chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm, 24hr; tiredness the next day; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) administration date 02Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: " neurocardiogenic syncope (P.O.T.S)" (unspecified if ongoing). Concomitant medication(s) included: FLORINEF taken for syncope. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm, 24hr"; FATIGUE (non-serious), outcome "unknown", described as "tiredness the next day".  Additional Information: Caller said that she experienced the next day after vaccine, Sore arm, 24hr, "felt like someone punched me" and tiredness the next day. She have heard that people who had COVID had worse side effects after shot, she asked if was that true. She had been prescribed 0.1mg FLORINEF, which her husband was also taking for about a week for -POTS- neurocardiogenic syncope She was asking for information about how the medication might affect the vaccine, since it was a corticosteroid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP). The reporter is the patient. A 24-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Fatigue for 2.5 days after vaccine". Additional information: Event took place after use of product. Batch and expiry date was unavailable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm just being sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm just being sore".  Additional information: It was reported that the patient was fine with her arm just being sore, but nothing bothering her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal
Clinical narrative: could not find her car. She states she had brain fog, thought she walked 5 blocks/ foggy; confused; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "could not find her car. She states she had brain fog, thought she walked 5 blocks/ foggy"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confused".  Additional information: She went out on Tuesday to do some shopping and could not find her car. She stated she had brain fog, thought she walked 5 blocks. She was confused and foggy for about an hour and then that passed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jan2021 08:30 (Lot number: EL9261) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Jan2021 12:00, outcome "recovered", described as "Sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks and no Covid prior vaccination and not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263437 same patient/drug, different dose/event
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache, Hypokinesia, Limb discomfort
Clinical narrative: Severe pain in my legs, my back, my arm where they injected me/Pain in arm; Severe pain in my legs, my back, my arm where they injected me; Can't move right now; I am slow moving because I am in pain; severe pain in right side and in right arm at injection site; Muscle pain; cannot lift right arm; Dizziness; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 17:15 (Lot number: EN6198) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Mar2021, outcome "not recovered" and all described as "Severe pain in my legs, my back, my arm where they injected me"; HYPOKINESIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "Can't move right now; I am slow moving because I am in pain"; DIZZINESS (non-serious) with onset 03Mar2021 17:45, outcome "recovered" (04Mar2021 17:45), described as "Dizziness"; HEADACHE (non-serious) with onset 03Mar2021 17:45, outcome "recovering", described as "Headache"; INJECTION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "severe pain in right side and in right arm at injection site"; MYALGIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Muscle pain"; LIMB DISCOMFORT (non-serious) with onset 04Mar2021, outcome "not recovered", described as "cannot lift right arm". Therapeutic measures were taken as a result of pain in extremity, back pain, pain in extremity, headache, injection site pain, myalgia.  Additional information: Consumer took some Tylenol for pain in extremity, back pain, pain in extremity, headache, injection site pain, myalgia, Tylenol 500 mg 2 tabs every 6 hours. Consumer reported his right leg seems okay and no fever. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The AE(s) did not require visit emergency Room and physician office. No prior vaccinations within 4 weeks and no AE following prior vaccine reported. No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Severe pain in my legs, my back, my arm where they injected me/Pain in arm; Severe pain in my legs, my back, my arm where they injected me; Can't move right now; I am slow moving because I am in pain; severe pain in right side and in right arm at injection site; Muscle pain; cannot lift right arm; Dizziness; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 17:15 (Lot number: EN6198) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 04Mar2021, outcome "not recovered" and all described as "Severe pain in my legs, my back, my arm where they injected me"; HYPOKINESIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "Can't move right now; I am slow moving because I am in pain"; DIZZINESS (non-serious) with onset 03Mar2021 17:45, outcome "recovered" (04Mar2021 17:45), described as "Dizziness"; HEADACHE (non-serious) with onset 03Mar2021 17:45, outcome "recovering", described as "Headache"; INJECTION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "severe pain in right side and in right arm at injection site"; MYALGIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Muscle pain"; LIMB DISCOMFORT (non-serious) with onset 04Mar2021, outcome "not recovered", described as "cannot lift right arm". Therapeutic measures were taken as a result of pain in extremity, back pain, pain in extremity, headache, injection site pain, myalgia.  