chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin mass, Urticaria
Clinical narrative: Sometimes they are accompanied by raised skin; Hives are very itchy; Hives on her torso, back of her legs, and upper arms; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Sometimes they are accompanied by raised skin), PRURITUS (Hives are very itchy) and URTICARIA (Hives on her torso, back of her legs, and upper arms) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A, 046B21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced SKIN MASS (Sometimes they are accompanied by raised skin), PRURITUS (Hives are very itchy) and URTICARIA (Hives on her torso, back of her legs, and upper arms). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN MASS (Sometimes they are accompanied by raised skin), PRURITUS (Hives are very itchy) and URTICARIA (Hives on her torso, back of her legs, and upper arms) outcome was unknown.            Patient started hives which randomly appear and disappear.These episodes lasted 10-15 minutes.  Concomitant product information was not provided   This case was linked to MOD-2021-090609 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of alopecia (hair loss) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced alopecia (hair loss). At the time of the report, alopecia (hair loss) outcome: unknown. No concomitant medication or treatment information provided. Reporter wanted to know if hair loss was side effect of the Moderna vaccine. Most recent follow-up information incorporated: On Jan 27, 2022: Follow-up received contained no new information.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The reporter reported that, the patient received 2 doses of the Moderna COVID-19 vaccine 28 days apart. The patient received a booster dose 6 months after the second dose. He received a booster dose 6 months after the second dose. Now, 5 months after the booster dose, his doctor told him to get another booster dose. The reporter reported that the patient's doctor did not tell him to get a third dose and hence he got a booster dose.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HYALURONIC ACID (RESTYLANE) for an unknown indication.    The patient's past medical history included Dental cleaning. Previously administered products included for Product used for unknown indication: Flu shot; for Drug use for unknown indication: BOTOX. Past adverse reactions to the above products included No adverse event with BOTOX and Flu shot. Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication.   On 11-Jan-2022, the patient started HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced ORAL HERPES (Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.). The patient was treated with CEFALEXIN (CEPHALEXINE) ongoing from 15-Jan-2022 at a dose of 500 microgram and VALACYCLOVIR [VALACICLOVIR] ongoing from 20-Jan-2022 at a dose of 1 gram (4). At the time of the report, ORAL HERPES (Bottom left side of her lip, and right side of her upper lip, she broke out in 6 or 7 cold sores/lumps from the cold sores on one side of lower lip in the corner along the edge.) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information include triple antibiotic ointment. The consumer received COVID Moderna vaccine year ago in January 2 shots, and last fall got the booster. Patient had no dental procedures in the past 6 to 12 months, other than a dental cleaning.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Fear, Pruritus
Clinical narrative: sudden itching / it was so, so itchy; shaking; night she was chilling; feels tired; very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site; rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird; feels kind of scared / she was in panic / she was so scared; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (sudden itching / it was so, so itchy), FEAR (feels kind of scared / she was in panic / she was so scared), TREMOR (shaking), RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird) and CHILLS (night she was chilling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE for Blood pressure.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2022, the patient experienced RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird) and VACCINATION SITE RASH (very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site). On 15-Jan-2022, the patient experienced PRURITUS (sudden itching / it was so, so itchy), TREMOR (shaking), CHILLS (night she was chilling) and FATIGUE (feels tired). In January 2022, the patient experienced FEAR (feels kind of scared / she was in panic / she was so scared). On 11-Jan-2022, VACCINATION SITE RASH (very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site) had resolved. At the time of the report, PRURITUS (sudden itching / it was so, so itchy), FEAR (feels kind of scared / she was in panic / she was so scared), TREMOR (shaking), RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird), CHILLS (night she was chilling) and FATIGUE (feels tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: temperature of 95 temperature of 95°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment included allergy pills and antihistamine. Patient visited the hospital and was told that the reactions would go away.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tremor, Vaccination site rash
