chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis C virus test, Investigation, Red blood cell sedimentation rate, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Rheumatoid arthritis; This is a literature report for the following literature source(s): Private. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), 7 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antinuclear antibody: negative; C-reactive protein: 3.7 mg/dl; Hepatitis B virus test: negative; Hepatitis C virus test: negative; HIV test: negative; classsification criteria for rheumatoid arthritis.: met the 2010 ACR, notes: classification; remarkable for synovitis, notes: at the bilateral wrists and second to fourth MCP joints; Red blood cell sedimentation rate: 41, notes: Unit:mm/h; Rheumatoid factor (0-13.9): 16 IU/ml; SARS-CoV-2 test: negative; X-ray limb: negative, notes: for erosive changes; negative, notes: for erosive changes. Therapeutic measures were taken as a result of rheumatoid arthritis.  Clinical course: The patient was presented to rheumatology with 4 months of symmetric polyarthritis involving the wrists and MCP joints in the setting of prolonged morning stiffness. Symptom onset occurred 1 week after completing the Pfizer-BioNTech vaccination series. The patient had a history of Hashimoto thyroiditis, no history COVID infection, and no family history of autoimmune disease. The patient never received immunosuppression in the past, and no medication changes were made at the time of vaccination. Examination was remarkable for synovitis at the bilateral wrists and second to fourth MCP joints. The patient met the 2010 ACR classification criteria for rheumatoid arthritis. She was treated initially with a prednisone taper and achieved clinical remission on oral methotrexate.; Sender's Comments: Based on the temporal relation, the association between the event of rheumatoid arthritis and the suspect product cannot be completely ruled out.  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: SARS-CoV-2 test, X-ray limb
Clinical narrative: Rheumatoid arthritis; This is a literature report for the following literature source(s): Private. A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), 7 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antinuclear antibody: negative; C-reactive protein: 3.7 mg/dl; Hepatitis B virus test: negative; Hepatitis C virus test: negative; HIV test: negative; classsification criteria for rheumatoid arthritis.: met the 2010 ACR, notes: classification; remarkable for synovitis, notes: at the bilateral wrists and second to fourth MCP joints; Red blood cell sedimentation rate: 41, notes: Unit:mm/h; Rheumatoid factor (0-13.9): 16 IU/ml; SARS-CoV-2 test: negative; X-ray limb: negative, notes: for erosive changes; negative, notes: for erosive changes. Therapeutic measures were taken as a result of rheumatoid arthritis.  Clinical course: The patient was presented to rheumatology with 4 months of symmetric polyarthritis involving the wrists and MCP joints in the setting of prolonged morning stiffness. Symptom onset occurred 1 week after completing the Pfizer-BioNTech vaccination series. The patient had a history of Hashimoto thyroiditis, no history COVID infection, and no family history of autoimmune disease. The patient never received immunosuppression in the past, and no medication changes were made at the time of vaccination. Examination was remarkable for synovitis at the bilateral wrists and second to fourth MCP joints. The patient met the 2010 ACR classification criteria for rheumatoid arthritis. She was treated initially with a prednisone taper and achieved clinical remission on oral methotrexate.; Sender's Comments: Based on the temporal relation, the association between the event of rheumatoid arthritis and the suspect product cannot be completely ruled out.  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: Aldolase, Antinuclear antibody, Blood creatine phosphokinase, C-reactive protein, Investigation
Clinical narrative: Polymyalgia rheumatica; This is a report for the following source.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech (DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), 7 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Aldolase: normal; Antinuclear antibody: normal; Blood creatine phosphokinase: normal; C-reactive protein: normalized; C-reactive protein: 5.07 mg/dl; Examination: notable for tenderness in the bilateral shoulders, notes: wrists, hips and knees; 2012 ACR criteria; Red blood cell sedimentation rate: 79, notes: Unit: mm/h; normalized; Rheumatoid factor: normal; SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical course:A 69-year-old  man presented to BAMC rheumatology with 2 months of bilateral arthralgias and stiffness in the shoulders, hips, wrists, and knees. Symptom onset was 1 week after completing the Pfizer-BioNTech vaccination series. The patient had a primary relative with rheumatoid arthritis, but no personal history of autoimmune disease or COVID infection. The patient never received immunosuppression in the past, and nomedication changes were made at the time of vaccination. Examination was notable for tenderness in the bilateral shoulders, wrists, hips, and knees, which resolved with a 3-week course of prednisone. He had no clinical evidence of temporal arteritis. Laboratory evaluation was remarkable for an elevated ESR (79 mm/h) and CRP (5.07 mg/dL). Rheumatoid factor, ACPA, creatine kinase, and aldolase testing were normal. COVID-19 testing (PCR) was negative. Repeat ESR and CRP normalized in 3 weeks on prednisone. The patient met the 2012 ACR criteria for polymyalgia rheumatica and was treated with a slow steroid taper over a period of 13 months.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of  "POLYMYALGIA RHEUMATICA ". The impact of this report on the benefit/risk profile of the Pfizer drug 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: Polymyalgia rheumatica, Red blood cell sedimentation rate, Rheumatoid factor, SARS-CoV-2 test
