chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination complication
Clinical narrative: booster dose; slight fever; body aches; chills; Tenderness; very little swelling around the mouth where she received dermal fillers; she gets reactions after every vaccine given to her; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: EW0175) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "received dermal fillers", start date: May2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 30Mar2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "she gets reactions after every vaccine given to her"; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735), administration date: 24Apr2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "she gets reactions after every vaccine given to her". The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "booster dose"; PYREXIA (non-serious) with onset 20Nov2021, outcome "recovered", described as "slight fever"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered", described as "body aches"; CHILLS (non-serious) with onset 20Nov2021, outcome "recovered", described as "chills"; TENDERNESS (non-serious) with onset 20Nov2021, outcome "recovered", described as "Tenderness"; MOUTH SWELLING (non-serious) with onset 20Nov2021, outcome "recovered", described as "very little swelling around the mouth where she received dermal fillers"; VACCINATION COMPLICATION (non-serious) with onset 20Nov2021, outcome "recovered", described as "she gets reactions after every vaccine given to her". Therapeutic measures were taken as a result of pyrexia, pain. Therapeutic measures were not taken as a result of chills, tenderness, vaccination complication.  Additional information: patient reported tenderness and very little swelling around the mouth where she received dermal fillers on May2021. the swelling and tenderness resolved in less than 24 hours. she mentioned that she gets reactions after every vaccine given to her. No treatment received. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. She mentioned that she gets reactions after every vaccine given to her. she ran a slight fever and had body aches and chills. motrin helped with the pain and fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypersplenism, Platelet count, SARS-CoV-2 test, Sickle cell anaemia with crisis, Thrombocytopenia
Clinical narrative: vaso-occlusive event; thrombocytopenia; splenic sequestration and abdominal ultrasound showed a diffusely echogenic and atrophied spleen.; This is a literature report for a Pfizer sponsored program (005851) for the following literature source(s): "Thrombocytopenia in a teen with sickle cell disease following COVID-19 vaccination.",  As per source verbatim: Drug Safety : ADR Case Report. COVID-19-vaccine-pfizerbiontech/ibuprofen/oxycodone. Vaso-occlusive event, thrombocytopenia and lack of efficacy: case report. Serious. Narrative Summary: A 14-year-old boy developed vaso-occlusive event and thrombocytopenia following vaccination with COVID-19 vaccine pfizer biontech. Additionally, he exhibited lack of efficacy with ibuprofen and oxycodone while being treated for vaso-occlusive event [dosages and routes not stated]. The boy, who had homozygous sickle cell disease and was chronically prescribed with hydroxycarbamide [hydroxyurea] and voxelotor, received COVID-19 vaccine pfizer biontech [Pfizer COVID-19 vaccine] 23 days before presentation. He presented with the 3-day history of bilateral anterior hip and back pain (first vaso-occlusive event). He had received treatment with ibuprofen and oxycodone at home; however, the treatment was unsuccessful (lack of efficacy). He had a history of acute chest syndrome. At the time of presentation, he had nonpalpable spleen, elevated WBCs, and decreased platelet count i.e. thrombocytopenia [duration of treatment to reactions onsets not stated]. His SARS-Cov-2 PCR was negative. He was hospitalised and was found to have splenic sequestration and abdominal ultrasound showed a diffusely echogenic and atrophied spleen. The boy was treated with unspecified opiates and anti-inflammatory medications. He was discharged after 4 days of hospitalisation. Four days after discharge, during follow-up, his platelet count was found to be normalized.  Author's Comment: "The teen presented here is the first child with SCD reported to develop [vaso-occlusive event] and thrombocytopenia after the [COVID-19-vaccine-pfizer-biontech]." "He had unsuccessfully been treating symptoms at home with ibuprofen and oxycodone."; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound abdomen, White blood cell count
