chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen, red and itchy at injection site; Swollen, red and itchy at injection site; Swollen, red and itchy at injection site; Fatigue; Achy muscles; dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FG3527) via an unspecified route of administration in the left arm on 04Nov2021 at 12:15 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hashimotos and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient received the first dose of influenza vaccine (MANUFACTURER UNKNOWN; lot number: 49281042150) in the left arm via unspecified route of administration on 12Oct2021 for immunisation, within 4 weeks prior to the COVID vaccine. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID) and hydrochlorothiazide, lisinopril (LISINOPRIL/HYDROCHLOROTHIAZIDE) 20/12.5; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 52-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 52-year-old); both as single dose for COVID-19 immunisation. The patient previously received methylchloroisothiazolinone (MANUFACTURER UNKNOWN) and prochlorperazine maleate (COMPAZINE); both for unknown indications from unknown date and experienced drug allergy. On 04Nov2021 at 21:00, the patient experienced swollen, red and itchy at injection site, fatigue and achy muscles. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen, red and itchy at injection site, fatigue and achy muscles was resolving at the time of this report.
mom says pt devel fine rash (feels like cornmeal) couple of days p/vax;rash began @ inj site & spread to back, chest & neck;c/o itching;denies other sxs;
Covid Positive Illness; Covid Positive Illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 08Jan2022 as dose 3 (booster), single (Lot number: FJ5682) at the age of 48 years for covid-19 immunisation. The patient relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "not recovered" and all described as "Covid Positive Illness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: No other medications in two weeks and no other vaccination in four weeks. No covid prior vaccination. Tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
pt recv vax; pt back for TB reading 5jul95, lt deltoid swollen, red down to  elbow;
Intense, extremely painful, red flushing starting at head & face, down to toes. Dizziness along with it. No sweating, no hives, no itching, no breathing problems. Felt like passing out. After about 10 min husb. called 911. Vitals ok, though they didn't check temp. I took Benadryl & symptoms quickly resolved, though face was reddish about 24 hours & had 1 minor flushing next day. I had NEVER experienced anything like this. These were NOT hot flashes.
This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions or allergies. On 31-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J011828, expiry date 26-DEC-2014, 0.65 ml, subcutaneous (anatomical location not specified). Concomitant therapies included CYMBALTA and HEATHER. On approximately 01-APR-2014, reported as 24 hours after injection, the patient called the pharmacy to report that she experienced itching, redness and pain at the injection site. The patient reported that the itching, redness and pain had spread to her elbow and she was seen in the ER of an unspecified hospital, but was not admitted. An unspecified ER physician diagnosed her with an allergic reaction and possible cellulitis. The patient was given BENADRYL OTC, prednisone and an unspecified steroid injection and was prescribed KEFLEX. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
J96.00 ACUTE RESPIRATORY FAILURE 2/26/2023 SEPSIS UNSPECIFIED ORGANISM J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/25/2023 SEPSIS UNSPECIFIED ORGANISM J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/22/2023 SEPSIS UNSPECIFIED ORGANISM J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/22/2023 SEPSIS UNSPECIFIED ORGANISM
Left arm at injection site became tinder and mildly painful and then Severe muscle pain in neck, & aches- then proceeded to spread throughout whole body over the course of the next few hours from 8PM to 3AM.  Haven?t slept more than an hour if that.  Whole body became tingly and itchy, super uncomfortable.  Lower back hurts so bad  and no form of moving, walking sitting laying stretching  makes it feel better.  Anxious and uneasy.  No treatment- hoping these symptoms/side effects will pass.
