chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non HCP). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included being COVID-19 positive (unspecified if ongoing), and severe fatigue (ongoing), notes: due to COVID-19 infection. The patient's concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunisation. The patient experienced an unexpected therapeutic response (the patient was no longer fatigued upon receiving the second BNT162B2 dose), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021157711 same reporter, suspect drug, event; different patient.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: fell asleep while working after Covid until her 2nd dose of vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19 Positive" (unspecified if ongoing); "Severe fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for Covid-19 Immunization. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "fell asleep while working after Covid until her 2nd dose of vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: malaise; I do a lot of outside work and the first one kept me not doing anything for three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old 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: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "I do a lot of outside work and the first one kept me not doing anything for three days"; MALAISE (non-serious), outcome "recovered", described as "malaise".  Additional information: It was reported that the patient was energetic prior to vaccination. Malaise just got up and went away. Patient was afraid if the second dose will put him down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tremor
Clinical narrative: headache; shaky; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis due to pollen" (unspecified if ongoing); "Disorder of bone, unspecified" (unspecified if ongoing); "Iron deficiency anemia secondary to blood loss (chronic)" (unspecified if ongoing); "antineoplastic chemotherapy" (unspecified if ongoing); "Neoplasm related pain" (unspecified if ongoing), notes: acute and chronic; "Type 2 diabetes mellitus without complications" (unspecified if ongoing); "Neoplasm of uncertain behavior of left breast" (unspecified if ongoing). Concomitant medication(s) included: ANASTRAZOLE DENK; ASPIRIN EC; ATENOLOL; ATORVASTATIN CALCIUM; CALCIUM 600 WITH VITAMIN D3; CALCIUM CARBONATE; CETIRIZINE; FEROSUL; GLIPIZIDE;METFORMIN; LOSARTAN POTASSIUM; MELOXICAM; MONTELUKAST SODIUM; COQ-10. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; TREMOR (non-serious), outcome "unknown", described as "shaky". The events "headache" and "shaky" were evaluated at the physician office visit.  Additional information: Patient concomitant medication included multivitamin (as reported). It was reported that the doctor was aware of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain
Clinical narrative: sore left arm; nausea; fatigue (slight); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 14:30 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Aortic stenosis" (ongoing); "TAVR Valve", start date: 22May2018 (unspecified if ongoing); "Atrial fibrillation" (ongoing); "Edwards Sapien 3 bovine TAUR Model 9600 TFX-23MM Serila" (unspecified if ongoing); "Cholesterol management" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for transcatheter aortic valve implantation (ongoing); ATORVASTATIN [ATORVASTATIN CALCIUM] taken for blood cholesterol (ongoing); SOTALOL taken for atrial fibrillation (ongoing). Vaccination history included: Bnt162b2 (Lot number: EN6200 at 14:30 intramuscularly in left upper arm as dose 1, single), administration date: 16Feb2021, when the patient was 72 years old, for COVID-19 immunisation, reaction(s): "Sore left arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Mar2021, outcome "unknown", described as "sore left arm"; NAUSEA (non-serious) with onset 14Mar2021, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 14Mar2021, outcome "unknown", described as "fatigue (slight)". Therapeutic measures were not taken as a result of vaccination site pain, nausea, fatigue.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Patient had not been tested for COVID-19. Events was experienced in the afternoon of 14Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer) for a Pfizer sponsored program (005570).   A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 30Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date 06Mar2021 (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 "unknown", described as "arm was a little sore". Additional information: The patient reported already had vaccine on 30Jan2021 and 2nd vaccine 06Mar2021; arm was a little sore one day but just fine.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Dyskinesia, Fatigue, Feeling abnormal, Gait inability
