chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon laxity, Tendon rupture
Clinical narrative: Persistent weakening of connective tissue/ ligaments; Persistent weakening of connective tissue/ ligaments; Persistent weakening of connective tissue/ ligaments; connective tissue laxity; Spontaneous rupture of tendons; chronic pain; dislocation of joints spine, hands, wrists, feet and ankles; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm left, administration date 12Jan2021 (Lot number: El0142) at the age of 45 years 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 Number: 1, Batch/Lot No: Ek5730, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 45 years old, for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: ASTHENIA (disability), CONNECTIVE TISSUE DISORDER (disability), LIGAMENT DISORDER (disability) all with onset 02Feb2021, outcome "not recovered" and all described as "Persistent weakening of connective tissue/ ligaments"; TENDON LAXITY (disability) with onset 02Feb2021, outcome "not recovered", described as "connective tissue laxity"; TENDON RUPTURE (disability) with onset 02Feb2021, outcome "not recovered", described as "Spontaneous rupture of tendons"; PAIN (disability) with onset 02Feb2021, outcome "not recovered", described as "chronic pain"; JOINT DISLOCATION (disability) with onset 02Feb2021, outcome "not recovered", described as "dislocation of joints spine, hands, wrists, feet and ankles". The events "persistent weakening of connective tissue/ ligaments", "persistent weakening of connective tissue/ ligaments", "persistent weakening of connective tissue/ ligaments", "connective tissue laxity", "spontaneous rupture of tendons", "chronic pain" and "dislocation of joints spine, hands, wrists, feet and ankles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures taken included orthopedic splints.; Sender's Comments: The events considered as intercurrent conditions and unrelated to product bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine). This case will be reassessed upon receipt of follow-up information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Multifocal motor neuropathy
Clinical narrative: Multifocal muscle neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  An 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 83 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Hyponatraemia" (unspecified if ongoing). The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included: NACL. Vaccination history included: Bnt162b2 (Dose Number: 1), administration date: 15Feb2021, when the patient was 83 years old, for COVID-19 immunization. The following information was reported: MULTIFOCAL MOTOR NEUROPATHY (hospitalization, disability, life threatening) with onset 15Apr2021, outcome "not recovered", described as "Multifocal muscle neuropathy". The patient was hospitalized for multifocal motor neuropathy (hospitalization duration: 40 day(s)). The event "multifocal muscle neuropathy" was evaluated at the physician office visit and emergency room visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; 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 (005570). The reporter is the parent.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 (Lot number: EW0170) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety depression" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: JUNEL taken for contraception; ESCITALOPRAM taken for depression. Vaccination history included: Bnt162b2 (First Dose; lot: EW0153), administration date: 08Apr2021, when the patient was 20 years old, for Covid-19 Immunization. No prior vaccinations within 4 weeks. The following information was reported: APPENDICITIS (medically significant) with onset 04May2021, outcome "unknown", described as "Appendicitis". Clinical course: developed appendicitis 4 days after the second Covid shot and had to have emergency surgery, to remove her appendix. Therapeutic measures were taken as a result of appendicitis.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Swelling face
Clinical narrative: The left side of her face became swollen; Booster; Her first two doses were Moderna; Her first two doses were Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:50 (Lot number: FF8841) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Moderna (1st dose: , lot number 002B21A,), administration date: 31Mar2021, when the patient was 41 years old, for Immunization; Moderna (2nd dose:, lot :039A21A,), administration date: 28Apr2021, when the patient was 41 years old, for Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 15Dec2021, outcome "unknown" and all described as "Her first two doses were Moderna"; IMMUNISATION (non-serious) with onset 15Dec2021 15:50, outcome "unknown", described as "Booster"; SWELLING FACE (non-serious) with onset 17Dec2021 01:00, outcome "recovering", described as "The left side of her face became swollen".  Additional information: The patient stated sometime over night last night the left side of her face became swollen. She knows this is a possible side effect and is seeking recommendations on what to do about it and to ensure it is reported. She got the vaccine at the Patent trade office. She doesn't know the address. The swelling has improved a little. She did not receive any other vaccines. AE(s) didn't require a visit to Emergency Room or Physician Office. Any prior vaccination within 4 weeks was not reported.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Encephalitis