Clinical narrative: Polymyalgia rheumatica; This is a report for the following source.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech (DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), 7 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Aldolase: normal; Antinuclear antibody: normal; Blood creatine phosphokinase: normal; C-reactive protein: normalized; C-reactive protein: 5.07 mg/dl; Examination: notable for tenderness in the bilateral shoulders, notes: wrists, hips and knees; 2012 ACR criteria; Red blood cell sedimentation rate: 79, notes: Unit: mm/h; normalized; Rheumatoid factor: normal; SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical course:A 69-year-old  man presented to BAMC rheumatology with 2 months of bilateral arthralgias and stiffness in the shoulders, hips, wrists, and knees. Symptom onset was 1 week after completing the Pfizer-BioNTech vaccination series. The patient had a primary relative with rheumatoid arthritis, but no personal history of autoimmune disease or COVID infection. The patient never received immunosuppression in the past, and nomedication changes were made at the time of vaccination. Examination was notable for tenderness in the bilateral shoulders, wrists, hips, and knees, which resolved with a 3-week course of prednisone. He had no clinical evidence of temporal arteritis. Laboratory evaluation was remarkable for an elevated ESR (79 mm/h) and CRP (5.07 mg/dL). Rheumatoid factor, ACPA, creatine kinase, and aldolase testing were normal. COVID-19 testing (PCR) was negative. Repeat ESR and CRP normalized in 3 weeks on prednisone. The patient met the 2012 ACR criteria for polymyalgia rheumatica and was treated with a slow steroid taper over a period of 13 months.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of  "POLYMYALGIA RHEUMATICA ". The impact of this report on the benefit/risk profile of the Pfizer drug 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: Arthralgia, Dizziness, Musculoskeletal stiffness, Pain in extremity, Sluggishness
Clinical narrative: Tightness in his fingers; First work up my hands were hurting; Knees were hurting; feeling a little sluggish now.; Feeling a little lightheaded; Joints in his legs are sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 17-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Mar2023 as dose number unknown (booster), single (Lot number: GL0447), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 13Mar2023, outcome "unknown", described as "Feeling a little lightheaded"; ARTHRALGIA (non-serious) with onset 13Mar2023, outcome "unknown", described as "Joints in his legs are sore"; ARTHRALGIA (non-serious) with onset 13Mar2023, outcome "unknown", described as "Knees were hurting"; SLUGGISHNESS (non-serious) with onset 13Mar2023, outcome "unknown", described as "feeling a little sluggish now."; PAIN IN EXTREMITY (non-serious) with onset 14Mar2023, outcome "unknown", described as "First work up my hands were hurting"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 14Mar2023, outcome "unknown", described as "Tightness in his fingers".  Additional information: A grandfather called for his 17-year-old male grandson and stated that he got the Pfizer Covid 19 booster but did not say when. Stated he went to school the other day and was feeling a little lightheaded but that has passed now. This morning he felt a little lightheaded but has resolved. The joints in his legs are sore and he also had some tightness in his fingers started around 5 this morning standard time. Grandson got on call and said when he first woke up this morning his hands were hurting. He stayed home from school today. Called to report his side effects. Stated that his joints in his legs and knees were hurting. The caller had to get his glasses and he is reading from the vaccine card, the record shot. Stated that it happened after the third booster. Patient Height is 5'9.5"-5'10". The caller stated outcome is unknown; subsided somewhere down the line on 13Mar2023, he came back this morning and called him and told him that he was feeling lightheaded, and his fingers were hurting. Also stated Is feeling a little sluggish now. Stated that the tightness in his fingers and his hands hurting were all the same things. Started today, 14Mar2023. Resolved today 14Mar2023. Recovered completely.