chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the Covid 19 virus after taken the second doze of the vaccine; tested positive for the Covid 19 virus after taken the second doze of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for the Covid 19 virus after taken the second doze of the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical information: Reporter also wanted to let know that reporter's son tested positive for the Covid 19 virus after taken the second doze of the vaccine and it wasn't a good experience for reporter's family  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dehydration, Gait disturbance, SARS-CoV-2 test
Clinical narrative: I wasn''t able to walk by myself; Dehydrated; 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 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (Dose:2), for Covid-19 Immunization. The following information was reported: GAIT DISTURBANCE (hospitalization) with onset Jan2022, outcome "unknown", described as "I wasn''t able to walk by myself"; DEHYDRATION (hospitalization) with onset Jan2022, outcome "unknown", described as "Dehydrated". The patient was hospitalized for gait disturbance, dehydration (start date: 28Jan2022). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) negative, notes: found tested negative; (Jan2022) positive. It was reported that reason for hospitalization included patient not being able to walk by herself, they ended up bringing an ambulance. As far as patient thinks, she was dehydrated, she had no idea with admitting diagnosed issue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: I have tested positive for COVID. I am in the hospital, they admitted me; I have tested positive for COVID. I am in the hospital, they admitted me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Jan2022, outcome "unknown" and all described as "I have tested positive for COVID. I am in the hospital, they admitted me". The patient was hospitalized for drug ineffective, covid-19 (start date: 28Jan2022). The patient underwent the following laboratory tests and procedures: oxygen saturation: (Jan2022) unknown; sars-cov-2 test: (unspecified date) negative; (Jan2022) positive. Therapeutic measures were taken as a result of covid-19. It was reported that the patient had the two vaccination, (Clarified as COVID 19 Vaccine) then had the booster shot and even had a flu shot (Further not clarified, hence captured as Unspecified Flu shot). So and then patient tested since there were so many breakthrough cases we tested again and patient was found tested negative for it and then just like couple of weeks later patient when patient got shortness of breath and everything and they decided that patient should go to the hospital and then they did a test again and patient was positive. So, the patient was admitted right away. Patient was not sure about the outcome of the event it was mentioned that they were still trying to adjust an oxygen level. They just tap on oxygen and they keep fluctuating it. Reason of hospitalization was reported as shortness of breath, patient wasn't able to walk by herself, they ended up bringing her an ambulance. As far as patient thought she was dehydrated, patient had no idea with admitting diagnose issue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered; placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered; placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jan2022 (Lot number: FK5618, Expiration Date: 20Jan2022) as dose number unknown (tris), 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant), PRODUCT STORAGE ERROR (medically significant), EXPIRED PRODUCT ADMINISTERED (medically significant) all with onset Jan2022 and all described as "placed in the fridge and the beyond use date was 20Jan2022/ There were doses administered".  Clinical course: Product Details: Lot FK5618, NDC 59267105501. The product is the Pfizer covid vaccine specifically involving the orange cap vials. The Vaccines were administered beyond the 10 weeks, agent explains that it can be stored in the fridge for 10 weeks but it was used beyond that, the beyond use date would have been 20Jan2022. 15 doses in total were administered. The administration took place on 21Jan2022, 24Jan2022, 25Jan2022, 26Jan2022, and 28Jan2022.   Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information currently available in narrative ,the casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. 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.,Linked Report(s) : US-PFIZER INC-202200175416 Same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Feb2021 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Enlarged Prostate" (ongoing), notes: onset Date: 4 years ago, Stop Date: ongoing, Pertinent Details: None; "Spinal Surgeries", start date: 2019 (ongoing), notes: Illness/AE: Spinal Surgeries/Disc repair/Fusion, onset Date: (2019), (2017), (2011), Stop Date: Ongoing; "fusion", start date: 2011 (ongoing), notes: Illness/AE: Spinal Surgeries/Disc repair/Fusion, onset Date: (2019), (2017), (2011), Stop Date: Ongoing; "Disc repair", start date: 2017 (ongoing), notes: Illness/AE: Spinal Surgeries/Disc repair/Fusion, onset Date: (2019), (2017), (2011), Stop Date: Ongoing. Concomitant medication(s) included: ASA taken for prophylaxis (ongoing); ALPRULI taken for benign prostatic hyperplasia (ongoing). The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Decreased appetite, Dry skin, Feeling cold, Skin wrinkling
