chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm, with red rash around injection site. Redness went away and returned a week later nearly triple the size and warm. Injection site became painful and bruised about 2 weeks post injection.
Patient was indicated to receive the standard dose vaccine; but was invertedly given the HD (High dose) vaccine. The error was caught immediately after vaccination.
A report has been received from a health professional concerning a 7 year old male patient. The patient's concomitant diseases and concomitant medications were unknown. On an unknown date the patient started to receiving nasal FLUMIST. The patient was administered of complete FLUMIST dose in one nostril which started on 23-SEP-2012. The action taken of FLUMIST was not applicable. The outcome of the event was unknown. The report was considered to be non-serious by the reporter. Corrected report 15-APR-2013. The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv. Additional reporter added as patient.
Staff used technique on cap removal of vaccine dose using left hand while right was holding patient right arm. This resulted in said staff member sticking themselves in left index finger, drawing blood. Staff stopped what they were doing and disposed of the contaminated vaccine into a sharps container. Staff secured all other items and informed the patient they would be back after a moment at which point other members were notified of the situation. Staff member cleaned site of puncture of left index finger and proceeded to immunizations for direction on encounter.
About an hour after receiving the vaccine I developed a large white hive just below the injection site. (hive approx 2 inches in diameter) I began to itch on rest of body/ no more hives just itch. I took 50mg of Benadryl. 4 hours later still itching so I took 50mg of Benadryl. Approx, 4.5 hours later, woke up with tightening feeling in throat, itching in throat and roof of mouth, itching tingling of tongue, and tingling sensation of lips. went to the emergency room. Was admitted and monitored, benadryl was administered.  Duration of hospital stay 1 day.
Narrative:  COVID infections following completion of COVID vaccine series 03/05/21 COVID vaccine dose #1 03/26/21 COVID vaccine dose #2 06/24/21 Pt calls into clinic reporting purulent cough, nasal congestion, sinus pain, runny nose, sore throat; given rx for rhinitis - azithromycin, benzonatate, fluticasone 07/25/21 COVID POSITIVE from antigen rapid test 07/26/21 Pt reports sore throat, persistent sinus headache pressure, decreased smell, occasional cough; reports increased use of proair inhaler every 6 hours with difficulty in taking deep breaths; states boyfriend also has COVID and is taking his boyfriend to ER due to worsening symptoms; rx given for ascorbic acid, DM/guaifenesin, zinc 07/27/21 Pt reports CXR was done and negative at ER, declines daily calls as he feels better with albuterol use; rx given for albuterol
Chills 3 hrs, nausea, sore throat, coughing, back pain, body aches, conjunctivitis started about 4 to 5 hrs after vaccine lasted 5 to 12 hrs & recovered.
Information was received on 24-JUL-2017 from an attorney regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about August 2012, the patient was vaccinated at a local pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-NOV-2012, the patient was treated for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. His condition worsened as the shingles spread to his eyes. On or about 07-NOV-2012, he was treated by eye surgeon for treatment of shingles in the eye, diagnosed as herpes zoster keratitis with vision interference. The patient has been treated continuously for ongoing issues with his eyes secondary to herpes zoster keratitis. As a direct an proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review the event of herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
This patient is a 34 y.o. female presenting to the emergency department with a chief complaint of anxiety onset 1130. The patient reports that she had her second dose of the COVID vaccine, and 4 minutes after, had chest tightness with palpitations. She had associated nausea, vomiting and a mild headache. She states that her symptoms come in waves and are similar to a panic attack. She has had panic attacks in the past. She reports that she had similar symptoms after her fist dose, but states that they were much more mild.
Dose given may have been outside the 6 hour limit on an open vial of Moderna vaccine.
