chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4261290-00 (RA). A 63-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1155267) till 2021 at citrate free and second regimen since Oct2021 (Lot number: 1155267) at citrate free (increased to weekly dosage (1 in 1 wk.)), all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The reporter's assessment of the causal relationship of "polymyalgia rheumatica", "fatigue", "sore arm with all Pfizer Covid vaccines", "inflammation", "abdominal distress" and "nausea" with the co suspect product adalimumab (HUMIRA) was not provided at the time of this report and the reporter's assessment of the causal relationship of "fatigue", "sore arm with all Pfizer Covid vaccines and "abdominal distress" was possible with suspect product BNT162b2 and of the event Polymyalgia rheumatica and Inflammation  was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information the events of  Inflammation, Pain in extremity, Abdominal discomfort, Fatigue, Nausea, Polymyalgia Rheumatica are assessed as possibly related to the suspect vaccine BNT162B2 based on causal association. 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.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Small intestinal haemorrhage, Vaccination site pain
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4344715-00 (RA). A 79-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore arm following Covid vaccine"; SMALL INTESTINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Hemorrhage duodenum"; ANAEMIA (non-serious), outcome "unknown", described as "Anemic". The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (adalimumab): The reporter's causality for the event (s) of hemorrhage in duodenum, sore arm following COVID VACCINE and anemic was not provided. Regulatory Authority opinion is that the events of hemorrhage in duodenum and anemic are not assessable. Regulatory Authority opinion is that there is no reasonable possibility that the event of sore arm following COVID VACCINE is related to HUMIRA (ADALIMUMAB). Causality for (BNT162b2): The reporter's assessment of the causal relationship of "hemorrhage duodenum", "sore arm following Covid vaccine" and "anemic" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. 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 available information and the known product safety profile, a causal relationship between the reported events, Duodenal hemorrhage, vaccination site pain, anemia and BNT162B2 is considered possible. 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: ADAMTS13 activity assay, Blood bilirubin unconjugated, Blood lactate dehydrogenase, Complement factor C3, Complement factor C4
Clinical narrative: This is a literature report.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 min for Covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia of unknown etiology" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for Arrhythmia. The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: ADAMTS13 activity assay: less than 5, notes: inhibitor 0.4 (ref range less than 0.4). Novel homozygous variant in the ADAMTS13 gene, NM_139025.4:c.1584+5G greater than A; Blood bilirubin unconjugated: 1.4 mg/dl; Blood lactate dehydrogenase: 354 IU/l; Complement factor C3: 130 mg/dl; Complement factor C4: Not obtained; Haemoglobin: 6.5 g/dl; Platelet count: 33000 cells/uL; Reticulocyte count: 0.286 cells; SARS-CoV-2 antibody test: positive, notes: after vaccination; positive, notes: after vaccination; Smear test: yes; Weight: gain. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura. Clinical information: This is a literature report. 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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be 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-202200544325 same article, drug different patient.
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Platelet count, Reticulocyte count, SARS-CoV-2 antibody test, Smear test
Clinical narrative: This is a literature report.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 min for Covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia of unknown etiology" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for Arrhythmia. The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: ADAMTS13 activity assay: less than 5, notes: inhibitor 0.4 (ref range less than 0.4). Novel homozygous variant in the ADAMTS13 gene, NM_139025.4:c.1584+5G greater than A; Blood bilirubin unconjugated: 1.4 mg/dl; Blood lactate dehydrogenase: 354 IU/l; Complement factor C3: 130 mg/dl; Complement factor C4: Not obtained; Haemoglobin: 6.5 g/dl; Platelet count: 33000 cells/uL; Reticulocyte count: 0.286 cells; SARS-CoV-2 antibody test: positive, notes: after vaccination; positive, notes: after vaccination; Smear test: yes; Weight: gain. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura. Clinical information: This is a literature report. 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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be 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-202200544325 same article, drug different patient.
