chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, headache, body aches, joint pain, nausea 32 hours
Patient is 14 YO male,  arrived to clinic with mother for third dose Pfizer on 10/09/2021 at 11:00 am. Patient's second dose Pfizer was not reviewed and verified by staff.  Patient was administered the Pfizer third dose today. Per staff, patient and mother left Clinic with no adverse events. Writer reviewed patient's prevaccination Checklist for COVID-19 Vaccines and noticed that patient's age group is not eligible for the booster COVID-19 vaccine at this time. Mother contacted and confirmed that patient's second dose was administered on 06/12/2021. Mother stated that patient is not experiences any adverse events at this time; however, it appears that patient may be catching a cold. Patient was scheduled with a HCP at a local HCF  for a post vaccination follow up to address any concerns and questions. Per patient's visit with HCP, mother stated that patient is having nasal congestion. Writer follow up today and mother stated that patient is doing better and that nasal congestion has improved. Mother instructed to monitor symptoms and follow-up with PCP as needed.
67 year old female patient administered of Fluzone Quadrivalent instead of Fluzone High Dose , no AE; Initial information received on 14-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 67 year old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 14-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot QFAA2021 and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered (same day latency).  At the time of report no adverse event was reported.  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 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
heart attack who were hospitalized; lupus flare up; Swelling around heart; high palpitations; severe hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (heart attack who were hospitalized), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up), PERICARDITIS (Swelling around heart), PALPITATIONS (high palpitations) and URTICARIA (severe hives) 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 MYOCARDIAL INFARCTION (heart attack who were hospitalized) (seriousness criteria hospitalization, medically significant and life threatening), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up) (seriousness criterion medically significant), PERICARDITIS (Swelling around heart) (seriousness criterion medically significant), PALPITATIONS (high palpitations) (seriousness criterion medically significant) and URTICARIA (severe hives) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (heart attack who were hospitalized), SYSTEMIC LUPUS ERYTHEMATOSUS (lupus flare up), PERICARDITIS (Swelling around heart), PALPITATIONS (high palpitations) and URTICARIA (severe hives) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.  Company Comment: This case concerns subject with no reported medical history, who experienced the unexpected events of myocardial infarction, systemic lupus erythematosus, urticaria and palpitations and the expected event of pericarditis. Time to onset from vaccination was not reported for the events. The rechallenge was unknown, as there's no information about vaccination doses, either dates or dose number. The event pericarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report. Further information is expected.; Sender's Comments: This case concerns subject with no reported medical history, who experienced the unexpected events of myocardial infarction, systemic lupus erythematosus, urticaria and palpitations and the expected event of pericarditis. Time to onset from vaccination was not reported for the events. The rechallenge was unknown, as there's no information about vaccination doses, either dates or dose number. The event pericarditis is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of drug Spikevax is not affected by this report. Further information is expected.
Pain along left scapula into shoulder beginning 2 days after vaccine and then out break papular rash with pain/itch pain relieved with NEURONTIN.  This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a physician concerning a 60 year old female with no known allergies or medical conditions who on 27-OCT-2006 in the AM was vaccinated SC in the right arm with a 0.65 mL first dose of VARIVAX (Merck) (lot # 652936/0981F). Concomitant vaccination on the same day included a first IM dose in the left deltoid of PNEUMOVAX (lot # 651320/1008P). There were no other concomitant vaccinations. There was no illness at the time of vaccination. After vaccination, on approximately 06-NOV-2006, the patient developed an atypical shingles rash with pain. Unspecified medical attention was sought and the patient was treated with NEURONTIN for the pain. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that on 06-NOV-2006 the patient had pain along the left scapula into the shoulder beginning "two days after the vaccine" and then an outbreak of a papular rash with pain and itching. The pain was relieved with NEURONTIN. At the time of the report, the patient was recovering. No further information is expected.