Clinical narrative: sudden itching / it was so, so itchy; shaking; night she was chilling; feels tired; very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site; rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird; feels kind of scared / she was in panic / she was so scared; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (sudden itching / it was so, so itchy), FEAR (feels kind of scared / she was in panic / she was so scared), TREMOR (shaking), RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird) and CHILLS (night she was chilling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE for Blood pressure.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2022, the patient experienced RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird) and VACCINATION SITE RASH (very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site). On 15-Jan-2022, the patient experienced PRURITUS (sudden itching / it was so, so itchy), TREMOR (shaking), CHILLS (night she was chilling) and FATIGUE (feels tired). In January 2022, the patient experienced FEAR (feels kind of scared / she was in panic / she was so scared). On 11-Jan-2022, VACCINATION SITE RASH (very bright rash around the injection site /oval rash around the injection site/white bumps started growing from inside/3-4 inches rash around the injection site) had resolved. At the time of the report, PRURITUS (sudden itching / it was so, so itchy), FEAR (feels kind of scared / she was in panic / she was so scared), TREMOR (shaking), RASH (rash in her hands was very bright. The rash was all over the arms and elbows/rash went down to her arms, elbow and wrist/ rash all over the body it was so weird), CHILLS (night she was chilling) and FATIGUE (feels tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: temperature of 95 temperature of 95°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment included allergy pills and antihistamine. Patient visited the hospital and was told that the reactions would go away.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse Reactions To Coronavirus Vactionations; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse Reactions To Coronavirus Vactionations) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 VACCINATION COMPLICATION (Adverse Reactions To Coronavirus Vactionations). At the time of the report, VACCINATION COMPLICATION (Adverse Reactions To Coronavirus Vactionations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment medications was not reported.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of pyrexia (99.5 fever) in an 85-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (99.5 fever). At the time of the report, pyrexia (99.5 fever) outcome: unknown. Diagnostic results: On an unknown date, body temperature: 99.5 (high). The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered 1st dose of vaccine to a 17 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old). On 20-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of vaccine to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I couldn't stay awake for 5 days after that; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (22Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 64-year-old female patient started to receive tofacitinib citrate (XELJANZ XR 11mg) via an unspecified route of administration from an unspecified date to an unspecified date at unspecified dose and frequency from an unspecified indication and BNT162B2 Solution for injection from an unspecified date to an unspecified date via unspecified route (Lot number-unknown) as dose number-unknown, single for COVID-19 immunization and he patient's medical history and concomitant medications were not reported. The patient was completely out of medication as of today because her shipment did not arrive to her as stated for 09Jan2017. Upon follow-up on 22Mar2021, inbound call from patient to schedule refill. The patient stated, "I got the COVID vaccine. Does this medication interfere with it because I couldn't stay awake for 5 days after that." The patient was prescribed tofacitinib citrate 11mg tablets. The action taken in response to the event for tofacitinib citrate and the outcome of the event were unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up (25Jan2022): This is a follow-up report to notify that the case 2017022503 and 2021330703 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2017022503 . The new information reported from a contactable consumer (patient)  includes suspect product BNT162B2 and clinical information  No follow-up attempts are needed.No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood bilirubin increased, Blood potassium, Blood potassium decreased, Blood pressure measurement
Clinical narrative: Potassium was low (3.5); Bilirubin was high (1.1); WBC High; RDW High; Still a visible knot and tenderness; Still a visible knot and tenderness; Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Aug2021 18:00 (Lot number: EW0180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing). Family history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol and high BP runs in family; "High BP" (unspecified if ongoing), notes: High cholesterol and high BP runs in family. Concomitant medication(s) included: ZYPITAMAG; EZETIMIBE. Past drug history included: Keflex, reaction(s): "Known Allergy: Keflex", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine.; Epinephrine, reaction(s): "Bad reaction to Epinephrine", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Aug2021 08:30, outcome "recovered" (2021), described as "Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy"; TENDERNESS (non-serious), MASS (non-serious) all with onset 11Aug2021 08:30, outcome "recovering" and all described as "Still a visible knot and tenderness"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Potassium was low (3.5)"; BLOOD BILIRUBIN INCREASED (non-serious), outcome "unknown", described as "Bilirubin was high (1.1)"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "WBC High"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "RDW High". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, tenderness, mass.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Heart rate, Lymphadenopathy, Mass
