chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Immunology test, Magnetic resonance imaging, Thyroid function test, Ultrasound Doppler
Clinical narrative: 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; 3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP, Physician and Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 10Sep2021 12:30 (Lot number: FC3183) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol". The following information was reported: DIZZINESS (non-serious), DISORIENTATION (non-serious), BALANCE DISORDER (non-serious) all with onset 02Oct2021 12:00, outcome "not recovered" and all described as "3.5 hours after first Pfizer vaccine I became extremely dizzy, disoriented and unstable on my feet". The event "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet", "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet" and "3.5 hours after first pfizer vaccine i became extremely dizzy, disoriented and unstable on my feet" was 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 dizziness, disorientation, balance disorder.  Additional information: The patient was treated with Steroid for 1 day 26Jan2022 unable to take. The seriousness criteria was provided as persistent. The patient neither have Covid prior vaccination not had tested positive post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks.  No follow-up attempts are possible. No further information is expected
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal oedema, Neck pain, Sinusitis
Clinical narrative: headache; dizziness; ear problem/hurting; ear problems at times, it swells,; eye/ nose back of the neck hurts; allergies; Sinus infection/ congestion; don't feel good; feels like act up right now/feels lousy; congestion; swelling on the right side of nose and eye; swelling on the right side of nose and eye; After taking it, all the sinus infection and congestion has increased; 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 88 year-old female patient received bnt162b2 (BNT162B2), administration date 04Jan2022 13:00 (Batch/Lot number: unknown) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Migraine" (unspecified if ongoing), notes: She takes Imitrex for her migraine; "neck problem" (unspecified if ongoing), notes: due to car accident; "sinus infection" (unspecified if ongoing); "congestion" (unspecified if ongoing). Concomitant medication(s) included: AMITRAZ taken for migraine. The following information was reported: HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset Jan2022, outcome "unknown", described as "dizziness"; EAR PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "ear problem/hurting"; EAR SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "ear problems at times, it swells,"; NECK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "eye/ nose back of the neck hurts"; HYPERSENSITIVITY (non-serious) with onset Jan2022, outcome "unknown", described as "allergies"; SINUSITIS (non-serious) with onset Jan2022, outcome "unknown", described as "Sinus infection/ congestion"; MALAISE (non-serious) with onset Jan2022, outcome "unknown", described as "don't feel good"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "feels like act up right now/feels lousy"; NASAL CONGESTION (non-serious) with onset Jan2022, outcome "unknown", described as "congestion"; NASAL OEDEMA (non-serious), EYE SWELLING (non-serious) all with onset Jan2022, outcome "unknown" and all described as "swelling on the right side of nose and eye"; CONDITION AGGRAVATED (non-serious) with onset Jan2022, outcome "unknown", described as "After taking it, all the sinus infection and congestion has increased".  Additional information: she has received 1st dose of Pfizer COVID 19 vaccine yesterday and she has dizziness, headache and swelling on the right side of nose and eye. Her neck hurts. She also had sinus infection before taking vaccine and congestion. After taking it, all the sinus infection and congestion has increased. She also had migraine, arthritis, and was feeling lousy. She was transferred from Pfizer Medical Information and wanted to know if these were because of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: moderate sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 23Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Skin/Acne" (unspecified if ongoing), notes: Concomitant drug:, Drug name: Retin-A, Reason for use: Skin/Acne; "Low level" (unspecified if ongoing), notes: Drug name: Vitamin D, Reason for use: Low level. Concomitant medication(s) included: RETIN-A taken for acne (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "moderate sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no reaction after my 1st dose on 23Feb, other than a moderate sore arm for a couple days. UP UNTIL the vaccine 2 dose, I was a completely healthy and happy 42 year old female. My life is blessed and even throughout the pandemic up until the vaccine 2nd dose  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: she cannot walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4434308.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "she cannot walk".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Limb discomfort, Myofascitis, Pain
