chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone increased, Eczema, Pruritus, Thyroid hormones increased
Clinical narrative: eczema deteriorated/his excema began to get worse after the first shot; itch; thyroid levels have increased; he also developed thyroid whereby his Tsh levels shot up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "eczema deteriorated/his excema began to get worse after the first shot"; PRURITUS (non-serious), outcome "unknown", described as "itch"; THYROID HORMONES INCREASED (non-serious), outcome "unknown", described as "thyroid levels have increased"; BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "he also developed thyroid whereby his Tsh levels shot up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of thyroid hormones increased, blood thyroid stimulating hormone increased.  Additional Information: My son, 14 years old, eczema deteriorated, and he also developed thyroid whereby his Tsh levels shot up after taking both the Pfizer COVID shots. Have you received similar feedback from other parents whose children's have taken these shots. Successful outbound callback made at 3:47 PM on 14Feb2022. Caller also reports that his excema began to get worse after the first shot. The urge to itch has increased specially between the hours of 2AM - 5AM, prior to vaccination he was sleeping well at night. His thyroid levels have increased. Caller also reports patient takes thyroid medication.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Echocardiogram, Fatigue, Flushing, Magnetic resonance imaging
Clinical narrative: Fatigue; migraines; vomiting; flushed cheeks; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Nov2021 10:00 (Lot number: Fl0007) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Macrophage Activation Syndrome both in remission" (unspecified if ongoing), notes: Verbatim:Macrophage Activation Syndrome both in remission; "Known allergies: contrast" (unspecified if ongoing), notes: Verbatim: Known allergies: contrast; "Known allergies: adhesives" (unspecified if ongoing), notes: Verbatim:Known allergies: adhesives; "Known allergies: Possible wheat allergy" (unspecified if ongoing), notes: Verbatim:Possible wheat allergy; "Known allergy-NSAIDs" (unspecified if ongoing), notes: Known allergy-NSAIDs; "Systemic Jia" (unspecified if ongoing), notes: Verbatim:Systemic Jia , She is in remission from Systemic Jia for 1 year 7 months. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "Fatigue"; MIGRAINE (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "migraines"; VOMITING (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "vomiting"; FLUSHING (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "flushed cheeks". The events "fatigue", "migraines", "vomiting" and "flushed cheeks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, migraine, vomiting, flushing.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Pretreating with Zyrtec for possible reactions. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: Fatigue; migraines; vomiting; flushed cheeks; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Nov2021 10:00 (Lot number: Fl0007) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Macrophage Activation Syndrome both in remission" (unspecified if ongoing), notes: Verbatim:Macrophage Activation Syndrome both in remission; "Known allergies: contrast" (unspecified if ongoing), notes: Verbatim: Known allergies: contrast; "Known allergies: adhesives" (unspecified if ongoing), notes: Verbatim:Known allergies: adhesives; "Known allergies: Possible wheat allergy" (unspecified if ongoing), notes: Verbatim:Possible wheat allergy; "Known allergy-NSAIDs" (unspecified if ongoing), notes: Known allergy-NSAIDs; "Systemic Jia" (unspecified if ongoing), notes: Verbatim:Systemic Jia , She is in remission from Systemic Jia for 1 year 7 months. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "Fatigue"; MIGRAINE (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "migraines"; VOMITING (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "vomiting"; FLUSHING (non-serious) with onset 08Nov2021 07:00, outcome "recovering", described as "flushed cheeks". The events "fatigue", "migraines", "vomiting" and "flushed cheeks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, migraine, vomiting, flushing.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Pretreating with Zyrtec for possible reactions. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Memory impairment, SARS-CoV-2 test
