chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Vaccination site erythema, Vaccination site nodule
Clinical narrative: visible redness and a round knot under the skin at the injection site.; visible redness and a round knot under the skin at the injection site.; other vaccine same date product flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 15:30 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KEFLEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right , Vaccine Administration Time: 14:00 PM), administration date: 01Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 14:00 PM), administration date: 08Feb2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE NODULE (non-serious) all with onset 27Oct2021 21:00, outcome "not recovered" and all described as "visible redness and a round knot under the skin at the injection site."; PRODUCT USE ISSUE (non-serious) with onset 27Oct2021, outcome "unknown", described as "other vaccine same date product flu". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site nodule. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination patient has not had covid. After vaccination patient has not tested covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Migraine
Clinical narrative: 3 day headache/migraine that just won't fully go away even with medication; tremors; insomnia; headaches/3 day headache/migraine that just won't fully go away even with medication; muscle aches; severe arm pain of injected arm; chills; fatigue/ extreme fatigue; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 17:30 (Lot number: FF2588) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic migraine" (unspecified if ongoing); "chronic sinus infections" (unspecified if ongoing); "Prior to vaccination, was the patient diagnosed with COVID-19?: Yes" (unspecified if ongoing). Concomitant medication(s) included: SUMATRIPTAN; AMPHETAMINE; ESTRADIOL; HYDROXYZINE. The following information was reported: MIGRAINE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "3 day headache/migraine that just won't fully go away even with medication"; TREMOR (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "tremors"; INSOMNIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "insomnia"; HEADACHE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "headaches/3 day headache/migraine that just won't fully go away even with medication"; MYALGIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "muscle aches"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "severe arm pain of injected arm"; CHILLS (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "fatigue/ extreme fatigue"; PYREXIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "fever". Therapeutic measures were taken as a result of migraine, headache. Therapeutic measures were not taken as a result of tremor, insomnia, myalgia, pain in extremity, chills, fatigue, pyrexia.  Additional information: Since the vaccination, has the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: 3 day headache/migraine that just won't fully go away even with medication; tremors; insomnia; headaches/3 day headache/migraine that just won't fully go away even with medication; muscle aches; severe arm pain of injected arm; chills; fatigue/ extreme fatigue; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 17:30 (Lot number: FF2588) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic migraine" (unspecified if ongoing); "chronic sinus infections" (unspecified if ongoing); "Prior to vaccination, was the patient diagnosed with COVID-19?: Yes" (unspecified if ongoing). Concomitant medication(s) included: SUMATRIPTAN; AMPHETAMINE; ESTRADIOL; HYDROXYZINE. The following information was reported: MIGRAINE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "3 day headache/migraine that just won't fully go away even with medication"; TREMOR (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "tremors"; INSOMNIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "insomnia"; HEADACHE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "headaches/3 day headache/migraine that just won't fully go away even with medication"; MYALGIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "muscle aches"; PAIN IN EXTREMITY (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "severe arm pain of injected arm"; CHILLS (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "fatigue/ extreme fatigue"; PYREXIA (non-serious) with onset 13Sep2021 23:00, outcome "not recovered", described as "fever". Therapeutic measures were taken as a result of migraine, headache. Therapeutic measures were not taken as a result of tremor, insomnia, myalgia, pain in extremity, chills, fatigue, pyrexia.  Additional information: Since the vaccination, has the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-1 test
Clinical narrative: Severely sore throat; congestion in throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: EN6199) at the age of 74 years as dose 2, single and administered in arm left, administration date 26May2021 (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lymphoma" (unspecified if ongoing); "Known allergies:Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LYRICA; TYLENOL. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 07Mar2021, outcome "not recovered", described as "Severely sore throat"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 07Mar2021, outcome "not recovered", described as "congestion in throat". The events "severely sore throat" and "congestion in throat" 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 oropharyngeal pain, respiratory tract congestion.  Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Ear pain, Headache, Vomiting
