chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache; nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 17:15 (Lot number: Fk5127) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if Covid prior vaccination: Yes" (unspecified if ongoing), notes: if Covid prior vaccination: Yes. Concomitant medication(s) included: MELATONIN AND MULTIVITAMIN. The following information was reported: HEADACHE (non-serious) with onset 24Nov2021 20:30, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 24Nov2021 20:30, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 24Nov2021 20:30, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of headache, nausea, vomiting.  Additional information: The vaccine was facilitated in Doctor's office/urgent care. It was unknown, if other vaccine in four weeks. Patient did Not experienced Covid test post vaccination. Patient did not have any known allergy.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ovarian failure
Clinical narrative: My wife suffered ovarian failure as a result of the Pfizer Covid; 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) (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: OVARIAN FAILURE (non-serious), outcome "unknown", described as "My wife suffered ovarian failure as a result of the Pfizer Covid". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Injection site pain
Clinical narrative: Felt soreness at injection site; Felt soreness at injection site and inside the under arm (armpit); Booster dose; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 41 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Nov2021 (Lot number: 320305D) 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 02), for Covid-19 immunization; Bnt162b2 (Dose 01), for Covid-19 immunization; Flu vaccine vii (Anatomical site of injection: Right arm.). The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "Booster dose"; INJECTION SITE PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "Felt soreness at injection site"; AXILLARY PAIN (non-serious) with onset 22Nov2021, outcome "recovered" (2021), described as "Felt soreness at injection site and inside the under arm (armpit)". The event "booster dose" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of injection site pain, axillary pain.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: she got achy; Her joints were hurting; She had a headache; Chills; Lymph nodes stayed swollen for a few months; She also had a fever with her 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EK9231, Anatomical Location: Right arm, Time: 9:00), administration date: 14Jan2021, for Covid-19 Immunization, reaction(s): "Lymph nodes stayed swollen for a few months", "Achy", "Joints were hurting", "Had a headache", "Chills". The following information was reported: PAIN (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "she got achy"; ARTHRALGIA (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Her joints were hurting"; HEADACHE (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "She had a headache"; CHILLS (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Lymph nodes stayed swollen for a few months"; PYREXIA (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "She also had a fever with her 2nd dose". Therapeutic measures were not taken as a result of pain, arthralgia, headache, chills, lymphadenopathy, pyrexia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she got achy; Her joints were hurting; She had a headache; Chills; Lymph nodes stayed swollen for a few months; She also had a fever with her 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EK9231, Anatomical Location: Right arm, Time: 9:00), administration date: 14Jan2021, for Covid-19 Immunization, reaction(s): "Lymph nodes stayed swollen for a few months", "Achy", "Joints were hurting", "Had a headache", "Chills". The following information was reported: PAIN (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "she got achy"; ARTHRALGIA (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Her joints were hurting"; HEADACHE (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "She had a headache"; CHILLS (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "Lymph nodes stayed swollen for a few months"; PYREXIA (non-serious) with onset 04Feb2021, outcome "recovered" (2021), described as "She also had a fever with her 2nd dose". Therapeutic measures were not taken as a result of pain, arthralgia, headache, chills, lymphadenopathy, pyrexia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Only after vaccine I became allergic to amoxicilin, bug bites, foods, spices, enviromental factors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL9266) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ehlers danlos syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "Only after vaccine I became allergic to amoxicilin, bug bites, foods, spices, enviromental factors".  Addition Information: Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Lethargy, Pain, Pain in extremity