Clinical narrative: My face went numb for about 30 minutes with slight dyspnea; My face went numb for about 30 minutes with slight dyspnea; difficulty focusing and remembering stuff; Been having headaches daily ever since booster; difficulty focusing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 (Lot number: FK9729) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "s/p lap cholecystectomy more than 5 years ago" (unspecified if ongoing), notes: s/p lap cholecystectomy more than 5 years ago; "Spinach" (unspecified if ongoing), notes: known allergies: Spinach; "some type of alcoholic beverages" (unspecified if ongoing), notes: known allergies: Some type of alcoholic beverages. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 32 years old, for Covid-19 Immunization, reaction(s): "My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses", "slight dyspnea"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 32 years old, for Covid-19 Immunization, reaction(s): "My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses", "slight dyspnea". The following information was reported: HYPOAESTHESIA (non-serious), DYSPNOEA (non-serious), outcome "recovered with sequelae" and all described as "My face went numb for about 30 minutes with slight dyspnea"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "recovered with sequelae", described as "difficulty focusing and remembering stuff"; HEADACHE (non-serious) with onset 2022, outcome "recovered with sequelae", described as "Been having headaches daily ever since booster"; VISION BLURRED (non-serious) with onset 2022, outcome "recovered with sequelae", described as "difficulty focusing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, memory impairment, headache, vision blurred, dyspnoea.  Additional Information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: My face went numb for about 30 minutes with slight dyspnea; My face went numb for about 30 minutes with slight dyspnea; difficulty focusing and remembering stuff; Been having headaches daily ever since booster; difficulty focusing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 (Lot number: FK9729) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "s/p lap cholecystectomy more than 5 years ago" (unspecified if ongoing), notes: s/p lap cholecystectomy more than 5 years ago; "Spinach" (unspecified if ongoing), notes: known allergies: Spinach; "some type of alcoholic beverages" (unspecified if ongoing), notes: known allergies: Some type of alcoholic beverages. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 32 years old, for Covid-19 Immunization, reaction(s): "My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses", "slight dyspnea"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 32 years old, for Covid-19 Immunization, reaction(s): "My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses", "slight dyspnea". The following information was reported: HYPOAESTHESIA (non-serious), DYSPNOEA (non-serious), outcome "recovered with sequelae" and all described as "My face went numb for about 30 minutes with slight dyspnea"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "recovered with sequelae", described as "difficulty focusing and remembering stuff"; HEADACHE (non-serious) with onset 2022, outcome "recovered with sequelae", described as "Been having headaches daily ever since booster"; VISION BLURRED (non-serious) with onset 2022, outcome "recovered with sequelae", described as "difficulty focusing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, memory impairment, headache, vision blurred, dyspnoea.  Additional Information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Hiccups, SARS-CoV-2 test, Somnolence
Clinical narrative: Slept a lot; Tired; Some coughing; Hiccups; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Oct2021 10:00 (Lot number: FC3184) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Time(24hr): 10, Site and route of injection: , Anatomical site if injection: Upper Right arm, Route of administration: Intramuscular, Batch/Lot number: EM9809), administration date: 13Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose: 02, Time(24hr): 14, Site and route of injection: , Anatomical site if injection: Upper Right arm, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 06Mar2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "developed Hiccups".  The following information was reported: HICCUPS (non-serious) with onset 2021, outcome "recovered" (08Feb2022), described as "Hiccups"; FATIGUE (non-serious) with onset 04Feb2022, outcome "unknown", described as "Tired"; COUGH (non-serious) with onset 04Feb2022, outcome "unknown", described as "Some coughing"; SOMNOLENCE (non-serious) with onset 05Feb2022, outcome "unknown", described as "Slept a lot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Anatomical site of injection for 3rd dose was upper arm right. Patient had no prior vaccinations (within 4 weeks). Patient had no medical history. On Fri 04Feb2022, Patient had symptoms of covid [Fatigue, cough, congestion, hiccups(!)]. on sat 05Feb2022 patient was tested + using a OTC test [Binax now]. Sat and sun the symptoms wear at their worst, but patient never had shortness of breath, or a fever. By Tuesday patient was almost fully recovered. With vaccine #2 and booster (#3)- patient developed hiccups that lasted over 2hrs at a time- gone the next a day. With my current covid infection- hiccups started on FRI. By sat and sunday (05Feb2022 and 06Feb2022) they could last 5 to 6 hours. But they tapered out on mon (07Feb2022) and were gone by Tuesday. Patient was started tested + [health] for covid on wed 09Feb2022.