Clinical narrative: vaso-occlusive event; thrombocytopenia; splenic sequestration and abdominal ultrasound showed a diffusely echogenic and atrophied spleen.; This is a literature report for a Pfizer sponsored program (005851) for the following literature source(s): "Thrombocytopenia in a teen with sickle cell disease following COVID-19 vaccination.",  As per source verbatim: Drug Safety : ADR Case Report. COVID-19-vaccine-pfizerbiontech/ibuprofen/oxycodone. Vaso-occlusive event, thrombocytopenia and lack of efficacy: case report. Serious. Narrative Summary: A 14-year-old boy developed vaso-occlusive event and thrombocytopenia following vaccination with COVID-19 vaccine pfizer biontech. Additionally, he exhibited lack of efficacy with ibuprofen and oxycodone while being treated for vaso-occlusive event [dosages and routes not stated]. The boy, who had homozygous sickle cell disease and was chronically prescribed with hydroxycarbamide [hydroxyurea] and voxelotor, received COVID-19 vaccine pfizer biontech [Pfizer COVID-19 vaccine] 23 days before presentation. He presented with the 3-day history of bilateral anterior hip and back pain (first vaso-occlusive event). He had received treatment with ibuprofen and oxycodone at home; however, the treatment was unsuccessful (lack of efficacy). He had a history of acute chest syndrome. At the time of presentation, he had nonpalpable spleen, elevated WBCs, and decreased platelet count i.e. thrombocytopenia [duration of treatment to reactions onsets not stated]. His SARS-Cov-2 PCR was negative. He was hospitalised and was found to have splenic sequestration and abdominal ultrasound showed a diffusely echogenic and atrophied spleen. The boy was treated with unspecified opiates and anti-inflammatory medications. He was discharged after 4 days of hospitalisation. Four days after discharge, during follow-up, his platelet count was found to be normalized.  Author's Comment: "The teen presented here is the first child with SCD reported to develop [vaso-occlusive event] and thrombocytopenia after the [COVID-19-vaccine-pfizer-biontech]." "He had unsuccessfully been treating symptoms at home with ibuprofen and oxycodone."; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine, Myalgia
Clinical narrative: Migraine; Polymyalgia; Taking everything and still having migraines and polymyalgia; This is a spontaneous report from a contactable reporter (other healthcare professional-nurse) received from a Pfizer-sponsored Program. The reporter is the patient.  A 75- year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included: "pericarditis," start date: Jan2021 (unspecified if ongoing); "migraine," start date: Jan2021 (unspecified if ongoing); "polymyalgia," start date: Jan2021 (unspecified if ongoing); "fibromyalgia," start date: Jan2021 (unspecified if ongoing); "stomach issues," start date: Jan2021 (unspecified if ongoing); "diabetes" (ongoing); "COVID," start date: Jan2021 (unknown if ongoing), notes: She added in January she had Covid. The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (first dose (batch/lot number: unknown) as DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "blood sugar was below 50 the whole night," "fibromyalgia," "polymyalgia," "heart problems," "high blood pressure," and "had issues with her appetite."   The following information was reported: MIGRAINE (non-serious), outcome "not recovered," described as "Migraine"; MYALGIA (non-serious), outcome "not recovered," described as "Polymyalgia." Therapeutic measures were taken as a result of migraine, myalgia.  Additional information: The patient had a migraine every day since the second dose. She wanted to know if there was something she can do. She experienced migraine every day and had been taking a Z-Pak, had Prednisone already, and it's not subsiding. She still has migraines and has been going on for two weeks now. The patient also experienced polymyalgia on an unspecified date. Patient further reported she has been bedridden since the second dose and this has been for two weeks. Patient clarified she had been bedridden for longer than two weeks. She mentioned she is bedridden now and was bedridden two weeks prior to that. She is trying to find some things out. She has nothing against the vaccine but has medical reactions to things. She is wondering and trying to find out if other people have had this. She wanted to know if there is any other way to help the situation. She is on oxycodone three times a day, on delta 8 gummies. She had spoken to her health care provider and they don't know what to do. She is taking everything and still having migraines and polymyalgia. She has tried Prednisone and it did nothing. Patient wanted to know if other people are having reactions to the Comirnaty vaccines.   The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101651160 same reporter/patient/drug, different dose and AE.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Blood disorder, Cerebral haemorrhage, Coagulopathy, SARS-CoV-2 test
Clinical narrative: change of behavior; Brain bleed surgery; Subdural Hematoma; 2 separate pools of blood and clotting; 2 separate pools of blood and clotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 11:30 (Lot number: EW0167) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number=EW0161, administration date=15Apr2021, administration time=01:30 PM, dose number=1, vaccine location=Right arm), administration date: 15Apr2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: SUBDURAL HAEMATOMA (hospitalization, disability) with onset 15Jul2021 12:00, outcome "recovered with sequelae", described as "Subdural Hematoma"; CEREBRAL HAEMORRHAGE (hospitalization, disability) with onset 07Oct2021, outcome "recovered with sequelae", described as "Brain bleed surgery"; ABNORMAL BEHAVIOUR (hospitalization, disability), outcome "recovered with sequelae", described as "change of behavior"; BLOOD DISORDER (hospitalization, disability), COAGULOPATHY (hospitalization, disability) all with onset 15Jul2021 12:00, outcome "recovered with sequelae" and all described as "2 separate pools of