chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypokinesia, Pain, Pyrexia
Clinical narrative: Pain in arm, neck, shoulder, back.; Arm pain restricted movement; Headache; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 09:30 (Lot number: FF2589) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; TOUJEO; XIGDUO; GLIMEPIRIDE; BUPROPION. 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=Misplaced/ discarded, Prev dose administration date=07Apr2021,, Prev dose administration time=10:30 AM,, Prev dose dose number=2,, Prev dose vaccine location=Left arm), administration date: 07Apr2021, when the patient was 63 years old, 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=Misplaced/ discarded,, Prev dose administration date=17Mar2021,, Prev dose administration time=10:30 AM, Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 17Mar2021, when the patient was 63 years old, for covid-19 immunization.  The following information was reported: PAIN (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Pain in arm, neck, shoulder, back."; HYPOKINESIA (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Arm pain restricted movement"; HEADACHE (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 14Oct2021 12:00, outcome "recovering", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, hypokinesia, headache, pyrexia.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Myalgia
Clinical narrative: joint pain; muscle pain; headache; chills; pains in her back; tremendous amount of aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 16Sep2021 (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), for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Oct2021, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 13Oct2021, outcome "not recovered", described as "muscle pain"; HEADACHE (non-serious) with onset 13Oct2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 13Oct2021, outcome "not recovered", described as "chills"; BACK PAIN (non-serious) with onset 13Oct2021, outcome "not recovered", described as "pains in her back"; PAIN (non-serious) with onset 13Oct2021, outcome "not recovered", described as "tremendous amount of aches and pains".  Additional information: Caller stated that patient received the second dose of the Pfizer covid 19 vaccine on 16Sep2021. 2 days ago, 13Oct2021, she started to get the symptoms that were similar to those that got the vaccine and asked could these be side effects of the vaccine after 4 weeks and if so how long would they last. it was reported that patient had joint pain, muscle pain, headache and chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: joint pain; muscle pain; headache; chills; pains in her back; tremendous amount of aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 16Sep2021 (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), for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 13Oct2021, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 13Oct2021, outcome "not recovered", described as "muscle pain"; HEADACHE (non-serious) with onset 13Oct2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 13Oct2021, outcome "not recovered", described as "chills"; BACK PAIN (non-serious) with onset 13Oct2021, outcome "not recovered", described as "pains in her back"; PAIN (non-serious) with onset 13Oct2021, outcome "not recovered", described as "tremendous amount of aches and pains".  Additional information: Caller stated that patient received the second dose of the Pfizer covid 19 vaccine on 16Sep2021. 2 days ago, 13Oct2021, she started to get the symptoms that were similar to those that got the vaccine and asked could these be side effects of the vaccine after 4 weeks and if so how long would they last. it was reported that patient had joint pain, muscle pain, headache and chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Feeling abnormal, Feeling of body temperature change, Gait disturbance
Clinical narrative: he felt so bad and felt like he has COVID again; fatigue; fever that is "hot and cold"; fever that is "hot and cold"; could not walk; throat hurts; his "bones were hurting"; 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 68 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Oct2021 (Lot number: FF8841) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "cholesterol" (unspecified if ongoing), notes: cholesterol; "COVID" (unspecified if ongoing), notes: COVID. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, LOT number: EN6201), administration date: 02Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2 , LOT number: ER2613), administration date: 23Mar2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 14Oct2021, outcome "unknown", described as "he felt so bad and felt like he has COVID again"; FATIGUE (non-serious) with onset 14Oct2021, outcome "unknown", described as "fatigue"; PYREXIA (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset 14Oct2021, outcome "unknown" and all described as "fever that is "hot and cold""; GAIT DISTURBANCE (non-serious) with onset 14Oct2021, outcome "recovering", described as "could not walk"; OROPHARYNGEAL PAIN (non-serious) with onset 14Oct2021, outcome "unknown", described as "throat hurts"; BONE PAIN (non-serious) with onset 14Oct2021, outcome "unknown", described as "his "bones were hurting"". Therapeutic measures were not taken as a result of feeling abnormal, fatigue, pyrexia, feeling of body temperature change, gait disturbance, oropharyngeal pain, bone pain. Additional information: consumer who already received his 2 doses of the Pfizer BioNTech COVID19 vaccine and yesterday got the booster shot. Caller said last night, he felt so bad and felt like he has COVID again. Caller mentioned that he had COVID in the past. Through the night, caller had fatigue, fever that is "hot and cold", could not walk, and his throat hurts. Caller also added that his "bones were hurting". Caller stated that this morning, he started feeling a little bit better.