Clinical narrative: cannot ambulate and lift arm; Entire left side including breast, leg , arm myofacitis, can not ambulate and lift arm, cannot sleep more than 3 hrs due to pain; Paresthesia left leg; cannot sleep more than 3 hrs due to pain; cannot ambulate and lift arm; Entire left side including breast, leg , arm myofacitis; Entire left side including breast, leg , arm myofacitis, cannot ambulate and lift arm, cannot sleep more than 3 hrs due to pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: 6N6203) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Kiwi" (unspecified if ongoing), notes: known allergies: Kiwi. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 6L8982, Location of injection: Arm Left), administration date: 01Feb2021, when the patient was 81 years old, for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), GAIT DISTURBANCE (non-serious) all with onset 24Feb2021, outcome "recovered with sequelae" and all described as "cannot ambulate and lift arm"; PAIN (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Entire left side including breast, leg , arm myofacitis, can not ambulate and lift arm, cannot sleep more than 3 hrs due to pain"; PARAESTHESIA (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Paresthesia left leg"; SLEEP DEFICIT (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "cannot sleep more than 3 hrs due to pain"; MYOFASCITIS (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Entire left side including breast, leg , arm myofacitis"; HYPOAESTHESIA (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Entire left side including breast, leg , arm myofacitis, cannot ambulate and lift arm, cannot sleep more than 3 hrs due to pain". The events "cannot ambulate and lift arm", "entire left side including breast, leg , arm myofacitis, can not ambulate and lift arm, cannot sleep more than 3 hrs due to pain", "paresthesia left leg", "cannot sleep more than 3 hrs due to pain", "cannot ambulate and lift arm", "entire left side including breast, leg , arm myofacitis" and "entire left side including breast, leg , arm myofacitis, cannot ambulate and lift arm, cannot sleep more than 3 hrs due to pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of limb discomfort, pain, paraesthesia, sleep deficit, gait disturbance, myofascitis, hypoaesthesia.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Sleep deficit
Clinical narrative: cannot ambulate and lift arm; Entire left side including breast, leg , arm myofacitis, can not ambulate and lift arm, cannot sleep more than 3 hrs due to pain; Paresthesia left leg; cannot sleep more than 3 hrs due to pain; cannot ambulate and lift arm; Entire left side including breast, leg , arm myofacitis; Entire left side including breast, leg , arm myofacitis, cannot ambulate and lift arm, cannot sleep more than 3 hrs due to pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: 6N6203) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Kiwi" (unspecified if ongoing), notes: known allergies: Kiwi. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 6L8982, Location of injection: Arm Left), administration date: 01Feb2021, when the patient was 81 years old, for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), GAIT DISTURBANCE (non-serious) all with onset 24Feb2021, outcome "recovered with sequelae" and all described as "cannot ambulate and lift arm"; PAIN (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Entire left side including breast, leg , arm myofacitis, can not ambulate and lift arm, cannot sleep more than 3 hrs due to pain"; PARAESTHESIA (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Paresthesia left leg"; SLEEP DEFICIT (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "cannot sleep more than 3 hrs due to pain"; MYOFASCITIS (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Entire left side including breast, leg , arm myofacitis"; HYPOAESTHESIA (non-serious) with onset 24Feb2021, outcome "recovered with sequelae", described as "Entire left side including breast, leg , arm myofacitis, cannot ambulate and lift arm, cannot sleep more than 3 hrs due to pain". The events "cannot ambulate and lift arm", "entire left side including breast, leg , arm myofacitis, can not ambulate and lift arm, cannot sleep more than 3 hrs due to pain", "paresthesia left leg", "cannot sleep more than 3 hrs due to pain", "cannot ambulate and lift arm", "entire left side including breast, leg , arm myofacitis" and "entire left side including breast, leg , arm myofacitis, cannot ambulate and lift arm, cannot sleep more than 3 hrs due to pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of limb discomfort, pain, paraesthesia, sleep deficit, gait disturbance, myofascitis, hypoaesthesia.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Pain in extremity
