chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, fever and swelling. On an unknown date, the outcome of the pain, fever and swelling were unknown. It was unknown if the reporter considered the pain, fever and swelling to be related to SHINGRIX. Additional information was received as follows: The reporting physician stated that three patients experienced expected side effects of SHINGRIX including aches, fever, and swelling. The age at vaccination was not reported. The reporting physician stated that he and his wife are two of three patients who experienced expected side effects of SHINGRIX. The reporting physician stated that one patient experienced a fever. This case was one of three cases, reported by same reporter.
16 hours after shot she got dizzy, lightheaded. Passed out on the bathroom floor. Her body then went into muscle spasms her hands and feet crippled up and wouldn't release. Her body was going numb and she was struggling to breath. Her face was white her lips turned blue. When paramedics arrived her blood pressure was 93/57 her pulse was tachycardia and around 52-59. They were unable to get an IV in her and transported her immediately to local hospital. Where she couldn?t remember much and still had numbness in her body. Her pulse remained low as well as her blood pressure.  EKG showed abnormal T waves.
11:50 AM twinrix given in R deltoid. By 12:30 PM mother called stating that her right arm was swollen all the way down to her hand. Her hand was so swollen she couldn't make a fist. Advised mother to giver her Benadryl, if decreased all swelling and did not come back.
HE RECEIVED MODERNA VACCINE 1/21/2021. FOR HIS SECOND DOSE HE WENT TO AN OFFSITE WE WERE HOSTING. THE VACCINATING NURSE GRABBED A SYRINGE THAT SHE THOUGHT WAS MODERNA.AFTERWORD IT WAS REALIZED IT WAS JANSSEN VACCINE.  I NOTIFED HIM AND SENT HIM AN UPDATED CDC VACCINATION CARD. HE UNDERSTANDS THE SERIES IS COMPLETE
There was an Excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an Excursion from the freezer) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.  On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an Excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an Excursion from the freezer) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis. The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Fahrenheit and maximum 5.7 degree Fahrenheit. The excursion duration was 6 minutes. On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.  No concomitant medications were reported.  No treatment information was provided.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Information was not reported.  Concomitant product information was not reported.   Reporter did not allow further contact
Hives/rash/dermatitis, mostly concentrated around hairline, pubic region, elbows and knees. Swollen upper lip on right side, throat soreness/tightness on left side and vomiting.  Symptoms lasted for about 36 hours. Symptoms started subsiding after receiving steroid injection, oral steroids, daytime anti-histamine and ointment for itching.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Apr2023 to 20Apr2023.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M043306, expiration date 24-APR-2018 (albumin status, dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced temperature excursions of -14 degrees Celsius to -10 degrees Celsius for 105 hours 50 minutes and -14.1 degrees Celsius for 6 hours 26 minutes. Data logger was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014640.
Annual checkup  at Cardiologist revealed atrial fibrilation. (9/1/2022).  Recommended treatment (cardioversion) on 9/8/2022 restored sinus wave in heart rhythm.
Blood pressure 184/82; ankles swollen up; Sweat; 101°F temp; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure 184/82), JOINT SWELLING (ankles swollen up), HYPERHIDROSIS (Sweat), PYREXIA (101°F temp) and CHILLS (severe chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Blood pressure measurement: 184/82 (High) increased. On 15-Feb-2021, Body temperature: 101 (High) degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow-up information received  on 29 Mar 2021 reporter contact details updated. On 31-Mar-2021: Follow up was received on 31 Mar 2021 included no new information.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Per Dr.: Left deltoid with a 2  cm area of induration below the injection site. No skin erythema. Further down on the forearm is a 5 cm area of streaky red, blanching rash that patient says is extremely itchy and has been tempted to scratch it. There are a few petechiae from scratching. No axillary lymphadenopathy noted. No tenderness on palpation and exam of indurated area of red area.
Inflammation throughout entire body, arthritic response in 2 fingers on right hand, pain in both upper thighs, at times to the point I could not stay still,   Significant change in thyroid function lab tests.   Extreme fatigue and continuous headaches.
Large welt at site of injection. Welt measures 4 1/2 inches long by 2 inches wide. Welt is very hot, painful, red. I also have a dull headache that will not go away.
pt started exp paralysis on lt side of face, initially dx Bell's Palsy-spread to both sides of face exp numbing & pain;neuro dx  probable MS, vision impaired; no subsequent doses of series taken;Annual follow-up dated 10/27/00 states still has numbing in face and eyes blur.
