chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was moved to fridge on 06-Oct-2021.  PAT_MRN_ID was  reported as 06011954 It was unknown that if the lot number undergone to temperature excursion on not.  The state of the vaccine was partially thawed/liquid at the time of excursion. The vials size were 5.5 mL or 7.5 mL. Total duration of excursion was reported as maximus as 4 hours.  No treatment medications were reported.   This case was linked to MOD-2022-496015 (Patient Link).
Information has been received from a licensed practical nurse concerning 4 or 5 pt who in 2000 were vaccinated with pneumovax-23. The LPN stated that it seems 4 or 5 of our younger pts that got this vaccine this year had some mild site reaction. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: hospitalized for COVID-19 infection with acute hypoxemic respiratory failure and c. diff infection.  Received oxygen, antimicrobials, and steroids and discharged to home medically stable.
Information has been received from a registered nurse concerning her 16 year old daughter who in June 2007, was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection.  In August 2007 the patient received a second dose of Gardasil (lot# unknown) 0.5 mL injection.  In October 2007, the patient skipped her period.  Medical attention was sought.  As per the nurse, the patient is not pregnant.  The nurse also reported that the patient received a third dose of Gardasil vaccine (lot# unknown) 0.5 mL injection in December 2007 and so far the patient is already one week later for her January period.  To date the patient had not had her period yet.  On an unspecified date the patient had a regular Pap smear performed.  No further information was provided.  Additional information is not expected.
1.5 hrs post vax pt developed hives, SOB, nausea, h/a;
pt recvd vax intradermally;exp a "large cellulitis rxn";pt inadvertently recvd this vax instead of a PPD vax;Med Affairs comment:TD is labelled for IM use;
Tachycardia at 150 bpm 7 hrs after vaccine. Went to the ER, but it was self limiting
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild
Mother states redness occured at site of injection on 12/6/2006 on left thigh also with swelling.   Patient went to Dr.  and  Dr. upset nurse did not tell mother of Guillan Barre Syndrome.
Kidney pain started the day after the last shot and continued for about 3  or 4 weeks then stopped but now it has begun again on 4/9/22.
Initial and follow-up information has been received from a RN concerning a 57 year old female pt with elevated cholesterol and an allergy to Celebrex (caused hives) who on 07/30/04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 648139/0009P).  Concomitant therapy included Hepatitis B vaccine, recomb which was reported to have been given "in the other arm, no adverse symptoms", boron (unspecified)(+) calcium carbonate (+) cimicifuga (+) folic acid (+) kava (+) kudzu (+) selenomethionine (+) soy isoflavones (+) vitamin B complex (+) vitamin E (Estroven) and tretinoin (Retin-A). On 07/30/04, later in the day, the pt experienced right hand pain with burning down the arm. The inside of the arm was slightly swollen. On follow up it was reported that after vaccination, the pt broke out in hives, had lip swelling and pain in her arm. The pt's hives lasted for 3 days, the lip swelling lasted for 1 day and the arm pain lasted for 5 days. The nurse stated that what the pt had was most likely an allergic reaction to pneumococcal 23v polysaccharide vaccine. The pt was treated with Benadryl for the allergic reaction and acetaminophen (+) hydrocodone bitartrate (Vicodin) for the pain. The nurse reported that the event would most likely have been life-threatening if the pt had not been treated. The pt was not hospitalized. On 08/06/04 the pt had recovered and was feeling much better. No further information is available.  Pain in arm, right hand pain with burning down the arm, slightly swollen on the inside of the arm, hives and lip swelling were reported to be other important medical events (OMIC).
developed "funny" feeling in the tongue at about 12:15.  by 7pm had itching as well.  started Benadry that evening (Friday) & through weekend.  resolved by Monday 2/1/21 Had this tongue reaction to allergy shots in the past.
Chest Pain, Fever, Chills, Fatigue, Body Ache - These got better after around 6-7 weeks  Pain in muscles around neck, shoulder, chest, under arms on the left side - still there after almost 4 months
death Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 03/08/2021. Patient died 03/09/2021.  Medical examiner received report that patient was alert before a fall on the night of 03/08/2021. Death certificate will report death likely due to arrhythmia due to underlying CHF. Contributing factors include diabetes.
