chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: fully vaccinated at Pfizer, Covid in August 2021; Side Effects are brutal and worse than Omicron symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart" (unspecified if ongoing), notes: Dx: Heart Dx: COPD, Polio; "COPD" (unspecified if ongoing), notes: Dx: Heart Dx: COPD, Polio; "Polio" (unspecified if ongoing), notes: Dx: Heart Dx: COPD, Polio. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "fully vaccinated at Pfizer, Covid in August 2021"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "Side Effects are brutal and worse than Omicron symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) positive, notes: Positive. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Customer verbatim was Side Effects are brutal and worse than Omicron symptoms.Covid 19+ Fully vaccinated with Pfizer in Jan2021. Pfizer Booster received Sep2021. Covid+ in Aug2021. Received monoclonal antibodies infusion. Covid+ again Jan2022 prescribed the paxlovid. Held statin while taking paxlovid as advised.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Paraesthesia
Clinical narrative: foggy feeling; headaches; Tingling in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: FEELING ABNORMAL (non-serious), outcome "recovered", described as "foggy feeling"; HEADACHE (non-serious), outcome "recovered", described as "headaches"; PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling in hands".  Additional Information: Patient had tingling in hands, headaches, foggy feeling, since taking the booster, It has lasted over a month, Has this occurred before with the booster. Patient had no side effects after the first 2 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Computerised tomogram thorax, Diagnostic aspiration, Lymphadenopathy, Lymphocyte count
Clinical narrative: metastatic melanoma; Acute axillary lymphadenopathy; This is a literature report for the following literature source(s):  A 53 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Family history included: "breast cancer" (unspecified if ongoing), notes: In a Grand parent. The patient's concomitant medications were not reported.  The following information was reported: METASTATIC MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "metastatic melanoma"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Acute axillary lymphadenopathy". The patient underwent the following laboratory tests and procedures: biopsy: atypical intraepidermal melanocytic, notes: proliferations on his right upper extremity and right lower back 1 year prior to presentation; unknown results, notes: Biopsy was performed prior to the 18FFDG PET/CT; computerised tomogram thorax: unremarkable; diagnostic aspiration: consistent with metastatic melanoma, notes: performed less than 2 months after receiving the vaccine, revealed a background of lymphocytes with scattered malignant cells positive for SOX10 and negative for pan-cytokeratin; lymphocyte count: with scattered malignant cells positive for sox10; negative for pan-cytokeratin, consistent with, notes: metastatic melanoma; magnetic resonance imaging head: unremarkable; physical examination: palpable left axillary lymphadenopathy, notes: measuring approximately 5 cm in diameter; positron emission tomogram: demonstrated, notes: intensely avid left axillary and supraclavicular adenopathy without visualization of a primary lesion; skin test: negative for any cutaneous lesions, notes: suspicious for a primary melanoma. Therapeutic measures were taken as a result of metastatic malignant melanoma, lymphadenopathy.  Follow-up activities completed. No further information is expected.  Follow up(02-Feb-2022):This is a literature follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: patients identifiers.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event metastatic melanoma and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Metastatic malignant melanoma, Physical examination, Positron emission tomogram, Skin test
Clinical narrative: metastatic melanoma; Acute axillary lymphadenopathy; This is a literature report for the following literature source(s):  A 53 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Family history included: "breast cancer" (unspecified if ongoing), notes: In a Grand parent. The patient's concomitant medications were not reported.  The following information was reported: METASTATIC MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "metastatic melanoma"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Acute axillary lymphadenopathy". The patient underwent the following laboratory tests and procedures: biopsy: atypical intraepidermal melanocytic, notes: proliferations on his right upper extremity and right lower back 1 year prior to presentation; unknown results, notes: Biopsy was performed prior to the 18FFDG PET/CT; computerised tomogram thorax: unremarkable; diagnostic aspiration: consistent with metastatic melanoma, notes: performed less than 2 months after receiving the vaccine, revealed a background of lymphocytes with scattered malignant cells positive for SOX10 and negative for pan-cytokeratin; lymphocyte count: with scattered malignant cells positive for sox10; negative for pan-cytokeratin, consistent with, notes: metastatic melanoma; magnetic resonance imaging head: unremarkable; physical examination: palpable left axillary lymphadenopathy, notes: measuring approximately 5 cm in diameter; positron emission tomogram: demonstrated, notes: intensely avid left axillary and supraclavicular adenopathy without visualization of a primary lesion; skin test: negative for any cutaneous lesions, notes: suspicious for a primary melanoma. Therapeutic measures were taken as a result of metastatic malignant melanoma, lymphadenopathy.  