chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Sore arm on side of injection; mild fever; chills; fatigue; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm, administration date 26Nov2021 (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: Covid-19 vaccine (Dose no:1, MANUFACTURER: UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (Dose no:2, MANUFACTURER: UNKNOWN), for COVID-19 Immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "Sore arm on side of injection"; PYREXIA (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "mild fever"; CHILLS (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "chills"; FATIGUE (non-serious) with onset 27Nov2021, outcome "recovered" (28Nov2021), described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reportedly, the patient had sore arm on side of injection, mild fever and chills, fatigue all symptoms occurred on 27Nov, late afternoon to early evening. All symptoms were resolved by early morning of 28Nov. Reportedly, the events took place after use of the product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Immunisation
Clinical narrative: Headache; significant muscle aches; joint pain; nausea; fatigue; pain at the injection site; dizziness; fever; vision changes; sleep disturbance; booster; 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), dose 3 (Lot number: 30155BA) via unspecified route of administration at arm right, on 03Dec2021 11:30 at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis; "acid reflux" (unspecified if ongoing), notes: other medical history: acid reflux; "Known allergies: Sulfa antibiotics" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sesame, reaction(s): "Known allergies: Sesame", notes: Known allergies: Sesame. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EN6203), via unspecified route of administration on 27Feb2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EM9810), via unspecified route of administration on 06Feb2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 11:30, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "Headache"; MYALGIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "significant muscle aches"; ARTHRALGIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "joint pain"; NAUSEA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "pain at the injection site"; DIZZINESS (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "dizziness"; PYREXIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "fever"; VISUAL IMPAIRMENT (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "vision changes"; SLEEP DISORDER (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "sleep disturbance". Therapeutic measures were not taken as a result of headache, myalgia, arthralgia, nausea, fatigue, vaccination site pain, dizziness, pyrexia, visual impairment, sleep disorder.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Sleep disorder, Vaccination site pain
Clinical narrative: Headache; significant muscle aches; joint pain; nausea; fatigue; pain at the injection site; dizziness; fever; vision changes; sleep disturbance; booster; 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), dose 3 (Lot number: 30155BA) via unspecified route of administration at arm right, on 03Dec2021 11:30 at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis; "acid reflux" (unspecified if ongoing), notes: other medical history: acid reflux; "Known allergies: Sulfa antibiotics" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sesame, reaction(s): "Known allergies: Sesame", notes: Known allergies: Sesame. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EN6203), via unspecified route of administration on 27Feb2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EM9810), via unspecified route of administration on 06Feb2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 11:30, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "Headache"; MYALGIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "significant muscle aches"; ARTHRALGIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "joint pain"; NAUSEA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "pain at the injection site"; DIZZINESS (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "dizziness"; PYREXIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "fever"; VISUAL IMPAIRMENT (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "vision changes"; SLEEP DISORDER (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "sleep disturbance". Therapeutic measures were not taken as a result of headache, myalgia, arthralgia, nausea, fatigue, vaccination site pain, dizziness, pyrexia, visual impairment, sleep disorder.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Headache; significant muscle aches; joint pain; nausea; fatigue; pain at the injection site; dizziness; fever; vision changes; sleep disturbance; booster; 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), dose 3 (Lot number: 30155BA) via unspecified route of administration at arm right, on 03Dec2021 11:30 at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis; "acid reflux" (unspecified if ongoing), notes: other medical history: acid reflux; "Known allergies: Sulfa antibiotics" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sesame, reaction(s): "Known allergies: Sesame", notes: Known allergies: Sesame. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EN6203), via unspecified route of administration on 27Feb2021, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EM9810), via unspecified route of administration on 06Feb2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 11:30, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "Headache"; MYALGIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "significant muscle aches"; ARTHRALGIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "joint pain"; NAUSEA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "nausea"; FATIGUE (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "fatigue"; VACCINATION SITE PAIN (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "pain at the injection site"; DIZZINESS (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "dizziness"; PYREXIA (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "fever"; VISUAL IMPAIRMENT (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "vision changes"; SLEEP DISORDER (non-serious) with onset 04Dec2021 03:00, outcome "recovering", described as "sleep disturbance". Therapeutic measures were not taken as a result of headache, myalgia, arthralgia, nausea, fatigue, vaccination site pain, dizziness, pyrexia, visual impairment, sleep disorder.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging head, Myalgia, Nasal congestion