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: he felt so bad and felt like he has COVID again; fatigue; fever that is "hot and cold"; fever that is "hot and cold"; could not walk; throat hurts; his "bones were hurting"; 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 68 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Oct2021 (Lot number: FF8841) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "cholesterol" (unspecified if ongoing), notes: cholesterol; "COVID" (unspecified if ongoing), notes: COVID. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, LOT number: EN6201), administration date: 02Mar2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2 , LOT number: ER2613), administration date: 23Mar2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 14Oct2021, outcome "unknown", described as "he felt so bad and felt like he has COVID again"; FATIGUE (non-serious) with onset 14Oct2021, outcome "unknown", described as "fatigue"; PYREXIA (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset 14Oct2021, outcome "unknown" and all described as "fever that is "hot and cold""; GAIT DISTURBANCE (non-serious) with onset 14Oct2021, outcome "recovering", described as "could not walk"; OROPHARYNGEAL PAIN (non-serious) with onset 14Oct2021, outcome "unknown", described as "throat hurts"; BONE PAIN (non-serious) with onset 14Oct2021, outcome "unknown", described as "his "bones were hurting"". Therapeutic measures were not taken as a result of feeling abnormal, fatigue, pyrexia, feeling of body temperature change, gait disturbance, oropharyngeal pain, bone pain. Additional information: consumer who already received his 2 doses of the Pfizer BioNTech COVID19 vaccine and yesterday got the booster shot. Caller said last night, he felt so bad and felt like he has COVID again. Caller mentioned that he had COVID in the past. Through the night, caller had fatigue, fever that is "hot and cold", could not walk, and his throat hurts. Caller also added that his "bones were hurting". Caller stated that this morning, he started feeling a little bit better.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Chest pain; Palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 09:30 (Lot number: FF8839) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing); "Known allergies: Antibiotics +" (unspecified if ongoing). Concomitant medication(s) included: VIT D [COLECALCIFEROL]; EMERGEN-C. Vaccination history included: Bnt162b2 (dose 2, single, prev dose lot number= EW0151, prev dose administration time= 10:30AM, prev dose vaccine location= Left arm), administration date: 09Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (dose 1, single, prev dose lot number= EN6199, prev dose administration time= 01:30 PM, prev dose vaccine location= Left arm), administration date: 12Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10Oct2021 05:30, outcome "not recovered", described as "Chest pain"; PALPITATIONS (non-serious) with onset 10Oct2021 05:30, outcome "not recovered", described as "Palpitations". The events "chest pain" and "palpitations" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, palpitations.  Additional information: Report about Covid vaccine: Yes. Reporter type: Patient. Facility type Vaccine: Pharmacy or Drug Store. Other medications in two weeks: Vitamin d and Emergen-C. If Covid prior vaccination: No. If Covid tested post vaccination: No. Known allergies: Antibiotics +. If other vaccine in four weeks: No.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Rash, Tachycardia
Clinical narrative: Shortness of breath; Chest pain; Chest tightness; Patient developed a rash in whole left arm where shot happened in; Tachycardia; Patient got the shot in it turned red all the way down radiating to wrist and it was swollen; Patient got the shot in it turned red all the way down radiating to wrist and it was swollen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EN9581, Expiration Date: 31May2021) 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: DYSPNOEA (non-serious) with onset 15Feb2021, outcome "unknown", described as "Shortness of breath"; CHEST PAIN (non-serious) with onset 15Feb2021, outcome "unknown", described as "Chest pain"; CHEST DISCOMFORT (non-serious) with onset 15Feb2021, outcome "unknown", described as "Chest tightness"; RASH (non-serious) with onset 15Feb2021, outcome "unknown", described as "Patient developed a rash in whole left arm where shot happened in"; TACHYCARDIA (non-serious) with onset 15Feb2021, outcome "unknown", described as "Tachycardia"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 15Feb2021, outcome "unknown" and all described as "Patient got the shot in it turned red all the way down radiating to wrist and it was swollen". Therapeutic measures were taken as a result of dyspnoea, chest pain, chest discomfort, rash, tachycardia, vaccination site erythema, vaccination site swelling.  