chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very similar to COVID/flu-ish feeling; tightness in the chest (noticed every breath); malaise; achiness; lack of interest; brain fogs; heart doesn't feel like before; just sits there and never done that before; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness) and EMOTIONAL POVERTY (lack of interest) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 antibody test positive on 22-Feb-2021.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness), EMOTIONAL POVERTY (lack of interest), FEELING ABNORMAL (brain fogs), FEELING ABNORMAL (heart doesn't feel like before), ABNORMAL BEHAVIOUR (just sits there and never done that before) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness), EMOTIONAL POVERTY (lack of interest), FEELING ABNORMAL (brain fogs), FEELING ABNORMAL (heart doesn't feel like before), ABNORMAL BEHAVIOUR (just sits there and never done that before) and FATIGUE (fatigue) 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.   Concomitant and treatment medication details were not provided.   This case was linked to MOD-2021-053819 (Patient Link).
Information has been received from a registered nurse, concerning a 21 year old female patient, with a penicillin allergy and drug hypersensitivity including a history of rash from penicillin and acetaminophen/propoxyphene (DARVOCET), irritation from miconazole (MONISTAT) and urticaria from neosporin, who on 28-MAR-2007, was vaccinated with the third dose of Gardasil (Lot #655324/0088U). There were no problems reported with administration of the first and second dose of Gardasil (dates not specified). There was no concomitant medication. On 28-MAR-2007, at the time of the IM vaccination in the left arm, the patient experienced burning at the injection site, and the needle was withdrawn after only 0.3ml had been administered. The nurse stated that after "a short wait," the remaining 0.2ml of the dose was administered into the right arm, and the patient again complained of the burning sensation. Shortly after the vaccination was completed in the right arm, the nurse confirmed the "burning sensation went away and the client recovered." Additional information has been requested.
pt recvd vax & 10 mins p/vax exp inc in BP; this increase resolved p/20 mins;
Information has been received from a licensed practitioner nurse concerning a 16 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 25-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL, lot # K023432, expiration date 18-JUN-2016; dose and route were not reported, which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Employee c/o continued pain at injection site with use (R) arm or when rolls onto during sleep. Awakens her at noc. Takes Ibuprofen 600mg QHS now to prevent. No induration, erythema, at site. Has full AROM (R) arm.
Patient noticed some of the vaccine that was injected drip down her arm.  Patient was concerned whether she received enough of the vaccine.  The pharmacist consulted with a peer and the pharmacy care manager and it was determined that since the dose was 0.25 ml that it would be appropriate to administer another 0.25 ml dose.
Patient states Immediately felt burning during the vaccine administration. and beliefs it was injected incorrectly. Vaccine was more like a subcutaneous 45 degree then a 90 degree intramuscular. 50mm X 30 circular perimeter at the injection site , deltoid region ,mild and tender but mostly itchy.  I told her to take anti-histamine and continues to monitor the site if it gets worse follow up with primary care.
No localized redness at site where shots were given. Eyelids swollen and lip swollen, no respiratory symptoms, note fever and bilateral leg tenderness around area of shots (3).
They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Concomitant medication was not provided.  The administration of under dose bivalent vaccine to patient for either their 1st or 2nd doses. The patient was between 6 months to 5 years. They received incorrect guidance and gave the pink top. This resulted in 24 patients being under vaccinated.  Patient was under vaccinated when the switch from monovalent to bivalent. Patient received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.   Treatment information was not provided.  This case contains information for the 6th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
This spontaneous report has been received from a pharmacist via a company representative concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unknown date, unspecified patients were vaccinated with ZOSTAVAX, (lot #, exp. date, strength, route of administration and dose were not provided). There was not concomitant medication reported. The pharmacist reported that an article in a magazine, summarized VAERS data that patients who received ZOSTAVAX may have a higher incidence, 2 to 2.7 percent risk of developing alopecia or arthritis, on an unknown date. At the reporting time, the outcome of alopecia or arthritis was not reported. The causal relationship of alopecia or arthritis to ZOSTAVAX was not reported. Additional information is not expected due the reporter did not want to be contacted.