Immediate rash and slight fever.  The next day he started banging his head on the floor.  My nanny called and took him in for a check of his ears which we cannot currently find documentd in the medical records.  10/13/06 Received medical records from PCP which revealed patient had frequent OM & URI s/s & sinusitis.  Speech delay noted 1/06 but no mention of autism.  10/19/06 Received medical records from diagnosing physician which indicates delayed speech, sleep disturbance, dazed behavior, ADHD symptoms, echolalia, self stimulation activities & did not interact well with others.  Dx: speech impairment w/autistis traits, regressive symptoms, staring spells w/impaired responsiveness./ss Per 60 day follow up report: He is now diagosed with regressive autism due to MMR and thimerosal vaccines in flu/DTAP.  1/1/10- follow up - viral encephalitis; speech, language delay and/or brain disorder. the vaccine schedule is too "heavy" for children 2 & under. 38+ is ridiculous !
Bleeding while urinating and clearing my bowels. High amount of pelvic pain especially on right side. Body pain and odd body odor.
She is experiencing, her right eyes is sort of swelling and it's burning; right eye got swelling and is burning; She is hurting; She is experiencing, her right eyes is sort of swelling and it's burning; right eye got swelling and is burning; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's wife).  A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 26Aug2021 (Lot Number: EW0172) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she is experiencing her right eyes is sort of swelling and it's burning; right eye got swelling and is burning and she is hurting on an unspecified date. The clinical course reported as follows, reporter stated, "My wife and I both get the 2nd dose of the Covid Vaccine yesterday and she is experiencing, her right eyes is sort of swelling and it's burning. The caller was wondering that something which should we be concern about or what.  While confirming the concern, consumer further stated, "Her right eye got swelling and is burning." The outcome of event was unknown.
Lab tech received pre-exposure rabies vaccine, 2nd dose. Eve of immunization felt feverish, cold sweats. Next afternoon noticed hives, itching, that started on vaccination arm and spread to chest.
p/taking 2nd capsule devel nausea, lots of diarrhea & red bumpy rash; stomache cramps;
diffuse urticarial rash of face, trunk, extremities starting 9-10 hours after well-visit and vaccination. Treated with antihistamines (oral) with resolution over the next 48 hours
The spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Medical history and drug reaction/allergies were not reported. On 21-MAR-2014, the patient was vaccinated with an expired dose of ROTATEQ (lot # H012981, expiration date 28-FEB-2014) (dose and route were not reported). Co-suspect therapy was not reported. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Child is classified with Aspergers Syndrome Disorder. Tdap Booster/Vaccine administered on 12/11/2008. Site of vaccine severely swollen and inflammed (appearance of rash); parents noticed 2 days after being administered. At school, child's exhibited a high level of behavioral violent anger issues from 12/13/08 to present. Reviewed manufacturer's (Adacel) insert, which indicated the following side-effect: "easily angered and annoyed."
Patient stated he had only had the primary and secondary series, did not have a card, and Vax database was down for maintenance. RN gave Bivalent vaccine. Later when Vax database Was available, and the record showed he had already had the bivalent vaccine.
Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose.; Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Oct2021 13:00 (Lot number: 30125BA) at the age of 56 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 28Oct2021, outcome "not recovered" and all described as "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose."; BACK PAIN (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose". The events "severe joint pain starting in elbow, moved to lower back, then hips, and knees by between date of 1st and 2nd dose." all were evaluated at the physician office visit. Therapeutic measures were not taken as a result of arthralgia, arthralgia, arthralgia, arthralgia, back pain.  Additional information: The patient had not known allergies. The patient had not vaccination prior to COVID and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks. AE resulted in: Doctor or other healthcare professional office/clinic visit. The patient has not been received any treatment for AEs.  No follow-up attempts are possible. No further information is expected.
