chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Nerve injury, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Some food" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. The following information was reported: PAIN IN EXTREMITY (disability) with onset 03Nov2021, outcome "not recovered", described as "Her arm has been in major pain"; VACCINATION SITE PAIN (disability) with onset 03Nov2021, outcome "not recovered", described as "Her arm has been in major pain. Especially in the shot injection site"; MUSCLE TIGHTNESS (disability) with onset 03Nov2021, outcome "not recovered", described as "tension in her left side from left arm spanning all muscles in her neck and upper arms"; MYALGIA (disability) with onset 03Nov2021, outcome "not recovered", described as "extreme pain and tension in her left side from left arm spanning all muscles in her neck and upper arms"; VACCINATION SITE PRURITUS (disability), VACCINATION SITE BRUISING (disability) all with onset 03Nov2021, outcome "not recovered" and all described as "The injection site feel itchy and like an extreme bruise"; NERVE INJURY (disability) with onset 03Nov2021, outcome "not recovered", described as "slight nerve damage on her left arm and fingers"; PAIN (disability) with onset 03Nov2021, outcome "not recovered", described as "pain". Got shot in left arm 03Nov2021. She never once had Covid. Once the shot happened. Her arm has been in major pain. Especially in the shot injection site. That day and Still till today she has had extreme pain and tension in her left side from left arm spanning all muscles in her neck and upper arms. The injection site still felt itchy and like an extreme bruise and it was not going away. She has also experienced slight nerve damage on her left arm and fingers. It was not getting better and she was very scared to take her second shot and not sure when her arm, tension and the injection site will get better. She was so upset and it was affecting her badly. She was in so much pain. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, muscle tightness, myalgia, vaccination site pruritus, vaccination site bruising, nerve injury, pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site bruising, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Some food" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. The following information was reported: PAIN IN EXTREMITY (disability) with onset 03Nov2021, outcome "not recovered", described as "Her arm has been in major pain"; VACCINATION SITE PAIN (disability) with onset 03Nov2021, outcome "not recovered", described as "Her arm has been in major pain. Especially in the shot injection site"; MUSCLE TIGHTNESS (disability) with onset 03Nov2021, outcome "not recovered", described as "tension in her left side from left arm spanning all muscles in her neck and upper arms"; MYALGIA (disability) with onset 03Nov2021, outcome "not recovered", described as "extreme pain and tension in her left side from left arm spanning all muscles in her neck and upper arms"; VACCINATION SITE PRURITUS (disability), VACCINATION SITE BRUISING (disability) all with onset 03Nov2021, outcome "not recovered" and all described as "The injection site feel itchy and like an extreme bruise"; NERVE INJURY (disability) with onset 03Nov2021, outcome "not recovered", described as "slight nerve damage on her left arm and fingers"; PAIN (disability) with onset 03Nov2021, outcome "not recovered", described as "pain". Got shot in left arm 03Nov2021. She never once had Covid. Once the shot happened. Her arm has been in major pain. Especially in the shot injection site. That day and Still till today she has had extreme pain and tension in her left side from left arm spanning all muscles in her neck and upper arms. The injection site still felt itchy and like an extreme bruise and it was not going away. She has also experienced slight nerve damage on her left arm and fingers. It was not getting better and she was very scared to take her second shot and not sure when her arm, tension and the injection site will get better. She was so upset and it was affecting her badly. She was in so much pain. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, muscle tightness, myalgia, vaccination site pruritus, vaccination site bruising, nerve injury, pain. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, Gastrointestinal pain, Polymerase chain reaction
Clinical narrative: anaphylaxis reaction; strong intestinal pain; Test result: Positive; This is a spontaneous report received from contactable reporters (Consumer or other non-HCP and Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 13:00 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADD" (unspecified if ongoing); "allergies: Milk" (unspecified if ongoing); "allergies: food" (unspecified if ongoing); "allergies: dye" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication included: ADDERALL. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "strong intestinal pain"; COVID-19 (non-serious) with onset 21Mar2021, outcome "unknown", described as "Test result: Positive". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (21Mar2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of anaphylactic reaction.  When patient received her dose, she should have had an anaphylaxis reaction days later when she had a interaction with her forgot to ask for special instructions on a food ordered for curbside. She then started testing her allergy/ sensitivity. Normally it took several eppi pens to normalize the reaction and following days strong intestinal pain. But absolutely no issues with milk adverse reactions. Patient had her last dose in August and she could tell that her allergy was now coming back.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted Covid 19; contracted Covid 19; This is a spontaneous report received from non-contactable reporter (Other HCP) via a Pfizer sales representative.  A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Oct2021, outcome "unknown" and all described as "contracted Covid 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient received second dose of Pfizer's Covid 19 vaccine in Jul and contracted Covid 19 in Oct requiring admission to ICU (Intensive care units), with Covid PNA (peptide nucleic acid) and requiring high flow O2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The patient received the first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) and got COVID-19.  Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, SARS-CoV-2 test