- Chills: Only on Apr 6 - Fever: Apr 6-7 - Elevated resting heart rate: 110-145 bpm Apr 6, 80-125 bpm Apr 7 - Fatigue: Unable to do much Apr 6
Positive COVID test 17Sep2022; Positive COVID test 17Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B3 (ongoing); TYLENOL; IBUPROFEN. Past drug history included: Penicillin, reaction(s): "Allergy to Penicillin"; Sulfa, reaction(s): "Allergic to Sulfa". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Sep2022, outcome "unknown" and all described as "Positive COVID test 17Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient tested positive with minor symptoms, Patient received treatment for COVID-19 with ritonavir (Paxlovid), Lot/Batch number: 2815238, 150mg twice a day, started on 17Sep2022 and stop date was 21Sep2022 and Mucinex DM, started date was 17Sep2022 and stop date was 21Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Allergic reaction; allergic reaction which included / a red arm / red neck /  her reaction was "semi-bad" reaction; allergic reaction which included puffy eyes /  her reaction was "semi-bad" reaction; She never had Shingrix shot #2 / on 05-Jul-2018 she had the Shingrix shot #1; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 2 to 3 years before getting Shingrix shot).   On 5th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced allergic reaction, erythema of extremities, puffy eyes and incomplete course of vaccination. On an unknown date, the outcome of the allergic reaction, erythema of extremities, puffy eyes and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix. The reporter considered the erythema of extremities and puffy eyes to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself, but initial reporter was her husband who provided his email address. The age at vaccination was not applicable for 2nd dose of Shingrx The patient received 1st dose of Shingrix in arm (unknown) and she had an allergic reaction which included puffy eyes and a red neck and a red arm. According to the family physician her reaction was semi-bad reaction. The patient did not remember when the events were happened to her. It was implied that the red arm was the injected arm. Till the time of reporting, the patient did not receive 2nd dose, which led to Incomplete course of Vaccination. The reporter did not want to provide her physician contact information. The reporter did not consent to follow-up
Follow up with Employee health presented with a reddened edematous site of injection.  Documented fever associated with no other clinical symptoms.
5 days after receiving the first vaccine patients psoriasis flared up. Hands and feet were still itching at the time of this call (2/15/2021).
cough sour throat Pneumonia due to COVID-19 virus Severe sepsis secondary to COVID pneumonia Endorgan dysfunction:            Acute respiratory failure with hypoxia             Demand ischemia            Acute metabolic encephalopathy  Antibiotics
Pregnant; Initial Report Received on 22-Oct-2021  A pregnant female, over the age of 18 years, in the US (state, race and ethnicity not provided) reported to the pregnancy registry that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 16-Sep-2021, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) through an unknown route and site. The patient provided her last menstrual period as 11-Sep-2021.   At the time of the report, the patient was currently pregnant. The patient had gone to see her primary care physician (PCP) for a third vaccination and was advised during that visit that she would not be receiving another vaccination and requested she call the pregnancy registry. She had not yet seen an OB/GYN.  She declined participation in the registry and 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.
his tick started after vaccination; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (his tick started after vaccination) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Diabetes.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (his tick started after vaccination) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (his tick started after vaccination) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Cholesterol medicine, Medication for diabetes and Blood pressure medicine.  No treatment information was provided.
6/4/2018 SHINGRIX - Fever, nausea, severe pain and heat in left arm and left side, redness and swelling up to 6 inches diameter around injection site. Lasted for 5 days, now left with discoloration and nerve pain in upper left arm. Called doctor on 6/7/2018, told me to rest and take TYLENOL and not to get second dose. I was not initially told there was a second dose.
Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) 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 WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster).    No Concomitant medications were provided. It was reported that reporter found out that they could not give the Moderna as a booster starting 31 Aug 2022, but administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. and told that booster that patients received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.   No treatment medications were provided.
