chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from medical assistant concerning an unspecified amount of patients. The reporter stated that on an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, dosage schedule, route, lot number and expiry date not provided). There was no concomitant medication reported. No adverse effects were reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
The arm the PNEMOVAX 23 was given became very sore and warm to the touch. She got very ill with flu like symptoms that evening. She woke up the next day a little better. I gave her an ice pack the day of the vaccination and told her if it got worse to call her physician. I called her the next day and that's when I found out she got sick.
very sore arm; low grade fever; rash chest and back; electrical shock feeling like upper side of teeth; aches; This is a spontaneous report received from a contactable consumer (Patient). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9266 and Expiration date was not reported), via an unspecified route of administration, in left arm, on 21Feb2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9262 and Expiration date was not reported), via an unspecified route of administration, in arm left, on 31Jan2021 at 15:00 (at the age of 58 years), as a single dose for COVID-19 immunisation. On an unknown date, the patient stated that very sore arm for 2-3 days onset immediate stayed in bed next day aches, low grade fever better by evening, rash chest and back(shoulders) 3rd day electrical shock like feeling right side upper teeth-lasted about 1 week. AE doesn't require a visit to Emergency Room, Physician Office. There was no treatment received. Outcome of the events was reported as unknown.  No follow up attempts are needed. No further information is expected.
The needle stuck the patient in the arm; Tried to cover the needle with the cap and the end of the glass syringe broke off; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional and a consumer/ non health care professional via Medical Information (under reference number 00851878).   This case involves a 69 years old male patient who after administration of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], while pulling the needle out of the patient, they tried to cover the needle with the cap and the end of the glass syringe broke off (needle issue) and the needle stuck the patient in the arm (injury associated with device).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ773AB and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient after administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], while pulling the needle out of the patient, they tried to cover the needle with the cap and the end of the glass syringe broke off (needle issue) and the needle stuck the patient in the arm (injury associated with device)(unknown latency).  It was reported "Caller stated that they was an incident when administering FLUZONE High Dose (HD) to a patient. Caller stated that after administering the injection and pulling the needle out of the patient, they tried to cover the needle with the cap and the end of the glass syringe broke off and projected the needle through the air and the needle stuck the patient in the arm again."   Details of laboratory data were not provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
No adverse event. Staff member said that because the third shot inn the series was not Bivalent it had to be reported to VAERS. It was given because there was an issue with our shipment of bivalent vaccine. The patient is being notified that he got a monovaent and being offered a bivalent.
Period started day after first dose (about 2 weeks early); Period happening every other week since vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the arm left on 07Feb2021 at 00:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had no physical illness. The patient had an unknown food allergy and had sores on mouth. Concomitant medications included cariprazine hydrochloride (VRAYLAR) taken from unspecified date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Feb2021 at 00:00, the patient had her period started the day after the first dose (reported as about 2 weeks early) and this happened every other week. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events period started day after the first dose(reported as about 2 weeks early) and period happening every other week were not recovered.   No follow-up attempts are needed. No further information is expected.