Clinical narrative: achy and sore left arm( injection site); Temperature was 99.0, and 2 hours later was reported to be 100.0; sore arm; mild body aches; feeling lethargic; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 22Nov2021 16:00 (Batch/Lot number: unknown) as dose number unknown, single 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: LETHARGY (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "feeling lethargic"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "achy and sore left arm( injection site)"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "Temperature was 99.0, and 2 hours later was reported to be 100.0"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "sore arm"; PAIN (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "mild body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lethargy, vaccination site pain, body temperature increased, pain in extremity, pain. Additional information: Approximately 15 hours post vaccination , reported feeling lethargic, achy and sore left arm( injection site)Temperature was 99.0, and 2 hours later was reported to be 100.0. He took Acetaminophen for symptoms which all resolved without recurrence. Additional information: In the Follow up:(25Nov2021),it was reported that the patient took Acetaminophen only.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: achy and sore left arm( injection site); Temperature was 99.0, and 2 hours later was reported to be 100.0; sore arm; mild body aches; feeling lethargic; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 22Nov2021 16:00 (Batch/Lot number: unknown) as dose number unknown, single 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: LETHARGY (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "feeling lethargic"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "achy and sore left arm( injection site)"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "Temperature was 99.0, and 2 hours later was reported to be 100.0"; PAIN IN EXTREMITY (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "sore arm"; PAIN (non-serious) with onset 23Nov2021 09:30, outcome "recovered" (2021), described as "mild body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lethargy, vaccination site pain, body temperature increased, pain in extremity, pain. Additional information: Approximately 15 hours post vaccination , reported feeling lethargic, achy and sore left arm( injection site)Temperature was 99.0, and 2 hours later was reported to be 100.0. He took Acetaminophen for symptoms which all resolved without recurrence. Additional information: In the Follow up:(25Nov2021),it was reported that the patient took Acetaminophen only.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Headache, Product administered to patient of inappropriate age, Vomiting
Clinical narrative: Inappropriate age at vaccine administration; throwing up; Headache; Stomach pain; feels like no energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 24Nov2021 (Lot number: FK5618) at the age of 9 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: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 24Nov2021, outcome "unknown", described as "Inappropriate age at vaccine administration"; VOMITING (non-serious) with onset 24Nov2021, outcome "not recovered", described as "throwing up"; HEADACHE (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Stomach pain"; ASTHENIA (non-serious) with onset 24Nov2021, outcome "not recovered", described as "feels like no energy".  Additional information: The caller (mother) was calling about the pediatric Pfizer covid-19 vaccine on behalf of her son. The patient was having a reaction- he was throwing up, has headaches, stomach pain, and feels like no energy. The patient's symptoms started 1.5 hours ago.   No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 01:45 (Lot number: FK1527) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: mayonnaise" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 24Nov2021, outcome "unknown", described as "diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: No other vaccine in four weeks and no other medications in two weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Genital ulcer syndrome, Headache, Pyrexia, Vomiting
Clinical narrative: genital ulcer; fever; headache; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. n/a), administration date: 04Sep2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: GENITAL ULCER SYNDROME (non-serious) with onset 21Nov2021, outcome "unknown", described as "genital ulcer"; PYREXIA (non-serious) with onset 21Nov2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 21Nov2021, outcome "unknown", described as "headache"; VOMITING (non-serious) with onset 21Nov2021, outcome "unknown", described as "vomiting". The events "genital ulcer", "fever", "headache" and "vomiting" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of genital ulcer syndrome, headache, vomiting.  Additional Information: No other vaccine in fourweeks and also no other medication in two weeks. No covid prior vaccination and no covid tested post vaccination. Known allergies and Other medical history were not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: a sore arm; a little bit tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number: EP7533, and expiry date were not reported), via an unspecified route of administration, on 23Apr2021 at the age of 72 years as dose 1, single and on 14May2021 (Lot number: EW0158) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "a sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "a little bit tired".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: fever; vomiting; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". Additional information: Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Patient reports side effects of being achy, but it is manageable.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (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: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Patient reports side effects of being achy, but it is manageable.". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Immunisation, Nodule, Pruritus