blood and clotting". The patient was hospitalized for subdural haematoma, cerebral haemorrhage, abnormal behaviour, blood disorder, coagulopathy (hospitalization duration: 4 day(s)). The events "subdural hematoma", "brain bleed surgery", "change of behavior", "2 separate pools of blood and clotting" and "2 separate pools of blood and clotting" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of subdural haematoma, cerebral haemorrhage, abnormal behaviour, blood disorder, coagulopathy. Treatment included Surgery and blood drip. Subdural Hematoma. Brain bleed surgery on 07Oct2021. Symptoms started on 01Sep2021 but family described a change of behavior a few months before that. Surgeon described 2 separate pools of blood and clotting. One pool was a couple of months old while the other was of newer blood.   Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Subdural haematoma
Clinical narrative: change of behavior; Brain bleed surgery; Subdural Hematoma; 2 separate pools of blood and clotting; 2 separate pools of blood and clotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 11:30 (Lot number: EW0167) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, lot number=EW0161, administration date=15Apr2021, administration time=01:30 PM, dose number=1, vaccine location=Right arm), administration date: 15Apr2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: SUBDURAL HAEMATOMA (hospitalization, disability) with onset 15Jul2021 12:00, outcome "recovered with sequelae", described as "Subdural Hematoma"; CEREBRAL HAEMORRHAGE (hospitalization, disability) with onset 07Oct2021, outcome "recovered with sequelae", described as "Brain bleed surgery"; ABNORMAL BEHAVIOUR (hospitalization, disability), outcome "recovered with sequelae", described as "change of behavior"; BLOOD DISORDER (hospitalization, disability), COAGULOPATHY (hospitalization, disability) all with onset 15Jul2021 12:00, outcome "recovered with sequelae" and all described as "2 separate pools of blood and clotting". The patient was hospitalized for subdural haematoma, cerebral haemorrhage, abnormal behaviour, blood disorder, coagulopathy (hospitalization duration: 4 day(s)). The events "subdural hematoma", "brain bleed surgery", "change of behavior", "2 separate pools of blood and clotting" and "2 separate pools of blood and clotting" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of subdural haematoma, cerebral haemorrhage, abnormal behaviour, blood disorder, coagulopathy. Treatment included Surgery and blood drip. Subdural Hematoma. Brain bleed surgery on 07Oct2021. Symptoms started on 01Sep2021 but family described a change of behavior a few months before that. Surgeon described 2 separate pools of blood and clotting. One pool was a couple of months old while the other was of newer blood.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dehydration, Hypotension, Nausea
Clinical narrative: I had a really low drop in blood pressure probably like 74 over 54; I got really nauseous; I was just dehydrated; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0172) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient also received unspecified Vaccine. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication included: LOSARTAN taken for hypertension. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Flu vaccine 2 weeks prior to this vaccine. The following information was reported: HYPOTENSION with onset Apr2021, outcome "recovered", described as "I had a really low drop in blood pressure probably like 74 over 54"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "I got really nauseous"; DEHYDRATION (non-serious) with onset Apr2021, outcome "unknown", described as "I was just dehydrated". The patient reported: "With my second shot it was not 48 hours to probably more than 48 hours I had a really low drop in blood pressure probably like 74 over 54 which is pretty concerning that went away after couple of hours but it might have been there I was just dehydrated because I got really nauseous with the second shot. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Apr2021) probably like 74 over 54.  Follow-up (25Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Illness, Nausea, Pyrexia
Clinical narrative: the patient literally thought had COVID; the patient literally thought had COVID; got sick; Headache; Nauseas; Fever; throwing up; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: EW0178) as dose 2, single and (Lot number: EW0186) as dose 1, single for covid-19 immunisation. Relevant medical history included: "gone to the hospital before for injuries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "the patient literally thought had COVID"; ILLNESS (medically significant), outcome "unknown", described as "got sick"; HEADACHE (medically significant), outcome "unknown", described as "Headache"; NAUSEA (medically significant), outcome "unknown", described as "Nauseas"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; VOMITING (medically significant), outcome "unknown", described as "throwing up". Therapeutic measures were taken as a result of suspected covid-19, illness, headache, nausea, pyrexia, vomiting. The consumer got the Pfizer vaccine for the COVID-19 virus back probably in Mar, may be Apr (further clarification unknown) and 30 days after got it, patient got sick in the middle of night out of nowhere, like the patient have never get sick, patient had gone to the hospital before for injuries but did not ever get sick, patient hardly ever got a cold and then another 30 days were fine and 30 days to that day patient got sick at night again same thing the symptoms were headache, nauseas, fever, throwing up, like patient literally thought had COVID and then went back to sleep, after patient threw up, patient took some Tylenol then felt better the next day, now this has been happening every 30 days almost to the day patient had to begin last night but this time it was not full 30 days, it was like 27-29 days, it is almost every 30 days. Patient got sick in the middle of the night since took that vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vomiting