Case completed primary Covid vaccine series in June 2021, then was hospitalized for Covid in September of 2021. Hospitalized at the hospital Sepsis Assessment & Plan Resolved. Due to bacterial pneumonia. Tachycardia and tachypneic on admission with Lactate 6.5 so initially in ICU. Quickly improved with antibiotics and fluids and transferred to floor. Imaging with RLL consolidation c/w bacterial pneumonia as well as bilateral ground-glass opacities c/w COVID pneumonia. He is fully vaccinated against COVID and 2 weeks into his viral illness. Patient received CTX x3 doses before transitioning him to oral Ceftin. Also received 3d azithromycin. Patient was on room air at discharge. - Ceftin 500mg x3more doses - No home O2    Acute hypoxemic respiratory failure Assessment & Plan Improved. Hypoxic to 80s on arrival, quickly weaned off of oxygen. Secondary to viral and bacterial pneumonias. Plan as outlined elsewhere for pneumonia. - See treatment of sepsis   COVID Assessment & Plan Fully vaccinated with Moderna. Approx 2 weeks into symptoms. Suspect hypoxia and sepsis more from superimposed bacterial pneumonia. - Precautions x 20 days
Patient is unaware that he received a high dose vs regular flu shot. Patient was contacted but has not yet responded to the voicemail. He has not reported any adverse effects.   Md's office was contacted, and a note was put in the patients file
had the shingles vaccine still got the Shingles/ suspected vaccination failure; got the Shingles , was milder; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Shingles vaccine and still got the shingles, was milder. The patient's doctor said that it helps to have vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
developed 3x3in area of redness, warmth, itching to injection site at left deltoid this morning Narrative:
Extremely itchy; Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extremely itchy) and RASH (Full body rash) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 030L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced PRURITUS (Extremely itchy) and RASH (Full body rash). At the time of the report, PRURITUS (Extremely itchy) and RASH (Full body rash) had not resolved.            Concomitant medications were not provided. Treatment information includes patient's Primary care physician gave her steroid and allergy pill (antihistamine).
the patient had abnormal limb movements after they received their first dose of VAXELIS. The customer said the parents of the patient took the patient to the hospital, but the patient was not admitted to the hospital. T; This spontaneous safety report, with reference number 02464343 (Interaction # 02464340) was received by the partner on 01-SEP-2023 and forwarded on 04-SEP-2023, from a health professional.  Due to the nature of the event, the causality between the event " the patient had abnormal limb movements after they received their first dose of VAXELIS. The customer said the parents of the patient took the patient to the hospital, but the patient was not admitted to the hospital" and Vaxelis was related.   Further information is expected.
After being injected with the Evans Flu Vaccine, Lot # 765412, the patients arm became swollen and ached.  That evening the patient experienced flu-like symptoms, i.e. body aches and sore throat.  The MD and a co-worker were also given the same injection and both experienced the same symptoms.
peeing blood; back really hurts; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (peeing blood) and BACK PAIN (back really hurts) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced HAEMATURIA (peeing blood) and BACK PAIN (back really hurts). At the time of the report, HAEMATURIA (peeing blood) and BACK PAIN (back really hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator.  Treatment of these events were not provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Initial report received on 17 September 2009 from a health care professional. A cluster of two patients with no reported medical history experienced oculorespiratory syndrome after receiving FLUZONE SV (lot number not reported), on an unspecified date over the last two to three days. The syndrome consisted of very red and swollen eyes, upper respiratory tract symptoms (shortness of breath, chest pain, cough, congestion). Recovery status was not reported. No further information was provided. List of Documents held by Sender: none.
7/24/99 extremely lethargic, cont ringing in both ears, entire rt arm hurts like toothache from wrist to axis;h/a & dizziness;
Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Reporter has not yet contacted patients for follow up.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 06-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M026876 expiration date on 24-JUL-2017, subcutaneous for prophylaxis which was reconstituted with sterile diluent. At the reporting time, no adverse events were reported.
Severe diarrhea for the past 4 days; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jul2021 16:00 (age at vaccination 61 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient visited doctor or other healthcare professional office/clinic visit. The patient had no allergies. The patient experienced severe diarrhea for the past 4 days on 27Jul2021 8 hrs hours after vaccine application. Patient received treatment for reported event (Prescription). The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
two unspecified patients, who were over the age of 64 years old and already had cervical cancer; two unspecified patients, who were over the age of 64 years old and already had cervical cancer; No adverse events; This spontaneous report was received from a pharmacist via a company representative and refers to a female patient over the age of 64 years old. The patient had already experienced cervical cancer.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse events were reported.   This is one of two reports received from the same reporter (linked with MARRS # 1910USA000552).; Sender's Comments:  US-009507513-1910USA000552:
Severe abdominal pain, vomiting.  Went to ER for evaluation but started to resolve before being seen.  Resolved as of 4/11/21
Woke up 5 hours after the 2nd shot; Limping 6 hours after the 2nd shot; Leg is hurting 6 hours after the 2nd shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SLEEP DISORDER (Woke up 5 hours after the 2nd shot), GAIT DISTURBANCE (Limping 6 hours after the 2nd shot) and PAIN IN EXTREMITY (Leg is hurting 6 hours after the 2nd shot) in a 21-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1416B and AS1416B) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced SLEEP DISORDER (Woke up 5 hours after the 2nd shot), GAIT DISTURBANCE (Limping 6 hours after the 2nd shot) and PAIN IN EXTREMITY (Leg is hurting 6 hours after the 2nd shot). At the time of the report, SLEEP DISORDER (Woke up 5 hours after the 2nd shot), GAIT DISTURBANCE (Limping 6 hours after the 2nd shot) and PAIN IN EXTREMITY (Leg is hurting 6 hours after the 2nd shot) outcome was unknown.            No concomitant drug information was provided.  Patient had the second dose in the upper left leg and 6 hours after vaccination, it appeared patient's leg was hurting and she was crying. Patient didn't experience any events after the first vaccine.  No treatment drug information was provided.