Approx 24 hours after receiving varicella and hep A, child developed redness in her face and was itchy. The itching continued the  next day and the redness on the face became more rash like. Child has long history of environmental and food allergies. Symptoms: Rash, pruritic, Erythema, Pruritus.
there was blood; felt on the kitchen and bang it's head; felt on the kitchen and bang it's head; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (there was blood) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HAEMORRHAGE (there was blood) (seriousness criterion medically significant), HEAD INJURY (felt on the kitchen and bang it's head) and FALL (felt on the kitchen and bang it's head). At the time of the report, HAEMORRHAGE (there was blood), HEAD INJURY (felt on the kitchen and bang it's head) and FALL (felt on the kitchen and bang it's head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sore throat, cough, cold, chills, legs pinching (?), etc-Started these [symptoms] after end of 2nd day (ie, 16th). [On the] 17, 18, 19 were highest and I have lA (?) of cough and head still present (11/24/00).
elevated blood sugar; arm pain; body ache; Loss of appetite; Thirst; cognitively impaired; Coordination issues; night sweats; nausea; pounding headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite) and THIRST (Thirst) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M207J and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue). On 21-Mar-2021, BLOOD GLUCOSE INCREASED (elevated blood sugar), PAIN IN EXTREMITY (arm pain), PAIN (body ache), DECREASED APPETITE (Loss of appetite), THIRST (Thirst), COGNITIVE DISORDER (cognitively impaired), COORDINATION ABNORMAL (Coordination issues), NIGHT SWEATS (night sweats), NAUSEA (nausea), HEADACHE (pounding headache) and FATIGUE (fatigue) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided
Severe dermatographia & swelling of joints appeared 12 days following the booster. Symptoms are persistent 86 days later if not medicated. Treatment has included steroids & anti-histamines.
Very tired; Swelling at the injection area; Rash from the elbow to the shoulder; Lot of pain in the knees; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired), ARTHRALGIA (Lot of pain in the knees), RASH (Rash from the elbow to the shoulder) and VACCINATION SITE SWELLING (Swelling at the injection area) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for an unknown indication.     No medical history was provided by the reporter. .  Concomitant products included CALCIUM, LEVOTHYROXINE, OMEPRAZOLE (PROMEPRAZOLE) and ATORVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (Lot of pain in the knees). On 05-Feb-2021, the patient experienced RASH (Rash from the elbow to the shoulder). On an unknown date, the patient experienced FATIGUE (Very tired) and VACCINATION SITE SWELLING (Swelling at the injection area). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, FATIGUE (Very tired) and VACCINATION SITE SWELLING (Swelling at the injection area) outcome was unknown and ARTHRALGIA (Lot of pain in the knees) and RASH (Rash from the elbow to the shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Along with the extreme pain in my arm (expected from tetanus), my WHOLE body experianced the same pain: arms, legs torso. I was incapacitated from this pain. The reaction is not described in TDAP information statement. I spiked fever 101.2  I took aspirin 1st night, didn't help. called Doc next day. Call back in afternoon was told to take large dose (500) acetaminophen, I substituted Tylenol. Today 1/17/14 it is noon and starting to fell better.
Redness and swelling at site of DTaP injection. No tenderness. Low fever on 10/14/03. Resolved with Tylenol. Swelling and redness gone on Thursday 10/16/03.
Swollen Lymph node in armpit.; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 09:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. 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 12Apr2021, the patient experienced swollen lymph node in the armpit. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event swollen lymph node in the armpit was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented for the first time after 10/11/18 vaccinations on 11/01/2018 complaining of scattered, scaly rash all over trunk, chest wall, and legs. Office note states mother noticed a swollen area on left upper thigh approximately 1 or 2 days prior to this office visit.  The nurse's note states that the site was swollen, warm and tender to touch, without drainage. Patient was afebrile. The diagnoses for this date was pruritis, tinea corporis, and cutaneous abscess of left lower limb. Medications prescribed at this visit were Griseofulvin, Sulfamethazole-Trimethoprim, and topical Mupirocin. On 12/6/2018 patient returned to office complaining of bilateral eyelid swelling and eye pain. She was afebrile and denied cough. Medications continued were Griseofulvin and topical Ketoconazole 2% for the tinea rash. Zaditor and Cetirizine were also added.  She still complained that the left thigh abscess had not resolved and was referred to wound care with Dr. Office notes on 12/7/19 state that mother noticed lesion on left thigh 3 weeks prior to the office visit and stated that child did not have any pain at that time. Notes state the lesion on that date measured 1x1x1cm with serosanguineous drainage, red granulation, and subcutaneous tissue exposed. The wound was cleaned and dressed.  Child returned to pediatrician?s office on 2/7/19 with rash, cough and congestion. She was diagnosed with viral URI, hives, contact dermatitis, pruritis, left thigh abscess improved. She was prescribed Prednisolone 15mg/5ml twice daily for 5 days and Cetirizine 10 ml daily. Returned to Pediatrician?s office on 2/22/19 for skin peeling of hands and feet. Complained of burning skin. She was diagnosed with Eczema and Allergic Rhinitis. Patient was prescribed topical hydrocortisone 2.5% cream bid for 5-10 days and Children?s Loratadine 5ml once daily. Returned to Pediatrician 3/21/19 for congestion and ear pain. She had an ear infection and was prescribed Augmentin 600-42.9mg/5ml for 10 days. She returned to wound care on 4/10/19 complaining of left thigh pain at site of abscess for 3 weeks duration after bumping into an object. Wound care nurse reported that the abscess on left thigh had not healed since vaccines were given on 10/11/18. Wound had serous fluid and some tenderness. The wound was cleaned dressed and patient was referred for a surgical evaluation with Dr. 4/11/19 phone note from nurse practitioner stated that mother says the wound site was healed for months then started swelling again so she went back wound care to have it checked. She stated her allergies were also flaring again causing her eyes to swell. She was prescribed Zaditor eye drops and advised to continue Cetirizine.
