chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red became itchy; Saw colors like a Kaleidoscope and fell; Redness; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHROMATOPSIA (Saw colors like a Kaleidoscope and fell), PRURITUS (Red became itchy), ERYTHEMA (Redness) and PAIN IN EXTREMITY (Sore arm at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ERYTHEMA (Redness) and PAIN IN EXTREMITY (Sore arm at the injection site). On 20-Jan-2021, the patient experienced DYSCHROMATOPSIA (Saw colors like a Kaleidoscope and fell). On 22-Jan-2021, the patient experienced PRURITUS (Red became itchy). On 22-Jan-2021, PAIN IN EXTREMITY (Sore arm at the injection site) had resolved. On 29-Jan-2021, DYSCHROMATOPSIA (Saw colors like a Kaleidoscope and fell) had resolved. At the time of the report, PRURITUS (Red became itchy) outcome was unknown and ERYTHEMA (Redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Poison ivy cream on the itch.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI
2 weeks after getting 2nd COVID vaccine shot I had pain moving left arm. By March 2021 it had progressed to where I could not move arm behind back (to remove bra, to tuck in shirt, to remove arm from sleeve). Could not stretch left arm to reach for items on the bottom refrigerator shelf, on the back car seat, behind me. Could not use left arm to scratch outside of right arm/shoulder.  Could not sleep on my left side. All these symptoms are still issues. I have gone to Physical Therapy and Massage for months and have not had relief. I have also tried heat/ice.
A hard knot  the size of a lime with a mild bruise in the middle developed with itchy red welts in an arc under the knot. The area was hot to the touch. While very itchy, it did not hurt. This knot and rash was at the location the shot was administered.
3/31 Headache, chills. 4/1 pain at site, chills, bodyaches, runny nose with(congestion), sneezing, heaviness in chest and coughing (congestion),  lack of energy. 4/2 all symptoms starting to subside. 4/3 almost all symptoms gone except, heaviness in chest and urge to cough. 4/4 all symptoms gone, except heaviness in chest and urge to cough (less prominent). 4/5 heaviness and urge to cough (slight). 4/6 very slight heaviness and very slight urge to cough.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: tested positive again two days later; (May2022) Positive, notes: testing positive since with increasingly severe symptoms. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical Course previously Paxlovid was taken for covid-19 and  recovered after taking Paxlovid, then tested positive again two days later and have been testing positive since with increasingly severe symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 5 mins of FLUZONE RA admin, pt. "felt clammy"; pt. was pale in face with visible diaphoresis; after 2-3 mins, pt. continued to complain of blurred vision and light headedness. Resolved in approx 15 mins after pt. supine with legs elevated pt. able to stand/ambulate without dizziness and subsequently left pharmacy on own accord.
Received the 1st Dose of Heplisav-B at 23 Weeks; Initial Report Received on 22-Oct-2021  A pregnant 30 year-old female (race and ethnicity not provided) reported that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at 23 weeks pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 24-Sep-2021, at 23 weeks of pregnancy, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) from a pharmacist.   On 22-Oct-2021, at 27 weeks gestation, the patient went back to receive her second dose of HEPLISAV-B but was informed by her pharmacist that it was not recommended for pregnant women.  The patient had the pharmacy send her documentation to her physician and had not spoken with her physician about this yet.  The patient's due date is 16-Jan-2022. She did not report any adverse reactions.   On 22-Oct-2021, the patient contacted the pregnancy registry but was not interested in enrolling since she was enrolling into another trial. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
"had a allergy to" the Pfizer-BioNTech COVID-19; "swelling" and redness at the injection site; "swelling" and redness at the injection site; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 66-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route in the right arm on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a allergy to the Pfizer-BioNTech COVID-19 vaccine. He experienced "swelling" and redness at the injection site, after the receipt of the first dose in the right arm. He specified it was red where the needle was inserted and it got a little big, as the size of a penny. He added it lasted 9 days and it not inapparent now. He asked if he could receive the second dose of the vaccine after reacting to the first dose. The clinical outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Febrile convulsion reported on 1/3/03 per father. Admitted to hospital on 12/31/02. Fever 104, febrile seizure with temperature. Fever until 1/3/03. Discharged 1/4/03. Otitis media, croup.
Vaccine #3 given on 3/4. resulting in extreme pain x 3.5 months and counting.  Swelling from neck and down arm, Rash L arm. Underarm swelling bilat. Now DX of frozen shoulder. No Pain or issues in L arm prior to vaccine. Lost work days as sole supporter of family this hurts. Currently dealing with neck, back, and arm pain from vaccine. Injection site pain present also. Disturbed sleep. Pain so intense I am unable to lay down for many hours every night. currently getting about 2-4 hours before pain gets me up
Redness, swelling, rash raditaing from site area of inject up & down arm; pt took DPH & the sx subsided;
Myalgia, Urticaria, Pruritus and chills, shortness of breath.
Skin around injection site has visible redness even though it's been 2 weeks since injection.