-Left arm pain, swelling, nausea, headache, temperature of 100.6
Neck pain; Tiredness; shivering; underlining headache constantly; the glands in neck is swollen; Ache NOS; Tenderness NOS; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Ache NOS), TENDERNESS (Tenderness NOS), NECK PAIN (Neck pain), FATIGUE (Tiredness) and CHILLS (shivering) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced MYALGIA (Ache NOS), TENDERNESS (Tenderness NOS), FATIGUE (Tiredness), CHILLS (shivering), HEADACHE (underlining headache constantly) and LYMPHADENOPATHY (the glands in neck is swollen). On an unknown date, the patient experienced NECK PAIN (Neck pain). At the time of the report, MYALGIA (Ache NOS), TENDERNESS (Tenderness NOS), NECK PAIN (Neck pain), FATIGUE (Tiredness), CHILLS (shivering), HEADACHE (underlining headache constantly) and LYMPHADENOPATHY (the glands in neck is swollen) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No treatment medication were reported.    This case was linked to MOD-2021-118409.
syringe leaked most of the vaccine out of the hub of the needle, not sure how much actually got into patient
Itchy, swelling feet and hands, nausea, vomiting, dizzy, hives all over body face hand feet.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Additional Details: patient experienced swelling soreness, warmth and pain at injection site
Syncope & shock at time of vaccination. Weakness & pain at injection site and throughout the arm, which remains unresolved. Developed chronic fatigue and migraines (lasting several days at a time). Developed insomnia, going 5+ days without sleep despite sleep aids. Digestive health issues & abdominal pain worsened. Two months following vaccination patient went to the ER for severe flank pain. Hematology, KUB and CT scan revealed various calcium calcifications in the hemipelvis and superimposed over the right kidney. Three months after vaccination an endoscopy was performed. Findings included duodenal mucosal atrophy, gastric mucosal abnormality, and irregular Z-line. Food sensitivities increased & diet became extremely limited. Elemental Analysis (Packed Erythocytes) via Genova Diagnostics was done four months following vaccination and showed excess levels of Mercury. Various HTMA have been performed to show high levels of Mercury and Aluminum. Abnormal pap smear followed by colposcopy revealed low grade SIL (CIN1) in June of 2008. Beginning in 2012 there have been persistent vaginal health complaints, with the cause yet to be identified. Experienced irregular menses, having 1-2 menstrual cycles per year for several years. Only within the last year has it begun to stabilize. Other symptoms include: tinnitus, brain fog, muscle pain & weakness, joint pain, fatigue, tachycardia and palpitations, sensitivity to lights/sounds, all which remain unresolved. In 2015, chest pain & palpation were monitored using the iRhythm Zio for two weeks and a CE Echo 2D w/Stress performed. Diagnosis was Dysautonomia. Neuralgia, particularly in palms and soles of feet began in 2016.
pt recvd vax;v as soon as arrived at home approx 1/2 hr & cont to vomit rest of the day;fussy & unable to hold down apap;
This spontaneous report was received from a healthcare worker refers to an unspecified number of unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. These patients were inadvertently administered with an unspecified number of improperly stored doses of GARDASIL (lot # K011562, expiry date: 08-APR-2017), on unspecified dates since 09-JUN-2015. Concomitant medications were unspecified. No adverse effect was reported. This is one of the two reports received from the same reporter (MARRS # 1507USA013292). Additional information has been requested.
Approximately 2 minutes following the injection client complained of "tingling" in mouth and lips. No visible "rash/hive" or swelling present. Able to swallow without difficulty. Vital signs within normal limits except for b/p noted as 150/110. States b/p has been elevated prior to this time. Oxygen saturations remained at 99%. Noted as being "hot" no flushing observed. Chewable Benadryl 50 mg administered and EMS contacted. Patient stated during this time that she had previously taken inhalers (both albuterol and steroid) prior to the clinic and admitted to having chronic breathing problems. Referred to Emergency Department. Refused ambulance and was taken to ED by private car.