Clinical narrative: It is the Pfizer booster; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Nov2021 (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 (First Dose, I get both shot), for COVID-19 immunization; Bnt162b2 (Second Dose, I get both shot), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "It is the Pfizer booster"; PRURITUS (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 30Nov2021, outcome "unknown" and all described as "red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches"; NODULE (non-serious), SWELLING (non-serious) all with onset 30Nov2021, outcome "unknown" and all described as "Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick". Therapeutic measures were taken as a result of pruritus, nodule, erythema, feeling hot, swelling. Additional information: Consumer stated, It was swollen a little bit and it had like a hard node begin with, now that hard node has spread out this was not as quite hard but it was still sick like that you can tell it was swollen and it itches and it was warm and it was pink so in another words, it was grown from the size of dime but now it was the size of three of your fingers. Consumer stated, "patient mean patient was just wondering what to do. Patient took some Benadryl (not a Pfizer product) thinking that would make it go away and it did not. Do you have a suggestion what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: It is the Pfizer booster; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches; Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Nov2021 (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 (First Dose, I get both shot), for COVID-19 immunization; Bnt162b2 (Second Dose, I get both shot), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "It is the Pfizer booster"; PRURITUS (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 30Nov2021, outcome "unknown" and all described as "red circular where the shot was; it is grown if you put three of your fingers together it is that wide and the length is that the length of your fingers; still pink, warm and it itches"; NODULE (non-serious), SWELLING (non-serious) all with onset 30Nov2021, outcome "unknown" and all described as "Swollen a little bit and it had like a hard node begin with, now that hard node has spread out this is not as quite hard but it is still sick". Therapeutic measures were taken as a result of pruritus, nodule, erythema, feeling hot, swelling. Additional information: Consumer stated, It was swollen a little bit and it had like a hard node begin with, now that hard node has spread out this was not as quite hard but it was still sick like that you can tell it was swollen and it itches and it was warm and it was pink so in another words, it was grown from the size of dime but now it was the size of three of your fingers. Consumer stated, "patient mean patient was just wondering what to do. Patient took some Benadryl (not a Pfizer product) thinking that would make it go away and it did not. Do you have a suggestion what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Booster; First two injections were Moderna that was 08Mar21 and 09Mar21. The booster was Pfizer and that was 30Oct2021 of this year.; First two injections were Moderna that was 08Mar21 and 09Mar21. The booster was Pfizer and that was 30Oct2021 of this year.; headache literally right before she is due to have that next injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): AGN279967 (Allergan).  A 51 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 30Oct2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation; botulinum toxin type a (BOTOX) (Batch/Lot number: unknown) for migraine. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine, administration date: 08Mar2021, for covid-19 immunisation; Moderna covid-19 vaccine, administration date: 09Mar2021, for covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 30Oct2021, outcome "unknown" and all described as "First two injections were Moderna that was 08Mar21 and 09Mar21. The booster was Pfizer and that was 30Oct2021 of this year."; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache literally right before she is due to have that next injection". The action taken for botulinum toxin type a was unknown.  Additional information: It was reported that patient was one of the (unlisted) Support Specialist and just calling to report do have a patient three years on Botox for chronic migraines reporting headaches literally right before she is due to get her next injection series, so right at that 12th week. She did give permission to reach out to her and/or her doctor. So, yes to reach out to her and or her doctor. No idea about the number a units she was receiving. Her last injection was on 30Nov2021 of this year. Her next injection series is on 08Mar2022. She has had two COVID shots and a booster. So, COVID information. First two injections were Moderna that was 08Mar2021 and 09Mar2021. The booster was Pfizer and that was 30Oct2021. And again. So, the patient does not have a headache today but she is having she stated it just stated within the last six months or so she will get a headache literally right before she is due to have that next injection." Headaches literally right before she is due to get her next injection series within the last 6 months.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy, Product use issue