15 mo old patient was supposed to receive flu vaccine. Received oral rotavirus vaccine instead of flu vaccine by mistake.
Post vax, pt states his right arm started hurting and swelling. He has been taking some aspirin for the pain and swelling is getting worse. He called to report the problems this morning, 1/16/03. I have sent him to his PMD stat for DX and TX.
Fatigue, headache, imbalance, general unwell feeling, head fog, injection site soreness
Blood pressure skyrocketed by next morning, still high, despite increased medication. Diastolic remains high no matter what. This began the morning after the first dose.
Began with a head ache and slight dizziness followed by shaking/chills, after a while with those side effects I took ibuprofen. Later that night I had a fever, body aches and I woke up nauseous in the middle of the night. Other than being very tired and sleeping very late the next day all side effects subsided by Sunday March 14th.
HORRIBLE HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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, the patient experienced horrible headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible headaches was not reported. This report was non-serious.
arm a little swollen; where she received the vaccine there is a pale pink area/about the size of a quarter; arm was kind of sore; She said her arm is more swollen than the last two times. It was red, pinkish, blotchy, and had a circle. She also said there was a knot under her skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 08Oct2021 (Lot number: EW0177) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Heart Rhythm" (unspecified if ongoing), notes: Verbatim: Heart Rhythm; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: XARELTO; FLECAINIDE; ATORVASTATIN taken for blood cholesterol; AMLODIPINE taken for blood pressure measurement. Vaccination history included: Bnt162b2 (1st dose., fine after her first two doses with no reaction.), when the patient was 68 years old, for Covid-19 Immunization; Bnt162b2 (2nd dose, fine after her first two doses with no reaction.), when the patient was 68 years old, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 09Oct2021, outcome "recovered" (Oct2021), described as "arm a little swollen"; VACCINATION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "where she received the vaccine there is a pale pink area/about the size of a quarter"; PAIN IN EXTREMITY (non-serious) with onset 09Oct2021, outcome "recovered", described as "arm was kind of sore"; SKIN DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "She said her arm is more swollen than the last two times. It was red, pinkish, blotchy, and had a circle. She also said there was a knot under her skin". Therapeutic measures were not taken as a result of peripheral swelling, vaccination site erythema, pain in extremity.  Additional information: The patient her arm a little swollen on Saturday that had gone down. However where she received the vaccine there is a pale pink area that was larger than where the vaccine was given about the size of a quarter, larger than it initially was with a firmness underneath. caller states that the knot doesn't hurt today and she feels fine. Caller also reports feeling fine after her first two doses with no reaction.  No follow-up attempts are possible. No further information is expected.
PT STATED NOT FEELING WELL AND SHE SAID SHE IS NOT ABLE TO SEE. PT FELT DIZZY AND FAINTED. SHE FELT BETTER AFTER ELEVATING FEET AND WAITED 30 MIN FOR OBERVATION.
Headache, Myalgia, inj site pain/discomfort/swelling/itchy; chills, tiredness Narrative: symptoms lasted for 3 days
Rec'd flu shot 9/9/10. On 9/10/10 night pt very agitated & hallucinating. Seen in ER as mtr felt pt might hurt himself. Medication hx: ATIVAN given PRN. Recd doses 9/9 & 9/10 without relief of anxiety, agitation. Rec'd lower dose of LEXAPRO (30mg on 9/8) reduced to 20mg on 9/9 & 9/10.
Prevnar site swollen and red- was given 2 days ago. Advised cool compress and Benadryl.
prolonged crying <24 hrs past vax; no erythema or edema @ inj site-inj given @ another facility-MD feels adverse rxn to vax >29 hrs pt better
My grandson who is only 16 was given the moderns COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My grandson who is only 16 was given the moderns COVID 19 vaccine) in a 16-year-old male patient 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My grandson who is only 16 was given the moderns COVID 19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My grandson who is only 16 was given the moderns COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No adverse events were reported.