Clinical narrative: heavy hair loss; loss of appetite; feeling cold; : Caller reported that since last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90-year-old" and not 70; : Caller reported that since last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90-year-old" and not 70; 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 patient.  A 79 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Oct2021 (Lot number: FL3209) as dose 3 (booster), single, administration date 23Jun2021 (Lot number: EW0178) as dose 1, single and administration date 14Jul2021 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy: chicken" (unspecified if ongoing), notes: Caller stated she does not want to eat chicken, meat nor fish; "Known allergy: meat" (unspecified if ongoing), notes: Caller stated she does not want to eat chicken, meat nor fish; "Known allergy: fish" (unspecified if ongoing), notes: Caller stated she does not want to eat chicken, meat nor fish; "hair loss" (unspecified if ongoing), notes: Caller reported that the heavy hair loss began last summer and it is still continuing today. Concomitant medication(s) included: TOPROL XL, start date: 01Jan2021. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "heavy hair loss"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "loss of appetite"; FEELING COLD (non-serious) with onset 2021, outcome "not recovered", described as "feeling cold"; DRY SKIN (non-serious), SKIN WRINKLING (non-serious) all with onset 2021, outcome "unknown" and all described as ": Caller reported that since last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90-year-old" and not 70".  Additional information: Caller reported she has been experiencing heavy hair loss since the last summer and it is still continuing today. Caller mentioned that last summer she talked with an Internist from Primary Care about the loss of appetite and she was very concerned about it but has not connected with her since then Caller ask for further information. Caller stated she does not want to eat chicken, meat nor fish and that it not normal on her; then, last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90 years old" and not 70.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have contracted Covid. I am vaccinated with Pfizer; have contracted Covid. I am vaccinated with Pfizer; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have contracted Covid. I am vaccinated with Pfizer". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: Patient currently a nurse that works in the Health Department. Patient was prescribed Paxlovid but patient not able to get it filled due to lack of supply. Patient have contacted pharmacies but they are not willing to give information if they have it in stock. Patient's risk of being hospitalized and not making it are pretty high.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chest X-ray, Computerised tomogram head, Facial paralysis, Investigation
Clinical narrative: Diagnosed with bell palsy; left side of face drooping; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Jan2022 12:00 (Lot number: FJ5683) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: FJ5683, Arm Left, 12:00 PM), administration date: 18Jan2022, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EM9809, Arm Left, 12:00 PM), administration date: 16Apr2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 28Jan2022 15:15, outcome "not recovered", described as "Diagnosed with bell palsy"; FACIAL PARALYSIS (medically significant) with onset 28Jan2022 15:15, outcome "not recovered", described as "left side of face drooping". The events "diagnosed with bell palsy" and "left side of face drooping" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) unknown results; computerised tomogram head: (unspecified date) unknown results; investigation: (31Jan2022) unknown results; sars-cov-2 test: (31Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy, facial paralysis.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Diagnosed with bell palsy; left side of face drooping; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Jan2022 12:00 (Lot number: FJ5683) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: FJ5683, Arm Left, 12:00 PM), administration date: 18Jan2022, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EM9809, Arm Left, 12:00 PM), administration date: 16Apr2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 28Jan2022 15:15, outcome "not recovered", described as "Diagnosed with bell palsy"; FACIAL PARALYSIS (medically significant) with onset 28Jan2022 15:15, outcome "not recovered", described as "left side of face drooping". The events "diagnosed with bell palsy" and "left side of face drooping" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (unspecified date) unknown results; computerised tomogram head: (unspecified date) unknown results; investigation: (31Jan2022) unknown results; sars-cov-2 test: (31Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy, facial paralysis.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Periorbital angiedema; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Sep2021 12:15 (Lot number: EW0178) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. No covid prior vaccination. No covid tested post vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EL1284, Intramuscular, dose number=2, vaccine location=Left arm), administration date: 14Jan2021, when the patient was 42 years old, for Covid-19 Immunization; Bnt162b2 (lot number=EL0140, Intramuscular, dose number=1, vaccine location=Left arm), administration date: 23Dec2020, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: ANGIOEDEMA (medically significant) with onset 27Sep2021 13:00, outcome "recovered", described as "Periorbital angiedema". The event "periorbital angiedema" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of angioedema including Benadryl.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event Angioedema and the suspect drug BNT162B2 cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Chronic fatigue syndrome, Disease recurrence, Mast cell activation syndrome, Menstrual disorder