Clinical narrative: the patient literally thought had COVID; the patient literally thought had COVID; got sick; Headache; Nauseas; Fever; throwing up; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: EW0178) as dose 2, single and (Lot number: EW0186) as dose 1, single for covid-19 immunisation. Relevant medical history included: "gone to the hospital before for injuries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "the patient literally thought had COVID"; ILLNESS (medically significant), outcome "unknown", described as "got sick"; HEADACHE (medically significant), outcome "unknown", described as "Headache"; NAUSEA (medically significant), outcome "unknown", described as "Nauseas"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; VOMITING (medically significant), outcome "unknown", described as "throwing up". Therapeutic measures were taken as a result of suspected covid-19, illness, headache, nausea, pyrexia, vomiting. The consumer got the Pfizer vaccine for the COVID-19 virus back probably in Mar, may be Apr (further clarification unknown) and 30 days after got it, patient got sick in the middle of night out of nowhere, like the patient have never get sick, patient had gone to the hospital before for injuries but did not ever get sick, patient hardly ever got a cold and then another 30 days were fine and 30 days to that day patient got sick at night again same thing the symptoms were headache, nauseas, fever, throwing up, like patient literally thought had COVID and then went back to sleep, after patient threw up, patient took some Tylenol then felt better the next day, now this has been happening every 30 days almost to the day patient had to begin last night but this time it was not full 30 days, it was like 27-29 days, it is almost every 30 days. Patient got sick in the middle of the night since took that vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, SARS-CoV-2 test
Clinical narrative: 1st dose went in and out of AFib; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 05Jan2021 17:00 (Lot number: EL9261) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "svt" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Bees stings" (unspecified if ongoing); "asthma (now)" (ongoing). Concomitant medication(s) included: DILTIAZEM; FLECAINIDE; XARELTO; LASIX [FUROSEMIDE SODIUM]; POTASSIUM [POTASSIUM CHLORIDE]; TRIAZ [AZITHROMYCIN]. Past drug history included: Morphine, reaction(s): "known allergies: morphine"; Keflex, reaction(s): "known allergies: Keflex"; Levaquin, reaction(s): "known allergies: levaquin"; Xanax, reaction(s): "known allergies: Xanax", notes: breo versed; Aspartame, reaction(s): "known allergies: aspartame"; Metoprolol, reaction(s): "known allergies: metoprolol"; Erythromycin, reaction(s): "known allergies: erythromycin". No Other vaccine in four weeks. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 05Jan2021 19:00, outcome "unknown", described as "1st dose went in and out of AFib". The event "1st dose went in and out of afib" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Jan2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of atrial fibrillation included Cardizem drip. No Covid prior vaccination.; Sender's Comments: The event Atrial fibrillation is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: same affliction - neuropathy; This is a spontaneous report received from a contactable Consumer from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "same affliction - neuropathy". The consumer reported the patient had the "same affliction" in different part of the body.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac infection, Chest pain, Dyspnoea, Inflammation
Clinical narrative: inflammation; shortness of breath; chest pain; inflammation of her heart; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on [24Nov2021], this case contains serious adverse reaction(s) and all safety information is processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (sister) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC INFECTION (medically significant), outcome "recovered", described as "inflammation of her heart"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain". Clinical course: Sister genetically similar to reporter. Patient was Clinical pharmacist. She had inflammation. She had shortness of breath, chest pain.  Experiencing that. It states she found out her sister had it for a day, with the 2 vaccines she had inflammation of her heart and it went away after a day, she is a pharmacist specializing in cardiology.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Oxygen saturation, Oxygen saturation increased
