chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure, Vomiting
Clinical narrative: tested positive for COVID; tested positive for COVID; vomiting; headache; lower back pain; fever (101.7); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: FK5127) at the age of 7 years as dose 2,(tris) single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=FK5127,, prev dose lot unknown=False,, prev dose administrator route=Intramuscular,, prev dose administration date=11Dec2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 11Dec2021, when the patient was 7 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovering" and all described as "tested positive for COVID"; VOMITING (non-serious) with onset 20Jan2022, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 20Jan2022, outcome "recovering", described as "headache"; BACK PAIN (non-serious) with onset 20Jan2022, outcome "recovering", described as "lower back pain"; PYREXIA (non-serious) with onset 20Jan2022, outcome "recovering", described as "fever (101.7)". The events "tested positive for covid", "tested positive for covid", "vomiting", "headache", "lower back pain" and "fever (101.7)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 101.7; sars-cov-2 test: (20Jan2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, vomiting, headache, back pain, pyrexia. Symptoms on 20Jan were vomiting, headache, lower back pain, and fever (101.7). At the time of submitting this report, he has improved and no longer has any of the symptoms above (only congestion). Treatment received with Tylenol. No other vaccine in four weeks and no other medications in two weeks. No covid prior to vaccination and covid tested post vaccination. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Since I received the vaccine I have my period three times in one month. Every month I am going through the same situation.; Also, my period is heavier and different than before I received the vaccine.; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP) . The reporter is the patient.  A 37-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: POLYMENORRHOEA (non-serious) with onset 24Sep2021, outcome "not recovered", described as "Since I received the vaccine I have my period three times in one month. Every month I am going through the same situation"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 24Sep2021, outcome "not recovered", described as "Also, my period is heavier and different than before I received the vaccine". Therapeutic measures were not taken as a result of polymenorrhoea and heavy menstrual bleeding.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Rash, Urticaria
Clinical narrative: Patient c/o itchy feet within 24 hours of receiving his booster.; He developed a rash; Hives all over his body; Dose number: 3; This is a spontaneous report from a contactable reporter (nurse).  A 13-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Jan2022 (Lot number: FD7218) at the age of 13 Years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was reported as none. It was unknown whether the patient had received any concomitant medications. Past drug history included: Amoxicillin, reaction: "Drug allergy", notes: known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of Administration: Unspecified), administration date: 14May2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Route of Administration: Unspecified), administration date: 04Jun2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Jan2022, outcome "unknown", described as "Dose number: 3"; PRURITUS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Patient c/o itchy feet within 24 hours of receiving his booster"; RASH (non-serious) with onset 18Jan2022, outcome "not recovered", described as "He developed a rash"; URTICARIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Hives all over his body". The events "Patient c/o itchy feet within 24 hours of receiving his booster.", "He developed a rash" and "Hives all over his body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash and urticaria.  Additional information: 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-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment included oral steroid and topical steroid for pruritus, urticaria and rash.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Immunisation, Muscle twitching
Clinical narrative: Chills; Fatigue; Muscle twitching; Tingling (feet) persisting for 2 weeks; Cold/ ice feeling in bloodstream; Nausea; dose number= 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Jan2022 (Lot number: unknown) at the age of 45 Year(s) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: unspecified), administration date: 13Apr2021, when the patient was 44 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: unspecified), administration date: 04May2021, when the patient was 44 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022, outcome "unknown", described as "dose number= 3"; CHILLS (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Chills"; FATIGUE (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Fatigue"; MUSCLE TWITCHING (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Muscle twitching"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Tingling (feet) persisting for 2 weeks"; FEELING COLD (non-serious) with onset 07Jan2022, outcome "unknown", described as "Cold/ ice feeling in bloodstream"; NAUSEA (non-serious) with onset 07Jan2022, outcome "unknown", described as "Nausea". The events "Chills", "Fatigue", "Muscle twitching", "Tingling (feet) persisting for 2 weeks", "Cold/ ice feeling in bloodstream" and "Nausea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, fatigue, muscle twitching, paraesthesia, feeling cold and nausea.