Clinical narrative: Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; vertigo; dysautonomia; POTS; MCAS; menstrual cycle changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 15:00 (Lot number: EW0169) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER; GABAPENTIN; VENLAFAXINE XR; LAMICTAL. Past drug history included: Septra, reaction(s): "Known allergies:Septra". The following information was reported: CHRONIC FATIGUE SYNDROME (disability), POST VIRAL FATIGUE SYNDROME (disability), DISEASE RECURRENCE (disability) all with onset 13Apr2021 18:00, outcome "not recovered" and all described as "Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline."; VERTIGO (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "vertigo"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "POTS"; MAST CELL ACTIVATION SYNDROME (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "MCAS"; MENSTRUAL DISORDER (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "menstrual cycle changes". The events "worst relapse of me/cfs i''ve ever had in 18 years. have been bed bound since, never returned to baseline.", "vertigo", "dysautonomia", "pots", "mcas" and "menstrual cycle changes" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) negative, notes: Blood test; (10Dec2021) negative, notes: Nasal Swab. Therapeutic measures (MCAS labs, Valtrex, Claritin, Pepcid AC, Benadryl) were taken as a result of chronic fatigue syndrome, post viral fatigue syndrome, disease recurrence, vertigo, autonomic nervous system imbalance, postural orthostatic tachycardia syndrome, mast cell activation syndrome, menstrual disorder.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Post viral fatigue syndrome, Postural orthostatic tachycardia syndrome, SARS-CoV-2 test, Vertigo
Clinical narrative: Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline.; vertigo; dysautonomia; POTS; MCAS; menstrual cycle changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 15:00 (Lot number: EW0169) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN ER; GABAPENTIN; VENLAFAXINE XR; LAMICTAL. Past drug history included: Septra, reaction(s): "Known allergies:Septra". The following information was reported: CHRONIC FATIGUE SYNDROME (disability), POST VIRAL FATIGUE SYNDROME (disability), DISEASE RECURRENCE (disability) all with onset 13Apr2021 18:00, outcome "not recovered" and all described as "Worst relapse of ME/CFS I''ve ever had in 18 years. Have been bed bound since, never returned to baseline."; VERTIGO (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "vertigo"; AUTONOMIC NERVOUS SYSTEM IMBALANCE (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "dysautonomia"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "POTS"; MAST CELL ACTIVATION SYNDROME (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "MCAS"; MENSTRUAL DISORDER (disability) with onset 13Apr2021 18:00, outcome "not recovered", described as "menstrual cycle changes". The events "worst relapse of me/cfs i''ve ever had in 18 years. have been bed bound since, never returned to baseline.", "vertigo", "dysautonomia", "pots", "mcas" and "menstrual cycle changes" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) negative, notes: Blood test; (10Dec2021) negative, notes: Nasal Swab. Therapeutic measures (MCAS labs, Valtrex, Claritin, Pepcid AC, Benadryl) were taken as a result of chronic fatigue syndrome, post viral fatigue syndrome, disease recurrence, vertigo, autonomic nervous system imbalance, postural orthostatic tachycardia syndrome, mast cell activation syndrome, menstrual disorder.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough covid case; breakthrough covid case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (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: DRUG INEFFECTIVE (medically significant) with onset 26Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 26Jan2022, outcome "recovered" (2021) and all described as "breakthrough covid case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Jan2022) positive. Therapeutic measures were not taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Covid-19; Covid-19/Trouble breathing, Fever and Lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 20220124000818.  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; dupilumab (DUPIXENT) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 07Jan2022, outcome "unknown", described as "Covid-19"; COVID-19 (medically significant) with onset 07Jan2022, outcome "unknown", described as "Covid-19/Trouble breathing, Fever and Lethargy". The reporter reported lethargy, fever, trouble breathing for 3 days after receiving Dupixent first dose and Pfizer COVID dose 2 on same day. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (07Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Vertigo, X-ray
Clinical narrative: falling; vertigo spells; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jan2021 (Lot number: EL3247) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "seasonal environmental allergies" (unspecified if ongoing), notes: just seasonal environmental allergies like sneezing when she is out walking the dog. Concomitant medication(s) included: RESTASIS taken for dry eye. Vaccination history included: Bnt162b2 (Dose 1; Lot EL0142), administration date: 09Jan2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: VERTIGO (medically significant) with onset Feb2021, outcome "unknown", described as "vertigo spells"; FALL (non-serious) with onset Mar2021, outcome "unknown", described as "falling". The patient underwent the following laboratory tests and procedures: x-ray: unknown results. Patient received the initial 2 doses and booster dose of the Pfizer COVID Vaccine. She reported that after her 2nd dose and booster dose, she would experience vertigo spells, in which she would end up falling because of it. Caller states that she first noticed the vertigo in Feb2021, she was turning over in bed, and pushing the dog off of her and the whole room started spinning, this was a couple weeks after when she fell.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Tinnitus