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: severe debilitating nausea; she was vomiting so much she went to the ER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 28Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose:1), administration date: 07Mar2021, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "severe debilitating nausea"; VOMITING (non-serious) with onset Mar2021, outcome "unknown", described as "she was vomiting so much she went to the ER". The events "severe debilitating nausea" and "she was vomiting so much she went to the er" required emergency room visit. Therapeutic measures were taken as a result of nausea, vomiting.  Additional information: Female consumer states that she received her 1st dose 07Mar2021, 2nd dose 28Mar2021, and a booster dose 19Dec2021. She reports severe debilitating nausea starting 12 hours after the second dose. States she was vomiting so much she went to the ER. She took Zofran which did not help. They gave her something for the nausea at the ER that did help after a couple hours. States she had to get an IV. 12 hours after the booster dose she had severe nausea and vomiting again and went to the ER again. States it wouldn't stop. States she would like to stay up to date on her vaccines but she is concerned and cant put her body through that every time.  Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112924 Same patient/vaccine/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nervousness, Trigeminal neuralgia, Weight, Weight increased
Clinical narrative: Weight gain (gained like 40 pounds); Anxiety; Trigeminal neuralgia; Nervous; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: Had it really bad. The patient's concomitant medications were not reported. The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "Weight gain (gained like 40 pounds)"; ANXIETY (non-serious), outcome "unknown"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown"; NERVOUSNESS (non-serious), outcome "unknown", described as "Nervous". The events "weight gain (gained like 40 pounds)", "anxiety", "trigeminal neuralgia" and "nervous" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had anxiety, too, and weight gain (gained like 40 pounds). They think it's trigeminal neuralgia. The patient had to see a neurologist about it, and she was very nervous about it. The patient had a living will on her phone for her kids in case anything happens. The patient considered the events as non-serious (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Illness, Nausea, Weight
Clinical narrative: Metallic taste in mouth is just horrible; Nausea; I still feel so exhausted, I can hardly function; I probably lost 2, I probably lost 10 pounds; I go the boosters, I would not get this sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEBREX; SYNDOPA [LEVODOPA]. Vaccination history included: coviD-19 vaccine (DOSE 2, SINGLE , Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm."), administration date: 28Jan2021, when the patient was 78-year-old, for COVID-19 immunization; coviD-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm."), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm.", Date of vaccination was given as 21Oct (as reported)), for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "Metallic taste in mouth is just horrible"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "I still feel so exhausted, I can hardly function"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "I probably lost 2, I probably lost 10 pounds"; ILLNESS (non-serious), outcome "unknown", described as "I go the boosters, I would not get this sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she experienced, the metallic taste in mouth was just horrible. she had the nausea and she knew that's one of the side effects that everyone know. She stated that she still feel so exhausted, she can hardly function, have been since 03Mar. The vaccination information was given as she had just were on 21Oct, I had 28Jan2021, 17Feb2021, she just had the booster of 21Feb (as reported). other medical conditions was reported as 'no'. Concomitant medication was also given as she takes multiple vitamins (further not clarified). Pfizer COVID 19 booster dose was confirmed as 'yeah, on 21 (clarified as 2021 year) (as reported)'.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109931 same patient/drug, different event/dose number;
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Metallic taste in mouth is just horrible; Nausea; I still feel so exhausted, I can hardly function; I probably lost 2, I probably lost 10 pounds; I go the boosters, I would not get this sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEBREX; SYNDOPA [LEVODOPA]. Vaccination history included: coviD-19 vaccine (DOSE 2, SINGLE , Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm."), administration date: 28Jan2021, when the patient was 78-year-old, for COVID-19 immunization; coviD-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm."), administration date: 17Feb2021, when the patient was 78-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Anatomical site of vaccination: Consumer stated, "No. You know in my arm. I don't know what arm.", Date of vaccination was given as 21Oct (as reported)), for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "Metallic taste in mouth is just horrible"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "I still feel so exhausted, I can hardly function"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "I probably lost 2, I probably lost 10 pounds"; ILLNESS (non-serious), outcome "unknown", described as "I go the boosters, I would not get this sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she experienced, the metallic taste in mouth was just horrible. she had the nausea and she knew that's one of the side effects that everyone know. She stated that she still feel so exhausted, she can hardly function, have been since 03Mar. The vaccination information was given as she had just were on 21Oct, I had 28Jan2021, 17Feb2021, she just had the booster of 21Feb (as reported). other medical conditions was reported as 'no'. Concomitant medication was also given as she takes multiple vitamins (further not clarified). Pfizer COVID 19 booster dose was confirmed as 'yeah, on 21 (clarified as 2021 year) (as reported)'.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300109931 same patient/drug, different event/dose number;