Clinical narrative: Dizziness; Diagnosed with Encephalitis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 30Nov2021 16:30 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); " Irritable bowel syndrome (IBS)" (unspecified if ongoing). Concomitant medications included: GABAPENTIN; lamotrigine (LAMICTAL); levetiracetam (KEPPRA); TRAZODONE; OMEPRAZOLE. Past drug history included: carbamazepine (TEGRETOL), reaction: "Allergy"; venlafaxine hydrochloride (EFFEXOR), reaction: "Allergy". Vaccination history included: Bnt162b2 (lot unknown; dose administration time=12:00; dose number=2; location=Left arm), administration date: 26Apr2021, when the patient was 40 years old, for COVID-19 immunization; Bnt162b2 (dose administration time=12:00; dose number=1; vaccine location=Left arm; lot unknown), administration date: 05Apr2021, when the patient was 40 years old, for COVID-19 immunization. The following information was reported: ENCEPHALITIS (medically significant) with onset 30Nov2021 21:00, outcome "not recovered", described as "Diagnosed with Encephalitis"; DIZZINESS (medically significant) with onset Dec2021, outcome "not recovered", described as "Dizziness". The events "diagnosed with encephalitis" and "dizziness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of encephalitis which included prednisone. Clinical course: 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 patient was diagnosed with encephalitis. The patient was getting migraines four to five times a day for eight days. The patient had to go to the emergency room (ER) and was then put on new medications. The patient now had cluster headaches. At the time of the report, it had been almost three weeks and the patient had terrible head pain and dizziness. The patient went to see five specialists. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pain
Clinical narrative: off label use; Provided his sister receive the primary series with the Moderna vaccine; Booster dose; tiredness/ fatigue; sore arm; achiness/really achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 65 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: Moderna vaccine (First Dose), for Covid-19 Immunization; Moderna vaccine (Second Dose), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 15Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Dec2021, outcome "unknown", described as "Provided his sister receive the primary series with the Moderna vaccine"; IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster dose"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "tiredness/ fatigue"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "achiness/really achy".  Additional information: Reporter called on behalf of his sister who received the Pfizer Biontech COVID 19 vaccine booster dose last Wednesday 15Dec2021. Reporter stated his sister unintentionally mentioned experiencing tiredness and fatigue, a sore arm and achiness after receiving the booster dose. Provided his sister receive the primary series with the Moderna vaccine. This all happened strictly by accident and he had sent an email today asking if she wanted to meet for breakfast and she responded that she did not want to get up that early and mentioned she had the Pfizer Biontech COVID 19 vaccine booster on 15Dec2021, and was feeling tired and fatigued after getting shot. Then he asked if there were any other symptoms and she said she had a sore arm and was feeling a little achy. He did not know her height and weight. He did not know her primary care provider's email. He did not know exactly what date or time it started. He did not know the outcome. 1st two dose dates were back in the Spring of 2021. He wants to say that they were both Moderna and he cannot confirm that. In any event he did not have exact dates and did not know the lot numbers or expiration dates. He knows of no other health concerns. Her email suggested that she had the typical reaction after a vaccine. That may indicate she had something before, but he was not sure.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: off label use; Provided his sister receive the primary series with the Moderna vaccine; Booster dose; tiredness/ fatigue; sore arm; achiness/really achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 65 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: Moderna vaccine (First Dose), for Covid-19 Immunization; Moderna vaccine (Second Dose), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 15Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Dec2021, outcome "unknown", described as "Provided his sister receive the primary series with the Moderna vaccine"; IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster dose"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "tiredness/ fatigue"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "achiness/really achy".  Additional information: Reporter called on behalf of his sister who received the Pfizer Biontech COVID 19 vaccine booster dose last Wednesday 15Dec2021. Reporter stated his sister unintentionally mentioned experiencing tiredness and fatigue, a sore arm and achiness after receiving the booster dose. Provided his sister receive the primary series with the Moderna vaccine. This all happened strictly by accident and he had sent an email today asking if she wanted to meet for breakfast and she responded that she did not want to get up that early and mentioned she had the Pfizer Biontech COVID 19 vaccine booster on 15Dec2021, and was feeling tired and fatigued after getting shot. Then he asked if there were any other symptoms and she said she had a sore arm and was feeling a little achy. He did not know her height and weight. He did not know her primary care provider's email. He did not know exactly what date or time it started. He did not know the outcome. 1st two dose dates were back in the Spring of 2021. He wants to say that they were both Moderna and he cannot confirm that. In any event he did not have exact dates and did not know the lot numbers or expiration dates. He knows of no other health concerns. Her email suggested that she had the typical reaction after a vaccine. That may indicate she had something before, but he was not sure.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Eye pain, Fatigue, Headache
Clinical narrative: Heart slow but it's better now; Dry mouth; Dizziness; Nausea; Headache; Fatigue; Muscle pain; Eyes kind of hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEART RATE DECREASED (non-serious) with onset 17Dec2021, outcome "recovering", described as "Heart slow but it's better now"; DRY MOUTH (non-serious) with onset 17Dec2021, outcome "unknown", described as "Dry mouth"; DIZZINESS (non-serious) with onset 17Dec2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 17Dec2021, outcome "unknown", described as "Nausea"; HEADACHE (non-serious) with onset 17Dec2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 17Dec2021, outcome "unknown", described as "Fatigue"; MYALGIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "Muscle pain"; EYE PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "Eyes kind of hurt". The lot number for bnt162b2 was not provided and will be requested during follow up.   .
