chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling at site of injection, rash as site of injection that spread from day 7 to day 8, itchiness at site of injection, heat production t site of injection.
Patient is a 57-year-old whom had his booster shot (Moderna) October 30.  He reports beginning the night of November 5 he developed constant sharp substernal chest pain.  This peaked in intensity overnight and he presented to the ER November 6 with constant pleuritic chest pain worse when lying on his back.  EKG suggested pericarditis.  The pain has gradually subsided and is almost gone today.  He has no known history of CAD.
paleness, dizziness, heart pounding, nausea, achiness in back by shoulder blades;sough MD tx 11/17/99 in the PM; stayed home from school 11/17/99;slept all day;devel diarrhea later in wk;MD ordered no meds but advised not to recv hep b;
Information has been received from a nurse concerning a 20 year old female who on 02-OCT-2007 was vaccinated with GARDASIL. On 02-OCT-2007 the patient experienced passed out, syncope and bump on head. Subsequently, within the first 5 minutes after receiving the vaccine she passed out and experienced syncope. She fell over and bumped her head on the wall. The nurse who was present in the room called out the patient's name and hit her on the face the patient woke up. The patient developed a bump on her head. Additional information has been requested.
COVID-19; Chills; Fever; Sore throat; Slight cough; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Slight cough), PAIN (Body ache), COVID-19 (COVID-19) and CHILLS (Chills) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Slight cough), PAIN (Body ache), CHILLS (Chills) and PYREXIA (Fever). On 16-Apr-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency; VITAMIN D NOS at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PAIN (Body ache), COVID-19 (COVID-19), CHILLS (Chills) and PYREXIA (Fever) had resolved and COUGH (Slight cough) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102 (Inconclusive) 102F. On 15-Apr-2021, SARS-CoV-2 test: and posituve (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient is having possible delay in receiving the 2nd dose of Moderna vaccine.
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that the vial puncture on 11/11/21, dose given, kept in refrigerator after puncture
pain at site of injection/ arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (For tolerance of 1st dose refer link case US2019098197).   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 29th May 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The Shingrix vaccine was administred on left deltoid. The patient arm was really hurt after receiving Shingrix vaccine.  The reporter consented to follow up.
No adverse reaction.  3rd dose.  Other 2 doses given at Rehab.
Hives in multiple spots on body including in the nose where administered, swelling of joints, swelling of hands and feet, itchy. Patient is currently taking OTC Benadryl, Pepsid AC, and a perscription liquid oral steroid course for four days.
Immunizations given 6-28-2005.  Seen on 7-8-2005 left leg puffy.  History of fever previously (week before).
expired PENTACEL vaccine was administered to a patient with no reported adverse event; Initial information received on 14-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves an unknown demographic patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number not reported, expiry date-04-Apr-2021) via an unknown route at an unknown administration site for prophylactic vaccination on 14-Apr-2021 (expired product administered) .  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency same day).  It was reported that, something like this happened before and there was a 30 day window after expiration that product could be used; the reporter had a query about, does PENTACEL have a window like that or should we tell the patient what happened. As the agent unable to clarify which product reporter was referring to that has a 30-day window after expiration that product could be used.  At time of reporting, 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 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.  There will be no information available on the lot number for this case.
Symptomatic COVID post vaccination that required hospitalization. Patient has SOB/Weakness and Covid.  Treatment: Dexamethasone 6mg.
Information has been received from a 72 year old female with hypertension, a history of dry cough and codeine allergy who in approximately November 2007 "about two months ago," was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant drug therapy included atenolol and LOTREL. In approximately November 2007, the patient developed a lump at injection site that had not resolved after 2 months. The patient also mentioned that he experienced "dry, unproductive cough while taking LOTREL and that NORVASC caused the same reaction." The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. Follow-up information from a physician indicated that the 72 year old female who on 01-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658395/0966U) in the left deltoid. The patient did not report any adverse event to the physician when contacted regarding this notice. The patient told the physician she had a small "lump at the injection site which resolved spontaneously. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 87-year-old, elderly patient of an unspecified gender. It was report that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 30-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, route of administration, anatomical location, expiry date and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805528 was crossed linked to original case 201804863 due to same reporter.
Information has been received from a MD of pharmacy concerning a female pt who on 7/27/99 was vaccinated with Hep B. Subsequently, in less than 12 hours, the pt experienced dizziness, nausea, pale skin, and tingling in both hands and feet. The pt had blood drawn after the adverse experiences which revealed that she is pregnant. Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a 73-year-old patient who, "one week ago", on 19-OCT-2006 was vaccinated subcutaneously one time with a 0.5 ml dose of Varivax. The administration of Varivax was an error, patient was suppose to receive Zostavax. It was unspecified if medical attention was sought. It was reported that the patient did not experience any known symptoms. No product quality complaint was involved. Additional information has been requested.
At first, I experienced severe swelling, itching, tenderness and warmth. This subsided over a course of 10 days.  My major concern is that now I have a hand tremor in my left hand which I did not experience before the vaccination.  My reason for submitting it is twofold, to inform you and to learn if this has been reported by anyone else.
This spontaneous report was received from a pharmacist refers to a 50 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient did not have any known drug reactions or allergies. On 25-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N021171, expiration date 01-NOV-2018 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (lot# M035268, expiration date 19-apr-2019). Other suspect therapies included FLUARIX (dose, route of administration, lot# and expiration date were not reported) administered in opposite arm on the same day. On 26-SEP-2017, a day after injection, the patient experienced injection site reaction that gradually developed: swelling, round red area, itching and warmth. There was no rash. The patient visited pharmacy on 28-SEP-2017. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the events and the suspect drugs was not reported.