Achy; Flu like symptoms; Product supply issue; felt bad for about 24 hrs; Aching back; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 53-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 25th August 2018, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feeling unwell, back pain and tiredness. On an unknown date, the patient experienced pain, influenza-like symptoms and product supply issue. On an unknown date, the outcome of the feeling unwell, pain, influenza-like symptoms, back pain, tiredness and product supply issue were unknown.   It was unknown if the reporter considered the feeling unwell, pain, influenza-like symptoms, back pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient received 1st dose and had pain, feeling unwell, influenza-like symptoms, back pain and tiredness. The patient did not receive the 2nd dose between 2 to 6 months due to product supply issue. The reporter asked do the patient need to have the 2nd dose within 6 months after the 1st dose or might the patient need to get a 3rd dose. The patient mom had shingles many years ago.
Started to get sore throat 2 days after vaccine (01/23/2022), lasted until 01/27/2022. On 01/27/2022 sore throat turned into congestion and body aches. Developed body aches and fatigue; fever of 99 degrees 01/25/2022. Symptoms lasted until 02/03/2022.
Onset of redness left anterioe thigh noted by foster mom early 02/12/04. Ibuprofen given.  Redness faded to mildly pink and swelling increased.He refused to walk on leg and complains of pain when it is touched.  Examined in office.  Afebrile, talkative, alert and cooperative. Mildly pink edematous  anterior left thigh, mildy warm to touch and painful to touch.  No induration.  Treatment plan: continue p.o. ibuprofen, use warm moist packs to area for 15 minutes 3-4 times per day, gradually place more weight on leg.  Return to clinic or seek emergent care if fever, severe redness and hot to touch, if area becomes hard to touch, if area develops soft/fluctuant area in center, if left groin lymph nodes become enlarged.
This spontaneous case initially received on 02-Nov-2016, was reported by a health professional and concerns a 94 year old patient. Weight: not provided; Height: not provided. Concomitant medications: Not reported. Administration of company suspect drug(s): On 13-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 13-Sep-2-16, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 to 23-Set-2016.
1 day p/vax cold sx w/runny nose, scratchy throat, 11JUL fever w/flu-like sx, 12JUL seen in ER & tx for bornchitis w/ATB, resp inhaler & cough med;
chills; Cold sore; Have a real bad day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ORAL HERPES (Cold sore) and FEELING ABNORMAL (Have a real bad day) 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) (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. On an unknown date, the patient experienced CHILLS (chills), ORAL HERPES (Cold sore) and FEELING ABNORMAL (Have a real bad day). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 1 dosage form. At the time of the report, CHILLS (chills), ORAL HERPES (Cold sore) and FEELING ABNORMAL (Have a real bad day) outcome was unknown. Not Provided          The concomitant medications were not provided.
Pt recvd HIB vax only; following day pt had a red rash over the inject site arm; afebrile; no tx;
Pt seen 6/6 for PE, given HPV-9 valent (dose #3) prior two HPV were quadrivalent 6/3/15 and 8/6/15. Had vaccine approximately 1030 AM, then approximately 6 PM had sudden onset fever, abd. pain, HA, myalgia, then later that PM had facial swelling, tongue tingling, no hives -> in ER 6/6 PM. Family gave history of previous tick removal in recent wks (lg ticks). Had had braces put on 6 days prior. ER (-) mono, (-) RS. Told he had a rash (not present at PE). Started on BENADRYL, steroids, doxy. 6/7 developed stiff neck, HA, lg temp. 6/8 pt seen in office - (-) rash alert, in NAD, (-) facial swelling, felt better. (+) neck soreness, (+) enlarged sm nodes, mild upper abd soreness. Weaned off steroids 6/9 continued doxy added labs to blood drawn in ER Lyme, RMSF, EBV. EBV ord infections (past)/(-) Lyme/RMSF (-). 6/13 seen again in ER for continued HA, neck stiffness. No LP done. Had nl WBC, CMP. 6/14 seen in office. Still with neck soreness, not rigidity, Lg HA, afebrile. States he felt a little weak. Nl strength on exam, good. Completed 14 days doxy for ? tick borne illness although felt to be HPV reaction. Was to RTC in a week. 7/24 I called mom as pt did not RTC symptoms had all resolved by 7/1/16.