Clinical narrative: Enormous baseball size swollen lymph node in my right armpit that was very painful; Enormous baseball size swollen lymph node in my right armpit that was very painful; Booster; Other vaccine same date vaccine date 02Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 14:00 (Lot number: FJ1161) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 02Dec2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 22Feb2021, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9264, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 12Mar2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 14:00, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 04Dec2021 04:00, outcome "recovered" (07Dec2021) and all described as "Enormous baseball size swollen lymph node in my right armpit that was very painful"; PRODUCT USE ISSUE (non-serious) with onset 02Dec2021, outcome "unknown", described as "Other vaccine same date vaccine date 02Dec2021". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient had no known allergies. The patient was not diagnosed with Covid-19 prior vaccination. The patient was not tested for COVID-19 since the vaccination. Onset latency for the events Enormous baseball size swollen lymph node in my right armpit that was very painful was 01 day 14 hrs.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Pain, Sluggishness
Clinical narrative: body aches; sluggishness/fatigue (discovered upon waking); sluggishness/fatigue (discovered upon waking); Soreness in muscles of left arm; headache; The patient received third dose of vaccine/ booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 15:30 (Lot number: FG3527) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; LORATADINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 24Mar2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 03Mar2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 15:30, outcome "unknown", described as "The patient received third dose of vaccine/ booster"; PAIN (non-serious) with onset 03Dec2021 07:00, outcome "recovered" (Dec2021), described as "body aches"; SLUGGISHNESS (non-serious), FATIGUE (non-serious) all with onset 03Dec2021 07:00, outcome "recovered" (Dec2021) and all described as "sluggishness/fatigue (discovered upon waking)"; VACCINATION SITE PAIN (non-serious) with onset 03Dec2021 07:00, outcome "recovered" (Dec2021), described as "Soreness in muscles of left arm"; HEADACHE (non-serious) with onset 03Dec2021 07:00, outcome "recovered" (Dec2021), described as "headache". Therapeutic measures were not taken as a result of pain, sluggishness, fatigue, vaccination site pain, headache.  Additional information-Patient did not receive any other vaccine in four weeks. Patient did not experienced covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: body aches; sluggishness/fatigue (discovered upon waking); sluggishness/fatigue (discovered upon waking); Soreness in muscles of left arm; headache; The patient received third dose of vaccine/ booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 15:30 (Lot number: FG3527) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; LORATADINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 24Mar2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 03Mar2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 15:30, outcome "unknown", described as "The patient received third dose of vaccine/ booster"; PAIN (non-serious) with onset 03Dec2021 07:00, outcome "recovered" (Dec2021), described as "body aches"; SLUGGISHNESS (non-serious), FATIGUE (non-serious) all with onset 03Dec2021 07:00, outcome "recovered" (Dec2021) and all described as "sluggishness/fatigue (discovered upon waking)"; VACCINATION SITE PAIN (non-serious) with onset 03Dec2021 07:00, outcome "recovered" (Dec2021), described as "Soreness in muscles of left arm"; HEADACHE (non-serious) with onset 03Dec2021 07:00, outcome "recovered" (Dec2021), described as "headache". Therapeutic measures were not taken as a result of pain, sluggishness, fatigue, vaccination site pain, headache.  Additional information-Patient did not receive any other vaccine in four weeks. Patient did not experienced covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: painful lymph node swelling in my left underarm; painful lymph node swelling in my left underarm; pain was radiating yesterday into my left breast as well, causing tenderness too; pain was radiating yesterday into my left breast as well, causing tenderness too; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 16:45 (Lot number: FJ1611) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Peanut allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, administration date 03Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 24Apr2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 02Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021 16:45, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 04Dec2021 17:00, outcome "not recovered" and all described as "painful lymph node swelling in my left underarm"; BREAST PAIN (non-serious), BREAST TENDERNESS (non-serious) all with onset 04Dec2021 17:00, outcome "not recovered" and all described as "pain was radiating yesterday into my left breast as well, causing tenderness too". The events "painful lymph node swelling in my left underarm", "painful lymph node swelling in my left underarm", "pain was radiating yesterday into my left breast as well, causing tenderness too" and "pain was radiating yesterday into my left breast as well, causing tenderness too" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain. Therapeutic measures were not taken as a result of breast pain, breast tenderness.  Additional information: The patient was taking advil and icing the underarm area since Saturday 04Dec2021. It was Monday 06Dec2021 and there was still pain. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient had received prescription birth control within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 Prior to vaccination and since the vaccination, had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Immunisation