Clinical narrative: She experienced severe muscle pain in her neck, back an lower legs, along with nasal congestion; fatigue; She experienced severe muscle pain in her neck, back an lower legs, along with nasal congestion; 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 43-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EW0168) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (FIRST DOSE- 11May2021, Lot- EW0167), administration date: 11May2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset Jul2021, outcome "not recovered", NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown" and all described as "She experienced severe muscle pain in her neck, back a lower leg, along with nasal congestion"; FATIGUE (non-serious) with onset Jul2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia.  Additional information: Patient reported that, after receiving the Pfizer Covid 19 Vaccination series she experienced severe muscle pain in her neck, back and lower legs, along with nasal congestion. Patient stated that she experienced so much muscle aches on neck and lower back, fatigue she has never had before, states it has just gotten worse. Patient stated she going to work and everything it got really bad, due to the pains she had to start seeing orthopaedic doctors and chiropractors, just using muscle and pain killers, states it is overwhelming, state to do this she has had to stop working. Patient wants to know now that it is time for her booster, she is hesitating and wants to know if she should get the booster, states she is looking for guidance on the booster shot when she has experienced these effects from the other vaccines. States she couldn't walk properly because of this, had to start using a cane. She says she spoke to someone previously, and this affected her job, family, and emotional. Patient asked if the booster can be Moderna? Asking if there have been any reactions from the Moderna after taking the Pfizer.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Premature menarche
Clinical narrative: had her very first period (more spotting than an actual period); had her very first period (more spotting than an actual period); had her very first period (more spotting than an actual period); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 16:30 (Lot number: FK5618) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LORATADINE. Vaccination history included: Bnt162b2 (DOSE 1, lot number=FK5127, administration date=12Nov2021, administration time=04:45 PM, vaccine location=Left arm), administration date: 12Nov2021, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: PREMATURE MENARCHE (non-serious), MENSTRUATION IRREGULAR (non-serious), INTERMENSTRUAL BLEEDING (non-serious) all with onset 05Dec2021, outcome "unknown" and all described as "had her very first period (more spotting than an actual period)". Therapeutic measures were not taken as a result of premature menarche, menstruation irregular, intermenstrual bleeding.  Additional information: Reporter stated that her daughter had her very first period (more spotting than an actual period) on 05Dec2021, which was 2 days after she received her second Covid-19 shot. She will be 11, so it isn't that drastic, but they suspect her period came 12-18 months early due to the shot. The patient did not receive any other vaccine in four weeks.  Follow-Up (13Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Renal pain
Clinical narrative: I feel like severe pain in both kidneys; lot of pain in my stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 07Dec2021 13:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: RENAL PAIN (non-serious) with onset 07Dec2021, outcome "recovering", described as "I feel like severe pain in both kidneys"; ABDOMINAL PAIN UPPER (non-serious) with onset 07Dec2021, outcome "recovering", described as "lot of pain in my stomach".  Additional information: The patient had never felt this thing before and was unsure if it was normal. Almost 7 hours after the patient felt severe pain in the kidneys. She felt severe pain in her kidneys and now lot of pain in her stomach. The patient was going to the hospital.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Extreme swelling of the left eyelid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: 33130BA) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8028, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 15Nov2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: SWELLING OF EYELID (non-serious) with onset 07Dec2021 19:00, outcome "recovering", described as "Extreme swelling of the left eyelid". The event "extreme swelling of the left eyelid" was evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling of eyelid.  Additional information: Other vaccine in four weeks: No. Covid prior vaccination: No. Covid tested post vaccination: No. AE treatment: Oral steroid.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain, Pain in extremity, Pyrexia