Follow-up activities completed. No further information is expected.  Follow up(02-Feb-2022):This is a literature follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: patients identifiers.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event metastatic melanoma and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pain
Clinical narrative: Headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): UNT-2022-000931.  A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; treprostinil sodium (TREPROSTINIL SODIUM), first regimen since 09Jul2021 (Lot number: 2102084, Expiration Date: 31Mar2023) at 4x/day (unk, 4x/day [18-72 µg (3-12 breaths), qid, inhalation]) and second regimen (Lot number: 2102100, Expiration Date: 31Mar2023) for pulmonary arterial hypertension. Relevant medical history included: "Pulmonary arterial hypertension" (ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Single; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single; MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "Headache"; PAIN (non-serious), outcome "not recovered", described as "body aches". The action taken for treprostinil sodium was unknown.  Additional information: patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 09Jul2021 for primary pulmonary arterial hypertension. The current dose was reported as 18-72 µg (3-12 breaths), four times a day. On an unreported date, the patient experienced the events of headaches (headache) and body aches (pain). On 12Jan2022, it was reported that the patient had unspecified side effects from the COVID-19 booster. On 18Jan2022, it was reported that she had continued headaches and body aches. Action taken with IH Tyvaso was not reported for the events of headache and pain. At the time of reporting, the outcome of headache and pain was not resolved. The reporter did not provide causality for the events of headache and pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Physical examination
Clinical narrative: felt her heart racing; 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 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Apr2021, outcome "unknown", described as "felt her heart racing". The event "felt her heart racing" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient went to ER in Apr2021 after 1st dose of Pfizer, felt her heart racing, they could not find anything wrong and her 2nd dose she was fine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Eating disorder, Feeling cold, Feeling hot, Headache
Clinical narrative: headache; fever; shakes; feeling cold; They said they woke up in bed and were hot; experienced slight discomfort; due to overeating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: anxiety, others unknown, see previous AE for loose bone in foot/leg; "gastrointestinal issues" (unspecified if ongoing), notes: that in general nerves can manifest via gastrointestinal issues sometimes for her.; "suicidal tendencies." (unspecified if ongoing), notes: anxiety medication that she was on at the time, since it was causing a side effect of suicidal tendencies. The patient's concomitant medications were not reported. Past drug history included: Lavender, others unknown, reaction(s): "Known allergies: lavender", notes: Known allergies: lavender, others unknown. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache"; PYREXIA (non-serious), outcome "recovered", described as "fever"; TREMOR (non-serious), outcome "recovered", described as "shakes"; FEELING COLD (non-serious), outcome "recovered", described as "feeling cold"; FEELING HOT (non-serious), outcome "recovered", described as "They said they woke up in bed and were hot"; DISCOMFORT (non-serious) with onset 26Jan2022, outcome "unknown", described as "experienced slight discomfort"; EATING DISORDER (non-serious) with onset 26Jan2022, outcome "unknown", described as "due to overeating".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: headache; fever; shakes; feeling cold; They said they woke up in bed and were hot; experienced slight discomfort; due to overeating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: anxiety, others unknown, see previous AE for loose bone in foot/leg; "gastrointestinal issues" (unspecified if ongoing), notes: that in general nerves can manifest via gastrointestinal issues sometimes for her.; "suicidal tendencies." (unspecified if ongoing), notes: anxiety medication that she was on at the time, since it was causing a side effect of suicidal tendencies. The patient's concomitant medications were not reported. Past drug history included: Lavender, others unknown, reaction(s): "Known allergies: lavender", notes: Known allergies: lavender, others unknown. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache"; PYREXIA (non-serious), outcome "recovered", described as "fever"; TREMOR (non-serious), outcome "recovered", described as "shakes"; FEELING COLD (non-serious), outcome "recovered", described as "feeling cold"; FEELING HOT (non-serious), outcome "recovered", described as "They said they woke up in bed and were hot"; DISCOMFORT (non-serious) with onset 26Jan2022, outcome "unknown", described as "experienced slight discomfort"; EATING DISORDER (non-serious) with onset 26Jan2022, outcome "unknown", described as "due to overeating".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Slight fever/  I felt like I had a little fever and then I felt okay after about two days and now on day six, I am having a fever; Little fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received BNT162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 15:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing), notes: Verbatim: Gout. Concomitant medication(s) included: COLCHICINE taken for gout; ALLOPURINOL taken for gout. The following information was reported: PYREXIA (non-serious) with onset 10Jan2022, outcome "unknown", described as "Slight fever/  I felt like I had a little fever and then I felt okay after about two days and now on day six, I am having a fever "; FATIGUE (non-serious) with onset 10Jan2022, outcome "unknown", described as "Little fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, fatigue.  Additional Information: The patient received his first dose on Monday and this morning he woke up with a fever. When he first had the shot, that day he had little fatigue and he felt like he ha a litter fever and then he felt okay after about two days and now on day six, he is having a fever again. The consumer had taken some Tylenol this morning (16Jan2022) and Dicam as treatment. The patient did not have any prior vaccination within 4 weeks.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: everything started back up again with my hip pain and I had, it hurts me to like sit down/ Joint pain/ they got worse again; It hurts me to like sit down; It hurts me to sit or lay down like, it depends on the height of the seat. Like when I get up it''s really painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received BNT162b2 (BNT162B2), administered in arm, administration date 16Aug2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I did have covid previously like last March", start date: Mar2021 (unspecified if ongoing); "hip pain and joint pain" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), administration date: Aug2021, when the patient was 43 years,  for COVID-19 immunization, reaction(s): "I had bunch of hip pain from that and joint pain". The following information was reported: ARTHRALGIA (non-serious) with onset 23Aug2021, outcome "unknown", described as "everything started back up again with my hip pain and I had, it hurts me to like sit down/ Joint pain/ they got worse again"; PAIN (non-serious) with onset 23Aug2021, outcome "not recovered", described as "It hurts me to like sit down; It hurts me to sit or lay down like, it depends on the height of the seat. Like when I get up it''s really painful". Therapeutic measures were not taken as a result of arthralgia, pain.  Additional Information: The patient did not have prior vaccinations within 4 weeks.  The patient stated that she didn't have the events before she had covid and then the events got better and then she got the vaccine and then the event got worse again. The first dose was two weeks before second dose. The side effects started right after a week the patient got the vaccine. The outcome for "hip pain" and "It hurts me to like sit down; It hurts me to sit or lay down like, it depends on the height of the seat. Like when I get up it's really painful" was not recovered and the outcome for "joint pain" was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: right eye was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A 9 year-old female patient received BNT162b2 (BNT162B2), administration date 15Jan2022 (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: EYE SWELLING (non-serious) with onset 16Jan2022, outcome "unknown", described as "right eye was swollen". The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Muscle twitching, Paraesthesia, Small fibre neuropathy
Clinical narrative: peripheral nerve issues/permanent small fiber neuropathy; nerve tingling; muscle twitches; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported:  The patient stated that he/she acquired significant peripheral nerve issues approximately 2 weeks after receiving the second Pfizer COVID vaccination shot. After many months of testing and analysis of symptoms, the patient's neurologist has determined that he/she has permanent small fiber neuropathy that will result in experiencing constant nerve tingling and muscle twitches for the rest of his/her life. All events were not recovered and all events were evaluated at the physician office visit.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: pityriasis rosacea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28Dec2021 (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; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: PITYRIASIS ROSEA (non-serious), outcome "unknown", described as "pityriasis rosacea".  Additional information: After receiving booster shot on 28Dec patient developed pityriasis rosacea and was seen by patient primary care physician he feels like this is a reaction from the booster shot that patient received just inquiring if this was something that has been common with the third shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Eye pain, Headache