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Myalgia, Nausea
Clinical narrative: Heart slow but it's better now; Dry mouth; Dizziness; Nausea; Headache; Fatigue; Muscle pain; Eyes kind of hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HEART RATE DECREASED (non-serious) with onset 17Dec2021, outcome "recovering", described as "Heart slow but it's better now"; DRY MOUTH (non-serious) with onset 17Dec2021, outcome "unknown", described as "Dry mouth"; DIZZINESS (non-serious) with onset 17Dec2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 17Dec2021, outcome "unknown", described as "Nausea"; HEADACHE (non-serious) with onset 17Dec2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 17Dec2021, outcome "unknown", described as "Fatigue"; MYALGIA (non-serious) with onset 17Dec2021, outcome "unknown", described as "Muscle pain"; EYE PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "Eyes kind of hurt". The lot number for bnt162b2 was not provided and will be requested during follow up.   .
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscular weakness, Neuropathy peripheral
Clinical narrative: neuropathy; lymphadenopathy; muscle weakness; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team and a sales representative.  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: Covid-19 vaccine (1st dose:, Unknown manufacturer), for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "recovered", described as "neuropathy"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymphadenopathy"; MUSCULAR WEAKNESS (non-serious), outcome "recovered", described as "muscle weakness". The patient reported experiencing extensive lymphadenopathy and neuropathy, muscle weakness after dose two which lasted 3 months.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Influenza like illness
Clinical narrative: dose received 3; Severe headache and flue like symptoms starting 18hrs past the vaccination and continuing 26 hrs past the shot; Severe headache and flue like symptoms starting 18hrs past the vaccination and continuing 26 hrs past the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left (Lot number: ew0164) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history was not reported. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0183, Location of injection: Arm Left), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: fj8757, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose received 3"; HEADACHE (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 17Dec2021 04:00, outcome "not recovered" and all described as "Severe headache and flue like symptoms starting 18hrs past the vaccination and continuing 26 hrs past the shot". Therapeutic measures were not taken as a result of headache, influenza like illness.  Additional information: the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not received other medications in two weeks. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Immunisation, Lymphadenopathy, Rash
Clinical narrative: bad rash all over the back; Swollen lymph node on the left side; Pain in the left breast/chest; Pain in the left breast; Booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), administration date: May2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), administration date: May2021, when the patient was 36 years old, for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks; was not diagnosed with COVID prior to vaccination; had not been tested for COVID since vaccination; and had no known allergies. The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "not recovered", described as "Booster shot"; RASH (medically significant) with onset 13Dec2021, outcome "not recovered", described as "bad rash all over the back"; LYMPHADENOPATHY (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Swollen lymph node on the left side"; CHEST PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Pain in the left breast/chest"; BREAST PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Pain in the left breast". After the booster shot, the patient developed bad rash all over the back and received steroid after consulting with healthcare provider. The patient also experienced swollen lymph node on the left side and pain in the left breast/chest. The events were reported as non-serious and did not require hospitalization. The events "booster shot", "bad rash all over the back", "swollen lymph node on the left side", "pain in the left breast/chest" and "pain in the left breast" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash. The patient was treated with methylprednisolone (MEDROL) and cetirizine hydrochloride (ZYRTEC). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Hallucination, auditory, Hyperhidrosis, Nightmare, Retching
Clinical narrative: The following evening awoke with auditory hallucinations that repeated multiple times throughout the night; 12 hours after the second dose awoke with extreme abdominal pains.; Threw up 3 times; dry heaving for 12 hours nonstop; Woke up in a sweat; They were like nightmares that continued to hear after woke up.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 9-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 14:15 (Batch/Lot number: unknown) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 21Nov2021, when the patient was 8-years-old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: HALLUCINATION, AUDITORY (medically significant) with onset 16Dec2021 01:00, outcome "unknown", described as "The following evening awoke with auditory hallucinations that repeated multiple times throughout the night"; ABDOMINAL PAIN (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "12 hours after the second dose awoke with extreme abdominal pains."; VOMITING (non-serious) with onset 16Dec2021 01:00, outcome "recovered" (Dec2021), described as "Threw up 3 times"; RETCHING (non-serious) with onset 16Dec2021 01:00, outcome "recovered" (Dec2021), described as "dry heaving for 12 hours nonstop"; HYPERHIDROSIS (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "Woke up in a sweat"; NIGHTMARE (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "They were like nightmares