chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; temperature and His back was warm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (temperature and His back was warm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (temperature and His back was warm). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and Physical therapy (wet cloth) for Pyrexia. On 13-Feb-2021, HEADACHE (headache) and PYREXIA (temperature and His back was warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash, fever started 10 days after vaccination sent to Dermatologist, put on ATB.
The pt experienced a fever of 104 to 106 (per mom) on 9/13/00. Was seen in office on 9/13/00 with a fever of 101.9. Diagnosed with otitis media. Fever decreased after 2 days.
pt had a breakthrough infection of COVID-19 which was diagnosed on 8/14/2021.
Swollen lymph nodes under left arm. Same as injection site. It was the size of a softball. It felt like a third breast.
no additional adverse event; patient received improperly stored vaccine; This spontaneous report was received from an medical assistant referring to a female patient of unknown age. Information about the patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.      On 03-FEB-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis administered via an unspecified route (concentration, number of administered dose, vaccination scheme frequency, and anatomical location of vaccination were not reported; reported lot number S033516 has been verified to be a valid lot number, expiration date was reported and validated as 29-JUN-2021) (product storage error). No adverse effects were reported for the patient.  According to the reporter, the highest temperature excursion was 52.5 degrees Fahrenheit for a time frame of fifteen minutes, with other previous temperature excursions; which were detected by a digital data logger.
Tingling of pins and needles of leg; Achiness of feet; Sore throat; continous sore throat; severe sore throat from a procedure; Mild bleeding gums once a week; Growth to back of throat next to uvula; papilloma removed from the; Irritation in her throat since having the papilloma removed; pharyngeal mass; Headache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week) and LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Papilloma excision on 18-Mar-2021. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT), SILDENAFIL CITRATE and WARFARIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass) and HEADACHE (Headache) outcome was unknown and CHILLS (Chills) and PYREXIA (Low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pain assessment: 6.00 (Inconclusive) Rated 6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Was okay until 0145 that evening. Uncontrollable nausea and shaking from rapid onset of chills followed by fever. Body aches and headache. Had to remain in bed in a dark room entire next day due to migraine caused by any light. I?ve never had a migraine before. Spend all of today (second day after shot) in bed with body aches, fever, nausea, and fatigue.
Started with constipation, chest pressure, nausea, vomiting and malaise about 6 hours after vaccination.  Symptoms persistent for one week then developed jaundice and dark urine. These symptoms persisted for 3 days then self resolved.
Development of Bells Palsy.  At approximately 11 pm on 4/14/2021 noticed limited lip movement left side. By next morning, left side of face paralyzed. Evaluated at ER approximately 8:30 am on 4/15/2021 who diagnosed episode of Bells Palsy. Advised to follow up with Primary first of next week and also follow up with Nuerologist in approximately 3 weeks.
By 48 hrs after MMR noticed "bumps" on both palms, progressing to vesicular rash covering palms, between fingers & finger pads.  Puritic.  Hives on L arm only.  States similar, milder rash age 5 after rubella vaccine.  Referred to PCP who rx'd w/clarinex & Kenalog 0.1% cream & felt it was a "severe reaction" to MMR.
arm was red, hot, and swollen down to the elbow; arm was red, hot, and swollen down to the elbow; diarrhea; aches; vomiting; arm was red, hot, and swollen down to the elbow; chills; experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.; had diagnosed COVID19 in Nov 2020 before getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches) and COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (November  2020).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2020, the patient experienced COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine). On 05-Feb-2021, the patient experienced DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (arm was red, hot, and swollen down to the elbow), CHILLS (chills) and PYREXIA (experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches), COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (arm was red, hot, and swollen down to the elbow), CHILLS (chills) and PYREXIA (experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, COVID-19: (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Got sick when vaccinated; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Got sick when vaccinated) and SINUSITIS (Sinus infection) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient experienced IMMUNISATION REACTION (Got sick when vaccinated) and SINUSITIS (Sinus infection). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Got sick when vaccinated) outcome was unknown and SINUSITIS (Sinus infection) was resolving.            Concomitant product use was not provided by the reporter.  The formulation of Humira was solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Information has been received from a health professional concerning an 18 month old male with no allergies or medical history who on 2/23/06 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot # 652557/1024R). There was no concomitant medication. On 3/8/06, about 2 weeks later, the patient experienced an abscess at the injection site. The patient was seen in the office and a black line was drawn around the site to monitor any growth. Cefdinir was ordered as treatment, but no labs were done. At the time of this report, the patient had not recovered. The reporter felt the injection site abscess was an other important medical event (OMIC). Additional information ahs been requested.