Clinical narrative: mild fatigue; run down feeling; Also pain in my arm - I couldn't lay on that side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 10:00 (Lot number: EW0187) at the age of 50 years as dose 2, single and administered in arm left, administration date 24Apr2021 10:15 (Lot number: EW0176) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "mild fatigue"; DEPRESSED MOOD (non-serious) with onset 2021, outcome "unknown", described as "run down feeling"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Also pain in my arm - I couldn't lay on that side".  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No, Reported Event: Extreme fatigue, high fever, pain in all my muscles and joints (extreme) I could barely walk up the stairs. Chills, sweating, sore throat, congestion, migraines, cough . I couldn't even get out of bed. The pain I had in my muscles was so severe it was difficult to stay in one position or find relief. I took OTC Tylenol , Sudafed. I never felt like this in my entire life . Pain in right calf was unbearable. As was pain in my quads, shoulders , traps and neck. Words cannot express or describe what I went thru. I felt like death! 1st/2nd doses - mild fatigue , run down feeling . Also pain in my arm - I couldn't lay on that side. adverse event start date: 03Jan2022, adverse event start time: 11:00 AM, ae resulted in: [None of the above], if patient recovered: Recovered with lasting effects, if treatment ae: No, Prior to vaccination, was the patient diagnosed with COVID-19: No, Since the vaccination, has the patient been tested for COVID-19: No, Device Date : 05Jan2022.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Dyspnoea, Feeling abnormal, Gait disturbance
Clinical narrative: 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 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 29Dec2021, outcome "unknown", described as "she is not well at all"; GAIT DISTURBANCE (non-serious) with onset 29Dec2021, outcome "unknown", described as "barely walk"; DYSPNOEA (non-serious) with onset 29Dec2021, outcome "unknown", described as "keeps getting out of breath"; ASTHENIA (non-serious) with onset 29Dec2021, outcome "unknown", described as "weak"; PANIC REACTION (non-serious) with onset 29Dec2021, outcome "unknown", described as "little bit alarmed"; WEIGHT DECREASED (non-serious) with onset 29Dec2021, outcome "unknown", described as "loosing weight"; FEELING ABNORMAL (non-serious) with onset 29Dec2021, outcome "unknown", described as "feel strange"; BEDRIDDEN (non-serious) with onset 29Dec2021, outcome "unknown", described as "has not been out of bed since it happened". The events "she is not well at all", "barely walk", "keeps getting out of breath", "weak", "little bit alarmed", "loosing weight", "feel strange" and "has not been out of bed since it happened" were evaluated at the emergency room visit. Additional information: The Patient stated she is not well at all. She can barely walk and keeps getting out of breath. She is no good for work or for her kids, she cannot do nothing, has not been out of bed since it happened. She stated on Monday she came to work and got there for 5 minutes and could not do it. She couldn't on Tuesday or Wednesday. She is there now again and cannot work like this. She wanted to know how long this is supposed to last because it has been a week. The paper they gave her only said a couple days. She reported she was not feeling well at all. She can barely walk. She was loosing weight, and she did not like, it feels 'strange'. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Panic reaction, Weight decreased
Clinical narrative: 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 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 29Dec2021, outcome "unknown", described as "she is not well at all"; GAIT DISTURBANCE (non-serious) with onset 29Dec2021, outcome "unknown", described as "barely walk"; DYSPNOEA (non-serious) with onset 29Dec2021, outcome "unknown", described as "keeps getting out of breath"; ASTHENIA (non-serious) with onset 29Dec2021, outcome "unknown", described as "weak"; PANIC REACTION (non-serious) with onset 29Dec2021, outcome "unknown", described as "little bit alarmed"; WEIGHT DECREASED (non-serious) with onset 29Dec2021, outcome "unknown", described as "loosing weight"; FEELING ABNORMAL (non-serious) with onset 29Dec2021, outcome "unknown", described as "feel strange"; BEDRIDDEN (non-serious) with onset 29Dec2021, outcome "unknown", described as "has not been out of bed since it happened". The events "she is not well at all", "barely walk", "keeps getting out of breath", "weak", "little bit alarmed", "loosing weight", "feel strange" and "has not been out of bed since it happened" were evaluated at the emergency room visit. Additional information: The Patient stated she is not well at all. She can barely walk and keeps getting out of breath. She is no good for work or for her kids, she cannot do nothing, has not been out of bed since it happened. She stated on Monday she came to work and got there for 5 minutes and could not do it. She couldn't on Tuesday or Wednesday. She is there now again and cannot work like this. She wanted to know how long this is supposed to last because it has been a week. The paper they gave her only said a couple days. She reported she was not feeling well at all. She can barely walk. She was loosing weight, and she did not like, it feels 'strange'. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: One of my joints swelled on right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Apr2021 (Lot number: ER8734) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number=EN6199, dose number=1), administration date: 06Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "One of my joints swelled on right hand". The event "one of my joints swelled on right hand" was evaluated at the physician office visit. Therapeutic measures were taken as a result of joint swelling.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks. After second vaccine one of her joints swelled on right hand. It was probably a week or a few days after the vaccine but couldn't be sure it was related. Got a steroid injection. Post the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Weight decreased