Clinical narrative: DOSE 3 (BOOSTER), SINGLE; His O2 levels tanked on day 24 and he's back in the ICU.; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: My dad, withheld is inpatient at withheld on day 25 of COVID. The patient's concomitant medications were not reported. Past drug history included: Rituxan for a recurrence of ANKA. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant), outcome "unknown", described as "DOSE 3 (BOOSTER), SINGLE"; OXYGEN SATURATION INCREASED (hospitalization, medically significant), outcome "unknown", described as "His O2 levels tanked on day 24 and he's back in the ICU.". The events "dose 3 (booster), single" and "his o2 levels tanked on day 24 and he's back in the icu." were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: increased, notes: His O2 levels tanked on day 24. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: My 8 yr old had an allergic reaction while in the observation area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  An 8-year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 2021, outcome "unknown", described as "My 8 yr old had an allergic reaction while in the observation area". The event "my 8 yr old had an allergic reaction while in the observation area" was evaluated at the emergency room visit.Clinical course:  ''Both my 6 yr & 8 yr old daughters received their 1st covid vaccine. My 8 yr old had an allergic reaction while in the observation area, they sent her by ambulance to ER, we just received an email from withheld (our insurance) that we owe $2000.00. Wouldn't think be covered since she got the vaccine as suggested and has no history or ever reacting to medications, vaccines or anything...our insurance says we must pay, we believe in vaccines and find this unsettling.''  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Inappropriate schedule of product administration, Vomiting
Clinical narrative: Severe stomach pain; vomiting; Dose 1: 09Jul2021, Dose 2: 10Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Sep2021 (Lot number: FC3183) at the age of 13 years as DOSE 2, SINGLE for covid-19 immunisation. Relevant medical history included: "Spinal cord injury" (unspecified if ongoing), notes: Spinal cord injury at birth that affects muscles. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EW0171, Location of injection: Arm Left), administration date: 09Jul2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (medically significant) with onset 11Sep2021, outcome "recovered", described as "Severe stomach pain"; VOMITING (medically significant) with onset 11Sep2021, outcome "recovered", described as "vomiting"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Sep2021, outcome "unknown", described as "Dose 1: 09Jul2021, Dose 2: 10Sep2021". The events "severe stomach pain" and "vomiting" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of abdominal pain upper, vomiting with IV fluids and nausea medication.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 1st and 2nd dose of the vaccine then got covid; 1st and 2nd dose of the vaccine then got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 1, SINGLE and (Batch/Lot number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "1st and 2nd dose of the vaccine then got covid". Additional information: Caller withheld asked If someone received the 1st and 2nd dose of the vaccine then got covid how long they can take the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: The test was positive for Covid 19 infection; The test was positive for Covid 19 infection. Sneezing and a runny nose were his symptoms; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 08Nov2021 (Lot number: FG3527) as dose 3 (booster), single, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 08Nov2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant) with onset 24Nov2021 14:45, outcome "unknown", described as "The test was positive for Covid 19 infection"; COVID-19 (medically significant) with onset 24Nov2021 14:45, outcome "unknown", described as "The test was positive for Covid 19 infection. Sneezing and a runny nose were his symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: at 14:45. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pyrexia
Clinical narrative: booster; Fatigue; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose unknown single (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PYREXIA (non-serious), outcome "unknown", described as "low grade fever". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Pain
Clinical narrative: after a month about 15 days I was feeling intermitten shock like pain in the region near my right air; I am experiencing dull pain in my head region also near my ear; I feel like my head is being heavy sometime.; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "after a month about 15 days I was feeling intermitten shock like pain in the region near my right air"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "I am experiencing dull pain in my head region also near my ear"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "I feel like my head is being heavy sometime.".  Additional Information: The patient reported for self that doubly vaccinated by pfizer vaccine couple of month ago in withheld. I didn't have any immediate side effect. However, after a month about 15 days I was feeling intermittent shock like pain in the region near my right air. Now the shock like pain is gone. However I am experiencing dull pain in my head region also near my ear. I feel like my head is being heavy sometime. And questioned is this the side effect of vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Limb discomfort, Limb injury, Peripheral swelling