I received the Merderna on 4-30-21 at 11am in my left arm. By 2:30pm, my arm swelled considerably. At the injection site, I developed a huge red rash/lesion, pain and itching. Today is 5-8-21 and symptoms have never gone away. Swelling, Pain and itching is increasing.
he can feel an indentation; after receiveind the second dose the soreness eventualy went away as well / however this time the soreness returned / the soreness is present when he "pushes on it with a finger"; he later receied a 2nd dose and experienced soreness again; the patient is unable to clarify if he received GARDASIL or GARDASIL 9 vaccines / the patient was over the age of 45 at the time of his first vaccine; he experienced soreness on his arm at the injection site; This spontaneous report was received from a physician and a 48-year-old male patient referring to himself. The patient's medical history included diagnosis of (HPV), effects to the vaccine in his tight and his shoulder when he was an infant and a rash to Jerhen's soap/ shampoo. The patient's concurrent conditions included flaxseed allergy, hyperlipidemia, depression, pain and diabetes. Concomitant therapies included atorvastatin, (VIIBRYD), pregabalin and metformin.  On an unknown date in August 2021 (reported as about 6 or 7 months ago), the patient received the first dose of an unidentified Merck hpv vaccine (name and lot number not provided) administered intramuscularly for prophylaxis (product administered to patient of inappropriate age). On an unknown date in 2021, the patient experienced soreness on his arm at the injection site and after an unspecified amount of time the soreness went away. On 27-JAN-2022 (reported also as "about 2 months ago), the patient received a 2nd dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, administered intramuscularly in the left deltoid region, lot # T039467, expiration date 20-MAY-2023 for prophylaxis and on the same day, he experienced soreness/ pain at injection site (reported also as vaccine reaction). On an unknown date in 2022, the soreness eventually went away as well. On an unknown date in February 2022 (reported as about a month ago), the soreness returned and the patient could feel it when he "pushed on it with a finger". The patient reported he also felt an indentation. The patient sought medical attention and was advised to use a warm compress. At the time of the report, the patient did not recover from the event of the indentation and soreness when he "pushed on it with a finger".   The physician considered the soreness/ pain at injection site (vaccine reaction) that occurred after the second dose of the vaccine to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The casualty assessment between the soreness on the patient's arm after the first dose, the indentation that the patient could feel, the soreness that the patient could feel when he "pushed on it with a finger" and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The casuality assessment between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
A warm, itchy, and red patch 10cmx7cm appeared 4 cm below PREVNAR-13 injection site.
This spontaneous case reported by an other healthcare professional, describes the occurrence of malaise (not feeling quite right), fatigue, chills (some chills) and extra dose administered in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 24, 2022, patient received the  fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 24, 2022, patient had an extra dose administered. On Jan 28, 2022, patient experienced malaise (not feeling quite right), fatigue and chills (some chills). On Jan 24, 2022, extra dose administered: resolved. At the time of the report, malaise (not feeling quite right), fatigue) and chills (some chills) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
pt recv vax 16SEP97 & 6OCT97 pt devel 8 lesions which looked like chickenpox & were pruritic;pt had no other signs or sx;
she was with infection of covid but that date is not available as it is not in front of her at this time and she does not remember which prior dose of her covid vaccines this is associated with; she was with infection of covid but that date is not available as it is not in front of her at this time and she does not remember which prior dose of her covid vaccines this is associated with; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: She is taking Amlodipine and Losartan; "prediabetic" (ongoing), notes: prediabetic began many years ago, maybe 4-5 years ago. Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing); METFORMIN taken for glucose tolerance impaired. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she was with infection of covid but that date is not available as it is not in front of her at this time and she does not remember which prior dose of her covid vaccines this is associated with". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: She is taking Amlodipine and Losartan but cannot recall the date the hypertension began and it was all prior to receiving the Pfizer covid vaccine back in 2021 and prior to this booster vaccine that she got for 2023. Caller stated before the most recent dose, she did have a third Pfizer covid vaccine but does not have the date, lot number or further details to provide as that patient card is not with her at this time. She was missing one dose from her patient card because she had a total of four doses of covid shots that were all Pfizer. Despite further attempts at clarification, this information is captured as provided by the caller. She was feeling much better and they remain covid negative today although the caller did get covid post her shot and had covid post injection but they said that was due to an expected thing and she was with infection of covid but that date is not available as it is not in front of her at this time and she does not remember which prior dose of her covid vaccines this is associated with but she did get two infections of covid and was treated successfully and did not required hospitalization.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300347227 same patient, vaccine different dose, different AE;
As per staff note, PT was speaking with staff member regarding her allergies and mentioned a past incident where she received "a shingles shot and when she woke up, the left side of her body was frozen". No further information was provided.
