chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 28SEP95 & 9OCT95 pt devel pruritic rash w/ 44 or 5 lesions & was seen by MD on 11OCT95;the lesions were vesicular or crusted/excoriated upon exam consistent w/varicella lesions;
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included Anaphylaxis (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Anaphylaxis (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Itching (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Confusion (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Electrolyte imbalance (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Consciousness decreased (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Pricking skin sensation (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Tingling sensation (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Hospitalization (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2005, Hospitalization (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Swelling (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Disorientation (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Upper airway obstruction (swelling of lips, tongue, throat, uvula, or larynx. Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Throat tightness (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019, Red eye (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019 and Itchy eyes (Reaction due to Golytely for Colonoscopy (polyethylene glycol) allergy) in 2019. Concurrent medical conditions included Drug allergy (Anaphylaxis Reactions, Hypersensitivity, Hospitalized, itching, confusion, electrolyte imbalance) since 2005 and Drug allergy (Anaphylaxis Reactions, Hypersensitivity, Hospitalized, Swelling, disorientation, throat) since 2019. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). On 11-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant product use was reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: On additional information received on 09 Jun 2021 had  patient demographics, updated patient's relevant medical history and reactions. Added updated event description.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/ allergies were unknown. On an unspecified date in June 2017, the patient was vaccinated with improperly stored doses of PROQUAD (Lot # M007960, expiration date 15-AUG-2017 or Lot # M049122, expiration date 13-JUN-2018) dose, route were unknown for prophylaxis (the nurse reported that since 02-JUN-2017 this patient and 5 more received the improperly stored doses of vaccine). The lot # and expiration date for the properly stored sterile Water diluent used to reconstitute the doses of PROQUAD was not provided. No adverse effects were reported. The temperature excursion was from 6°F to 14°F for 1 hour, no previous temperature excursion was reported, the call was because a data logger. No product quality complaint was involved. This is one of 6 cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA006743: US-009507513-1706USA010999: US-009507513-1706USA011000: US-009507513-1706USA011001: US-009507513-1706USA011002.
Client was given an extra dose of Janssen, client did not disclose that she had already recieved a Janssen vaccine on 4/10/21 Lot # 201A21A.
Adult patient has been prescribed MMR II off label.; No additional AE reported; This spontaneous report as received from a medical assistant refers to a adult patient of unknown age.    On an unspecified date, the patient has been prescribed measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, indication, dose, frequency, lot number and expiration date were not provided).  It was confirmed that the patient has not received the suspect therapy, however, it was reported as precaution due to an adult patient being prescribed measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (off label use).
Information has been received from a physical therapist concerning a female patient between the ages of 18-20 years old who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported). It was reported that on an unspecified date, the patient experienced dysautonomia. At the time of the report, the patient's outcomes was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. No further information is available.
Immediately after receiving the last vaccine patient had an episode of syncope. She regained consciousness quickly and was moved to our Trendelenburg chair. Vitals were checked within a few minutes (BP 108/62 P 70) and she was given water as well. She was accompanied by her mother and was able to leave after about 15 minutes.
Pain; Chills; Headache; Ran a fever; A spontaneous report was received from a healthcare professional concerning 41-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain, chills, headache and ran fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (011J20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient complained of pain, chills, headache and fever. After the first dose, she developed fever. The vitals included temperature readings at 101 degrees. Later in the evening, her temperature was recorded at 102 degrees.   On 25 Dec 2020, the temperature readings of 100.5 degrees was reported.   Treatment of symptoms included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events pain, chills, headache and ran fever were not resolved.; Reporter's Comments: This case concerns a 41-year-old, female, patient, who experienced an expected non-serious events of Myalgia, Chills, Headache, and Pyrexia. The events occurred on the same day after first dose of mRNA-1273 (lot # 011J20A). Treatment included Tylenol for her symptoms. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Administered site for pneumococcal vaccine became swollen and painful. Had hard time raising the arm up. Symptoms lasted 4 days. Pt. had no reactions for the administered site of flu vaccine.
