chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Simply tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Simply tired) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Simply tired). At the time of the report, FATIGUE (Simply tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old male patient who received HBV (Engerix B pediatric) (batch number 25n39, expiry date 16th March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th December 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 7th December 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient inadvertently administered pediatric dose of Engerix-B instead of an adult dose, which led to underdose and adult use of a child product.
Arm pain, all over music pain, dizziness, fatigue, fever, headache. Tylenol was sufficient in treating the symptoms, symptoms lasted about 1.5 days
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
Patient complains vaccinated arm is sore and swollen at and around injection site.  Advised him to take naproxen or ibuprofen and I would follow up this afternoon to inquire about condition of arm.
EXTREMELY LARGE  BRUISE 5 INCH LONG ON FOREARM; BUMP NODULE PEA SIZE; CRAMPING IN LEGS; SORE ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 09-JUL-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure, benazepril for blood pressure, and metformin for diabetes. On 25-JUN-2021, the subject experienced extremely large bruise 5 inch long on forearm. On 25-JUN-2021, the subject experienced bump nodule pea size. On 25-JUN-2021, the subject experienced cramping in legs. On 25-JUN-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extremely large bruise 5 inch long on forearm, bump nodule pea size, sore arm, and cramping in legs. This report was non-serious.
Symptoms started on 10/18/21: cough, chest tightness, fever, headache, earache, body aches.
No adverse event; bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) in an elderly male patient 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 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 05-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (bivalent vaccine administered on 5OCT2022, however it was administered as a dose of 0.25mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    Concomitant drugs were not reported. It was reported that patient was in 70s and have had 4 doses of Moderna COVID-19 vaccines. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-680188 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680188:Case for Wife
30 yo male with <24 hour admission on 5/9/2012 at clinic for increasing myalgias and loss of motor control in fingers/hands. The clinic was contacted my Internal Medicine at another clinic during patient's discharge re VAERS. History by an employee. This patient began developing symptoms the day following receipt of the yellow fever immunization, dose #2, on 4/30/2012. Over the next 10 days his symptoms progressed from mild to severe when he presented to clinic on 5/9 and c/o general muscle fatigue, motor weakness and paresthesias of hands and left foot. He was struggling with ADL's such as getting out of bed, buttoning clothing and putting children into car seats. He had a headache the first few days that resolved. No N, V, fever, chills, rash, cognitive changes, back or abdominal pain, or previous illness. Treated with fluids in ED with near complete recovery in 1 day. LP wnl.
This is the 2nd dose of this vaccine that I have received. These are the side effects I had -fever, chills, nausea, severe pain in arm radiating to shoulder, diarrhea, lethargic, unable to do any normal activities. All of these symptoms lasted for two days except for the diarrhea, I only experienced that for one day.  I currently still have the pain in my arm but it is not as intense. This is 3 days after the vaccine.  I also experienced similar symptoms with the first dose of this vaccine with the exception of the diarrhea.    I found out that the effectiveness of this vaccine is only for 5 years. I will not get a booster for this vaccine unless the manufacturers improve this vaccine so that there are minimal side effects associated with it. I have all my vaccines and have never had such an adverse effect as with this Shingrix vaccine.
Information has been received from a mother, who is a registered nurse, concerning her 15 month old son with no allergies or medical history who on 8/27/04 was vaccinated SC with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant vaccinations included MMR (lot # 648462/0044P) given SC. On 9/12/04 the patient developed 2 red lesions that looked like bug bites on his hip and stomach. The next day, the rash was covering his belly and back and appeared like white pustules. It was estimated that he had approximately 100 lesions. He was afebrile. The patient's mother talked to the pediatrician via phone and no interventions were noted. It was reported that the patient as recovering. There was no product quality complaint involved. Additional information has been requested.
laryngitis; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 25Feb2021 (at the age of 66-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported) for COVID-19 Immunisation. After the first dose Patient had some weird symptoms and had a very negative reaction to 1st dose. The patient medical history and concomitant medications were not reported. 2 weeks after vaccination, patient stated her coworker tested positive for COVID and she went to urgent care and got tested. She got tested for antibodies and had a PCR test which both tested negative. Caller was wondering if she was supposed to test negative for antibodies. She took a Medrol dose pack after her second dose of the vaccine and was wondering if that may suppress the immunity of the vaccine and negated antibodies in her system. After 2nd vaccine, patient developed laryngitis. They gave me Medrol dose pack, a prednisone steroid. Patient filled out something online and they sent me this booklet to fill out but have not gotten to it yet. She had just a little reaction to the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 27OCT96 & on 28OCT96 pt exp swollen lymph nodes & soreness of the arm;
Narrative: Pt received 1st COVID-19 vaccine dose on 1/8/21 and developed a rash on injection site/arm.  Other Relevant Hx: Treatment: DIPHENHYDRAMINE 25 MG ONCE
Fever, chills, sweating, shivers, myalgias, fatigue, headache, not feeling well in general.
