chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects were worse after the 2nd dose; She was unable to move due to the pain; Pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (She was unable to move due to the pain), VACCINATION COMPLICATION (side effects were worse after the 2nd dose) and MYALGIA (Pain all over body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036821A) for COVID-19 vaccination.     The patient's past medical history included Radiotherapy (radiation treatment). Concurrent medical conditions included Cancer and Asthma. Concomitant products included GABAPENTIN and VERAPAMIL for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOBILITY DECREASED (She was unable to move due to the pain). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects were worse after the 2nd dose) and MYALGIA (Pain all over body). At the time of the report, MOBILITY DECREASED (She was unable to move due to the pain) had not resolved and VACCINATION COMPLICATION (side effects were worse after the 2nd dose) and MYALGIA (Pain all over body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Patient stated that the pain has continued for three weeks after the administration of the 2nd dose. She also stated that the side effects were worse after the 2nd dose of the Moderna COVID-19 vaccine. She is scheduled to go to the hospital on Monday, 3May2021, for her cancer condition. She wanted to know if her underlying conditions and radiation treatments exacerbate the pain experienced after taking the Moderna COVID-19 vaccine and whether she get COVID-19 after receiving the vaccine   This case was linked to MOD-2021-095188 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information TCR received on 28-MAY-2021, patient declined further follow up and stated that she felt Moderna vaccine did a lot of permanent damage to a lot of people.
Dizziness,fatigue, shaky. 10/22/2009 - Same symptoms but worse, visited urgent care, blood tests all normal.  10/23/2009 - ER, same symptoms with loss of appetite and weight loss-did xray, blood work, ct scan - all normal.  11/07/2009 - Dizziness and shakes gone.  Fatigue better but energy level still not as good as pre-vaccine. Still have reduced appetite.
Moderna COVID-19 vaccine EUA  sore arm, fever 101.1, chills, body aches, fatigue.
Several hours after receiving this vaccine I started with severe pain in my legs.  They hurt to the point where I had trouble walking on them and the pain continued and has yet to fully go away.  It has been 15 months and I am still having effects from it. Prior to getting this vaccine I was walking 3+ miles daily and I felt great.  Ever since getting this vaccine I haven't been the same. Besides the pain in my legs, I also feel short of breath and winded doing certain tasks.
Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022; No adverse event; Approximately 50 doses administered after 30-day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Approximately 50 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Approximately 50 doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Approximately 50 doses administered after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Approximately 50 doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 08-Aug-2022).    No concomitant medications was reported.  The reporter mentioned that, they administered approximately 50 doses of Moderna COVID-19 Vaccine after 30-day use by date and also informed that, vials were initially stored in the fridge on 08-Jul-2022.   The reporter was not aware of any symptoms for the patient after the vaccine received.  No treatment drug details was reported.
SINUS HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was prone to sinus headaches.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sinus headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sinus headache was not reported. This report was non-serious.
Small red raised "pimples" x 10 on upper back, between shoulder blades. Now larger in size ( papular) Now also with 2 papules/ vesicles on back of right hand between finger and thumb and 1 papule between eyes. 1 Papule/ vesicle on abdomen. States appears pruritic and "looks like chicken pox" no fever or other systemic s/s.
HEART ATTACK; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and concurrent conditions included: G6PD (glucose-6-phosphate-dehydrogenase deficiency), and other pre-existing medical conditions included: Patient was not on any medication before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in AUG-2021, the patient experienced heart attack. Patient reported that it was second heart attack and it was almost an occluded artery. Patient was taking blood thinner and other medications (total 3).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220219093-JANSSEN COVID-19 VACCINE Ad26.COV2.S- HEART ATTACK. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Ancillary health issues; Had COVID; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Ancillary health issues) and COVID-19 (Had COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 ILLNESS (Ancillary health issues) and COVID-19 (Had COVID). At the time of the report, ILLNESS (Ancillary health issues) and COVID-19 (Had COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were  reported.  Patient received monoclonal antibodies 60 days ago as he had COVID and some ancillary health issues.  Company comment: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 and unspecified ancillary health issues. The events Covid-19 and unspecified ancillary health issues occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Patient received monoclonal antibodies for treatment of Covid-19. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 and unspecified ancillary health issues. The events Covid-19 and unspecified ancillary health issues occurrence unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. Patient received monoclonal antibodies for treatment of Covid-19. The outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Heaviness in arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heaviness in arm) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced LIMB DISCOMFORT (Heaviness in arm). On 18-Mar-2021, LIMB DISCOMFORT (Heaviness in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. The patient did not receive any treatment.
