chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VIAL OF VACCINE KEPT IN REFRIGERATOR FOR A DAY; PUNCTURED VIAL VACCINE GIVEN AFTER A DAY; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced punctured vial of vaccine kept in refrigerator for a day. On 23-JUN-2021, the subject experienced punctured vial vaccine given after a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial of vaccine kept in refrigerator for a day and punctured vial vaccine given after a day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210651118.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Depressed mood, Headache, Injection site pain, Myalgia
Clinical narrative: PAIN IN LEFT ARMPIT THAT RADIATES TO HER LEFT BREAST; FEELING DOWN; FEVER; PAIN AT THE INJECTION SITE; HEADACHE; MUSCLES ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced feeling down. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced pain at the injection site. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced muscles aches. On 14-APR-2021, the subject experienced pain in left armpit that radiates to her left breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling down, fever, headache, and muscles aches on 02-APR-2021, and pain at the injection site on APR-2021, and had not recovered from pain in left armpit that radiates to her left breast. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN IN LEFT ARMPIT THAT RADIATES TO HER LEFT BREAST; FEELING DOWN; FEVER; PAIN AT THE INJECTION SITE; HEADACHE; MUSCLES ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced feeling down. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced pain at the injection site. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced muscles aches. On 14-APR-2021, the subject experienced pain in left armpit that radiates to her left breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling down, fever, headache, and muscles aches on 02-APR-2021, and pain at the injection site on APR-2021, and had not recovered from pain in left armpit that radiates to her left breast. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Urticaria
Clinical narrative: FEEL VERY HOT IN THAT PART WHERE THEY APPLIED THE VACCINE; GOT A SKIN WELT ON THE PART WHERE THEY APPLIED THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced feel very hot in that part where they applied the vaccine, and got a skin welt on the part where they applied the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the got a skin welt on the part where they applied the vaccine and feel very hot in that part where they applied the vaccine was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PUNCTURED VIAL STORED MORE THAN A DAY; RECEIVED AN EXPIRED VACCINE  DOSE/ POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned a 26 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: 15-SEP-2021) dose was not reported, administered on 24-JUN-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced punctured vial stored more than a day. On 24-JUN-2021, the subject experienced received an expired vaccine dose/ poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial stored more than a day and received an expired vaccine dose/ poor quality product administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nasopharyngitis, Nausea
Clinical narrative: BASIC COLD SYMPTOMS; PRETTY AWFUL; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced basic cold symptoms, pretty awful, headaches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from basic cold symptoms, pretty awful, headaches, and nausea. This report was non-serious.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod sting, Vaccination site swelling
Clinical narrative: Stung by 200 bees; Slight swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD STING (Stung by 200 bees) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced ARTHROPOD STING (Stung by 200 bees) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Slight swelling at injection site). The patient was hospitalized on 20-Feb-2021 due to ARTHROPOD STING. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) at an unspecified dose and frequency. At the time of the report, ARTHROPOD STING (Stung by 200 bees) and VACCINATION SITE SWELLING (Slight swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Additional treatment for the event included IV steroids.  Company Comment : Based on provided information of patient being stung by bees, the event Arthropod sting is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site swelling, a causal relationship cannot be excluded.; Sender's Comments: Based on provided information of patient being stung by bees, the event Arthropod sting is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site swelling, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Cough, Dizziness
Clinical narrative: Joint pain; Chills; Congested chest; So bad COVID-19 infection after the 2nd dose; Very sick; A lot of phlegm; Lots of coughing; Congested head/ Sinus infection; Dizziness; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY CONGESTION (Congested chest) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL, PROGESTERONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE (CLARITIN [LORATADINE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PULMONARY CONGESTION (Congested chest) (seriousness criterion medically significant), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, PULMONARY CONGESTION (Congested chest), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Aleve, Mucinex DM to breakup the phlegm, Tylenol, and Pain pill as a treatment medications.  Company Comment : For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Productive cough, Pulmonary congestion, Sinus congestion