First Dose on 26 March and second on 2 April... less than dosing window; Unresolved Itch; Unresolved Small blisters; Breaking out since 1st dose; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 26 March and second on 2 April... less than dosing window), PRURITUS (Unresolved Itch), BLISTER (Unresolved Small blisters), RASH (Breaking out since 1st dose) and MYALGIA (Arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017b21a and 017b21a) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (Unresolved Itch), BLISTER (Unresolved Small blisters) and RASH (Breaking out since 1st dose). 26-Mar-2021, the patient experienced MYALGIA (Arm soreness). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 26 March and second on 2 April... less than dosing window). The patient was treated with MOMETASONE FUROATE (MOMENTASONE) at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Dose on 26 March and second on 2 April.. less than dosing window) had resolved and PRURITUS (Unresolved Itch), BLISTER (Unresolved Small blisters), RASH (Breaking out since 1st dose) and MYALGIA (Arm soreness) outcome was unknown.            This case was linked to MOD-2021-384200, MOD-2021-384247 (Patient Link).
Developed a red rash in right shoulder; Swelling in right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Developed a red rash in right shoulder) and INJECTION SITE SWELLING (Swelling in right shoulder) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Developed a red rash in right shoulder) and INJECTION SITE SWELLING (Swelling in right shoulder). At the time of the report, RASH ERYTHEMATOUS (Developed a red rash in right shoulder) and INJECTION SITE SWELLING (Swelling in right shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood pressure measurement: 199/96 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient report that since she got the vaccine she has had severe vomiting and diarrhea that last for 5-6 hours... also sweating heavily and abdominal pain
Patient with history of CKD on dialysis and diabetes type II. He was seen in the ED on 10/28 after missing a week of dialysis. Patient with symptoms of leg swelling, shortness of breath, and cough. He tested positive for COVID-19 by PCR in the ED on 10/28. Patient was admitted initially for acute on chronic pleural effusion causing shortness of breath due to missed dialysis, also admitted for acute on chronic hypoxic respiratory failure and COVID-19 pneumonia. Patient required 5 liters O2 during admission, however, was able to be weaned down to his baseline oxygen needs. Admission was from 10/28 - 11/6. He has received the COVID primary vaccine series.
07/26/2002 Edema right thigh. Painful at palpation. Give Ibuprofen for discomfort.
Red rash appeared on upper arm approximately 7 inches by 5 inches in size. It was very itchy and had burning sensation and skin was swollen and warm to touch. It appeared suddenly on 6th day after date of vaccine. Treated with oral antihistamine, cool compresses and hydrocortisone cream. Symptoms have diminished on day 4 of occurence. Consulted with medical professional about it on Jan 29, 2021.
swelling in left hand, hives on arms, armpit crease, chest, legs, throat, chin and face. pt states Benadryl helps but new hives are still developing from Friday 10/7/22 through sunday 10/9/22. advised to contact PCP Monday morning
Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter has not yet contacted patients for follow up.
Information has been received from a physician concerning a 16 year old female student with hypersensitivity to Zithromax and a history of arthralgia due to allergic reaction to unspecified medications, who on 15-JUN-2007 was vaccinated IM with a first dose of Gardasil (lot #0469U). There was no concomitant medication. On 01-JUL-2007 the patient experienced "joint finger arthritis type pain," event to touch in both hands. On 10-JUL-2007, the patient recovered. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Shaking chills noted, today (12/4/2012 2:00 PM) some vague body ache without HA and light-headed feeling noted.
4 days p/DTP had 2 episodes high pitched cry assoc w/stiffening of neck x 30 sec, episodes 10 seconds apart; no tonic-clonic, no eye rolling (eyes closed) no post ictal sleep or flaccidity, no incontinence or cyanosis;
lt deltoid area & down to elbow & under arm to elbow is red, swollen & extremely warm starting on 19OCT93; pt went to MD & was told had an infect;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 07-FEB-2017 at 08:37, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Itchy rash over entire body (maculopapular)Rx: Orapred 2 1/2 tsp day one, 1 1/2 tsp qd days 2 thru 5, Bendryl 1 tsp q4-6hrs for 24 hours, oatmeal baths
rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.