Additional information: Consumer took some Tylenol for pain in extremity, back pain, pain in extremity, headache, injection site pain, myalgia, Tylenol 500 mg 2 tabs every 6 hours. Consumer reported his right leg seems okay and no fever. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The AE(s) did not require visit emergency Room and physician office. No prior vaccinations within 4 weeks and no AE following prior vaccine reported. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills headache tired; Chills headache tired; Chills headache tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 09:30 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious), FATIGUE (non-serious) all with onset 04Mar2021 02:00, outcome "recovering" and all described as "Chills headache tired". Therapeutic measures were not taken as a result of chills, headache, fatigue. Additional information: The patient did not have COVID tested post-vaccination. The patient did not have known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient prior to vaccination was an unknown the patient was diagnosed with COVID-19. The patient did not have the patient been tested for COVID-19, since the vaccination. The patient did not have allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test normal, Computerised tomogram head, Diplopia
Clinical narrative: Overview: Double vision and weakness starting in April and getting worse - Saw eye doctor and neurologist - tests inconclusive - referred to neuro-ophthalmologist who confirmed Myasthenia gravis in  who confirmed Myasthenia gravis in  early fall  Details: In April 2021, felt like I had a kidney / bladder infection but it was negative (history of chronic UTIs but none in years). I was in the ER in May 2021 - left wrist pain and weakness, did a CT Head scan and x-rays - discharged Saw ortho in May 2021 - thought it might be carpal tunnel syndrome or related to EDS.   June 4 - test with neuro to address numbness and tingling in both hands - tests done: MUSC test done w/n test comp and motor&/SENS 5 - 6 NRV CNDJ TST - not carpal tunnel, wore braces to help with numbness and weakness June 28: saw doctor who treats me for migraines - suspected Myasthenia gravis - bloodwork was negative RAD MRI on July 15 Referred to neuro-ophthalmologist who confirmed Myasthenia gravis
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Lower urinary tract symptoms, Magnetic resonance imaging head normal, Muscular weakness
Clinical narrative: Overview: Double vision and weakness starting in April and getting worse - Saw eye doctor and neurologist - tests inconclusive - referred to neuro-ophthalmologist who confirmed Myasthenia gravis in  who confirmed Myasthenia gravis in  early fall  Details: In April 2021, felt like I had a kidney / bladder infection but it was negative (history of chronic UTIs but none in years). I was in the ER in May 2021 - left wrist pain and weakness, did a CT Head scan and x-rays - discharged Saw ortho in May 2021 - thought it might be carpal tunnel syndrome or related to EDS.   June 4 - test with neuro to address numbness and tingling in both hands - tests done: MUSC test done w/n test comp and motor&/SENS 5 - 6 NRV CNDJ TST - not carpal tunnel, wore braces to help with numbness and weakness June 28: saw doctor who treats me for migraines - suspected Myasthenia gravis - bloodwork was negative RAD MRI on July 15 Referred to neuro-ophthalmologist who confirmed Myasthenia gravis
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis, Myasthenic syndrome, Nerve conduction studies, Ophthalmological examination, Orthosis user
Clinical narrative: Overview: Double vision and weakness starting in April and getting worse - Saw eye doctor and neurologist - tests inconclusive - referred to neuro-ophthalmologist who confirmed Myasthenia gravis in  who confirmed Myasthenia gravis in  early fall  Details: In April 2021, felt like I had a kidney / bladder infection but it was negative (history of chronic UTIs but none in years). I was in the ER in May 2021 - left wrist pain and weakness, did a CT Head scan and x-rays - discharged Saw ortho in May 2021 - thought it might be carpal tunnel syndrome or related to EDS.   June 4 - test with neuro to address numbness and tingling in both hands - tests done: MUSC test done w/n test comp and motor&/SENS 5 - 6 NRV CNDJ TST - not carpal tunnel, wore braces to help with numbness and weakness June 28: saw doctor who treats me for migraines - suspected Myasthenia gravis - bloodwork was negative RAD MRI on July 15 Referred to neuro-ophthalmologist who confirmed Myasthenia gravis
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Urine analysis normal, X-ray
Clinical narrative: Overview: Double vision and weakness starting in April and getting worse - Saw eye doctor and neurologist - tests inconclusive - referred to neuro-ophthalmologist who confirmed Myasthenia gravis in  who confirmed Myasthenia gravis in  early fall  Details: In April 2021, felt like I had a kidney / bladder infection but it was negative (history of chronic UTIs but none in years). I was in the ER in May 2021 - left wrist pain and weakness, did a CT Head scan and x-rays - discharged Saw ortho in May 2021 - thought it might be carpal tunnel syndrome or related to EDS.   June 4 - test with neuro to address numbness and tingling in both hands - tests done: MUSC test done w/n test comp and motor&/SENS 5 - 6 NRV CNDJ TST - not carpal tunnel, wore braces to help with numbness and weakness June 28: saw doctor who treats me for migraines - suspected Myasthenia gravis - bloodwork was negative RAD MRI on July 15 Referred to neuro-ophthalmologist who confirmed Myasthenia gravis
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pfizer-BioNTech COVID-19 vaccine EUA
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: nausea; weird sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a PFIZER sponsored program (159558). The reporter is the patient.  A male patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) administration date 25Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset Feb2021, outcome "unknown", described as "nausea"; FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "unknown", described as "weird sensation".  Additional Information: The caller got the first dose of the COVID-19 vaccine on 25Feb2021. Then 3 days after the first dose, he started experiencing nausea and a weird sensation. He needed information for not taking the second dose which was scheduled on 18Mar2021, as was scared of the side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: The day after getting vaccinated, my mother felt tired and had mild chills.; The day after getting vaccinated, my mother felt tired and had mild chills.; Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 15:45 (Batch/Lot number: unknown) at the age of 74 years as DOSE 2, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "unknown", described as "Sore Arm"; FATIGUE (non-serious), CHILLS (non-serious) all with onset 07Mar2021, outcome "recovered" (2021) and all described as "The day after getting vaccinated, my mother felt tired and had mild chills.". Therapeutic measures were not taken as a result of pain in extremity, fatigue, chills.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient received any other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19. No treatment was received for adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Psychiatric symptom
Clinical narrative: feels over whelmed; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSYCHIATRIC SYMPTOM (non-serious) with onset 05Mar2021, outcome "unknown", described as "feels over whelmed"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue".  Additional information: This spontaneous report is from a Pfizer sponsored program Support. It was reported that the patient received 1st shot on Monday 01Mar2021. "Today feels over whelmed, does not know how long the fatigue will last as it comes and goes."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PAIN (non-serious), outcome "unknown", described as "asking what type of pain relief medication she can take".Additional information: Reason for no lot number of Pfizer Covid Vaccine: The reporter was unwilling to complete the report. The patient states that yesterday when she got the vaccine they said not allowed to take any types pain relief medication. The reporter states that she already gave all this information to the other place that transferred her to this number and been waiting over an hour and they said that this department could answer her question and states can call handler just get her to Medical Information? She refuses a report and to answer further questions.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site pain
Clinical narrative: vaccination pain near site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 96 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Lot number: EL3247) at the age of 96 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Cholestrol" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR taken for blood cholesterol; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "vaccination pain near site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination facility type is reported as Hospital. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my only side effect was a sore injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "my only side effect was a sore injection site".  Additional information: The reporter a Healthcare Professional was unknown.The reporter the prescribing HCP as no.The reporter's contact information available to you or a sub-contracted party as yes Verbatim and Event Description: Consumer called to check if Pristiq enrollment is still active. During call stated how getting second second Pfizer shot."my only side effect was a sore injection site."The following information was not confirmed during the call, but retrieved from the system: Patient DOB, Reporter Address, The following information was not provided during the call: Patient gender.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Limb discomfort, Visual impairment
Clinical narrative: Chills; Dizzy; Vision not good; Legs tightened up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1 single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "Vision not good"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Legs tightened up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0153) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Frontal fibrosing alopecia" (unspecified if ongoing); "Known allergies: Singulair" (unspecified if ongoing). Concomitant medication(s) included: VENTOLIN ACCUHALER. Vaccination history included: Bnt162b2 (First dose., Administration time: 14:00., Anatomical location: Left arm., Lot number: ER2613.), administration date: 18Mar2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "blistercin L.palm of hand". The following information was reported: DIZZINESS (non-serious) with onset 11Apr2021, outcome "recovering", described as "dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information:  Treatment was not received for the adverse event. The adverse event of 1st shot was blistercin L.palm of hand. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in Hospital. Pfizer have permission to contact patient about this report. Pfizer had not permission to contact the patient's healthcare provider about this report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: MENB, UNK
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent.  A 17 year-old male patient received meningococcal group b rlp2086 (TRUMENBA) administered in arm (Batch/Lot number: unknown) as dose number unknown, single for immunization; meningococcal vaccine a/c/y/w conj (tet tox) (MENACWY TT) administered in arm (Batch/Lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: MENB
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient (unknown if pregnant) received meningococcal group b rlp2086 (TRUMENBA) administered in arm (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "inflammation on the side of shot, pain, they couldn't lift up or move their arm, and redness, for a couple of days".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves an adult and unknown gender patient who had got a flu shot (influenza), after receiving INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious got a flu shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event influenza was reported as unknown. There will be no information available for the batch number for this case.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of pentacel with no adverse event; Initial information received on 30-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 6 months old female patient who had expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered)  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient's medical history included Pre-Term birth.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) (lot numbers and expiration date not reported) for prophylactic vaccination.  On 03-Nov-2021, the patient received a third dose of suspect PENTACEL (lot UJ393AAA and expiration date: 12-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was reported "One of the study participant received the 3rd dose of vaccines (6 months of age) on November 3rd 2021, the Pentacel dose that was administered was taken from the initial lot that was provided to the sites, with an expiry date of Oct 12 ,2021 instead of the new lot."  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: made feel sicker; Initial information was received on 13-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number US-SA-SAC20211217000525).  This case involves a patient of (unknown demographics) who experienced feel sicker (illness) when received vaccine INFLUENZA VACCINE.  The patient's vaccination included Covid vaccine. But glad got it.  The patient's medical history, past medical treatment, concomitant medication 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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious feel sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (illness).  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient (demographics unknown) who had flu (influenza) after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's medical treatment(s), past vaccination(s), concomitant medications 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 was not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Only time I ever got a flu shot. I got the flu! Haven't had the shot or the flu since". It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome of event was unknown. There will be no information available on the batch number for this case.
Age: 9.0
Sex: M
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Medication error, Poor quality product administered
Clinical narrative: child was given an IPOL injection that had been punctured/ no AE; Initial information was received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a Physician via Agency (Reference number- 00893353.  This case involves a nine-year-old male patient who was given IPV (VERO) [IPOL] injection that had been punctured with no adverse event (Poor quality product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 10-Dec-2021, the patient received 0.5 mL (total) dose of suspect IPV (VERO) [lot T1E872M and expiry date 10-Oct-2022] via subcutaneous route in left arm for prophylactic vaccination.  It was reported "Nurse calling to report that a child was given an IPOL injection today from a MDV that had been punctured on 14Oct2021. Caller is wanting to know if the child needs another dose".  Product used: Used. First time product used: No. Still using product: No.  It was a case of actual medication error due to Deteriorated drug administered (latency on the same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered
Clinical narrative: This case involves a patient (unknown age and gender) who administered an expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no adverse event (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot QFAA2026 and expiry date 30-Jun-2021] via unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error case due to Expired vaccine used (latency was on the same day). At the time of report, no adverse event 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. 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.
