chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EARLY PM GOT SWELLING AND REDNESS AT INJECTION SITE. ABOUT 10:30 PM GOT CHILLS WITH SORE SHOULDERS. WENT TO BED WITH SEVERE SHAKING CHILLS. ABOUT 3 AM 01/09/2014 WOKE UP WITH SWEATING, STOMACH CRAMPS, AND NAUSEA.  VERY DIZZY WHEN TRIED TO GET UP. GOT UP AT ABOUT 11:45 AM AND FEEL BETTER BUT STILL HAVE SORE SHOULDERS, ACHY JOINTS AND FEEL FAINT.
RN gave wrong dose of vaccine. Patient was notified of error. No adverse side effects thus far. He was given phone # to contact if he experience any problems. He'll be monitored for next few weeks with phone calls.
Reddened swollen left deltoid 4" diameter. (Patient thinks he might have had tetanus immunization 6 years ago, has no documentation.
My arm was sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 040A21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). At the time of the report, PAIN IN EXTREMITY (My arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient also experienced sore arm on 18-Mar-2021 and 23-Oct-2021 after administration of 2nd dose and 1st booster respectively.  No treatment medications were reported.   This case was linked to MOD-2022-657153 (Patient Link).
Numbness, tingling, and light pain in right leg. Vaccine about midday and symptoms can about 10 hours later.
Patient developed a rash on face and spread to all his body, no fever, 12 days after vaccination.
Member described "baseball size" lump with redness and warmth at injection site occurring 2 days post injection. Examined in clinic 10/15/02. 7cm x 4cm area of induration rt deltoid without erythema, tenderness or warmth at site.
Chills and shakes for 2 hours Stomach pain- very sharp stabbing pain Headache Arm injection site very tender
4/29/14 pt called DOH to report a reaction to MMR vaccine she received on 4/15/14. She is experiencing fever (102), rash and swollen glands in neck and feels achy. Pt advised to call MD which she did. Was told by MD probable reaction to MMR, take TYLENOL and if sx worsen to go to ER. 4/30/14 Spoke pt she is afebrile and rash is fading.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 21-AUG-2017, the patient was vaccinated with one dose (1 DF) of improperly stored dose of VARIVAX lot # M048200 expiry date 07-DEC-2018 (route, anatomical location unknown) for prophylaxis (incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) (lot # and expiry date were unknown) used for reconstitution did not undergo a temperature excursion. The vaccine was exposed to a temperature of -14 degree Centigrade to -10 degree Centigrade for a time frame of 7 hours. There was no previous temperature excursion The call was due to a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
14 years old Flublok instead of prescribed Fluzone Quadrivalent, No adverse events; 14 years old Flublok instead of prescribed Fluzone Quadrivalent, No adverse events; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse via office Staff.  This case is linked with 2019SA267180, 2019SA267187, 2019SA267186 (same reporter)  This case involves a 14 years old female patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  no other vaccine was given.   On 11 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1903 , exp date: 19 May 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the 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  List of documents held by the sender: none
p/vax pt reports intense pain @ inj site for several days;also reports weakness & tingling in lt arm;
Left breast implant (on same side of body where vaccine was administered) Became hard and swollen as if it was developing capsular contracture. It was tender and had shifted upward on my chest. This lasted for several days until swelling and hardening went away .  I also developed noticeable  hair loss  that started about one week post  vaccination and lasted several seeks before slowing down.  Lastly, menstrual changes with heavier and more painful periods have developed with this now being my second cycle post vaccination that is still  heavier and more painful than before vaccination.