First COVID-19 vaccine: arm was really, really painful; This is a spontaneous report from a contactable consumer. This 76-Year-old  female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via Intramuscular route of administration on 14Jan2021 (at 76-years old) on left arm, as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant products included thyroid pills. No further details provided or obtained regarding this statement. On 14Jan2021 15 minutes after the first vaccine her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. On 15Jan2021 the patient recovered. It was mentioned that the caller declined to include a healthcare professional for this report. It was attempted to gather product information for the first and second vaccine, but caller stated that she could not read the writing.   There was a product complaint: The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain.  Information on the lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Within a few minutes of 1st dose of vaccine I felt a sudden increase in HR - resolved on its own within 10 - 15 minutes; This is a spontaneous report from a contactable nurse (patient). A 47-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at left arm, on 19Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included myasthenia gravis, allergy to IV contrast used for CT scans. Concomitant medication included pyridostigmine bromide (MESTINON), melatonin, ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within a few minutes of the vaccine, on 19Dec2020 13:00, the patient felt a sudden increase in heart rate (HR) and resolved on its own within 10 to 15 minutes on 19Dec2020. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
inadvertently administered Fluzone QIV Np instead of the intended Fluzone High Dose QIV to a patient who is over 65 years old with no reported adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 75 years old male patient who was inadvertently administered fluzone qiv np instead of the intended fluzone high dose qiv to a patient who is over 65 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine, Suspension for injection lot UT8076MA via unknown route in the left deltoid for immunization (strength, expiry date: unknown),  inadvertently administered fluzone qiv np instead of the intended fluzone high dose qiv to a patient who is over 65 years old with no reported adverse event (wrong product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event wrong product administered  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After 1st dose: extreme arm soreness, felt very heavy, that was all  After 2n dose: 2 hours after shot, heartrate spiked, over 120 bpm, dizziness, lightheaded, sent home from work. Happened for 2 days, was not resolving. For a week after, had migraines and sensation of heart beating in head. Threw up several times (dizziness and pain), made head pain even worse. Just stayed in bed taking Ibuprofen.   Found out July 24th (went to ER for dizzy and extreme sweating, nausea). Initially, they believed I had a stroke, but did not find stroke found a 3 mm aneurism on left side of brain. No issues with arteries found. All blood work was good, there was no indication of heart problems or any other things that would normally cause an aneurism. Going to neurosurgeon for brain surgery soon.
Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20
Presented to the ED c/o weakness; admitted for recurrent UGI bleed & hypotension, COVID-19+ finding but asymptomatic
Narrative: Nursing home Emergency Room, CHF, dialysis, d/c back to nursing home, Covid+, moderna +3
Bell's Palsy, treated with Valtrex 1 g x 10 days & Prednisone 50 mg x 5 days, incomplete recovery as of 12/17/2021
Syncopal reaction-she passed out while standing about 5 min. after receiving vaccine.  She came back to within 1-2 min but was confused for a few minutes and then could recall what happened and how she felt just prior to passing out.  For about 15 minutes after awakening, she was clammy and pale.  We kept her for 30 min. and then she felt well enough to leave but was with her husband.
Chicken Pox vaccine. Large red bump appeared at injection site 15 days after vaccination. Tiny red bumps in the middle of back. Complaining that her back was "itchy."
Lt deltoid - meningitis shot MENVEO given swollen, 8 cm round area of erythema warm to touch - x 3 days.
Patient received monovalent vaccine as booster dose, when the bivalent booster vaccine should have been administered.
I experienced generalized urticaria starting about 2 weeks after my moderna bivalent booster shot (December 31st). The most affected areas were my face, chest, back, neck and arms. The hives were present all the time but were occasionally very severe. I took benadryl to treat them, then on January 10th I went to a dermatologist. He suggested the hives might be related to my booster shot and told me that several of his patients have had a similar reaction. I continued to manage the hives by taking over the counter claritin and zyrtec 4-6 times per day. I still have hives but they are much less severe and I have gradually cut back on the amount of antihistamines I'm taking to manage them.
diarrhea; This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 7 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but selected as an adult as per vaccine indication. The reporter did not consent to follow up.
cold-like symptoms; sniffling; coughing; when she inhales her chest hurts a little bit; sneezing; body aches; tired; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 30Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cold-like symptoms, sniffling, coughing, sneezing, does not have a fever. She also added that even when she inhales her chest hurts a little bit, she has slight body aches and was tired. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20May2021. Patient was asking whether to get the 2nd dose while having cold-like symptoms as scheduled on 21May2021. Reporter seriousness for cold-like symptoms was unspecified. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information is expected.
Patient had rash and itchiness around the face and neck later in the day.  Patient called the PCP and went strait to the Emergency Department per PCP recommendation where she received prednisone and diphenhydramine.  on 4/30, patient's rash was still not resolved and still had itching.  PCP prescribed hydroxyzine. At no time did patient have shortness of breath per PCP.  Patient was advised to go to the ER if she develops shortness of breath.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 25th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 26th September 2018, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. After receiving SHINGRIX, the patient experienced pain at the injection site on the same day. The next day her injection site was red and warm. This case has been linked with the case US2018182664 (patient's husband), reported by same reporter.
2 yo child developed fever 101, increased warmth @ inject site,pain in joints, infantile spasms, paresthesias, screaming episode & refusal to walk /p immun., 3 days later, enlarged lymph node, recovered 9 days
Knot in the injection site; Red mark on the injection site; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red mark on the injection site), VACCINATION SITE INDURATION (Knot in the injection site) and FATIGUE (Feeling tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red mark on the injection site), VACCINATION SITE INDURATION (Knot in the injection site) and FATIGUE (Feeling tired). At the time of the report, VACCINATION SITE ERYTHEMA (Red mark on the injection site), VACCINATION SITE INDURATION (Knot in the injection site) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.