Flu shot killed the patient; Initial information was received on 22-Nov-2020 regarding an unsolicited valid serious case received from a consumer.  This case involves a male patient (unknown age) who died (death), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient died (death) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign it was assumed that the consumer was referring to the Sanofi flu vaccine  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and the cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This was a poorly documented case involves a male patient (unknown age) who died (death) after receiving INFLUENZA VACCINE (unknown manufacturer). Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at time of vaccination and laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: death NOS
COVID vaccine breakthrough event. Pfizer 3/19/21 EN6200, 4/10/21 ER8733, and boosted 8/26/21 FC3182 and 4/8/22 FK9895.
Asthma attacks, fatigue, brain fog, eyebrow hairs fell out, endometriosis pain unbearable, chills, nausea, headaches
This case was reported by a other health professional via call center representative and described the occurrence of erythema in a adult patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .2 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and pharmaceuticals product complaint. On an unknown date, the outcome of the erythema and pharmaceuticals product complaint were unknown. The reporter considered the erythema to be probably related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case as reported by a pharmacy buyer. On 15th September 2015 or after (exact date of administration unknown), the patient received FLUARIX QUADRIVALENT on an unknown arm. The patient experienced localized redness around injection site and on arm. This is one of the five cases reported by the same reporter (see cases US2015133738, US2015133740, US2015133746 and US2015133773). The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. At the time of reporting, any further details were not known by the reporter.
9/11/06 screamed high pitched for 3-4 hours, inconsolable, moaning/whining, temp up to 103.6, warmth at injection site.  Temp went down at 4am.  Dr said would not report.
Patient is a 26 year old female who presents immediately following administration of a single dose of J&J COVID19 vaccine in the left deltoid.  Patient was walking with her mother to their vehicle when she lost consciousness.  Per patient?s mother, the patient has a developmental delay and can be a poor historian.  Patient states that she has never experienced syncope.  She denies allergies to medications and foods.  She has never had a vaccine in the past.  Patient denies a medical history.  Patient states that she takes Concerta and Lexapro on a daily basis.  She denies chest pain/tightness, shortness of breath, wheezing, swelling of the face/lips/mouth/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.  Vasovagal syncope with loss of consciousness. Patient not displaying active signs and symptoms of anaphylaxis.  Patient was transferred to a cot and very quickly regained consciousness.  Patient was A&O x 4 and in NAD. EMS was called to the scene for further evaluation due to limited resources.    EMS called to the site for further evaluation due to vasovagal syncope with loss of consciousness.  EMS related patient was experiencing orthostatic hypotension.  EKD and blood sugar levels were within normal limits.  Patient transported to ER.
2 red raised areas on right arm, no warmth, no fever upper right arm 0.8x0.5cm red & raised lower right arm 2.0cm x 2.0cm red & raised.
Right hand tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Right hand tingling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20Q) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PARAESTHESIA (Right hand tingling). On 26-Jan-2021, PARAESTHESIA (Right hand tingling) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-370489, MOD-2021-374893 (Patient Link).