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Chills; Fatigue; Muscle twitching; Tingling (feet) persisting for 2 weeks; Cold/ ice feeling in bloodstream; Nausea; dose number= 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Jan2022 (Lot number: unknown) at the age of 45 Year(s) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: Unknown; Route of administration: unspecified), administration date: 13Apr2021, when the patient was 44 year(s) old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Route of administration: unspecified), administration date: 04May2021, when the patient was 44 year(s) old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022, outcome "unknown", described as "dose number= 3"; CHILLS (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Chills"; FATIGUE (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Fatigue"; MUSCLE TWITCHING (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Muscle twitching"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "recovered" (21Jan2022), described as "Tingling (feet) persisting for 2 weeks"; FEELING COLD (non-serious) with onset 07Jan2022, outcome "unknown", described as "Cold/ ice feeling in bloodstream"; NAUSEA (non-serious) with onset 07Jan2022, outcome "unknown", described as "Nausea". The events "Chills", "Fatigue", "Muscle twitching", "Tingling (feet) persisting for 2 weeks", "Cold/ ice feeling in bloodstream" and "Nausea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, fatigue, muscle twitching, paraesthesia, feeling cold and nausea.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Immunisation
Clinical narrative: Dose number: 3; Persistent eye twitch since booster shot; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: 33313OBA) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0165; Route of administration unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0179; Route of administration unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number: 3"; BLEPHAROSPASM (non-serious), outcome "unknown", described as "Persistent eye twitch since booster shot". Therapeutic measures were not taken as a result of blepharospasm.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain lower, Amenorrhoea, Breast pain, Nipple pain
Clinical narrative: I have not had a period since my 2nd vaccination.; My breasts and nipples have intense pain; Nipples have intense pain; My lower abdomen has bloating; My lower abdomen has bloating, cramping and heaviness; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 11Oct2021 at 13:00 (Lot number: FF2590) at the age of 43 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FF2588, Anatomical location: Left arm, Administration time: 13:00), administration date: 20Sep2021, when the patient was 43 years old, for COVID-19 immunisation.  The following information was reported: AMENORRHOEA (non-serious) with onset 24Oct2021, outcome "not recovered", described as "I have not had a period since my 2nd vaccination"; BREAST PAIN (non-serious) with onset 24Oct2021, outcome "not recovered", described as "My breasts and nipples have intense pain"; NIPPLE PAIN (non-serious) with onset 24Oct2021, outcome "not recovered", described as "Nipples have intense pain"; ABDOMINAL DISTENSION (non-serious) with onset 24Oct2021, outcome "not recovered", described as "My lower abdomen has bloating"; ABDOMINAL PAIN LOWER (non-serious) with onset 24Oct2021, outcome "not recovered", described as "My lower abdomen has bloating, cramping and heaviness". The events "I have not had a period since my 2nd vaccination.", "My breasts and nipples have intense pain", "Nipples have intense pain", "My lower abdomen has bloating" and "My lower abdomen has bloating, cramping and heaviness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of amenorrhoea, breast pain, nipple pain, abdominal distension and abdominal pain lower.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Lymphadenopathy, Neuralgia
Clinical narrative: Severe pain and lymph node swelling in right arm; Lymph node swelling in right arm; Nerve pain in right arm and left leg; High fever; Chills; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 22Jan2022 at 10:00 (Lot number: FD7218) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Proteinuria" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: High blood pressure and "Nickel sensitivity" (unspecified if ongoing), notes: Known allergies: Nickel. Concomitant medication included: LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Anatomical location: Left arm, Administration time: 15:30), administration date: 31Mar2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8736, Anatomical location: Right arm, Administration time: 15:00), administration date: 23Apr2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Jan2022 at 10:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Severe pain and lymph node swelling in right arm"; LYMPHADENOPATHY (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Lymph node swelling in right arm"; NEURALGIA (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Nerve pain in right arm and left leg"; PYREXIA (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "High fever"; CHILLS (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, neuralgia, pyrexia and chills.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe pain and lymph node swelling in right arm; Lymph node swelling in right arm; Nerve pain in right arm and left leg; High fever; Chills; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 22Jan2022 at 10:00 (Lot number: FD7218) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Proteinuria" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: High blood pressure and "Nickel sensitivity" (unspecified if ongoing), notes: Known allergies: Nickel. Concomitant medication included: LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Anatomical location: Left arm, Administration time: 15:30), administration date: 31Mar2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8736, Anatomical location: Right arm, Administration time: 15:00), administration date: 23Apr2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Jan2022 at 10:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Severe pain and lymph node swelling in right arm"; LYMPHADENOPATHY (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Lymph node swelling in right arm"; NEURALGIA (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Nerve pain in right arm and left leg"; PYREXIA (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "High fever"; CHILLS (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, neuralgia, pyrexia and chills.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eructation, Gastrooesophageal reflux disease, Immunisation, Oesophageal pain, SARS-CoV-2 test