Clinical narrative: dizziness; palpitations; lightheadedness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2021 (Lot number: ek9231) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: covid prior vaccination. There were no concomitant medications. The following information was reported: DIZZINESS (hospitalization, disability) with onset 07Jan2021, outcome "not recovered", described as "dizziness"; PALPITATIONS (hospitalization, disability) with onset 07Jan2021, outcome "not recovered", described as "palpitations"; DIZZINESS (hospitalization, disability) with onset 07Jan2021, outcome "not recovered", described as "lightheadedness". The patient was hospitalized for dizziness, palpitations, dizziness (hospitalization duration: 3 day(s)). The events "dizziness", "palpitations" and "lightheadedness" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of dizziness, palpitations, dizziness including IV fluids, meds. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage]. No other medications the patient received within 2 weeks of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of Dizziness, Palpitations cannot be totally 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Heart rate increased, Immunisation, Rash, Swelling
Clinical narrative: Booster; Anaphylactic Shock; throat closure; rash; swelling; rapid heart rate; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 14:00 (Lot number: FF2590) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Rhuematoid Arth" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergy to Poultry" (unspecified if ongoing); "allergy to Eggs" (unspecified if ongoing); "allergy to gluten" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medications included: LANTUS; HUMALOG; ENBREL; SINGULAIR; LISINOPRIL. Past drug history included: Dimetapp, reaction(s): "Allergy"; Guaifenesin, reaction(s): "Allergy"; Erythromycin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 38 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 23Apr2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; ANAPHYLACTIC SHOCK (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "Anaphylactic Shock"; THROAT TIGHTNESS (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "throat closure"; RASH (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "rash"; SWELLING (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "swelling"; HEART RATE INCREASED (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "rapid heart rate". The events "anaphylactic shock", "throat closure", "rash", "swelling" and "rapid heart rate" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic shock, throat tightness, rash, swelling, heart rate increased included Epipen, Benadryl 75 mg, steroids, pepcid, fluids. She had Covid prior vaccination, no Covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Booster; Anaphylactic Shock; throat closure; rash; swelling; rapid heart rate; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 14:00 (Lot number: FF2590) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Rhuematoid Arth" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "allergy to Poultry" (unspecified if ongoing); "allergy to Eggs" (unspecified if ongoing); "allergy to gluten" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medications included: LANTUS; HUMALOG; ENBREL; SINGULAIR; LISINOPRIL. Past drug history included: Dimetapp, reaction(s): "Allergy"; Guaifenesin, reaction(s): "Allergy"; Erythromycin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Apr2021, when the patient was 38 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 23Apr2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; ANAPHYLACTIC SHOCK (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "Anaphylactic Shock"; THROAT TIGHTNESS (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "throat closure"; RASH (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "rash"; SWELLING (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "swelling"; HEART RATE INCREASED (medically significant) with onset 15Nov2021 14:30, outcome "recovering", described as "rapid heart rate". The events "anaphylactic shock", "throat closure", "rash", "swelling" and "rapid heart rate" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of anaphylactic shock, throat tightness, rash, swelling, heart rate increased included Epipen, Benadryl 75 mg, steroids, pepcid, fluids. She had Covid prior vaccination, no Covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was fully vaccinated with the Pfizer vaccine, had tested through a rapid test, positive for Covid; was fully vaccinated with the Pfizer vaccine, had tested through a rapid test, positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE, COVID-19 all with onset 16Nov2021, outcome "unknown" and all described as "was fully vaccinated with the Pfizer vaccine, had tested through a rapid test, positive for Covid". Symptoms included mild sinus congestion and fatigue. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on 16Nov2021; Tested positive for COVID on 16Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE, COVID-19 all with onset 16Nov2021, outcome "unknown" and all described as "Tested positive for COVID on 16Nov2021". Symptoms: chills, fatigue, headache, sore throat. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid19 illness - Nov2021 (vaccination May2021); Covid19 illness - Nov2021 (vaccination May2021); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Nov2021, outcome "recovering" and all described as "Covid19 illness - Nov2021 (vaccination May2021)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Asthma, Condition aggravated, Facial spasm, Flushing