Clinical narrative: not being able to swallow or talk; fingers have been swollen and numb; fingers have been swollen and numb; Her toes can't bend- only bend half way; It feels like I have extra skin, like socks on my feet; 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 in her 50's received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHAGIA (medically significant) with onset 2021, outcome "unknown", described as "not being able to swallow or talk"; PERIPHERAL SWELLING (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "unknown" and all described as "fingers have been swollen and numb"; LIMB INJURY (non-serious) with onset 2021, outcome "unknown", described as "Her toes can't bend- only bend half way"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "It feels like I have extra skin, like socks on my feet". The event "not being able to swallow or talk" was evaluated at the physician office visit.  Clinical information: She has a CNA on the line who received first dose of the Pfizer BioNtech COVID 19 vaccine in Apr2021, and second in May2021. She has been out of town. Since she got the vaccine, her fingers have been swollen and numb. She can only bend her toes halfway. She said it feels like she has extra skin on her feet like she has socks on her feet. While out of town in (withheld), she could not swallow or talk and was seen by a doctor in (withheld). She did not say what they told her. She has spoken to her Pharmacy and they said they have had similar complaints from other patients. She declined specific age but said she was in her 50's. Agent provided answer to her questions and said her symptoms were not reported and referred her back to her primary care provider. Caller disconnected prior to transfer.  No further details provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Axillary pain, Chills, Depressed mood, Dizziness
Clinical narrative: Pain on the injection site, the arm under the armpit and around the heart; I do had the booster shot; Dizzy; I already felt down; pain on the injection site, the arm under the armpit and around the heart; Feeling unwell; Muscle pain; Chills; Nausea; pain on the injection site, the arm under the armpit and around the heart; pain on the injection site, the arm under the armpit and around the heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown, Expiry date: unknown, NDC/UPC number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization; Bnt162b2 (2nd Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "Pain on the injection site, the arm under the armpit and around the heart"; IMMUNISATION (medically significant), outcome "unknown", described as "I do had the booster shot"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I already felt down"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain on the injection site, the arm under the armpit and around the heart".   Clinical information: The patient wanted to know if the booster shot really was the right one or not. The patient was in a little bit in time pressure when requested for further information and was unwilling to complete the report. Regarding the lot number the patient thought of talking about it to medical info department. On request an attempt was made to transfer the call to Pfizer Medical Information Department however it was unsuccessful and call got hung up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Pain on the injection site, the arm under the armpit and around the heart; I do had the booster shot; Dizzy; I already felt down; pain on the injection site, the arm under the armpit and around the heart; Feeling unwell; Muscle pain; Chills; Nausea; pain on the injection site, the arm under the armpit and around the heart; pain on the injection site, the arm under the armpit and around the heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown, Expiry date: unknown, NDC/UPC number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization; Bnt162b2 (2nd Dose, I do have the both dose injection of also Pfizer.), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "Pain on the injection site, the arm under the armpit and around the heart"; IMMUNISATION (medically significant), outcome "unknown", described as "I do had the booster shot"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "I already felt down"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain on the injection site, the arm under the armpit and around the heart".   Clinical information: The patient wanted to know if the booster shot really was the right one or not. The patient was in a little bit in time pressure when requested for further information and was unwilling to complete the report. Regarding the lot number the patient thought of talking about it to medical info department. On request an attempt was made to transfer the call to Pfizer Medical Information Department however it was unsuccessful and call got hung up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.