Clinical narrative: Next day after booster, pain when swallowed location in chest left side like where stomach meets esophagus; Burping acid reflux; Burping acid reflux. Got worse 5 days out, pain went away 2 days after trying Pepcid ac but the acid reflux is lingering and sitting there lower esophageal; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 at 10:00 (Lot number: FL3198) at the age of 46 Years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Alcohol allergy" (unspecified if ongoing), notes: Alcohol allergy gives rash and "Egg allergy" (unspecified if ongoing), notes: Eggs give diarrhea. Concomitant medications included multi vitamins chewable. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0167; Route of administration: unspecified; Anatomical location: Left arm.), administration date: 27Apr2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0185; Route of administration: unspecified; Anatomical site: Left arm; Time of administration: 14:30), administration date: 18May2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022 at 10:00, outcome "unknown", described as "Dose number: 3"; OESOPHAGEAL PAIN (non-serious) with onset 13Jan2022 at 08:00, outcome "recovered" (15Jan2022), described as "Next day after booster, pain when swallowed location in chest left side like where stomach meets esophagus"; ERUCTATION (non-serious) with onset 13Jan2022 at 08:00, outcome "not recovered", described as "Burping acid reflux"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 13Jan2022 at 08:00, outcome "not recovered", described as "Burping acid reflux. Got worse 5 days out, pain went away 2 days after trying Pepcid ac but the acid reflux is lingering and sitting there lower esophageal". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oesophageal pain, eructation and gastrooesophageal reflux disease.  Additional information: 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. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room or urgent care. Since the vaccination, the patient had been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Pain in extremity, Pyrexia
Clinical narrative: Dose received: 3; Fever; Chill; Arm pain; Body pain; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Jan2022 (Lot number: FL3198) as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8731), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8736), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Jan2022, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Chill"; PAIN IN EXTREMITY (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Arm pain"; PAIN (non-serious) with onset 22Jan2022, outcome "not recovered", described as "Body pain". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity and pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pleurisy
Clinical narrative: Pleurisy, when I breath deeply it hurts I cannot breath deeply; Pleurisy, when I breath deeply it hurts I cannot breath deeply; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Epilepsy" (unspecified if ongoing), notes: little bit of epilepsy. so patient taking medication for this.; "pneumonia" (unspecified if ongoing), notes: I think I had pneumonia. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Jan2022, outcome "unknown", described as "Booster"; PLEURISY (non-serious), PAIN (non-serious) all with onset 21Jan2022, outcome "not recovered" and all described as "Pleurisy, when I breath deeply it hurts I cannot breath deeply". Therapeutic measures were not taken as a result of pleurisy, pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: patient was not received any treatment as it was not severe hence patient did not gone to the doctor or anything.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Bell's Palsy; I went to the ER because I couldn't feel my left side of my face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200132291 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: I was perfectly normal before I had Covid. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 24Jan2022, outcome "unknown", described as "Bell's Palsy"; HYPOAESTHESIA (non-serious) with onset 24Jan2022, outcome "unknown", described as "I went to the ER because I couldn't feel my left side of my face". The events "bell's palsy" and "i went to the er because i couldn't feel my left side of my face" were evaluated at the emergency room visit.  Additional information: The patient was perfectly normal before patient had COVID and the Pfizer vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got sick with COVID; Got sick with COVID; Feeling ill; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP). The reporter is the patient. A 43 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 09Feb2021 (Lot number: EL3247) at the age of 42 years as dose 2, single and administration date 20Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Facility type vaccine: Workplace clinic. Relevant medical history included: "Known allergies: bananas" (unspecified if ongoing); "Known allergies: demerol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Demerol, reaction(s): "Known allergies: demerol". The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "recovered" and all described as "Got sick with COVID"; MALAISE (non-serious) with onset 29Dec2021, outcome "recovered", described as "Feeling ill".The patient underwent the following laboratory tests and procedures: Nasal Swab: (Aug2021) negative; (29Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, illness. Since the vaccination, the patient had been tested for COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Confirmed Covid positive; Confirmed Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Mar2021 (Lot number: EN6203) at the age of 61 years as dose 2, single and intramuscular, administered in arm left, administration date 04Mar2021 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had no other vaccines in the four weeks prior and no COVID prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "Confirmed Covid positive". Patient reported she was confirmed COVID positive on 10Jan2022. The event "confirmed COVID positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: COVID test nasal swab: (06Jan2022) positive. Therapeutic measures were not taken as a result of the event.
