chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Cardiac function test, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: the grandmother then developed chest pain/tightness; the grandmother then developed chest pain/tightness; She developed shortness of breath, redness, and "not feeling well" a few minutes after the PNEUMOV AX-23 shot.; She developed shortness of breath, redness, and "not feeling well" a few minutes after the PNEUMOV AX-23 shot.; She developed shortness of breath, redness, and "not feeling well" a few minutes after the PNEUMOV AX-23 shot.; This spontaneous report was received from a patient's grandchild and refers to a 75-year-old female patient. The patient's concurrent conditions included hypertension and diabetes mellitus. Her concomitant therapies included insulin, cyanocobalamin (Vitamin B 12), pregabalin (LYRICA), oxybutynin, metformin, simvastatin (manufacturer unknown), famotidine, Vitamin D, Vitamin A, quetiapine fumarate (SEROQUEL), lisinopril (manufacturer unknown) and hydrochlorothiazide (reported as HCTZ). She had no known drug allergies. On an unknown date, reported as "slightly before", the patient received a flu shot without incident.    On 04-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #, expiry date, exact dose, route of administration and vaccination site were not specified) for prophylaxis.       On the same date, a few minutes after the vaccination, she developed shortness of breath, redness, and she was not feeling well. A member of the pharmacy staff where she received the vaccine gave her a shot of epinephrine. After this, the patient developed chest pain and tightness, and emergency medical services (EMS) was called. She was taken to the emergency room (sought medical attention), where a full exam was performed (including electrocardiogram (ECG) and "everything for the heart"). She received diphenhydramine hydrochloride (BENDARYL) and steroids in the hospital and she was there for almost a full day for observation after the vaccination. The outcome of the events was reported as recovering/resolving.     The aforementioned events were considered to be life threatening by the reporter.  Causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 75.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Erythema, Malaise
Clinical narrative: the grandmother then developed chest pain/tightness; the grandmother then developed chest pain/tightness; She developed shortness of breath, redness, and "not feeling well" a few minutes after the PNEUMOV AX-23 shot.; She developed shortness of breath, redness, and "not feeling well" a few minutes after the PNEUMOV AX-23 shot.; She developed shortness of breath, redness, and "not feeling well" a few minutes after the PNEUMOV AX-23 shot.; This spontaneous report was received from a patient's grandchild and refers to a 75-year-old female patient. The patient's concurrent conditions included hypertension and diabetes mellitus. Her concomitant therapies included insulin, cyanocobalamin (Vitamin B 12), pregabalin (LYRICA), oxybutynin, metformin, simvastatin (manufacturer unknown), famotidine, Vitamin D, Vitamin A, quetiapine fumarate (SEROQUEL), lisinopril (manufacturer unknown) and hydrochlorothiazide (reported as HCTZ). She had no known drug allergies. On an unknown date, reported as "slightly before", the patient received a flu shot without incident.    On 04-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #, expiry date, exact dose, route of administration and vaccination site were not specified) for prophylaxis.       On the same date, a few minutes after the vaccination, she developed shortness of breath, redness, and she was not feeling well. A member of the pharmacy staff where she received the vaccine gave her a shot of epinephrine. After this, the patient developed chest pain and tightness, and emergency medical services (EMS) was called. She was taken to the emergency room (sought medical attention), where a full exam was performed (including electrocardiogram (ECG) and "everything for the heart"). She received diphenhydramine hydrochloride (BENDARYL) and steroids in the hospital and she was there for almost a full day for observation after the vaccination. The outcome of the events was reported as recovering/resolving.     The aforementioned events were considered to be life threatening by the reporter.  Causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature range 6°F to 14°F Time frame 80 hours; This spontaneous report was received from an office manager, referring to a 12-months-old patient of unknown gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.    On 31-AUG-2020, at the age of 12-months-old, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S004554 which has been verified to be valid, expiration date reported and validated as 14-FEB-2021) as prophylaxis. The vaccine administered experienced a temperature range from 6 degrees Fahrenheit (F) to 14F, for 80 hours, as recorded by a data logger (product storage error). There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA007304: US-009507513-2009USA007311:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: unspecified injection site side; This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that the Shingrix seems to have a high side effect rate in his practice. Pharmacist did not elaborate about any patient types or specific events, only that Shingrix vaccine had a lot of side effects to it. The reporter did not consented to follow-up. This case is linked with US2020187143, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187143:same reporter
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: pharmacist accidentally gave a 63 year old patient, 0.7 ml dose of Fluzone High Dose Quadrivalent, no AE; pharmacist accidentally gave a 63 year old patient, 0.7 ml dose of Fluzone High Dose Quadrivalent, no AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist via phone.  This case involves a 63 year old female patient who was vaccinated with a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Prefilled syringe, lot number UJ450AA and expiration date 30-Jun-2021) via an intramuscular route in the upper arm on 01-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccine concomitantly.    It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, the patient had no adverse event.  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.