Severe fussiness, pain, fever, trouble breathing, rash, constipation, vomiting.  04/18/08 Reviewed PCP medical records, consultations & vax records. FINAL DX: Autism spectrum disorder w/macrocephaly. Records reveal patient experienced recurrent OM & URIs. Had not completely reolved OM on 3/8/06.  Returned to offive 3/9/06 w/irritability, respiratory distress w/retractions & wheezing, cough, nasal congestion.  Dx w/acute bronchiolitis. Tx w/nebs.  Continued to have recurrent bilateral OM & asthma & also developed viral xanthem.  Referred to ENT.  8/06 sleep difficulties, kicking & screaming after recently changed to whole milk.  Changed back to soy milk w/some improvement.  Concerns for speech delay first noted 8/23/06 & referred for eval.  Fever & viral respiratory illness 9/2006 w/acute bilateral OM w/purulent effusions.  Unable to clear w/repeated oral antibiotics into 10/2006. Tx w/IM antibiotics, referred again to ENT & PE tubes done 11/2006. Continued to have recurrent OM after PE tubes placed.  10/2007 not making progress in ST, parallel repetitive playing in daycare.  When seen for eval of macrocephaly recommended further testing which revealed ASD.  Patient on DAN protocol, gluten/dairy free diet, continuing ST/OT & attending early intervention daycare.  Referred for additional allergy testing.
pt states after getting the booster her arm was sore and she had a really bad headache.  The next day her left arm pit was swollen.  She states she has a third nipple and it was swollen around that are under the arm pit.  She  also had a swollen left wrist.  She iced it and wrapped it.  The headache and swelling of the wrist subsided after a couple of days but she still has some tenderness and slight swelling under the left arm pit.  She had an already scheduled appt w/ Oncologist so she had them check her armpit.  She was told it was probably from her booster shot  but to come back if the swelling does not go down and they would run test.   She has a FU visit in a couple of months with her Oncologist so she will have it checked then if it still swollen.
Chills, Fever, Fatigue, Sweating, Dizziness, Joint pain.  Treated with fluids and Tylenol.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL0140), in right arm, on 29Jan2021 as dose 2, single (Lot number: EL3249), in right arm and on 29Sep2021 as dose 3 (booster), single (Lot number: FB3592) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "NASH" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "cardiac arrhythmia with past ablations" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy"; Dilauded, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (06Jun2022) Positive, notes: Tested positive with home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Took last doses of Paxlovid felt better symptoms resolved. Tested negative with home antigen testing 3 days later. Then on 06Jun2022 began feeling Ill sore throat, headache, nasal congestion , fatigue. Tested positive with home antigen test x's 2.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, vaccination failure and the administration of the vaccine cannot be excluded.
Patient states that after 2nd vaccine on 4/29/21, he woke up with severe chest pain episode in the middle of the night. He went to the ER, where he was admitted overnight. He was discharged on 4/30/21.
Patient noticed lump and itching night of 5-9-12 when trying to sleep. MD observed a red, egg-sized lump that was itchy at the injection site morning of 5-10-12. Lump is not hot or painful & patient has no temperature.
Narrative: Patient was immunized in timely manner with Pfizer mRNA vaccine.  The course for COVID was generally unremarkable with patient presenting with no  symptoms with the exception of mild diarrhea. Hospital stay was unrelated to  COVID.
Heart Palpitations developed immediately after I got my third booster shoot remained severe for two-three weeks began to subside after I went to my doctor where it was found PDC's and PAC's.
Redness, swelling, and itching at injection site, "hard knot" at injection site.
Pt recv vax on 1/20/99; on 1/22/99 pt exp fever, blisters on chin; tx=Zovirax cream, triple antibiotic ointment
one day p/vax pt devel redness & puffiness armm @ are site; rx ATB Clindamycin/Hydroxyz
p/vax pt had localized react; redness; swelling; inflamed rt leg up to groin area; T103
Limited arm mobility to shoulder height and can't reach behind her, muscle pain, can pick arm up over her head but can't lift it that high on its own.