(R) upper arm reddened & swollen. Pain with light palpation. No fever. Children's ADVIL recommended.
Chronic headaches, neck pain, high blood pressure. Started blood pressure meds yesterday headaches remain chronic
Pt presented on 03/20/2004 with 3 erythematous nodules around 3-4 cm in diameter, each capped with small umbilicated pustule. Pt states they began around 4 days ago and are now tender and itchy. One is few cm away from SPV site, one on torso and one on L leg. There is also erythema/scale around SPV site c/w contact dermatitis from Band-aid. Pt diagnosed with inadvertent innoculation and treated with Naprosyn and Allegra.
headache, nausea, light headed, swelling of the hands Patient was given 1000mg of acetaminophen and 25mg diphenhydramine. Patient was monitored for 60 minutes.
Hives on left arm and lower chest area; Hives on left arm and lower chest area; A spontaneous report was received from a consumer concerning a 65-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on left arm (vaccination site urticaria) and lower chest area (urticaria).  The patient's medical history was not provided. Concomitant medications were not provided by reporter.  On 8 Feb 2021, the patient received their planned dose of mRNA-1273 (Batch number: 007M20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 10 Feb 2021, reporter stated he developed hives on left arm (injection site) and lower left chest area. Treatment information not provided. Lab tests not provided.  Action taken with response to mRNA-1273 was not reported.  The outcome of the events, hives on left arm and lower chest area was considered unknown.
pt recvd vax 12N 27MAY92 & reported t105-106 evening of 27MAY; spoke w/mom 28MAY; t103 evening of 28MAY had coughing, flexing arms, ?cyanosis & rushed to ER; ? of febrile seizure; @ time of peds eval pt stable;
most painful vaccine, left is so very sore, hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: most painful vaccine, left is so very sore, hurts). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had shingles, it was the most painful vaccine he/she ever had. The patient was worried about the 2nd dose after 6 months, as he/she would have the same or deal again.  Until now the left was so very sore. It hurts. The follow-up could not be possible as no contact details were available.
Patient received 5 doses of the Janssen vaccine instead of 1 dose. This is an administration error. Follow up was done with patient, patient displays no severe symptoms from vaccine except mild fever. Patient is in good health.
no adverse effects reported; VARlVAX that was improperly stored was administered on 7/20/2020 to a patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 20-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S035126, expiration date 04-NOV-2021 (formulation, strength, exact dose and route of administration were not reported) for prophylaxis (product storage error). No adverse effects were reported. The temperature excursion was -11.8 degrees Celsius for 3 hours and 52 minutes. There was no previous temperature excursion recorded. A data logger was involved in recording the temperature.
Expired Moderna was administered on 11/19/2021 lot# 046C21A. Patient was called back to the clinic and vital signs were taken and were WNL. Patient showed no s/s of any distress and when asked he states no s/s. Provider was notified and also Moderna manufacture and they will update with guidelines.
This spontaneous report as received from a physician refers to a 59 year old female patient. The patient's pertinent medical history included back pain and allergy to penicillin. On 14-FEB-2015, the patient was vaccinated with ZOSTAVAX lot # K018172, expiration date: 02-DEC-2015, 0.65 ml, subcutaneous for routine vaccination. Concomitant therapies included MEDROL. On 15-FEB-2015, less than 24 hours after receiving ZOSTAVAX, the patient developed an injection-site rash. The rash was described as painful, red, and slightly indurated. The patient did not received any treatment for the adverse event and no lab diagnostics studies were performed. The patient sought medical attention by contacted physician. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
vial was stored in refrigerator on 28-Dec-2022 and was administered on 31-jan-2023; No adverse event; patient received an expired 2nd primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired 2nd primary dose), PRODUCT STORAGE ERROR (vial was stored in refrigerator on 28-Dec-2022 and was administered on 31-jan-2023) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired 2nd primary dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in refrigerator on 28-Dec-2022 and was administered on 31-jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired 2nd primary dose), PRODUCT STORAGE ERROR (vial was stored in refrigerator on 28-Dec-2022 and was administered on 31-jan-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired 2nd primary dose) and PRODUCT STORAGE ERROR (vial was stored in refrigerator on 28-Dec-2022 and was administered on 31-jan-2023).    No concomitant medications were reported. The vial was initially stored in the refrigerator was 28-Dec-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
flu like symptoms; peeing terribly; body aches; bad fatigue that she hardly get up; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), POLLAKIURIA (peeing terribly), MYALGIA (body aches) and FATIGUE (bad fatigue that she hardly get up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METHOTREXATE, FOLIC ACID and AMLODIPINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), POLLAKIURIA (peeing terribly), MYALGIA (body aches) and FATIGUE (bad fatigue that she hardly get up). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), POLLAKIURIA (peeing terribly), MYALGIA (body aches) and FATIGUE (bad fatigue that she hardly get up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient was admitted to the hospital on 4/5/2021 for severe AKI with hyperkalemia. Patient had a prolonged hospital course due to kidney failure and AIDS. The patient developed acute respiratory failure on 5/1/21 and was transferred to the ICU, where he was found to be in septic shock. Patient passed away on 5/4/21 at 9:59am
4FEB94 dry heaves-very bad-nausea; evening time only; 6FEB94 dry heaves-less severe;
My skin is sensitive to the touch, I am achy and my joints feel inflamed. I started this reporting because I noticed that my supraclavicular lymph nodes were swollen (bilaterally) and painful to the touch (also bilaterally). My joints didn't hurt as bad yesterday, and my skin didn't feel the way it does today.
