chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin burning sensation
Clinical narrative: on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Rash erythematous, Vertigo
Clinical narrative: on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Pain, Pain of skin
Clinical narrative: on first day felt vertigo and headache second day felt chillscold sore, fatigue, headache continued, joint pain. These symptoms lasted 5 days. skin felt sunburned all over and hurt to touch which lasted 2 days
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Feeling abnormal, Oropharyngeal discomfort, Throat clearing
Clinical narrative: she needed to clear her throat a few times; felt dizzy; disoriented; foggy headed; mouth felt full; tongue was larger than normal and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 22Jan2021 at 09:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the clinic. The patient had no medical history; she had no allergies to medications, food, or other products. Concomitant medications included aloe ferox gum, aloe vera gum, atropa belladonna herb, peumus boldus leaf oil, rhamnus frangula (SPARK, "Advocare Spark") and "NLA for Her Shred Her" as diet supplement (sup). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jan2021 at 10:00, also reported as 10-13 minutes after vaccination, the patient needed to clear her throat a few times. Within seconds or minutes, she felt dizzy, disoriented, and foggy headed. Then her mouth felt full and she looked in the mirror and noticed her tongue was larger than normal and swollen. The reporter assessed the events as non-serious. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included a steroid and diphenhydramine (BENADRYL) shot. The patient recovered from all the events on an unspecified date.  Information on the batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue disorder
Clinical narrative: she needed to clear her throat a few times; felt dizzy; disoriented; foggy headed; mouth felt full; tongue was larger than normal and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 22Jan2021 at 09:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the clinic. The patient had no medical history; she had no allergies to medications, food, or other products. Concomitant medications included aloe ferox gum, aloe vera gum, atropa belladonna herb, peumus boldus leaf oil, rhamnus frangula (SPARK, "Advocare Spark") and "NLA for Her Shred Her" as diet supplement (sup). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jan2021 at 10:00, also reported as 10-13 minutes after vaccination, the patient needed to clear her throat a few times. Within seconds or minutes, she felt dizzy, disoriented, and foggy headed. Then her mouth felt full and she looked in the mirror and noticed her tongue was larger than normal and swollen. The reporter assessed the events as non-serious. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included a steroid and diphenhydramine (BENADRYL) shot. The patient recovered from all the events on an unspecified date.  Information on the batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dizziness, Feeling abnormal, Oral discomfort, Oropharyngeal discomfort
Clinical narrative: she needed to clear her throat a few times; felt dizzy; disoriented; foggy headed; mouth felt full; tongue was larger than normal and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 22Jan2021 at 09:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the clinic. The patient had no medical history; she had no allergies to medications, food, or other products. Concomitant medications included aloe ferox gum, aloe vera gum, atropa belladonna herb, peumus boldus leaf oil, rhamnus frangula (SPARK, "Advocare Spark") and "NLA for Her Shred Her" as diet supplement (sup). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jan2021 at 10:00, also reported as 10-13 minutes after vaccination, the patient needed to clear her throat a few times. Within seconds or minutes, she felt dizzy, disoriented, and foggy headed. Then her mouth felt full and she looked in the mirror and noticed her tongue was larger than normal and swollen. The reporter assessed the events as non-serious. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included a steroid and diphenhydramine (BENADRYL) shot. The patient recovered from all the events on an unspecified date.  Information on the batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: she needed to clear her throat a few times; felt dizzy; disoriented; foggy headed; mouth felt full; tongue was larger than normal and swollen; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 22Jan2021 at 09:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the clinic. The patient had no medical history; she had no allergies to medications, food, or other products. Concomitant medications included aloe ferox gum, aloe vera gum, atropa belladonna herb, peumus boldus leaf oil, rhamnus frangula (SPARK, "Advocare Spark") and "NLA for Her Shred Her" as diet supplement (sup). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Jan2021 at 10:00, also reported as 10-13 minutes after vaccination, the patient needed to clear her throat a few times. Within seconds or minutes, she felt dizzy, disoriented, and foggy headed. Then her mouth felt full and she looked in the mirror and noticed her tongue was larger than normal and swollen. The reporter assessed the events as non-serious. The adverse events did result in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all the events, which included a steroid and diphenhydramine (BENADRYL) shot. The patient recovered from all the events on an unspecified date.  Information on the batch/lot number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip pruritus, Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: 45 minutes after injection lips tingling and itch. 5 minutes later throat irritated. 10 minutes later lower lip swollen.   Benadryl 25mg 1/2 tab. Reaction no worse. 1 hour later symptoms began to subside. Never had any difficulty breathing or swallowing.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: 45 minutes after injection lips tingling and itch. 5 minutes later throat irritated. 10 minutes later lower lip swollen.   Benadryl 25mg 1/2 tab. Reaction no worse. 1 hour later symptoms began to subside. Never had any difficulty breathing or swallowing.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Malaise, Myalgia, Pyrexia