Clinical narrative: Severe headache; earache; stomach pain; vomiting; uncontrollable chills;  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10-year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Nov2021 16:15 (Batch/Lot number: unknown) at the age of 10 years as dose 1, single for covid-19 immunisation. Concomitant medication(s) included FLU, administration date Oct2021 administered in Left Arm; MELATONIN; TYLENOL. Past drug history included Amoxicillin, with reaction of Known Allergy. The following information was reported as HEADACHE (non-serious) with onset 08Nov2021 23:30, outcome recovering; EAR PAIN (non-serious) with onset 08Nov2021 23:30, outcome recovering; ABDOMINAL PAIN UPPER (non-serious) with onset 08Nov2021 23:30, outcome recovering; VOMITING (non-serious) with onset 08Nov2021 23:30, outcome recovering; CHILLS (non-serious) with onset 08Nov2021 23:30, outcome recovering. The events severe headache, earache, stomach pain, vomiting, and uncontrollable chills were evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache, ear pain, abdominal pain upper, vomiting, and chills.   The most recent COVID-19 vaccine was administered at Doctor's office/urgent care. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Maternal exposure during pregnancy, Photophobia
Clinical narrative: Headache; light sensativity; vommitting; severe chills; uncontrollable shaking; Is pregnant Yes / last menstrual date 05Aug2021; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 09:00 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 05Aug2021. The patient was 14 weeks pregnant at the time of exposure to bnt162b2; 12 weeks pregnant to influenza vaccine. The patient was 14 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12May2022. Concomitant medication(s) included: FLU, administration date 02Nov2021. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, dose administration date: 07Apr2021, Vaccine Administration Time: 04:00 PM, Dose Number: 2, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 32 years old, for COVID-19 immunisation; Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, dose administration date: 16Mar2021, Vaccine Administration Time: 08:00 PM, Dose Number: 1, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021 09:00, outcome "unknown", described as "Dose Number: 3"; HEADACHE (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "Headache"; PHOTOPHOBIA (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "light sensativity"; VOMITING (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "vommitting"; CHILLS (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "severe chills"; TREMOR (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "uncontrollable shaking"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 11Nov2021 09:00, outcome "unknown", described as "Is pregnant Yes / last menstrual date 05Aug2021". Therapeutic measures were not taken as a result of headache, photophobia, vomiting, chills, tremor.  Additional information: The patient received FLU other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Headache; light sensativity; vommitting; severe chills; uncontrollable shaking; Is pregnant Yes / last menstrual date 05Aug2021; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 09:00 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 05Aug2021. The patient was 14 weeks pregnant at the time of exposure to bnt162b2; 12 weeks pregnant to influenza vaccine. The patient was 14 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 12May2022. Concomitant medication(s) included: FLU, administration date 02Nov2021. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, dose administration date: 07Apr2021, Vaccine Administration Time: 04:00 PM, Dose Number: 2, Location of injection: Arm Left), administration date: 07Apr2021, when the patient was 32 years old, for COVID-19 immunisation; Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, dose administration date: 16Mar2021, Vaccine Administration Time: 08:00 PM, Dose Number: 1, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Nov2021 09:00, outcome "unknown", described as "Dose Number: 3"; HEADACHE (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "Headache"; PHOTOPHOBIA (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "light sensativity"; VOMITING (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "vommitting"; CHILLS (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "severe chills"; TREMOR (non-serious) with onset 12Nov2021, outcome "recovered" (Nov2021), described as "uncontrollable shaking"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 11Nov2021 09:00, outcome "unknown", described as "Is pregnant Yes / last menstrual date 05Aug2021". Therapeutic measures were not taken as a result of headache, photophobia, vomiting, chills, tremor.  Additional information: The patient received FLU other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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.