Severe Chills, shaking and fever of 102 Lathargic completely unable to get out of bed for at least 6 hours
Beginning 24 hours after the vaccine, I had shortness of breath, chest pain and increased heart rate. I did not have these reactions with prior doses. I went to urgent care, and they transferred me to the emergency room. They discharged me 10 hours later, and told me it was mild myocarditis. I had symptoms for 6 days. I still have slight shortness of breath and rapid heart rate when exerting myself.
Lingering Cough; Choking in the middle of the night; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Lingering Cough) and CHOKING SENSATION (Choking in the middle of the night) 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.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Lingering Cough). an unknown date, the patient experienced CHOKING SENSATION (Choking in the middle of the night). At the time of the report, COUGH (Lingering Cough) and CHOKING SENSATION (Choking in the middle of the night) outcome was unknown.            The 2nd shot was either on May 2nd or 9th, patient could not remember Patient slept with a CPAP machine (Continuous Positive Airway Pressure Therapy) No concomitant medications information was reported. No treatment medications were provided.
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store-level, they were not able to give any information on anything other than the single-use vials were studied. Called the morning of 8/3/21 and spoke to the medical team at Pfizer who gave the same information. The reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Client became pale, nauseated, weak and dizzy after immunization. Spit up a small amount of mucus. Student ws very anxious before injection. Father was present and stated child is very anxious and scared of shots. Client remained pale and weak for about 45 min. Client ate breakfast and had taken his Concerta shortly before immunization done. Had child remain; gave him juice, child gradually improved. Child left to go home with father approx. 1 1/2 hr later and feeling ok.
soreness at injection site with swelling itchy eyes, sore throat, coughing, fever and chills, runny nose, stuffed up head
Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus and Immunocompromised. Concomitant products included HYDROXYCHLOROQUINE, METHOTREXATE, FOLIC ACID, OMEPRAZOLE, CALCIUM FOLINATE (LEUCOVORIN CALCIUM), DICYCLOVERINE, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-314852, MOD-2021-314862 (Patient Link).
Right arm swelled from armpit to elbow. Although injection was on deltoid, redness and swelling was on inner arm. Pt showed arm 2 days after pneumo injection. 1st 24 hours was very red and swollen, 2nd 24 hours was pain radiating from elbow down to hand. Dark redness and swelling still occurred 48 hours later. Pt went to ER 10/12/03. By 10/13, swelling down, redness turned to yellow. Left arm pneumococcal site problem.
pt devel a rash on rt inner thigh, c/w herpes lesions;lesions spread down legs,c/w varicella zoster-cult confirmed varicella present-total course 3wk;
No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.   Patient administered booster dose.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
fever to 105.6 sx lasted for 36 hrs-treated w/Advil & APAP;
24 hours after vaccination patient hospitalized with "metabolic encephalopathy." Had confusion & joint disorder. Did not recover. Sent to rehab nursing home when CTV 4/16/21 found with cerebral venous thrombosis. 85 yo. man in good health with hypertension, GERD and prostate CA in remission. Had COVID-19 pneumonia 12/30/2020-1/2/21 complicated by full and cerebral concussion. Had confusion, memory loss, and balance disorder which improved by 2/5/21. Received COVID-19 Vaccination 3/18/21. 24 hours thereafter found by wife more confused with gait disorder. Hospitalized at hospital and had low grade fever, normal labs, and noncontrast CT brain showed cerebral atrophy. Dx metabolic encephalopathy. Did not recover and sent to rehab and nursing home. 3/23/21. Evaluated 4/14/21 there by myself with persistent cognitive loss (mini-mental status after 9/27), frequent falls and normal labs. CTV 4/16/21 showed filling defect in distal thrombosis sinus with nonopacification of sigmoid sinus. No hemorrhage. Moderate chronic microvascular ischemic change. Dx. L dural sinus venous thrombosis. Pt, begun on Xarelto. No neurologic changes since then. Patient has not returned to baseline neuro status. Family informed. Local health authority informed. Records including hospitalization, nursing home reports, office notes, labs, XRays, treatments available. Thank you, Reporting physician.
