chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: covid vaccine details: administration date=08Mar2021, administration time=01:30 PM; pain/stiffness in all knuckles- esp- middle finger; pain/stiffness in all knuckles- esp- middle finger; Unable to bend middle finger at all or grasp for 2 weeks; R hand swelled- esp knuckles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 13:30 (Lot number: ER8727) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "envir. allergy" (unspecified if ongoing); "depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "cold sores" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; MONTELUKAST; NEFAZODONE; VIT D [VITAMIN D NOS]; ACYCLOVIR [ACICLOVIR]. Past drug history included: Bactrim, reaction(s): "Known allergies:Bactrim"; Keflex, reaction(s): "Known allergies: Keflex"; Lisinopril, reaction(s): "Known allergies: Lisinopril", BZDs. Vaccination history included: Bnt162b2, administration date: 08Mar2021, when the patient was 61 years old, for COVID-19 immunisation, reaction(s): "Hand swelled"; Bnt162b2, administration date: 08Mar2021, when the patient was 61 years old, for Covid-19 immunization, reaction(s): "Swelled especially knuckles", "Swelled especially knuckles", "Pain in all knuckles especially middle finger".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "covid vaccine details: administration date=08Mar2021, administration time=01:30 PM"; PERIPHERAL SWELLING (non-serious) with onset 09Mar2021 12:00, outcome "recovering", described as "R hand swelled- esp knuckles"; PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovering" and all described as "pain/stiffness in all knuckles- esp- middle finger"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "Unable to bend middle finger at all or grasp for 2 weeks". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, musculoskeletal stiffness, loss of personal independence in daily activities.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: sacral pain got worse after first Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Sacral pain" (ongoing). The patient took concomitant medications. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "sacral pain got worse after first Covid vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: Mentions she thinks she has gained weight recently, called it COVID fat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 13:00 (Lot number: ER8731, Expiration Date: 31Jul2021) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: from 6 months. Family history included: "MS" (unspecified if ongoing), notes: Her daughter has MS. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement (ongoing). The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "Mentions she thinks she has gained weight recently, called it COVID fat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Though I (reporter) had Covid vaccine, I did not feel well, the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Covid 19, for covid 19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Though I (reporter) had Covid vaccine, I did not feel well, the second dose".  Additional Information: Patient (reporter) had Covid vaccine, She did not feel well, the second dose, She took vitamin C and Vitamin D and all, She was fine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: she received the covid vaccine the pain lessened by about 10 to 20 %; 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) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: She has shingles for 5 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "she received the covid vaccine the pain lessened by about 10 to 20 %".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain
Clinical narrative: pain in armpit and breast after receiving her second covid vaccine; pain in armpit and breast after receiving her second covid vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer survivor" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:1), for COVID-19 immunization, reaction(s): "No reaction". The following information was reported: BREAST PAIN (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "pain in armpit and breast after receiving her second covid vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was sick from her covid shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.   A 77 year-old 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: ILLNESS (non-serious), outcome "unknown", described as "she was sick from her covid shot.".  Additional information: Spoke with patient prescribed Ibrance. Patient advised me that she was late taking her medication and she was sick from her covid shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Malaise, Product administration error
Clinical narrative: nurse injected an empty syringe into her husband's arm; her husband's arm is extremely burning; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program .  A male patient received bnt162b2 (BNT162B2), administration date 06May2021 (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 number:1), for Covid-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 06May2021, outcome "unknown", described as "nurse injected an empty syringe into her husband's arm"; BURNING SENSATION (non-serious) with onset 06May2021, outcome "unknown", described as "her husband's arm is extremely burning"; MALAISE (non-serious) with onset 06May2021, outcome "unknown", described as "not feeling well".  