Clinical narrative: Third dose/booster dose; lymph node swelling; swelling under her left arm pit; body aches/It hurts a lot/has a lot of body aches/pain; left arm pain (the arm she received the injection in); Fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 12:30 (Batch/Lot number: FJ8762) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing). Concomitant medication included: METOPROLOL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0162, Expiry Date: Unknown, Route, Anatomical Location: Not provided.), administration date: 08Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "Experienced left arm soreness and swelling", "Lymph node swelling", "Experienced left arm soreness and swelling/Left deltoid arm it is really sore", "Soreness at injection site/Left deltoid arm it is really sore", "swelling in the arm where she got vaccinated"; Bnt162b2 (Dose 2, Lot: ER8736, Expiry Date: Unknown), administration date: 29Apr2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 12:30, outcome "unknown", described as "Third dose/booster dose"; LYMPHADENOPATHY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "lymph node swelling"; SWELLING (non-serious) with onset 07Dec2021, outcome "not recovered", described as "swelling under her left arm pit"; PAIN (non-serious) with onset 07Dec2021, outcome "not recovered", described as "body aches/It hurts a lot/has a lot of body aches/pain"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "left arm pain (the arm she received the injection in)"; PYREXIA (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Fever".  Additional information: The patient wanted to know if lymph node swelling can happen anywhere or only specific areas. The patient knows that fever and body aches were part of the side effects of the vaccine and knows it's just the vaccine working. It was stated that onset of all events were maybe 3 to 4 hours after being administered the booster dose; which would be around 15:30 to 16:30 approximate time of onset. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event did not caused Emergency Room or Physician Office visit and was not hospitalized. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE following prior vaccinations was provided.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Third dose/booster dose; lymph node swelling; swelling under her left arm pit; body aches/It hurts a lot/has a lot of body aches/pain; left arm pain (the arm she received the injection in); Fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 12:30 (Batch/Lot number: FJ8762) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing). Concomitant medication included: METOPROLOL taken for blood pressure measurement (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot: EW0162, Expiry Date: Unknown, Route, Anatomical Location: Not provided.), administration date: 08Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "Experienced left arm soreness and swelling", "Lymph node swelling", "Experienced left arm soreness and swelling/Left deltoid arm it is really sore", "Soreness at injection site/Left deltoid arm it is really sore", "swelling in the arm where she got vaccinated"; Bnt162b2 (Dose 2, Lot: ER8736, Expiry Date: Unknown), administration date: 29Apr2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 12:30, outcome "unknown", described as "Third dose/booster dose"; LYMPHADENOPATHY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "lymph node swelling"; SWELLING (non-serious) with onset 07Dec2021, outcome "not recovered", described as "swelling under her left arm pit"; PAIN (non-serious) with onset 07Dec2021, outcome "not recovered", described as "body aches/It hurts a lot/has a lot of body aches/pain"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "left arm pain (the arm she received the injection in)"; PYREXIA (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Fever".  Additional information: The patient wanted to know if lymph node swelling can happen anywhere or only specific areas. The patient knows that fever and body aches were part of the side effects of the vaccine and knows it's just the vaccine working. It was stated that onset of all events were maybe 3 to 4 hours after being administered the booster dose; which would be around 15:30 to 16:30 approximate time of onset. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The event did not caused Emergency Room or Physician Office visit and was not hospitalized. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE following prior vaccinations was provided.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling a little bit at the injection site was reported as worsened/ a little red at the injection site was reported as worsened/ itching at the injection site was reported as worsened; swelling a little bit at the injection site; a little red at the injection site; itching at the injection site; Booster dose; 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 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 (Lot number: FH8028) at the age of 67 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:1, Lot,no- EN6201), administration date: 11Feb2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, EN6206), administration date: 06Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "Booster dose"; VACCINATION SITE SWELLING (non-serious) with onset 08Dec2021, outcome "not recovered", described as "swelling a little bit at the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08Dec2021, outcome "not recovered", described as "a little red at the injection site"; VACCINATION SITE PRURITUS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "itching at the injection site"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "swelling a little bit at the injection site was reported as worsened/ a little red at the injection site was reported as worsened/ itching at the injection site was reported as worsened". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pruritus.  Additional information: No other products and no patient history. There was no investigation assessment.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Peripheral swelling, Vaccination site pain
