chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: after 46 laps the patient felt nauseous; vomited; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201 and expiration: not reported), via an unspecified route of administration on arm left on 16Feb2021 12:15 at single for covid-19 immunisation at hospital. Medical history included bladder cancer, radical cystectomy, vasectomy, vasectomy reversal, gastrooesophageal reflux disease (GERD)and had no allergies. The patient had not received other vaccines in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 .Concomitant medications in two weeks included apixaban (ELIQUIS); pramipexole dihydrochloride (MIRAPEX); montelukast sodium (SINGULAIR); sucralfate (SUCRALFATE); atorvastatin (LIPITOR). No covid prior vaccination and no covid tested post vaccination. No known allergies. On 17Feb2021 13:45 (about after 24.5 hours following first shot), the patient did lap swimming. Normally, the patient swim 52 laps but after 46 laps the patient felt nauseous. Then the patient got out of the pool and vomited and then he went home & vomited more. Bed rest and BRAT diet plus anti-nausea pill were given as therapeutic measures. Outcome for the events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: This is a spontaneous report from contactable Nurse (the patient). A 71-year-old female received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 20Feb2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included allergies to Nitrofuradantoin from an unknown date and unknown if ongoing. Concomitant medication included probiotics (PROBIOTICS), ergocalciferol (CALCIFEROL VIT D), ascorbic acid, biotin, calcium, equisetum arvense stem, ferrous fumarate, nicotinamide, panicum miliaceum seed, proteins nos, shark cartilage (VIVISCAL ADVANCED HAIR HEALTH) and colecalciferol, ubidecarenone (COQ10 + D3). The patient reported that, after approximately 10 min after receiving vaccine her lips and tongue became numb. Slight throat constriction and heaviness in chest -15min later. The patient stated that, she got the 1st dose on Saturday, 20Feb2021. While she was there waiting after she got her injection, about 10 minutes, all the sudden her mouth and tongue became numb. So, she called the EMS guy over and asked him if she was having a reaction, he said that it probably was and asked her if she felt like her tongue or throat was swelling. States that she did not feel like they were swelling, but she did feel a little constricted in her throat. Stated that she still has the numbness, though it was a little less in her lips, but now her right cheek was numb on 23Feb2021. The patient experienced right cheek numbness on 23Feb2021, after approximately 10 min after receiving vaccine my lips and tongue became numb on 20Feb2021 16:10 with outcome of not recovered on 20Feb2021 16:10, slight throat constriction and heaviness in chest -15 min later on 20Feb2021 16:25. The event was assessed as medically significant. The patient was not tested for COVID-19 since the vaccination. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Hypoasthesia,Throat constriction,Chest discomfort.. The case will be reassessed once new information is available. 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: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: This is a spontaneous report from contactable Nurse (the patient). A 71-year-old female received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 20Feb2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included allergies to Nitrofuradantoin from an unknown date and unknown if ongoing. Concomitant medication included probiotics (PROBIOTICS), ergocalciferol (CALCIFEROL VIT D), ascorbic acid, biotin, calcium, equisetum arvense stem, ferrous fumarate, nicotinamide, panicum miliaceum seed, proteins nos, shark cartilage (VIVISCAL ADVANCED HAIR HEALTH) and colecalciferol, ubidecarenone (COQ10 + D3). The patient reported that, after approximately 10 min after receiving vaccine her lips and tongue became numb. Slight throat constriction and heaviness in chest -15min later. The patient stated that, she got the 1st dose on Saturday, 20Feb2021. While she was there waiting after she got her injection, about 10 minutes, all the sudden her mouth and tongue became numb. So, she called the EMS guy over and asked him if she was having a reaction, he said that it probably was and asked her if she felt like her tongue or throat was swelling. States that she did not feel like they were swelling, but she did feel a little constricted in her throat. Stated that she still has the numbness, though it was a little less in her lips, but now her right cheek was numb on 23Feb2021. The patient experienced right cheek numbness on 23Feb2021, after approximately 10 min after receiving vaccine my lips and tongue became numb on 20Feb2021 16:10 with outcome of not recovered on 20Feb2021 16:10, slight throat constriction and heaviness in chest -15 min later on 20Feb2021 16:25. The event was assessed as medically significant. The patient was not tested for COVID-19 since the vaccination. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Hypoasthesia,Throat constriction,Chest discomfort.. The case will be reassessed once new information is available. 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: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Hypoaesthesia oral, Throat tightness