Additional information: The nurse injected an empty syringe (air) into patient's arm, the nurse apologized and then proceed with the second dose and then coming home his arm was extremely burning as the particular and not feeling well. His wife wanted to know what to do the next. Product details (LOT#, Expiration Date, NDC# and UPC#) were reported as unknown. Limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: some of the covid-19 vials, they are able to extract 6 doses and a few only 4 doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) 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: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "some of the covid-19 vials, they are able to extract 6 doses and a few only 4 doses".  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: after her second dose of the COVID-19 vaccine, she was tired and experienced chills; after her second dose of the COVID-19 vaccine, she was tired and experienced chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 25 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), administration date: 24Mar2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), CHILLS (non-serious) all with onset 15Apr2021, outcome "unknown" and all described as "after her second dose of the COVID-19 vaccine, she was tired and experienced chills".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 3 patients (all adults so over 18 years old), 2 males plus 1 female, were administered the Pfizer covid vaccine that had been stored outside of EUA prescribing information guidelines.; 3 patients (all adults so over 18 years old), 2 males plus 1 female, were administered the Pfizer covid vaccine that had been stored outside of EUA prescribing information guidelines.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An adult 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: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "3 patients (all adults so over 18 years old), 2 males plus 1 female, were administered the Pfizer covid vaccine that had been stored outside of EUA prescribing information guidelines.".  Additional information: This pharmacist reported similar events for 3 patients. This is 2nd of three reports. This pharmacist reported for an adult female patient. 1 of the refrigerators temperature monitors were not working for about 3-4 hours, he believes the undiluted Pfizer covid vaccines were at room temperature (55F) for a total of 4 hours maximum. After they were taken out of the refrigerator, they were administered to 3 patients.  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-2021523525 same reporter/drug/event, different patient;US-PFIZER INC-2021530570  same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: after receiving his first dose of the Covid-19 vaccine he starting getting a metallic taste in his mouth while eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (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: DYSGEUSIA (non-serious) with onset 02May2021, outcome "unknown", described as "after receiving his first dose of the Covid-19 vaccine he starting getting a metallic taste in his mouth while eating".  Additional information: Reporter stated that son, age 20 (unit: unknown), informed me yesterday 09May2021 that 2 days after receiving his first dose of the Covid-19 vaccine he starting getting a metallic taste in his mouth while eating. He received his 1st dose on 30Apr2021. Please let me know if you need any further information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for three days after second dose of the Covid Vaccine; 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 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered" (2022), described as "Sick for three days after second dose of the Covid Vaccine". When calling to ask about the second dose of the Covid Vaccine caller mentions that her friend was sick for three days after having the second dose.  Declines to complete report.  States her friend was fine now, she was just sick for three days after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: after her first Covid vaccine, her arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 09:00 (Lot number: ER8734) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovered" (11Apr2021), described as "after her first Covid vaccine, her arm was sore". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not have any family history and relevant test. Patient did not receive additional vaccine on same date of the pfizer suspect and not have any prior vaccination. Clinical course: It was reported that after her first Covid vaccine, patient arm was sore, but she was reading that was normal. The patient received second dose of BNT162B2, administered in arm left, administration date 07May2021 (Lot number: EW0183) at the age of 63 years as dose 2, single for covid-19 immunisation and experienced two round oval rash at side and a little swollen and warm on 09May2021, redness at injection site on 08May2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: An intermittent pain in her inner left lower leg/receiving the second Pfizer Covid 19 Vaccine the pain started back intermittently; Muscle pain; I have had my second shot I am still having the peculiar pain; 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 (BNT162B2), administration date 19Apr2021 (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 number: 1), administration date: 28Mar2021, for Covid-19 immunization, reaction(s): "Intermittent pain in her inner left lower leg". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "An intermittent pain in her inner left lower leg/receiving the second Pfizer Covid 19 Vaccine the pain started back intermittently"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN (non-serious), outcome "unknown", described as "I have had my second shot I am still having the peculiar pain".  