18 hours post administration: Redness, swelling, warmth upper arm around vaccine injection site between shoulders and elbow.
This is a 70y.o. female who presented for the above procedure. Postoperative course was complicated by COVID diagnosis discovered given respiratory insufficiency, SOB and CP. ID was consulted and she was determined to not be a candidate for COVID tx. She additionally had afib and was placed on amiodarone gtt which was transitioned to PO metoprolol with Cardiology following. Cardiology eventually requested CTA to assess for coronary disease requiring intervention without evidence of obstructive CAD and she was deemed stable for discharge with outpatient follow up for discussion of anticoagulation resumption. Diet was advanced to full liquids. Diet education given. Pain was controlled on PO medications. Patient was passing flatus, having bowel movements, ambulating. The patient was deemed stable for discharge on POD8. Please see record for further details on care.
Headache, fatigue, low-fever (99.8) for one day after second dose. Tylenol helped with symptoms. Fully recovered two days after second dose.
Reddened area at site of vaccine, rash spread around thigh, warm to touch and firm
5 minutes after shots patient complained felt light headed, dizzy, headache, complained of feeling hot, room was warm in temperature, pallor noted, no anaphylaxis noted, no shortness of breath. Blood pressure monitored 92/54, 86/51 by EMS personnel/co-located with EMS. Patient did vomit small amount, had not eaten prior to vaccines since 7:30 PM night before. Patient rested 45 minutes and then felt better, mom took her home.
24 hrs high pitched crying non stop & not eating; no sz, ; fever to 102;
2 hours, post vax, parent brought child into health dept. Child had whelps on chest and throat hurt, child states, no respiratory distress. Sent child to PMD for evaluation and treatment. Health dept called office for follow-up visit. PMD used epinephrine and steroids for 24 hours and child's whelps disappeared.
migraine head ache, back ache, fever, nausea, lack of apatite , brain fog,, i had covid in november, felt about the same, was very sick for 5 days, felling much better  8 days after the vaccine, very afraid to get the second dose, if reaction is more severe as reported in the second dose, i'm afraid i won't servive
gave 3rd vaccine dose from the expired vial; Patient took the third dose outside the window period; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 3rd vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the third dose outside the window period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E211A, 037K20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, SIMVASTATIN and ANASTROZOLE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 3rd vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the third dose outside the window period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave 3rd vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the third dose outside the window period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was immunocompromised.  The treatment information was unknown.
Second dose: was a little tired was similar to how to caller felt after receiving the second dose; little bit like had the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Lot number: EN6203) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of covid vaccine, Lot: EL9269, NDC: Unknown , Expiration: Unknown , Route of administration: left arm), administration date: 04Feb2021, when the patient was 70 years old, for COVID-19 immunization; Pneumonia vaccine (Reaction the caller had to the second dose Pneumonia vaccine, where arm became swollen: Pneumonia Vaccine: NDC/lot/expiration: The caller is unable to provide this information, states this was over 2 years ago., where arm became swollen), for Immunization, reaction(s): "where arm became swollen"; Pneumonia vaccine (1st dose of pneumonia vaccine), for Immunization. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Second dose: was a little tired was similar to how to caller felt after receiving the second dose"; INFLUENZA LIKE ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "little bit like had the flu".  Additional information: The patient was a little tired after receiving the second dose. The patient does not remember when the tiredness began after the second dose, patient states this was in Feb2021. The patient states after the first dose Pfizer Vaccine the caller did not feel anything. The patient also felt a little bit like had the flu and tired maybe for a day and it went away. Reaction the patient had to the second dose of Pneumonia vaccine, where arm became swollen. The patient was unable to provide the information, as this was over 2 years ago.  No follow-up attempts are possible. No further information is expected.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: NA
One Janssen vial of lot number 206A21A was pulled from the fridge at 10:50AM of Octobe 26,2021. 0.5ml was drawn and administered at 11:20AM intramuscularly onto the left arm of the patient. The assigned expiration date on filed posted on the box of Janssen vials was April 9, 2022 but upon verifying on the Janssen website the lot number administered to the patient was found to have an expiration date of September 21, 2021. The patient did not have any immediate adverse reaction within the 15 minute required observation period following the administration. Will follow up with the patient.
Within 24 hours of below vaccines pt developed erythema, induration and warmth of right thigh up to 6.5 by 12 cm erythema with 6 cm induration; erythema poorly demarcated, occasional decreased right lower extremity weight bearing, fever 11/29-11/30/2001 up to 101.3 rectally. Briefly on Augmentin and hospitalized times 1 day for presumed cellulitis. Augmentin stopped 11/30/01. Improved by 12/1/2001. Resolved by 12/05/2001 or sooner. Reaction felt to be to DTaP and to be consistent to previously described cases, not cellulitis.
Development of substernal chest pain with elevated troponin 3 days after vaccination. Normal EKG. CT angio w/o evidence of PE.
Suspected vaccination failure; gotten shingles 3 times; This case was reported by a consumer via Shingrix interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the shots. The patient asked for suggestions since he or she experienced shingles 3 times. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up was not possible as no contact details were available.
Tingling in hands bilaterally (intermittent)-ongoing  Sore arm x 3 days
lymphodema, swelling, pain, arthralgia, headaches, dizziness, stiffness, tenderness, neck pain, balance disorder, right side of body issues
Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain; Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) and ARTHRALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) in a female 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 MYALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) and ARTHRALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain). At the time of the report, MYALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) and ARTHRALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-269783 (Patient Link).