Clinical narrative: worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; Covid-19 Booster; felt like passing out; Pain; flushed; tooth infection; has not helped with hives; trigeminal neuralgia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hemifacial spasms" (ongoing); "weight gain" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Recollection is not good with dates" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR; BOTOX; TEGRETOL. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Nov2021, outcome "unknown", described as "Covid-19 Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2021, outcome "unknown", described as "felt like passing out"; ANGIOEDEMA (medically significant) with onset 02Nov2021, outcome "unknown", described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain"; HYPERSENSITIVITY (non-serious), ASTHMA (non-serious), FACIAL SPASM (non-serious), WEIGHT INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 02Nov2021, outcome "unknown" and all described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain."; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Pain"; FLUSHING (non-serious) with onset Nov2021, outcome "unknown", described as "flushed"; TOOTH INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "tooth infection"; URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "has not helped with hives"; TRIGEMINAL NEURALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "trigeminal neuralgia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation, Loss of consciousness, Pain, Tooth infection
Clinical narrative: worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; Covid-19 Booster; felt like passing out; Pain; flushed; tooth infection; has not helped with hives; trigeminal neuralgia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hemifacial spasms" (ongoing); "weight gain" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Recollection is not good with dates" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR; BOTOX; TEGRETOL. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Nov2021, outcome "unknown", described as "Covid-19 Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2021, outcome "unknown", described as "felt like passing out"; ANGIOEDEMA (medically significant) with onset 02Nov2021, outcome "unknown", described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain"; HYPERSENSITIVITY (non-serious), ASTHMA (non-serious), FACIAL SPASM (non-serious), WEIGHT INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 02Nov2021, outcome "unknown" and all described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain."; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Pain"; FLUSHING (non-serious) with onset Nov2021, outcome "unknown", described as "flushed"; TOOTH INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "tooth infection"; URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "has not helped with hives"; TRIGEMINAL NEURALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "trigeminal neuralgia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia, Urticaria, Weight increased
Clinical narrative: worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; Covid-19 Booster; felt like passing out; Pain; flushed; tooth infection; has not helped with hives; trigeminal neuralgia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hemifacial spasms" (ongoing); "weight gain" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Recollection is not good with dates" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR; BOTOX; TEGRETOL. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Nov2021, outcome "unknown", described as "Covid-19 Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2021, outcome "unknown", described as "felt like passing out"; ANGIOEDEMA (medically significant) with onset 02Nov2021, outcome "unknown", described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain"; HYPERSENSITIVITY (non-serious), ASTHMA (non-serious), FACIAL SPASM (non-serious), WEIGHT INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 02Nov2021, outcome "unknown" and all described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain."; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Pain"; FLUSHING (non-serious) with onset Nov2021, outcome "unknown", described as "flushed"; TOOTH INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "tooth infection"; URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "has not helped with hives"; TRIGEMINAL NEURALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "trigeminal neuralgia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Thrombosis