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 52 year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8727), at the age of 52, intramuscularly, in right arm, on Mar 27, 2021, at 16:45, single dose, for COVID-19 immunisation. Medical history included back pain, start date: Nov 2020 (unspecified if ongoing). The patient's concomitant medications not reported. The patient had pain in extremity (with the first COVID-19 vaccine, he had some pain in his left arm), onset Mar 2021, with outcome of recovered (2021). No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: had received his 2nd COVID 19 vaccine and got very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient 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 (1st dose), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "had received his 2nd COVID 19 vaccine and got very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: experienced a sore shoulder at the injection site; mild body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 11:40 (Lot number: EK5730) 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 Immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "recovered", described as "experienced a sore shoulder at the injection site"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered", described as "mild body aches"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered", described as "fatigue". Therapeutic measures were taken as a result of vaccination site pain, pain, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain of skin, Sensitive skin
Clinical narrative: Total head/body aches; Total head/body aches; Skin very sensitive/tender; Skin very sensitive/tender; Chills; Injection site extremely tender; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Lot number: EL9263) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "High cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: High BP. Concomitant medication(s) included: METOPROLOL SUCCINATE; CANDESARTAN; VIIBRYD; ESTRADIOL; AMLODIPINE BESYLATE; BUPROPION; HCTZ; ATORVASTATIN; JUICE PLUS; OMEGA 3 [FISH OIL]; PREVAGEN [APOAEQUORIN]; VIT B 12. The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Total head/body aches"; SENSITIVE SKIN (non-serious), PAIN OF SKIN (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Skin very sensitive/tender"; CHILLS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Injection site extremely tender". Additional information:  The patient did not have any known allergies to food, medication or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Total head/body aches; Total head/body aches; Skin very sensitive/tender; Skin very sensitive/tender; Chills; Injection site extremely tender; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Lot number: EL9263) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; "High cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: High BP. Concomitant medication(s) included: METOPROLOL SUCCINATE; CANDESARTAN; VIIBRYD; ESTRADIOL; AMLODIPINE BESYLATE; BUPROPION; HCTZ; ATORVASTATIN; JUICE PLUS; OMEGA 3 [FISH OIL]; PREVAGEN [APOAEQUORIN]; VIT B 12. The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Total head/body aches"; SENSITIVE SKIN (non-serious), PAIN OF SKIN (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "Skin very sensitive/tender"; CHILLS (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Injection site extremely tender". Additional information:  The patient did not have any known allergies to food, medication or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site warmth
Clinical narrative: covid vaccine injection site turned pink and felt hot; covid vaccine injection site turned pink and felt hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) based on information received by Pfizer. (manufacturer control number: US-AMGEN-USASP2021072816.  A 73-year-old female patient 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 (1st dose), for covid-19 immunisation. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "covid vaccine injection site turned pink and felt hot".  No follow-up attempts possible. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Dizziness, Headache, Movement disorder, Pain
Clinical narrative: I woke up unable to move my body without extreme pain; still had horrible body aches; headache; sharp shooting pains in my left breast.; very dizzy/light headed; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 16:30 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "I woke up unable to move my body without extreme pain"; PAIN (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "still had horrible body aches"; HEADACHE (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "headache"; BREAST PAIN (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "sharp shooting pains in my left breast."; DIZZINESS (non-serious) with onset 18May2021 04:00, outcome "unknown", described as "very dizzy/light headed". The events "i woke up unable to move my body without extreme pain", "still had horrible body aches", "headache" and "sharp shooting pains in my left breast." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of movement disorder, pain, headache, breast pain, dizziness.  Additional information: Adverse event start date: 18May2021,Adverse event start time: 04:00 AM, If patient recovered: Unknown, If treatment AE: No, If covid prior vaccination: No, If covid tested post vaccination: No. Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No, Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No, Reported Event: About 8 hours after my second Covid shot I woke up unable to move my body without extreme pain. The follow day about 16 hours after shot I still had horrible body aches, headache and sharp shooting pains in my left breast. Now almost 48 hours after the shot I'm still currently very dizzy, light headed, sore and still have very sharp pains in my left breast. Did the adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19:No. Since the vaccination, has the patient been tested for COVID-19:No  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Calcinosis, Computerised tomogram, Echocardiogram
