chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-GAD antibody positive, Anti-zinc transporter 8 antibody positive, Blood glucose increased, Blood insulin normal, Cardiac monitoring abnormal
Clinical narrative: Latent Autoimmune Diabetes, I began struggling with symptoms of diabetes.; Premature Atrial Complexes; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A 60-year-old non-pregnant female patient received the first dose (Lot Number: EL3246) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Jan2021 at 11:00, then the second dose (Lot Number: EM9810) on 13Feb2021 at 11:45, both via an unspecified route of administration, in arm left as a single dose (at the age of 60-years-old) for COVID-19 immunisation. Medical history included autoimmune thyroiditis/Hashimoto's thyroiditis; the patient had allergy to penicillin. The patient previously received tetracycline and experienced allergy. The patient had a family history of type 2 diabetes (dad and sister). The patient's had other concomitant medications (unspecified) in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that since the week after the first Pfizer vaccine, in 2021, she began struggling with symptoms of diabetes. The patient experienced extreme thirst, frequent urination and she lost 17 pounds in the 3 weeks following the first dose, in Feb2021. The patient never associated it with the vaccine, initially, because she never heard of any side effects like increased glucose, and her dad and sister have type 2 diabetes, so she was altering her diet, but the symptoms did not subside. Her A1C on 15Oct2020 was 6.1. The patient did not have COVID-19 prior to vaccination. The patient had a negative COVID nasal swab test on 11Feb2021. On 23Mar2021, it was reported that the patient received the second dose on 13Feb2021, and she knew something was seriously wrong. That afternoon her blood sugar was 528, her vision was blurred, and she experienced a strange feeling in her heart. On 15Feb2021, she saw her general physician (GP). She was diagnosed with diabetes and put on medication (metformin and glipizide). She proceeded to see an endocrinologist, she was put on insulin and after additional blood tests was diagnosed with latent autoimmune diabetes and premature atrial complexes. The outcome of the events was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (23Mar2021): This is a follow-up report combining information from duplicate reports 2021270075 and 2021251855. The current and all subsequent information will be reported under manufacturer report number 2021251855. The new information reported from the same contactable consumer includes lab data (added Blood sugar test, Blood test and HbA1C/A1C), suspect drug details (added second dose), concomitant therapy and reaction details (updated treatment received for event premature atrial complexes).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glomerular filtration rate decreased, Insulin C-peptide, Latent autoimmune diabetes in adults, Pollakiuria, Supraventricular extrasystoles
Clinical narrative: Latent Autoimmune Diabetes, I began struggling with symptoms of diabetes.; Premature Atrial Complexes; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A 60-year-old non-pregnant female patient received the first dose (Lot Number: EL3246) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Jan2021 at 11:00, then the second dose (Lot Number: EM9810) on 13Feb2021 at 11:45, both via an unspecified route of administration, in arm left as a single dose (at the age of 60-years-old) for COVID-19 immunisation. Medical history included autoimmune thyroiditis/Hashimoto's thyroiditis; the patient had allergy to penicillin. The patient previously received tetracycline and experienced allergy. The patient had a family history of type 2 diabetes (dad and sister). The patient's had other concomitant medications (unspecified) in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that since the week after the first Pfizer vaccine, in 2021, she began struggling with symptoms of diabetes. The patient experienced extreme thirst, frequent urination and she lost 17 pounds in the 3 weeks following the first dose, in Feb2021. The patient never associated it with the vaccine, initially, because she never heard of any side effects like increased glucose, and her dad and sister have type 2 diabetes, so she was altering her diet, but the symptoms did not subside. Her A1C on 15Oct2020 was 6.1. The patient did not have COVID-19 prior to vaccination. The patient had a negative COVID nasal swab test on 11Feb2021. On 23Mar2021, it was reported that the patient received the second dose on 13Feb2021, and she knew something was seriously