Sex: F
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: blood poisoning reaction from the injection site; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) 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), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: SEPSIS (medically significant), outcome "unknown", described as "blood poisoning reaction from the injection site". It was reported that the patient recently got the booster and has had to call the doctor everyday about her side effects. She is pretty concerned about this. She does not believe there was any warning. They said that it was exactly like the first 2 doses and is propaganda they gave her.  She had the booster last Wednesday. She said that she was told it was the same ingredients and dose as the first 2 vaccines. It does not make sense. She said that she is not getting a 4th shot. She said that she has switched sides and said that she will tell everyone that she meets about her experience. Her doctor called in a antibiotic over the weekend because he was concerned that she was having a blood poisoning reaction from the injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fear, Feeling abnormal, Heart rate
Clinical narrative: Severe muscle tension; About 12 hours after receiving my second Pfizer vaccine dose, I had EXTREME, VIOLENT CHILLS for SEVERAL HOURS with severe muscle tension to try and control the chills. I used 4 or 5 blankets but that; My heart rate was between 120-130 bpm whenever I checked it.; Fever; POUNDING HEART for SEVERAL HOURS; Symptoms were miserable and frightening; Symptoms were miserable and frightening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:45 (Lot number: ER2613) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE]; SIMVASTATIN. Past drug history included: No., reaction(s): "Allergy". Vaccination history included: Bnt162b2 (1st Dose, 1 Batch/Lot No: Pfizer EN6208 Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "Severe muscle tension"; CHILLS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "About 12 hours after receiving my second Pfizer vaccine dose, I had EXTREME, VIOLENT CHILLS for SEVERAL HOURS with severe muscle tension to try and control the chills. I used 4 or 5 blankets but that"; HEART RATE ABNORMAL (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "My heart rate was between 120-130 bpm whenever I checked it."; PYREXIA (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "Fever"; PALPITATIONS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "POUNDING HEART for SEVERAL HOURS"; FEELING ABNORMAL (non-serious), FEAR (non-serious) all with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00) and all described as "Symptoms were miserable and frightening". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle tightness, chills, heart rate abnormal, pyrexia, palpitations, feeling abnormal, fear.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. I had a Fever of 100-101.I had a pounding heart for several hours (along with the chills). My heart rate was between 120-130 bpm whenever I checked it.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Muscle tightness, Palpitations, Pyrexia
Clinical narrative: Severe muscle tension; About 12 hours after receiving my second Pfizer vaccine dose, I had EXTREME, VIOLENT CHILLS for SEVERAL HOURS with severe muscle tension to try and control the chills. I used 4 or 5 blankets but that; My heart rate was between 120-130 bpm whenever I checked it.; Fever; POUNDING HEART for SEVERAL HOURS; Symptoms were miserable and frightening; Symptoms were miserable and frightening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 09:45 (Lot number: ER2613) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: L-THYROXINE [LEVOTHYROXINE]; SIMVASTATIN. Past drug history included: No., reaction(s): "Allergy". Vaccination history included: Bnt162b2 (1st Dose, 1 Batch/Lot No: Pfizer EN6208 Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "Severe muscle tension"; CHILLS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "About 12 hours after receiving my second Pfizer vaccine dose, I had EXTREME, VIOLENT CHILLS for SEVERAL HOURS with severe muscle tension to try and control the chills. I used 4 or 5 blankets but that"; HEART RATE ABNORMAL (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "My heart rate was between 120-130 bpm whenever I checked it."; PYREXIA (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "Fever"; PALPITATIONS (non-serious) with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00), described as "POUNDING HEART for SEVERAL HOURS"; FEELING ABNORMAL (non-serious), FEAR (non-serious) all with onset 16Apr2021 22:00, outcome "recovered" (17Apr2021 02:00) and all described as "Symptoms were miserable and frightening". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle tightness, chills, heart rate abnormal, pyrexia, palpitations, feeling abnormal, fear.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. I had a Fever of 100-101.I had a pounding heart for several hours (along with the chills). My heart rate was between 120-130 bpm whenever I checked it.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Immunisation, Myalgia, Pain