Clinical narrative: when I got up I was moving all over the place my arms my legs my head; In order to eat she has to have her head against the chair to make it be still; Tired; Shaking violently; Her body is constantly moving; Thinking is really slow; Thinking is really slow and she forgets what she's doing all of the time and she has to use a walker; When she lays down she feels like her body is vibrating/Her body is constantly moving; I could not walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:45 (Batch/Lot number: unknown) at the age of 60 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Functional movement disorder" (unspecified if ongoing), notes: She was diagnosed in 2017 or 2018.; "MS", start date: 2003 (ongoing); "Sea sickness" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: GAIT INABILITY (non-serious) with onset 17Mar2021, outcome "not recovered", described as "I could not walk"; VERTIGO (non-serious), outcome "unknown", described as "when I got up I was moving all over the place my arms my legs my head"; BRADYPHRENIA (non-serious) with onset 17Mar2021, outcome "unknown", described as "Thinking is really slow"; MEMORY IMPAIRMENT (non-serious) with onset 17Mar2021, outcome "unknown", described as "Thinking is really slow and she forgets what she's doing all of the time and she has to use a walker"; VIBRATORY SENSE INCREASED (non-serious) with onset 17Mar2021, outcome "unknown", described as "When she lays down she feels like her body is vibrating/Her body is constantly moving"; FEELING ABNORMAL (non-serious) with onset 18Mar2021, outcome "unknown", described as "In order to eat she has to have her head against the chair to make it be still"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Tired"; TREMOR (non-serious) with onset 17Mar2021, outcome "recovered with sequelae", described as "Shaking violently"; DYSKINESIA (non-serious) with onset 17Mar2021, outcome "recovering", described as "Her body is constantly moving". The events "i could not walk" and "shaking violently" were evaluated at the physician office visit. The event "her body is constantly moving" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of gait inability, vertigo, bradyphrenia, memory impairment, feeling abnormal, fatigue, tremor, dyskinesia. Therapeutic measures were taken as a result of vibratory sense increased.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Tremor, Vertigo, Vibratory sense increased
Clinical narrative: when I got up I was moving all over the place my arms my legs my head; In order to eat she has to have her head against the chair to make it be still; Tired; Shaking violently; Her body is constantly moving; Thinking is really slow; Thinking is really slow and she forgets what she's doing all of the time and she has to use a walker; When she lays down she feels like her body is vibrating/Her body is constantly moving; I could not walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:45 (Batch/Lot number: unknown) at the age of 60 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Functional movement disorder" (unspecified if ongoing), notes: She was diagnosed in 2017 or 2018.; "MS", start date: 2003 (ongoing); "Sea sickness" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: GAIT INABILITY (non-serious) with onset 17Mar2021, outcome "not recovered", described as "I could not walk"; VERTIGO (non-serious), outcome "unknown", described as "when I got up I was moving all over the place my arms my legs my head"; BRADYPHRENIA (non-serious) with onset 17Mar2021, outcome "unknown", described as "Thinking is really slow"; MEMORY IMPAIRMENT (non-serious) with onset 17Mar2021, outcome "unknown", described as "Thinking is really slow and she forgets what she's doing all of the time and she has to use a walker"; VIBRATORY SENSE INCREASED (non-serious) with onset 17Mar2021, outcome "unknown", described as "When she lays down she feels like her body is vibrating/Her body is constantly moving"; FEELING ABNORMAL (non-serious) with onset 18Mar2021, outcome "unknown", described as "In order to eat she has to have her head against the chair to make it be still"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Tired"; TREMOR (non-serious) with onset 17Mar2021, outcome "recovered with sequelae", described as "Shaking violently"; DYSKINESIA (non-serious) with onset 17Mar2021, outcome "recovering", described as "Her body is constantly moving". The events "i could not walk" and "shaking violently" were evaluated at the physician office visit. The event "her body is constantly moving" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of gait inability, vertigo, bradyphrenia, memory impairment, feeling abnormal, fatigue, tremor, dyskinesia. Therapeutic measures were taken as a result of vibratory sense increased.