Arm soreness; She couldn't sleep; Woken up every 20 minutes; Was on fire all last night; Sweaty; Very irritable; This is a spontaneous report from a contactable consumer (patient). This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. Medical history included an ankle sprain which the patient stated occurred prior to vaccination, from  an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received a tetanus shot on an unknown date for immunisation. The patient reported she received the first dose of BNT162B2 yesterday and last night she couldn't sleep and was woken up every 20 minutes, further reporting she was on fire all last night, was sweating and was very irritable. She also reported today (as of 22Mar2021) she developed arm soreness. She inquired if this was normal. The clinical outcomes of she couldn't sleep, woken up every 20 minutes, on fire all last night, sweaty and arm soreness were unknown. The clinical outcome of very irritable was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Low grade fever and diarrhea; Fever lasted for 3 days; followed by constipation and diarrhea ongoing for 2+ weeks.
Immunized 21FEB91 - vomiting began about 2AM on the 22nd & has persisted temp 101 - advised to call MD for poss visit;
within 2 days of vaccination, patient developed full body rash from head to toes.  Body was covered in painful itchy red blotches.  Patient had to see dermatologist to help treat and was given cream for it.  Patient describes the rash as very painful and uncomfortable. It is 2 months later and patient still has the rash although it's intensity has subsided
This spontaneous report as received from a medical assistant refers to a 28 year old patient. On an unknown date the patient was inadvertently vaccinated with ZOSTAVAX instead of (Merck) VARIVAX. No adverse effect reported. Additional information has been requested.
Chills, nausea, myalgias, redness and swelling of injection site.
Developed vomiting, diarrhea & sandy stools x 2-3 days p Rotateqn given c #1 & #2 doses mom reported sx when in office 9/28/09.
Vaccine administered on 6/2/23. Vaccine expired 5/31/23. Awaiting patient to return call to inform her of error and if any adverse effects. Seqirus was contacted for information for which I was told to revaccinate.MD was notified of error and told what manufacturer recommended.  MD responded that flu season has ended so revaccination was not needed. However patient could get revaccinated again if she wished
6 weeks following administration of vaccine, heavy menstrual bleeding began which last 8 weeks. By heavy menstrual bleeding - a super tampon was saturated every 2 hours.  I also experienced significant difficulty in obtaining a doctor's appointment which delayed assessment by 3 weeks.  Multiple laboratory tests were run in addition to a vaginal Ultra sound, endometrial biopsy and an ECHO to determine cause.  An elevated testosterone level was identified and I was started on Spirolactone with resolution of the bleeding.
Patient lied about patient's age. Changing her DOB to make her older. She was held for 1 hour. Patient's doctor was contacted. It was reviewed with mom what could happen.
PT received 2nd dose of Pfizer COVID-19 vaccine on 26Feburary and tested positive for COVID-19 via nasal swab 24March.
