chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 21Nov2021 at 17:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine/pseudoephedrine hydrochloride (ALLEGRA-D) 24hours, zinc (MANUFACTURER UNKNOWN) and vitamin D NOS (MANUFACTURER UNKNOWN); all for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 48-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 15May2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient previously received neomycin sulfate (MANUFACTURER UNKNOWN) for an unknown indications on an unknown date and experienced drug allergy. On 22Nov2021 at 05:00, the patient experienced major swelling in the left armpit, pain in jaw and ears, joint pain and pain in the groin area. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events major swelling in the left armpit, pain in jaw and ears, joint pain and pain in the groin area was resolving at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dizziness, Hypokinesia, Vaccination site pain
Clinical narrative: Injection site pain; Inability to lift arm; Dizzy; Anxiety; Chills; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 32030BD) via an unspecified route of administration in the left arm on 23Nov2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), metformin (MANUFACTURER UNKNOWN) and norethisterone acetate/ ethinylestradiol (AUROVELA); all for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Nov2021 at 21:00, the patient experienced injection site pain, inability to lift arm, dizzy, anxiety and chills. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, inability to lift arm, dizzy, anxiety and chills was not resolved at the time of the report. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Lymph node pain, Lymphadenopathy, Nasal congestion
Clinical narrative: tender (but not enlarged) cervical lymph nodes; with minimal nasal congestion and no other symptoms; had delayed onset isolated tender unilateral cervical lymphadenopathy; URI symptoms; asymptomatic COVID PCR positive/Two rapid tests were positive, and a PCR was subsequently positive.; asymptomatic COVID PCR positive/Two rapid tests were positive, and a PCR was subsequently positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "asymptomatic COVID PCR positive/Two rapid Abbott tests were positive, and a PCR was subsequently positive."; LYMPH NODE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "tender (but not enlarged) cervical lymph nodes"; NASAL CONGESTION (non-serious) with onset Aug2021, outcome "unknown", described as "with minimal nasal congestion and no other symptoms"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "had delayed onset isolated tender unilateral cervical lymphadenopathy"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2021, outcome "unknown", described as "URI symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive; (2021) positive. The patient has no history/suggestion of immune deficiency disorder. At the beginning of August, the patient has sore throat symptoms. Her social situation changed over 3 months. This week, before she was able to get a COVID booster shot, she developed more significant febrile illness with URI symptoms, fever, chills, myalgias, and a slight loss of smell. Certainly, different viral variants could be an explanation, as well as an unknown immunodeficiency state, but this still seems to be an unusual occurrence.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Upper respiratory tract infection
Clinical narrative: tender (but not enlarged) cervical lymph nodes; with minimal nasal congestion and no other symptoms; had delayed onset isolated tender unilateral cervical lymphadenopathy; URI symptoms; asymptomatic COVID PCR positive/Two rapid tests were positive, and a PCR was subsequently positive.; asymptomatic COVID PCR positive/Two rapid tests were positive, and a PCR was subsequently positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "asymptomatic COVID PCR positive/Two rapid Abbott tests were positive, and a PCR was subsequently positive."; LYMPH NODE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "tender (but not enlarged) cervical lymph nodes"; NASAL CONGESTION (non-serious) with onset Aug2021, outcome "unknown", described as "with minimal nasal congestion and no other symptoms"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "had delayed onset isolated tender unilateral cervical lymphadenopathy"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2021, outcome "unknown", described as "URI symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive; (2021) positive. The patient has no history/suggestion of immune deficiency disorder. At the beginning of August, the patient has sore throat symptoms. Her social situation changed over 3 months. This week, before she was able to get a COVID booster shot, she developed more significant febrile illness with URI symptoms, fever, chills, myalgias, and a slight loss of smell. Certainly, different viral variants could be an explanation, as well as an unknown immunodeficiency state, but this still seems to be an unusual occurrence.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the right arm on 18Oct2021 at 20:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and hypertension (HTN). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN)); both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 30Sep2021 at 20:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 05Nov2021, the patient experienced shingles on the left side of the abdomen. On 08Nov2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19.  The clinical outcome of the event shingles on the left side of the abdomen was resolved on an unknown date in Nov2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Immunisation, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Nov2021 at 10:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as single doses for COVID-19 immunisation. On 27Nov2021 at 19:00, the patient experienced fever of 100.3 (unspecified units), headache, chills and aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 100.3, headache, chills and aches was unknown at the time of the report.