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Head is going to explode; feel like my body has been run over; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation; Typhoid vaccine; Hepatitis a vaccine; Hepatitis b vaccine; Polio vaccine; Yellow fever vaccine; Japanese encephalitis vaccine; Meningitis vaccine. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Head is going to explode"; FATIGUE (non-serious), outcome "unknown", described as "feel like my body has been run over".  Additional information: The patient stated that the side effects are absolutely abysmal that no one should have to go through that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: muscle spasms in my chest, back, left calf and neck for over 24 hours; pain was not constant and was sporadic / chest and leg spasms were so painful; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: ER2613) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN. Past drug history included: Lisinopril, reaction(s): "allergy", notes: Allergies to medications, food, or other products: Lisinopril. Vaccination history included: Bnt162b2 (Dose 1; Lot number: EN6202; , administration time: 09:00 AM,, vaccine_location: Left arm.), administration date: 06Mar2021, when the patient was 57 years old, for Covid-19 Immunization, reaction(s): "lightheaded and dizzy". The following information was reported: MUSCLE SPASMS (non-serious) with onset 28Mar2021 02:00, outcome "recovering", described as "muscle spasms in my chest, back, left calf and neck for over 24 hours"; PAIN (non-serious) with onset 28Mar2021, outcome "recovering", described as "pain was not constant and was sporadic / chest and leg spasms were so painful". Therapeutic measures were not taken as a result of muscle spasms, pain. Additional information: After the second shot, the patient experienced muscle spasms in her chest, back, left calf and neck for over 24 hours. The pain was not constant and was sporadic. The chest and leg spasms were so painful the evening of the 27th and the patient was awakened out of her sleep. 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 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling
Clinical narrative: My arm was just swollen; I felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Hypertension/Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LANTUS taken for diabetes mellitus; HYDROCHLOROTHIAZIDE taken for hypertension; METFORMIN taken for diabetes mellitus. Past drug history included: Lisinopril for Blood pressure, reaction(s): "I am allergic to Lisinopril". The following information was reported: ILLNESS (non-serious) with onset 26Mar2021, outcome "unknown", described as "I felt sick"; PERIPHERAL SWELLING (non-serious) with onset 27Mar2021, outcome "unknown", described as "My arm was just swollen". Therapeutic measures were taken as a result of illness, peripheral swelling.  Additional information: Patient took paracetamol (TYLENOL) as treatment for the events.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Soreness at the injection site on my arm; Aches; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Mar2021 11:10 (Lot number: EL3248) 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: Covid-19 vaccine (dose 1; manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "Soreness at the injection site on my arm"; PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "Aches"; FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "Fatigue".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after getting the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 11Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm after getting the 1st dose".  Additional information: The patient wanted to set up an appointment for the first dose of vaccine for her husband. The patient wanted to know if after getting the 2nd dose, would she experienced more symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection (UTI) after the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 80 year-old female 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: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "Urinary Tract Infection (UTI) after the 1st dose".  Additional Information: The patient was asking if she should take the second dose because of her UTI or not. The was also asking if how long should she wait before getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: feeling light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: DIZZINESS (non-serious), outcome "unknown", described as "feeling light headed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: glucose numbers are a lot higher; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (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 (First dose), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 26Mar2021, outcome "unknown", described as "glucose numbers are a lot higher". 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.