Clinical narrative: severe fatigue; weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient in his 70's received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "severe fatigue"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "recovering", described as "weight loss".  Additional information:  Reporter Contact Information: (Name withheld) is the patient. I spoke with him for the first time after many years and he relayed his experience. I asked him to request his attending physician contact Pfizer with the details. Approximately 3 weeks following (Name withheld) dose of Comirnaty in Jan2021 he experienced severe fatigue and weight loss requiring investigations and follow up by his attending physician. This has taken many months to resolve and now 1 year later describes himself as 95% back to normal. Physical details hopefully will be provided by his physician- he is a male in his mid-seventies of medium height and build and in otherwise good health - as far as I know. Optional Information: I did not probe deeply into his medical background but have requested he ask his physician to provide all to Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza, SARS-CoV-2 test
Clinical narrative: headache; flu; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): MOD22-000778 (Moderna).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache, Malaise, Pain
Clinical narrative: Fatigue; malaise; confusion; headaches; body ached; Vaccine administered at inappropriate site / dose vaccine location=Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in leg left, administration date 24Apr2021 11:00 (Lot number: EW0122) at the age of 17 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Sulfa" (unspecified if ongoing), notes: Known allergy: Sulfa. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev_dose_vaccine_location=Left leg},, {prev_dose_product=COVID 19,, prev_dose_brand=Pfizer ,, prev_dose_brand_unknown=False,, prev_dose_lot_number=Ew0150,, prev_dose_lot_unknown=False,, prev_dose_administration_date=01A, pr2021,, prev_dose_administration_time=04:00, PM, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left leg}]), administration date: 01Apr2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Vaccine administered at inappropriate site / dose vaccine location=Left leg"; FATIGUE (non-serious) with onset 05Dec2021, outcome "unknown", described as "Fatigue"; MALAISE (non-serious) with onset 05Dec2021, outcome "unknown", described as "malaise"; CONFUSIONAL STATE (non-serious) with onset 05Dec2021, outcome "unknown", described as "confusion"; HEADACHE (non-serious) with onset 05Dec2021, outcome "unknown", described as "headaches"; PAIN (non-serious) with onset 05Dec2021, outcome "unknown", described as "body ached". Therapeutic measures were not taken as a result of product administered at inappropriate site, fatigue, malaise, confusional state, headache, pain.   Additional information: On 17Dec2021 at 02:00 pm, patient received Dose 3 (Lot number: FH8028) on right arm. Prior or post vaccination patient did not have COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Fatigue; malaise; confusion; headaches; body ached; Vaccine administered at inappropriate site / dose vaccine location=Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in leg left, administration date 24Apr2021 11:00 (Lot number: EW0122) at the age of 17 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Sulfa" (unspecified if ongoing), notes: Known allergy: Sulfa. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev_dose_vaccine_location=Left leg},, {prev_dose_product=COVID 19,, prev_dose_brand=Pfizer ,, prev_dose_brand_unknown=False,, prev_dose_lot_number=Ew0150,, prev_dose_lot_unknown=False,, prev_dose_administration_date=01A, pr2021,, prev_dose_administration_time=04:00, PM, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left leg}]), administration date: 01Apr2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Vaccine administered at inappropriate site / dose vaccine location=Left leg"; FATIGUE (non-serious) with onset 05Dec2021, outcome "unknown", described as "Fatigue"; MALAISE (non-serious) with onset 05Dec2021, outcome "unknown", described as "malaise"; CONFUSIONAL STATE (non-serious) with onset 05Dec2021, outcome "unknown", described as "confusion"; HEADACHE (non-serious) with onset 05Dec2021, outcome "unknown", described as "headaches"; PAIN (non-serious) with onset 05Dec2021, outcome "unknown", described as "body ached". Therapeutic measures were not taken as a result of product administered at inappropriate site, fatigue, malaise, confusional state, headache, pain.   Additional information: On 17Dec2021 at 02:00 pm, patient received Dose 3 (Lot number: FH8028) on right arm. Prior or post vaccination patient did not have COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, SARS-CoV-2 test