Clinical narrative: Tinnitus in the right ear; First dose Janssen covid-19 vaccine/second dose bnt162b2; First dose Janssen covid-19 vaccine/second dose bnt162b2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 12:45 (Lot number: FJ1614) at the age of 21 years as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "suspected shell fish allergy" (unspecified if ongoing); "suspected gluten allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Janssen covid-19 vaccine (DOSE 1,SINGLE, Lot number: 1805031, Administration time: 10:00 AM , Administration location: Left arm), administration date: 22May2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 31Jan2022 12:45, outcome "unknown" and all described as "First dose Janssen covid-19 vaccine/second dose bnt162b2"; TINNITUS (non-serious) with onset 01Feb2022 10:00, outcome "unknown", described as "Tinnitus in the right ear". It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional information:  The facility type vaccine was pharmacy or drug store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergy, had suspected shellfish and gluten allergy.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Breast mass, Mammogram
Clinical narrative: lumps appear in my breast; 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. Relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST MASS (non-serious), outcome "unknown", described as "lumps appear in my breast". The event "lumps appear in my breast" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the vaccine and shortly after receiving it the patient had lumps appear in the patient breast. The patient's physician sent the patient for a mammogram because the patient had missed their mammogram the previous year because of Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: mild case of Shingles; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 65 year-old male patient received bnt162b2 (BNT162B2), administration date 09Dec2021 (Batch/Lot number: unknown) at the age of 65 years as dose number unknown (booster), single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), since 01Feb2021 (Batch/Lot number: unknown) at 11 mg. 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; Covid-19 vaccine (Dose 2, Manufacturer Unknown, ), for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "recovered", described as "mild case of Shingles". The action taken for tofacitinib citrate was temporarily withdrawn. Therapeutic measures were taken as a result of herpes zoster.  Additional information: No contactable reporter. Reporter was not a Healthcare Professional. Reporters contact information available to you or a sub-contracted party was reported as unknown.The reporter the prescribing HCP was reported as no. Patient noted he was instructed by MD to hold Xeljanz for 7 days after getting COVID-19 booster on 09Dec. Subsequently, patient  was restarted Xeljanz for 2 days and then developed mild case of Shingles, and was instructed by MD to once again hold Xeljanz for 7 days. Shingles were subsequently cleared with Valtrex therapy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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 was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022 22:00, outcome "not recovered" and all described as "Covid test result: Positive"; INFECTION (non-serious) with onset 31Jan2022 22:00, outcome "not recovered", described as "Breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Lymphoedema, Oedema, SARS-CoV-2 test
Clinical narrative: Lymphatic Edema in both legs; Full body edema, including face, eyes, arms, hands, abdomen, legs, and feet.; Weight gain in excess of 50lbs; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Aug2021 15:15 (Lot number: FC3180) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE; POTASSIUM CITRATE. The following information was reported: LYMPHOEDEMA (disability) with onset 01Sep2021, outcome "not recovered", described as "Lymphatic Edema in both legs"; OEDEMA (disability) with onset 01Sep2021, outcome "not recovered", described as "Full body edema, including face, eyes, arms, hands, abdomen, legs, and feet."; WEIGHT INCREASED (disability) with onset 01Sep2021, outcome "not recovered", described as "Weight gain in excess of 50lbs"; DYSPNOEA (disability) with onset 01Sep2021, outcome "not recovered", described as "Shortness of breath". The events "lymphatic edema in both legs", "full body edema, including face, eyes, arms, hands, abdomen, legs, and feet.", "weight gain in excess of 50lbs" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative, notes: Nasal swab; weight: (2021) increased, notes: Weight gain in excess of 50lbs within 4 months; blood pressure measurement: (unspecified date) high. Therapeutic measures taken as a result of lymphoedema, oedema, weight increased, dyspnoea included Acupuncture and Lymphatic drainage Massage. Clinical course: the patient received second dose of COMIRNATY (lot number: 320308D) on 31Oct2021 02:45 PM administered in Left arm. No other vaccine in four weeks. No covid prior vaccination. No known allergies.