Clinical narrative: Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right arm injection site swelling/red circle/pain; Right axillary lymph node swelling; Tiredness; Headache; Muscle pain; Chills; Fever; Feeling unwell; Received the first dose of vaccination on 21Dec2020/second dose on 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the right arm on 22Jan2021 (16:00) at a single dose for COVID-19 immunization at the workplace clinic. Medical history included hypertension; obstructive sleep apnea; had used continuous positive airway pressure (CPAP); obesity; polycystic ovarian syndrome; and had COVID-19. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), metformin, acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S), vitamin D, echinacea, cranberry, melatonin and black elderberry. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) intramuscularly on the right arm on 21Dec2020 (when the patient was 40 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021 (16:00), the patient had received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020. On 23Jan2021 (13:00), the patient had right arm injection site swelling, red circle and pain; right axillary lymph node swelling; tiredness; headache; muscle pain; chills; fever; and was feeling unwell. The patient did not receive any treatment for the reported events. The outcome of the events was recovering for 'right arm injection site swelling, red circle and pain', 'right axillary lymph node swelling', 'tiredness', 'headache', 'muscle pain', 'chills', 'fever' and 'feeling unwell'; and was unknown for 'received the second dose of vaccination of BNT162B2 when the first dose was received on 21Dec2020'. The patient had not been tested for COVID-19 since the vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Pyrexia
Clinical narrative: A few days later period started, and it's literally the heaviest period I've ever had. I'm perimenopausal, and haven't had a period in 5 months; 100-101 fever; Inappropriate schedule of vaccine administration; This is a spontaneous report from a contactable consumer, the patient. This 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3302),  dose  2 , single dose via an unspecified route of administration in the left arm on 19Jan2021 at 01:45 PM (at the age of 51 years-old) for COVID-19 vaccination.  Medical history included a nickel allergy and perimenopausal (hasn't had a period in 5 months). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), single dose, dose 1 in the left arm on 02Jan2021 at 01:00 PM. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications.  The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021, the patient received the second dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. On 20Jan2021, the patient had a 100-101 fever starting at 12 hours after and lasting for 24 hours.  A few days later on 23Jan2021, her period started, and "it's literally the heaviest period I've ever had." She is perimenopausal, and hasn't had a period in 5 months. Laboratory data included a COVID polymerase chain reaction (PCR) test (nasal swab) post vaccination on 19Jan2021 that was negative. The clinical outcome of heaviest period  was not recovered, recovered from 100-101 fever on an unknown date and unknown for received the second dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. Treatment was not received for the event. It was also reported that since the vaccination, the patient had been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Menorrhagia, Product use issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: A few days later period started, and it's literally the heaviest period I've ever had. I'm perimenopausal, and haven't had a period in 5 months; 100-101 fever; Inappropriate schedule of vaccine administration; This is a spontaneous report from a contactable consumer, the patient. This 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3302),  dose  2 , single dose via an unspecified route of administration in the left arm on 19Jan2021 at 01:45 PM (at the age of 51 years-old) for COVID-19 vaccination.  Medical history included a nickel allergy and perimenopausal (hasn't had a period in 5 months). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), single dose, dose 1 in the left arm on 02Jan2021 at 01:00 PM. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications.  The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 19Jan2021, the patient received the second dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. On 20Jan2021, the patient had a 100-101 fever starting at 12 hours after and lasting for 24 hours.  A few days later on 23Jan2021, her period started, and "it's literally the heaviest period I've ever had." She is perimenopausal, and hasn't had a period in 5 months. Laboratory data included a COVID polymerase chain reaction (PCR) test (nasal swab) post vaccination on 19Jan2021 that was negative. The clinical outcome of heaviest period  was not recovered, recovered from 100-101 fever on an unknown date and unknown for received the second dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. Treatment was not received for the event. It was also reported that since the vaccination, the patient had been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of head; This is a spontaneous report from a contactable nurse. This 34-Year-Old female nurse (patient) received 2nd dose of BNT162B2 (lot number=EL3247) Intramuscular on 21Jan2021 00: 00 AM (reported as 20Jan2021 12:00 PM) on Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Past drug was Known allergies to doxycycline. Historical Vaccine was 1st dose of BNT162B2 (lot number=EL1284, on 31Dec2020, 12:15 PM, administrator route=Intramuscular, vaccine location=Right arm). No other vaccine in four weeks. Patient received vaccine on Wednesday 20Jan2021, went to ER on Sunday 24Jan2021 with right sided facial paralysis and headache/migraine from base of R skull radiating to R Ear and top of head from 23Jan2021 10:00 AM with outcome was Recovering. Treatment was medications prednisone and antiviral. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of facial paralysis due to temporal relationship and current drug safety profile.  This case will be reassessed once additional 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Headache, Hemiplegia, Migraine, Pain
