chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eczema on skin; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema on skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema on skin). At the time of the report, ECZEMA (Eczema on skin) outcome was unknown.            The concomitant medication were not reported. No treatment medication were reported.    Reporter did not allow further contact
got the flu shot and still got the flu; was sick for 3 weeks; Initial information was received on 31-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves Adult and unknown gender patient who stated got the flu shot and still got the flu and was sick for 3 weeks after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of events got the flu shot and still got the flu (influenza) and was sick for 3 weeks (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
HIVES STARTED ON DIAPER LINE AND IN 20 MINUTES WERE ALL OVER HER ARMS, LEGS AND STOMACH.
Redness and warmth with mild edema at injection site that is the size of a orange after 48 hours.  It slowly increased in size from time of injection.  Instructed the patients mother to apply hydrocortisone cream to site BID, cool packs, and take benadryl routinely every 6 hours while symtpms are present.  Denies any SOB.  Instructed mother to call if worsens and prednisone may be sent into pharmacy.  The mother is outlining the diameter of the redness.
Information has been received from a health professional concerning a 43 year old female with a history of varicella who on 12-DEC-2007, while administering a dose of varicella virus vaccine live (Oka/Merck), was splashed in the eye with the vaccine. It was reported that she removed her contact lens and flushed the eye with sterile saline. It was reported that she developed "irritation" on the day of the event. At the time of this report, she was no longer experiencing any complaints. It was indicated that the patient who was receiving the vaccine, did not receive the full dose. A product quality complaint was not reported. This case is closed. This is one of tow reports from the same source.
low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (low grade fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not provided by the reporter Treatment information were not provided.
Headache, Myalgia,  tennis elbow, fatigue  Narrative:  The employee complains of L elbow pain and discomfort which has worsened and continues after 4 weeks. The discomfort had radiated to his left hand and is causing weakness in his left hand.
1 cm cutaneous nodule, right deltoid area. Minimally tender without significant erythema or warmth. OTC BENADRYL, cool compress.
I developed a rash at the injection site 8 days following the injection. Approximately 2 by 3 inches in size, slightly warm,  minimal irritation. Applied a topical steroid only once. Gradually fading.
Immunization on 10-3-13. Pt reported fever of 101 degrees for next 3 days. (R) arm warm to touch, swollen blotchy red patches with areas of hardness under skin.
Pt started experiencing right arm soreness that was worse than normal. Pain is all around shoulder and back. Injection site is swollen.
Extreme increase in average blood pressure (ongoing and current). Approx. 120/75 to 150/105.  I was proscribed Lisinopril.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. On 07-APR-2015, the patient was inadvertently vaccinated with an expired dose of (Merck) VARIVAX dose and route were not reported (lot# was not provided, expiration date: 15-MAR-2015). No adverse effects reported. Additional information has been requested.
Developed hives 9 days s/p vaccine.  Continued hives now dx as Chronic Urticaria.  All other sources of reaction have been ruled out.
RESIDENT HAD RASH THAT WAS ON BODY AND HEAD  BOTH ARMS. RASH WAS RED AND ANGRY IN NATURE. ITCHING OCCURRING BEFORE RASH APPEAR
Information has been received from a female with no known drug allergies who was vaccinated with a 0.5 mL first dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced nausea and pain on injection site after getting the Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered from nausea and pain on injection site. Additional information is not expected.
Pt recvd vax & 24 hrs later exp hives, which subsided;
No adverse event; Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1 lot number AS1417B) on 23-Mar-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine.    On 11-Aug-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 11-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.