Clinical narrative: Two calcifications were seen in CT scan; Headaches 3 days after shot; Dose 1: 22Jan2021; Dose 2: 02Feb2021 (as reported); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left arm, administration date 02Feb2021 18:00 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS", start date: 2019 (ongoing); "Anxiety", start date: 2013 (ongoing). Concomitant medication(s) included: COLESTIPOL taken for irritable bowel syndrome (ongoing); XANAX taken for anxiety (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EL9262) intramuscular in left arm, at 18:00), administration date: 22Jan2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "Headache", "extreme dizziness", "heart palpitations", "Vertigo". The following information was reported: HEADACHE (non-serious) with onset 05Feb2021 18:00, outcome "not recovered", described as "Headaches 3 days after shot"; CALCINOSIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "Two calcifications were seen in CT scan"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Feb2021, described as "Dose 1: 22Jan2021; Dose 2: 02Feb2021 (as reported)". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Headache, Inappropriate schedule of product administration, Magnetic resonance imaging
Clinical narrative: Two calcifications were seen in CT scan; Headaches 3 days after shot; Dose 1: 22Jan2021; Dose 2: 02Feb2021 (as reported); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left arm, administration date 02Feb2021 18:00 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS", start date: 2019 (ongoing); "Anxiety", start date: 2013 (ongoing). Concomitant medication(s) included: COLESTIPOL taken for irritable bowel syndrome (ongoing); XANAX taken for anxiety (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EL9262) intramuscular in left arm, at 18:00), administration date: 22Jan2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "Headache", "extreme dizziness", "heart palpitations", "Vertigo". The following information was reported: HEADACHE (non-serious) with onset 05Feb2021 18:00, outcome "not recovered", described as "Headaches 3 days after shot"; CALCINOSIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "Two calcifications were seen in CT scan"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Feb2021, described as "Dose 1: 22Jan2021; Dose 2: 02Feb2021 (as reported)". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Menstrual disorder, Paraesthesia
Clinical narrative: I have tinging and numbness on my right hand since 21May. It especially get worse at night where the tingling is severe; I have tinging and numbness on my right hand since 21May. It especially get worse at night where the tingling is severe; Changes in menstrual cycle- I have tinging and numbness on my right hand since 21May. It especially get worse at night where the tingling is severe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 15:00 (Lot number: EK8429) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 21May2021, outcome "not recovered" and all described as "I have tinging and numbness on my right hand since 21May. It especially get worse at night where the tingling is severe"; MENSTRUAL DISORDER (non-serious) with onset 21May2021, outcome "not recovered", described as "Changes in menstrual cycle- I have tinging and numbness on my right hand since 21May. It especially get worse at night where the tingling is severe". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, menstrual disorder.  Additional Information: Hospitalization Prolonged was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The other medical history was reported as no.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: sore arm; almost fell from the weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 27Jan2021 15:00 (Lot number: EL9265) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "a fib" (unspecified if ongoing), notes: Diagnosed years ago, its monitored; "allergy to iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ASTHENIA (non-serious), outcome "unknown", described as "almost fell from the weakness". Additional information: It was reported that the patient a fib was on a recording monitor and it sends reports to her cardiologist every night and it has not noted an event in over 90 days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021344895 Same reporter/patient/drug/events, different dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: headache; fatigue; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EL3248) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medications included: SYNTHROID, start date: 1994 (ongoing); WELLBUTRIN, start date: Mar2020 (ongoing); NALTREXONE, start date: Mar2020 (ongoing). Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EL0140) in the left arm at 15:45), administration date: 06Jan2021, when the patient was 61 years old, for Covid-19 Immunization, reactions: "Chills", "Body Aches", "Cold", "fever", "Pain at injection site", "Felt ill", "Fatigue", "Felt like I had COVID again for 24 hrs". The following information was reported: HEADACHE (non-serious) with onset 28Jan2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 28Jan2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Adverse events did not require a visit to emergency room or physician office. The day after the second dose, she felt fine but maybe a slight headache and fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021010972 Same patient and drug; Different dose and events