wrong. That afternoon her blood sugar was 528, her vision was blurred, and she experienced a strange feeling in her heart. On 15Feb2021, she saw her general physician (GP). She was diagnosed with diabetes and put on medication (metformin and glipizide). She proceeded to see an endocrinologist, she was put on insulin and after additional blood tests was diagnosed with latent autoimmune diabetes and premature atrial complexes. The outcome of the events was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (23Mar2021): This is a follow-up report combining information from duplicate reports 2021270075 and 2021251855. The current and all subsequent information will be reported under manufacturer report number 2021251855. The new information reported from the same contactable consumer includes lab data (added Blood sugar test, Blood test and HbA1C/A1C), suspect drug details (added second dose), concomitant therapy and reaction details (updated treatment received for event premature atrial complexes).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst, Vision blurred, Weight decreased
Clinical narrative: Latent Autoimmune Diabetes, I began struggling with symptoms of diabetes.; Premature Atrial Complexes; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A 60-year-old non-pregnant female patient received the first dose (Lot Number: EL3246) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Jan2021 at 11:00, then the second dose (Lot Number: EM9810) on 13Feb2021 at 11:45, both via an unspecified route of administration, in arm left as a single dose (at the age of 60-years-old) for COVID-19 immunisation. Medical history included autoimmune thyroiditis/Hashimoto's thyroiditis; the patient had allergy to penicillin. The patient previously received tetracycline and experienced allergy. The patient had a family history of type 2 diabetes (dad and sister). The patient's had other concomitant medications (unspecified) in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that since the week after the first Pfizer vaccine, in 2021, she began struggling with symptoms of diabetes. The patient experienced extreme thirst, frequent urination and she lost 17 pounds in the 3 weeks following the first dose, in Feb2021. The patient never associated it with the vaccine, initially, because she never heard of any side effects like increased glucose, and her dad and sister have type 2 diabetes, so she was altering her diet, but the symptoms did not subside. Her A1C on 15Oct2020 was 6.1. The patient did not have COVID-19 prior to vaccination. The patient had a negative COVID nasal swab test on 11Feb2021. On 23Mar2021, it was reported that the patient received the second dose on 13Feb2021, and she knew something was seriously wrong. That afternoon her blood sugar was 528, her vision was blurred, and she experienced a strange feeling in her heart. On 15Feb2021, she saw her general physician (GP). She was diagnosed with diabetes and put on medication (metformin and glipizide). She proceeded to see an endocrinologist, she was put on insulin and after additional blood tests was diagnosed with latent autoimmune diabetes and premature atrial complexes. The outcome of the events was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (23Mar2021): This is a follow-up report combining information from duplicate reports 2021270075 and 2021251855. The current and all subsequent information will be reported under manufacturer report number 2021251855. The new information reported from the same contactable consumer includes lab data (added Blood sugar test, Blood test and HbA1C/A1C), suspect drug details (added second dose), concomitant therapy and reaction details (updated treatment received for event premature atrial complexes).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose abnormal, Blood test, Glycosylated haemoglobin, Latent autoimmune diabetes in adults, SARS-CoV-2 test
Clinical narrative: Latent Autoimmune Diabetes, I began struggling with symptoms of diabetes.; Premature Atrial Complexes; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A 60-year-old non-pregnant female patient received the first dose (Lot Number: EL3246) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Jan2021 at 11:00, then the second dose (Lot Number: EM9810) on 13Feb2021 at 11:45, both via an unspecified route of administration, in arm left as a single dose (at the age of 60-years-old) for COVID-19 immunisation. Medical history included autoimmune thyroiditis/Hashimoto's thyroiditis; the patient had allergy to penicillin. The patient previously received tetracycline and experienced allergy. The patient had a family history of type 2 diabetes (dad and