The day after the vaccination the patient described having redness around the injection site. Later in the day and into the next day the patient's arm was swollen, red and hot. The reaction did get better with time. But happened to 3 other people with the same lot number. Those forms to come.
suspected vaccination failure had vaccination got shingles/suspected vaccination failure; shingles; had vaccination was 10; strip in chest to backbone itch; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a child male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure had vaccination got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), itchy rash (Verbatim: strip in chest to backbone itch) and inappropriate age at vaccine administration (Verbatim: had vaccination was 10). The outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were not reported and the outcome of the itchy rash was recovered/resolved (duration 5 weeks).   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and itchy rash to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 07-MAR-2023 This case was reported by a patient's grandparent via interactive digital media. The patient had his shingles vaccination which was a school vaccination requirement. He was about 10 when he got the shingles and he had a strip that stretched from in front of his chest to the backbone. The reporter remembered him complaining about the itch, it lasted about five weeks and then it faded away. The patient received the shingles vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Information has been received from a pharmacist concerning a 70 year old with high cholesterol, high blood pressure and BPH. The patient was vaccinated with, .65 ml ZOSTAVAX (reported Lot# H011426; exp. 12-SEP-2013) on 25-SEP-2012. Concomitant medications included hydrochlorothiazide, potassium chloride, quinapril hydrochloride and finasteride. On 26-SEP-2012, the patient developed fever, malaise, and shingles on the upper chest and back on the left side. The patient was treated with acyclovir. At the time of this report the patient has not recovered. Additional information has been requested.
Sun 6/13 - moderate fatigue, elevated temperature, treatment none. Mon 6/14 - extreme fatigue, fever (no data), dizziness, headache, treatment ibuprofen. Tues 6/14 - extreme fatigue 103 degrees F fever, headache, treatment ibuprofen. Wed 6/15 - extreme fatigue, fever (no data), uncontrollable shivering, treatment ibuprofen. Thurs 6/16 - moderate fatigue, slight fever, headache, pain under left lung, treatment naproxon. Fri 6/17 - pressure in hand especially when moving eyes to extreme positions, neck stiffness, pain under left lung, treatment none.
pt exp rash over trunk & arms, vomiting for 3 days, stopped verbalizing
Nauseous, vomiting, headaches every day, weakness, light headedness, disoriented. No Treatment, still feeling this way
36 hours after vaccine, bilateral paresthesia of arms legs, hands, feet and tip of tongue.
This case involves adult patient (unknown age and gender) who had shoulder is a little sore (arthralgia) and a little soreness at the injection site (vaccination site pain), after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease, or risk factor. The patient's medical treatment, vaccination, concomitant medication, and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious shoulder is a little sore (arthralgia) and a little soreness at the injection site (vaccination site pain), (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Just got mine yesterday. Didn't even feel it go in. A little soreness at the injection site an hour later and my shoulder is a little sore today but no fever or any other symptoms at all. Plan on getting my coronavirus disease (covid) booster the last week of November. I've been fully vaccinated since March 25th". It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for the reported events. There will be no information available on the batch number for this case.
Information has been received from a physician concerning a 12 month old white male with no allergies or medical conditions who on 05/27/2004, at 11:00AM, was vaccinated in the right forearm with a first dose of varicella virus vaccine live.  Concomitant therapy included a dose of measles vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no illness at the time of vaccination.  It was reported that it was given intradermally by accident.  The syringe was withdrawn and the patient only received about 0.1ml of vaccine.  It was reported that the child developed a wheal, induration and erythema at the injection site.  Medical attention was sought but no treatment was required.  No product quality complaint was involved.  Follow up information from the physician indicated that the patient had mild induration and erythema 5mm in diameter that appeared 15 minutes and resolved completely after 2 hours.  No medication was given and no labs were done.  Conflicting information indicated that the vaccine was given subcutaneously.  Additional information is not expected.
Pt recvd 1st dose of Hep B (recomb) in SEP90 for a needle stick injury; In OCT90 pt was vaxed w/2nd dose & deve acne & was found to have elevated liver function tests;
Initial unsolicited report received from a consumer on 06-MAY-2015.  A female patient (age not provided), whose medical history and concomitant medications were not reported had received a dose of INFLUENZA (dose details, batch number, route of administration and site of administration were not reported) on an unspecified date in the year 2015.  On an unspecified date in the year 2015 after vaccination, the patient had developed flu twice. Laboratory investigations and corrective treatments were not provided. At the time of this report, the outcome was unknown. Documents held by sender: none.
Pain, hard knot of skin, red welts around an area of bright red rash, very warm to touch.