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Nov2021 at 10:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as single doses for COVID-19 immunisation. On 27Nov2021 at 19:00, the patient experienced fever of 100.3 (unspecified units), headache, chills and aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 100.3, headache, chills and aches was unknown at the time of the report.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient. A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Feb2021 16:30 (Lot number: EL9262) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Cantaloupe" (unspecified if ongoing), notes: Known allergies:Cantaloupe. Concomitant medications included: AIRBORNE; ADVIL [IBUPROFEN], and "MULTIVITA".The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Feb2021 18:30, outcome "recovered", described as "Sore arm for 2-3 days". Therapeutic measures were not taken as a result of pain in extremity. The patient did not receive treatment for the event. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid prior vaccination and was not tested post vaccination. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219722 same patient/vaccine, different dose/event.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2020 09:30 (Lot number: EK9231) at the age of 22 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm (injection site pain)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain. Additional information: It was reported that the patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and post vaccination, the patient has been tested for COVID-19. The facility where the most recent COVID-19 vaccine was administered in hospital. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache
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 parent. A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (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 (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "cant walk straight".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, 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 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: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness"; PAIN (non-serious), outcome "unknown", described as "Body ache".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Sender's Comments: Linked Report(s) : US-PFIZER INC-2021242765 same reporter, drug and events; different patient.
Sex: M
Vaccine: COVID19
Symptoms: Illness
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 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: ILLNESS (non-serious), outcome "unknown", described as "got sick".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2021 10:15 (Lot number: E13246) at the age of 81 years as 1st dose, single and administered in arm right, administration date 29Jan2021 (Lot number: E19262) as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure /diagnosed when she was 21; "Diabetes" (ongoing), notes: Verbatim: Diabetes /diagnosed about 5 years ago; "sulfa drugs that's all, makes her nauseous" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, administration date: Oct2020, for Immunisation.The following information was reported: Nausea, No appetite, Vomited with outcome of recovering, unknown, Feeling unwell, Weakness with outcome unknown, Bout of diarrhoea, Dehydration with outcome of recovered and all described as "She had the dry heaves and was gagging". The events "nausea", "feeling unwell" and "bout of diarrhoea" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, vomiting. No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Malaise, Nausea, Retching, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2021 10:15 (Lot number: E13246) at the age of 81 years as 1st dose, single and administered in arm right, administration date 29Jan2021 (Lot number: E19262) as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure /diagnosed when she was 21; "Diabetes" (ongoing), notes: Verbatim: Diabetes /diagnosed about 5 years ago; "sulfa drugs that's all, makes her nauseous" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, administration date: Oct2020, for Immunisation.The following information was reported: Nausea, No appetite, Vomited with outcome of recovering, unknown, Feeling unwell, Weakness with outcome unknown, Bout of diarrhoea, Dehydration with outcome of recovered and all described as "She had the dry heaves and was gagging". The events "nausea", "feeling unwell" and "bout of diarrhoea" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, vomiting. No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2021 10:15 (Lot number: E13246) at the age of 81 years as 1st dose, single and administered in arm right, administration date 29Jan2021 (Lot number: E19262) as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure /diagnosed when she was 21; "Diabetes" (ongoing), notes: Verbatim: Diabetes /diagnosed about 5 years ago; "sulfa drugs that's all, makes her nauseous" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, administration date: Oct2020, for Immunisation.The following information was reported: Nausea, No appetite, Vomited with outcome of recovering, unknown, Feeling unwell, Weakness with outcome unknown, Bout of diarrhoea, Dehydration with outcome of recovered and all described as "She had the dry heaves and was gagging". The events "nausea", "feeling unwell" and "bout of diarrhoea" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, vomiting. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Ligament sprain, Muscle spasms, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 70 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: FALL (non-serious) with onset 23Mar2021, outcome "unknown", described as "He fell yesterday"; LIGAMENT SPRAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 23Mar2021, outcome "unknown" and all described as "suffered a severe sprain to his right hamstring with muscle spasms"; PAIN (non-serious) with onset 23Mar2021, outcome "unknown", described as "pain". Therapeutic measures were taken as a result of fall, ligament sprain, muscle spasms, pain.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.Additional Information included The patient had fell while running and suffered a severe sprain to his right hamstring with muscle spasms. He is taking tramadol every 4 hours and is using a lidocaine patch for 12 hours daily and removed at night. The  patient was prescribed to be on Tramadol every 4 hours and he has Lidocaine patch. He wants to know if he can take the medication since he is in pain.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Headache, Limb discomfort, Migraine, Myalgia