Sex: F
Vaccine: COVID19
Symptoms: Thrombotic thrombocytopenic purpura, Weight
Clinical narrative: This is a literature report.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 min for Covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia of unknown etiology" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for Arrhythmia. The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: ADAMTS13 activity assay: less than 5, notes: inhibitor 0.4 (ref range less than 0.4). Novel homozygous variant in the ADAMTS13 gene, NM_139025.4:c.1584+5G greater than A; Blood bilirubin unconjugated: 1.4 mg/dl; Blood lactate dehydrogenase: 354 IU/l; Complement factor C3: 130 mg/dl; Complement factor C4: Not obtained; Haemoglobin: 6.5 g/dl; Platelet count: 33000 cells/uL; Reticulocyte count: 0.286 cells; SARS-CoV-2 antibody test: positive, notes: after vaccination; positive, notes: after vaccination; Smear test: yes; Weight: gain. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura. Clinical information: This is a literature report. 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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be 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-202200544325 same article, drug different patient.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received the 4th dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in arm for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st, 2nd and 3rd dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. Reportedly, vaccination site pain occurred in the spot where they did the shot; his arm hurt a bunch. Maybe two hours later, he woke up again and his arm still hurt a bunch; outcome: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Eating disorder, Gait disturbance, Illness, Incoherent, Pyrexia
Clinical narrative: became incoherent for 2.5 days after Booster 1/could not talk or form thoughts; major reaction to Booster 1/ very very ill; nor walk w/o help; had fever; did not eat/drink for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic kidney patient Lev. 2" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "fever". The following information was reported: INCOHERENT (non-serious) with onset Oct2021, outcome "unknown", described as "became incoherent for 2.5 days after Booster 1/could not talk or form thoughts"; EATING DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "did not eat/drink for 2 days"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "had fever"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "major reaction to Booster 1/ very very ill"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "nor walk w/o help".  Additional information: Patient was fairly active and had major reaction to booster 1 vaccine in Oct2021. With 2nd vaccine had fever, then patient was okay. With Booster 1, patient was very ill. Patient had a chronic kidney Lev. 2 under care of Dr. Normally, patient was doing well and functioning within normal range. Patient became incoherent for 2.5 days after booster 1, had fever and could not talk or form thoughts, nor walk w/o help. Patient did not eat/drink for 2 days.   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-202200544435 same patient/ reporter, different product/ AE
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: became incoherent for 2.5 days after Booster 1/could not talk or form thoughts; major reaction to Booster 1/ very very ill; nor walk w/o help; had fever; did not eat/drink for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic kidney patient Lev. 2" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "fever". The following information was reported: INCOHERENT (non-serious) with onset Oct2021, outcome "unknown", described as "became incoherent for 2.5 days after Booster 1/could not talk or form thoughts"; EATING DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "did not eat/drink for 2 days"; PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "had fever"; ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "major reaction to Booster 1/ very very ill"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "nor walk w/o help".  Additional information: Patient was fairly active and had major reaction to booster 1 vaccine in Oct2021. With 2nd vaccine had fever, then patient was okay. With Booster 1, patient was very ill. Patient had a chronic kidney Lev. 2 under care of Dr. Normally, patient was doing well and functioning within normal range. Patient became incoherent for 2.5 days after booster 1, had fever and could not talk or form thoughts, nor walk w/o help. Patient did not eat/drink for 2 days.   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-202200544435 same patient/ reporter, different product/ AE