Upon inquiring about a COVID-19 booster, patient reports that she experienced sharp chest pain after each dose in her primary vaccination (both Moderna). Evaluated by cardiologist. Patient had multiple risk factors for coronary artery disease prior to vaccinations per cardiology note. Cardiologist assessed and determined that the patient likely had atypical chest pain after the two vaccinations. After reporting this and being evaluated, the patient was diagnosed with
Information has been received from a pharmacist concerning an approximately 62 year old female who on 17-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 658396/0967U) 0.65 mL, subcutaneously and then developed an injection site reaction. The injection site was described as warm and hardened on 20-OCT-2008. The patient reported that she had a similar reaction with tetanus toxoid vaccination and it lasted for 3 weeks. At the time of the report, the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. In follow up information received from the Pharmacist reported that the patient saw her physician regarding her injection site reaction and her symptoms resolved in a few days. The Pharmacist request that no additional forms be mail to her. Additional information is not expected.
Tested positive for Covid 19 on 1/5/21 after became symptomatic (none required hospitalization)  on 1/3/21.  5 RN's at ICU became positive 1-2 weeks after receiving  this vaccine.  Perhaps a coincidence, but feel it should be reported
chills beginning @ 2030 on 12/30/2020 & lasting til the am @ 0500, 0500 on 12/31/2020, hypotension causing dizziness 0800: flank pain, right temporal headache
muscle weakness upper extremities, extreme fatigue weakness WITH HAND GRIPS bilaterally; insomnia, bilateral arm pains "floating muscle pains in arms" "arthritic pain bilat hands when lifting, pulling or holding something in hands - pains inner elbows + forearms continues to present day
Either just before or immediately following the second dose of the Pfizer vaccine for COVID-19, developed tinnitus in both ears.  Has persisted for approximately a week so far.
I had hives and scratching all over; I had hives and scratching all over; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (Pfizer covid19 vaccine,Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021, as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced hives and scratching all over on Mar2021.The Consumer was informed about Pfizer Medical information department and was provided with the number.Product details (LOT#, expiration date, NDC# and UPC#) and other details were unknown as the Consumer hung up the call abruptly.The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Fever, myalgias, malaise and obtundation. Local reaction with vesicular skin changes, erythema and induration.
Patient given moderna booster vaccine that was left in syringe at room temperature for 17 hours.  Patient tolerated vaccine without any reported adverse effects.  Provider notified.  Moderna notified to verify validity of dose.   Will continue to monitor patient for any adverse outcome/side effects.
Horrible cramps, major pain in lower abdomen, treated with antibiotics for diverticulitis
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED ( received dose from vials beyond 30-day use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED ( received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED ( received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.  Date of Refrigeration of vaccine is 07-May-2021.
Fever/chills weakness- resolved 1/27/2021  Bechets disease flare- 1/27/2021- continuing mouth ulcers >10 , fever, lymphadenopathy, dysphagia
Patient originally received the J&J shot. Presented to get the booster moderna shot. The next day (10/30/2021) patients daughter called stating that patient had broken out in hives all over his body as well as facial area. Advised daughter to take her dad to the emergency room.