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: Pain in my head; Extremely sick; 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 left, administration date 21May2021 12:00 (Lot number: EW0182) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "pneumonia", start date: 29Jan2021 (unspecified if ongoing), notes: had pneumonia was in hospital for 1 ½ days. The patient's concomitant medications were not reported. Past drug history included: Tylenol, start date: 18Apr2021, stop date: 18Apr2021, for To Prepare for Pain. Vaccination history included: Bnt162b2 (Dose1, Time: 1:00 pm, Anatomical site of injection: Left arm, Lot number: EW0153, I was extremely sick for 3 days after 1st dose), administration date: 18Apr2021, for COVID-19 immunization, reaction(s): "I was extremely sick for 3 days after 1st dose", "flu like symptoms could not lift head or move just slept.", "flu like symptoms could not lift head or move just slept.". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Pain in my head"; ILLNESS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "Extremely sick".  Additional information: Prior Vaccinations (Within 4 weeks): None. Patient was extremely sick for 3 days after 1st dose and 4 days after 2nd dose. The first dose flue like symptoms could not lift head or move just slept. Second dose much more severe it was like pin ball machine of pain in my head. I never had pain like that due to adverse reactions after both doses I have opted not of the booster. I regret ever having the vaccine as I feel this may shot my life span.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (173415). A 27-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), May 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had pain in extremity (arm soreness for a couple hours), onset 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2021 (Lot number: EM9809) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Auto immune" (unspecified if ongoing); "Convulsions many years ago" (unspecified if ongoing). Concomitant medication(s) included: PHENYTOIN taken for seizure, start date: 1970 (ongoing); DILANTIN taken for seizure, start date: 1970 (ongoing); VIT D; VIT E; FOLIC ACID; PRESERVISION; CRANBERRY. Vaccination history included: Bnt162b2 (Lot/Batch number: EL8982, Route of administration: Intramuscular, Time (24hr): PM, Anatomical location: Left arm, Dose no: 1), administration date: 21Jan2021, when the patient was 74 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itchy".  Comments/Narrative: Relevant test was none. Specific relevant test for thromboembolic events with thrombocytopenia was none About a month after second shot, patient experienced outing a rash. They itchy like crazy- feels like a red ant stinging. None had ever going away- just get more, That pop up like a little purple. And then looked like large ringworm. Absolutely horrible- I had a case of covid prior to my shots and it were nothing but a runny nose, I have them everywhere but on my face I cannot find a thing that helps! It is measurable.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced alopecia (a patient who also experienced hair loss after being vaccinated), with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses; Dyspnoea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 (Lot number: FK9729) at the age of 33 years as dose 3 (booster), single, administered in arm left, administration date 03Mar2021 (Lot number: EN6201) as dose 2, single and administered in arm left, administration date 10Feb2021 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lap cholecystectomy" (unspecified if ongoing), notes: s/p lap cholecystectomy more than 5 years ago; "Known allergy: Spinach" (unspecified if ongoing), notes: Known allergy: Spinach; "Known allergy: some type of alcoholic beverages" (unspecified if ongoing), notes: Known allergy: some type of alcoholic beverages. The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "recovered with sequelae", described as "My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses"; DYSPNOEA (non-serious), outcome "unknown", described as "Dyspnoea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses. Been having headaches daily ever since booster with difficulty focusing and remembering stuff. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Rash, Skin burning sensation
Clinical narrative: dizziness; Rash on body; burning sensation on skin; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 06Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; RASH (non-serious), outcome "unknown", described as "Rash on body"; SKIN BURNING SENSATION (non-serious), outcome "unknown", described as "burning sensation on skin".  Additional information: Patient received first dose Pfizer Covid vaccine on 06Jan2021. States he developed an allergic reaction so he could not qualify for 2nd dose. States he developed a rash on body; burning sensation on skin, and dizziness; he stayed at home for 4-5 days. He did not see his hcp at the time but informed his hcp later on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Condition aggravated