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Eating disorder, Gait disturbance, Illness, Incoherent, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 70-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (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: PYREXIA (non-serious), outcome "recovered", described as "had fever". Additional information: Customer Verbatim: Patient enquired Dear Pfizer, stating fairly active withheld and had major reaction to Booster #1 vaccine in Oct2021. With 2nd vaccine had fever; then was okay; then with Booster #1, patient was very ill. Further stated FYI was a chronic kidney pt., Lev. 2 under care of Dr. withheld. Normally, patient was doing well and functioning within normal range. but became incoherent for 2.5 days after Booster #1, had fever and could not talk or form thoughts, nor walk w/o help! did not eat/drink for 2 days. Patient enquired if What happened. Sender's Comments: Linked Report(s): US-PFIZER_INC-202200544434 same patient/ reporter, different product/ AE.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. A 70-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (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: PYREXIA (non-serious), outcome "recovered", described as "had fever". Additional information: Customer Verbatim: Patient enquired Dear Pfizer, stating fairly active withheld and had major reaction to Booster #1 vaccine in Oct2021. With 2nd vaccine had fever; then was okay; then with Booster #1, patient was very ill. Further stated FYI was a chronic kidney pt., Lev. 2 under care of Dr. withheld. Normally, patient was doing well and functioning within normal range. but became incoherent for 2.5 days after Booster #1, had fever and could not talk or form thoughts, nor walk w/o help! did not eat/drink for 2 days. Patient enquired if What happened. Sender's Comments: Linked Report(s): US-PFIZER_INC-202200544434 same patient/ reporter, different product/ AE.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer, Lymphadenitis
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A female patient received BNT162b2 (BNT162B2), on 07May2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 28May2021 as dose 2. single (Batch/Lot number: unknown), in right arm for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant), outcome "unknown", described as "She now has breast cancer"; LYMPHADENITIS (non-serious), outcome "unknown", described as "lumps in lymph nodes". Additional information: Forwarded as an Adverse Event by the team on 08Apr2022. Reporter provided verification of contact address on 07Apr2022. My mother took your Covid-19 vaccine on 07May and 28May. She now has breast cancer and lumps in lymph nodes, all on right side, same arm vaccinations were given. Shortly thereafter, the cancer grew. There is no cancer on her side of the family. I am demanding compensation for her. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: noticed an itch on her left outer arm; an itchy welp there; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 06Apr2022 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. 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; Covid-19 vaccine (DOSE 3; MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 07Apr2022 at 13:45, outcome "unknown", described as "an itchy welp there"; PRURITUS (non-serious) with onset 07Apr2022 at 13:45, outcome "recovering", described as "noticed an itch on her left outer arm".  Additional information: The patient got administered second booster of Pfizer Covid-19 Vaccine which she was administered on 06Apr2022 (reported as last night). Over her lunch hour 07Apr2022 at 13:45 (reported as today), she noticed an itch on her left outer arm and an itchy welp there. It does not itch now like it did at onset time of 13:45.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Tremor
Clinical narrative: Sweated; shaking; chills; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Triglycerides" (unspecified if ongoing); "High Triglycerides and lipids" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "recovered", described as "Sweated"; TREMOR (non-serious), outcome "recovered", described as "shaking"; CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body pain".  Reporter by: Consumer  Event description: I sweated, have shaking chills and body pain after 15 hrs of vaccination. The symptoms last for 8 hrs. 48 years old. Female. 65kg, 165 cm  Optional Information: High Triglycerides and lipids.  Name of product: Pfizer covid-19 vaccine. Batch: FJ5683  The event happened during the use of the product.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (11Apr2022): Follow-up attempts are completed. No further information is expected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching intensely all over his body; just a lot of intense itching; he feels like even his eye balls are itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 18:00 as dose number unknown, single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 08Apr2022, outcome "unknown", described as "itching intensely all over his body; just a lot of intense itching; he feels like even his eye balls are itching".  Additional information: Reporter stated, "My husband and myself (Further clarifications unknown) received the Pfizer COVID Vaccine at about 6 'O' clock this evening. My husband is now having, he doesn't have a rash but he is itching intensely all over his body but there is no rash. It's just a lot of intense itching. He said even, he feels like even his eyeballs are itching, is that any, I can't find anything about that being reported."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Second booster: fingers were all sore; Second booster: shoulders hurt; Second booster: stiff neck; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, She has never had a reaction to any of the 3 prior doses of Pfizer Covid-19, not even sore arm.), for Covid-19 Immunization, reaction(s): "never had a reaction to any of the 3 prior doses of Pfizer Covid-19"; Bnt162b2 (Dose:2, She has never had a reaction to any of the 3 prior doses of Pfizer Covid-19, not even sore arm.), for Covid-19 Immunization, reaction(s): "never had a reaction to any of the 3 prior doses of Pfizer Covid-19"; Bnt162b2 (Dose:3, Booster, She has never had a reaction to any of the 3 prior doses of Pfizer Covid-19, not even sore arm.), administration date: Sep2021, for Covid-19 Immunization, reaction(s): "never had a reaction to any of the 3 prior doses of Pfizer Covid-19". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Second booster: fingers were all sore"; ARTHRALGIA (non-serious), outcome "unknown", described as "Second booster: shoulders hurt"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Second booster: stiff neck".  Additional Context: This consumer is the patient who just had the second booster dose of Pfizer Covid-19 on Wednesday. She tried searching to find the side effects. Thursday, the day after she got the shot of Pfizer Covid-19, it seemed like her fingers were all sore, her shoulders hurt and she has had a stiff neck now for 2 days. Is this something that been reported? She just wants to find out if these things are because of the booster. She has never had a reaction to any of the 3 prior doses of Pfizer Covid-19, not even sore arm. She wants to know because if these events are not a reaction to the Pfizer Covid-19 she needs to see her doctor and find out what it is  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Suspected COVID-19
Clinical narrative: positive to COVID-19; positive to COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), on 04Apr2022 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), for COVID-19 immunization; Bnt162b2 (dose:2), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "positive to COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive. The course of the event: Caller states that one patient got the booster dose of the Pfizer-BioNTech COVID-19 Vaccine on monday 04Apr2022 and he tested positive to COVID-19 in the last couple of days. Caller would like to know if it's possible to test positive to COVID-19 as a result of being vaccinated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction, Myocarditis
Clinical narrative: Presumed myocarditis following the second dose of COVID-19 mRNA vaccine; Myocardial infarction; This is a literature report.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: Covid-19 vaccine (dose 1; manufacturer unknown), for Covid-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Presumed myocarditis following the second dose of COVID-19 mRNA vaccine"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown". Per previous case-report about vaccine-related cardiac complication, one patient experienced myocardial infarction with mRNA vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.    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: U
Vaccine: COVID19
Symptoms: Transplant rejection
Clinical narrative: acute cellular rejection in a liver transplants recipient occuring after the first dose of the mRNA vaccine; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "liver transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TRANSPLANT REJECTION (medically significant), outcome "unknown", described as "acute cellular rejection in a liver transplants recipient occuring after the first dose of the mRNA vaccine".  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 information in the case report and a plausible temporal relationship, a possible causal relationship between the event acute cellular rejection and suspect drug BNT162B2 cannot be 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: drug ineffective; suspected covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: E146207), on 27Apr2021 as dose 2, single (Lot number: Ew0169) and on 07Dec2021 as dose 3 (booster), single (Lot number: Fj8757) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "former smoker" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; MELATONIN; IBUPROFEN; VITAFUSION CALCIUM; NATROL ACAI BERRY ANTIOXIDANT PROTECTION; FIBER SUPPLEMENT.   The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, 12 hrs after the suspect product(s) administration, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset Apr2022, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "suspected covid 19". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: The patient took Meijer (lot number: Ohe2514a), start date: 03Apr2022 and stop date: 06Apr2022 in 2 weeks.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: had shingles recently; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (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: Covid-19 vaccine (Primary immunization series complete,, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "had shingles recently". Therapeutic measures were taken as a result of herpes zoster. Additional information; Call transferred by withheld from Covax support CEP 159558. The patient is a consumer (refused to give phone number or address) who is asking about when he can get the Pfizer COVID 19 2nd booster vaccine. The patient stated he had his 1st Pfizer COVID 19 booster vaccine 6 months ago patient stated that his doctor thought he may have had shingles recently and had him taking an antiviral. The patient stated his doctor told him to wait 2 weeks until getting his 2nd Pfizer Covid19 booster vaccine since he recently had shingles. The patient is asking "do I need to wait 2 weeks before having my 2nd booster vaccine". Response: Confirmed Pfizer Covid19 2nd booster vaccine. Resolution: Swap Survey: First Connect to Covax US Support. Read privacy statement and Gather info, The patient refused to provide his address and phone number. Read. Provided PMI's HOO and phone number. Warm transferred (withheld).  Provided: COVAX US Support and CEP159558. Created Manual AE Form  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash
Clinical narrative: She started developing a rash in different parts of her body, following the vaccination/It is on her legs, her elbows, chest, upper and low back, both front and back of the neck.; Rash has gotten worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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: RASH (non-serious), outcome "not recovered", described as "She started developing a rash in different parts of her body, following the vaccination/It is on her legs, her elbows, chest, upper and low back, both front and back of the neck."; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Rash has gotten worse".  Additional Information: Rash is on her legs, her elbows, chest, upper and low back, both front and back of the neck./She explained that this rash has been moving from one part to another since it started developing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mammogram, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Swollen lymph node; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Extreme pain and swelling in left arm for a week after each dose; Extreme pain and swelling in left arm for a week after each dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive"; BNT162b2 (Dose Number: 1, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 43-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Extreme pain and swelling in left arm for a week after each dose"; MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), PARAESTHESIA (non-serious) all with onset 10Dec2021, outcome "not recovered" and all described as "Stiffness, soreness and tingling in left arm"; LYMPHADENOPATHY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Swollen lymph node". The events "swollen lymph node", "stiffness, soreness and tingling in left arm" and "extreme pain and swelling in left arm for a week after each dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, musculoskeletal stiffness, myalgia, paraesthesia, pain in extremity.  Additional information: No other vaccine in four weeks. Multi vitamins medications was in two weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Swollen lymph node; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Extreme pain and swelling in left arm for a week after each dose; Extreme pain and swelling in left arm for a week after each dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive"; BNT162b2 (Dose Number: 1, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 43-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Extreme pain and swelling in left arm for a week after each dose"; MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), PARAESTHESIA (non-serious) all with onset 10Dec2021, outcome "not recovered" and all described as "Stiffness, soreness and tingling in left arm"; LYMPHADENOPATHY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Swollen lymph node". The events "swollen lymph node", "stiffness, soreness and tingling in left arm" and "extreme pain and swelling in left arm for a week after each dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, musculoskeletal stiffness, myalgia, paraesthesia, pain in extremity.  Additional information: No other vaccine in four weeks. Multi vitamins medications was in two weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Swollen lymph node; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Stiffness, soreness and tingling in left arm; Extreme pain and swelling in left arm for a week after each dose; Extreme pain and swelling in left arm for a week after each dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive"; BNT162b2 (Dose Number: 1, Batch/Lot No:  EN6205, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 43-year-old, for COVID-19 immunization, reaction(s): "covid test result=Positive", "Extreme pain and swelling in left arm", "Extreme pain and swelling in left arm", "covid test result=Positive". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Extreme pain and swelling in left arm for a week after each dose"; MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), PARAESTHESIA (non-serious) all with onset 10Dec2021, outcome "not recovered" and all described as "Stiffness, soreness and tingling in left arm"; LYMPHADENOPATHY (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Swollen lymph node". The events "swollen lymph node", "stiffness, soreness and tingling in left arm" and "extreme pain and swelling in left arm for a week after each dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, musculoskeletal stiffness, myalgia, paraesthesia, pain in extremity.  Additional information: No other vaccine in four weeks. Multi vitamins medications was in two weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mammogram, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: SARS-COV-2, qPCR: Positive; SARS-COV-2, qPCR: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 01Apr2021 as dose 2, single (Lot number: EN6205), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy: Latex" (unspecified if ongoing), notes: Reaction. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]. Past drug history included: Aspirin for known allergies: aspirin, notes: Reaction. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Dec2021, outcome "unknown" and all described as "SARS-COV-2, qPCR: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2021) Positive, notes: Other.  No follow-up attempts are possible. No further information is expected.