Age: 8.0
Sex: M
Vaccine: FLU4, HEPA, IPV, RUB, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient was inadvertently administered an expired Ipol, No AE; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.   This case involves a 8 years and 9 months old male patient who was inadvertently administered an expired POLIOMYELITIS VACCINE (INACTIVATED) IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RUBELLA VACCINE, HEPATITIS A VACCINE, VARICELLA ZOSTER VACCINE (VARICELLA) and INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  On 02-Sep-2020, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot P1A171M, expiry date: 24-Apr-2020) once via intramuscular route in unknown administration site for prophylactic vaccination. On the same day, the patient visited the physician.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error..
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered a 0.7 ml  Fluzone High Dose to 8 years old patient, no AE; administered a 0.7 ml  Fluzone High Dose to 8 years old patient, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the nurse via phone.  This case is linked to case 2020SA242573 (same reporter).  This case involves an eight-years-old female patient who was vaccinated with a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, lot UJ450AB and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid on 01-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not received any other vaccine concomitantly.    It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  At the 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 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.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Injection site pain, Nausea, Sleep disorder
Clinical narrative: severe pain in shoulder and arm where shot was administered. Up all night with major nausea. Next day so far mild nausea still present, weakness and extreme fatigue.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Palpitations
Clinical narrative: palpitations, nausea, dizziness Close monitoring and supportive treatment
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Feeling abnormal, Rash, Rash pruritic
Clinical narrative: SHE FELT BAD FOR A COUPLE OF DAYS, RUN DOWN AND TIRED, BUT THAT WAS EXPECTED.  ON SATURDAY SHE NOTICED A RASH ALL OVER TORSO, BOTTOM, AND LEGS.  IT IS ITCHY.  SHE USED CALAMINE AND ORAL BENADRYL.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse drug reaction, Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Hypoaesthesia
Clinical narrative: 9-21-2020 8:45 a.m. received a Influenza  vaccine at my Clinic CNP/ nurse administered it and gave me the Influenza. My chart says .5ml(6mo fluzone/Flulaval/Fluarix, 3yr + Afluria) . I inquired and the company is Santa Fe. I have only had one flu shot in the past and that was last year. This the same company for both last years and this years vaccine.  At approximatley 12:30 p.m. I noticed that my left arm to my finger tips felt numb and tingling. At approximatley 1:30 p.m. I called the Clinic to report the symptoms, as I did not see that list of symptoms of the handout and awaited a call back.  I called the clinic back again at about 2:00 p.m. and by then the numbness and tingling was now in my left shoulder, neck and face. I was advised to go the ER. I arrived at the ER at the Hospital at approximatley 2:45 p.m. I was there until 6:00 p.m. As of 9-22-2020  I am still experiencing numb and tingling in my left arm down to my forearm and also in my left cheekbone area.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia, Urine analysis normal
Clinical narrative: 9-21-2020 8:45 a.m. received a Influenza  vaccine at my Clinic CNP/ nurse administered it and gave me the Influenza. My chart says .5ml(6mo fluzone/Flulaval/Fluarix, 3yr + Afluria) . I inquired and the company is Santa Fe. I have only had one flu shot in the past and that was last year. This the same company for both last years and this years vaccine.  At approximatley 12:30 p.m. I noticed that my left arm to my finger tips felt numb and tingling. At approximatley 1:30 p.m. I called the Clinic to report the symptoms, as I did not see that list of symptoms of the handout and awaited a call back.  I called the clinic back again at about 2:00 p.m. and by then the numbness and tingling was now in my left shoulder, neck and face. I was advised to go the ER. I arrived at the ER at the Hospital at approximatley 2:45 p.m. I was there until 6:00 p.m. As of 9-22-2020  I am still experiencing numb and tingling in my left arm down to my forearm and also in my left cheekbone area.
Age: 89.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient presented with redness on her left arm that went from her deltoid muscle to her elbow.  It was warm to the touch and patient claimed it was painful.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: pt received severe swelling and redness, pt went to physician and was told to take Benadryl and ice, swelling subsided after 4 days
Age: 34.0
Sex: U
Vaccine: FLUA4, PPV
Symptoms: Allergy test, Injection site pain, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: On 09/19/20 woke up with severe arm pain. Persisted entire day. Next morning noticed that large (2-3" diameter) welt near injection site. Warm to touch and very painful. Dr. recommended  Benadryl and Advil and ordered allergy panel (blood drawn 9/21). Today welt is gone, but still tender.
Age: 34.0
Sex: U
Vaccine: FLUA4, PPV
Symptoms: Urticaria
Clinical narrative: On 09/19/20 woke up with severe arm pain. Persisted entire day. Next morning noticed that large (2-3" diameter) welt near injection site. Warm to touch and very painful. Dr. recommended  Benadryl and Advil and ordered allergy panel (blood drawn 9/21). Today welt is gone, but still tender.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: pt stated that he had passed out at his doctors office after receiving 2 shots at the same time before but that he has had shots since without problems. I informed him that if he wanted the shot then he would have to remain seated for awhile after his shot to make sure he was ok. After the shot, I asked him how he felt and he said he felt fine and that if he was going to pass out it would be instantaneous. I told him to sit in the chair for 10-15 minutes so we could be sure he was ok. After about 5 minutes he passed out
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia, Tenderness
Clinical narrative: I received the Shingles shot at 3:00 Pm at the doctor's office went home, in about 2 hours after receiving it my upper arm was feeling sore, as the night progressed on my upper right arm felt like someone punched me in the arm. Went to bed at 10:30Pm  woke up at 3:00 Am  Shivering,some muscle ache, upper right arm still sore. I took a tylenol when the tylenol kicked in it helped a bit with the soreness in my upper right arm fell back asleep 40 mins after woke up at 10:30 am No shivering but, feel tired arm still sore to the touch
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given high dose vaccine due to improper patient intake at a vaccine clinic provided to the facility. Pt is 61 years old. No adverse reaction reported.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: rash, sore arm, cant lift arm above shoulder height, rash traveling to elbow.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received FLUBLOK intended for patients aged 18 or older.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives -- not allergic to eggs as I was questioned before the vaccine was adminitered
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: patient received a pediatric dose and needs an adult dose.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient reported redness, swelling, and soreness to the area. She reports that the redness then spread down her arm. When I looked at her arm a week from the date she received it. There was bruise like redness below her elbow. The point of injection side had no swelling or redness.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Migraine, Neurological examination normal, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt received seasonal flu vaccine at pharmacy on a Sunday evening (which preparation is not known so do not know if this was a fluzone product). Monday morning awakening with redness, tenderness, and swelling in area of vaccine on left shoulder and with migraine.  Presented to clinic on Tuesday due to area of swelling, swelling and tenderness on left shoulder increasing and migraine not responding to medication. Neuro exam intact at visit. No limited ROM, weakness or changes in grip strength at visit.  Pain localized to affected area at visit. Pt denies any numbness or tingling at visit.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Left upper arm. Reaction wraps around arm and is about 4 inches wide. Informed pt to use cool compress and OTC Benadryl. Pt understands.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: patient came in today and showed right arm there was a red rash all around the area and down the upper arm a little. patient said had been sore and itchy and burning after injection and she rubbed her arm alot didnt know if that made it worse. I told patient to have it looked at by md
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: sore arm, mobility issues
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: hives
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Malaise
Clinical narrative: Patient felt sick and had trouble walking and eventually went to the emergency room
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MMRV, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt had syncope, loss of consciousness for 1 or 2 minutes. Ammonia inhalant used to arouse patient. Pt remained in clinic for 30 minutes to assure patient was feeling better.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Large red area bigger than patient hand on patient's left arm. Area has grown in size over the last couple of days.  It is warm to the touch, and patient has reported a fever of 100.8 F. Patient has not tried any treatments to relieve the symptoms. Patient has not contacted her provider about the incident.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Limb injury, Mobility decreased
Clinical narrative: Shoulder injury;   Two hours after injection, experienced severe pain in left arm with no mobility.  Called Pharmacy and was advised that "it might be frozen shoulder"...  take anti inflammatory.   Unable to take anti-inflammatories due to kidney cancer resulting in 1/2 of one functioning kidney and complete removal of other.  Followed up with PCP.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Laboratory test, Lip swelling, Paraesthesia oral, Urticaria
Clinical narrative: Patient called 2 hours later with hives and tingling in her lips. She went to the urgent care where she had IV steroids, benadryl and Pepcid. Hives had progressed and she had swelling of her upper lip. She had no respiratory symptoms. She was discharged on a Medrol Dosepak and Benadryl. She had elevated blood pressure during the medication course.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Contusion, Injection site nodule, Pain in extremity
Clinical narrative: Several hours after patient was administered flu shot, she complained of sore arm, bruising, and a knot at the site of the injection
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pharyngeal swelling
Clinical narrative: Patients throat swelled up and had to get medical attention from the ER.
Age: 70.0
Sex: M
Vaccine: FLUA4, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient has experienced pain in the left shoulder since vaccination.  Pain comes and goes.  Patient has not received any treatment for this condition.  Patient mentioned he heard a "weird" noise during the vaccination that sounded like a squeegee.
Age: 76.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Asthenia, Chest discomfort, Feeling abnormal, Influenza like illness, Pruritus
Clinical narrative: Rash, itching, "flu-ish", weakness, chest tightness Pt has undocumented on profile allergy to all steroids + neomycin. Previously tolerated Fluzone HD w/o incident. Status of allergy has been added to profile. At time of vaccination pt was concerned about this and was told it wasn't in the vaccine. No mention of neomycin or steroid allergy. Pt. is extremely uncomfortable & is hoping someone will reach out to her. She was seen @ the clinic and was prescribed Atarax for rash. The nurse heard nothing in the lungs but prescribed Albuterol MDI. Pt is concerned that is now over 10 days and she still Feels "awful" when will the affects subside. We will follow up with pt on 9/29.
Age: 76.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Rash
Clinical narrative: Rash, itching, "flu-ish", weakness, chest tightness Pt has undocumented on profile allergy to all steroids + neomycin. Previously tolerated Fluzone HD w/o incident. Status of allergy has been added to profile. At time of vaccination pt was concerned about this and was told it wasn't in the vaccine. No mention of neomycin or steroid allergy. Pt. is extremely uncomfortable & is hoping someone will reach out to her. She was seen @ the clinic and was prescribed Atarax for rash. The nurse heard nothing in the lungs but prescribed Albuterol MDI. Pt is concerned that is now over 10 days and she still Feels "awful" when will the affects subside. We will follow up with pt on 9/29.
Age: 76.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Dyspnoea, Pruritus, Pyrexia, Rash
Clinical narrative: Rash, itching, "flu-ish", weakness, chest tightness Pt has undocumented on profile allergy to all steroids + neomycin. Previously tolerated Fluzone HD w/o incident. Status of allergy has been added to profile. At time of vaccination pt was concerned about this and was told it wasn't in the vaccine. No mention of neomycin or steroid allergy. Pt. is extremely uncomfortable & is hoping someone will reach out to her. She was seen @ the clinic and was prescribed Atarax for rash. The nurse heard nothing in the lungs but prescribed Albuterol MDI. Pt is concerned that is now over 10 days and she still Feels "awful" when will the affects subside. We will follow up with pt on 9/29.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: vaccines that were administered to patients after excursion occurred; This spontaneous report was received from a nursing assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 12-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T002846, expiration date reported and validated as 23-JAN-2022) for prophylaxis, that experienced a temperature excursion (product storage error). Digital Data logger was involved. The administered dose of the vaccine experienced a temperature and time frame of -10.2 degrees Celsius for 1 hour and 53 minutes. No previous temperature excursion was reported.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA014803:AE Case # 01697212 US-009507513-2009USA000113: US-009507513-2008USA014888: US-009507513-2008USA014697:
Age: 21.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details; improperly stored vaccine administered to patient; This spontaneous report was received from a nurse and refers to a 21-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot# S008151, expiry date 20-NOV-2021 (route and site of administration were not reported) for prophylaxis.  The vaccine underwent a temperature excursion of 48.39 degrees Fahrenheit (F) for 1 hour and 45 minutes. There were no previous excursions. The call was because of digital data logger. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE/PQC reported; PROQUAD that expired yesterday was given today; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 17-SEP-2020, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) 0.5 milliliter, lot # S008571, expiration date 16-SEP-2020 (route of administration was not reported) for prophylaxis. There was no other adverse events or product quality complaint reported.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took two doses of Vivotif which were not stored correctly; Spontaneous report received on 28JUL2020.  A male consumer reported that he "took two doses of Vivotif which were not stored correctly" (PT: Product storage error). He was receiving Vivotif for immunisation. The consumer started Vivotif and he took only two viable doses around three weeks ago. Later, he took two remaining doses of Vivotif which were not stored correctly and he wanted to know if Vivotif was still viable after a temperature excursion exceeding 50 degree Fahrenheit for 2 to 4 days. He did not have the lot number. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took two doses of Vivotif which were not stored correctly (Incorrect product storage). This consumer took other doses correctly but took the remaining doses where the Vivotif was exposed to temperatures exceeding 50 degrees Fahrenheit for 2 to 4 days. Vivotif should always be stored in refrigerator at the recommended temperature. Considering the case information, the causality of incorrect product storage is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer took two doses of Vivotif which were not stored correctly (Incorrect product storage). This consumer took other doses correctly but took the remaining doses where the Vivotif was exposed to temperatures exceeding 50 degrees Fahrenheit for 2 to 4 days. Vivotif should always be stored in refrigerator at the recommended temperature. Considering the case information, the causality of incorrect product storage is assessed as not applicable to Vivotif due to the nature of the event.