Clinical narrative: Severe muscle ache; Light sensitivity/ The patient was not able to keep her eyes open for the first half of the day; Fever; Chills; Sweats; Feeling the body aches; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 19:00 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Penicillin allergy/amoxicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. , Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 07Apr2021, when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 17Mar2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 19:00, outcome "unknown", described as "Booster"; MYALGIA (non-serious) with onset 20Nov2021 12:00, outcome "unknown", described as "Severe muscle ache"; PHOTOPHOBIA (non-serious) with onset 20Nov2021 12:00, outcome "unknown", described as "Light sensitivity/ The patient was not able to keep her eyes open for the first half of the day"; PYREXIA (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Sweats"; PAIN (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Feeling the body aches". Therapeutic measures were not taken as a result of myalgia, photophobia, pyrexia, chills, hyperhidrosis, pain.  Additional information: These event did not result in causing hospitalization and prolongation of hospitalization; life threatening; death; disabling or incapacitating; congenital anomaly or birth defect.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she experienced severe muscle ache within 24 hrs and light sensitivity and she was not able to keep her eyes open for the first half of the day. This continued until 21Nov2021 (at the time of reporting) and the patient was still feeling the body aches, fever, chills and sweats.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia
Clinical narrative: Severe muscle ache; Light sensitivity/ The patient was not able to keep her eyes open for the first half of the day; Fever; Chills; Sweats; Feeling the body aches; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 19:00 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Penicillin allergy/amoxicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. , Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 07Apr2021, when the patient was 24 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Location of injection: Arm Right, Vaccine Administration Time: 12:00 AM), administration date: 17Mar2021, when the patient was 24 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 19:00, outcome "unknown", described as "Booster"; MYALGIA (non-serious) with onset 20Nov2021 12:00, outcome "unknown", described as "Severe muscle ache"; PHOTOPHOBIA (non-serious) with onset 20Nov2021 12:00, outcome "unknown", described as "Light sensitivity/ The patient was not able to keep her eyes open for the first half of the day"; PYREXIA (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Sweats"; PAIN (non-serious) with onset 20Nov2021 12:00, outcome "not recovered", described as "Feeling the body aches". Therapeutic measures were not taken as a result of myalgia, photophobia, pyrexia, chills, hyperhidrosis, pain.  Additional information: These event did not result in causing hospitalization and prolongation of hospitalization; life threatening; death; disabling or incapacitating; congenital anomaly or birth defect.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she experienced severe muscle ache within 24 hrs and light sensitivity and she was not able to keep her eyes open for the first half of the day. This continued until 21Nov2021 (at the time of reporting) and the patient was still feeling the body aches, fever, chills and sweats.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Ataxia, Confusional state, Musculoskeletal stiffness, Myelitis transverse
Clinical narrative: Transverse mylitis; angio edema; ataxia; vertigo; stiffness; mild confusion; This is a spontaneous report received from contactable reporter(s) (nurse). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Oct2021 11:00 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sojgrans" (unspecified if ongoing); "RA" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE; BENADRYL; CROMOLYN [CROMOGLICIC ACID]; OXYCODONE; FAMOTIDINE; CELLCEPT [MYCOPHENOLATE MOFETIL].  The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "Transverse mylitis"; ANGIOEDEMA (medically significant) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "angio edema"; ATAXIA (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "ataxia"; VERTIGO (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "vertigo"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "stiffness"; CONFUSIONAL STATE (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "mild confusion". The events "transverse mylitis", "angio edema", "ataxia", "vertigo", "stiffness" and "mild confusion" were evaluated at the physician office visit. Therapeutic measures were taken as a result of myelitis transverse, angioedema, ataxia, vertigo, musculoskeletal stiffness, confusional state: Steroids benadryl asprin. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Transverse mylitis; angio edema; ataxia; vertigo; stiffness; mild confusion; This is a spontaneous report received from contactable reporter(s) (nurse). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Oct2021 11:00 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sojgrans" (unspecified if ongoing); "RA" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE; BENADRYL; CROMOLYN [CROMOGLICIC ACID]; OXYCODONE; FAMOTIDINE; CELLCEPT [MYCOPHENOLATE MOFETIL].  The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "Transverse mylitis"; ANGIOEDEMA (medically significant) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "angio edema"; ATAXIA (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "ataxia"; VERTIGO (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "vertigo"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "stiffness"; CONFUSIONAL STATE (non-serious) with onset 07Oct2021 00:30, outcome "recovered with sequelae", described as "mild confusion". The events "transverse mylitis", "angio edema", "ataxia", "vertigo", "stiffness" and "mild confusion" were evaluated at the physician office visit. Therapeutic measures were taken as a result of myelitis transverse, angioedema, ataxia, vertigo, musculoskeletal stiffness, confusional state: Steroids benadryl asprin. The patient did not have COVID prior vaccination, and was not covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: left arm Swelling; Pain Under the Left Arm/left arm Tenderness; booster; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Nov2021 12:30 (Batch/Lot number: unknown) at the age of 55 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 (First Dose, Lot: EM9810, Right Arm), administration date: 20Mar2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Site Soreness Arm"; Bnt162b2 (Second Dose, Lot: EW0169, Left Arm), administration date: 18Apr2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Site Soreness"; Flu shot (within 4 weeks the week before in her Right Arm), for immunisation. The following information was reported: HEADACHE (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; PERIPHERAL SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "left arm Swelling"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain Under the Left Arm/left arm Tenderness"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of headache, peripheral swelling, pain in extremity. Clinical courses: No additional vaccines administered on same date of the Pfizer suspect. The time of onset of AE(s) was evening. No family medical history relevant to AE(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Back pain
Clinical narrative: Extreme back pain where i have permanent injury to spine; Extreme back pain where i have permanent injury to spine; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in arm left, administration date 04Nov2021 16:00 (Lot number: FF2593) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient had no known allergies. The patient took unspecified concomitant medications two weeks prior to vaccination. The patient did not receive other vaccines in four weeks. The vaccine was administered in other facility. The patient was not diagnosed with Covid prior vaccination and was not tested post vaccination.  The following information was reported: BACK PAIN (medically significant), BACK INJURY (medically significant) all with onset 06Nov2021, outcome "not recovered" and all described as "Extreme back pain where i have permanent injury to spine". Therapeutic measures were not taken as a result of back pain, back injury.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Feeling hot, Immunisation, Induration
Clinical narrative: Arthus reaction; necrosis; redness; swelling; induration; heat; bruising; Dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 18:00 (Lot number: FH8030) at the age of 67 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: Bnt162b2 (Dose Number: 2, lot number: EL9267, administration time: 10:00 AM,  vaccine location: Left arm), administration date: 09Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, lot number: EN6200, administration time: 10:00 AM, vaccine location: Left arm), administration date: 16Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: TYPE III IMMUNE COMPLEX MEDIATED REACTION (medically significant) with onset 16Nov2021, outcome "recovering", described as "Arthus reaction"; NECROSIS (medically significant) with onset 16Nov2021, outcome "recovering", described as "necrosis"; ERYTHEMA (non-serious) with onset 16Nov2021, outcome "recovering", described as "redness"; SWELLING (non-serious) with onset 16Nov2021, outcome "recovering", described as "swelling"; INDURATION (non-serious) with onset 16Nov2021, outcome "recovering", described as "induration"; FEELING HOT (non-serious) with onset 16Nov2021, outcome "recovering", described as "heat"; CONTUSION (non-serious) with onset 16Nov2021, outcome "recovering", described as "bruising"; IMMUNISATION (non-serious) with onset 15Nov2021 18:00, outcome "unknown", described as "Dose received: 3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative: Other. Therapeutic measures were taken as a result of type iii immune complex mediated reaction, necrosis, erythema, swelling, induration, feeling hot, contusion. The patient self medicated with cold pack and acetaminophen. Arthus reaction (redness, swelling, induration, heat) began several hours after booster inoculation. This reaction peaked about 4 days later (with bruising - necrosis) and spreading of "red" zone. The area of the redness/swelling peaked with a circumference of 10 cm or about 4 inches in diameter. Red area persists but seems to be resolving somewhat one week later.