Clinical narrative: Pain in both eyes; Headache; Tapping pressure in his ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A child male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE PAIN (non-serious), outcome "unknown", described as "Pain in both eyes"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; EAR DISCOMFORT (non-serious), outcome "unknown", described as "Tapping pressure in his ears". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: both thumbs went numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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: HYPOAESTHESIA (non-serious), outcome "recovered", described as "both thumbs went numb".  Additional Information: The reporter (wife) stated that both thumbs went numb immediately after first dose and after a few hours resolved.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Pain, Pruritus
Clinical narrative: tiny red itchy spots on my abdomen; tiny red itchy spots on my abdomen; low grade fever; body aches; chills; fatigue; cause discomfort for 4 months all over my body.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [08Feb2022], this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 10:00 (Lot number: ER8727) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPROL XL. Vaccination history included: Bnt162b2 (dose 1, single. Batch/Lot No: EN6203, Location of injection: Arm Right, Time (24 hrs): AM), administration date: 02Mar2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: RASH MACULAR (disability), PRURITUS (disability) all with onset 30Mar2021, outcome "recovered" (Jul2021) and all described as "tiny red itchy spots on my abdomen"; PYREXIA (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "low grade fever"; PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "body aches"; CHILLS (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "chills"; FATIGUE (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "fatigue"; DISCOMFORT (non-serious) with onset 30Mar2021, outcome "not recovered", described as "cause discomfort for 4 months all over my body.". The events "tiny red itchy spots on my abdomen", "tiny red itchy spots on my abdomen" and "cause discomfort for 4 months all over my body." were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash macular, pruritus, chills; patient was prescribed with steroid cream, Clobetasol cream. Clinical course: Initial experience after shot was low grade fever, chills, body aches along with fatigue which lasted 3 days.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular
Clinical narrative: tiny red itchy spots on my abdomen; tiny red itchy spots on my abdomen; low grade fever; body aches; chills; fatigue; cause discomfort for 4 months all over my body.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [08Feb2022], this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 10:00 (Lot number: ER8727) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPROL XL. Vaccination history included: Bnt162b2 (dose 1, single. Batch/Lot No: EN6203, Location of injection: Arm Right, Time (24 hrs): AM), administration date: 02Mar2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: RASH MACULAR (disability), PRURITUS (disability) all with onset 30Mar2021, outcome "recovered" (Jul2021) and all described as "tiny red itchy spots on my abdomen"; PYREXIA (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "low grade fever"; PAIN (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "body aches"; CHILLS (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "chills"; FATIGUE (non-serious) with onset 30Mar2021, outcome "recovered" (02Apr2021), described as "fatigue"; DISCOMFORT (non-serious) with onset 30Mar2021, outcome "not recovered", described as "cause discomfort for 4 months all over my body.". The events "tiny red itchy spots on my abdomen", "tiny red itchy spots on my abdomen" and "cause discomfort for 4 months all over my body." were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash macular, pruritus, chills; patient was prescribed with steroid cream, Clobetasol cream. Clinical course: Initial experience after shot was low grade fever, chills, body aches along with fatigue which lasted 3 days.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "Penicillian allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; VIT B12 [CYANOCOBALAMIN]; CITALOPRAM; LOSARTAN POTASSIUM. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "tired".  Additional Information: It was reported that the patient was tired for a few hours 24 hours after vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion
Clinical narrative: excessive salivation; 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 5 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date 08Jan2022 (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: SALIVARY HYPERSECRETION (non-serious) with onset 09Jan2022, outcome "unknown", described as "excessive salivation".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Worn out; achy all over; This is a spontaneous report received from a contactable nurse. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but unknown Manufacturer), for Covid-19 immunization, on unspecified dates.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Worn out"; PAIN (non-serious), outcome "unknown", described as "achy all over".  Additional information: Additional Context: patient  got her adult Pfizer BioNtech COVID booster shot. The next day, she was worn out and achy all over. She knew that could happen, and it did.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Nasal congestion, Seasonal allergy
Clinical narrative: seasonal allergies; congestion; headache; earache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 13Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, She did not presented any side effects after the 1st and 2nd shots.), for COVID-19 immunization, reaction(s): "did not presented any side effects"; Bnt162b2 (DOSE 2, SINGLE, She did not presented any side effects after the 1st and 2nd shots.), for COVID-19 immunization, reaction(s): "did not presented any side effects". The following information was reported: SEASONAL ALLERGY (non-serious) with onset Jan2022, outcome "unknown", described as "seasonal allergies"; NASAL CONGESTION (non-serious) with onset Jan2022, outcome "unknown", described as "congestion"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; EAR PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "earache".  Additional information: The caller indicates that she was took the 1st, 2nd and booster shots from pfizer (covid19 vaccine). She did not presented any side effects after the 1st and 2nd shots. but she was presenting some symptoms and she wants to know if they were related to the booster shoot, or some seasonal allergies. She received the booster shoot last Thursday (1 week from now). She was presenting congestion, headache, earache. I spoke to the pharmacist and he was told me that there was a lot of issues related to the weather, i don't know if it was allergy related or vaccinated related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Experienced chest pains after receiving a Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adolescent female patient received COVID-19 Vaccine - Manufacturer Unknown, (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: CHEST PAIN (non-serious), outcome "unknown", described as "Experienced chest pains after receiving a Covid vaccine". The event "experienced chest pains after receiving a covid vaccine" was evaluated at the physician office visit. Additional Information: It was reported as patient was 16-17 years, experienced chest pains after receiving a COVID vaccine at a local retail pharmacy. Patient was following up with her Paediatrician (withheld) to be cleared to continue basketball. (withheld) does not know which manufacturer of the COVID vaccine she received or if it was her first or second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Immunisation, Neuralgia, Paraesthesia
Clinical narrative: Third dose/booster dose; some nerving sensations (tingling) all over my body.; flushing; Face got itchy, flushed, red; Face got itchy, flushed, red; Face got itchy, flushed, red; tongue got very, very dry; Felt little pricks of nerve endings all over her body, in different parts of her body; This is a spontaneous report received from contactable reporter.   The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200133585.  A 69 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administration date 12Nov2021 (Lot number: FH8028) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EN6201), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, provided as either EV6207, EU6207 or EN6207-this is handwritten on the vaccine record card.), administration date: 19Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Third dose/booster dose"; PARAESTHESIA (non-serious), outcome "unknown", described as "some nerving sensations (tingling) all over my body."; FLUSHING (non-serious), outcome "unknown", described as "flushing"; PRURITUS (non-serious) with onset 12Nov2021, outcome "unknown", FLUSHING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "recovering" and all described as "Face got itchy, flushed, red"; TONGUE DRY (non-serious) with onset 12Nov2021, outcome "unknown", described as "tongue got very, very dry"; NEURALGIA (non-serious) with onset 12Nov2021, outcome "not recovered", described as "Felt little pricks of nerve endings all over her body, in different parts of her body". Therapeutic measures were taken as a result of paraesthesia, flushing, pruritus, flushing.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tongue dry