that continued to hear after woke up". The patient reported nothing like this ever happened before. The events "the following evening awoke with auditory hallucinations that repeated multiple times throughout the night", "12 hours after the second dose awoke with extreme abdominal pains.", "threw up 3 times", "dry heaving for 12 hours nonstop", "woke up in a sweat" and "they were like nightmares that continued to hear after woke up." were evaluated at the physician office visit. The patient was not hospitalized for the events. Therapeutic measures were not taken as a result of hallucination, auditory, abdominal pain, vomiting, retching, hyperhidrosis, nightmare. It was also reported that since the vaccination the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: The following evening awoke with auditory hallucinations that repeated multiple times throughout the night; 12 hours after the second dose awoke with extreme abdominal pains.; Threw up 3 times; dry heaving for 12 hours nonstop; Woke up in a sweat; They were like nightmares that continued to hear after woke up.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 9-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 14:15 (Batch/Lot number: unknown) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 21Nov2021, when the patient was 8-years-old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccine.  The following information was reported: HALLUCINATION, AUDITORY (medically significant) with onset 16Dec2021 01:00, outcome "unknown", described as "The following evening awoke with auditory hallucinations that repeated multiple times throughout the night"; ABDOMINAL PAIN (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "12 hours after the second dose awoke with extreme abdominal pains."; VOMITING (non-serious) with onset 16Dec2021 01:00, outcome "recovered" (Dec2021), described as "Threw up 3 times"; RETCHING (non-serious) with onset 16Dec2021 01:00, outcome "recovered" (Dec2021), described as "dry heaving for 12 hours nonstop"; HYPERHIDROSIS (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "Woke up in a sweat"; NIGHTMARE (non-serious) with onset 16Dec2021 01:00, outcome "unknown", described as "They were like nightmares that continued to hear after woke up". The patient reported nothing like this ever happened before. The events "the following evening awoke with auditory hallucinations that repeated multiple times throughout the night", "12 hours after the second dose awoke with extreme abdominal pains.", "threw up 3 times", "dry heaving for 12 hours nonstop", "woke up in a sweat" and "they were like nightmares that continued to hear after woke up." were evaluated at the physician office visit. The patient was not hospitalized for the events. Therapeutic measures were not taken as a result of hallucination, auditory, abdominal pain, vomiting, retching, hyperhidrosis, nightmare. It was also reported that since the vaccination the patient had not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Heart rate increased, Myocarditis
Clinical narrative: A fast heartbeat that lasted for a few hours; He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety; He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 13Dec2021 18:00 (Batch/Lot number: unknown) at the age of 11 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: MYOCARDITIS (medically significant), ANXIETY (non-serious) all with onset 13Dec2021, outcome "unknown" and all described as "He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety"; HEART RATE INCREASED (non-serious) with onset 13Dec2021 20:00, outcome "recovered" (Dec2021), described as "A fast heartbeat that lasted for a few hours". The events "he went to the er for treatment where they ruled out myocarditis and thinks it was anxiety", "a fast heartbeat that lasted for a few hours" and "he went to the er for treatment where they ruled out myocarditis and thinks it was anxiety" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (13Dec2021) fast heartbeat.  The clinical course of events was as follows: An 11 year old male patient received his first dose of Pfizer Biontech covid 19 vaccine on 13Dec2021 at 6 PM and at 8 PM he developed a fast heartbeat that lasted for a few hours. He went to the ER for treatment where they ruled out myocarditis and thinks it was anxiety. Caller seeking information if the patient should get a his second dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, it is not clear if myocarditis was diagnosed. The reported symptom of fast heartbeat was possibly due to anxiety. Additional information has been requested. The case will be re-evaluated if more information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain in extremity
Clinical narrative: Booster; Headache; Some arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Lot number: FH8030) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and 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 13Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Some arm pain". Additional information: The patient received the Pfizer-BioNTech COVID-19 Vaccine booster dose on Monday and had headache now, 3 days later and asked for information how to treat this. Patient mentioned she would still need to contact her Doctor. E-transmitting potential AE for review (47 years old, Female). Response: Checked EUA, Revised: 16Dec2021. Spoke from attached documents and explained that Pfizer is unable to make treatment recommendations specific for individual patients, referred to HCP for further guidance. Follow-up received on 17Dec2021: This is a spontaneous follow-up report received from the same contactable consumer. This 47-year-old female consumer (patient) reported for herself that: Updated Information: New event added. Additional Information: This report is not related to a study or programme. Reporter seriousness for Severe headache and Arm pain: Unspecified. Reporter states that: She received the Pfizer vaccine, the booster on Monday and she had severe headache since then. Patient wanted to confirm whether she should go to the ER. Patient had queried if this Is major cause of concern and what should she do.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Eye pain, Headache, Pruritus, SARS-CoV-2 test