Clinical narrative: since the administration of the second dose she's been having worsening memory loss issues; really progressing badly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: she thinks the patient has a little anxiety but it is nothing that was diagnosed medically with depression.; "Fibromyalgia" (ongoing), notes: This was diagnosed probably prior to the Pfizer COVID vaccine. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prior Vaccinations (within 4 weeks): None other than 1st dose Pfizer COVID vaccine administered Feb2021.), administration date: Feb2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: AMNESIA (non-serious), outcome "not recovered", described as "since the administration of the second dose she's been having worsening memory loss issues"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "really progressing badly".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Underweight, Weight decreased
Clinical narrative: nausea; lost weight, and is now underweight; lost weight, and is now underweight; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 24 years as dose 2, single and administration date May2021 (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: NAUSEA (non-serious), outcome "unknown", described as "nausea"; WEIGHT DECREASED (non-serious), UNDERWEIGHT (non-serious), outcome "unknown" and all described as "lost weight, and is now underweight".  Additional information: The reporter was asking about the booster dose of the vaccine for her 24 year old daughter. She asked if it is the same as the first 2 doses. She mentioned that her daughter experienced nausea after the first 2 doses, which she received in May2022. She also states that her daughter lost weight, and is now underweight, but unsure if she attributed that to the vaccine. The reporter asked that how long the vaccine protects people? She asked whether or not her daughter should get the booster dose due to her weight being so low, whether or not that was safe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Headache, Illness, Nausea
Clinical narrative: Vivid dreams; Pain on her right head; Nausea; She got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "She got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "Vivid dreams"; HEADACHE (non-serious), outcome "unknown", described as "Pain on her right head"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional Information: Reporter mentioned that she was sick for over a month now after getting the booster and she got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine. She also experienced vivid dreams, pain on her right head and nausea over and over.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She was sick for over a month now after getting the booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (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), for COVID-19 immunization, reaction(s): "vivid dreams", "pain on her right head", "she got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine", "nausea"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "vivid dreams", "pain on her right head", "she got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine", "nausea". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She was sick for over a month now after getting the booster".  Additional Information: It was reported that the patient was sick for over a month now after getting the booster and she got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine. She also experienced vivid dreams, pain on her right head and nausea over and over.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: tired; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Heart rate irregular, Peripheral swelling, X-ray
Clinical narrative: hands swelled up; had a arthritis left over in my middle finger; heart irregularities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 years as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "hands swelled up"; ARTHRITIS (non-serious), outcome "unknown", described as "had a arthritis left over in my middle finger"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "heart irregularities". The event "had a arthritis left over in my middle finger" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that his hands swelled up for 3 months as soon as he got the first shot and when it went down, he had a arthritis left over in his middle finger. No prior vaccinations to COVID vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal disorder, Anxiety, Depression, Hot flush
Clinical narrative: Debilitating anxiety; I am the point now where I cant even work because I have the debilitating anxiety; I was healthy before this; Adrenal flushes and stuff like that but it is debilitating; I can barely do anything anymore because of this; anxiety and depression out of nowhere; I started getting these ''flashes'', like adrenaline ''dumps''; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 (Lot number: 301458A) at the age of 48 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: ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Debilitating anxiety; I am the point now where I cant even work because I have the debilitating anxiety; I was healthy before this"; ADRENAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Adrenal flushes and stuff like that but it is debilitating; I can barely do anything anymore because of this"; DEPRESSION (non-serious) with onset 2021, outcome "unknown", described as "anxiety and depression out of nowhere"; HOT FLUSH (non-serious) with onset 2021, outcome "unknown", described as "I started getting these ''flashes'', like adrenaline ''dumps''".