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: Lymphatic Edema in both legs; Full body edema, including face, eyes, arms, hands, abdomen, legs, and feet.; Weight gain in excess of 50lbs; Shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Aug2021 15:15 (Lot number: FC3180) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure; "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE; POTASSIUM CITRATE. The following information was reported: LYMPHOEDEMA (disability) with onset 01Sep2021, outcome "not recovered", described as "Lymphatic Edema in both legs"; OEDEMA (disability) with onset 01Sep2021, outcome "not recovered", described as "Full body edema, including face, eyes, arms, hands, abdomen, legs, and feet."; WEIGHT INCREASED (disability) with onset 01Sep2021, outcome "not recovered", described as "Weight gain in excess of 50lbs"; DYSPNOEA (disability) with onset 01Sep2021, outcome "not recovered", described as "Shortness of breath". The events "lymphatic edema in both legs", "full body edema, including face, eyes, arms, hands, abdomen, legs, and feet.", "weight gain in excess of 50lbs" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) negative, notes: Nasal swab; weight: (2021) increased, notes: Weight gain in excess of 50lbs within 4 months; blood pressure measurement: (unspecified date) high. Therapeutic measures taken as a result of lymphoedema, oedema, weight increased, dyspnoea included Acupuncture and Lymphatic drainage Massage. Clinical course: the patient received second dose of COMIRNATY (lot number: 320308D) on 31Oct2021 02:45 PM administered in Left arm. No other vaccine in four weeks. No covid prior vaccination. No known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a literature report.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "3 previous episodes of Bell's palsy ageusia Facial weakness" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunisation. The following information was reported: BELL'S PALSY (medically significant), outcome "recovering", described as "Bell's palsy". Therapeutic measures were taken as a result of bell's palsy included prednisone. No neuroimaging was taken.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal association, a causal relationship between the event Bell's palsy and BNT162B2 cannot be completely excluded. 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
Symptoms: Cardiac failure chronic
Clinical narrative: CHF; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 104 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (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: CARDIAC FAILURE CHRONIC (death) with onset 2022, outcome "fatal", described as "CHF". It was reported that the patient received two Pfizer COVID-19 vaccines at the age of 102 and died this year (as reported) at the age of 104 due to chronic heart failure (CHF), not due to COVID-19.  The patient date of death was 2022. The reported cause of death was cardiac failure chronic.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: CHF
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Joint swelling, Peripheral swelling, Rash
Clinical narrative: Rash; Chills; Swelling of ankles, feet and legs; Swelling of ankles, feet and legs; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 14Jan2022 at 16:00 (Lot number: FF2855) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Acid reflux (esophageal)" (unspecified if ongoing), notes: reflux and "Allergy" (unspecified if ongoing), notes: Known allergies: yes. Concomitant medications included unspecified prescribed medication. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW6207, Anatomical Location: Left arm, Administration Time: 16:00), administration date: 21Mar2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0150, Anatomical Location: Left arm, Administration Time: 16:00), administration date: 09Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: RASH (non-serious) with onset an unknown date in 2022, outcome "recovering", described as "Rash"; CHILLS (non-serious) with onset an unknown date in 2022, outcome "recovering", described as "Chills"; JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset an unknown date in 2022, outcome "recovering", and all described as "Swelling of ankles, feet and legs". The events "Rash", "Chills" and "Swelling of ankles, feet and legs" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of rash, chills, joint swelling and peripheral swelling.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paralysis
Clinical narrative: experienced numbness and tingling on her left side, which is the side she has terrible palsy; experienced numbness and tingling on her left side, which is the side she has terrible palsy; experienced numbness and tingling on her left side, which is the side she has terrible palsy; 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 37 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2022 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Exposure to COVID-19", start date: 06Jan2022 (unspecified if ongoing), notes: Caller said that she was exposed on the 06Jan but she don't experience any symptoms. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PARALYSIS (medically significant), outcome "unknown", HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 03Feb2022, outcome "unknown" and all described as "experienced numbness and tingling on her left side, which is the side she has terrible palsy".  Clinical course reported as the patient received the Pfizer covid-19 vaccine booster shot on 25Jan. she has a underlying terrible palsy. she experienced numbness and tingling on her left side, which is the side she has terrible palsy. she wanted to know if the side effect was from the booster. she was exposed on the 06Jan but she don't experience any symptoms. She wanted to know if she needed to take a test for covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date=31Dec2021; covid test result=Positive; covid test date=31Dec2021; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 18:30 (Lot number: ER2613) at the age of 56 years as dose 2, single and administered in arm right, administration date 18Mar2021 18:30 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. Relevant medical history included: "latex" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "covid test date=31Dec2021; covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab.