chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & exp delayed hypersensitivity & devel rheumatoid arthritis following vax w/Hep B vax; No further details were provided;
pt states had temp of 99 on 3DEC;also c/o pain @ site & redness today;4DEC small area of swelling noted apparently can move arm
This spontaneous report was received from Nurse, referring to 2 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications wee not reported. In 2017, between 18-JAN-2017 and 07-FEB-2017, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB with lot # M036056 and expiration date on 18-MAY-2019 (anatomical route of vaccination was not provided) for prophylaxis. The Nurse stated that, LIQUID PEDVAXHIB, was exposed to a temperature between 0 °C and 2 °C, for a time frame of 208 hours. Data logger was not involved. Furthermore, it was reported that LIQUID PEDVAXHIB, was never expose to a temperature excursion before and that no product quality issue was involved. Additionally, no adverse events were suffered. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007841: US-009507513-1702USA007843: US-009507513-1702USA004171:
6.5 x 4.5cm red, induration around site of immun on lt deltoid;no tx other than DPH;
swollen arm; itching; warm/fever arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and INJECTION SITE WARMTH (warm/fever arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and INJECTION SITE WARMTH (warm/fever arm). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and INJECTION SITE WARMTH (warm/fever arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter.
Multiple pulmonary embolisms both right and left lungs , coughing up blood 5 days after second moderne shot. Very healthy non smoker , no history of heart problems. Non drinker, Heath professional DDS degree.
Approximately 7 hours after receiving vaccine (per mother)pt. c/o increased heart rate, chest hurting, room spinning and difficulty taking a deep breath.  No tx. per mom. Still c/o increased heart rate today 1/18/2006. Advised to call family physician.
This patient received covid vaccine x2 > 2 weeks ago and then had a positive covid test 3/3/21
COVID-19 exposure and subsequent positive COVID-19 test on 3/30/21.  Was asymptomatic.
Vaccination given too far up and to the right of deltoid. Severe arm and shoulder pain lasting for 2 months despite anti-inflammatories and stretching.
Infant received vaccines at 10 AM, did well, went home and slept. Infant woke up at 2:30 pm (4 1/2 hr later) screaming and grunting but not discolored. Had a nl bm. Cryed x 1 1/2 hr then resolved with TYLENOL. XM was WNL. Did well.
Dizzy; Nauseated; I was going to fall over every time I bent over to pick something, lost my balance and all day long I was like that; Have intense cramps; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Lot number: EN6202) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: High blood pressure; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "Osteopenia" (unspecified if ongoing), notes: Verbatim: Osteopenia. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased; ALENDRONATE taken for osteopenia; METOPROLOL taken for hypertension. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; NAUSEA (non-serious), outcome "unknown", described as "Nauseated"; BALANCE DISORDER (non-serious), outcome "unknown", described as "I was going to fall over every time I bent over to pick something, lost my balance and all day long I was like that"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Have intense cramps"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Additional information: Patient stated "her doctor put her on a different medications (unspecified medications) and had been on it a month, so thought it was due to that medication because she thought the side effects of the Covid vaccine would came on her immediately like within 24 hours, so she didn't associated that with the Covid vaccine but she was now began to think that what it was because when she called her doctor anyway so she was reporting."  No follow-up attempts are possible. No further information is expected.