hyperglycemia in the 400s; I have had no other problems following the vaccine other than a sore arm.; This is a spontaneous report from a contactable Other HCP (patient).   A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK9231) at single dose at left arm on 08Jan2021 10:45 for Covid-19 immunisation, administered at hospital.  Medical history included type 1 diabetes mellitus, allergies to adhesives. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication in two weeks included biotin (BIOTIN), insulin aspart (NOVOLOG INSULIN), ascorbic acid, bacopa monnieri, biotin, boron citrate, calcium, choline bitartrate, chromium, colecalciferol, copper, deanol, docosahexaenoic acid, electrolytes nos, folic acid, gamma-aminobutyric acid, huperzia serrata, inositol, iodine, iron, levoglutamide, magnesium, manganese, molybdenum, n-acetyltyrosin, nicotinic acid, pantothenic acid, phosphatidyl serine, pidolic acid, potassium, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopheryl acid succinate, trace elements nos, vaccinium myrtillus, vanadyl sulfate, vinpocetine, vitamin a nos, vitamin b12 nos, vitis vinifera, zinc (FOCUS FACTOR), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced hyperglycemia in the 400s and a sore arm on 09Jan2021 14:30. She had no other problems following the vaccine. No fever. She cannot get her blood glucose level down. She has been at this range for 6 hours. The patient underwent lab tests and procedures which included blood glucose: 400. Treatment for event hyperglycemia was insulin pump continues increasing insulin. The outcome of events was not recovered. Post vaccination, the patient has not been tested for COVID-19. She was not sure if hyperglycemia was related to vaccine.
I recieved the Covid19 vaccine first shot on March 29th. Approximately 1-2 weeks later, I had a brief (<hour) experience of numbness on the left side of my face. Concerned with possible stroke, I examined myself and found nothing of any concern. On May 1st, about 5 days after the second and final Covid19 vaccine shot, I felt the same numbess and did the same check. This time, there was disctinct loss of muscle function on the left side of my face. A call to available urgent-care services indicated it was highly likely that is was -not- a stroke. I went to Urgent Care, which immediately moved me to Emergency Care for a full stroke evaluation (under the -just in case). The diagnosis was Bell's Palsy ("likely triggered by a viral event"). Treatment is oral steroids, antivirals, and lubrications for the affected eye. Expected to clear up between 2 weeks -> 6 months.
HYPOTENSION 2/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pain at injection site; Back pain; Extreme fatigue; Runny nose; Sore throat; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 14May2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, hypothyroidism and depression. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication was unknown if ongoing. Previously, the patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Apr2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. It was reported that the patient had no allergies to medications, food, or other products. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15May2021 at 14:00, the patient experienced pain at the injection site, back pain, extreme fatigue, runny nose, sore throat. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain at the injection site, back pain, extreme fatigue, runny nose, sore throat was recovering at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
onset of diarrhea beginning pm of date administered; no elevated temp; no rash; diarrhea reported to hlth dept 48 hrs p/vax; parents reported inc amount of spitting up formula but denies vomiting; instructed to see MD stat;
FACIAL AND THROAT SWELLING, DIFFICULTY BREATHING, MYALGIAS, ARTHRALGIAS, PURITIC RASH, WEAKNESS
Patient was noted with hypotension and altered mental status several hours after vaccine administration. Doctor sent the patient the hospital to rule out AKI.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills, fatigue, soa Narrative:  Headache, fever 101.9, chills, nausea, myalgia,  arthralgia, fatigue, soa, stiff neck; tylenol/ibuprofen; resolved 48  hours.
inadvertently administered Bexsero instead of Menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: A Medical Assistant reported they inadvertently administered Bexsero instead of Menactra to the patient. A Medical Assistant wanted to know if it would it be safe to administer Menactra after Bexsero. If so, how long to wait. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received Bexsero instead of Menactra, which led to wrong vaccine administered. This case has been linked with the case US2022061050 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022061050:same reporter
Fever chills body aches for 2 days was taking Motrin and Tylenol Tired since vaccine
Slight bleeding and a lump formed almost immediately after the PREVNAR 13 injection. Pt remained sitting and applied an ice pack to the area for 15 minutes. There was no redness or irritation at site just a lump. After about 30-45 min condition didn't worsen and pt felt just mild tenderness in muscle after the 2 shots. Pt's physician was contacted. Condition didn't really improve or worsen pt went home with instructions to take BENADRYL and pain killers as indicated and proceed to ER if conditions worsens. Physician's nurse believed potential hemotoma and also wanted pt to seek emergent care if warranted.