Additional information: Nurse stated, "I was just calling, I received the shot in 15Feb and following the shot I had shortness of breath plus chest pain, chest tightness. Hey, I was just calling. So, I received the shot in February the 15th and I developed a rash in my whole left arm where my shot happened in, where I got the shot in it turned red all the way down radiating to my wrist and it was swollen and I also had a chest pain and tightness, kind of tachycardia and shortness of breath. So, the doctor choose to treat me with Prednisone and I take Benadryl (Treatment). So, at the moment he encouraged me to get the second shot. But I am trying to figure out am I a good candidate for the second shot based on my adverse reaction." When probed for the causality, Nurse stated, "Yes, I mean that is the arm I got the shot in. It happened within that day. I had a whole rash on my arm, my whole arm started getting red at the site of the shot and then it started radiating up to my wrist and it was swollen and then I developed a black hole and I had chest pain and tightness and shortness of breath."  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Shortness of breath; Chest pain; Chest tightness; Patient developed a rash in whole left arm where shot happened in; Tachycardia; Patient got the shot in it turned red all the way down radiating to wrist and it was swollen; Patient got the shot in it turned red all the way down radiating to wrist and it was swollen; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: EN9581, Expiration Date: 31May2021) 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: DYSPNOEA (non-serious) with onset 15Feb2021, outcome "unknown", described as "Shortness of breath"; CHEST PAIN (non-serious) with onset 15Feb2021, outcome "unknown", described as "Chest pain"; CHEST DISCOMFORT (non-serious) with onset 15Feb2021, outcome "unknown", described as "Chest tightness"; RASH (non-serious) with onset 15Feb2021, outcome "unknown", described as "Patient developed a rash in whole left arm where shot happened in"; TACHYCARDIA (non-serious) with onset 15Feb2021, outcome "unknown", described as "Tachycardia"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 15Feb2021, outcome "unknown" and all described as "Patient got the shot in it turned red all the way down radiating to wrist and it was swollen". Therapeutic measures were taken as a result of dyspnoea, chest pain, chest discomfort, rash, tachycardia, vaccination site erythema, vaccination site swelling.  Additional information: Nurse stated, "I was just calling, I received the shot in 15Feb and following the shot I had shortness of breath plus chest pain, chest tightness. Hey, I was just calling. So, I received the shot in February the 15th and I developed a rash in my whole left arm where my shot happened in, where I got the shot in it turned red all the way down radiating to my wrist and it was swollen and I also had a chest pain and tightness, kind of tachycardia and shortness of breath. So, the doctor choose to treat me with Prednisone and I take Benadryl (Treatment). So, at the moment he encouraged me to get the second shot. But I am trying to figure out am I a good candidate for the second shot based on my adverse reaction." When probed for the causality, Nurse stated, "Yes, I mean that is the arm I got the shot in. It happened within that day. I had a whole rash on my arm, my whole arm started getting red at the site of the shot and then it started radiating up to my wrist and it was swollen and then I developed a black hole and I had chest pain and tightness and shortness of breath."  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Piloerection, Pyrexia
Clinical narrative: She started shivering and she got goose bumps like cold, when you are cold; She started shivering and she got goose bumps like cold, when you are cold; I checked her neck and I realized she was hot; this morning she woke up 101.9; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sickle cell disease" (unspecified if ongoing), notes: Verbatim: Sickle cell disease; "Seizure" (unspecified if ongoing), notes: Verbatim: Seizures; "Asthmatic" (unspecified if ongoing), notes: Verbatim: Asthmatic. Concomitant medication(s) included: KEPPRA [LEVETIRACETAM] taken for seizure; SINGULAIR; QVAR; FOLIC ACID; ALAVERT; CALCIUM; ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (Dose: 1st), when the patient was 22 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd), when the patient was 22 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious), PILOERECTION (non-serious), outcome "unknown" and all described as "She started shivering and she got goose bumps like cold, when you are cold"; PYREXIA (non-serious), outcome "unknown", described as "I checked her neck and I realized she was hot; this morning she woke up 101.9". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: The patient received Tylenol for pyrexia.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema, Swelling
Clinical narrative: Swelling/edema under left arm.; Swelling/edema under left arm.; 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 12Oct2021 18:15 (Lot number: FF2590) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 15Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 43 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious), OEDEMA (non-serious) all with onset 14Oct2021, outcome "recovering" and all described as "Swelling/edema under left arm.". Therapeutic measures were not taken as a result of swelling, oedema.  Additional information: The patient did not realize the extent of the AE until 16Oct2021 at this point she noticed that swelling progressed significantly to the point she wanted to report it. Initial swelling was not significant enough for her to be clear that it may have been associated with the vaccine. The patient was not a pregnant at the time of vaccination. The patient did not receive any other medication within two weeks of vaccine. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste to food; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 14Apr2021 14:00 (Lot number: EW0158) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; Lot Number: ER2613; at 14:00; administered in left arm.), administration date: 24Mar2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "Metallic taste", "Body aches", "Extremely tired".  The following information was reported: DYSGEUSIA (non-serious) with onset 14Apr2021, outcome "recovered" (15Apr2021), described as "Metallic taste to food". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Urticaria
Clinical narrative: Hives covering body; Felt like on fire; Redness on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (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: URTICARIA (non-serious) with onset 14Oct2021 17:00, outcome "recovered" (Oct2021), described as "Hives covering body"; FEELING ABNORMAL (non-serious) with onset 14Oct2021 17:00, outcome "recovered" (Oct2021), described as "Felt like on fire"; ERYTHEMA (non-serious) with onset 14Oct2021 17:00, outcome "recovered" (Oct2021), described as "Redness on arm". The events "hives covering body", "felt like on fire" and "redness on arm" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of urticaria, feeling abnormal, erythema.  Additional information: The events were reported as non-serious. The patient was treated with Antihistamines. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown, if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks were reported as unknown.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Neck pain, Pain, Pyrexia
Clinical narrative: vomiting; body aches; neck pain; chills; fever up to 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 10:00 (Lot number: 8841) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid", start date: Mar2020 (unspecified if ongoing), notes: Severe illness from covid; "Severe illness", start date: Mar2020 (unspecified if ongoing), notes: Severe illness from covid; "blood clot after birth" (unspecified if ongoing), notes: blood clot after birth; "intestinal resection after diverticulitis" (unspecified if ongoing), notes: intestinal resection after diverticulitis at age 27; "intestinal resection after diverticulitis" (unspecified if ongoing), notes: intestinal resection after diverticulitis at age 27; "pericarditis", start date: 2014 (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; BIOTIN; MAGNESIUM; MIRENA. The following information was reported: VOMITING (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "vomiting"; PAIN (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "body aches"; NECK PAIN (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "neck pain"; CHILLS (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "fever up to 103". The events "vomiting", "body aches", "neck pain", "chills" and "fever up to 103" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vomiting, pain, neck pain, chills, pyrexia.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, has the patient been tested for COVID-19 was no. Relevant past drug history was None. Reaction Allergy. List of any other medications the patient received within 2 weeks of vaccination: Vitamin c, vitamin D, biotin, magnesium and mirena.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; body aches; neck pain; chills; fever up to 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 10:00 (Lot number: 8841) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid", start date: Mar2020 (unspecified if ongoing), notes: Severe illness from covid; "Severe illness", start date: Mar2020 (unspecified if ongoing), notes: Severe illness from covid; "blood clot after birth" (unspecified if ongoing), notes: blood clot after birth; "intestinal resection after diverticulitis" (unspecified if ongoing), notes: intestinal resection after diverticulitis at age 27; "intestinal resection after diverticulitis" (unspecified if ongoing), notes: intestinal resection after diverticulitis at age 27; "pericarditis", start date: 2014 (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; BIOTIN; MAGNESIUM; MIRENA. The following information was reported: VOMITING (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "vomiting"; PAIN (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "body aches"; NECK PAIN (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "neck pain"; CHILLS (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "fever up to 103". The events "vomiting", "body aches", "neck pain", "chills" and "fever up to 103" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vomiting, pain, neck pain, chills, pyrexia.