He states that typically every after immunizations he would only have fever and muscle aches but these would go away; He states that typically every after immunizations he would only have fever and muscle aches but these would go away; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) and MYALGIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 028L20A and 033F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Anxiety and Depression. Concomitant products included TELMISARTAN for Anxiety and Depression, NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) and MYALGIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away). At the time of the report, PYREXIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) and MYALGIA (He states that typically every after immunizations he would only have fever and muscle aches but these would go away) had resolved.            Patient was taking meds before going to bed statin drug. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743833:Master case for SPIKEVAX 2023-2024 PFS
Unprovoked Pulmonary Embolism - symptom onset week of 1/18, hospitalized 1/30-1/31 - treated with oral anticoagulants
Got the vaccine and within 3 minutes her left little finger went completely numb.  Then a couple minutes after that had a really severe stiff neck on the left side, painfully stiff neck.  Then 5 minutes later felt like a knife was being jabbed into her left ear.  She did not inform them of the reaction, and went home.  The symptoms stayed the same and lasted for about an hour and a half and then all were completely gone.  Her arm was a little sore, but mothing severe.
(R) leg cellulitis, erythema, tenderness at inj. site and 8 cm beyond. (R) thigh only 1st KINRIX.
bad cough; fever; fatigue; achiness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bad cough), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (achiness) in a 40-year-old female 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced COUGH (bad cough), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (achiness). At the time of the report, COUGH (bad cough), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (achiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Crosslinked to case MOD21-083038 and MOD21-083112.  No relevant concomitant medications reported. No treatment information was provided.
The adverse reaction made me feel worse on the 20th (48hrs later) and most noticeable was the left side of jaw/ face, near ear was swollen and swelling of left arm pit. When I swallow, I feel pressure in my left ear / eardrum.  This is everything up to 11am this morning. No treatment given. Hoping the pain and swelling go away.
Hives on arms, hives in mouth, extreme itching, headache, hives on chest, trouble swallowing, trouble breathing, dizziness, loss of balance.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 16-month-old patient, who on 28-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 476 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA007325.
Burning and swelling at site of injection. Noticed 2 days after. Pt described 2" lump.
Early the next morning I had a red rash on my chest and the back of my shoulders. It really itched and I went to the Doctor. They gave me anti-itch stuff from the injection.  Then my Lymph nodes swelled up in my throat. I went home and took my medicine and the itching stopped in about two days.
Narrative:  COVID infection after completion of COVID vaccine series: 03/05/2021 COVID vaccine dose #1 03/30/2021 COVID vaccine dose #2 07/14/2021 Pt reported onset of cough, fever, and rhinorrhea. Stated had close contact with COVID positive case (spouse). 07/19/2021 COVID positive per agency nasopharyngeal swab 07/20/2021 Pt reported continuation of symptoms with concern for cough producing brown phlegm 07/21/2021 Pt reported improvement of symptoms 07/22/2021 Pt reported improvement of symptoms
Information has been received from a physician concerning a 9 week old male patient with Hirschsprung's disease, a history of ileostomy and no known drug reactions/allergies who on 03-MAY-2010 was vaccinated with a 2 ml PO dose of ROTATEQ (lot# 665169/0018Z). There was no concomitant medication. On 06-MAY-2010 the patient experienced large amounts of "out put" from the ileostomy and dehydration after receiving ROTATEQ and was hospitalized. Medical attention was sought by an office visit. The patient received treatment with intravenous fluids. At the time of the report, the patient had not recovered. The reporting physician considered large amounts of "out put" from the ileostomy and dehydration to be disabling and other important medical events. Additional information has been requested.
Client reports waited 15 minutes post vaccine and felt fine, started feeling on heway home that her throat and chest were tight so retuned to vaccination site. Vitals were all normal with O2 at 99%. Administered 100 mg Benadryl IM. All tightness resolved within 15 minutes of receiving Benadryl. Continued to monitor client for 30 minutes, client released to family member with insructions  to call 911 for any further complications.
p/recv vax pt several weeks later devel rotavirus; no lab tests performed to confirm the dx
Large area of redness/swelling at injection sites 17 hours after vaccinating. Sites warm to touch. Worsening of symptoms at 48 hours. Swelling subsiding at 72 hours.
pt recvd vax on 7JUN94 lt upper arm became swollen/indurated w/loss of ROM; pruritus; recommended warm compresses; DPH given;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 08Jul2022 at 12:00 as dose 4 (booster), single (Lot number: FP7135), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Aug2023 to 19Aug2023.