sister). The patient's had other concomitant medications (unspecified) in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that since the week after the first Pfizer vaccine, in 2021, she began struggling with symptoms of diabetes. The patient experienced extreme thirst, frequent urination and she lost 17 pounds in the 3 weeks following the first dose, in Feb2021. The patient never associated it with the vaccine, initially, because she never heard of any side effects like increased glucose, and her dad and sister have type 2 diabetes, so she was altering her diet, but the symptoms did not subside. Her A1C on 15Oct2020 was 6.1. The patient did not have COVID-19 prior to vaccination. The patient had a negative COVID nasal swab test on 11Feb2021. On 23Mar2021, it was reported that the patient received the second dose on 13Feb2021, and she knew something was seriously wrong. That afternoon her blood sugar was 528, her vision was blurred, and she experienced a strange feeling in her heart. On 15Feb2021, she saw her general physician (GP). She was diagnosed with diabetes and put on medication (metformin and glipizide). She proceeded to see an endocrinologist, she was put on insulin and after additional blood tests was diagnosed with latent autoimmune diabetes and premature atrial complexes. The outcome of the events was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (23Mar2021): This is a follow-up report combining information from duplicate reports 2021270075 and 2021251855. The current and all subsequent information will be reported under manufacturer report number 2021251855. The new information reported from the same contactable consumer includes lab data (added Blood sugar test, Blood test and HbA1C/A1C), suspect drug details (added second dose), concomitant therapy and reaction details (updated treatment received for event premature atrial complexes).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Supraventricular extrasystoles
Clinical narrative: Latent Autoimmune Diabetes, I began struggling with symptoms of diabetes.; Premature Atrial Complexes; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer-sponsored program. A 60-year-old non-pregnant female patient received the first dose (Lot Number: EL3246) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Jan2021 at 11:00, then the second dose (Lot Number: EM9810) on 13Feb2021 at 11:45, both via an unspecified route of administration, in arm left as a single dose (at the age of 60-years-old) for COVID-19 immunisation. Medical history included autoimmune thyroiditis/Hashimoto's thyroiditis; the patient had allergy to penicillin. The patient previously received tetracycline and experienced allergy. The patient had a family history of type 2 diabetes (dad and sister). The patient's had other concomitant medications (unspecified) in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that since the week after the first Pfizer vaccine, in 2021, she began struggling with symptoms of diabetes. The patient experienced extreme thirst, frequent urination and she lost 17 pounds in the 3 weeks following the first dose, in Feb2021. The patient never associated it with the vaccine, initially, because she never heard of any side effects like increased glucose, and her dad and sister have type 2 diabetes, so she was altering her diet, but the symptoms did not subside. Her A1C on 15Oct2020 was 6.1. The patient did not have COVID-19 prior to vaccination. The patient had a negative COVID nasal swab test on 11Feb2021. On 23Mar2021, it was reported that the patient received the second dose on 13Feb2021, and she knew something was seriously wrong. That afternoon her blood sugar was 528, her vision was blurred, and she experienced a strange feeling in her heart. On 15Feb2021, she saw her general physician (GP). She was diagnosed with diabetes and put on medication (metformin and glipizide). She proceeded to see an endocrinologist, she was put on insulin and after additional blood tests was diagnosed with latent autoimmune diabetes and premature atrial complexes. The outcome of the events was not recovered.  Follow up attempts are needed. Further information has been requested.  Follow-up (23Mar2021): This is a follow-up report combining information from duplicate reports 2021270075 and 2021251855. The current and all subsequent information will be reported under manufacturer report number 2021251855. The new information reported from the same contactable consumer includes lab data (added Blood sugar test, Blood test and HbA1C/A1C), suspect drug details (added second dose), concomitant therapy and reaction details (updated treatment received for event premature atrial complexes).