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Immune system disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot number: unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed eczema (bad eczema outbreak), and immune system disorder/immune system issues, with outcome of unknown. Therapeutic measures were taken as a result of eczema and immune system disorder. Additional information: Patient had to take a steroid (prednisone) this week as a result of events. Second dose of COVID-19 vaccine was scheduled on the 31st of March. Patient wanted to know if it was safe to take steroid close to vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Left breast is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 20Mar2021 (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: BREAST PAIN (non-serious), outcome "unknown", described as "Left breast is hurting ".  Additional information: The patient wanted to know if lymph nodes in the breast is one of the side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Middle insomnia, Nausea, Pain
Clinical narrative: tired; achy; arm very sore; nausea; feeling unwell; throbbing injection site that was very hot; throbbing injection site that was very hot; She woke up twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 11:00 (Lot number: ER8732) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: From 40 years. There were no concomitant medications. Vaccination history included: Flu vaccine (Adds after getting the flu vaccine she contracted the flu. When ask for information regarding the flu vaccine that she took and then got the flu she states that was many years ago and she was working for a hospital and it was required.), for Immunisation, reaction(s): "then had the flu". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "tired"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "achy"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "arm very sore"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "nausea"; MALAISE (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "feeling unwell"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 25Mar2021, outcome "recovered" (26Mar2021) and all described as "throbbing injection site that was very hot"; MIDDLE INSOMNIA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "She woke up twice".  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated she had a history in reacting to a long list of unspecified medications that were mostly heart medications. Patient reported she was fine until evening on the day of vaccination (25Mar2021) and then she was tired, achy, her arm was very sore, she had nausea and was feeling unwell. During the night, she woke up twice with throbbing at injection site that was very hot. She mentioned she has a very high pain tolerance so it was pretty bad to wake her up. Adds all of her symptoms went away by the next morning. Events did not result to emergency room visit and physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vaccination site warmth
Clinical narrative: tired; achy; arm very sore; nausea; feeling unwell; throbbing injection site that was very hot; throbbing injection site that was very hot; She woke up twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 11:00 (Lot number: ER8732) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: From 40 years. There were no concomitant medications. Vaccination history included: Flu vaccine (Adds after getting the flu vaccine she contracted the flu. When ask for information regarding the flu vaccine that she took and then got the flu she states that was many years ago and she was working for a hospital and it was required.), for Immunisation, reaction(s): "then had the flu". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "tired"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "achy"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "arm very sore"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "nausea"; MALAISE (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "feeling unwell"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 25Mar2021, outcome "recovered" (26Mar2021) and all described as "throbbing injection site that was very hot"; MIDDLE INSOMNIA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "She woke up twice".  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated she had a history in reacting to a long list of unspecified medications that were mostly heart medications. Patient reported she was fine until evening on the day of vaccination (25Mar2021) and then she was tired, achy, her arm was very sore, she had nausea and was feeling unwell. During the night, she woke up twice with throbbing at injection site that was very hot. She mentioned she has a very high pain tolerance so it was pretty bad to wake her up. Adds all of her symptoms went away by the next morning. Events did not result to emergency room visit and physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Muscle spasms, Tremor, Vomiting
Clinical narrative: Chills; muscle spasms; shaking; throwing up; Upset stomach; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 40 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 11:00 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing); "hypo thalassemia" (unspecified if ongoing). Concomitant medications included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; QVAR REDIHALER; ATIVAN. Past drug history included: Percocet, reaction: "allergies". Vaccination history included: BNT162B2 (Dose 1, Lot number: N6204, Administration time: 11:00 AM), administration date: 03Mar2021, when the patient was 40 years old, for covid-19 immunization, reaction: "Achy Joints". The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Chills"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "muscle spasms"; TREMOR (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "shaking"; VOMITING (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "throwing up"; ABDOMINAL DISCOMFORT (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Upset stomach". Therapeutic measures were not taken as a result of chills, muscle spasms, tremor, vomiting and abdominal discomfort.  Additional information: Adverse events for second vaccine were chills, muscle spasms, shaking, and throwing up, lasted for 3 hours. Upset stomach for a few days. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021343178 same patient/reporter/drug in separate time