Clinical narrative: 2X period a month for 7 months, irregular period, difficulty trying to conceive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 11:00 (Lot number: EW0161) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Soy" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Mar2021, when the patient was 30 years old, for COVID-19 immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 19Apr2021 12:00, outcome "recovered with sequelae", described as "2X period a month for 7 months, irregular period, difficulty trying to conceive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The reporter stated the event as non serious.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: She also came down with a cold also around that time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 66 years as dose number unknown, single for covid-19 immunisation; The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She also came down with a cold also around that time". Therapeutic measures were taken as a result of nasopharyngitis. Additional Information: The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. The patient stated that she took her COVID-19 (corona virus disease 2019) shot back in November. The patient ended up flaring because she stopped the medication briefly. The patient also came down with a cold around that time. Subsequently, the patient was prescribed Flonase and an unspecified antibiotic. Treatment for the event nasopharyngitis included Flonase (fluticasone propionate). The outcome of the events condition aggravated and nasopharyngitis was reported as unknown. The causal relationship between the events nasopharyngitis, condition aggravated and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after both doses of his Pfizer COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm after both doses of his Pfizer COVID". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Weight
Clinical narrative: 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 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Lot number: FL3198) at the age of 46 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "she does not have a thyroid" (unspecified if ongoing); "needed glasses" (unspecified if ongoing), notes: she needed glasses prior to getting the vaccines; "seasonal allergies", start date: 2012 (unspecified if ongoing), notes: She just takes medication for seasonal allergies. This began about 10 years ago; "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 2017 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot EN6208, expiration is unknown. Injected in left arm), administration date: 12Mar2021, when the patient was 45 years old, for Covid-19 immunisation; Bnt162b2 (Dose 2, Lot EW0151, expiration unknown, injected in left arm), administration date: 09Apr2021, when the patient was 45 years old, for Covid-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Caller reports experiencing numbness at the injection site that spread upwards to her- neck and side of her face". Relevant laboratory tests and procedures are available in the appropriate section. Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.; Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.; Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200045695 (Pfizer).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jan2022 10:00 (Lot number: FL0007) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 04Jan2022 10:00, outcome "not recovered" and all described as "Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.". The event "lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days.", "lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days." and "lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy, axillary pain.  Additional Information: Seriousness criteria reported as No. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any vaccines within four weeks prior to the vaccination. No list of any other medications the patient received within 2 weeks of vaccination. Reported Event: Lymph node in armpit of injection arm extremely swollen and painful to touch after 4 days. Cannot lift arm above head due to pain.  Site of injection is not painful.  Only lymph node is swollen and painful. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination patient was not diagnosed with covid-19. since the vaccination the patient had not been tested for COVID-19. Customer Verbatim: Please advise if child should receive second dose of vaccine given reaction reported. Product: Pfizer Covid 19 vaccine orange top pediatric. Caller's 10 year old daughter had the first dose of the vaccine. Afterward her lymph nodes became extremely swollen and painful under the injection site for 6 days.    No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Fever of 101 to 102.5 F; chills; bad headache; terrible night, no sleep; he is not taking a shower and then laying down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid 19" (not ongoing), notes: he actually had Covid 19 virus a year ago, beat Covid in a week. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, After the first dose of the Pfizer Covid-19 Vaccine the patient was fine.), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovering", described as "Fever of 101 to 102.5 F"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; INSOMNIA (non-serious), outcome "unknown", described as "terrible night, no sleep"; FATIGUE (non-serious), outcome "unknown", described as "he is not taking a shower and then laying down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Reporter was the father of a 18 year old patient who received the second dose of the Pfizer COVID 19 vaccines on 06Jan2021. He had been experiencing the fever of 101 to 102.5 F, chills, bad headache, terrible night, no sleep, describes it as much worse than he felt when he actually had Covid 19 virus a year ago. After the first dose of the Pfizer Covid-19 Vaccine the patient was fine. After the second dose of the Pfizer Covid-19 Vaccine the patient had a terrible night, couldn't sleep, had chills. Patient woke up, reporter guessed patient was up, and his fever had gone up to 102.5-unit/degree of measurement not provided. Patient had really bad chills. Patient had been drinking a lot of water, has had about 3-38 ounce bottles of water. Patient took a Motrin, Ibuprofen-unable to clarify if this was 2 different products, or the same product. The patient lay down but his fever was up to 102.5. The patient was a really healthy kid, he never gets sick; They are concerned that maybe patient was exposed to COVID and then got the second dose of the Pfizer Covid-19 Vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101 to 102.5 F; chills; bad headache; terrible night, no sleep; he is not taking a shower and then laying down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid 19" (not ongoing), notes: he actually had Covid 19 virus a year ago, beat Covid in a week. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, After the first dose of the Pfizer Covid-19 Vaccine the patient was fine.), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "recovering", described as "Fever of 101 to 102.5 F"; CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; INSOMNIA (non-serious), outcome "unknown", described as "terrible night, no sleep"; FATIGUE (non-serious), outcome "unknown", described as "he is not taking a shower and then laying down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: Reporter was the father of a 18 year old patient who received the second dose of the Pfizer COVID 19 vaccines on 06Jan2021. He had been experiencing the fever of 101 to 102.5 F, chills, bad headache, terrible night, no sleep, describes it as much worse than he felt when he actually had Covid 19 virus a year ago. After the first dose of the Pfizer Covid-19 Vaccine the patient was fine. After the second dose of the Pfizer Covid-19 Vaccine the patient had a terrible night, couldn't sleep, had chills. Patient woke up, reporter guessed patient was up, and his fever had gone up to 102.5-unit/degree of measurement not provided. Patient had really bad chills. Patient had been drinking a lot of water, has had about 3-38 ounce bottles of water. Patient took a Motrin, Ibuprofen-unable to clarify if this was 2 different products, or the same product. The patient lay down but his fever was up to 102.5. The patient was a really healthy kid, he never gets sick; They are concerned that maybe patient was exposed to COVID and then got the second dose of the Pfizer Covid-19 Vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Periarthritis, Vaccination site pain
Clinical narrative: Left upper arm pain after 1st dose; Unable to lift and continues to be frozen shoulder; Unable to lift and continues to be frozen shoulder/my range of motion is very limited; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:00 (Lot number: EW0162) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. Concomitant medication(s) included: LAMICTAL.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021 13:15, outcome "not recovered", described as "Left upper arm pain after 1st dose"; PERIARTHRITIS (non-serious) with onset 24Mar2021 13:15, outcome "not recovered", described as "Unable to lift and continues to be frozen shoulder"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 24Mar2021 13:15, outcome "not recovered", described as "Unable to lift and continues to be frozen shoulder/my range of motion is very limited". The events "left upper arm pain after 1st dose", "unable to lift and continues to be frozen shoulder" and "unable to lift and continues to be frozen shoulder/my range of motion is very limited" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pain, periarthritis, joint range of motion decreased.  Additional information: Dose received: 2. The patient did not receive any other vaccines within four weeks. Left upper arm pain after 1st dose. Unable to lift and continues to be frozen shoulder. She have been to 3 doctors which all concur frozen should joint was because of the Covid shot. She have been in physical therapy for 6 months. It was 50% better nine months after the first injection. The pain was horrible and range of motion was very limited. Treatment received was 3 steriod injections, 3 months of physical therapy. The patient did not been tested for COVID-19 post vaccination. No known allergies. device time stamp was 08Jan2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site of COVID vaccine still hurts several weeks later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUCATURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Injection site of COVID vaccine still hurts several weeks later".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.