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, has the patient been tested for COVID-19 was no. Relevant past drug history was None. Reaction Allergy. List of any other medications the patient received within 2 weeks of vaccination: Vitamin c, vitamin D, biotin, magnesium and mirena.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle pain; Joint pain; I have a rash behind my ear, rash on my chin, rash on my face and a rash on my chest; Extremely tired; really irritating me; 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 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot/batch number, expiry date and route of administration unspecified), for covid-19 Immunization; Bnt162b2 (dose 2, single, lot/batch number, expiry date and route of administration unspecified), for covid-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; RASH (non-serious), outcome "unknown", described as "I have a rash behind my ear, rash on my chin, rash on my face and a rash on my chest"; FATIGUE (non-serious), outcome "unknown", described as "Extremely tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "really irritating me".  Additional information: Patient received bnt162b2 (COMIRNATY) via unspecified route of administration. It was reported that the patient was having side effects because of the booster shot of Pfizer. It was reported that the patient had an allergic reaction with this booster shot." Reportedly the patient had a fever, muscle pain, joint pain, the patient also had rash behind patient ear, chin, face and on a chest. It was reported that the patient was extremely tired and that was basically it." It was reported that the patient is Probation officer of law enforcement at (withheld). When probed for consent to follow up: the reporter stated, yes that was fine, but patient just want to know when these side effects go away because this was really irritating for patient." It was further stated that so there was really nothing you can do for the self call. We (further clarification unknown) have side effects so there was literally nothing you can provide patient. What patient can do to get rid of it." Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Fever; Muscle pain; Joint pain; I have a rash behind my ear, rash on my chin, rash on my face and a rash on my chest; Extremely tired; really irritating me; 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 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot/batch number, expiry date and route of administration unspecified), for covid-19 Immunization; Bnt162b2 (dose 2, single, lot/batch number, expiry date and route of administration unspecified), for covid-19 Immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; RASH (non-serious), outcome "unknown", described as "I have a rash behind my ear, rash on my chin, rash on my face and a rash on my chest"; FATIGUE (non-serious), outcome "unknown", described as "Extremely tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "really irritating me".  Additional information: Patient received bnt162b2 (COMIRNATY) via unspecified route of administration. It was reported that the patient was having side effects because of the booster shot of Pfizer. It was reported that the patient had an allergic reaction with this booster shot." Reportedly the patient had a fever, muscle pain, joint pain, the patient also had rash behind patient ear, chin, face and on a chest. It was reported that the patient was extremely tired and that was basically it." It was reported that the patient is Probation officer of law enforcement at (withheld). When probed for consent to follow up: the reporter stated, yes that was fine, but patient just want to know when these side effects go away because this was really irritating for patient." It was further stated that so there was really nothing you can do for the self call. We (further clarification unknown) have side effects so there was literally nothing you can provide patient. What patient can do to get rid of it." Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Glassy eyes, Pallor, Pyrexia, SARS-CoV-2 test
Clinical narrative: For 2 days had fever of 104-105 degrees; eyes glassy & pale; eyes glassy & pale; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2021 11:00 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Possibly penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM, Route of administration: Intramuscular), administration date: 15Jan2021, when the patient was 78 years old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "For 2 days had fever of 104-105 degrees"; PALLOR (non-serious), GLASSY EYES (non-serious) all with onset Feb2021, outcome "recovered" (Feb2021) and all described as "eyes glassy & pale". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pallor, glassy eyes.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Device Date :16Oct2021. The patient was concerned if the Booster shot had the side effects same as with the 2nd dose. By taking aspirin after booster shot, will the high fever alleviate.   Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Heart rate, Heart rate increased