Case number PHEH2012US015141 is an initial spontaneous report received from a nurse on 30 Jul 2012. This report refers to multiple patients whose identifiers were not reported. It was reported that on an unknown date the patients were intramuscularly vaccinated with MENVEO (batch number: not reported) that reached 31F for less than eight hours in Mat 2011. No adverse events were reported.
concerned that the taste of the newer ROTARIX  more infants" are spitting it out; concerned that the taste of the newer ROTARIX  more infants" are spitting it out; This non-serious case was reported by a other health professional via sales rep and described the occurrence of regurgitation of medication in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.  On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: concerned that the taste of the newer ROTARIX  more infants" are spitting it out) and accidental underdose (Verbatim: concerned that the taste of the newer ROTARIX  more infants" are spitting it out). The outcome of the regurgitation of medication and accidental underdose were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Oral Applicator Device.   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: 07-AUG-2023 The vaccine contract manager reported that customer reported concern about the taste of the newer Rotarix oral formulation. The customer stated that there might be changed flavors as more infants were spitting it out. No other information was provided. The infants split it out which led to regurgitation of medication and accidental underdoes. The reporter denied the consent to follow up.
Information has been received from a physician regarding a case in litigation concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23.  Subsequently the patient experienced an allergy to the vaccine which caused a rash and swelling in her arm.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Shoulder and arm pain x 15 days out of proportion to the common reaction. No sign of infection, allergy or weakness.
heart burn; chestburn; chest discomfort; Burning in throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heart burn), CHEST PAIN (chestburn), CHEST DISCOMFORT (chest discomfort) and THROAT IRRITATION (Burning in throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     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 DYSPEPSIA (heart burn), CHEST PAIN (chestburn), CHEST DISCOMFORT (chest discomfort) and THROAT IRRITATION (Burning in throat). At the time of the report, DYSPEPSIA (heart burn), CHEST PAIN (chestburn), CHEST DISCOMFORT (chest discomfort) and THROAT IRRITATION (Burning in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
Severe redness and swelling at injection site initiated at day 2 and continued for approximately 2 weeks before resolution. At day 12 a lesion appeared on her lower right extremity. Several more appeared and one grew to a rather large size, approx. 2&1/2 inches in diameter. As of current date (3/22/13) most lesions have resolved with some topical irritation remaining.
pt recvd vax 1FEB94 & 6FEB94 pt exp nausea, vomiting & fever; pt devel a body rash that was similar to hives; No further details were provided;
PT RECEIVED VACCINE ON 3/22/21 CAME BACK TO PHARMACY 3/25/21 WITH RASH ON FACE. RECOMMENDED PT GO TO DR TO HAVE EVALUATION. 3/29/2021 FOLLOWED UP WITH PATIENT. PT REPORTED HE WAS DIAGNOSED WITH SHINGLES AND TAKING ANTIVIRAL MED AS WELL AS CORTICOSTEROIDS FOR SHINGLES.  RASH WAS IMPROVING.
I got this involuntary movement of my neck and shuttering while seating; I got this involuntary movement of my neck and shuttering while seating; I was so tired; sleeping all the time; heaviness of my forehead; I can't seat properly; I can't talk properly.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 13Jul2021 12:07 as dose 1, single for COVID-19 immunization. Medical history included bronchial asthma, scoliosis, unstable angina, kidney stone in 2019 and dye contrast allergy. The patient's concomitant medications were not reported. The patient experienced involuntary movement of neck and shuttering while seating, almost 20 minutes after vaccination, on 13Jul2021. The patient was rushed to the hospital (emergency room) for these events and was administered medicines. The patient could not talk or sit properly on 13Jul2021. After 7 hours in emergency room, the patient was back to normal. On 18Jul2021, 5 days after vaccination, the patient was tired, sleeping all the time and felt heaviness of forehead. The patient underwent lab tests and procedures at hospital on 13Jul2021 which included CT scan, ECG, Chest x-ray and other blood test and all the results were normal. The patient was given a shot of medicines as treatment for involuntary movement of neck and shuttering while seating and the events caused hospitalization of the patient. The patient was scheduled to have an MRI (at the time of report). The outcome of the events involuntary movement of neck and shuttering while seating, could not talk or sit properly was recovered on 13Jul2021. The outcome of events tired and sleeping all the time was unknown. The outcome of events heaviness of forehead was not recovered.   Information about lot/batch number has been requested.