Clinical narrative: Fatigue; multiple fevers (102.7F); malaise; headache; loss of appetite; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 15:30 (Lot number: FJ8757) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: tree nuts" (unspecified if ongoing); "known allergies: stinging insects" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose 2, Lot number: EP7533, Previous dose administration date: 09Apr2021, Previous dose vaccine location: Left arm), administration date: 09Apr2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Lot number: ER8727, Previous dose administration date: 19Mar2021, Previous dose vaccine location: Left arm), administration date: 19Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 15:30, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "Fatigue"; PYREXIA (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "multiple fevers (102.7F)"; MALAISE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "malaise"; HEADACHE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "headache"; DECREASED APPETITE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, malaise, headache, decreased appetite.  Additional information: The patient had fatigue, multiple fevers (102.7F), malaise, headache, loss of appetite for duration of 72 hours. The vaccine was administered at public health clinic/veterans administration facility. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Fatigue; multiple fevers (102.7F); malaise; headache; loss of appetite; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Dec2021 15:30 (Lot number: FJ8757) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: tree nuts" (unspecified if ongoing); "known allergies: stinging insects" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose 2, Lot number: EP7533, Previous dose administration date: 09Apr2021, Previous dose vaccine location: Left arm), administration date: 09Apr2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Lot number: ER8727, Previous dose administration date: 19Mar2021, Previous dose vaccine location: Left arm), administration date: 19Mar2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 15:30, outcome "unknown", described as "booster"; FATIGUE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "Fatigue"; PYREXIA (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "multiple fevers (102.7F)"; MALAISE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "malaise"; HEADACHE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "headache"; DECREASED APPETITE (non-serious) with onset 01Dec2021 19:00, outcome "recovered" (Dec2021), described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, malaise, headache, decreased appetite.  Additional information: The patient had fatigue, multiple fevers (102.7F), malaise, headache, loss of appetite for duration of 72 hours. The vaccine was administered at public health clinic/veterans administration facility. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar rise; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar rise". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:patient have blood sugar rise after she had the shots each time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101742491 same vaccine, AE and different patient;US-PFIZER INC-202101742407 same vaccine, AE and different patient;US-PFIZER INC-202101741528 same patient, different dose/AE.;US-PFIZER INC-202101744009 same vaccine, AE and different patient;US-PFIZER INC-202101744010 same vaccine, AE and different patient
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Her daughter developed a redness in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 17 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: I know she had covid , she got covid-19 2 months ago, that's why we waited to get her the shot. The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "Her daughter developed a redness in her arm". Additional information: Her daughter got the pfizer covid 19 vaccine on Monday, and now the redness was going down her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 test
Clinical narrative: I have a mass on the inner arm, about the size of a fist; It's painful and not going away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Feb2021 12:00 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Hip surgery" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Jan2021, when the patient was 75 years old, for COVID-19 Immunization. The following information was reported: AXILLARY MASS (disability, medically significant) with onset 08Feb2021 14:00, outcome "not recovered", described as "I have a mass on the inner arm, about the size of a fist"; PAIN IN EXTREMITY (disability) with onset 08Feb2021 14:00, outcome "not recovered", described as "It's painful and not going away". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (08Feb2021) mass on the inner arm, about the size of a fist; sars-cov-2 test: (30Apr2021) negative. Therapeutic measures were not taken as a result of axillary mass, pain in extremity. The lot number for bnt162b2 was not provided and will be requested during follow up.