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS.The following information was reported: MIGRAINE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Migraine"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "headache"; MYALGIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "muscle soreness"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "body soreness"; LIMB DISCOMFORT (non-serious) with onset 01Apr2021, outcome "unknown", described as "heavy limbs"; NAUSEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "nausea"; DEHYDRATION (non-serious) with onset 01Apr2021, outcome "unknown", described as "dehydration"; PYREXIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "fever".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS.The following information was reported: MIGRAINE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Migraine"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "headache"; MYALGIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "muscle soreness"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "body soreness"; LIMB DISCOMFORT (non-serious) with onset 01Apr2021, outcome "unknown", described as "heavy limbs"; NAUSEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "nausea"; DEHYDRATION (non-serious) with onset 01Apr2021, outcome "unknown", described as "dehydration"; PYREXIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "fever".No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0187) as dose 1, single and administered in arm left (Lot number: EW0187) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE. Past drug history included: Oxycodone for Allergy, notes: Oxycodone, Albuterol; Albuterol for Allergy. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 30May2021, outcome "recovered", described as "Light spotting for a week after the first dose administration while still on the contraceptive pill. Heavier spotting after the second administered dose while still on the pill.". Therapeutic measures were not taken as a result of intermenstrual bleeding.Additional information: Vaccine was administered in Pharmacy or Drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no covid prior vaccination. The patient has not been tested for COVID-19 post vaccination.No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20210625000138 (Sanofi).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. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization.The following information was reported: PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "headaches"; ARTHRALGIA (non-serious), outcome "recovered", described as "joint pain". Therapeutic measures were taken as a result of pain, fatigue, pyrexia, headache, arthralgia.Additional Information: Events lasted about 24-36 hours. Took Tylenol and hydrated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Six patients were vaccinated with FluBlok QIV, patients were under the indicated age, no AE; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves six patients (demographic unknown) who were under the indicated age when they were vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  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 patients received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE produced by Sanofi Pasteur (lot number and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency same day).  It was reported "This case created for 6 Patients. pharmacovigilance: I want to alert you of the following report where a product was used outside of indication: Product: FluBlok QIV Incident: 6 patients were given FluBlok QIV, which the indication starts at 18 years of age. These patients were under the indicated age. Actions Taken: representative communicated to the Centers for Disease Control and Prevention (CDC) the incident and was told FluBlok was less effective in this age group and possibly may have to immunize. I instructed her to call in to report incident. She also shared the nurses who administered the vaccine said the product syringes and boxes are similar and easy to mix up"  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.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This case involves child male patient who experienced vomited while receiving INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE]. 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. Concomitant medications included COVID-19 VACCINE for Prophylactic vaccination. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site Prophylactic vaccination. On 14-Nov-2021, the patient developed a non-serious vomiting (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. It was unknown if there were laboratoy data/results available. It was not reported if the patient received any corrective treatment for the event (vomited). At time of reporting, the outcome was resolved on an unknown date for the event vomited. There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Drug ineffective
Clinical narrative: Flu shots do not work; Initial information received on 20-Nov-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) whom INFLUENZA VACCINE shots do not work (drug ineffective).  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  The patient had no 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, a flu shots do not work on patient (drug ineffective, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Flu shots do NOT work! I know this personally from patients I have cared for and co-workers who have had this shot and still get the flu!"  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.