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: slightly sore arm/had the same problems with different symptom; they were so chilled, and under the covers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slightly sore arm/had the same problems with different symptom"; CHILLS (non-serious), outcome "unknown", described as "they were so chilled, and under the covers".  Additional Information: Reporter seriousness for slightly sore arm, felt so depleted she couldn't get out of bed and they were so chilled, and under the covers was unspecified. She got the first shot of the Pfizer-BioNTech COVID-19 vaccine she didn't have a problem except for a slightly sore arm. Agent reports caller said after the booster dose she felt so depleted she couldn't get out of bed, and mentioned that she was immunocompromised so she will need to get a fourth vaccine, but she hasn't gotten that. After the first dose, she would turn over in bed and think she shouldn't have, it was mild, and when she woke up the next day it was gone, it was not a big deal. She says this happened both times, with her first and second dose, and no treatment was needed, it was a mild inconvenience. she was depleted after her booster dose and had to drag herself out of bed the next day. She says she knows someone who also had no problems with the first two doses, and then the booster put her away.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Speech disorder
Clinical narrative: It started to affect my speech. It is slowing down. It is quite involved; Mobility problem; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MOBILITY DECREASED (non-serious) with onset 2022, outcome "unknown", described as "Mobility problem"; SPEECH DISORDER (non-serious), outcome "unknown", described as "It started to affect my speech. It is slowing down. It is quite involved". The events "mobility problem" and "it started to affect my speech. it is slowing down. it is quite involved" were evaluated at the physician office visit.  Additional information: The patient did not like what has happened to her. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Fatigue, Insomnia, Ocular hyperaemia
Clinical narrative: Fatigue; she has had a rash down there, has a red belly; skin feel achy; Can't sleep good; Lower back is killing her; Can't sit still; anxious; eyes have become weird; really red in the corners and foggy; eyes have become weird; really red in the corners and foggy; Rash down there where you go pee and poop; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 12Sep2021 (Lot number: 1113687) as dose 1, single and administered in arm right, administration date 03Oct2021 (Lot number: 1117702) as dose 2, single for covid-19 immunisation. Relevant medical history included: "celiac" (unspecified if ongoing), notes: celiac; "gluten free" (unspecified if ongoing), notes: gluten free; "allergic to soy" (unspecified if ongoing), notes: allergic to soy, she tried soy and it gave her eczema on her leg; "allergic to soy and diary" (unspecified if ongoing), notes: allergic to soy and diary; "eczema on her leg" (unspecified if ongoing), notes: eczema on her leg. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "she has had a rash down there, has a red belly"; PAIN OF SKIN (non-serious), outcome "unknown", described as "skin feel achy"; INSOMNIA (non-serious), outcome "unknown", described as "Can't sleep good"; BACK PAIN (non-serious), outcome "unknown", described as "Lower back is killing her"; SITTING DISABILITY (non-serious), outcome "unknown", described as "Can't sit still"; ANXIETY (non-serious), outcome "unknown", described as "anxious"; OCULAR HYPERAEMIA (non-serious), VISION BLURRED (non-serious), outcome "unknown" and all described as "eyes have become weird; really red in the corners and foggy"; RASH (non-serious), outcome "unknown", described as "Rash down there where you go pee and poop". The event "rash down there where you go pee and poop" was evaluated at the physician office visit. Additional information: After getting the two shots of vaccine patient really doesn't want another shot. She really didn't want to get the shots at all, but her husband works at the hospital and he convinced her to get it. She is so tired she can't stand. It's changed her life and she is not happy. The time of vaccination given was around noon. No additional Vaccines administered on same date of the Pfizer Suspect. Adverse effects did not require a visit to emergency room. She visited physician office for a couple of times and is going in Mar2022. No prior vaccinations within 4 weeks prior to Covid vaccine. No adverse events reported following prior vaccinations. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Rash, Rash erythematous, Sitting disability, Vision blurred