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Epinephrine, Heart rate increased, Immediate post-injection reaction, Nausea, Pruritus
Clinical narrative: EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory rate increased, Retching
Clinical narrative: EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Oropharyngeal discomfort, Pain, Pruritus
Clinical narrative: EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse reaction, Asthenia, Asthma, Hypoaesthesia, Injection site pain
Clinical narrative: EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Nausea, Pain, Panic attack, Pruritus
Clinical narrative: EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: EXACERBATED SIDE EFFECTS OF DAILY MEDICATION; ITCHING; HIVES; SHOOTING PAIN; SENSATION OF COTTON BALL IN THROAT; NAUSEA; SORE ARM AT SITE OF INJECTION; SWOLLEN ARM AT SITE OF INJECTION; WEAKNESS; NUMBNESS IN HANDS AND FEET; ASTHMA; PANIC ATTACKS; his spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included fever, and concurrent conditions included anaphylactic allergy to milk, tree nut allergy, asthma, allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with ciprofloxacin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered in left arm on 10-MAR-2021 12:43 for prophylactic vaccination. Concomitant medications included dexamethasone, diphenhydramine hydrochloride, epinephrine, famotidine, lisdexamfetamine mesilate, and sodium chloride. On MAR-2021, the subject experienced asthma. On MAR-2021, the subject experienced panic attacks. On 10-MAR-2021, the subject experienced numbness in hands and feet. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced sore arm at site of injection. On 10-MAR-2021, the subject experienced swollen arm at site of injection. On 10-MAR-2021 12:48, the subject experienced shooting pain. On 10-MAR-2021 12:48, the subject experienced sensation of cotton ball in throat. On 10-MAR-2021 12:48, the subject experienced hives. On 10-MAR-2021 12:48, the subject experienced nausea. On an unspecified date, the subject experienced exacerbated side effects of daily medication, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma, exacerbated side effects of daily medication, panic attacks, nausea, shooting pain, hives, sensation of cotton ball in throat, weakness, numbness in hands and feet, swollen arm at site of injection, sore arm at site of injection and itching was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Communication disorder, Cyanosis, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction and severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 2021032606-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Gait inability, Malaise, Metamorphopsia, Nausea
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction and severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 2021032606-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cyanosis, Dizziness, Dyspnoea, Nausea
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction and severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 2021032606-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction and severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 2021032606-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction and severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 2021032606-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She still has are that she still doesn't have her taste and sense of smell back; She still has are that she still doesn't have her taste and sense of smell back; Had a little congestion; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable Nurse (patient) A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3302, Expiration date MAY-2021), via an unspecified route of administration, anatomical location- Left Arm on 18Jan2021 15:20, as single dose for Covid-19 immunization. The patient medical history and concomitant medication were not reported. It was reported that since she got her first dose injected 18Jan2021 at 15:20 and then tested positive 24Jan2021 for COVID-19 with an unknown name rapid test. She says she would like to know if she is supposed to wait or not get the second dose of the vaccine. Also reported that they did start her on new medications when she got sick. She says that her COVID-19 symptoms she still has are that she still doesn't have her taste and sense of smell back. She says for treatment she is taking Vitamins D, C, and Zinc (NDC/LOT/EXP: Unknown). She says that they also started her on Azithromycin (NDC/LOT/EXP: Unknown), a steroid, Decadron 6mg day (NDC/LOT/EXP: Unknown). She says she also was put on a Symbicort inhaler (NDC/LOT/EXP: Unknown), if she had not started these medications, her oxygen saturation was going down, it would have been medically significant if she hadn't taken these medications she would have ended up in the hospital. She says that she has not run a fever, she has had a little congestion, and she cannot taste or smell anything. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Nasal congestion, SARS-CoV-2 test