Clinical narrative: Potassium was low (3.5); Bilirubin was high (1.1); WBC High; RDW High; Still a visible knot and tenderness; Still a visible knot and tenderness; Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Aug2021 18:00 (Lot number: EW0180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing). Family history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol and high BP runs in family; "High BP" (unspecified if ongoing), notes: High cholesterol and high BP runs in family. Concomitant medication(s) included: ZYPITAMAG; EZETIMIBE. Past drug history included: Keflex, reaction(s): "Known Allergy: Keflex", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine.; Epinephrine, reaction(s): "Bad reaction to Epinephrine", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Aug2021 08:30, outcome "recovered" (2021), described as "Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy"; TENDERNESS (non-serious), MASS (non-serious) all with onset 11Aug2021 08:30, outcome "recovering" and all described as "Still a visible knot and tenderness"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Potassium was low (3.5)"; BLOOD BILIRUBIN INCREASED (non-serious), outcome "unknown", described as "Bilirubin was high (1.1)"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "WBC High"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "RDW High". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, tenderness, mass.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell analysis, Red blood cell count increased, Tenderness, White blood cell count, White blood cell count increased
Clinical narrative: Potassium was low (3.5); Bilirubin was high (1.1); WBC High; RDW High; Still a visible knot and tenderness; Still a visible knot and tenderness; Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Aug2021 18:00 (Lot number: EW0180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing). Family history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol and high BP runs in family; "High BP" (unspecified if ongoing), notes: High cholesterol and high BP runs in family. Concomitant medication(s) included: ZYPITAMAG; EZETIMIBE. Past drug history included: Keflex, reaction(s): "Known Allergy: Keflex", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine.; Epinephrine, reaction(s): "Bad reaction to Epinephrine", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Aug2021 08:30, outcome "recovered" (2021), described as "Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy"; TENDERNESS (non-serious), MASS (non-serious) all with onset 11Aug2021 08:30, outcome "recovering" and all described as "Still a visible knot and tenderness"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Potassium was low (3.5)"; BLOOD BILIRUBIN INCREASED (non-serious), outcome "unknown", described as "Bilirubin was high (1.1)"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "WBC High"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "RDW High". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, tenderness, mass.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 31-year-old patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had vaccination site pain/soreness around the injection spot, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Chills, Vaccination site pain
Clinical narrative: pain underneat under the armpit; breast of the same side of the injection site; started getting pain, not too much pain, but felt something there.; then had a little shiver,; 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 10Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Received first two doses in Mar2021 of Pfizer COVID-19 Vaccine), administration date: Mar2021, for COVID-19 immunization, reaction(s): "pain in the arm where she got it"; Bnt162b2 (DOSE 2, SINGLE, Received first two doses in Mar2021 of Pfizer COVID-19 Vaccine), administration date: Mar2021, for COVID-19 immunization, reaction(s): "pain in the arm where she got it". The following information was reported: AXILLARY PAIN (non-serious) with onset 11Dec2021, outcome "unknown", described as "pain underneat under the armpit"; BREAST PAIN (non-serious) with onset 11Dec2021, outcome "unknown", described as "breast of the same side of the injection site"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "unknown", described as "started getting pain, not too much pain, but felt something there."; CHILLS (non-serious) with onset 10Dec2021, outcome "unknown", described as "then had a little shiver,".  Additional information: The caller was a consumer she indicates that she received the booster dose of pfizer covid 19 on 10Dec and she presented pain underneat under the armpit and in the breast of the same side of the injection site. shot Received first two doses in Mar2021 of Pfizer COVID-19 Vaccine. Everything went fine, except she had some little pain in the arm where she got it. Now she received her booster shot at (Pharmacy name). Was fine for a couple hours In evening time, started getting pain, not too much pain, but felt something there. Then had a little shiver, which is something she knew she would probably get Then suddenly the next morning, felt like under her armpit started hurting her and the side of her breast was hurting. Now her arm was not hurting anymore, but the underarm and side of breast, she can still feel it. Hurts when she is moving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1st injection was 06Nov2021. On 08Nov2021 and then again on 09Nov2021, had a local urticarial reaction that self resolved each time, occurred after a warm shower; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 06Nov2021 (Batch/Lot number: unknown) at the age of 5 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: URTICARIA (non-serious) with onset 08Nov2021, outcome "recovered", described as "1st injection was 06Nov2021. On 08Nov2021 and then again on 09Nov2021, had a local urticarial reaction that self resolved each time, occurred after a warm shower".   