Clinical narrative: Joint pain; Chills; Congested chest; So bad COVID-19 infection after the 2nd dose; Very sick; A lot of phlegm; Lots of coughing; Congested head/ Sinus infection; Dizziness; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY CONGESTION (Congested chest) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL, PROGESTERONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE (CLARITIN [LORATADINE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PULMONARY CONGESTION (Congested chest) (seriousness criterion medically significant), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue) and CHILLS (Chills). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, PULMONARY CONGESTION (Congested chest), COVID-19 (So bad COVID-19 infection after the 2nd dose), ILLNESS (Very sick), PRODUCTIVE COUGH (A lot of phlegm), COUGH (Lots of coughing), SINUS CONGESTION (Congested head/ Sinus infection), DIZZINESS (Dizziness), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took Aleve, Mucinex DM to breakup the phlegm, Tylenol, and Pain pill as a treatment medications.  Company Comment : For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: For the event of COVID-19:Based on mechanism of action of mRNA -1273 vaccine, the event is assessed as unlikely related to mRNA-1273.(Moderna COVID-19 Vaccine) For other events:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Contusion, Fall, Fear, Head injury
Clinical narrative: Was like passing out briefly; Fell down losing total control three times the morning after taking second done; Injured my head scare; Bruises on my shoulder and hip; Concerned me a lot; Injury my head scare; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was like passing out briefly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Was like passing out briefly) (seriousness criterion medically significant), FALL (Fell down losing total control three times the morning after taking second done), HEAD INJURY (Injured my head scare), CONTUSION (Bruises on my shoulder and hip), ANXIETY (Concerned me a lot) and FEAR (Injury my head scare). At the time of the report, LOSS OF CONSCIOUSNESS (Was like passing out briefly), FALL (Fell down losing total control three times the morning after taking second done), HEAD INJURY (Injured my head scare), CONTUSION (Bruises on my shoulder and hip), ANXIETY (Concerned me a lot) and FEAR (Injury my head scare) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient Fell down losing total control three times the morning after taking second dose.  Action taken with mRNA-1273 was not applicable.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Was like passing out briefly; Fell down losing total control three times the morning after taking second done; Injured my head scare; Bruises on my shoulder and hip; Concerned me a lot; Injury my head scare; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was like passing out briefly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Was like passing out briefly) (seriousness criterion medically significant), FALL (Fell down losing total control three times the morning after taking second done), HEAD INJURY (Injured my head scare), CONTUSION (Bruises on my shoulder and hip), ANXIETY (Concerned me a lot) and FEAR (Injury my head scare). At the time of the report, LOSS OF CONSCIOUSNESS (Was like passing out briefly), FALL (Fell down losing total control three times the morning after taking second done), HEAD INJURY (Injured my head scare), CONTUSION (Bruises on my shoulder and hip), ANXIETY (Concerned me a lot) and FEAR (Injury my head scare) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient Fell down losing total control three times the morning after taking second dose.  Action taken with mRNA-1273 was not applicable.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Therapeutic product effect decreased
Clinical narrative: Patient contracted covid-19 virus after second vaccination; lack of effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient contracted covid-19 virus after second vaccination) and THERAPEUTIC PRODUCT EFFECT DECREASED (lack of effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient contracted covid-19 virus after second vaccination) (seriousness criterion medically significant) and THERAPEUTIC PRODUCT EFFECT DECREASED (lack of effect) (seriousness criterion medically significant). At the time of the report, COVID-19 (Patient contracted covid-19 virus after second vaccination) and THERAPEUTIC PRODUCT EFFECT DECREASED (lack of effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.  This case concerns a patient of unknown age and gender with serious unexpected events of COVID-19, and therapeutic product effect decreased. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a patient of unknown age and gender with serious unexpected events of COVID-19, and therapeutic product effect decreased. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional. This report was received via a Pfizer sales representative. This consumer reported similar events for 6 patients. This is 2nd of 6 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Symptoms lasted approximately 7 hours and symptoms were relieved with one dose of Tylenol. Patient states that 5 other individuals within her department also experienced similar symptoms after receiving the second dose. On an unspecified date patient experienced fever of 101 f, muscle aches. On an unspecified date the patient underwent lab tests which included body temperature pyrexia: 101 fahrenheit. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal
Clinical narrative: Chest pressure; funny feeling in face, tongue and throat; This is a spontaneous report from a contactable consumer or other non hcp.   A 54-year-old (non-pregnant) female patient received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in right arm on 05Mar2021 (at the age of 54-years-old) as dose 1, single for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing. The patient previously took morphine and experienced allergy.  Concomitant medication(s) included amlodipine benazepril hydrochloride (Amlodipine and Benazepril Hydrochloride) taken for an unspecified indication, start and stop date were not reported; trazodone (Trazodone) taken for an unspecified indication, start and stop date were not reported; Lexapro (escitalopram oxalate) taken for an unspecified indication, start and stop date were not reported; Omega 100 (carbinoxamine maleate) taken for an unspecified indication, start and stop date were not reported; D (colecalciferol) taken for an unspecified indication, start and stop date were not reported; Tizanidin (tizanidine hydrochloride) taken for an unspecified indication, start and stop date were not reported. The patient experienced chest pressure and funny feeling in face, tongue and throat on 05Mar2021. Therapeutic measures were taken with medications administered via IV as a result of event chest pressure. The outcome of event was resolved.  Amendment: This follow-up report is being submitted to amend previously reported information: Event " Chest pressure " upgraded as serious--Medically significant checked as assessed by DSU only and not from reporter, patient's name added in general tab and patient tab, patient's address added in patient tab,  Allergies to medications, food, or other products: morphin coded as Past Drug Event: Morphine,  Vaccine Facility Information added, Concomitant drug amlodepin w/ben coded as Amlodipine and Benazepril Hydrochloride, Trazadone coded as trazodone, omega coed as Omega 100,  Emergency Room Visit and Physician Office Visit ticked and leading sentence updated to a contactable consumer.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: muscle ache in the whole body; mild fever; fatigue; injection site muscle ache; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 17Mar2021 at 09:30 am (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Patient had no medical history. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication was not reported. On 17Mar2021 at 9:00 PM, the patient had experienced muscle ache in the whole body 12 hour after injection, mild fever with a temperature of 38.5 C, injection site muscle ache and fatigue. The patient had received ibuprofen for two days. It was reported that most symptoms improved 48 hours after injection. The clinical outcome of the events muscle ache in the whole body, injection site muscle ache, fatigue and fever were recovering at the time of the report. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: medical history added as none, vaccine dose information and narrative updated, event onset date for fever, injection site muscle pain and fatigue updated as 17Mar2021 09:00 pm.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: Right eye is very painful; Right eye is very swollen; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UNKNOWN) as a single dose via unspecified route on 18Mar2021 at 10:15 AM (at the age of 33-year-old) for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, the patient experienced right eye is very painful and swollen almost to the point, cannot open it. The patient didnot received any treatment for the events.  The clinical outcome of right eye is very painful and swollen was not recovered at the time of report.    No further information is expected, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a Pfizer-sponsored program via a patient. A 60-years-old female patient received pregabalin (LYRICA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation (age at vaccination unknown). The patient medical history and concomitant medications were not reported. Historical vaccine included ZOSTER (Shingles Shot) on 21Nov2020. The patient experienced sinus infection on an unspecified date. She had to be on amoxicillin for 7 days, she also stated that she got her Pfizer COVID shot on March 21st and will get her next dose on April 18th. The action taken in response to the event for pregabalin was unknown. Outcome of the event was unknown.  Information on the lot number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: diarrhea, headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: Late start to my menstruation, about a week late, when usually on time. My menstruation is about 7 days and always regular. My period started a week late and now I am currently on the 9th day and I am bleeding heavily. Feeling very tired and no energy. I have also developed a twitch to the right side of my face that comes and goes but is very uncomfortable. I get random sensitivity to the site of where my vaccine was administered. The twitch on my face started about 5 days after first dose of pfizer was administered and went on for two weeks straight. It stopped for a few days but came back after the second dose was administered and now it comes and goes daily.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dysarthria, Hallucination