Clinical narrative: This is a spontaneous report from contactable Nurse (the patient). A 71-year-old female received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 20Feb2021 at 16:00 as a single dose for COVID-19 immunisation. Medical history included allergies to Nitrofuradantoin from an unknown date and unknown if ongoing. Concomitant medication included probiotics (PROBIOTICS), ergocalciferol (CALCIFEROL VIT D), ascorbic acid, biotin, calcium, equisetum arvense stem, ferrous fumarate, nicotinamide, panicum miliaceum seed, proteins nos, shark cartilage (VIVISCAL ADVANCED HAIR HEALTH) and colecalciferol, ubidecarenone (COQ10 + D3). The patient reported that, after approximately 10 min after receiving vaccine her lips and tongue became numb. Slight throat constriction and heaviness in chest -15min later. The patient stated that, she got the 1st dose on Saturday, 20Feb2021. While she was there waiting after she got her injection, about 10 minutes, all the sudden her mouth and tongue became numb. So, she called the EMS guy over and asked him if she was having a reaction, he said that it probably was and asked her if she felt like her tongue or throat was swelling. States that she did not feel like they were swelling, but she did feel a little constricted in her throat. Stated that she still has the numbness, though it was a little less in her lips, but now her right cheek was numb on 23Feb2021. The patient experienced right cheek numbness on 23Feb2021, after approximately 10 min after receiving vaccine my lips and tongue became numb on 20Feb2021 16:10 with outcome of not recovered on 20Feb2021 16:10, slight throat constriction and heaviness in chest -15 min later on 20Feb2021 16:25. The event was assessed as medically significant. The patient was not tested for COVID-19 since the vaccination. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Hypoasthesia,Throat constriction,Chest discomfort.. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye swelling, Fatigue, Herpes zoster, Injection site pain
Clinical narrative: developed shingles. It began on my scalp and then traveled down my forehead and into my eye; developed shingles. It began on my scalp and then traveled down my forehead and into my eye; My eye became so swollen, it shut completely; fatigue; aches/ soreness; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9267) dose 1, via an unspecified route of administration, administered on the left arm on 15Feb2021 05:00 AM as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 (prior vaccination), ulcerative Colitis and known allergies red food coloring. Concomitant medications included infliximab (INFLECTRA), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); zinc and ergocalciferol (VITAMIN D). Upon receiving the vaccine, the patient initially had a typical reaction including soreness, fatigue, aches, and chills (Feb2021). On 19Feb2021 07:00 AM, patient developed shingles. It began on her scalp and then traveled down her forehead and into her eye. This was all on the left side of her scalp and face (the vaccine was given on my left side). Her eye became so swollen, it shut completely. She visited both the ER and urgent care as well as an ophthalmologist. She is now 12 days post vaccine and she still have shingles and extreme swelling of left eye. Currently taking Valtrex, oral steroids, steroid eyedrops, and using antibiotic ointment on her eye. The events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events which included Valtrex, steroids, antibacterial ointment. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events fatigue, aches/ soreness and chills was unknown and not recovered for the other events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event Ophthalmic Herpes zoster with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: developed shingles. It began on my scalp and then traveled down my forehead and into my eye; developed shingles. It began on my scalp and then traveled down my forehead and into my eye; My eye became so swollen, it shut completely; fatigue; aches/ soreness; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9267) dose 1, via an unspecified route of administration, administered on the left arm on 15Feb2021 05:00 AM as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 (prior vaccination), ulcerative Colitis and known allergies red food coloring. Concomitant medications included infliximab (INFLECTRA), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); zinc and ergocalciferol (VITAMIN D). Upon receiving the vaccine, the patient initially had a typical reaction including soreness, fatigue, aches, and chills (Feb2021). On 19Feb2021 07:00 AM, patient developed shingles. It began on her scalp and then traveled down her forehead and into her eye. This was all on the left side of her scalp and face (the vaccine was given on my left side). Her eye became so swollen, it shut completely. She visited both the ER and urgent care as well as an ophthalmologist. She is now 12 days post vaccine and she still have shingles and extreme swelling of left eye. Currently taking Valtrex, oral steroids, steroid eyedrops, and using antibiotic ointment on her eye. The events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events which included Valtrex, steroids, antibacterial ointment. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events fatigue, aches/ soreness and chills was unknown and not recovered for the other events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event Ophthalmic Herpes zoster with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye swelling, Fatigue, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: developed shingles. It began on my scalp and then traveled down my forehead and into my eye; developed shingles. It began on my scalp and then traveled down my forehead and into my eye; My eye became so swollen, it shut completely; fatigue; aches/ soreness; chills; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9267) dose 1, via an unspecified route of administration, administered on the left arm on 15Feb2021 05:00 AM as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19 (prior vaccination), ulcerative Colitis and known allergies red food coloring. Concomitant medications included infliximab (INFLECTRA), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); zinc and ergocalciferol (VITAMIN D). Upon receiving the vaccine, the patient initially had a typical reaction including soreness, fatigue, aches, and chills (Feb2021). On 19Feb2021 07:00 AM, patient developed shingles. It began on her scalp and then traveled down her forehead and into her eye. This was all on the left side of her scalp and face (the vaccine was given on my left side). Her eye became so swollen, it shut completely. She visited both the ER and urgent care as well as an ophthalmologist. She is now 12 days post vaccine and she still have shingles and extreme swelling of left eye. Currently taking Valtrex, oral steroids, steroid eyedrops, and using antibiotic ointment on her eye. The events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events which included Valtrex, steroids, antibacterial ointment. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events fatigue, aches/ soreness and chills was unknown and not recovered for the other events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event Ophthalmic Herpes zoster with BNT162b2 can not be fully 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: SOME DAYS SHE DID NOT USE HER LEFT ARM; LEFT ARM WEAK; JOINT PAIN; CHILLS; FATIGUE / TIRED; HEADACHE; FEVER 101F; MUSCLE PAIN; SHORTNESS OF BREATH; DRY COUGH; BRAIN FOG; ALL SHE DID WAS SLEEP FOR 2 WEEKS; RACING HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 150 pounds, and height was 175.26 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, alcohol use, sulfonamide allergy, high blood lead level, and neurological problems, and other pre-existing medical conditions included the patient had no known allergies and no food allergy. the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, clindamycin, erythromycin, and nortriptyline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced racing heart rate. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced dry cough. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced all she did was sleep for 2 weeks. On 09-MAR-2021, the subject experienced left arm weak. On 09-MAR-2021, the subject experienced joint pain. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fatigue / tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever 101f. On 09-MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced some days she did not use her left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart rate on 17-MAR-2021, dizziness on 04-APR-2021, and joint pain, chills, and fever 101 F on MAR-2021, was recovering from dry cough, fatigue / tired, headache, brain fog, left arm weak, and muscle pain, had not recovered from shortness of breath, and the outcome of all she did was sleep for 2 weeks and some days she did not use her left arm 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Dizziness
Clinical narrative: SOME DAYS SHE DID NOT USE HER LEFT ARM; LEFT ARM WEAK; JOINT PAIN; CHILLS; FATIGUE / TIRED; HEADACHE; FEVER 101F; MUSCLE PAIN; SHORTNESS OF BREATH; DRY COUGH; BRAIN FOG; ALL SHE DID WAS SLEEP FOR 2 WEEKS; RACING HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 150 pounds, and height was 175.26 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, alcohol use, sulfonamide allergy, high blood lead level, and neurological problems, and other pre-existing medical conditions included the patient had no known allergies and no food allergy. the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, clindamycin, erythromycin, and nortriptyline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced racing heart rate. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced dry cough. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced all she did was sleep for 2 weeks. On 09-MAR-2021, the subject experienced left arm weak. On 09-MAR-2021, the subject experienced joint pain. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fatigue / tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever 101f. On 09-MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced some days she did not use her left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart rate on 17-MAR-2021, dizziness on 04-APR-2021, and joint pain, chills, and fever 101 F on MAR-2021, was recovering from dry cough, fatigue / tired, headache, brain fog, left arm weak, and muscle pain, had not recovered from shortness of breath, and the outcome of all she did was sleep for 2 weeks and some days she did not use her left arm 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: SOME DAYS SHE DID NOT USE HER LEFT ARM; LEFT ARM WEAK; JOINT PAIN; CHILLS; FATIGUE / TIRED; HEADACHE; FEVER 101F; MUSCLE PAIN; SHORTNESS OF BREATH; DRY COUGH; BRAIN FOG; ALL SHE DID WAS SLEEP FOR 2 WEEKS; RACING HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 150 pounds, and height was 175.26 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, alcohol use, sulfonamide allergy, high blood lead level, and neurological problems, and other pre-existing medical conditions included the patient had no known allergies and no food allergy. the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, clindamycin, erythromycin, and nortriptyline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced racing heart rate. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced dry cough. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced all she did was sleep for 2 weeks. On 09-MAR-2021, the subject experienced left arm weak. On 09-MAR-2021, the subject experienced joint pain. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fatigue / tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever 101f. On 09-MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced some days she did not use her left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart rate on 17-MAR-2021, dizziness on 04-APR-2021, and joint pain, chills, and fever 101 F on MAR-2021, was recovering from dry cough, fatigue / tired, headache, brain fog, left arm weak, and muscle pain, had not recovered from shortness of breath, and the outcome of all she did was sleep for 2 weeks and some days she did not use her left arm 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: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Muscular weakness, Myalgia, Palpitations, Pyrexia
Clinical narrative: SOME DAYS SHE DID NOT USE HER LEFT ARM; LEFT ARM WEAK; JOINT PAIN; CHILLS; FATIGUE / TIRED; HEADACHE; FEVER 101F; MUSCLE PAIN; SHORTNESS OF BREATH; DRY COUGH; BRAIN FOG; ALL SHE DID WAS SLEEP FOR 2 WEEKS; RACING HEART RATE; DIZZINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 150 pounds, and height was 175.26 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included non-smoker, alcohol use, sulfonamide allergy, high blood lead level, and neurological problems, and other pre-existing medical conditions included the patient had no known allergies and no food allergy. the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, clindamycin, erythromycin, and nortriptyline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced racing heart rate. On 06-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced dry cough. On 09-MAR-2021, the subject experienced brain fog. On 09-MAR-2021, the subject experienced all she did was sleep for 2 weeks. On 09-MAR-2021, the subject experienced left arm weak. On 09-MAR-2021, the subject experienced joint pain. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fatigue / tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever 101f. On 09-MAR-2021, the subject experienced muscle pain. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date, the subject experienced some days she did not use her left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart rate on 17-MAR-2021, dizziness on 04-APR-2021, and joint pain, chills, and fever 101 F on MAR-2021, was recovering from dry cough, fatigue / tired, headache, brain fog, left arm weak, and muscle pain, had not recovered from shortness of breath, and the outcome of all she did was sleep for 2 weeks and some days she did not use her left arm 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Productive cough, SARS-CoV-2 test
Clinical narrative: started with a dry cough that turned into a productive cough; This is a spontaneous report from a contactable consumer (reported for herself). A 48-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL 3246) administered in right arm via an unknown route of administration on 12Jan2021 08:00 am as single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included Ascorbic acid. The patient previously administered first dose of vaccine (Lot number: EF5730) on 22Dec2020 at 08:00am on left arm and experienced no adverse event. On 14Jan2021, the patient started with a dry cough that turned into a productive cough. The outcome of the event was recovering with lasting effect. It was reported that the 2nd day after second dose, patient started with a dry cough that turned into a productive cough. Going on week 5 and still have the cough. A week ago, the patient went to doctor and had dexamethasone injection and Zithromax. She still has the cough after treatment. Prior vaccination, the patient did take a COVID test (rapid nasal swab) on 01Feb2021 and was negative. No other vaccine was given in four weeks. Other medications in two weeks included Synthesis. The patient had no known allergies.  Follow-up attempts were completed. No further information was expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Productive cough, SARS-CoV-2 test