Arm was swollen for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was swollen for a couple of days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included OMEPRAZOLE, IRON (IRON ORAL) and BUPROPION for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was swollen for a couple of days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Jan-2021, VACCINATION SITE SWELLING (Arm was swollen for a couple of days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment for the event included ice.   This case was linked to MOD-2021-065230 (Patient Link).
Thursday I got extremely nauseous, muscle weakness as well as muscle pains, started vomiting throughout the night. Friday, I was still extremely weak and had muscle pains and nauseousness, struggling to get up for very long because I felt like I was going to pass out. Still have been nauseous through the weekend and very weak.
I got them/I had that shot too got them . not fun , got the Two ones / Suspect vaccination failure; I got them/I had that shot too got them . not fun , got the Two ones; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, 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 Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles. The patient stated that he/she had that shot too and still got them, not fun and mentioned he/she got the two ones now they had to pay for each shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Pt c/o pain left arm. Limited ROM. Arm is swollen and warm to touch. Ice area, take benadryl and Medrol dose pak prescribed for worsening symptoms
muscle pain, All joints hurt except my elbow joints,  I have stabbing pain in both sides of my face when I get these stabbing pains I get nauseous, dizzy and weak. I also hear a very horrible noise in my head. it sounds like lots of wind chimes chiming horribly at the same time. It feels like a heat lamp is held on both buttocks. and like both my feet are in warm water. my eye sight have drastically declined.
p/vax next morning entire upper arm firm, warm to touch, red & swollen;remains itchy;hot & swollen 2 days later;
patient received COVID-19 vaccine at the ER on 12/21 at 1515 and developed severe allergic reaction to the vaccine. Vitals reported at 1642 were as follow:  BP :148/77 Pulse: 82 Temp: 98.4 °F (36.9 °C) Resp: 18 SpO2: 96 % . Patient received Benadryl 50 mg IV, Epipen 1 mg IM injection, pepcid 20 mg IVP, and solu-medrol 125 mg IVP. She was observed for 2 hours then discharged with no issues
Pt. reported feeling itchy all over her body approximately 1 hour after receiving Moderna Vaccine.  Pt. was given oral Loratadine and Benadryl 50mg at approximately 12:05 and found relief with medications but also reported a tingling sensation on both sides of cheeks that extended to her lips.  At approximately 1:30 pt. reported feeling heart palpitations, Dr. ordered an EKG - results were nornal.  An IV was started at this time and pt. received .  IV Bolus of LR 1 L was administered.  Pt. was evaluated by Dr. and discharged home at approximately 4pm that same day.  Pt. symptoms did not worsen
1 hr after vaccination, pt reported to feel dizzy, weak, vision went black for a few seconds, got pale with purple lips x 1/2hr. Felt better after drinking OJ. Then got temp 101F and chills x 1 day.
received undiluted doses of the vaccine; received undiluted doses of the vaccine; This is a spontaneous report from a contactable physician reported same events under the same suspect product for 4 patients. This is three of 4 reports.  A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: EW0179; expiration date: Aug2021), dose 2 via an unspecified route of administration, administered in left arm on 01Jul2021 (at the age of 12 years), as 0.3 ml single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number and expiration date were not reported), administered on an unknown date, as single dose for COVID-19 immunisation. On 01Jul2021, patient received undiluted 0.3 ml dose of the vaccine. The physician reported as serious. Outcome of an events was unknown. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the serious event "overdose"and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021822170 Same reporter/product/event, different patient
107 patients received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 10:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 26-Aug-2021 at 10:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine). On 26-Aug-2021 at 10:02 AM, EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.  No concomitant medicines were reported No treatment medicines were reported