Clinical narrative: he felt a sensation under his arm and then today, he checked, and it was swollen; He had Booster shot; Pain injection site; 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. Other Case identifier(s): US-PFIZER INC-202101758865 (Pfizer).  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (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: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "He had Booster shot"; VACCINATION SITE PAIN (non-serious) with onset 07Dec2021, outcome "unknown", described as "Pain injection site"; PERIPHERAL SWELLING (non-serious) with onset 08Dec2021, outcome "unknown", described as "he felt a sensation under his arm and then today, he checked, and it was swollen".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Palpitations
Clinical narrative: my heart felt like it was beating out of my chest; BP was very high; heart was gonna pound out of her chest; 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 74 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: She has had high blood pressure before and is on medication for it. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose no:1, 1st one was in Mar2021.), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 27Sep2021 01:00, outcome "unknown", described as "my heart felt like it was beating out of my chest"; BLOOD PRESSURE INCREASED (non-serious) with onset 27Sep2021 01:00, outcome "unknown", described as "BP was very high"; PALPITATIONS (non-serious) with onset 27Sep2021 01:00, outcome "recovered", described as "heart was gonna pound out of her chest". The events "my heart felt like it was beating out of my chest", "bp was very high" and "heart was gonna pound out of her chest" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, blood pressure increased, palpitations.  Additional information- Patient states that she has had both of the Pfizer shots, the last one was on 12Apr2021, and the 1st one was in Mar2021. She clarified the product as the Pfizer Covid 19 Vaccine. States that several months after getting the 2nd shot she woke up at 1am and felt like her heart was gonna pound out of her chest, but her blood pressure was through the roof also. Her doctor said that she needs to get the booster, but she was a little leery of getting it now. States that she had the pounding heart, but it may not have been from the vaccine. She has had high blood pressure before and was on medication for it. She is reading that myocarditis and pericarditis has been found in children after receiving the vaccine, but she is 74 years old, so she doesn't know if it's been found in her age group, and the pounding heart only happened the one time.She states that they put her on a low dose of another blood pressure medication after it happened, though she doesn't know that she really needs it.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Vaccination site pain
Clinical narrative: Mild chills; Moderate headache/ Mild headache; Moderate fatigue; booster; Moderate Injection site pain/Mild Injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 13:00 (Lot number: 330308D) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 24Mar2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 03Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 13:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 13:00, outcome "recovered", described as "Moderate Injection site pain/Mild Injection site pain"; CHILLS (non-serious) with onset 07Dec2021, outcome "recovered", described as "Mild chills"; HEADACHE (non-serious) with onset 07Dec2021, outcome "recovered", described as "Moderate headache/ Mild headache"; FATIGUE (non-serious) with onset 07Dec2021, outcome "recovered", described as "Moderate fatigue". Therapeutic measures were taken as a result of vaccination site pain, chills, headache, fatigue.  Additional information: Patient received AE treatment in the form of Advil. Patient had covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. no further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Dizziness, Headache
Clinical narrative: booster; Head ach; dizziness; stomach issues; swollen lymph node under my left arm; low grade fever with chills; low grade fever with chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 10:00 (Lot number: FC3183) at the age of 62 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 2, SINGLE, Batch/Lot No: EW0162, Location of injection: Arm Right), administration date: 19Apr2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "headache", "dizziness", "stomach issues"; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Mar2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "stomach issues", "dizziness", "headache". The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:00, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 06Dec2021, outcome "recovering", described as "Head ach"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "recovering", described as "dizziness"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Dec2021, outcome "recovering", described as "stomach issues"; LYMPHADENOPATHY (non-serious) with onset 06Dec2021, outcome "recovering", described as "swollen lymph node under my left arm"; PYREXIA (non-serious) with onset 06Dec2021, outcome "recovering", CHILLS (non-serious) with onset 06Dec2021, outcome "recovered" (2022) and all described as "low grade fever with chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness, abdominal discomfort, lymphadenopathy, pyrexia, chills.  Additional information: Patient did not receive any other vaccines in four weeks. Patient did not received vaccination prior to covid and covid test was not performed during post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pyrexia
