chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00C21A2) for COVID-19 vaccination. No Medical History information was reported. On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided. The vaccines were stored in freezer, we took out one to two vials and placed in fridge each day as needed.
Sex: M
Vaccine: COVID19
Symptoms: Death, Pericardial effusion
Clinical narrative: YOUR POISON KILLED MY FATHER; began retaining fluid around us heart after his 2nd injection of your poison; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (YOUR POISON KILLED MY FATHER) and PERICARDIAL EFFUSION (began retaining fluid around us heart after his 2nd injection of your poison) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (YOUR POISON KILLED MY FATHER) (seriousness criteria death and medically significant) and PERICARDIAL EFFUSION (began retaining fluid around us heart after his 2nd injection of your poison) (seriousness criterion medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PERICARDIAL EFFUSION (began retaining fluid around us heart after his 2nd injection of your poison) outcome was unknown.            No concomitant medication were reported.  No treatment medication were reported.  On 01-Feb-2022, case MOD-2022-469236 became invalid as the case does not full fill the criteria's of an identifiable reporter (in social media case).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2022: Follow-up received on 03-Feb-2022 wherein newevent added.; Sender's Comments: This fatal spontaneous case concerns a male patient of unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected event of PERICARDIAL EFFUSION after receiving the second dose of mRNA-1273 and that died on an unknown date from an unknown cause. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after it had been punctured for greater than 12 hours) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 029H21B) for COVID-19 vaccination. No Medical History information was reported. On 08-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2022 at 11:05 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2022 at 11:05 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after it had been punctured for greater than 12 hours.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 03-Feb-2022 at 11:05 AM, EXPIRED PRODUCT ADMINISTERED (Dose administered after it had been punctured for greater than 12 hours.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had not reported any symptoms and not received any additional doses, medications or treatments at that time. No concomitant medications were reported. Treatment information was not provided.
Age: 94.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that no treatment was given on the patients. No concomitant medications were reported.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vaccine was administered to the from 20Oct2021 to 29Nov2021. Lot number of vial was 006C21 (10Feb2021), 026B21A (17Sep2021), 031B21A (22Sep2021). No treatment was given to the patients. No concomitant medications were reported.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (expired vaccine) in a 28-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031B21A) for COVID-19 immunization. No medical history reported. On Nov 12, 2021, patient received the 3rd (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient administered expired product (expired vaccine). On Nov 12, 2021, administered expired product (expired vaccine): resolved. The reporter did not provide any causality assessments or concomitant medication. Reportedly, no treatment given to the patient.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that no treatment was given on the patients. No concomitant medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: pH body fluid abnormal
Clinical narrative: 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 14:15 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID-19, brand=Pfizer, First dose, lot number=Unknown, lot unknown=False, administration time=02:45 AM, vaccine location=Left arm), administration date: 12Mar2021, for COVID-19 immunization, reaction(s): "Hives", "Itchy throat", "Swelling redness of skin", "Swelling redness of skin", "Stiff muscles", "Extremely fatigued". The following information was reported: PH BODY FLUID ABNORMAL (non-serious) with onset 04Apr2021 14:15, outcome "unknown", described as "Ph unbalance second dose third day". Additional information: Clinical course: The patient had Allergies. The Patient did not had Covid-19 prior vaccination and was not tested for Covid-19 post vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not received other medications within 2 weeks of vaccination. Hospital is reported as Facility where the most recent COVID-19 vaccine was administered. Other medical history reported as Yes (not specified). Ethnicity and Race information are available. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Feb2021 12:00 (Lot number: EL3247) at the age of 58 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Allergy: strawberries" (unspecified if ongoing), notes: Known allergies: Pan Strawberries; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. The following information was reported: MOUTH ULCERATION (non-serious) with onset 05Apr2021 17:00, outcome "not recovered", described as "red ulcers". Therapeutic measures were not taken as a result of mouth ulceration. Additional information: The patient had not received any other vaccine in four weeks. It was unknown if the patient had tested for Covid-19 prior vaccination. The patient had not tested for Covid-19 post vaccination. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Facial discomfort, Magnetic resonance imaging, Muscle tightness, Neck pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Apr2021, outcome "unknown" and all described as "pain in her left arm (arm of injection) that radiated to her neck & shoulder"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "She has ringing in her left ear"; FACIAL DISCOMFORT (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Facial & jaw tightness"; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "vibration feeling in body when in certain places". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, tinnitus, facial discomfort, muscle tightness, tremor, arthralgia, vaccination site pain, and treatment included essential oils. Additional information: Caller received her first Pfizer Covid-19 Vaccine on 13April2021. About three days later she experienced pain in her left arm (arm of injection) that radiated to her neck & shoulder. She has seen several doctors & tried essential oils. Spoke from the attached document under "Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: arm pain. Facial & jaw tightness, weakness (greater strength on one side of the body), vibration feeling in body when in certain places. Response: Spoke from the attached document under "adverse reaction/side effects." No reports at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Tremor, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Apr2021, outcome "unknown" and all described as "pain in her left arm (arm of injection) that radiated to her neck & shoulder"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "She has ringing in her left ear"; FACIAL DISCOMFORT (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Facial & jaw tightness"; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "vibration feeling in body when in certain places". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, tinnitus, facial discomfort, muscle tightness, tremor, arthralgia, vaccination site pain, and treatment included essential oils. Additional information: Caller received her first Pfizer Covid-19 Vaccine on 13April2021. About three days later she experienced pain in her left arm (arm of injection) that radiated to her neck & shoulder. She has seen several doctors & tried essential oils. Spoke from the attached document under "Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: arm pain. Facial & jaw tightness, weakness (greater strength on one side of the body), vibration feeling in body when in certain places. Response: Spoke from the attached document under "adverse reaction/side effects." No reports at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder, Wheezing
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A 58-year-old adult male patient received BNT162b2 (BNT162B2), administration date 21May2021 (Batch/Lot number: unknown) at the age of 58 years 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: RESPIRATORY DISORDER (non-serious) with onset 22May2021, outcome "unknown", described as "breathing problems"; WHEEZING (non-serious) with onset 22May2021, outcome "unknown", described as "wheezing". Therapeutic measures were not taken as a result of respiratory disorder, wheezing. Follow-up attempts completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 66 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Mar2021 16:30 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for Covid-19 immunization. Relevant medical history included: "Liver problems" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: Gabapentin; Atorvastatin; Fenofibrate. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "pain at the injection site". Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient was not allergic to any medications, food or other products. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 14Mar2021 16:15 (Lot number: EN6208) at the age of 48 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Allergies: Iodine contrast" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness CTCAE v 4.03 grade 1 as initial symptom similar to dose 1". Therapeutic measures were not taken as a result of dizziness. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior vaccination and has not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2021402313 same patient/reporter, different vaccine dose and event.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: 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: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "One lady hasn't had a flare up in 30 years but after her injection did have flare up". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Stroke", start date: 2000 (unspecified if ongoing); "Back surgery", start date: 2001 (unspecified if ongoing), notes: Two back surgeries, in 2001 and 2017, both were on lower back. In 2017 they put titanium blocks in; "COVID-19", start date: Feb2021, stop date: 2021; "Used a cane" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN, start date: 2021. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Feeling unwell". Follow-up (27Sep2021): Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I have not had a period since my second vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 (Lot number: EN8733) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6205, Vaccine location: Left arm), administration date: 06Mar2021, when the patient was 32 years old, for COVID-19 immunization, reaction(s): "Fatigue", "My period came a week early", "was lighter/didn't last as long", "Headache". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "I have not had a period since my second vaccine". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: No other vaccine in four weeks. No Known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that, patient's period came a week early and was not on birth control and have had a regular period for her lifetime. After first vaccine, patient's period started one week earlier than expected (22Mar2021) and was lighter/didn't last as long. Pregnancy test negative (taken 07Apr2021). She also had a headache and fatigue two hours after getting first vaccine. After the second dose (31Mar2021), patient no symptoms. she have not had a period since second vaccine to know if menses has been affected again (usually the last weekend of the month). Patient stated she reported this because, she have spoken to other (#) healthcare professionals like her that have gotten the pfizer vaccine have changes in their menses as well. Mainly a heavier/longer menses however.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: HA; low grade temperature; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (ongoing), notes: Illness: HBP; "Covid inf.", start date: 02Nov2020, stop date: 12Aug2021. Concomitant medication(s) included: HCTZ taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (dose 1, via intramuscular administered on left arm), for COVID-19 immunisation, reaction(s): "lip numbness", "tongue numbness". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "HA"; PYREXIA (non-serious), outcome "unknown", described as "low grade temperature"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chest pain, Headache, Pain
Clinical narrative: chest pains; can't get out of bed.; body aches; no energy; Fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 18:00 (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "chest pains"; BEDRIDDEN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "can't get out of bed."; PAIN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "no energy"; PYREXIA (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "headache". The events "chest pains", "can't get out of bed.", "body aches", "no energy", "fever" and "headache" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of chest pain, bedridden, pain, asthenia, pyrexia, headache.  Additional information: The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chest pains; can't get out of bed.; body aches; no energy; Fever; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 18:00 (Batch/Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "chest pains"; BEDRIDDEN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "can't get out of bed."; PAIN (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "body aches"; ASTHENIA (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "no energy"; PYREXIA (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 20Aug2021 03:00, outcome "not recovered", described as "headache". The events "chest pains", "can't get out of bed.", "body aches", "no energy", "fever" and "headache" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of chest pain, bedridden, pain, asthenia, pyrexia, headache.  Additional information: The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Aug2021 16:00 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). Concomitant medication(s) included: MOTRIN IB. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 21Aug2021 16:00, outcome "unknown", described as "My 1st shot went to my mouth and throat got swollen with sore throat, little hard to breathe, chest got tighten"; PHARYNGEAL SWELLING (non-serious) with onset 21Aug2021 16:00, outcome "unknown", described as "throat got swollen"; OROPHARYNGEAL PAIN (non-serious) with onset 21Aug2021 16:00, outcome "unknown", described as "sore throat". It was unknown if therapeutic measures were taken as a result of chest discomfort, pharyngeal swelling, oropharyngeal pain. Additional information: The facility where the most recent COVID-19 vaccine was administered was Pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Facial pain, Headache, Insomnia, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 11:00 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Allergy to Fluoroquinolone antibiotics" (unspecified if ongoing); "Known allergies- contrast dye" (unspecified if ongoing). Concomitant medication(s) included: Nortriptyline; Ambien; Advil [Ibuprofen]. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer,, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=26Jul2021, administration time=09:30 AM, dose number=1, vaccine location=Left arm}), administration date: 26Jul2021, for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Insomnia"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Aug2021 22:30, outcome "recovering" and all described as "Widespread muscle and joint pain"; HEADACHE (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Headache"; FACIAL PAIN (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Facial pain"; VACCINATION SITE PAIN (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Pain at injection site". The events "insomnia", "widespread muscle and joint pain", "widespread muscle and joint pain", "headache", "facial pain" and "pain at injection site" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of insomnia, myalgia, arthralgia, headache, facial pain, and vaccination site pain. The patient did not had any treatment for AE. The patient did not had COVID prior vaccination. The patient did not tested COVID post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 11:00 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Allergy to Fluoroquinolone antibiotics" (unspecified if ongoing); "Known allergies- contrast dye" (unspecified if ongoing). Concomitant medication(s) included: Nortriptyline; Ambien; Advil [Ibuprofen]. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=Pfizer,, lot unknown=True, lot unknown reason=Unable to locate or read the details, administration date=26Jul2021, administration time=09:30 AM, dose number=1, vaccine location=Left arm}), administration date: 26Jul2021, for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Insomnia"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Aug2021 22:30, outcome "recovering" and all described as "Widespread muscle and joint pain"; HEADACHE (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Headache"; FACIAL PAIN (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Facial pain"; VACCINATION SITE PAIN (non-serious) with onset 20Aug2021 22:30, outcome "recovering", described as "Pain at injection site". The events "insomnia", "widespread muscle and joint pain", "widespread muscle and joint pain", "headache", "facial pain" and "pain at injection site" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of insomnia, myalgia, arthralgia, headache, facial pain, and vaccination site pain. The patient did not had any treatment for AE. The patient did not had COVID prior vaccination. The patient did not tested COVID post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: swelling; her arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (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. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "swelling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm is sore".  Additional information: reporter wants to know if there is something to worry about with his wife's condition since her arm is sore and swelling after getting the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: double ear infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EN6206) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: pcn" (unspecified if ongoing). There were no concomitant medications. The following information was reported: EAR INFECTION (non-serious) with onset 30Mar2021 05:30, outcome "not recovered", described as "double ear infection". The event "double ear infection" was evaluated at the physician office visit. Therapeutic measures were taken as a result of ear infection.  Additional information: Vaccine administration time=09:45 AM. Facility type vaccine other: No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. Known allergies: pcn. Other medical history: none. Double ear infection after first dose. AE treatment: steroid started 5 days after 2nd dose of vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: swollen lymph node on back of head; swollen knot was on her face; red hot swollen places on bottoms of feet and hands; itching; red hot swollen places on bottoms of feet and hands; red hot swollen places on bottoms of feet and hands; painful; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Batch/Lot number: unknown, Expiration Date: Oct2021) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jul2021, for Covid-19 immunization, reaction(s): "pain in feet". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Aug2021, outcome "unknown", described as "swollen lymph node on back of head"; ERYTHEMA (non-serious), FEELING HOT (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Aug2021, outcome "unknown" and all described as "red hot swollen places on bottoms of feet and hands"; PRURITUS (non-serious) with onset Aug2021, outcome "unknown", described as "itching"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "painful"; SWELLING FACE (non-serious) with onset 21Aug2021, outcome "recovered" (23Aug2021), described as "swollen knot was on her face".  Additional Information: The patient stated that she has red hot slightly swollen places on bottom of her feet and on hands that are really painful, they are itching when they first start, states she also has a swollen lymph node on back of head on the opposite side that she got the shot on, the other one that came up on her arm looked like a mast cell. The patient stated that she had something that came up after the first vaccine but was not sure if it was related, states at the time she was working in and on 30Jun2021 she went to doctor and he said kids fed her poison ivy on a candy, then she had ring worms, states this was all before the first dose of the vaccine, got first vaccine on 24Jul2021, had pain in feet two days after first shot but was not certain it was the vaccine. Stated that she got the second dose on Thursday 18Aug2021. The patient was unsure if it was completely recovered or if it will come back. Stated it comes up at night and then will go away. The patient stated that first swollen knot was on her face, on her right cheek, started 21Aug2021, lasted two days and went away and then swollen lymph node on the back of her head, directly behind right ear, appeared on night 23 AUG 2021. Lot number for second dose FC3181 or FL3181 cannot read the writing on the vaccine record card. Patient was not received other product. Investigation Assessment: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: swollen lymph node on back of head; swollen knot was on her face; red hot swollen places on bottoms of feet and hands; itching; red hot swollen places on bottoms of feet and hands; red hot swollen places on bottoms of feet and hands; painful; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Batch/Lot number: unknown, Expiration Date: Oct2021) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jul2021, for Covid-19 immunization, reaction(s): "pain in feet". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Aug2021, outcome "unknown", described as "swollen lymph node on back of head"; ERYTHEMA (non-serious), FEELING HOT (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Aug2021, outcome "unknown" and all described as "red hot swollen places on bottoms of feet and hands"; PRURITUS (non-serious) with onset Aug2021, outcome "unknown", described as "itching"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "painful"; SWELLING FACE (non-serious) with onset 21Aug2021, outcome "recovered" (23Aug2021), described as "swollen knot was on her face".  Additional Information: The patient stated that she has red hot slightly swollen places on bottom of her feet and on hands that are really painful, they are itching when they first start, states she also has a swollen lymph node on back of head on the opposite side that she got the shot on, the other one that came up on her arm looked like a mast cell. The patient stated that she had something that came up after the first vaccine but was not sure if it was related, states at the time she was working in and on 30Jun2021 she went to doctor and he said kids fed her poison ivy on a candy, then she had ring worms, states this was all before the first dose of the vaccine, got first vaccine on 24Jul2021, had pain in feet two days after first shot but was not certain it was the vaccine. Stated that she got the second dose on Thursday 18Aug2021. The patient was unsure if it was completely recovered or if it will come back. Stated it comes up at night and then will go away. The patient stated that first swollen knot was on her face, on her right cheek, started 21Aug2021, lasted two days and went away and then swollen lymph node on the back of her head, directly behind right ear, appeared on night 23 AUG 2021. Lot number for second dose FC3181 or FL3181 cannot read the writing on the vaccine record card. Patient was not received other product. Investigation Assessment: No.  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, Pyrexia
Clinical narrative: the same side effects as before of mild fever and fatique; the same side effects as before of mild fever and fatique; 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) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "the same side effects as before of mild fever and fatique".  Additional information: It was reported that she just got booster her third. She was asking if this was still ok. She also was asking if she should still expect the same side effects as before of mild fever and fatigue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Periorbital swelling
Clinical narrative: itching and puffiness in her eyes; itching and puffiness in her eyes; 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 91 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 17:30 (Batch/Lot number: unknown) at the age of 91 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "bladder disorder" (ongoing). Concomitant medication(s) included: PREMARIN taken for bladder disorder (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 06Jan2021, when the patient was 90 years old, for Covid-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: 20Jan2021, when the patient was 90 years old, for Covid-19 immunisation. The following information was reported: EYE PRURITUS (non-serious), PERIORBITAL SWELLING (non-serious) all with onset 2021, outcome "recovering" and all described as "itching and puffiness in her eyes".  Additional information: It is reported that the patient had the third dose of the COVID vaccine. She has experienced the events since. Also, her daughter in law had third dose as well, and experienced itching in both eyes. She doesn't want to get her daughter in law involved Her daughter in lase initials are withheld. The caller confirmed the details provided by the transferring agent. She doesn't want to do a report for her daughter in law. The caller got her third dose at (pharmacy name), but she doesn't know the address. The itching started after the vaccine. The itching started first, and then her eyes got a little puffy. He injection was at 530pm on 18Aug2021. Her eyes are still slightly puffy. She started putting ice on her eyes on Saturday, 21Aug2021. Her daughter in law's eyes were just itchy the day after. Her daughter in law read to put ice on the eyes. Her daughter in law iced her eyes as well. The third vaccine was given in her left arm. She got her first COVID vaccine on 06Jan2021, and two weeks later she got the second one. She knows she got one of those in her left arm, and the other in her right. Her card is too tiny to read the information so she cannot provide NDC/lot/expiration for any of the doses. The first two were a drive through thing. She was sitting in the car. The caller's puffiness is almost gone. Her daughter in law got the icing information from the internet because other people had the problem. No details on the other people provided. Prior vaccinations (within 4 weeks), patient's medical history (including any illness at time of vaccination) and relevant tests were not provided. Investigation Assessment was reported as no.  Follow-up (04Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Massive headache; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "wheat allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Massive headache".  Additional information: After the 2nd dose the patient had a massive headache. She had been having a progressing wheat allergy and wants to make sure before she gets 3rd dose that this isn't the reason why she got the massive headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.