8 hours after receiving J&J vaccination, the patient experienced upper stomach pain that radiated into the chest area with an increase in HR to 160 and increase in BP to 220/160.  Patient was taken to ER where they treated increased HR and BP. ER found nothing wrong with EKG, enzymes, etc.  cardiac work up was unremarkable. Patient again had increase in HR to 165 and increase in BP 2 days later (March 16th) at 6pm with no warning.  This time extreme upper abdominal pain that radiated into the chest.  Patient again went ER and treated for high Heart rate and BP.  Patient was admitted to hospital for 2 days. .  3 weeks later again had episode of increased HR and BP with upper abdominal pain that resulted in ER visit.  was released again after treatment.
Only liquid portion administered; Only liquid portion administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA902A, expiry date 31-JAN-2024) for prophylaxis.   On 16-MAR-2023, the patient received the 1st dose of Menveo. On 16-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion administered) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Mar-2023 The patient received only the liquid portion of Menveo.  The reporter gave information about the vaccine and patient.  The reporter approved to receive follow-up Consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient only received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Red swollen arm w/i 24 hours. Seen 11 AM:      1" induration 3" redness at site of shot ,      lethargic, then vomited 1PM 5/5/07
vaccinated with a lot number that just expired 2 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that the patient was vaccinated with booster dose with a lot number that just expired 2 days ago. The date the vial initially stored in the refrigerator was reported as 09-Jul-2022. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was provided by the reporter.
p/vax inj arm started to feel hot & began to swell;in AM arm from shoulder to elbow & part of shoulder blade was 3X larger;redness present;devel achiness in legs & arms today;seen by MD advised DPH;
Had severe H/A, progressing to significant flu like symptoms on the evening the flu vaccine was administered. The next day began having palpitations and went to ED.
The pt was brought into the doctor's office on 02/21/2002 by her father who stated that she developed a "night fever" about 2-3 pm. Also stated that she was "burning up" and did not feel well. She had fever until the next afternoon.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
6-7PM temp rose to 104-pt had sz adm to hosp cont having elevate temp for 2 days;
I have extensive swelling on the right side of my face under my eye and next to my nose. I did have dermal fillers injected into my face in November 2021 in the area where I current have swelling.
Pt states that at 4 am on the morning of the 19th following vaccination on the 17th, she was woken up with an itching sensation with pink welts growing together on her upper body up to her neck and ears. By the time she got to the ER at 4:30 AM, the welts had spread to her hands and were in between her fingers. Pt also has asthma, which flared during this episode. The injection site at the left deltoid was also red and swollen per patient report and took more than 1 week in total to dissipate. Pt was seen in the ER on December 19th and given prednisone, which did resolve her symptoms. At 7 AM on the 19th, after getting home from the ER, the patient noticed blurry vision both with and without her glasses. This has improved, but pt still has residual blurry vision as of 1/11/2022.
Day 1 -  Pfizer booster shot at 2:00pm on 10/20/2021 Day 2 - Fever of 99.5, joint pain, sore arm, headache and fatigue started at 9:00am on Day 2.      Day 3 in AM - Fever and joint pain were gone and fatigue and headache seemed to be better that time.   Day 3 in PM - Around 1:00pm,  fatigue, lightheadedness, headaches came back and I had to lie down all day.  My blood pressure got lower to 68/52 as the lowest and and 93/63 as the highest that day.   Day 4-6  Pressured headaches as if someone squeezing upper part of my head,  forehead aches, eye strains,  fatigue, lightheaded and lower blood pressure average of 89/62 stayed on.  Day 7  I got Electrocardiogram which was normal.  My cardiologist lowered the dosage of Entresto to see if my symptoms get better hoping my blood pressure adjust to normal by reducing in half dosage of Entresto.      So far, my headaches and eye strains are present.    Contacted my neuro-ophthalmologist about my symptoms since I am recovering from Double Vision caused by microvascular 6th nerve palsy.   Day 8 -    My blood pressure is no more low as I am taking ½ dose of Entresto.   However, my headaches, forehead pain and eye strains are the same. Day 9- Echocardiogram is done and was no new evidence.  Day 10- Still headaches, forehead aches, lightheaded, eye strains continue.   MRI of brain, orbits and sinuses is scheduled.
Quarter sized swelling-around site. Tender to touch at center. Warm/heat with redness.