Sex: F
Vaccine: PNC13
Symptoms: Death, Pneumonia
Clinical narrative: died from pneumonia even though she got her shot [Prevnar 13]; pneumonia; This is a spontaneous report from a Pfizer-sponsored program - Sept 2020 from a contactable consumer reported for a female patient (Mother). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient died from pneumonia even though she got her shot pneumococcal 13-val conj vac (dipht crm197 protein). It's been a year. The patient died on an unspecified date. It was unknown if an autopsy was performed.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Reported Cause(s) of Death: pneumonia; pneumonia even though she got her shot [Prevnar 13]
Age: 0.58
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient received Quadracel instead of Pentacel, No AE; A 7 month old patient received Quadracel, no AE; The patient received quadracel on right vastus lateralis, no AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 7 month old male patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] on right vastus lateralis instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered, product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 10-Aug-2020, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5688AA, expiry date: 26-Nov-2021) once via unknown route in the right vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered, product administered to patient of inappropriate age and product administered at inappropriate site.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: M
Vaccine: FLUC4
Symptoms: Escherichia infection, Escherichia test positive
Clinical narrative: E. coli infection; The patient was sent to emergency room/ symptoms unknown; This spontaneous case was received on 14-Sep-2020 from pharmacist via Med Communications (reference number: SEQW20-01644) and concerned 73-year-old, male patient.   The patient's medical history and concomitant medications were not reported.   On 24-Aug-2020, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) as protection against seasonal influenza. The reported batch number was 276530 and expiry date was 01-Jun-2021.   On 11-Sep-2020, 18 days after receiving Flucelvax QIV, the patient was sent to emergency room (ER) and sent home on the same day. He was not hospitalized. The reporter did not know the symptoms that prompted the ER visit.    On 13-Sep-2020, 20 days after receiving Flucelvax QIV, the patient was subsequently hospitalized. The patient underwent blood culture which revealed E. coli and the patient had E. coli infection. He was treated with unspecified intravenous (IV) antibiotics.   At the time of initial reporting on 14-Sep-2020, the patient was still in hospital and had not recovered.  The outcome of unevaluable event' was not reported.    The patient's hospital healthcare provider told that E. coli could have been due to receiving Flucelvax QIV. The reporter did not provide a causality assessment for unevaluable event'.  The reporter assessed the case as serious.  Company comment: The patient was vaccinated with the suspect product, Flucelvax QIV. Reportedly, 18 days after vaccination the patient was sent to emergency room (ER) and sent home on the same day. The reporter did not know the symptoms that prompted the ER visit. Twenty days post vaccination, the patient was hospitalized, and blood culture revealed Escherichia infection. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and Escherichia infection is assessed as not related due to biological implausibility. Causality for unevaluable event is assessed as unassessable.; Reporter's Comments: The patient's hospital healthcare provider told that E. coli could have been due to receiving Flucelvax QIV.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax QIV. Reportedly, 18 days after vaccination the patient was sent to emergency room (ER) and sent home on the same day. The reporter did not know the symptoms that prompted the ER visit. Twenty days post vaccination, the patient was hospitalized, and blood culture revealed Escherichia infection. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and Escherichia infection is assessed as not related due to biological implausibility. Causality for unevaluable event is assessed as unassessable.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Acute headache developed approximately 8:30a.m. the following morning. Extreme nausea onset approximately 11:30a.m. Arm extremely sore, began approx. 8 pm the night of injection.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: had swelling the "size of a lemon" at injection site
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Discomfort, Injection site pain, Pain, Sleep disorder
Clinical narrative: Pt complained of pain at time of injection, most painful shot she has had, thought it was high on arm, thought immunizer had trouble with plunger.  Shoulder has bothered her since. Currently throbbing at night and disturbing ability to sleep even though she is taking naproxen for sprained wrist in same arm that occurred 2 days prior to vaccination.  Pt sprained wrist on Tuesday, came in for naproxen Rx on Thursday and got flu shot while here to pick up. Pt feels discomfort not related to sprain event.