Clinical narrative: muscle aches occurring in the legs, along with worse lumps that are undiagnosed appearing to be blood clots in the legs; muscle aches occurring in the legs, along with worse lumps that are undiagnosed appearing to be blood clots in the legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2577013 (Genentech, Inc). A 79 year-old female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Melanoma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "2 Bad heart valves" (unspecified if ongoing); "Aortic insufficiency" (unspecified if ongoing); "Pancreatitis" (unspecified if ongoing); "Brain tumor" (unspecified if ongoing); "stage 1 Bronchioloalveolar carcinoma" (unspecified if ongoing); "stage 4 Bronchioloalveolar carcinoma" (unspecified if ongoing); "metastasis into both lungs" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "high triglycerides" (unspecified if ongoing); "thyroid obliterated" (unspecified if ongoing); "irregular heart beat" (unspecified if ongoing); "appendix removed" (unspecified if ongoing); "lung cancer surgery" (unspecified if ongoing); "benign meningioma surgery" (unspecified if ongoing); "Brain tumor" (unspecified if ongoing); "Lobectomy" (unspecified if ongoing); "Lung inflammation" (unspecified if ongoing); "Chronic bronchitis" (unspecified if ongoing). Concomitant medication(s) included: TARCEVA. Past drug history included: Levothyroxine sodium, reaction(s): "Allergy". The following information was reported: THROMBOSIS (medically significant), MYALGIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "muscle aches occurring in the legs, along with worse lumps that are undiagnosed appearing to be blood clots in the legs".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (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: DEATH (death, medically significant), outcome "fatal", described as "Died after receiving the vaccine". The patient date of death was unknown. The reported cause of death was "Died after receiving the vaccine". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up. ; Reported Cause(s) of Death: Died after receiving the vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Flushing, Heart rate increased, Nausea, Periorbital swelling
Clinical narrative: eyes felt puffy; itchy and flushed again/felt itchy all over; heart rate quickened; felt sick to stomach; coughing; itchy and flushed again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20May2021 03:30 (Lot number: EW0177) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mastocytosis" (unspecified if ongoing); "meningioma" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; ALLEGRA; PEPCID [FAMOTIDINE]; SINGULAIR; ASPIRIN [ACETYLSALICYLIC ACID]; ETORICOXIB. Vaccination history included: Bnt162b2 (dose 1), administration date: 29Apr2021, when the patient was 35 years old, for COVID-19 IMMUNIZATION, reaction(s): "felt itchy", "flushed". No other vaccine in four weeks. The following information was reported: PERIORBITAL SWELLING (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "eyes felt puffy"; PRURITUS (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "itchy and flushed again/felt itchy all over"; HEART RATE INCREASED (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "heart rate quickened"; NAUSEA (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "felt sick to stomach"; COUGH (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "coughing"; FLUSHING (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "itchy and flushed again". The events "eyes felt puffy", "itchy and flushed again/felt itchy all over", "heart rate quickened", "felt sick to stomach", "coughing" and "itchy and flushed again" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of periorbital swelling, pruritus, heart rate increased, nausea, cough, flushing included Epinephrine, pepcid.   Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: eyes felt puffy; itchy and flushed again/felt itchy all over; heart rate quickened; felt sick to stomach; coughing; itchy and flushed again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20May2021 03:30 (Lot number: EW0177) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mastocytosis" (unspecified if ongoing); "meningioma" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; ALLEGRA; PEPCID [FAMOTIDINE]; SINGULAIR; ASPIRIN [ACETYLSALICYLIC ACID]; ETORICOXIB. Vaccination history included: Bnt162b2 (dose 1), administration date: 29Apr2021, when the patient was 35 years old, for COVID-19 IMMUNIZATION, reaction(s): "felt itchy", "flushed". No other vaccine in four weeks. The following information was reported: PERIORBITAL SWELLING (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "eyes felt puffy"; PRURITUS (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "itchy and flushed again/felt itchy all over"; HEART RATE INCREASED (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "heart rate quickened"; NAUSEA (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "felt sick to stomach"; COUGH (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "coughing"; FLUSHING (medically significant) with onset 20May2021 19:30, outcome "recovered", described as "itchy and flushed again". The events "eyes felt puffy", "itchy and flushed again/felt itchy all over", "heart rate quickened", "felt sick to stomach", "coughing" and "itchy and flushed again" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of periorbital swelling, pruritus, heart rate increased, nausea, cough, flushing included Epinephrine, pepcid.   Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: experiencing blood clotting in my right leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EL9264) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal Allergies" (unspecified if ongoing); "known_allergies: Pecans" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose , Batch/Lot Number: EL3247, Location of injection: Arm Left), administration date: 19Jan2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 01Oct2021, outcome "not recovered", described as "experiencing blood clotting in my right leg". The event "experiencing blood clotting in my right leg" was evaluated at the physician office visit. Therapeutic measures were taken as a result of thrombosis. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 03:30 (Lot number: EW0167) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "systemic mastocytosis" (unspecified if ongoing); "Meningioma" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN]; ALLEGRA; PEPCID [FAMOTIDINE]; SINGULAIR; ASPIRIN [ACETYLSALICYLIC ACID]; ETORICOXIB. The following information was reported: FLUSHING (non-serious) with onset 2021, outcome "recovered", described as "flushed"; PRURITUS (non-serious) with onset 2021, outcome "recovered", described as "felt itchy". Therapeutic measures were taken as a result of flushing, pruritus. Additional information: No other vaccine in four weeks. The patient received Benedryl as treatment for events. The case considered non-serious. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101616420 same patient/drug, different AE and dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy- EE had a positive rapid COVID test on 18Nov with symptoms beginning 15Nov; had become symptomatic on 15Nov; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 (Lot number: EL3247) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer COVID19 vaccine Dose 1 ,  lot number: EL3247,  Intramuscular, Vaccine location: Left arm), administration date: 11Feb2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", described as "Lack of efficacy- EE had a positive rapid COVID test on 18Nov with symptoms beginning 15Nov"; EXPOSURE TO SARS-COV-2 (medically significant) with onset 13Nov2021, outcome "unknown", described as "COVID19 exposure on 13Nov2021"; COVID-19 (medically significant) with onset 15Nov2021, outcome "unknown", described as "had become symptomatic on 15Nov". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, exposure to sars-cov-2, covid-19.  Clinical course: On 18Nov2021 that she tested CV19 positive on 18Nov2021 by rapid test, had become symptomatic on 15Nov, and had close contact on 13Nov2021 to someone who later tested positive for COVID19. It was unknown if patient had covid prior to vaccination and unknown if received any other vaccine in four weeks   No follow-up attempts are possible; No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Night sweats, Pain, Pain in extremity
Clinical narrative: Sore left arm at injection site 1st two days; Swollen lymph node(s) under left armpit 2nd & 3rd days, golf-ballsized; very painful; Soaking night sweats Monday night and Tuesday nights.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 02:45 (Lot number: FG3527) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "IBS" (unspecified if ongoing); "PMR in remission" (unspecified if ongoing); "Latex" (unspecified if ongoing); "eggs" (unspecified if ongoing); "yeast" (unspecified if ongoing), notes: Known allergies: Yeast; "Sensitive to: Gluten" (unspecified if ongoing); "molds" (unspecified if ongoing); "preservative" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE ACETATE taken for polymyalgia rheumatica; SYNTHROID; NALTREXONE; BUPROPION. Past drug history included: Guaifenesin, reaction(s): "Known allergies: guaifenesin"; Erythromycin, reaction(s): "Known allergies: erythromycin"; Lactose, reaction(s): "known allergies: lactose". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, No effects at all 1st and 2nd injection), administration date: 07May2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "No reaction"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, No effects at all 1st and 2nd injection), administration date: 16Apr2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "No reaction".The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "Sore left arm at injection site 1st two days"; LYMPHADENOPATHY (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "Swollen lymph node(s) under left armpit 2nd & 3rd days, golf-ballsized"; PAIN (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "very painful"; NIGHT SWEATS (non-serious) with onset 15Nov2021 16:00, outcome "recovering", described as "Soaking night sweats Monday night and Tuesday nights.". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, pain, night sweats.Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID rapid antigen was done and positive; COVID rapid antigen was done and positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date 24Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administration date 13Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation; adalimumab (HUMIRA), subcutaneous since 2021 (Batch/Lot number: unknown) at 40 mg cyclic (40 mg, q 14 days) for juvenile idiopathic arthritis. Relevant medical history included: "Juvenile rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID rapid antigen was done and positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. The action taken for adalimumab was unknown. Clinical course: Later on 15Nov2021 date started not feeling well developing cough, fatigue, low grade fever with loss of taste and smell.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Axillary pain, Chills, Headache, Immunisation
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 (Lot number: EW0196) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EL3247), administration date: 03Mar2021, when the patient was 33 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 2, Lot Number: EL3247), administration date: 24Mar2021, when the patient was 33 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "booster"; PAIN (non-serious), outcome "unknown", described as "Body aches"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; AXILLARY PAIN (non-serious), outcome "unknown", described as "sore underarm"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills". No follow-up attempts are possible. No further information is expected.