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: died from clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "died from clots". The patient date of death was unknown. Reported cause of death: "died from clots". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112856 same reporter, drug and event, different patient;US-PFIZER INC-202300112855 same reporter, drug and event, different patient;; Reported Cause(s) of Death: died from clots
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: died from clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "died from clots". The patient date of death was unknown. Reported cause of death: "died from clots". It was not reported if an autopsy was performed.  Clinical course: The reporter had 3 clients died from clotting (also reported as died from clots).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112854 same reporter, drug and event, different patient;US-PFIZER INC-202300112855 same reporter, drug and event, different patient;; Reported Cause(s) of Death: died from clots
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: after the booster dose she had severe nausea; vomiting again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 19Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1), administration date: 07Mar2021, for COVID-19 immunization; BNT162b2 (Dose: 2), administration date: 28Mar2021, for COVID-19 immunization, reaction(s): "She reports severe debilitating nausea starting 12 hours after the second dose.", "States she was vomiting so much she went to the ER". The following information was reported: NAUSEA (non-serious) with onset Dec2021, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "after the booster dose she had severe nausea"; VOMITING (non-serious) with onset Dec2021, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "vomiting again". The events "after the booster dose she had severe nausea" and "vomiting again" required emergency room visit.  Additional information: Female consumer states that she received her 1st dose 07Mar2021, 2nd dose 28Mar2021, and a booster dose 19Dec2021. She reports severe debilitating nausea starting 12 hours after the second dose. States she was vomiting so much she went to the ER. She took Zofran which did not help. They gave her something for the nausea at the ER that did help after a couple hours. States she had to get an IV. 12 hours after the booster dose she had severe nausea and vomiting again and went to the ER again. States it wouldn't stop. States she would like to stay up to date on her vaccines, but she is concerned and could not put her body through that every time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112540 Same patient/vaccine/event, different dose;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: I tested + (Positive) for COVID-19 on 03Jan2023; I tested + (Positive) for COVID-19 on 03Jan2023; Dose 1 and Dose 2: Moderna/ Dose 3 and Dose 4: BNT162B2/ Dose 5: BNT162B2, BNT162B2 OMI BA.4-5; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FL3198), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 at 15:30 as dose 1, single (Lot number: 037K20A), in left arm and on 11Feb2021 at 15:30 as dose 2, single (Lot number: 042L20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "environmental allergies (dust mites, pollen)" (unspecified if ongoing); "environmental allergies (dust mites, pollen)" (unspecified if ongoing); "environmental allergies (dust mites, pollen)" (unspecified if ongoing); "PCN" (unspecified if ongoing), notes: known allergies: PCN. Concomitant medication included: FLONASE [FLUTICASONE PROPIONATE], start date: 01Jun2018, stop date: 03Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Dose 1 and Dose 2: Moderna/ Dose 3 and Dose 4: BNT162B2/ Dose 5: BNT162B2, BNT162B2 OMI BA.4-5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2023, outcome "unknown" and all described as "I tested + (Positive) for COVID-19 on 03Jan2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient reported, "I tested + for COVID-19 on 03Jan2023, isolated, started Paxlovid the evening of 04Jan2023 and completed my last dose on the morning of 09Jan2023."; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for the reported events interchange of vaccine products, COVID-19 and drug ineffective. This case will be reassessed upon receipt of additional information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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 "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID positive test; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Mar2023 to 08Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for the reported events COVID-19 and drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; Dose 1&2 pfizer; Moderna Dose 3; Pfizer Dose 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 49 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EN6204), in left arm and on 14Apr2021 as dose 2, single (Lot number: ER8734), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Lot number: 046C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged liver" (unspecified if ongoing); "hiatal hernia" (unspecified if ongoing). Concomitant medication(s) included: B19 [CYANOCOBALAMIN;PYRIDOXINE HYDROCHLORIDE;THIAMINE HYDROCHLORIDE], start date: 26Jan2022. Past drug history included: Albuterol, reaction(s): "one reaction of tongue, lip swelling", notes: Albuterol - one reaction of tongue, lip swelling; Melatonin, reaction(s): "one reaction full body hives for week", notes: melatonin - one reaction full body hives for week. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Nov2021, outcome "unknown", described as "Dose 1&2 pfizer; Moderna Dose 3; Pfizer Dose 4"; COVID-19 (medically significant) with onset Mar2023, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset Mar2023, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included treatment with Paxlovid from 12Mar2023.   Clinical course: Covid symptoms mostly suppressed.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 08:00 as dose number unknown, single (Lot number: EL9265), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing); "known allergies: some adhesives" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. COVID 19 Treatment was given with Paxlovid.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 16:15 as dose 5 (booster), single (Lot number: Gh9694), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) 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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID; Positive, notes: I was essentially had COVID twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Reported as, Rebound COVID The patient was essentially had COVID twice and missed ten days of work and two weeks of any productivity. With hindsight, think she would have probably done better had she not taken paxlovid. She wanted to report it so that they would have more accurate information to share with future patients. The patient received anti viral treatment with Paxlovid for COVID 19 form 02Mar2023 till 07Mar2023. No other medication in 2 weeks. No known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 at 10:00 as dose 4 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac's Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Throat Stricture" (unspecified if ongoing). Concomitant medication(s) included: RIVOSTATIN, stop date: 05Mar2023. Past drug history included: Sporonox, reaction(s): "Known allergies: Sporonox", notes: Known allergies: Sporonox. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Antiviral details included Brand was Paxlovid.Treatment start date was 06Mar2023 and Treatment stop date was 08Mar2023.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Vaccination site erythema
Clinical narrative: redness around the injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 65-year-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness around the injection site". Additional information: Patient has redness about 3 fingers down the injection site.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna Feb2023; Pfizer Jul2022; Jansen Jul2020; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 2, single (Batch/Lot number: unknown), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), in Feb2023 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), in Jul2020 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown", described as "Moderna Feb2023; Pfizer Jul2022; Jansen Jul2020"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (11Mar2023) Negative; (15Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid for covid-19 from 04Mar2023 to 09Mar2023. Became very ill Friday 03Mar2023, got Paxlovid on 4th - started p.m. Finished 9th in a.m. Tested negative the 11th Felt ill 14th p.m. tested positive for Covid a.m. 15Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 18:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Mar2023) Positive, notes: 5 days after finishing paxlovid, I tested positive again; (Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks was reported as no. The patient received anti viral COVID-19 Treatment Paxlovid from 28Feb2023 to 05Mar2023. The patient known allergies and other medical history was reported as none.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice; had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 "had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300114776 same patient, different dose/event.;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Wrong product administered
Clinical narrative: had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice; had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 "had 3 Pfizer Bio N Tech COVID 19 vaccines and has had COVID twice".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300114776 same patient, different dose/event.;