Age: 11.0
Sex: F
Vaccine: HEPA, MMRV, TDAP
Symptoms: Unevaluable event
Clinical narrative: Over vaccination
Age: 22.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain, Angiogram, Colonoscopy, Endoscopy, Feeding disorder
Clinical narrative: Immediately after vaccine was administered 05/02/2015 the patient started experiencing chronic gastrointestinal issues to include IBS-D, chronic abdominal pain, as well as a slight sensitivity to certain foods. Immediately following the 2nd vaccine administered 09/10/2018, all outstanding health issues caused by initial vaccine were exacerbated causing chronic pancreatitis, chronic abdominal pain, insomnia, inability to consume solid foods and continues to be an issue to this date.
Age: 22.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Food intolerance, Gastrointestinal disorder, Immediate post-injection reaction, Insomnia, Irritable bowel syndrome
Clinical narrative: Immediately after vaccine was administered 05/02/2015 the patient started experiencing chronic gastrointestinal issues to include IBS-D, chronic abdominal pain, as well as a slight sensitivity to certain foods. Immediately following the 2nd vaccine administered 09/10/2018, all outstanding health issues caused by initial vaccine were exacerbated causing chronic pancreatitis, chronic abdominal pain, insomnia, inability to consume solid foods and continues to be an issue to this date.
Age: 22.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Magnetic resonance cholangiopancreatography, Pancreatitis chronic, Vaccine positive rechallenge
Clinical narrative: Immediately after vaccine was administered 05/02/2015 the patient started experiencing chronic gastrointestinal issues to include IBS-D, chronic abdominal pain, as well as a slight sensitivity to certain foods. Immediately following the 2nd vaccine administered 09/10/2018, all outstanding health issues caused by initial vaccine were exacerbated causing chronic pancreatitis, chronic abdominal pain, insomnia, inability to consume solid foods and continues to be an issue to this date.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, injection site warm, red and tender to touch.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Granuloma annulare, Rash
Clinical narrative: Developed diffuse rash which has persisted, recent biopsy shows Granuloma Annularum
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe and intense left arm pain starting 2 hours after administration. Limited motion in left arm. Pt used heating pad and Tylenol to treat pain but with no effect on pain. Pt was prescribed acetaminophen-codeine to treat the pain, no effect on pain. 5-6 days later, pt noted a decrease pain. Spoke to pt on 9/22, still notes a limited range of motion.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swelling at the site of injection. It took about 10 seconds to swell came out to be size of half golf ball
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Within a 12-15 hour period post-vaccination patient began to experience pruritis with faint rash under her upper arms, forearms and abdomen.  Patchy, lightly raised rash noted.  No other symptoms noted.
