chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Blood pressure measurement, Fatigue, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the right arm, administration date 24Feb2021 12:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "blood pressure high" (unspecified if ongoing); "possibility she had had COVID" (unspecified if ongoing), notes: she was not diagnosed. The patient's concomitant medications were not reported. Vaccination history included: flu shot (left arm hurt for months, she could still feel where the person stuck her at), administration date: 2021, for immunisation, reaction: "left arm hurt".The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Feb2021, outcome "recovering", described as "lmph node under her arm was swollen"; AXILLARY PAIN (non-serious), PAIN (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "pain up under her arm and side"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "tired, didn't have a lot of energy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The events did not result to emergency room or physician office visit. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the right arm, administration date 24Feb2021 12:00 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "blood pressure high" (unspecified if ongoing); "possibility she had had COVID" (unspecified if ongoing), notes: she was not diagnosed. The patient's concomitant medications were not reported. Vaccination history included: flu shot (left arm hurt for months, she could still feel where the person stuck her at), administration date: 2021, for immunisation, reaction: "left arm hurt".The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Feb2021, outcome "recovering", described as "lmph node under her arm was swollen"; AXILLARY PAIN (non-serious), PAIN (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "pain up under her arm and side"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 25Feb2021, outcome "unknown" and all described as "tired, didn't have a lot of energy". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The events did not result to emergency room or physician office visit. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: This is a spontaneous report received from contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date Feb2021 (Lot number: EL9266) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: 2014 (unspecified if ongoing), notes: moderate to advanced, diagnosed 6 years ago 2014 maybe; "extreme muscle weakness" (unspecified if ongoing), notes: usually. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, Lot Number: EL9262), administered in the right arm, administration date: 04Feb2021, when the patient was 78 years old, for COVID-19 immunisation. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 26Feb2021, outcome "unknown", described as "muscle weakness has been exacerbated".Additional information: The reporter (patient's wife) believed that the patient's muscle weakness has been exacerbated by the vaccine. The reporter was unsure if it was improving or worsening. She wanted to know if this was a side effect of the vaccine. No follow-up attempts are possible. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Pain in extremity, Sensory loss
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional). The reporter is the patient. A 95-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 18Feb2021 (Lot number: EL9266) at the age of 95 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (lot number: EN9581, dose 1, single), administration date: 28Jan2021, when the patient was 95 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is still hurting so bad"; SENSORY LOSS (non-serious), outcome "unknown", described as "I lost complete feeling in my hand. I could not pick up anything"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "It (temperature) has been running 94.0 every day, until today it rose to 97.0". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, sensory loss, body temperature abnormal. Additional information: It was reported that the treatment received was Aspirin and patient stated that she was perfectly healthy and takes regular medications that the doctor gave. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Hyperhidrosis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 25Feb2021 09:30 (Lot number: EN6198) at the age of 56 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "known allergies: Gluten" (unspecified if ongoing); "Prehypertension" (unspecified if ongoing); "BMI 31" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HCTZ; CLARITIN [LORATADINE]; MAGNESIUM CITRATE [MAGNESIUM]; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3; VITAMIN C [ASCORBIC ACID]. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 25Feb2021 23:30, outcome "recovering", described as "abdominal cramping"; DIARRHOEA (non-serious) with onset 25Feb2021 23:30, outcome "recovering", described as "diarrhea"; HYPERHIDROSIS (non-serious) with onset 25Feb2021 23:30, outcome "recovering", described as "sweating". Therapeutic measures were not taken as a result of abdominal pain, diarrhoea, hyperhidrosis.Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The symptoms passed after bowel movement and emptying colon. The patient had no fever. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Feeling cold, Loss of personal independence in daily activities, Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer-sponsored program (134184). The reporter is the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her left arm just hurts from the injection"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "she cannot lift her arm/It is hard to move it"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she can't do anything"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; FEELING COLD (non-serious), outcome "unknown", described as "She is just cold". Therapeutic measures were taken as a result of vaccination site pain, mobility decreased, chills, loss of personal independence in daily activities, malaise, anxiety, feeling cold. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer-sponsored program (134184). The reporter is the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her left arm just hurts from the injection"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "she cannot lift her arm/It is hard to move it"; CHILLS (non-serious), outcome "unknown", described as "Chills"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she can't do anything"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; FEELING COLD (non-serious), outcome "unknown", described as "She is just cold". Therapeutic measures were taken as a result of vaccination site pain, mobility decreased, chills, loss of personal independence in daily activities, malaise, anxiety, feeling cold. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 26Jan2021 (Lot number: EL8982, Expiration Date: May2021) at the age of 71 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure measurement" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Prediabetic" (unspecified if ongoing), notes: Verbatim: Prediabetic. Concomitant medication included: TRAJENTA; AMLOD-OLMESA taken for blood pressure measurement. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little pain on bottom of my feet of heel for couple of days". No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Nausea
Clinical narrative: really dizzy sitting and standing; laid down and was dizzy; a little nauseous but didn't vomit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male 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: DIZZINESS POSTURAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "really dizzy sitting and standing; laid down and was dizzy"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "a little nauseous but didn't vomit".  Additional Information: The reporter/patient was pretty good at time of report but wanted to know if that was an effect of the vaccine and if this dizziness was normal, 30 hours after the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional). The reporter is the patient. A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 03Mar2021 13:45 (Lot number: EN6203) at the age of 40 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: CLARITINE; VELIVET; ZOLOFT; PLEXION SCT; NASACORT; CENTRUM A TO ZINC; VITAMIN D 3. The following information was reported: HEADACHE (non-serious) with onset 03Mar2021, outcome "recovering", described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Mar2021, outcome "recovering", described as "stomach cramping". Therapeutic measures were not taken as a result of headache, abdominal pain upper. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient had no allergies to medications, food, or other products.No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101654777 same patient/drug/event, different vaccine dose;US-PFIZER INC-2021352149 same patient/drug, different vaccine dose/event
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 03Mar2021 14:00 (Lot number: EL3248) at the age of 55 years as dose number unknown, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 18:00, outcome "recovered" (04Mar2021), described as "Arm soreness at injection site"; HEADACHE (non-serious) with onset 03Mar2021 18:00, outcome "recovered" (04Mar2021), described as "Slight headache"; FATIGUE (non-serious) with onset 03Mar2021 18:00, outcome "recovered" (04Mar2021), described as "Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue.Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The events did not result in death, were not life-threatening nor disabling/incapacitating, and did not cause/prolonged hospitalization nor result in congenital anomaly/birth defect.Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at injection site; Redness at injection site; Swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:15 (Lot number: EN6203) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; CENTRUM WOMEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "Pain at injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "Redness at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 03Mar2021, outcome "recovered" (03Mar2021), described as "Swelling at injection site". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site swelling. Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19. The patient had no reported allergies to medications, food, or other products. The events were considered as non-serious by the reporter. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "cardiac infusion" (unspecified if ongoing); "fluid on heart" (unspecified if ongoing); "had difficulty breathing" (unspecified if ongoing); "paralyzed vocal cords" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 04Jan2021, for COVID-19 immunisation, reaction(s): "tested positive 08Jan".The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Feb2021, outcome "unknown", described as "Said after vaccine, her mom was so much better like night and day"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Feb2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: slight nausea; liquid diarrhea; This is a spontaneous report received from a contactable reporter (other healthcare professional, nurse). The reporter is the patient. A 59-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), intramuscular, administered in arm right, administration date 22Dec2020 03:15 (Lot number: EK5730) at the age of 59 years as dose 1, single for COVID-19 immunisation. Family history included: "psoriasis" (unspecified if ongoing), notes: treated with biologic; "lymphocytis colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 22Dec2020 03:15, outcome "recovered", described as "slight nausea"; DIARRHOEA (non-serious) with onset 22Dec2020 03:15, outcome "recovered", described as "liquid diarrhea". Therapeutic measures were not taken as a result of nausea, diarrhoea. Additional information: The patient was not admitted to the hospital and not deceased. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site 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). A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (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: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "soreness in the injection site".Additional information: The reporter (patient's son) wanted to know if he could use a hot or cold pack for the soreness in the injection site on the patient's arm. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 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 "recovered", described as "Arm soreness"; CHILLS (non-serious), outcome "recovered", described as "chills"; PAIN (non-serious), outcome "recovered", described as "body aches". Therapeutic measures were taken as a result of pain in extremity, chills, pain. Additional Information: Events were resolved with paracetamol (TYLENOL) as treatment within 24hrs. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Gilliam-Barre Syndrome; paralyzes; Initial information received on 18-Nov-2021 regarding an unsolicited valid Social Media serious case received from a consumer non health care professional under reference .number: US-SA-SAC20211125000835.  This case involves an unknown age and unknown gender patient who experienced Gilliam-Barre Syndrome (Guillain-Barre syndrome) and was paralyzed (paralysis) after receiving vaccine INFLUENZA VACCINE..  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event Gilliam-Barre Syndrome (Guillain-Barre syndrome) and was paralyzed (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. The events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/ event.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case.; Sender's Comments: This case concerns an unknown age and unknown gender patient who experienced Guillain-Barre syndrome and was paralyzed after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Loss of consciousness, Malaise
Clinical narrative: This case involves an unknown age and unknown gender patient who was passing out (loss of consciousness), was sick with flu (influenza) and thought was gonna die after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, vaccinations, 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 unknown route in unknown administration site. On an unknown date the patient developed a serious thought was passing out (loss of consciousness), was sick with flu (influenza) and thought was gonna die (unknown latency) following the administration of INFLUENZA VACCINE. These event were assessed as medically significant. Sick (illness) and flu (influenza)(unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant. On an unknown date the patient developed a non-serious sick (illness), flu (influenza) (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 events. At time of reporting, the outcome of the event was reported as unknown; Sender's Comments: This case concerns an unknown age and unknown gender patient who experienced loss of consciousness, and influenza (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: heart attack; Initial information received on 22-Nov-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had heart attack (myocardial infarction) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, same day after vaccination, the patient developed a serious heart attack (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.; Sender's Comments: This case concerns an unknown demography patient who had myocardial infarction same day after vaccination with INFLUENZA VACCINE (from unknown manufacturer). The time to onset is compatible. However, more information on medical condition at time of vaccination, history and lab tests will be needed for further assessment. Based upon reported information, role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Paraplegia
Clinical narrative: paralyzed waist down from it; Initial information received on 18-Nov-2021 regarding an unsolicited valid social media serious case received from a consumer or non-healthcare professional via Digital Media.  This case involves adult patient who was paralyzed waist down from it (paraplegia) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious paralyzed waist down from it (paraplegia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Additional information was reported never got one, only had flu once, but my gramma almost died three years ago from it. Hospitalized for four days and had a friend in college paralyzed waist down from it. No thanks. 30 percentage efficacy and a crapshoot at if the jab is the strain prevalent at the time.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.; Sender's Comments: This case involves an adult patient who had paraplegia after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: severe allergies; Initial information was received on 25-Nov-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-SAC20211130000189).  This case involves an adult patient of unknown gender who experienced severe allergies (allergy to vaccine) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, 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 serious severe allergies (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as life-threatening.  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 (allergy to vaccine).  The reporter assessed the causal relationship for the event (allergy to vaccine) with the INFLUENZA VACCINE as not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult patient of unknown gender who experienced allergy to vaccine (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUC3
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Left arm began to become swollen red, and hard from the wrist up to the neck; Left arm began to become swollen red, and hard from the wrist up to the neck; Left arm began to become swollen red, and hard from the wrist up to the neck; This spontaneous case was received on 25-Oct-2021 from other non-health professional (consumer's mother) via agency (reference number: SEQW21-04503) and concerned a male patient of an unreported age.  The patient's current conditions included allergy to eggs, bananas and outdoor allergy. The patient's concomitant medications were not reported. The patient's historical vaccines included flu vaccines followed by a reaction in the past three years. As reported, the other two reactions were from different manufactures.  On an unspecified date in the fall of 2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; anatomical location: left arm, dose, and route of administration: not reported) to prevent influenza. The batch number reported was 261210.  On an unspecified date in 2019, an unknown amount of time after Flucelvax Quadrivalent, the patient's left arm became swollen, red and hard from the wrist up to the neck. The patient visited the doctor and was treated with steroids.   On an unspecified date in 2019, the patient recovered from the events.   The reporter assessed all events as related to Flucelvax Quadrivalent. As reported, her son received the vaccine in fall of 2019 and had a reaction.  The reporter assessed the case as non-serious.  Company comment: A male patient of unreported age developed swelling, induration and erythema of the arm after vaccination with Flucelvax Quadrivalent. Due to lack of information regarding chronology, causality for the reported events is unassessable.; Reporter's Comments: Her son received the vaccine in fall of 2019 and had a reaction.; Sender's Comments: A male patient of unreported age developed swelling, induration and erythema of the arm after vaccination with Flucelvax Quadrivalent. Due to lack of information regarding chronology, causality for the reported events is unassessable.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a lawyer referring to a 68 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 02-DEC-2016 and 17-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).        The case was split from a legal case referring the same patient.; Sender's Comments: US-009507513-2108USA005243:
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: was administered / 5 years old; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Boostrix was accidentally ordered in the system for the patient and it was administered, which led to inappropriate age at vaccine administration. It was a human error. The reporter did not agree to follow up from GSK, hence follow up permission denied.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (The patient also mentions that when he received dose 1 of Shingrix he had a fever but it only lasted 2 days.).   On 11th November 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received second dose of shingrix vaccine and 24 hours later had fever. The patient had fever ever since the vaccine.(17 days). The patient talked to his health care professional who changed some of his medications. The reporter consented for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR246108:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: ADMINISTRATION OF DOSE OF 0.25ML; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 10-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced administration of dose of 0.25ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of dose of 0.25ml was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder
Clinical narrative: I noticed that my menstrual cycle after the first dose (9/8/21) was abnormal. It only lasted 2 days and was extremely light, whereas it normally lasts 7 days. After my second dose (10/13/21) I did not have a menstrual cycle in October or November. My cycle was absent both months, when it has been regular.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Heart rate increased, Insomnia, Throat irritation
Clinical narrative: Heart hurts, heart randomly starts beating really fast. Feels like theres acid in my throat. Cant sleep, laying down worsens the pain.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Hot flush, Injection site pain
Clinical narrative: Within first hour of shot, headache  Within 2 hours after nausea, dizzy, lethargic, brain fog  Within 4 hours  achey, hot flashes heart palpitations   Approximately 11pm is vertigo when closing eyes, body aches that prevent sleep  Next day woke up with same symptoms mild progressing in intensity throughout the day.  Around 3pm  injection site soreness  11pm slept in 1-1.5 hour intervals, worsening nausea, body aches, racing cognitions, inability to fall asleep, muscle tenseness     At the time of filling out the report the symptoms still occurring
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Muscle tightness, Nausea, Pain, Palpitations
Clinical narrative: Within first hour of shot, headache  Within 2 hours after nausea, dizzy, lethargic, brain fog  Within 4 hours  achey, hot flashes heart palpitations   Approximately 11pm is vertigo when closing eyes, body aches that prevent sleep  Next day woke up with same symptoms mild progressing in intensity throughout the day.  Around 3pm  injection site soreness  11pm slept in 1-1.5 hour intervals, worsening nausea, body aches, racing cognitions, inability to fall asleep, muscle tenseness     At the time of filling out the report the symptoms still occurring
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tachyphrenia, Vertigo
Clinical narrative: Within first hour of shot, headache  Within 2 hours after nausea, dizzy, lethargic, brain fog  Within 4 hours  achey, hot flashes heart palpitations   Approximately 11pm is vertigo when closing eyes, body aches that prevent sleep  Next day woke up with same symptoms mild progressing in intensity throughout the day.  Around 3pm  injection site soreness  11pm slept in 1-1.5 hour intervals, worsening nausea, body aches, racing cognitions, inability to fall asleep, muscle tenseness     At the time of filling out the report the symptoms still occurring
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: It began as hives on his right forearm before bedtime, which later spread to his entire right arm the next morning along with some hives starting on the other arm. He was treated with a dose of benadryl and the symptoms dissipated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Dyspepsia, Flatulence, Pain
Clinical narrative: About 10 days or so after I received my 2nd Moderna vaccine, I started experiencing sharp and dull pain on the left side of my sternum/right side of my heart.  I thought it was indigestion or gas and did not relate it to the vaccine. But the symptoms persisted for about 2 weeks.  Also, the symptoms were different than anything I had felt before:  multiple times when walking up the hill on my street, I had to stop and wait for the pain to subside. My instincts told me that if I had kept walking something bad was going to happen. I also experienced the pain when sitting, laying down, etc. sporadically, for short periods - from a few seconds to minutes.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in lymph node under left armpit, which is the same arm in which booster shot was administered.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Supraventricular tachycardia
Clinical narrative: SVT
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling; Redness; Pain; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number CE45H, expiry date 1st October 2022) for prophylaxis.   On 24th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th November 2021, 1 days after receiving Shingrix, the patient experienced swelling, erythema and pain. On an unknown date, the outcome of the swelling, erythema and pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling, erythema and pain to be related to Shingrix.  Additional details were reported as follows: The pharmacy Intern called on behalf of a patient to inquire if the patient should receive the 2nd dose of the Shingrix vaccine if they are experiencing side effects.  The patient experienced pain,redness and swelling 1 day after receiving the vaccine and was still ongoing.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Engerix-B exposed to 27°F, administered; This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. A pharmacist staff called to report that an Engerix-B vaccine was exposed to a lowest temperature of 27 degree fahrenheit for 1 hour and 30 minutes and then administered to a patient, which led to incorrect storage of drug. Healthcare professional did not have any patient's details or date of the injection. The reporter consented to follow up and requested to follow up by email.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed second dose. First dose received 09/2019; Pharmacist reporting patient missed second dose of Shingrix. First dose received 09/2019. Did not consent to follow-up. Call Notes:Pharmacist reporting patient missed second dose of Shingrix. First dose received 09/2019. HCP disconnected and provided no AE information other than the first dose was received 09/2019. HCP did not give consent for collection of contact information and did not give consent for any follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nervous system disorder
Clinical narrative: second dose 10/25/2021, 11/1/2021 diagnosed with shingles; nerve sensitivity on right side of head and eye; This case was reported by a consumer and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 25th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 26th October 2021, 1 days after receiving Shingrix, the patient experienced shingles and nervous system disorder. On an unknown date, the outcome of the shingles and nervous system disorder were not recovered/not resolved.   It was unknown if the reporter considered the shingles and nervous system disorder to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received the Shingrix at her doctor's office on her right arm (unsure).  The patient experienced symptoms of shingles on 26th October 2021 and went to urgent care on 1st November 2021 where she was diagnosed with shingles.  The patient experienced nerve sensitivity and head and eye.  The reporter also inquired if Shingrix could cause shingles, If the 2nd dose was still effective or if she needs another dose of Shingrix, any problems if receive Shingrix whilst had shingles. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Consent obtained to contact HCP and patient.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Hypertensive urgency
Clinical narrative: Hypertensive urgency with severe epistaxis, requiring hospital admission for six days and three to five antihypertensive agents to control blood pressure.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Dyspnoea, Feeling abnormal
Clinical narrative: Excruciating upper back pain, sharp pain in both temples like  I was being hit with a sledgehammer, difficulty breathing due to pressure inside chest cavity that seemed to come fromy back, soreness in both shoulders
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Excruciating upper back pain, sharp pain in both temples like  I was being hit with a sledgehammer, difficulty breathing due to pressure inside chest cavity that seemed to come fromy back, soreness in both shoulders
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Left arm at injection site has been very painful during the past 6 weeks since I got the injection. It feels like I have a pulled muscle and sometimes I can barely move my arm. It is a sharp constant pain, right at injection site that causes pain and weakness.