Age: 94.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: shingles; Initial information received on 12-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a 94 years old male patient who developed shingles, while receiving vaccine 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 lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "shingles" (herpes zoster) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (shingles).  At time of reporting, the outcome was Unknown for the event shingles.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I don't take them they make me sick; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult and unknown gender patient who while receiving vaccine INFLUENZA VACCINE reported that he/she don't take them, they make him/her sick.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation and strength) produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious event "i don't take them they make me sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I don't take them they make me sick).  At time of reporting, the outcome was Unknown for the event i don't take them they make me sick.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event, Disability, Gait disturbance
Clinical narrative: trouble walking; had adverse effects from the first shingles vaccine; Initial information received from on 15-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an unknown age and unknown gender patient who had trouble walking and had adverse effects from the first shingles vaccine while receiving vaccine Influenza Vaccine and shingle 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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; formulation; strength; expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date, the patient received an unknown dose of suspect shingle vaccine produced by unknown manufacturer (lot number; formulation; strength; expiry date: not reported) via unknown route in unknown administration site for immunization. Information on the batch number was requested.  On an unknown date the patient had trouble walking (gait disturbance) (unknown latency) following the administration of Influenza Vaccine and shingle vaccine. This event was leading to disability.  On an unknown date the patient had adverse effects from the first shingles vaccine (adverse event) (unknown latency) following the administration of Influenza Vaccine and shingle vaccine. It was reported that FDA (Food and Drug Administration) has finally recalled it after many years because there were so many sever adverse effects.  Action taken: Not applicable for both events with respect to both suspects.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event trouble walking and for the event had adverse effects from the first shingles vaccine.; Sender's Comments: Sanofi Company comment dated 24-Jan-2022: This case involves an unknown age and unknown gender patient who had trouble walking while receiving vaccine Influenza Vaccine and shingle vaccine. The event was leading to disability. However, patient's medical condition at the time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Further information regarding previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Influenza, Sinusitis, Upper respiratory tract infection
Clinical narrative: upper respiratory infection; sinus infection; bronchitis; Flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via Digital Media.  This case involves an unknown age and unknown gender patient who experienced upper respiratory infection, sinus infection, bronchitis and flu while 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 (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious "upper respiratory infection" (upper respiratory tract infection) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious "sinus infection" (sinusitis) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious "bronchitis" (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " Author/Reporter Comment: Not getting this jab either. The only times I've had the flu was when I got the shot. Last time I had the flu, then upper respiratory infection then sinus infection then bronchitis. I'll take my chances without the flu jab. It is unknown if the patient experienced any additional symptoms/events. There were no lab data/results available."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (upper respiratory infection, sinus infection, bronchitis, Flu).  At time of reporting, the outcome was Unknown for the event upper respiratory infection, was Unknown for the event sinus infection, was Unknown for the event bronchitis and was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: sick with the flu harder than ever; sick; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported sick with the flu harder than ever and sick while receiving vaccine 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 lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event "sick with the flu harder than ever" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (sick with the flu harder than ever, sick).  At time of reporting, the outcome was Unknown for the event sick with the flu harder than ever and was Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine 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 suspect Influenza Vaccine (strength, formulation, route, dose, frequency: unknown) produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious "flu (influenza)" (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome: unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via interactive digital media.  This case involves an unknown age and gender patient who experienced flu ,while receiving vaccine 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 (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"I get the flu shot I get the flu."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: took one in my life and was never sicker; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced took one in my life and was never sicker while receiving vaccine 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 suspect influenza vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.   On an unknown date the patient developed a non-serious "took one in my life and was never sicker (illness)" (unknown latency) following the administration of influenza vaccine.  It was reported that "I took one in my life and was never sicker, won't take another, they mostly miss the strain that is out for the year anyway! After Covid with all the lies,I don't trust Government for much of anything! They only care about money, not people".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (took one in my life and was never sicker).  At time of reporting, the outcome was Unknown for the event took one in my life and was never sicker.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got a bad case of the flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves adult male patient who experienced got a bad case of the flu while receiving vaccine 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 suspect influenza vaccine (strength, formulation, route, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious got a bad case of the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got a bad case of the flu).  At time of reporting, the outcome was Unknown for the event got a bad case of the flu.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Severe reactions requiring a week in the hospital; Initial information received on 17-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves Adult of unknown gender patient who experienced severe reactions requiring a week in the hospital, while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Covid-19 Vaccine for Immunisation.  On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date(latency: unknown) , the patient reported he/she had three flu shots  each resulting in severe reactions requiring a week in the hospital (vaccination complication) same with the covid shots. Doctor says no more ever. The patient was hospitalized for this event during 7 days. (seriousness criteria: hospitalization during 7 days).  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event .  At time of reporting, the outcome was Unknown for the event severe reactions requiring a week in the hospital.; Sender's Comments: Sanofi company comment dated 24-Jan-2022: This case involves Adult of unknown gender patient who experienced severe reactions requiring a week in the hospital ,while receiving vaccine Influenza vaccine.(unknown manufacture). However, patient's medical condition at the time of vaccination and laboratory tests ruling out alternate etiologies were not reported. Further information regarding previous vaccination tolerance and laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Everyone I know who gets the shot, gets the flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a non-hcp (healthcare professional).  This case involves unknown gender adult patient for whom reporter stated everyone I know who gets the shot, gets the flu while receiving vaccine 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 an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; formulation; strength; expiry date not reported) via unknown route in unknown administration site. Information on batch number was requested.  On an unknown date the patient developed a non-serious event "everyone I know who gets the shot, gets the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I never get the shot and I don't get the flu. Everyone I know who gets the shot, gets the flu."  It is unknown if there were lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Everyone I know who gets the shot, gets the flu).  At time of reporting, the outcome was Unknown for the event everyone i know who gets the shot, gets the flu.