Redness; Fatigue; Chills; Sore arm; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Redness), MYALGIA (Sore arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs (Acyclovir), Allergy to chemicals (blue paint), Allergy to allopathic drugs (Dilantin), Allergy to allopathic drugs (Pristiq) and Allergy to allopathic drugs (Prolensa). Concomitant products included EPINEPHRINE (EPIPEN 2-PAK) for Angioedema, SUMATRIPTAN SUCCINATE for Complicated migraine, MACROGOL 3350 (MIRALAX) from 09-Nov-2020 to an unknown date for Dysuria, FAMCICLOVIR from 23-Nov-2021 to an unknown date for Herpes simplex oesophagitis, SUMATRIPTAN for Migraine, ONDANSETRON (ONDASETRON [ONDANSETRON]) for Nausea, GABAPENTIN (NEURONTIN) from 16-Dec-2020 to an unknown date for Neuralgia NOS, CLONAZEPAM, ESTRADIOL, ESTRADIOL, DICLOFENAC SODIUM, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), ONDANSETRON HYDROCHLORIDE (ONDASETRON [ONDANSETRON HYDROCHLORIDE]) from 16-Nov-2020 to an unknown date, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 16-Nov-2020 to an unknown date, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3, VORICONAZOLE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (Sore arm). On 02-May-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). On an unknown date, the patient experienced ERYTHEMA (Redness). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ONDANSETRON (ZOFRAN MELT) ongoing since an unknown date at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE (OXYCODON) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), MYALGIA (Sore arm), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication include opioid   This case was linked to US-MODERNATX, INC.-MOD-2021-081720 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added concomitant medications; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081720:1st dose of vaccine
Localized swelling on right side of shoulder, which the following day, spread to involve entire upper arm with mild pain and tenderness.  Subseqently developed blistering over the upper 1/3 of her arm.  However, had no fever, nausea or other symptoms. 9/23/08-records received for DOS 5/22-5/24/08- DC DX: Cellulitis versus immunization reaction. Presented with C/O swelling of right arm for past two days. Localized reaction with redness and swelling on right side of shoulder day prior to admission, which spread to involve whole upper arm with mild pain and tenderness. Blistering.
Pain at injection site radiates up to neck behind (L) ear & down to fingers. Edema (L) arm & wrist sl. edema in (L) hand. Started 11-16-11. No fever no numbness. Some pain behind ear approximately 10 mins. after injection woke up at 2:00AM with other symptoms.
Lymph nodes all over my body were swollen for about 10 days. Had the flu like symptoms severely for three and a half days. Took ibuprofen and Tylenol alternately for five days, then nothing. Eventually I felt better.
Patient complained of low grade fever (99) and myalgias and headache. Patient instructed to give ALEVE 2 tablets twice a day for 3 days. If fever greater than 101 or if having no relief in symptoms after 5 days--office visit recommended.
Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021 at 4:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 4:47 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 58.51.  Concomitant products were not provided.  On 21-Mar-2021 vials were moved to clinic. On 16-Mar-2021 the vaccines were moved to fridge. 21-Mar-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34, at 10 AM temperature was 32 and at 11 AM temperature was 34. The vaccine beyond use date was reported as 15-Apr-2021.  Vial was stored in cooler 1, on 21-Mar-2021, temperature excursion at 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 PM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41 and 4 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
Mother of patient called 7-14-11. Stated when took band aid off 7/13/11 from vaccine (PREVNAR 13) site there was a blister at site. Told mother to apply NEOSPORIN & call if fever, worse, red/hot to touch or concern.
Patient has history of neurological side effects from influenza vaccine. 2 days after vaccine experienced similar side effects. 5 days after vaccine went to ER with numbness, limb heaviness, difficulty walking and using arms
PATIENT STATED SHE HAD SLURRED SPEECH, DIZZINESS WITH SOME NAUSEA, MUSCLE SPASMS.
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 21-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 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 18-Jun-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 product use was not provided by the reporter.   No treatment information was provided.  Date of refrigeration of vaccine was provided on 7 May 2021.
Narrative: Admitted on 2/17 for CHF exacerbation found to be COVID positive on 2/18 and intermittently required O2. He received the Janssen vaccine on 7/16/2021 x 1. He was received 5 days of remdesivir and 5 days of dexamethasone. He was discharged on 2/22 and was no longer requiring O2.
Pt received one dose of Flulaval which is indicated for adult use only.  Pt was given injection in left deltoid.  Per patient's mom he did not have any reactions.
Patient admitted for CHF/Asthma exacerbation. Given Diuretics, albuterol, oxygen and steroids. Patient's shortness of breath was felt to be multi-factorial including asthma exacerbation, mild CHF exacerbation, and mild COVID-19 pneumonia. Inpatient medications improved the patients condition and she was discharged on dexamethasone and albuterol, advair and spiriva after a short 2 day stay.  Found to be COVID positive on admission.