Clinical narrative: Convulsions  Slurred speech Hallucinations  Twitching  4pm
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Seizure, Urine analysis
Clinical narrative: Convulsions  Slurred speech Hallucinations  Twitching  4pm
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dry skin, Insomnia, Rash
Clinical narrative: Scaly painful rash forming around lips, has grown up both of my cheeks and around my left eye. It has also formed on my neck knuckles  and hands. Its bumpy like braille individual bumps with space between the next bump. On my face it burns, and is dryer. I am itchy eveywhere to the point that I cannot sleep. I have taken an allergy pill today to try and get relief but I must admit this isn't pleasant.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing during regular activity; This is a spontaneous report from a contactable other hcp (For himself). A 64-year-old male patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot number/expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included high blood pressure and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included metoprolol, losartan and apixaban (ELIQUIS). The patient previously took aspirin (e.c.) and experienced drug hypersensitivity. The patient experienced difficulty breathing during regular activity on 29Mar2021. The patient received second dose of (BNT162B2, formulation: Solution for injection, Lot number/expiry date was not reported) on 21Apr2021 at 16:30 in the left arm for COID-19 Immunization. The patient had no other vaccine in four weeks: No. The patient has not tested for COVID-19 prior to vaccination and post vaccination. The patient has not received any treatment. The outcome of the event was not recovered.    Information about lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Diarrhoea, Laboratory test, Oropharyngeal pain, Vomiting
Clinical narrative: Sore throat; Vomiting; Diarrhea; Anemia; This is a spontaneous report from non-contactable consumer (patient) via COVAES. This non-pregnant 16-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 25May2021 at 10:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphocytic colitis from an unknown date and unknown if ongoing. The patient had no known allergies, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines in four weeks. Concomitant medications included calcium supplements, macrogol 3350 (MIRALAX), and nutrition shakes, all from unknown dates for unknown indications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 04May2021 at 10:00 (at the age of 16-years-old) for COVID-19 immunisation. On 26May2021 the patient experienced sore throat, vomiting, diarrhea, and anemia, which the patient reported was confirmed with labs. The events resulted in an emergency room visit; no treatment was received for the events. The clinical outcomes of sore throat, vomiting, diarrhea, and anemia were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in jaw
Clinical narrative: Exhaustion/Tiredness; headache; Excruciating jaw pain; This is a spontaneous report from a contactable consumer (patient's mother) based on information received by Pfizer from Moderna (manufacturer control number MOD21-097310). A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient's mother reported that her son received both doses, and experienced exhaustion, tiredness, headache and specifically excruciating jaw pain after the second dose for 4 days. The events did not require hospitalization. The clinical outcomes of exhaustion/tiredness, headache and excruciating jaw pain were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: takes my breath away; Sharp pains in chest that come and go; This is a spontaneous report from a contactable consumer (patient). This 16-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 01May2021 at 17:00 (at the age of 16-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included asthma, migraines, lactose intolerant, and eczema. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included stool softener and nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine (VITAMIN B-COMPLEX) from unknown dates for unknown indications. The patient did not have any known allergies. On 03May2021 the patient experienced sharp pains in chest that came and went. "Took her breath away." The patient did not receive any treatment for the events. The outcomes of sharp chest pains and took her breath away were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. The patient received dose 2 of BNT162B2 (lot number EW0180) on 22May2021 at 17:00 as a single dose in the right arm for COVID-19 immunization.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feeling bad; This is a spontaneous report from a contactable consumer. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling bad. The outcome of the event was unknown. It was reported that the patient ate early. The reporter was querying if it was normal for the patient to feel this way after the vaccine. The patient was not given paperwork about the vaccine and was advised to contact health care professional. The reporter was asking if the patient should go to the emergency.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythropsia
Clinical narrative: a red vertical line, like about 3 inches, in her vision; This is a spontaneous report received from a contactable consumer (patient). This consumer reported for herself that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Jun2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient historically received first single dose of BNT162B2 for COVID-19 immunization and had no reaction on previous exposure to drug. The patient reported that received her second dose yesterday morning on 09Jun2021, and at 20:30 (8:30 pm) in the evening, while she was watching television, all the sudden she experienced a red vertical line, like about 3 inches, in her vision for 30 seconds. She said that when she looked away from the television the red line was still with her. She was asking if this was related with the vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid virus after first Covid vaccine; Patient tested positive for Covid virus after first Covid vaccine; This is a spontaneous report from a contactable pharmacist via a Pfizer Sponsored Program. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included originally tested positive for the Covid virus on 18Apr2021. The patient's concomitant medications were not reported. It was reported that on 05Jun2021 the patient tested positive for Covid virus after first Covid vaccine. The reporting pharmacist reported for the patient who came into the pharmacy for her second dose of the Pfizer vaccine, and reported that she tested positive on Saturday for the Covid virus. It was mentioned that the patient was originally tested positive for the Covid virus on 18Apr2021 and then tested positive again, for the Covid virus, this past Saturday. The pharmacist would like to know what the recommendations are for a patient who had tested positive for Covid in getting the second Covid vaccine. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date with outcome of recovered. It was reported that when the patient got his first vaccine, he did not wait the 15 minutes after the vaccine, he just left without knowing he was supposed to do this. He got into his vehicle and then started having a seizure but commented that he was okay now. He wanted to know if it was common or if it was something he should be concerned about. He got it at (name withheld) and they didn't tell him he needed to wait. He added that everyone he has talked to said that he was supposed to wait. He just wanted to know he was not trying to make a big deal out of it or nothing. Should he be concerned about it or was it a quick weird reaction. Should he be concerned and talk to his doctor. He just wanted to check and see if this has been happening.  Follow up attempts are needed. Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Fatigue, Myalgia
Clinical narrative: Muscle pain; weakness; joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 14Jan2021 12:00 (Batch/Lot Number: EL1283) at age of 48-year-old as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included atorvastatin calcium; venlafaxine hcl; capsaicin, menthol (ALLEVESS).  No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced muscle pain and weakness, joint pain, fatigue on 15Jan2021 12:00. The outcome was not recovered.  The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included Blood tests, neurological tests, x-rays.  Follow up attempts needed. Further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Neurological examination, X-ray
Clinical narrative: Muscle pain; weakness; joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 administered in Arm Left on 14Jan2021 12:00 (Batch/Lot Number: EL1283) at age of 48-year-old as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included atorvastatin calcium; venlafaxine hcl; capsaicin, menthol (ALLEVESS).  No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced muscle pain and weakness, joint pain, fatigue on 15Jan2021 12:00. The outcome was not recovered.  The events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received included Blood tests, neurological tests, x-rays.  Follow up attempts needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pelvic fracture
Clinical narrative: fractured her pelvis; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient fractured her pelvis just days before she was to have her second dose of the Pfizer vaccine. The patient passed the 6-week deadline for taking the second dose, 10 weeks ago as of this writing. The reporter hasn't been able to find information in the web that says a second dose should still be pursued under such circumstances. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test, Skin exfoliation, Skin lesion, Urticaria
Clinical narrative: Hives; skin lesions; scale like skin that peals from the scalp and behind the ears; hair loss from pealing scalp skin; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EP7533), via an unspecified route of administration in the left arm on 18May2021 at 13:30 (at the age of 25-years-old) as a single dose for COVID-19 immunization. Medical history included mild Klippel Feil syndrome, gastroesophageal reflux disease (GERD), mild arthritis in lower spine, allergies to pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0172) on 27Apr2021 at 12:00 (at the age of 25-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 20May2021 at 10:00, the patient experienced hives, skin lesions, scale like skin that peeled from the scalp and behind the ears, hair loss from the peeling scalp skin. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with antihistamine. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 02Jun2021 with negative results. The clinical outcome of the events was resolved with sequel.