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site mass
Clinical narrative: Approximately one month after treatment, round lump the size of a marble appeared at vaccination site. It is not red and is not painful. Still persists as of 9/22/20.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hypoaesthesia
Clinical narrative: The evening of the vacination, I had severe chills in spite of the fact that I had taken 2 extra strength Acetaminophen a few hours before for my Sciatica.  The next morning the chills were gone.  Around 11:00am the morning following the vacination, I had a sudden loss of feeling in both of my hands.  This caused a numbness feeling as though both hands had fallen asleep.  I placed my hands under hot water, but could not feel the heat of the water.  I was able to flex my fingers.  After doing this for about 10 minutes the feeling returned in both hands.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Pt seen next day in office with large area of erythema, itching, redness, swelling and pain
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Confusional state, Gait inability, Peripheral swelling, Rash
Clinical narrative: mental confusion, weakness, unable to walk and rash with swelling on arm
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Concussion, Syncope
Clinical narrative: Patient was discharged from appointment and collapsed in lobby. After further review patient was not told to wait I exam room for 15 minutes.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt seen in clinic next day with large area of erythema, red, hot to touch and painful
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Minimal tenderness, mildly warm with redness and swelling around injection site.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia, Skin warm, Urticaria
Clinical narrative: Low-grade fever, welted up arm, warm to touch
Age: 83.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching and swelling at the vaccine site of the pneomovax
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: syncope approximately 5 minutes after injection while leaving the office building
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Lower portion of arm red and swollen for past 2 days
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Hypoaesthesia, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Extreme muscle pain and soreness in the buttocks and legs from Sep 15?18. I was unable to sleep on Sep16 because of the pain. On Sep 18 leg soreness subsided, but feet felt numb and it was nearly impossible to stand in place and bending over to pick something up off the floor is painful. I could walk, but with difficulty. Sep 20 to now the numbness has gotten much better, but it's totally gone.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: pain and soreness in right arm - continuing for 2 weeks
Age: 83.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis in the right arm  the same day they got the Pnemovax23 in that arm.  Pt went to urgent care on 09/20/20 and received antibiotic treatment.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Bursitis, Injected limb mobility decreased, Pain in extremity, Vaccination complication
Clinical narrative: Manufacturer Merck Company Lot 00006-4837-01    Patient received a flu and pneumonia shot  during her 09/21/2020 office visit and her flu shot was fine but the arm she got the pneumonia shot in, she had having excruciating pain in and could barely move it. Patient diagnosed 09/20/20 with subacromial bursitis caused by an immunization injection.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Severe body aches, headache, fever above 100
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Blood test normal, Eating disorder, Facial paralysis, Guillain-Barre syndrome
Clinical narrative: Started on 8-28 with tingling in toes, and pain in neck. The tingling turned to numbness, which began ascending through the body. The numbness took over the extremities, and there was excruciating pain (not muscular) in upper/mid back that made sleeping impossible. At this point legs could not support the weight of whole body. Doctor visit, and Neurologist visit on Friday September 4th- both could not make a diagnosis. On Saturday (9-5) left side of the face began to drop (eyes and mouth), made talking and eating more difficult. On Sunday evening went to ER and was immediately admitted. An MRI was conducted the night of the 6th, and was diagnosed with the Guillain Barre Syndrome on Monday, September 7th 2020.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Magnetic resonance imaging abnormal, Neck pain, Paraesthesia, Sleep disorder
Clinical narrative: Started on 8-28 with tingling in toes, and pain in neck. The tingling turned to numbness, which began ascending through the body. The numbness took over the extremities, and there was excruciating pain (not muscular) in upper/mid back that made sleeping impossible. At this point legs could not support the weight of whole body. Doctor visit, and Neurologist visit on Friday September 4th- both could not make a diagnosis. On Saturday (9-5) left side of the face began to drop (eyes and mouth), made talking and eating more difficult. On Sunday evening went to ER and was immediately admitted. An MRI was conducted the night of the 6th, and was diagnosed with the Guillain Barre Syndrome on Monday, September 7th 2020.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Speech disorder, Weight bearing difficulty
Clinical narrative: Started on 8-28 with tingling in toes, and pain in neck. The tingling turned to numbness, which began ascending through the body. The numbness took over the extremities, and there was excruciating pain (not muscular) in upper/mid back that made sleeping impossible. At this point legs could not support the weight of whole body. Doctor visit, and Neurologist visit on Friday September 4th- both could not make a diagnosis. On Saturday (9-5) left side of the face began to drop (eyes and mouth), made talking and eating more difficult. On Sunday evening went to ER and was immediately admitted. An MRI was conducted the night of the 6th, and was diagnosed with the Guillain Barre Syndrome on Monday, September 7th 2020.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: hives on back and arms starting the day after administration lasting about 2 days