Updated AE: 17 year old received Second Shot; Dizzy after Second Dose; Body felt warm  (Fever not measured) after Second Dose; Chills after Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Updated AE: 17 year old received Second Shot), DIZZINESS (Dizzy after Second Dose), FEELING HOT (Body felt warm  (Fever not measured) after Second Dose) and CHILLS (Chills after Second Dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], ALBUTEROL SULFATE and VENLAFAXINE for an unknown indication.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Updated AE: 17 year old received Second Shot), DIZZINESS (Dizzy after Second Dose), FEELING HOT (Body felt warm  (Fever not measured) after Second Dose) and CHILLS (Chills after Second Dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Updated AE: 17 year old received Second Shot) had resolved. At the time of the report, DIZZINESS (Dizzy after Second Dose), FEELING HOT (Body felt warm  (Fever not measured) after Second Dose) and CHILLS (Chills after Second Dose) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-250209 (Patient Link).
first 3 days arm sore. Next 2 days, nothing. 6th. day redness, itching , size 3 by 3 patch. Soreness to touch.  7th. day larger, redness, warm, itching. Each day growing in size . Today Feb. 18, 2021 the rash is 5 inches wide and 9 inches long. Warm, pink, itching, sore to touch moderate.
Info has been received from a nurse practitioner concerning an adult female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641116/1160L). Subsequently, the pt developed redness and swelling. The pt was treated with warm compress, acetaminophen (TYLENOL), and diphenhydramine HCl (BENADRYL). The nurse indicated that she would like a lot check performed on lot #641116/1160L. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was reported that 4 other adult females (WAES #0210USA02724, 0210USA02963, 0303USA02211 and 0306USA02761) and a male (WAES #0303USA02104) had a similar experience. No additional info is expected.
Rcv'd flu shot, L arm hurt. Tounge felt heavy. Back of mouth & throat felt numb. 3pm, to Osteopathic ER. Allergic rxn, Benadryl 50mg. Swelling dec. 10/21 cold symptoms, vomiting, sore throat. 10/27 cold symp still exist, hives in throat.
Only a sore arm after the first dose; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (12Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 37-year-old female consumer (patient) received bnt162b2, dose 1 via an unspecified route of administration, administered in arm left on 24Jan2021 at 12:00 (Batch/Lot Number: EL9262) as single for COVID-19 immunisation in hospital. The patient medical history and concomitant medications were not reported. The patient previously took MMR vaccine and experienced facial swelling and blotches on her face. The patient experienced only a sore arm after the first dose on Jan2021. The patient reported that she had bad reaction to an MMR vaccine in 1999 that resulted in facial swelling and blotches on her face. When she was admitted to the hospital, the MD told her to never receive a flu vaccine because she had "a bad reaction to eggs" in her history. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Narrative:  Patient with breakthrough covid infection. 2 doses of pfizer covid vaccine given previously. treated with monoclonal antibody.
Face and hands, feet swelling, redness, hives, itching, SOB, tachycardia PR - 110, BP - 148/98.
Swollen, reddened area around injection site of left thigh. Also, fever and diarrhea.
This spontaneous report was received from a male pharmacist of unknown age, reporting on himself. On an unknown date, while administrating ZOSTAVAX (19400 PFU, lot # L040445 and expiry:15-JAN-2017) to an unknown patient, the pharmacist had a difficult time withdrawing a needle and some of the vaccine got on to his cheekbone and face. The pharmacist did not think that the vaccine got into his eye. He washed his face and wiped the area with alcohol wipes. Later, the patient did receive the full dose of ZOSTAVAX. No adverse effects and no product quality complaint (PQC) reported. No further information provided. Additional information has been requested.
No additional AE information.; incorrect product storage; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S027465, 0.5 milliliter, expiration date 02-MAR-2021, orally for prophylaxis.     Since 01-NOV-2020, the Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) was exposed to multiple excursions that acumulate 2 hrs. There was no adverse event.  Digital data logger: yes.  This is one ov several reports from the same reporter; Sender's Comments:  US-009507513-2103USA001343: US-009507513-2103USA001024: US-009507513-2103USA001252:
Pediatric patient received second dose before the recommended time range after first dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pediatric patient received second dose before the recommended time range after first dose). No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.