Clinical narrative: Hives; Headaches; Shortness of breath; Eye pain; Itchy skin; Sinus problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 10:00 (Lot number: FC3181) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE; FINASTERIDE. The following information was reported: URTICARIA (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Hives"; HEADACHE (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Headaches"; DYSPNOEA (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Shortness of breath"; EYE PAIN (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Eye pain"; PRURITUS (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Itchy skin"; SINUS DISORDER (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Sinus problems". The events "hives", "headaches", "shortness of breath", "eye pain", "itchy skin" and "sinus problems" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, headache, dyspnoea, eye pain, pruritus, sinus disorder.  Additional information: The patient administered dose 2, single on 24Sept2021 11:00 AM, administered in arm left, (Lot number: FE3592). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid 19. Since the vaccination the patient had not tested for covid 19.  No follow-up attempts are possible. No further information is expected.  Follow-Up (28Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder, Urticaria
Clinical narrative: Hives; Headaches; Shortness of breath; Eye pain; Itchy skin; Sinus problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 10:00 (Lot number: FC3181) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE; FINASTERIDE. The following information was reported: URTICARIA (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Hives"; HEADACHE (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Headaches"; DYSPNOEA (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Shortness of breath"; EYE PAIN (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Eye pain"; PRURITUS (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Itchy skin"; SINUS DISORDER (non-serious) with onset 10Sep2021 12:00, outcome "not recovered", described as "Sinus problems". The events "hives", "headaches", "shortness of breath", "eye pain", "itchy skin" and "sinus problems" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria, headache, dyspnoea, eye pain, pruritus, sinus disorder.  Additional information: The patient administered dose 2, single on 24Sept2021 11:00 AM, administered in arm left, (Lot number: FE3592). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with covid 19. Since the vaccination the patient had not tested for covid 19.  No follow-up attempts are possible. No further information is expected.  Follow-Up (28Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Soreness at site of injection.; dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 17:30 (Lot number: FF2589) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Food allergies (gluten)" (unspecified if ongoing); "known_allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: PROBIOTICS; VITAMINS NOS. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 05:30 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, when the patient was 58 years old, for COVID-19 Immunisation; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 05:15 PM, Route of Administration: Intramuscular), administration date: 12Apr2021, when the patient was 58 years old, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 17:30, outcome "unknown", described as "dose received 3"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021 21:30, outcome "recovering", described as "Soreness at site of injection.". Therapeutic measures were not taken as a result of vaccination site pain.   Additional information: Patient did not receive any other vaccine in four weeks. Patient had not history of covid prior to vaccination. Patient was not tested positive for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: getting Covid; getting Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Oct2021 (Lot number: 30155BA, Expiration Date: 31Mar2022) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "getting Covid".
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Severe headache; Low grade fever; Vomiting; Joint pain; Chills; Sensitivity to light and sound; Sensitivity to light and sound; Dizziness; Shortness of breath; Booster (dose 3); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 13Dec2021 05:00 (Lot number: FH8030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Postural orthostatic tachycardic syndrome" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing). Concomitant medication(s) included: AVIANE. Vaccination history included: BNT162B2 (dose 2, single; lot: EW0171; site: right arm; time: 10:00), administration date: 04May2021, when the patient was 29 years old, for COVID-19 immunization; BNT162B2 (dose 1, single; lot: ER8729; site: right arm; time: 10:00), administration date: 19Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 05:00, outcome "unknown", described as "Booster (dose 3)"; HEADACHE (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Severe headache"; PYREXIA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Low grade fever"; VOMITING (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Vomiting"; ARTHRALGIA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Joint pain"; CHILLS (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Chills"; PHOTOPHOBIA (non-serious), HYPERACUSIS (non-serious) all with onset 14Dec2021 13:00, outcome "recovering" and all described as "Sensitivity to light and sound"; DIZZINESS (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Dizziness"; DYSPNOEA (non-serious) with onset 14Dec2021 13:00, outcome "recovering", described as "Shortness of breath". Therapeutic measures were not taken as a result of headache, pyrexia, vomiting, arthralgia, chills, photophobia, hyperacusis, dizziness, dyspnoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had no history of COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.