Right arm red & swollen from elbow to shoulder. Elevated temp 101. F for 2 days. Mother stated right arm felt hard to touch.
pt recvd vax & w/in 24hrs p/vax exp joint pain;sx were untreated & subsided p/2 wks;
Individual was vaccinated on 1/18 at 3pm, at time of vaccination she had no adverse events. Upon waking in the morning she noticed lower lip swelling, denies itching, denies trouble breathing or other symptoms. No history of allergy, anaphylaxis. Pt spoke with her PMD who recommended benadryl  and she noticed slight improvement.
Irritable Bowel Syndrome (ongoing)-Dicyclomine Diarrhea (ongoing) Diarrhea with blood (ongoing, infrequent) Fever  (occasional) Cold Sweats (with exertion) Abdominal Cramping (ongoing) Fatigue (ongoing) Bloating (ongoing) Nausea (ongoing) Vomiting (ongoing) Headaches (ongoing) Slurred and confused speech (ongoing)
Redness, bruise -> Pt came to pharmacy and her arm was red/with a bruise pt did not have any swelling (pt said she has sensitive skin and easily gets bruised) pt denied any pain or itchiness. Pt contacted her MD was told to take acetaminophen and reports symptom improvement (Pt contacted on 9/8/17) (Saw patient on 9
3 patients got a booster dose from an expired Moderna vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2022-455195, MOD-2022-455207, MOD-2022-455269, MOD-2022-455277, MOD-2022-455278 (Patient Link).
Pt received second dose on 04/02/2021 no adverse effects noted at this time. Pt contacted customer service on 04/13/2021  in regards to second dose vaccine administration. Pt reported " shortly after, they experienced extreme pain in arm and shoulder making daily activities difficult". Pt contacted PCP and told that they"re "experiencing SIRVA from vaccine being administered too high in arm"
Patient indicated to RN that she was feeling "warm." Patient denied any shortness of breath, difficulty breathing,chest pain, or itching. Patient denied feeling like they're ears were warm. RN took patient to secluded area and asked health history. Patient indicated they're blood pressure is supposed 130s/60s, however they were" running low" on all medication including lisinopril . Vital signs at 1525 were as follows: 156/85 mm Hg, 74 BPM, 16 BPM, and pulse ox. 96%. RN did relaxation techniques with patient, and had patient take off jacket. At 1537 vital signs were as follows: 146/75 mm Hg, 74 BPM, 16BPM, pulse ox. 97-98%, and 97.6F. Patient reported feeling not as warm, and stated they believed it was due to the jacket and face mask. Patient denied shortness of breath, difficulty breathing,chest pain, or itching. patient stated she would have medication refilled tomorrow AM. RN instructed to contact healthcare professional if symptoms worsened, and provided general care instructions.
tiredness; nausea; loss of appetite; shakiness; extreme feelings of being cold even inside at temperatures of 68 degrees; shaking under separate layers of blankets;
Pfizer 2/15/21, 3/6/21, 10/5/21. Moderna 9/29/22. Positive on 1/29/23
local inflammation-deltoid inject site on eve recvd shot; followed by chills & sweats; 31MAR94 & 1PAR94 pt states was squeasy & dizzy; sx cont until 6APR94; pt seen by MD;
Pain and swelling at injections site, shivering, severe headache, fatigue, low grade fever, diarrhea
There was redness and general swelling at the injection site (right arm) immediately after the vaccine was administered.  That subsided the next day, but remained tender.  About 2/4 a distinct rash appeared (right arm) approx 15mm in diameter.  On 2/5, the kidneys became painful and swollen.  The rash subsided after a few days.  The kidney pain diminished after a week.
tiredness; headache; This is a spontaneous report from a contactable consumer (reported for his wife) via a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for COVID-19 immunisation. The caller was asking for his wife who got the second dose yesterday 21Apr2021 then experiencing a bit of tiredness and headache in Apr2021. The caller wanted to know if his wife can take pain reliever medication like Ibuprofen. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a female nurse of unknown age via a company representative concerning herself. The patient's medical history included chemotherapy. On an unknown date in December 2011, the patient was vaccinated with a single dose of 0.5 ml PNEUMOVAX23 (lot # not reported). No concomitant medications were reported. On an unknown date in December 2011, while on PNEUMOVAX23 the patient arm was very hot around the injection site. There was massive swelling from her neck to her arm and wrist. The patient sought Medical Attention(unspecified). No treatment information was reported. This swelling cleared in about one week. On an unspecified date, the patient had recovered from the events. Additional information is not expected.