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Unable to sleep well / can't get a full night's sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: INSOMNIA (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Unable to sleep well / can't get a full night's sleep".  Additional Information: The reporter (patient's wife) mentioned that the patient had been experiencing the same symptom she had.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021338094 same report/drug/AE, different patient;US-PFIZER INC-2021355282 same report/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Unable to sleep well / can't get a full nights sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (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: INSOMNIA (non-serious), outcome "unknown", described as "Unable to sleep well / can't get a full nights sleep". Additional Information: The reporter mentioned that the patient had been experiencing the same symptom she had.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355281 Same reporter, drug and event; different patient.;US-PFIZER INC-2021338094 Same reporter, drug and event; different patient.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Feeling abnormal, Inappropriate schedule of product administration, Malaise
Clinical narrative: Malaise; Orientation was really off; Felt like equilibrium was off balance; Strange feelings; States first dose was 15Mar2021 and second was 26Mar2021; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 07:30 (Lot number: ER8727) at the age of 62 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EN6205, Expiration Date: Unknown) in the right arm), administration date: 15Mar2021, when the patient was 62 years old, for Covid-19 immunisation, reaction: "Denies any symptoms". The following information was reported: FEELING ABNORMAL (non-serious) with onset 26Mar2021 11:30, outcome "not recovered", described as "Strange feelings"; MALAISE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Malaise"; DISORIENTATION (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Orientation was really off"; BALANCE DISORDER (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Felt like equilibrium was off balance"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Mar2021 07:30, outcome "unknown", described as "States first dose was 15Mar2021 and second was 26Mar2021".  Additional Information: The patient received COVID Vaccine for inoculation. The patient got his second shot in his left arm shoulder this past Friday (26Mar2021) and about four hours later, he began experiencing strange feelings and had gone online to look up his symptoms. This morning 3 days later (29Mar2021), he felt malaise, his orientation was really off, and when he got out of bed, he felt like his equilibrium was off balance. He wanted to know if this was normal, and how long it would last. His symptoms were all persisting. He denied any symptoms after first vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patent did not receive prior vaccinations within 4 weeks and did not experience adverse events following prior vaccinations. No relevant tests were done by the patient.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain in extremity, Somnolence, Vaccination site pain
Clinical narrative: arm got sore; she was also tired and sleepy; she was also tired and sleepy; She felt discomfort the minute she got the shot; little more tender at the injection site; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Jan2021 12:45 (Lot number: E63247) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "started breaking out in shingles" (unspecified if ongoing), notes: Caller adds that last October, she started breaking out into shingles. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm got sore"; FATIGUE (non-serious), SOMNOLENCE (non-serious), outcome "recovered" and all described as "she was also tired and sleepy"; DISCOMFORT (non-serious), outcome "recovered", described as "She felt discomfort the minute she got the shot"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "little more tender at the injection site". Additional Information: The patient has not received any other products. On the first vaccine, her arm got sore, but she did not have problems so she thought that she would take the second. Her arm was sore right away from the first shot. It lasted a couple of days. She felt discomfort the minute she got the shot until a few days, 2 or 3 days later. She was also tired and sleepy, so it was not what she would have called an intense reaction to the shot. She did not think anything of it. It went away. There was a period of 20 minutes where she sat and waited after getting the vaccination and she said she was okay because she just got the shot and maybe it would hurt a little bit, but her arm did get progressively a little more tender at the injection site. Then it went up to her shoulder. This only lasted for a few days after the first vaccine. The shot was given lower not in shoulder muscle but a little below it. The second shot was given higher in her muscle than the first one. She figured this was why it did not hurt as much.  It was like on the back where it changed from muscle to flatter area, more like below the curve of your shoulder muscle toward the back side.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355267 Same patient, different dose and event.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling cold, Pain, Pain in extremity