Additional information:1st injection was 06Nov2021. On 08Nov2021 and then again on 09Nov2021, had a local urticarial reaction that self resolved each time, occurred after a warm shower. No other symptoms at all, either at the time of the injection nor at each episode of local urticaria.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: similar large local urticarial reaction at the injection site only; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Prev dose product: COVID 19, Prev dose Brand: Pfizer COVID-19, Prev dose Brand unknown: False, Prev dose Lot unknown: True, Prev dose Lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose administration date: 06Nov2021, Prev dose Dose number: 1), administration date: 06Nov2021, when the patient was 5 years old, for COVID-19 immunization, reaction(s): "had a local urticarial reaction that self resolved each time, occurred after a warm shower". The following information was reported: VACCINATION SITE URTICARIA (non-serious) with onset 09Dec2021 16:30, outcome "recovered", described as "similar large local urticarial reaction at the injection site only". Therapeutic measures were not taken as a result of vaccination site urticaria.  Additional information: The reporter type was Healthcare Professional reporting for a patient. The age group of the patient was "child (2-11 years)". 1st injection was 06Nov2021. On 08Nov2021 and then again on 09Nov2021, had a local urticarial reaction that self resolved each time, occurred after a warm shower. No other symptoms at all, either at the time of the injection nor at each episode of local urticaria. The 2nd injection was on 03Dec2021. No issues at all once again at the time of the injection. No issues at all until 09Dec2021 after a warm shower, similar large local urticarial reaction at the injection site only. Again, self resolved. No any other vaccine in four weeks. The Covid was not tested post vaccination. There was no known allergies and none other medical history. Other medications in two weeks was none  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Chest pain, Muscle spasms, Muscle twitching, Nausea
Clinical narrative: TWITCHING; MUSCLE SPASMS; PRESSURE IN BACK; PAIN THRU BACK INTO CHEST; NEUROLOGICAL ISSUES; NAUSEA; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 22Jul2021, outcome "not recovered", described as "TWITCHING"; MUSCLE SPASMS (non-serious) with onset 22Jul2021, outcome "not recovered", described as "MUSCLE SPASMS"; BACK DISORDER (non-serious) with onset 22Jul2021, outcome "not recovered", described as "PRESSURE IN BACK"; CHEST PAIN (non-serious) with onset 22Jul2021, outcome "not recovered", described as "PAIN THRU BACK INTO CHEST"; NERVOUS SYSTEM DISORDER (non-serious) with onset 22Jul2021, outcome "not recovered", described as "NEUROLOGICAL ISSUES"; NAUSEA (non-serious) with onset 22Jul2021, outcome "not recovered", described as "NAUSEA".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: TWITCHING; MUSCLE SPASMS; PRESSURE IN BACK; PAIN THRU BACK INTO CHEST; NEUROLOGICAL ISSUES; NAUSEA; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 22Jul2021, outcome "not recovered", described as "TWITCHING"; MUSCLE SPASMS (non-serious) with onset 22Jul2021, outcome "not recovered", described as "MUSCLE SPASMS"; BACK DISORDER (non-serious) with onset 22Jul2021, outcome "not recovered", described as "PRESSURE IN BACK"; CHEST PAIN (non-serious) with onset 22Jul2021, outcome "not recovered", described as "PAIN THRU BACK INTO CHEST"; NERVOUS SYSTEM DISORDER (non-serious) with onset 22Jul2021, outcome "not recovered", described as "NEUROLOGICAL ISSUES"; NAUSEA (non-serious) with onset 22Jul2021, outcome "not recovered", described as "NAUSEA".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Influenza like illness, Neck mass
Clinical narrative: Body aches; slight fever; brain fog; chills; felt like the flu; tired; getting a lump in my neck near my collarbone and one in my a pit area near my boob; both lumps sore both on the same side as the injection; 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 14Dec2021 13:30 (Lot number: FD 7218) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hernia" (unspecified if ongoing); "uterine fibroids" (unspecified if ongoing); "allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; GLYCOPYRROLATE. Past drug history included: Pecans, reaction(s): "allergies"; Nickel, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: FW0161, vaccine location: Left arm), administration date: 14May2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, vaccine location: Right arm), administration date: 23Apr2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 16Dec2021, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 16Dec2021, outcome "recovering", described as "slight fever"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "recovering", described as "brain fog"; CHILLS (non-serious) with onset 16Dec2021, outcome "recovering", described as "chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16Dec2021, outcome "recovering", described as "felt like the flu"; FATIGUE (non-serious) with onset 16Dec2021, outcome "recovering", described as "tired"; NECK MASS (non-serious) with onset 16Dec2021, outcome "recovering", described as "getting a lump in my neck near my collarbone and one in my a pit area near my boob"; NODULE (non-serious) with onset 16Dec2021, outcome "recovering", described as "both lumps sore both on the same side as the injection". Therapeutic measures were not taken as a result of pain, pyrexia, feeling abnormal, chills, influenza like illness, fatigue, neck mass, nodule.  Additional information: Patient did not tested for covid post and prior vaccination. Concomitant medication included multivitamins.  No follow-up attempts are possible. No further information is expected.  Follow-Up (04Jan2022):Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain, Pyrexia