Approximately eleven days after administration of vaccines (DTaP, HiB, Varivax, HAV, & MMR) at 15 month well child exam, patient developed erythematous pruritic oval shaped, scaly lesions to his torso to include the entire back, chest, and abdomen.  His mother also indicated that he had run a fever off and on since receiving the vaccines with maximum temperature to 101.1 F and had a decreased appetite for 4 to 5 days.  His mother brought him to be seen at our office on 6/19/07 due the rash appearing to spread to his face and diaper area.  Children's Benedryl (12.5mg/5ml) one teaspoon every six to eight hours as needed for itching and Children's Tylenol (160mg/5ml) one teaspoon every four to six as needed for fever were prescribed treatment.  The mother was also advised to follow up with her PCP if the child's symptoms worsened or other symptoms developed over the next two to three days.
diarrhea; felt tired; fever; chills; threw up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) in a 29-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.     NO medical history information was reported.     On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills), VOMITING (threw up) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) had not resolved and FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) in a 29-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.     NO medical history information was reported.     On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills), VOMITING (threw up) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) had not resolved and FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Very flush, shaky, elevated HR. Pt states she feels very anxious  Vital signs: BP 120/94 HR 102 Resp 14 O2Sat 97 Skin signs: Clammy, very flush  Circulation: Cap refill <2sec Respiratory: Breath sound clear bilaterally, HB normal  Monitor  At 10:20 BP 128/84 HR 88 Resp 14 O2Sat 96 Skin signs: Clammy  Circulation: Cap refill >2sec Respiratory: Breath sound clear bilaterally  Monitor. Patient noticeably more calm, less shaky, skin color noticeably improved.  BP 124/78 HR 89 Resp 12 O2sat 98  Skin signs: Clammy  Circulation: Cap refill <2sec Discharged with mother. Escorted to vehicle. States feels ok to drive. Steady. Denies dizziness or vision problems. Has had anxiety attacks.  Vaccine administered L. L skin noticeably darker, dark red. Pt states only oral intake x8 hours coffee.
pt had a positive COVID test on 8/1/22 and was hospitalized with pneumonia, COVID, urosepsis; 8/18/22 pt back to hospital with lethargy and SOB; UTI; chronic respiratory failure; O2 supplementation; pt's condition worsened and she passed away in the hospital; COD:  acute on chronic respiratory failure secondary to COVID infection
varicelliform rash over the trunk & extremities wt limited to site of inj lasted 5 days, no fever, no other sx didn't require tx, only observation;
48-72 Hours after the second dose of MMR, child development a harsh dry cough. No other symptoms were present and the child was not exposed to anyone sick prior to their vaccine. 2 Weeks before vaccines child had a cold / sore throat. Child's cough, after vaccine,  started as a throat clearing and development into dry cough that continued every 5-10 seconds throughout the day.
Day one-very painful arm Day two-chills, headache, nausea, fatigue, sore arm
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of ROTATEQ (lot # L033543, expiry date 30-MAY-2017), which were improperly stored under the temperature of 50F for 35 minutes. The data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This in one of several reports received from the same reporter. Additional information has been requested.
Narrative:  seen in walk in clinic, EKG normal but cardiac exam revealed premature beats
Information has been received from a physician concerning a 4-year-old female patient who on 28-Mar-2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  It was noted that there were no concurrent medication, significant past medical history or known allergies.  On 01-APR-2000 the patient experienced a macular, popular rash all over her body.  The patient was afebrile.  Additionally, it
COVID?19 Vaccine EUA; The injection site is swollen, hard and warm to the touch. It also has been itching a bit.
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Tachycardia, palpitations, chest pain, weakness, shortness of breath Visit to Hospital ER on 7/17 - IV fluids; follow up with PCP - heart monitor, antibiotics; and cardiologist - echocardiogram, heart monitor, beta blocker (propranolol) Improvement but not resolved as of 8/30/21.
There was not a hint of anything wrong with me when I went in, but it was a terrible night!  About 2 hours (5:30ish) after I got home I started getting a sore throat and a cough.  That lasted for a couple of hours and then I started getting aches and chills (7:30ish).  The chills were very violent and my whole body shook and shook.  I was finally able to get into bed (with lots of covers piled on) about 9:00 or 9:30.  I was so miserable that my husband called Dr. at home to make sure I would live.  I was able to go to sleep, but at midnight I woke up extremely nauseated and vomited for awhile.  Finally, I started feeling better and kicked all the covers off.  This morning I woke up with a bad headache, worn out and wet.  Guess I had a fever that broke in the night.