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Necrosis, SARS-CoV-2 test, Swelling, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction; necrosis; redness; swelling; induration; heat; bruising; Dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 18:00 (Lot number: FH8030) at the age of 67 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: Bnt162b2 (Dose Number: 2, lot number: EL9267, administration time: 10:00 AM,  vaccine location: Left arm), administration date: 09Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, lot number: EN6200, administration time: 10:00 AM, vaccine location: Left arm), administration date: 16Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: TYPE III IMMUNE COMPLEX MEDIATED REACTION (medically significant) with onset 16Nov2021, outcome "recovering", described as "Arthus reaction"; NECROSIS (medically significant) with onset 16Nov2021, outcome "recovering", described as "necrosis"; ERYTHEMA (non-serious) with onset 16Nov2021, outcome "recovering", described as "redness"; SWELLING (non-serious) with onset 16Nov2021, outcome "recovering", described as "swelling"; INDURATION (non-serious) with onset 16Nov2021, outcome "recovering", described as "induration"; FEELING HOT (non-serious) with onset 16Nov2021, outcome "recovering", described as "heat"; CONTUSION (non-serious) with onset 16Nov2021, outcome "recovering", described as "bruising"; IMMUNISATION (non-serious) with onset 15Nov2021 18:00, outcome "unknown", described as "Dose received: 3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative: Other. Therapeutic measures were taken as a result of type iii immune complex mediated reaction, necrosis, erythema, swelling, induration, feeling hot, contusion. The patient self medicated with cold pack and acetaminophen. Arthus reaction (redness, swelling, induration, heat) began several hours after booster inoculation. This reaction peaked about 4 days later (with bruising - necrosis) and spreading of "red" zone. The area of the redness/swelling peaked with a circumference of 10 cm or about 4 inches in diameter. Red area persists but seems to be resolving somewhat one week later.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 antibody test, Urticaria
Clinical narrative: I started itching the next day after the second vaccine.; Later on that day, the hives appeared. I have been to the urgent care to get treated. I reported it to my doctor. I have been breaking out in hives for the last 3 weeks after the second vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Nov2021 10:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "shellfish" (unspecified if ongoing). No covid prior vaccination. Concomitant medication(s) included: INSULIN. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: Oct2021, when the patient was 50 years old, for covid 19 immunization. The following information was reported: PRURITUS (medically significant) with onset 02Nov2021, outcome "not recovered", described as "I started itching the next day after the second vaccine."; URTICARIA (medically significant) with onset 02Nov2021, outcome "not recovered", described as "Later on that day, the hives appeared. I have been to the urgent care to get treated. I reported it to my doctor. I have been breaking out in hives for the last 3 weeks after the second vaccine.". The events "i started itching the next day after the second vaccine." and "later on that day, the hives appeared. i have been to the urgent care to get treated. i reported it to my doctor. i have been breaking out in hives for the last 3 weeks after the second vaccine." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (10Nov2021) negative. Therapeutic measures were taken as a result of pruritus, urticaria included injection of benadryly and prednisone.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Monoplegia, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient age 9; arm is paralyzed; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer) from medical information team. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 21Nov2021 16:45 (Lot number: FZ5127) at the age of 9 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Caller was notified by a Pharmacist that the patient received the adult dose (30mcg) vaccine. Caller said that almost immediately after the vaccine on 21Nov2021, the patient complained of a sore arm, not normal but really bad that his whole arm was paralyzed. It is better than 21Nov2021, half way it hurts. Caller states that his son did not take any pain medication to relieve his symptoms. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. No family medical history relevant to AE(s). The outcome of sore arm and arm was paralyzed was not recovered.