I got my first shot in the beginning of March and I have not had a single period since that first dose. It would have been at the end of March, but I haven't had one since I got the vaccine. I have talked to doctors and I am going to need to have multiple tests done and if it doesn't happen within 3 months, I need to get a procedure done to induce a period. I am on month 6 with no cycle.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Oka-Merck) PROQUAD: lot# L002419 with expiration date 23-JUL-2016 or lot# L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. came to pharmacy in the early afternoon on 11/29/2022 stating her husband experienced an adverse reaction to a flu vaccine he received at our pharmacy last week. Fluad was administered to him on 11/21/2022 around 12:45pm in the left deltoid. No issues were reported regarding the administration of the vaccination (e.g. pain during injection). About an hour after the vaccine was administered he experienced muscle and nerve weakness in his torso and upper legs. Wife noticed pt.'s knees buckling as he was trying to walk, his left shoulder slanted down while his hip seemed to push upwards. She stated she wanted to bring him back to the pharmacy but felt she would not be able get him back safely. Pt. was questioned whether or not he experienced any dizziness or feeling faint at the time he was experiencing muscle weakness. He denied any other symptoms besides feeling weak on one side and denies any other symptoms  (stated he felt stable, just weak on one side and aware something was not right, although his wife noticed he was unstable). Both pt. and his wife stated the symptoms lasted roughly an hour and a half until he ate food and then the symptoms went away. Pt. has a history of receiving flu shots with no issues. Wife said she contacted the telephone number on the paper we gave her (VAERs) on the day of the incident and has not received a call back at this point in time. Pt. states he has not experienced any symptoms since the incident occurred last week. Wife stated she looked up his symptoms and felt it resembled Guillain-Barre Syndrome. They were instructed to follow up with their primary care physician for an evaluation.
Fatigue, weakness, achiness- especially in legs  Now is in the hospital due to severe optic nerve swelling behind both eyes
Pt 7 days early for 2nd dose of vaccine. Pt made aware of CDC recommendations, still wished to proceed with vaccine.
This is a spontaneous report obtained from a contactable pharmacist. A 71-year-old female patient received, on 31Oct2017 (between 11:15 am and 11:30 am), the first dose of PREVNAR 13, (Lot. S58702, Expiration date: Aug2019, NDC number: 00005197102) intramuscularly, in the left deltoid, at single dose for immunization. Relevant medical history included high blood pressure, high cholesterol, chronic obstructive pulmonary disease (COPD), and arthritis. The patient experienced rashes in the past from bandages and tape. She was not sure if it was a latex allergy. The patient previously received, without any problems, FLUZONE on an unspecified date, in Nov2016, for immunization. Concomitant medications included oral alprazolam (tablet) 0.25 mg three times daily as needed from an unspecified date and ongoing; oral enalapril (tablet) 20 mg from 14Mar2014 and ongoing; oral atorvastatin (tablet) 40 mg, once daily from 14Mar2014 and ongoing; oral SYNTHROID, tablet 125 ug, once daily, from 29Apr2015 and ongoing; oral metoprolol tartrate (tablet) 100 mg, twice daily, from 02Dec2015 (dose was increased from 50 mg, one tablet twice a day, to 50 mg, two tablets twice a day. The pharmacist did not know the reason the dose was increased); and FLUZONE, (manufacturer: Sanofi Pasteur, Lot. UI877AA, Expiration date: 17May2018, NDC: 4928140188), received intramuscularly, in the left deltoid, at single dose, on 31Oct2017, for immunization. On 01Nov2017, the patient experienced severe bruising, tenderness, and itching. No treatment was received. The patient recovered from the adverse events on an unspecified date, in Nov2017. The events severe bruising and tenderness were assessed as serious (Medically Significant), while itching as non-serious. Sender's Comments: Current information is limited for fully medical assessment regarding the serious events of severe bruising and tenderness, especially lack of clinical course on the locations and the accompanying symptoms and the alternative etiology such as fall/trauma. Considering the close time association, bruising and pain at the vaccination site are the expected adverse events following the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Rec'd HD flu shot and PCV23 Monday afternoon both in left arm. Noticed redness, swelling, pain left arm Monday night. Worse on Tuesday. Denies fever.
15 yo male with myocarditis following 2nd dose of pfizer COVID-19 vaccine.  He reports that he received the Pfizer COVID-19 vaccine on 6/16/21. In the 1-2 days following the vaccine he experienced fatigue, body aches, and fever to Tmax 101F. Family treated this with anti-pyretics. On 6/18 he started having a pain in his left chest. He was again febrile at that time. On the day of admission his chest pain was worse and he was experiencing pain all over his body.   He was noted to be tachycardic in the ED. His initial labs showed a modestly elevated BNP to 593 with a markedly elevated troponin to 1233. CRP was mildly elevated at 3.8. Electrolytes were unremarkable as were LFTs. CBC w/ diff showed an absolute lymphopenia with ALC of 1000 but was otherwise unremarkable. D-Dimer was normal. He was admitted initially to hospital medicine and then was transferred to the ICU due to concern for risk of developing a cardiac arrhythmia. An echocardiogram done showed trace mitral regurgitation but was otherwise normal with normal LV function. CXR was fairly unremarkable. Coags are normal. Repeat electrolytes showed a slight bump in his creatinine. LFTs largely unchaged and procalcitonin of 0.16.    He does have a past medical history of PCR proven COVID-19 disease in December 2020.