Clinical narrative: started with a dry cough that turned into a productive cough; This is a spontaneous report from a contactable consumer (reported for herself). A 48-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL 3246) administered in right arm via an unknown route of administration on 12Jan2021 08:00 am as single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included Ascorbic acid. The patient previously administered first dose of vaccine (Lot number: EF5730) on 22Dec2020 at 08:00am on left arm and experienced no adverse event. On 14Jan2021, the patient started with a dry cough that turned into a productive cough. The outcome of the event was recovering with lasting effect. It was reported that the 2nd day after second dose, patient started with a dry cough that turned into a productive cough. Going on week 5 and still have the cough. A week ago, the patient went to doctor and had dexamethasone injection and Zithromax. She still has the cough after treatment. Prior vaccination, the patient did take a COVID test (rapid nasal swab) on 01Feb2021 and was negative. No other vaccine was given in four weeks. Other medications in two weeks included Synthesis. The patient had no known allergies.  Follow-up attempts were completed. No further information was expected.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nipple pain, Pyrexia
Clinical narrative: slight chills; cold; Extreme nausea/slightly nauseous; Extremely fatigued; Dizzy; Shakiness; Fever/ 101.6 fever/temperature was 100.3; Dehydration; Headache; Muscle ache; Arm pain; Pain; This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 06Feb2021 12:45 (at the time of 18-years-old) as second dose, single for covid-19 immunisation. Medical history included partial aortic bicuspid valve, aortic dialation, sulfa wellbutrin allergies (known allergies) and postural orthostatic tachycardia syndrome. No other vaccine administered in four weeks. The patient had not covid prior vaccination. The patient had not tested positive for covid post vaccination. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for an unspecified indication, from an unspecified date and unknown if ongoing. The patient previously took bnt162b2 (Pfizer, Lot no EL8982,Administration time=12:15 PM,Vaccine location Left arm, Dose no 1) on 16Jan2021 for COVID-19 immunisation. She received the vaccine at 12:50 PM and my temperature was 98.6 with no symptoms. At 1 am, her temperature went up to 99.6° and a headache, muscle aches and slight chills started. At 4:20 AM, woke up with a 101.6 fever, extreme nausea, dehydration and shakiness. In the morning at 9:00 AM temperature was 100.3 and when I got up around 12:00 PM, was extremely fatigued, dizzy when standing, and slightly nauseous which made it hard to eat normal foods. At 1:20 PM, temperature was 100.7. At 7:00 PM, nausea subsided slightly and was able to eat normal foods. At 10:00 PM, cold chills began in and at 11:00 PM, temperature was 100.4. The next day (08Feb2021), my temperature was at 97.8 upon awakening and felt dizzy, tired and winded with regular activities throughout the days but no fever. By the next day (09Feb), patient was completely syptom free. Arm pain was very minimal, pain level 1, on the day of vaccination and the day after and gone after that. The patient underwent lab tests and procedures which included body temperature: 101.6 (at 4:20 patient temperature was 101.6), 100.3 (at 9 temperature of patient was 100.3), 100.7 (at 13:20 patient temperature was 100.7), 100.4 (at 23:00 patient temperature was 100.4), 99.6 (at 13:00 patient temperature was 99.6F) on 07Feb2021, and 97.8 (patient temperature was 97.8) on 08Feb2021. The patient not received treatment for events. The outcome of events recovered on Feb2021.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dehydration, Dizziness, Fatigue
Clinical narrative: slight chills; cold; Extreme nausea/slightly nauseous; Extremely fatigued; Dizzy; Shakiness; Fever/ 101.6 fever/temperature was 100.3; Dehydration; Headache; Muscle ache; Arm pain; Pain; This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 06Feb2021 12:45 (at the time of 18-years-old) as second dose, single for covid-19 immunisation. Medical history included partial aortic bicuspid valve, aortic dialation, sulfa wellbutrin allergies (known allergies) and postural orthostatic tachycardia syndrome. No other vaccine administered in four weeks. The patient had not covid prior vaccination. The patient had not tested positive for covid post vaccination. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for an unspecified indication, from an unspecified date and unknown if ongoing. The patient previously took bnt162b2 (Pfizer, Lot no EL8982,Administration time=12:15 PM,Vaccine location Left arm, Dose no 1) on 16Jan2021 for COVID-19 immunisation. She received the vaccine at 12:50 PM and my temperature was 98.6 with no symptoms. At 1 am, her temperature went up to 99.6° and a headache, muscle aches and slight chills started. At 4:20 AM, woke up with a 101.6 fever, extreme nausea, dehydration and shakiness. In the morning at 9:00 AM temperature was 100.3 and when I got up around 12:00 PM, was extremely fatigued, dizzy when standing, and slightly nauseous which made it hard to eat normal foods. At 1:20 PM, temperature was 100.7. At 7:00 PM, nausea subsided slightly and was able to eat normal foods. At 10:00 PM, cold chills began in and at 11:00 PM, temperature was 100.4. The next day (08Feb2021), my temperature was at 97.8 upon awakening and felt dizzy, tired and winded with regular activities throughout the days but no fever. By the next day (09Feb), patient was completely syptom free. Arm pain was very minimal, pain level 1, on the day of vaccination and the day after and gone after that. The patient underwent lab tests and procedures which included body temperature: 101.6 (at 4:20 patient temperature was 101.6), 100.3 (at 9 temperature of patient was 100.3), 100.7 (at 13:20 patient temperature was 100.7), 100.4 (at 23:00 patient temperature was 100.4), 99.6 (at 13:00 patient temperature was 99.6F) on 07Feb2021, and 97.8 (patient temperature was 97.8) on 08Feb2021. The patient not received treatment for events. The outcome of events recovered on Feb2021.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Nasopharyngitis, Nausea, Pain
Clinical narrative: slight chills; cold; Extreme nausea/slightly nauseous; Extremely fatigued; Dizzy; Shakiness; Fever/ 101.6 fever/temperature was 100.3; Dehydration; Headache; Muscle ache; Arm pain; Pain; This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 06Feb2021 12:45 (at the time of 18-years-old) as second dose, single for covid-19 immunisation. Medical history included partial aortic bicuspid valve, aortic dialation, sulfa wellbutrin allergies (known allergies) and postural orthostatic tachycardia syndrome. No other vaccine administered in four weeks. The patient had not covid prior vaccination. The patient had not tested positive for covid post vaccination. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for an unspecified indication, from an unspecified date and unknown if ongoing. The patient previously took bnt162b2 (Pfizer, Lot no EL8982,Administration time=12:15 PM,Vaccine location Left arm, Dose no 1) on 16Jan2021 for COVID-19 immunisation. She received the vaccine at 12:50 PM and my temperature was 98.6 with no symptoms. At 1 am, her temperature went up to 99.6° and a headache, muscle aches and slight chills started. At 4:20 AM, woke up with a 101.6 fever, extreme nausea, dehydration and shakiness. In the morning at 9:00 AM temperature was 100.3 and when I got up around 12:00 PM, was extremely fatigued, dizzy when standing, and slightly nauseous which made it hard to eat normal foods. At 1:20 PM, temperature was 100.7. At 7:00 PM, nausea subsided slightly and was able to eat normal foods. At 10:00 PM, cold chills began in and at 11:00 PM, temperature was 100.4. The next day (08Feb2021), my temperature was at 97.8 upon awakening and felt dizzy, tired and winded with regular activities throughout the days but no fever. By the next day (09Feb), patient was completely syptom free. Arm pain was very minimal, pain level 1, on the day of vaccination and the day after and gone after that. The patient underwent lab tests and procedures which included body temperature: 101.6 (at 4:20 patient temperature was 101.6), 100.3 (at 9 temperature of patient was 100.3), 100.7 (at 13:20 patient temperature was 100.7), 100.4 (at 23:00 patient temperature was 100.4), 99.6 (at 13:00 patient temperature was 99.6F) on 07Feb2021, and 97.8 (patient temperature was 97.8) on 08Feb2021. The patient not received treatment for events. The outcome of events recovered on Feb2021.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: slight chills; cold; Extreme nausea/slightly nauseous; Extremely fatigued; Dizzy; Shakiness; Fever/ 101.6 fever/temperature was 100.3; Dehydration; Headache; Muscle ache; Arm pain; Pain; This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received bnt162b2 (Pfizer, Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 06Feb2021 12:45 (at the time of 18-years-old) as second dose, single for covid-19 immunisation. Medical history included partial aortic bicuspid valve, aortic dialation, sulfa wellbutrin allergies (known allergies) and postural orthostatic tachycardia syndrome. No other vaccine administered in four weeks. The patient had not covid prior vaccination. The patient had not tested positive for covid post vaccination. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) for an unspecified indication, from an unspecified date and unknown if ongoing. The patient previously took bnt162b2 (Pfizer, Lot no EL8982,Administration time=12:15 PM,Vaccine location Left arm, Dose no 1) on 16Jan2021 for COVID-19 immunisation. She received the vaccine at 12:50 PM and my temperature was 98.6 with no symptoms. At 1 am, her temperature went up to 99.6° and a headache, muscle aches and slight chills started. At 4:20 AM, woke up with a 101.6 fever, extreme nausea, dehydration and shakiness. In the morning at 9:00 AM temperature was 100.3 and when I got up around 12:00 PM, was extremely fatigued, dizzy when standing, and slightly nauseous which made it hard to eat normal foods. At 1:20 PM, temperature was 100.7. At 7:00 PM, nausea subsided slightly and was able to eat normal foods. At 10:00 PM, cold chills began in and at 11:00 PM, temperature was 100.4. The next day (08Feb2021), my temperature was at 97.8 upon awakening and felt dizzy, tired and winded with regular activities throughout the days but no fever. By the next day (09Feb), patient was completely syptom free. Arm pain was very minimal, pain level 1, on the day of vaccination and the day after and gone after that. The patient underwent lab tests and procedures which included body temperature: 101.6 (at 4:20 patient temperature was 101.6), 100.3 (at 9 temperature of patient was 100.3), 100.7 (at 13:20 patient temperature was 100.7), 100.4 (at 23:00 patient temperature was 100.4), 99.6 (at 13:00 patient temperature was 99.6F) on 07Feb2021, and 97.8 (patient temperature was 97.8) on 08Feb2021. The patient not received treatment for events. The outcome of events recovered on Feb2021.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: PATIENT PASSED OUT 30 SECONDS TO 1 MINUTE AFTER RECEIVING VACCINATION.  PATIENT'S BREATHING BECAME ABNORMAL AND STARTING TO SOUND LIKE SNORING.  AN EPIPEN WAS ADMINISTERED AT THAT TIME.  FACILITY EMERGENCY TEAM WAS CALLED.  Upon provider/nursing arrival patient was alert and oriented but very pale.  Patient denied complaints of shortness of breath, chest pain, racing heart.  Patient complained of feeling hot and sweaty.  Patient assisted to exam room and vitals obtained and examined by Dr..  Patient to be monitored for 30 minutes after administration by pharmacy department. Pt's significant other is the driver today.  Pt will be monitored and released to go home.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Feeling hot, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: PATIENT PASSED OUT 30 SECONDS TO 1 MINUTE AFTER RECEIVING VACCINATION.  PATIENT'S BREATHING BECAME ABNORMAL AND STARTING TO SOUND LIKE SNORING.  AN EPIPEN WAS ADMINISTERED AT THAT TIME.  FACILITY EMERGENCY TEAM WAS CALLED.  Upon provider/nursing arrival patient was alert and oriented but very pale.  Patient denied complaints of shortness of breath, chest pain, racing heart.  Patient complained of feeling hot and sweaty.  Patient assisted to exam room and vitals obtained and examined by Dr..  Patient to be monitored for 30 minutes after administration by pharmacy department. Pt's significant other is the driver today.  Pt will be monitored and released to go home.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiration abnormal
Clinical narrative: PATIENT PASSED OUT 30 SECONDS TO 1 MINUTE AFTER RECEIVING VACCINATION.  PATIENT'S BREATHING BECAME ABNORMAL AND STARTING TO SOUND LIKE SNORING.  AN EPIPEN WAS ADMINISTERED AT THAT TIME.  FACILITY EMERGENCY TEAM WAS CALLED.  Upon provider/nursing arrival patient was alert and oriented but very pale.  Patient denied complaints of shortness of breath, chest pain, racing heart.  Patient complained of feeling hot and sweaty.  Patient assisted to exam room and vitals obtained and examined by Dr..  Patient to be monitored for 30 minutes after administration by pharmacy department. Pt's significant other is the driver today.  Pt will be monitored and released to go home.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: a rash on her upper left thigh; shingles; blisters; discomfort; redness/color is reddish to Peach red now; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6206 and expiry: 30Jun2021), via an unspecified route of administration in left arm (upper) on 11Mar2021 (at the age of 58-years-old) as 1 st dose, single for covid-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. On 13Mar2021, the patient woke up and noticed a rash on her upper left thigh and it was a rash like she had never seen before and had it after the vaccine. The patient called the doctor then had virtual appointment after and they said it looks like shingles. Diagnosed with shingles by her HCP in Mar2021. The patient stated it was not a bothersome rash and progressively got better. If she had not seen the rash, she would not have known it was there, describing the rash as a nuisance. Her HCP told to call Pfizer to verify if she could get the second dose on 01Apr2021, wanted to verify if it was okay to have the second shot. They appeared almost like little blisters (in Mar2021) and according to her doctor she also had shingles looking rash but it was a mild case of shingles. She felt not more of pain but more of discomfort, she still has redness of it until now, before they elevated like blisters but now they were flat and the color was reddish to Peach red now in Mar2021. No treatment for the for the events as stated, "I didn't do anything". The outcome of erythema was not recovered while for the remaining events was unknown.