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: 6 days late with next Cycle/5 days late; very light in flow/lasting only 1 - 2 days/and extremely bright red in color; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0176) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (lot number: ER8726, administration time: 14:00 dose number: 1, vaccine location: Left arm), administration date: 07Apr2021, when the patient was 46 years old, for Covid-19 immunisation, reaction(s): "Was extremely light in flow and bright", "I was due for my monthly Cycle on 14Apr. Did not receive until 21Apr". The following information was reported: MENSTRUATION DELAYED (non-serious), outcome "not recovered", described as "6 days late with next Cycle/5 days late"; MENSTRUAL DISORDER (non-serious), outcome "not recovered", described as "very light in flow/lasting only 1 - 2 days/and extremely bright red in color". Therapeutic measures were not taken as a result of menstruation delayed, menstrual disorder.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff feet/ ankles/ wrists; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 28Apr2021, outcome "unknown", described as "stiff feet/ ankles/ wrists". Therapeutic measures were taken as a result of musculoskeletal stiffness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal
Clinical narrative: A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to; A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li; A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li; A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 12:00 (Lot number: Ew0173) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, administration time: 12:00 PM, Vaccine location: left arm, Lot no: Ew0153), administration date: 16Apr2021, when the patient was 31 years old, for COVID-19 Immunization.  The following information was reported: FATIGUE (non-serious) with onset 31May2021, outcome "not recovered", described as "A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to"; DIZZINESS (non-serious), DIZZINESS (non-serious), FEELING ABNORMAL (non-serious) all with onset 31May2021, outcome "not recovered" and all described as "A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily li".  Additional information: Patient reported A few weeks after my second dose, I am feeling extremely tired, I'm getting very dizzy and lightheaded and feeling very foggy in my brain, this is a daily occurrence and starting to affect my daily life and has lasted for 2 weeks and it's no relief, I do not have health insurance so it's very hard for me to get this checked out. Patient did not receive other vaccine in four weeks and other medications in two weeks. The patient did not receive any treatment.Patient did not had COVID-19 prior or since vaccination. patient was not tested for Covid post vaccination. Patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nerve compression
Clinical narrative: Fatigue; feverish till upto 2 weeks; Shooting pain behind head; seems like a pinched nerve; Body ache; chills that doesn't seem to go away more than 1.5 weeks after the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jun2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Low iron" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (product=COVID 19, Brand: Pfizer, Lot unknown: True, Lot unknown reason: Unable to locate or read the details, Administration date= 15May2021, Administration time: 03:00 PM, Dose number=1, Vaccine location= Left arm, Route of administration: Intramuscular), administration date: 15May2021, when the patient was 42 years old, for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "Fatigue"; PYREXIA (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "feverish till upto 2 weeks"; HEADACHE (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "Shooting pain behind head"; NERVE COMPRESSION (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "seems like a pinched nerve"; PAIN (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "Body ache"; CHILLS (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "chills that doesn't seem to go away more than 1.5 weeks after the shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, headache, nerve compression, pain, chills.  Additional Information: Patient did not have other vaccine in four weeks. Other medications in two weeks were Amlodipine, Vitamin D. Adverse Event: Fatigue, feverish till up to 2 weeks. Shooting pain behind head, seems like a pinched nerve. Body ache, chills that doesn't seem to go away more than 1.5 weeks after the shot. Patient did not have covid prior vaccination. Patient was not tested covid post vaccination. It was not known if patient had known allergies. Prior Vaccinations (within 4 weeks) reported as none. Patient's Medical History (including any illness at time of vaccination) reported as none. Relevant Tests reported as none. The seriousness criteria were reported as not serious. Patient did not received treatment for AEs.  Follow-up attempts completed. No further information is expected.