Clinical narrative: Third dose/booster dose; some nerving sensations (tingling) all over my body.; flushing; Face got itchy, flushed, red; Face got itchy, flushed, red; Face got itchy, flushed, red; tongue got very, very dry; Felt little pricks of nerve endings all over her body, in different parts of her body; This is a spontaneous report received from contactable reporter.   The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200133585.  A 69 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administration date 12Nov2021 (Lot number: FH8028) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EN6201), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, provided as either EV6207, EU6207 or EN6207-this is handwritten on the vaccine record card.), administration date: 19Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Third dose/booster dose"; PARAESTHESIA (non-serious), outcome "unknown", described as "some nerving sensations (tingling) all over my body."; FLUSHING (non-serious), outcome "unknown", described as "flushing"; PRURITUS (non-serious) with onset 12Nov2021, outcome "unknown", FLUSHING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "recovering" and all described as "Face got itchy, flushed, red"; TONGUE DRY (non-serious) with onset 12Nov2021, outcome "unknown", described as "tongue got very, very dry"; NEURALGIA (non-serious) with onset 12Nov2021, outcome "not recovered", described as "Felt little pricks of nerve endings all over her body, in different parts of her body". Therapeutic measures were taken as a result of paraesthesia, flushing, pruritus, flushing.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Nausea, Uterine spasm
Clinical narrative: Abnormal uterine cramps; nausea; confusion; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jan2022 15:45 (Batch/Lot number: unknown) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing), notes: other medical history: Celiac, CPTSD; "CPTSD" (unspecified if ongoing), notes: other medical history: Celiac, CPTSD. There were no concomitant medications. Past drug history included: Gluten, reaction(s): "Allergy", notes: known allergies: Gluten. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Phizer , prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Unable to locate or read the details, prev dose administration date=20Apr2021 , prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 20Apr2021, when the patient was 19 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Phizer , prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Unable to locate or read the details, prev dose dose number=1), for Covid-19 Immunization. The following information was reported: UTERINE SPASM (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "Abnormal uterine cramps"; NAUSEA (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "nausea"; CONFUSIONAL STATE (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "confusion"; DIZZINESS (non-serious) with onset 24Jan2022 02:00, outcome "not recovered", described as "dizziness". Therapeutic measures were not taken as a result of uterine spasm, nausea, confusional state, dizziness.  Additional information: Patient reported facility type where the vaccine administered was Pharmacy or Drug Store. No other vaccine received in four weeks of prior to the vaccination. No other medications taken in two weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have been having headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (051529).  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "I have been having headaches".  Additional information: Patient reported "I have been having headaches." She also reported that she has not taken the medication for about 3 weeks now. This is because she received her COVID-19 booster just over 3 weeks ago and the doctor told her to not take her Xeljanz for about 3 weeks after receiving her booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Thyroiditis
Clinical narrative: thyroiditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROIDITIS (non-serious), outcome "unknown", described as "thyroiditis".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Paraesthesia, Pyrexia, Swelling, Vaccination site swelling
Clinical narrative: underarm feeling like swelling; underarm feeling like Hurt; Tingle; have little fever; swollen at injection, the place that they put the injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 (1st dose), for Covid-19 immunization; Bnt162b2 (2nd dose), for Covid-19 immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "underarm feeling like swelling"; AXILLARY PAIN (non-serious), outcome "unknown", described as "underarm feeling like Hurt"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingle"; PYREXIA (non-serious), outcome "unknown", described as "have little fever"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swollen at injection, the place that they put the injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Onset of tinnitus in right ear.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 (Lot number: FF2589) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE BESILATE; LEVOTHYROXINE; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 80 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Left), administration date: 27Jan2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Sep2021, outcome "not recovered", described as "Onset of tinnitus in right ear. "Therapeutic measures were not taken as a result of tinnitus. Additional Information:The patient did not receive any other vaccine in four-week prior vaccination. The patient did not tested positive prior vaccination. The patient did not tested positive post vaccination. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.