Clinical narrative: booster; Head ach; dizziness; stomach issues; swollen lymph node under my left arm; low grade fever with chills; low grade fever with chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 10:00 (Lot number: FC3183) at the age of 62 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 2, SINGLE, Batch/Lot No: EW0162, Location of injection: Arm Right), administration date: 19Apr2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "headache", "dizziness", "stomach issues"; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Mar2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "stomach issues", "dizziness", "headache". The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 10:00, outcome "unknown", described as "booster"; HEADACHE (non-serious) with onset 06Dec2021, outcome "recovering", described as "Head ach"; DIZZINESS (non-serious) with onset 06Dec2021, outcome "recovering", described as "dizziness"; ABDOMINAL DISCOMFORT (non-serious) with onset 06Dec2021, outcome "recovering", described as "stomach issues"; LYMPHADENOPATHY (non-serious) with onset 06Dec2021, outcome "recovering", described as "swollen lymph node under my left arm"; PYREXIA (non-serious) with onset 06Dec2021, outcome "recovering", CHILLS (non-serious) with onset 06Dec2021, outcome "recovered" (2022) and all described as "low grade fever with chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, dizziness, abdominal discomfort, lymphadenopathy, pyrexia, chills.  Additional information: Patient did not receive any other vaccines in four weeks. Patient did not received vaccination prior to covid and covid test was not performed during post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Vomiting
Clinical narrative: Booster; Violent chills; Puking; Massive headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31 year-old male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose dose number: 2), for COVID-19 immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose dose number: 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; CHILLS (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Violent chills"; VOMITING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Puking"; HEADACHE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Massive headache"; FATIGUE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of chills, vomiting, headache, fatigue.  Additional information: Unknown If any other vaccine was taken in four weeks. Unknown if  the patient tested positive for Covid prior vaccination. Unknown if  the patient tested positive for Covid post vaccination:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Injection site bruising, Injection site erythema
Clinical narrative: It is still really red, I actually had couple more red spots where the shot was; I was just surprised to see it is still  pretty large bruised about 2 weeks after the shot; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (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: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: INJECTION SITE ERYTHEMA (non-serious) with onset Nov2021, outcome "unknown", described as "It is still really red, I actually had couple more red spots where the shot was"; INJECTION SITE BRUISING (non-serious) with onset Nov2021, outcome "unknown", described as "I was just surprised to see it is still pretty large bruised about 2 weeks after the shot"; IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Immunisation
Clinical narrative: She experienced a hoarse voice after her Booster dose; Booster; 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 64 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Sep2021, outcome "unknown", described as "Booster"; DYSPHONIA (non-serious), outcome "not recovered", described as "She experienced a hoarse voice after her Booster dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Body temperature increased, Fatigue, Immunisation, Pyrexia
Clinical narrative: fatigue; 99 degree temperature; rash on all parts of my torso; lost my sense of smell; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 10:00 (Lot number: FG3527) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "back problems" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 22Apr2021, when the patient was 57 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 01Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "recovered" (10Dec2021), described as "Booster"; FATIGUE (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "99 degree temperature"; RASH (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "rash on all parts of my torso"; ANOSMIA (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "lost my sense of smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, fatigue, body temperature increased, rash, anosmia.  Additional Information: The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested Covid post vaccination. Other medications in two weeks: Gabepentin-daily.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: fatigue; 99 degree temperature; rash on all parts of my torso; lost my sense of smell; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 10:00 (Lot number: FG3527) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "back problems" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 22Apr2021, when the patient was 57 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 01Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "recovered" (10Dec2021), described as "Booster"; FATIGUE (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "fatigue"; BODY TEMPERATURE INCREASED (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "99 degree temperature"; RASH (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "rash on all parts of my torso"; ANOSMIA (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "lost my sense of smell". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of immunisation, fatigue, body temperature increased, rash, anosmia.  Additional Information: The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested Covid post vaccination. Other medications in two weeks: Gabepentin-daily.   No follow-up attempts are possible. No further information is expected.