Clinical narrative: Chest pain over pectoral region; Tachycardia (normal HR =70BPM); 100-120 BPM at rest; Heat flashes; Chills; Rise in body temp (99.1 degree F); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:30 (Lot number: FF8839) at the age of 24 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 1, single, Batch/Lot No: Pfizer EK4176, anatomical location: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Jan2021, when the patient was 24 years old, for COVID-19 Immunization; Bnt162b2 (dose 2, single, Batch/Lot No: Pfizer EN5318, anatomical location: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 31Jan2021, when the patient was 24 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Chest pain over pectoral region"; TACHYCARDIA (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Tachycardia (normal HR =70BPM)"; HEART RATE INCREASED (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "100-120 BPM at rest"; HOT FLUSH (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Heat flashes"; CHILLS (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Rise in body temp (99.1 degree F) ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, tachycardia, heart rate increased, hot flush, chills, pyrexia.  Additional information: Seriousness criteria-Results in death was reported as no, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reporter as no, List of any other medications the patient received within 2 weeks of vaccination: No. Adverse event: Tachycardia (normal HR =70BPM) 12 hours post booster shot =100-120 BPM at rest, Rise in body temp (99.1 degree F) ,Heat flashes, Chills ,Chest pain over pectoral region Symptoms occurred within 30 hours of booster Pfizer vaccine (9 months after 2nd shot). Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19? No. Other medical history: NA  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Pyrexia, Tachycardia
Clinical narrative: Chest pain over pectoral region; Tachycardia (normal HR =70BPM); 100-120 BPM at rest; Heat flashes; Chills; Rise in body temp (99.1 degree F); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:30 (Lot number: FF8839) at the age of 24 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 1, single, Batch/Lot No: Pfizer EK4176, anatomical location: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 10Jan2021, when the patient was 24 years old, for COVID-19 Immunization; Bnt162b2 (dose 2, single, Batch/Lot No: Pfizer EN5318, anatomical location: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 31Jan2021, when the patient was 24 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Chest pain over pectoral region"; TACHYCARDIA (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Tachycardia (normal HR =70BPM)"; HEART RATE INCREASED (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "100-120 BPM at rest"; HOT FLUSH (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Heat flashes"; CHILLS (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 16Oct2021 02:00, outcome "recovering", described as "Rise in body temp (99.1 degree F) ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, tachycardia, heart rate increased, hot flush, chills, pyrexia.  Additional information: Seriousness criteria-Results in death was reported as no, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reporter as no, List of any other medications the patient received within 2 weeks of vaccination: No. Adverse event: Tachycardia (normal HR =70BPM) 12 hours post booster shot =100-120 BPM at rest, Rise in body temp (99.1 degree F) ,Heat flashes, Chills ,Chest pain over pectoral region Symptoms occurred within 30 hours of booster Pfizer vaccine (9 months after 2nd shot). Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19? No. Other medical history: NA  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Tight chest; Shortness of breath; Accelerated heart rate; 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 (Lot number: EM9809) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced tight chest, shortness of breath, accelerated heart rate. The patient underwent lab tests and procedures on an unspecified date for Accelerated heart rate. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow-up (24Nov2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Consumer wants to know if one is considered contagious once they have a fever after receiving the Pfizer-BioNTech Covid-19 Vaccine; 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 female patient received bnt162b2 (COMIRNATY) (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: PYREXIA (non-serious), outcome "unknown", described as "Consumer wants to know if one is considered contagious once they have a fever after receiving the Pfizer-BioNTech Covid-19 Vaccine".  Additional Information: Reported wanted to know if one takes the vaccine and gets the symptoms is one allergic at that point when they get the fever.   Follow-up attempts have been completed and no further information is expected.