Sex: F
Vaccine: FLUX
Symptoms: Death, Heart rate increased, Myocardial infarction
Clinical narrative: massive heartattack and died; after 6 hours it spead her heart up an cause her go into massive heartattack and died; Initial information received on 21-Nov-2021 regarding an unsolicited valid serious case received from a consumer via social media.  This case involves adult female patient who experienced after 6 hours it speed her heart up (heart rate increased) and cause her go into massive heartattack and died (myocardial infarction) after receiving INFLUENZA VACCINE.  The patient's past medical history, 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 (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 serious after 6 hours it speed her heart up (heart rate increased) (unknown latency) following the administration of INFLUENZA VACCINE. This event was leading to death.  On an unknown date, the patient developed a serious massive heartattack an died (myocardial infarction) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) massive heartattack and died.  Truly died after 6 hours it speed her heart up an cause her go into massive heartattack an died. it only took 6 hours to pass after she took the flu shot an on a news network listen to nope not the fake news media all the stated that had the most people vaccine giving now the people taking the flu shot is actually getting the flu.  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient died due to myocardial infarction. It was unknown at the time of reporting if an autopsy was done and the cause of death was reported as Myocardial infarction and Heart rate increased.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns an adult female patient who had myocardial infarction and heart rate increased after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. It was unknown if an autopsy was done. Further information regarding patient's past medical condition, previous vaccination tolerance and other laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Heart attack; speed her heart up
Sex: U
Vaccine: FLUX
Symptoms: Ill-defined disorder
Clinical narrative: almost died; Initial information received on 20-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who experienced almost died (ill-defined disorder) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past 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 non-serious almost died (ill-defined disorder) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Last time I got a flu shot was 1969. I almost died from it."  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: got them right now; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had shingles 7 times. The patient had Shingles vaccine and got them right now. The patient had to wait 6 months before he/she could get the shot. The patient stated a shot did not stop them and he/she hope this was the last time. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had her booster about a month ago and right now she has shingles/ suspected vaccination failure; has shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's sister. The age at vaccination was not reported. The reporter stated the patient had her Shingles booster about a month ago of reporting and at the time of reporting had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had a vaxxxcccine and got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Flu vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients got the Shingle vaccine and Flu shots and got shingles. The reporter knew of about ten people who had it and all ten received multiple vaccines. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had recurring shingles since patient was 18 years old). In March 2021, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In March 2021, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too short were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. At the time of reporting the patient was near 70 years age. The age at vaccination was not reported. The patient had the two Shingles vaccines in March 2021, received second dose of Shingles vaccine earlier than recommended interval, which led to shortening of vaccination schedule and had 2 episodes since then. The patient asked about keep getting shingles after the vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Why do I still get shingles after I had the vaccines?/Suspected vaccination failure; Why do I still get 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: This spontaneous report received from a patient concerned a 37 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient or the patient's immediate family had no history of Vertigo.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 04-NOV-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced severe vertigo (felt very dizzy and light headed also felt like the room was spinning around). On 23-NOV-2021, treatment medications included: meloxicam.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient was recovering from vertigo (felt very dizzy and light headed also felt like the room was spinning around).This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: LYMPH NODES IN MY RIGHT ARM (RIGHT ARM PIT) HAVE BEEN HURTING A GREAT DEAL; This spontaneous report received from a patient concerned a 70 year old male.The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Dose number series was 1. No concomitant medications were reported. On 11-NOV-2021, the patient experienced lymph nodes in my right arm (right arm pit) have been hurting a great deal. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient had not recovered from lymph nodes in my right arm (right arm pit) have been hurting a great deal.This report was non-serious.