Clinical narrative: Cold sensation in her shoulder and left arm/she got a cold sensation throughout her body. Her right arm has a coldness, freezing cold, radiates and travels from arm to neck; feeling kind of anxious; Sharp pain on right arm towards chest.; shooting pain that goes into body on the side; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious) with onset 08Mar2021, outcome "unknown", described as "Cold sensation in her shoulder and left arm/she got a cold sensation throughout her body. Her right arm has a coldness, freezing cold, radiates and travels from arm to neck"; ANXIETY (non-serious) with onset 08Mar2021, outcome "recovered" (Mar2021), described as "feeling kind of anxious"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sharp pain on right arm towards chest."; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "shooting pain that goes into body on the side". Therapeutic measures were taken as a result of feeling cold.  Additional information: Today was 3 weeks ago that she had the vaccine. The date she took her vaccine until 4-5 hours later, she got a cold sensation in her shoulder and neck and left arm. She took a couple of Tylenols. She started feeling kind of anxious. That went away. About 5-6 days ago, she got sharp pains on right arm towards her chest. She did not think much of it and dismissed it. A few hours later, she got a cold sensation throughout her body. Her right arm has a coldness, freezing cold, radiates and travels from arm to neck. She had this episode 3 times. The shooting pains were there. It was like one shooting pain that goes into body on the side. It was not like she was screaming with pain. She was not looking for any kind of legal. She just wanted to know if these feelings would go away, the coldness or sensation. Her concern was she wanted to say if this was common or not. Her second dose was coming up next week, and she was reconsidering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Deep brain stimulation, Energy increased, Therapeutic response unexpected
Clinical narrative: he felt a lot better/seems to get up easier, he gets out of bed a little easier with the bar, he is able to speak more loudly and clearly; like he just had more energy; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EN6208) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing); "multiple system atrophy" (unspecified if ongoing), notes: like Parkinson's plus; states there is no cure and no medications.; "Neuropathy" (unspecified if ongoing); "blood pressure drops down to 60/40" (unspecified if ongoing); "stem cell", start date: 2019 (unspecified if ongoing), notes: probably 2 years ago; "Parkinson's" (unspecified if ongoing); "chiropractic cervical work" (unspecified if ongoing). Concomitant medication(s) included: SINEMET taken for parkinson's disease, start date: May2014; GABAPENTIN taken for neuropathy peripheral; MIDODRINE taken for blood pressure decreased. Past drug history included: Symmetrel for multiple system atrophy, reaction(s): "did not work"; Azilect for multiple system atrophy, reaction(s): "did not work". Vaccination history included: Bnt162b2 (Lot number: EN6200 in right arm as dose 1, single), administration date: 26Feb2021, when the patient was 73 years old, for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 20Mar2021, outcome "unknown", described as "he felt a lot better/seems to get up easier, he gets out of bed a little easier with the bar, he is able to speak more loudly and clearly"; ENERGY INCREASED (non-serious) with onset 20Mar2021, outcome "unknown", described as "like he just had more energy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was a hospice patient. Because of the multiple system atrophy (MSA) the patient energy levels are very low, he has difficulty with balance and difficulty walking and was reported that nothing can be done for MSA. Patient had tried medications, amantadine (SYMMETREL), rasagiline (AZILECT) and Zydago (as reported) but they did not work and had been discarded. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The second dose was administered between 10:30 to 10:45. The patient had no adverse reaction but experienced an unexpected reaction to the vaccine. Reporter stated in terms of causality, she would really have to say yes and it was remarkable the reaction the patient had after the Pfizer COVID Vaccine; stated the patient has an aid out there every day that exercises with him and the aid stated how much better the patient's circulation was and his strength on exercises has improved.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Vaccination site discomfort
Clinical narrative: Feeling discomfortable at the injection site; Upset stomach; 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 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 26Feb2021 12:00 (Lot number: EN6203) at the age of 58 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 (First dose, Time: 12 pm, Anatomical site: left upper arm, Route: Intramuscular, Lot no. : EL9262, Expiry date: 30Jun2021), administration date: 05Feb2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Feeling discomfortable at the injection site", "Headache". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 26Feb2021, outcome "recovered" (2021), described as "Feeling discomfortable at the injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset 26Feb2021, outcome "recovered" (27Feb2021), described as "Upset stomach". Therapeutic measures were not taken as a result of vaccination site discomfort, abdominal discomfort.  Additional information: The events did not result to an admission to the hospital.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (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. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Fatigue". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.