Clinical narrative: Fatigue; she has had a rash down there, has a red belly; skin feel achy; Can't sleep good; Lower back is killing her; Can't sit still; anxious; eyes have become weird; really red in the corners and foggy; eyes have become weird; really red in the corners and foggy; Rash down there where you go pee and poop; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 12Sep2021 (Lot number: 1113687) as dose 1, single and administered in arm right, administration date 03Oct2021 (Lot number: 1117702) as dose 2, single for covid-19 immunisation. Relevant medical history included: "celiac" (unspecified if ongoing), notes: celiac; "gluten free" (unspecified if ongoing), notes: gluten free; "allergic to soy" (unspecified if ongoing), notes: allergic to soy, she tried soy and it gave her eczema on her leg; "allergic to soy and diary" (unspecified if ongoing), notes: allergic to soy and diary; "eczema on her leg" (unspecified if ongoing), notes: eczema on her leg. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "she has had a rash down there, has a red belly"; PAIN OF SKIN (non-serious), outcome "unknown", described as "skin feel achy"; INSOMNIA (non-serious), outcome "unknown", described as "Can't sleep good"; BACK PAIN (non-serious), outcome "unknown", described as "Lower back is killing her"; SITTING DISABILITY (non-serious), outcome "unknown", described as "Can't sit still"; ANXIETY (non-serious), outcome "unknown", described as "anxious"; OCULAR HYPERAEMIA (non-serious), VISION BLURRED (non-serious), outcome "unknown" and all described as "eyes have become weird; really red in the corners and foggy"; RASH (non-serious), outcome "unknown", described as "Rash down there where you go pee and poop". The event "rash down there where you go pee and poop" was evaluated at the physician office visit. Additional information: After getting the two shots of vaccine patient really doesn't want another shot. She really didn't want to get the shots at all, but her husband works at the hospital and he convinced her to get it. She is so tired she can't stand. It's changed her life and she is not happy. The time of vaccination given was around noon. No additional Vaccines administered on same date of the Pfizer Suspect. Adverse effects did not require a visit to emergency room. She visited physician office for a couple of times and is going in Mar2022. No prior vaccinations within 4 weeks prior to Covid vaccine. No adverse events reported following prior vaccinations. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: I only had a slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EP7533) at the age of 48 years as dose 2, single and administered in arm left, administration date Apr2021 (Lot number: ER8736) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Car accident in year 2008 that caused concussion and titanium pin in left shoulder near injection site.", start date: 2008 (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "titanium pin in left shoulder near injection site" (unspecified if ongoing), notes: due to a car accident about 10 years ago. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I only had a slight fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient only had a slight fever as a response and no serious side effects or mental diminution.  Follow-up (22Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Infection, Lymphadenopathy
Clinical narrative: Tiredness; Headache; Muscle ache at the infection area -right upper arm; Pain in the right armpit; Muscle ache at the infection area -right upper arm; sore arm; Lymph node in the right armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 17Feb2022 17:45 (Lot number: FJ6369) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 2, Lot number: EL3247, Administration time: 10:00 AM , Dose vaccine location: Left arm), administration date: 22Mar2021, when the patient was 52 years old, for Covid-19 immunization; Comirnaty (Dose 1, Lot number: EL3247, Administration time: 09:30 AM , Dose vaccine location: Left arm), administration date: 01Mar2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Tiredness"; HEADACHE (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious), INFECTION (non-serious) all with onset 18Feb2022 06:00, outcome "not recovered" and all described as "Muscle ache at the infection area -right upper arm"; AXILLARY PAIN (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Pain in the right armpit"; LYMPHADENOPATHY (non-serious) with onset 18Feb2022, outcome "not recovered", described as "Lymph node in the right armpit"; PAIN IN EXTREMITY (non-serious) with onset 18Feb2022 06:00, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, axillary pain, lymphadenopathy, infection.  Additional information: The patient had not received any other vaccine in 4 weeks. The patient had not other medications in 2 weeks. Patient had not covid prior vaccination and had not covid tested post vaccination. Patient had received the booster on (thursday) 17Feb around 17:45, and and events occurred was (friday) 18Feb. In early morning, around 6:00AM patient was experienced headache, sore arm etc. The lymph nodes part was a bit later during the day.  Follow-up attempts are completed. No further information is expected.