRO and WELLBUTRIN and "DEXLIN". On 01-JUN-2016, 8 days after onset of therapy, she experienced SVT (supraventricular tachycardia) and she had to go to emergency room (ER) in the hospital. In the emergency room (ER), her heart rate went up to 170-180 (units not provided) for about an hour and she was treated with adenosine. Additionally, she experienced high blood pressure and was given unspecified medication as a treatment for elevated blood pressure. The patient stated that she stayed in the emergency room (ER) for about 3 hours and was released. Therefore, on an unknown date in 2016, she followed up with two separate cardiologists and a complete cardiac work-up and electrophysiology study were ordered and everything came back negative. On 06-JUL-2016, the patient reported that she went to get a massage and her massage therapist noticed two scratch marks on her back (right side); she did not think too much about it and came home, but the next day on 07-JUL-2016, she looked at scratches through mirror and she noticed vesicles on those scratches. After that on the same date, the patient went to see dermatologist and the physician confirmed that it was shingles (herpes zoster) and the physician prescribed VALTREX as a treatment. The outcome of supraventricular tachycardia and blood pressure increased was reported as recovered, on an unknown date in 2016. The outcome of herpes zoster was reported as not recovered. The patient did not believe that the supraventricular tachycardia and blood pressure increased were related with ZOSTAVAX administration. However, the relatedness between herpes zoster and ZOSTAVAX administration was not provided. Upon internal review supraventricular tachycardia was considered medically significant. Additional information is not expected as the reporter did not wish further contact.
A consumer report was received on 29 Nov 2006 concerning a 5 year old male vaccinee. No details concerning the vaccinees past medical history or concomitant medications were provided. On 05 Nov 2005 the vaccinee received an influenza vaccine. Approximately 1-2 weeks later the vaccinee developed sores on his feet, then lumps on the joints of his toes. This then progressed to warty sores on his hands then the joints of his fingers. The condition progressed and the vaccinee developed muscle involvement. The events were diagnosed as dermatomyositis. The events are ongoing and the vacinee is currently being treated with Prednisone. Further information is requested.
Migraine headache. Tx w/ Advil and headache passed w/i 3 hrs. Pt also had visual distortion.
patient had urticaria with  itching to palms of hands and feet with rash extending forearms under arm pits and on waistline.
Cold chills approx 30 hrs after vaccine. Diarrhea 1 1/2 hrs noted 1st - Fever (Did not take temperature) 2nd bout of Diarrhea with nausea lasted 4 to 5 hrs. Vomitting x 2 (lasted approx 3 hrs) Quizzy stomach Sunday and Monday. Only took 2 doses of ASA.
Approximately five weeks after receiving the vaccine I noticed my right ear is closed with diminished hearing, it remains blocked as of the date of this report. I took ten days of prescription ear drops Neomycin Polymyxin B Sulfate  Hydrocortisone   11/18/2022-11/27/2022 without improvement, I also took Afrin with no results. On the thirteenth of December 2022 I was tested and it was noted I have diminished hearing and no vibration in my right eardrum.
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph that hurts when she takes a deep breath, cough, or laugh), PAIN (Sore), SENSATION OF FOREIGN BODY (Feels a small lump under the skin) and MUSCLE STRAIN (Feels like a muscle strain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph that hurts when she takes a deep breath, cough, or laugh), PAIN (Sore), SENSATION OF FOREIGN BODY (Feels a small lump under the skin) and MUSCLE STRAIN (Feels like a muscle strain). At the time of the report, LYMPHADENOPATHY (Swollen lymph that hurts when she takes a deep breath, cough, or laugh), PAIN (Sore), SENSATION OF FOREIGN BODY (Feels a small lump under the skin) and MUSCLE STRAIN (Feels like a muscle strain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
pt recv vax; pain in neck,shoulder,lt elbow,wrist,ankle & lt knee;was warm, rt elbow pain;lt area cont w/ pain;aches and some lt arm shaking; aches & neck pain cont; reported to hlth dept;
fully vaccinated but recently tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (fully vaccinated but recently tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, the patient experienced COVID-19 (fully vaccinated but recently tested positive for COVID-19). At the time of the report, COVID-19 (fully vaccinated but recently tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant drug details were reported. No treatment details were reported.
Temporary and reaccuring ache in the arm that was injected.  It is not debilitating, but has increasingly gotten stronger and lasts longer.  It does not hurt to press on it, but the area that it was injected aches.
unspecified number of patients may have been administered an improperly stored dose of VARIVAX or PROQUAD on unspecified dates.; This spontaneous report was received from a Medical assistant referring to an unspecified number of patients of unknown age and gender. Information on patients' medical history, concurrent conditions and drug reactions/ allergies were not reported.      On an unknown date, the patients were vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route, anatomical location, lot # and expiration date were not reported for both the vaccines) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent. Digital data logger was involved in this report. No additional adverse event information was provided. No product quality complaint was involved in this report.  This is a non-valid report due to lack of patient identifiers and unspecified number of patients.