70 doses of PfizerCovid Vaccine for pediatric patients (orange cap) Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
PATIENT PRESENTS TO COVID SITE FOR COVID VACCINATION. PATIENT'S PFIZER FORM INDICATES A FIRST DOSE NEEDED AND NO DOSE PREVIOUSLY GIVEN. PATIENT IS ADMINISTERED ONE PFIZER VACCINE LOT # EL9269 EXP 5/21 IN R DELTOID. UPON ENTRY INTO TENNIIS, IT IS DISCOVERED THAT THE PATIENT HAD IN FACT RECEIVED A FIRST DOSE OF MODERNA VACCINE LOT# 011J20A ON 1/11/21.
States not feeling well 1-2 days after IZ. On 1/21/02 PM, left arm sore, red and warm. Stayed off work Monday through Wednesday complaining of eyes red and swollen, light-headed also. The size of the area was 2" X 3 1/2" which was raised, reddened, slightly hardened on 1/25/02. No complaints of fever. Back to work on 1/25/02.
high pitch cry p/shot; trembling of the arms-hands-legs-head-tongue then a total inc of movement in pt;
THE PATIENT JUST COLLAPSED ABOUT 5 MINUTES AFTER THE SHOT BUT HE WAS CONSCIOUS AND WAS ABLE TO ANSWER ALL THE QUESTIONS. WE CALLED 911 AND 911 TOOK HIM TO THE HOSPITAL
Very weak and dazed again; Headache; Muscle pain in legs; Joint pain in legs; I felt itching at the injection site; The site was also somewhat red at first; Tired; Weak/very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/very weak), FEELING ABNORMAL (Very weak and dazed again), VACCINATION SITE PRURITUS (I felt itching at the injection site), VACCINATION SITE ERYTHEMA (The site was also somewhat red at first) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On 26-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced ASTHENIA (Weak/very weak) and FATIGUE (Tired). On 28-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (I felt itching at the injection site) and VACCINATION SITE ERYTHEMA (The site was also somewhat red at first). On 30-Jul-2021, the patient experienced FEELING ABNORMAL (Very weak and dazed again), HEADACHE (Headache), MYALGIA (Muscle pain in legs) and ARTHRALGIA (Joint pain in legs). At the time of the report, ASTHENIA (Weak/very weak), FEELING ABNORMAL (Very weak and dazed again), VACCINATION SITE PRURITUS (I felt itching at the injection site), VACCINATION SITE ERYTHEMA (The site was also somewhat red at first), HEADACHE (Headache), MYALGIA (Muscle pain in legs), FATIGUE (Tired) and ARTHRALGIA (Joint pain in legs) outcome was unknown.  No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated.
Information has been received from a physician her 23 year old daughter who in December 2006, was vaccinated with a first dose of Gardasil. On 18-DEC-2006, following the vaccination, the patient developed paraesthesia from the shoulder to elbow. On approximately 25-DEC-2006 the patient recovered. In February 2007, the patient was vaccinated with a second dose of Gardasil. On 14-FEB-2007, following the vaccination, the patient developed paraesthesia from the shoulder to elbow. On approximately 21-FEB-2007, the patient recovered. No further information is available.
This spontaneous report was received from a 31-year-old female patient reporting on herself. The patient had no pertinent medical history and drug reactions or allergies. On an unknown dates, reported as "few years ago, maybe 2011 or 2012", the patient received series of all three doses of GARDASIL for prevention from human papilloma virus (HPV) (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included NUVARING. On 06-APR-2017, the patient was diagnosed with an unspecified HPV infection. She was treated on 06-APR-2017 by the physician and would need to follow up with the physician in two weeks. No lab diagnostic studies were performed. The outcome of the event and the relatedness between the event and GARDASIL were not reported. Additional information has been requested.
pt recvd vax;apap given rt p/vax;2pm t elevated;apap given,t came down;t up again,did not respond to apap;would sleep only short period of time;moaned when not asleep;twitching & shaking;ofc visit;tx ATB;?tonsillitis;cont apap,ATB;improved
I have had Diarrhea since 10 pm Saturday, March 20, 2021.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Sick). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Ache, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Ache, at a dose of 1 dosage form. At the time of the report, ILLNESS (Sick), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Treatment medication added, event added.
pt recvd vax; fever 104 R less than 12 hrs p/ tetramune;also irritable w/ sl dec appetite; similar sxs w/out fever noted p/ 1st tetramune;