Significant skin outbreak of Hives primarily on extremities, legs and arms.  Started a week after second shot. Treatment Benadryl.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves female patient of 13 year who received suspect vaccine was FLUBLOK QIV which was given accidently as it was recommended to 18 years and above old. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medication was none. On 02-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1806 and expiry date: 06-May-2019) (dose and dose in series was not reported) via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported that if any adverse event was occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient COVID-Vaccination Registration form indicates patient has not received a different covid vaccine product. Given Pfizer vaccine today. When documenting, noted to have received Janssen vaccine on 3/13/2021 Patient states she was advised by her cardiologist and Dr. to receive Pfizer vaccine as a booster. Patient advised this is not the recommended practice and she will not receive another covid vaccine here. No adverse side effects noted
Information was received by a pharmacist. Between 2011 to 2012, a patient was vaccinated with ZOSTAVAX. It was reported that the patient's mother-in-law was diagnosed with shingles one to two weeks later. Additional information has been requested.
Onset of fever of 100.3F with pain and swelling of left upper arm. Entire upper arm red and hot with pruritus. Pain is subsiding but still complains of erythema and edema at site. Erythema with heat 10cm X 7cm in size. On 4/29/02, temperature was 99.1F.
Chest Pain. This started occurring about 2 and a half weeks after my second vaccine dose.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a runny nose. The next day the pt experienced 25 Lesions on his trunk, heel, head and behind his ear. The pt also had a fever of 101F and lymph node enlargement in the groin. At the time of reporting the lesions have crusted over however the pt continues to have lymph node enlargement in the groin and a low grade fever of 100.5F
Information has been received from a Registered Nurse concerning a 13 month old male who on 02-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 19-MAY-2007 the patient developed a maculopapular rash on his trunk and arms. He had 25 lesions. No other information was reported. Additional information is not expected.
9/17 acute right sided facial weakness diagnosed as Bells palsy followed by progressive right sided weakness for which he was admitted to the hospital on 9/26 and ultimately developed left sided weakness. Diagnosed as a demyelinating neuropathy and treated with IVIG and high dose steroids
Four patients received an expired 30-day use by date booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 036B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), METFORMIN and LOSARTAN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were reported.   This case was linked to MOD-2022-503133, MOD-2022-503153, MOD-2022-503157 (Patient Link).
Rash started Tues AM at 8 then down to elbow by Thurs. We contacted provider they recommended ice and TYLENOL. If gets worse pt. to go to urgent care. Rash is red and hot to touch.
This spontaneous report as received from physician concerning a 15 year old male patient who on 09-OCT-2007, was vaccinated with the first dose of VARIVAX (Merck) (lot#658294/1103U, exp 13-JUL-2009). On 09-AUG-2008, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# 0391X, exp 05-MAR-2010) and on 19-SEP-2009, the patient was vaccinated with the third dose of VARIVAX (Merck) (lot# 665103/1001Y, exp 13-JUL-2011). The physician reported that on 20-APR-2012, the patient had a negative titer for varicella (unspecified IgG titer was done). At the time of the report, the patient's outcome was unknown. The patient sought medical attention by physician's office contact. The relatedness for negative titer for varicella is unknown for VARIVAX (Merck). Additional information has been requested.
This case was reported by a consumer and described the occurrence of fever in a 63-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX. On 22nd September 2018, less than a month after receiving SHINGRIX, the patient experienced fever, shivering, headache and fatigue. On an unknown date, the outcome of the fever and shivering were recovering/resolving and the outcome of the headache and fatigue were not recovered/not resolved. The reporter considered the fever, shivering, headache and fatigue to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fever greater than 100 degrees F. The symptoms improved over the course of two days.
Product storage error; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Product storage error) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 5:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 5:03 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  A Series of patients approx. 540 patients received lot number 066H71A past its 30 days expired date. Vaccines went into 2-8 degree Celsius thaw state on or above 24-Dec-2021. This vaccine was administered up until its Mfg Exp date of 04-Apr-2022.   Treatment information was not provided.
14jun90 pt vax 2nd heptaB. 14jun90 pt devel flulike sx w/ intermittent n/v/f 37.5 C and arthralgia.  19jun90 pt advised to rest and take analgesic.  sx persisted until 22jun90.