Generalized stiffness pain, leg leg pain especially the knees with an unstable gait.  Her gait improved but it took 4 months for her symptoms to be much better.  Knee is still can be more stiff than she had prior to the Moderna.
a fine red rash over my entire body, intense itching,  facial swelling and feeling flush about 12 hrs after the vaccination.  Took 2 Benadryl and called the doctor when the office opened. Was scheduled to be seen and at the office visit, given a Decadron IM injection and started on prednisone taper dose, instructed to take  Claritin and Pepcid once daily, 2 Benadryl twice daily until symptoms subside. Within  24 hours of steroid injection, the rash was starting to clear . 5 days out, and I still  have some pruritis.
The patient returned to the clinic on on 15-AUG-2018, because "the urticaria had returned".; The patient experienced "worsening urticaria, facial swelling, and difficulty breathing"; The patient experienced "worsening urticaria, facial swelling, and difficulty breathing".; The patient returned to the clinic on 14-AUG-2019,, complaining of "globalized urticaria"/The patient experienced "worsening urticaria, facial swelling, and difficulty breathing".; This spontaneous report was received from a medical assistant, referring a 12-year-old female patient. It was reported that the patient did not have any concurrent conditions, medical history or concomitant medications.  On 14-AUG-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) as prophylaxis (strength, dose number, dose, route of administration, and anatomical location vaccination were not reported; lot number 1602281 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(; expiration date 21-JUL-2019). Also, the patient was vaccinated with a dose of meningococcal ACYW conj vaccine (carrier unspecified) and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (strengths, formulations, dose numbers, doses, routes of administration and indications were not reported for both therapies).  Consequently, on the same day, the patient returned to the clinic the patient experienced " globalized urticarial" therefore received Benadryl 25mg orally (unspecified) and intramuscular decadron 4mg (unspecified). It was reported that the patient experienced worsening urticaria (urticaria), facial swelling (swelling face), and difficulty breathing (dyspnoea) and received epinephrine 0.3 miligram (mg).  On 15-AUG-2019 the patient came back to the clinic because  the urticaria had returned, to sought medical attention. The patient received an epinephrine pen to use as needed, cetirizine, at a dose of 10 milligram orally; ranitidine hel capsule, at a dose of 50 milligram, twice a day, orally,  and montelukast sodium (SINGULAIR). On 16-AUG-2019, the patient was recovered from the events urticaria, swelling face, and dyspnoea. The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned events were not provided. The events swelling face, dyspnoea, and urticaria were determined to be medically significant and life threatening events.
Patient developed abd pain, current jelly stools and diagnosed with intussusception. Not able to reduce via gastrografin enema. Brought to OR for ex-lap. Ileo-cecal intussusception reduced manually. Records received 4/26/07-DC Summary for DOS 4/8-4/10/07 DX:Intussusception. HX of vomiting and bloody stool.  Exploratory laparotomy and appendectomy
Developed a lump, ecchymosis, rash/hives at injection site day of shot. Also developed hives/rash/itching on  both arms and back.
PT admit to hospital 4/3/22 w/ R MCA stroke likely related to hypercoagulability d/t COVID19 (positive test on 3/24/22). Pt received 3 prior doses of Moderna vaccine on 1/21/21, 2/18/21, and 8/26/21. Of note, pt is immunocompromised d/t monoclonal antibody for multiple myeloma.
1017 Epigastric pain, difficulty with breathing flushing in the face, hypertension, apprehensive, flank pain. 1018 BENADRYL 50mg IM, 911 called.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 03-SEP-2014, the patient received the first dose of RECOMBIVAX HB, intramuscularly, 10 mg/ml (lot # was not reported) and was in pharmacy to receive the second dose of RECOMBIVAX HB  on 07-MAY-2015. No adverse effect was reported. The outcome of the events were unknown. Additional information has been requested.
This non-serious medically confirmed spontaneous report (initial receipt 06-OCT-2014) concerns a female patient. On an unknown date, the patient received an unspecified flu vaccine (manufacturer and batch number not provided). On an unknown date, following the flu vaccine administration, the patient experienced pain and swelling at the injection site. The patient was doing fine. Outcome was not reported.