This spontaneous report has been received from a nurse prescriber referring to an unknown number of patients. Information regarding the patients' current conditions, medical history, concomitant therapies and drug reactions or allergies was not provided. It was reported that on 15-MAY-2017, an unknown number of patients were vaccinated with improperly stored doses of ROTATEQ orally, lot number M040267 and expiration date of 14-MAY-2018 (dose was not provided). The ROTATEQ doses were exposured to a temperature ranges between 32° (f) fahrenheit and 35 °f, during a time frame of 2 hours, which were called by a data logger. Then returned back in range, with no previous temperature excursions. No adverse events were reported. This is one of several cases from  the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008456: US-009507513-1705USA009812: US-009507513-1705USA009810:
This is a spontaneous report from a contactable consumer reporting for her daughter and from a contactable physician. A 17-year-old female patient received TRUMENBA; lot M37316, expiry date 01Apr2017 intramuscular, in left deltoid, on 15Jun2016 at 0.5 ml single. No other vaccines were given on the same day or within 4 weeks prior. Medical history included Crohn's disease (colon) since Nov2004, seasonal allergies and asthma. Concomitant medications included ASACOL HD, 800 mg, tablet since she was 6-7 years old and ongoing at two tablets 3 times a day, orally for Crohn's disease (colon), calcium/vitamin D and unspecified birth control pill (BCP). On 15Jun2016, few hours after injection, the patient experienced fever, chills, arms were extremely swelled for several days, headaches, general feeling of crappiness and left arm throbbing. On an unspecified date in Jun2016 C-reactive protein result high and sedimentation rate increased. Laboratory test on 21Jun2016 showed C- reactive protein and red blood cell sedimentation rate were high than the usual values. Patient was treated for fever, chills and headache with TYLENOL, tablet at 1000 mg once orally. Fever, chills, headache and general feeling of crappiness resolved the day after their occurrence (Jun2016, in the morning), while swollen arm lasted for several days, then resolved (Jun2016). Left arm throbbing resolved on an unspecified date in 2016. The outcome of c-reactive protein increased an sedimentation rate increased was unknown. The events did not require an emergency room or physician visit. High values of C-reactive protein and sedimentation rate could be because of patient gastrointestinal condition, but the reporting consumer was wondering if that could be the cause of getting the vaccine because it takes a few weeks for body to deal with the vaccine. The reporting physician considered the vaccine had a causal effect to the adverse event left arm throbbing. Follow-up (18Jul2016): New information from a contactable physician includes: additional medical history, concomitant drugs, vaccine lot number, expiry date, route and anatomical location of administration, additional event 'left arm throbbing', reporter causality assessment.
Pt recvd vax 23MAY91; 31MAY91 t103 ax; Seen by MD, dx w/ear infect, given Ceclor; 1JUN91 taken to clinic for diarrhea episodes; 2JUN91-3JUN91 devel rash to face & body; 3JUN91 meds discontinued; 4JUN91 rash resolved, no other problems noted
adacel being administered post excursion with no reported adverse event; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received via office manager. GMI number: 01562233.   This case involves 8 years old male patient who experienced Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] being administered post excursion with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2023SA107297, 2023SA108312, 2023SA107202 and 2023SA108228.  Concomitant medications included Hepatitis B vaccine for Prophylactic vaccination.  It was reported that office manager reported a temperature excursion involving administered after the excursion, unopened ADACEL at 134.70F for 6 minutes due to a refrigerator malfunction on 18-MAR-2023 (not human error). The product did not support by the extended stability data, and the caller informed that ADACEL has been administered after the excursion. This situation is reported as a medication error due to IPOL and ADACEL being administered post excursion.    On 21-Mar-2023, the 8-year-old patient administered post excursion suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection at dose 0.5ml once (lot: U7549AA, expiry date: 04-Nov-2024) via intramuscular route in the deltoid nos for prophylactic vaccination with no reported adverse event (poor quality product administered) at same day latency.  Action taken: Not applicable.   At time of reporting, the outcome was Unknown for the event poor quality 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 guidelines. 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.
Redness at injection site; Cellulitis at injection site requiring antibiotics; Fatigue; Fever; Nausea; Flu like symptoms; This is a spontaneous report from a contactable Nurse (patient). A 25-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EJ1686, Expiration Date: not reported), via intramuscular in left arm on 25Jan2021 10:00 as 2nd dose, single for COVID-19 immunization. The patient historic vaccine included first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration Date not reported) on 04Jan2021 09:00 AM for COVID-19 immunization. Facility type vaccine was Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was diagnosed with COVID-19 post vaccination. Medical history was not reported. Patient did not had known allergies and other medical history was reported as none. Concomitant medication included multivitamin in two weeks taken for an unspecified indication. The patient experienced redness at injection site, cellulitis at injection site requiring antibiotics, fatigue, fever, nausea and flu like symptoms on 26Jan2021 06:00. AE resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures included COVID test post vaccination: Nasal Swab on 28Jan2021, Negative. AE treatment was received antibiotics r/t cellulitis. The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.