Clinical narrative: She still has are that she still doesn't have her taste and sense of smell back; She still has are that she still doesn't have her taste and sense of smell back; Had a little congestion; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable Nurse (patient) A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3302, Expiration date MAY-2021), via an unspecified route of administration, anatomical location- Left Arm on 18Jan2021 15:20, as single dose for Covid-19 immunization. The patient medical history and concomitant medication were not reported. It was reported that since she got her first dose injected 18Jan2021 at 15:20 and then tested positive 24Jan2021 for COVID-19 with an unknown name rapid test. She says she would like to know if she is supposed to wait or not get the second dose of the vaccine. Also reported that they did start her on new medications when she got sick. She says that her COVID-19 symptoms she still has are that she still doesn't have her taste and sense of smell back. She says for treatment she is taking Vitamins D, C, and Zinc (NDC/LOT/EXP: Unknown). She says that they also started her on Azithromycin (NDC/LOT/EXP: Unknown), a steroid, Decadron 6mg day (NDC/LOT/EXP: Unknown). She says she also was put on a Symbicort inhaler (NDC/LOT/EXP: Unknown), if she had not started these medications, her oxygen saturation was going down, it would have been medically significant if she hadn't taken these medications she would have ended up in the hospital. She says that she has not run a fever, she has had a little congestion, and she cannot taste or smell anything. The outcome of the events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: My right hand started hurting, then started tingling and it radiated up my arm. I had a heavy wave of dizziness, my chest started feeling weird and I started having a little trouble swallowing. I alerted a pharmacist, who sat with me with an EpiPen, but I wasn't sure what was happening so I didn't want it. My hands started shaking, I got dizzier, had a headache, felt nauseous, my arm started hurting more and I could feel my throat getting tighter. I started panicking when I couldn't feel much air coming out of my throat, started feeling confused and so the pharmacist administered the EpiPen. Within a minute or so, I  was able to breathe a little better and within 15-30 minutes, I was able to breathe normally. At the hospital, my potassium levels crashed to a critical level  and I had a potassium transfusion, which normalized my levels. I felt better the next day. It's almost a month later and my right hand/arm is still having issues, which was determined to be an Ulnar Nerve Entrapment...most likely caused by the anaphylaxis since my arm tightened up. I have an EMG test this week for it.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Throat tightness, Tremor
Clinical narrative: My right hand started hurting, then started tingling and it radiated up my arm. I had a heavy wave of dizziness, my chest started feeling weird and I started having a little trouble swallowing. I alerted a pharmacist, who sat with me with an EpiPen, but I wasn't sure what was happening so I didn't want it. My hands started shaking, I got dizzier, had a headache, felt nauseous, my arm started hurting more and I could feel my throat getting tighter. I started panicking when I couldn't feel much air coming out of my throat, started feeling confused and so the pharmacist administered the EpiPen. Within a minute or so, I  was able to breathe a little better and within 15-30 minutes, I was able to breathe normally. At the hospital, my potassium levels crashed to a critical level  and I had a potassium transfusion, which normalized my levels. I felt better the next day. It's almost a month later and my right hand/arm is still having issues, which was determined to be an Ulnar Nerve Entrapment...most likely caused by the anaphylaxis since my arm tightened up. I have an EMG test this week for it.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood calcium decreased, Blood potassium decreased, Chest discomfort, Confusional state, Dizziness
Clinical narrative: My right hand started hurting, then started tingling and it radiated up my arm. I had a heavy wave of dizziness, my chest started feeling weird and I started having a little trouble swallowing. I alerted a pharmacist, who sat with me with an EpiPen, but I wasn't sure what was happening so I didn't want it. My hands started shaking, I got dizzier, had a headache, felt nauseous, my arm started hurting more and I could feel my throat getting tighter. I started panicking when I couldn't feel much air coming out of my throat, started feeling confused and so the pharmacist administered the EpiPen. Within a minute or so, I  was able to breathe a little better and within 15-30 minutes, I was able to breathe normally. At the hospital, my potassium levels crashed to a critical level  and I had a potassium transfusion, which normalized my levels. I felt better the next day. It's almost a month later and my right hand/arm is still having issues, which was determined to be an Ulnar Nerve Entrapment...most likely caused by the anaphylaxis since my arm tightened up. I have an EMG test this week for it.