Sex: U
Vaccine: FLU4
Symptoms: Exposure via skin contact, Extra dose administered, Syringe issue
Clinical narrative: Another FLUZONE QUAD prefilled syringe from the box had to be used to complete dose with no reported adverse event.; vaccine started to drip out from underneath the luer lock but at the top of syringe FLUZONE QUADRIVALENT prefilled syringe caller reports that it leaked during injection with no reported adverse event.; The liquid got on the patient and on the reporting pharmacist that was injecting with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via Agency (Reference number- 00898016) and transmitted to Sanofi on 14-Dec-2021.  This case involves an unknown demographic patient (unknown age and unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] another dose from the box had to be used to complete dose (extra dose administered), the liquid got on the patient and on the reporting pharmacist that was injecting (exposure via skin contact) and vaccine started to drip out from underneath the luer lock but at the top of syringe fluzone quadrivalent prefilled syringe caller reports that it leaked during injection (syringe leak).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ778AB, expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to extra dose administered, syringe issue and exposure via skin contact (latency: same day).  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: The first FLUZONE QIV NP vaccine in her office on 21SEP2021 vaccine in her office on 21SEP2021 with no ae; Initial information received on 14-Dec-2021 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves a 62 years old female patient who was administered an after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (inappropriate schedule of product administration).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  Concomitant medications included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE).  On 14-Dec-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via intramuscular route in unknown administration site for prophylactic vaccination.  On 21-Sep-2021 she also received a dose of the same vaccine  lot number:  UT738NA and expiry date not reported  via intramuscular route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to drug dose administration interval too short (latency: 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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Vaccination site pain
Clinical narrative: soreness in his arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness in his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 032L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in his arm). At the time of the report, VACCINATION SITE PAIN (soreness in his arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Antibody test: 83.9 (Low) S antibody count dropped to 83.9.. In December 2021, Blood test: not reported Results were not reported. On 18-Dec-2021, Antibody test: not reported Anti SARS CoV N and S tests Results were not reported.. On an unknown date, Antibody test: 110 (Low) S test showing a count of 110.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has stated that not sure whether was possible that the booster created absolutely no S antibodies and failed to trigger an immune response in the patient. No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-417990 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2021: Added reporter occupation as other health professional, Lab tests, event outcome as recovered.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Stress
Clinical narrative: This spontaneous report as received from a consumer via Regulatory Authority refers to a 67-year-old female patient. Her medical history included colon cancer and shingles. The patient suffered the first outbreak of Shingles on an unknown date, in approximately 2006, when she was recovering from an unspecified colon cancer treatment. No other details about her medical history, concomitant therapies and concurrent medical conditions were provided. On 05-AUG-2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (formulation, dose, lot number, expiration date, route of administration and site of administration were not reported) for prophylaxis. On 14-MAR-2021, the patient was vaccinated with her first dose of tozinameran (COMIRNATY), lot# EN6207 (formulation, dose, expiration date, site of administration and route of administration were not reported) for prophylaxis. On 04-APR-2021, the patient was vaccinated with her second dose of tozinameran (COMIRNATY), lot# ER8729 (formulation, dose, expiration date, site of administration and route of administration were not reported) for prophylaxis. On an unknown date in 2021, the patient experienced stress. On an unknown date in 2021, the patient experienced an outbreak of shingles due to "stress of everything". The intensity of this event was reported as mild. On 19-OCT-2021, the patient started therapy with valaciclovir hydrochloride (VALTREX) for Shingles. On 26-OCT-2021, the therapy with valaciclovir hydrochloride (VALTREX) was discontinued. On 16-NOV-2021, the patient was vaccinated with her third dose of tozinameran (COMIRNATY), lot# _D0809 (formulation, dose, expiration date, site of administration and route of administration were not reported) for prophylaxis. The outcome of the events was unknown. The causality assessment between the events and the suspect vaccines was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I received the vaccine and still got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.