Clinical narrative: Body aches; slight fever; brain fog; chills; felt like the flu; tired; getting a lump in my neck near my collarbone and one in my a pit area near my boob; both lumps sore both on the same side as the injection; 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 14Dec2021 13:30 (Lot number: FD 7218) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hernia" (unspecified if ongoing); "uterine fibroids" (unspecified if ongoing); "allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; GLYCOPYRROLATE. Past drug history included: Pecans, reaction(s): "allergies"; Nickel, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: FW0161, vaccine location: Left arm), administration date: 14May2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, vaccine location: Right arm), administration date: 23Apr2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 16Dec2021, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 16Dec2021, outcome "recovering", described as "slight fever"; FEELING ABNORMAL (non-serious) with onset 16Dec2021, outcome "recovering", described as "brain fog"; CHILLS (non-serious) with onset 16Dec2021, outcome "recovering", described as "chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16Dec2021, outcome "recovering", described as "felt like the flu"; FATIGUE (non-serious) with onset 16Dec2021, outcome "recovering", described as "tired"; NECK MASS (non-serious) with onset 16Dec2021, outcome "recovering", described as "getting a lump in my neck near my collarbone and one in my a pit area near my boob"; NODULE (non-serious) with onset 16Dec2021, outcome "recovering", described as "both lumps sore both on the same side as the injection". Therapeutic measures were not taken as a result of pain, pyrexia, feeling abnormal, chills, influenza like illness, fatigue, neck mass, nodule.  Additional information: Patient did not tested for covid post and prior vaccination. Concomitant medication included multivitamins.  No follow-up attempts are possible. No further information is expected.  Follow-Up (04Jan2022):Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hyperhidrosis, Pain in extremity
Clinical narrative: Chills; Sweating; Tired; Sore arm/achy arms; Zero energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm/achy arms"; ASTHENIA (non-serious), outcome "unknown", described as "Zero energy".  Follow-up attempts have been completed and no further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing), notes: Diagnosed maybe 10 years ago. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills".  Additional information: Reporter stated patient previous doses would have been in Feb2021, but she did not have exact dates or any product information to provide. The patient did not visit emergency room and physician office. Reported stated patient had the vaccine Tuesday, 14Dec2021, and tested positive for COVID today. Reporter clarified with the first Pfizer COVID vaccination, patient had a fever, body aches, chills- all that jazz for a couple days. This time, with the booster, patient had all the same things the second day. Yesterday, patient felt pretty good, but today patient was coughing a little bit and tested at work. The test came back positive and patient did not know if it was right.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: rash; shingles; pain; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: The caller has had shingles in the past. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, UNKNOWN MANUFACTURER), for COVID-19 immunisation; Covid-19 vaccine (dose 2, UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: HERPES ZOSTER (non-serious) with onset 17Dec2021, outcome "unknown", described as "shingles"; PAIN (non-serious) with onset 17Dec2021, outcome "unknown", described as "pain"; RASH (non-serious) with onset 18Dec2021, outcome "unknown", described as "rash".  Additional information: Patient received his booster dose of the adult formulation of the Pfizer BioNTech Covid 19 vaccine on 15Dec2021.  Two days after the vaccine he started to develop symptoms of shingles include pain in his side and 3-4 days later he developed a shingles rash.  Patient had shingles in the past so he knows what it feels like. He saw online that others have reported developing shingles after the vaccine. Patient is calling in to report his potential side effect.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Mental fatigue, Myalgia
Clinical narrative: muscle aches/aches; fatigue; mental fatigue "in a fog"; mental fatigue "in a fog"; 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 male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 65 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: MYALGIA (non-serious) with onset Mar2021, outcome "recovered" (12Mar2021), described as "muscle aches/aches"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (12Mar2021), described as "fatigue"; MENTAL FATIGUE (non-serious), FEELING ABNORMAL (non-serious) all with onset Mar2021, outcome "recovered" (12Mar2021) and all described as "mental fatigue "in a fog"".  Additional information: Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose last 08Mar2021. This was on a Monday, and reported that throughout the rest of the week until Friday (12Mar2021), he experienced muscle aches, fatigue (especially mental fatigue "in a fog"). He reported that he had mild list of things that could go wrong, like aches, and a lot of fatigue and mental fatigue. It passed. There was nothing serious enough to make him go to the hospital. He did not have fever, and just aches. It was mostly just the fatigue and mental fatigue.  He was in a fog for several days.  He didn't know if that was common or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.