Clinical narrative: right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of head; This is a spontaneous report from a contactable nurse. This 34-Year-Old female nurse (patient) received 2nd dose of BNT162B2 (lot number=EL3247) Intramuscular on 21Jan2021 00: 00 AM (reported as 20Jan2021 12:00 PM) on Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Past drug was Known allergies to doxycycline. Historical Vaccine was 1st dose of BNT162B2 (lot number=EL1284, on 31Dec2020, 12:15 PM, administrator route=Intramuscular, vaccine location=Right arm). No other vaccine in four weeks. Patient received vaccine on Wednesday 20Jan2021, went to ER on Sunday 24Jan2021 with right sided facial paralysis and headache/migraine from base of R skull radiating to R Ear and top of head from 23Jan2021 10:00 AM with outcome was Recovering. Treatment was medications prednisone and antiviral. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of facial paralysis due to temporal relationship and current drug safety profile.  This case will be reassessed once additional 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adrenocortical insufficiency acute, Blood gases, Blood glucose, Blood ketone body, Blood lactic acid
Clinical narrative: Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Condition aggravated, Culture urine, Differential white blood cell count
Clinical narrative: Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Glomerular filtration rate, Headache, Lipase, Metabolic function test
Clinical narrative: Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Microscopy, Multipathogen PCR test, Nausea, Renal function test, Sepsis
Clinical narrative: Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thyroxine free, Tri-iodothyronine free, Troponin T, Urine analysis, Vomiting
Clinical narrative: Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adrenocortical insufficiency acute, Blood test, Headache, Nausea, Pain
Clinical narrative: Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Approximately 24 hours after vaccination I began to get a headache; A few hours later I began to get nauseous; began to vomit; My body started to ache; adrenal crisis; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231) via an unknown route of administration in right arm on 22Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included Type 1 Diabetic, Addison's Disease, Graves Disease, Large B Cell Lymphoma (Remission). Concomitant medications included insulin aspart (NOVOLOG), prednisone. Approximately 24 hours after vaccination he began to get a headache on 23Jan2021 15:30. A few hours later he began to get nauseous and began to vomit, his body started to ache while also throwing his body into an adrenal crisis, on 23Jan2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. Stress dose steroids were received as treatment and also multiply blood tests were done in Jan2021. No other vaccine in four weeks. No Covid prior vaccination. Covid tested post vaccination: Nasal Swab with result of negative on 23Jan2021. The outcome of the events was recovered in Jan2021.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: my throat started swelling; had a hard time drinking water, felt like the water was going to come out of my nose; my lips started tingling and getting numb; my lips started tingling and getting numb; Under my nose was numb, felt like I had novacaine; This is a spontaneous report from a contactable other health professional reporting for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3246), via an unspecified route of administration on 25Jan2021 09:30 at SINGLE DOSE (2nd dose, Arm left) for COVID-19 immunization. Medical history included Allergies: Hair dye, henna dye, Allergies: latex, and Allergies: metals with the exception of gold from an unknown date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021, 10:30 (lot number: EL3246, age of vaccination 39 years old) for COVID-19 immunization. Concomitant medication included cetirizine hydrochloride (ZYRTEC) from an unspecified date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient received the vaccine at public health clinic/facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Jan2021 at 09:50, 20 minutes after the injection (Also reported as 09:15 AM), the patient experienced her lips started tingling and getting numb. Under her nose was numb, felt like she had novacaine. At 11:00, 1 hour and 30 minutes after the injection (also reported as 09:30 AM), her throat started swelling, had a hard time drinking water, felt like the water was going to come out of her nose. She took two BENADRYL pills and the throat swelling went away within 5 minutes. She stated she eats and had no issues regarding swelling. Her lips were still tingling and it has been 8 hours since getting the injection. Therapeutic measures for the events included BENARDRL. Outcome of the events her lips started tingling and getting numb (tingling lips) was not recovered; Outcome of the events her lips started tingling and getting numb (numb lips), Under her nose was numb, felt like she had novacaine, had a hard time drinking water, felt like the water was going to come out of her nose was reported as recovered/resolved with sequel, recovered with lasting effects (as provided by the reporter) on an unspecified date; while throat swelling recovered/resolved with sequel on 25Jan2021. The reporter considered the events as non-serious. No hospitalization was involved.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Flushing, Immediate post-injection reaction, Throat tightness
Clinical narrative: trouble swallowing; Cold metallic taste in back of throat; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-years-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included asthma and latex allergy. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously took demerol and experienced drug hypersensitivity. The patient experienced cold metallic taste in back of throat and trouble swallowing on 25Jan2021 12:45 with outcome of recovering.  The events resulted in emergency room/department or urgent care visit. The patient received Epi pen injection, Benadryl as treatment and underwent labwork and monitoring. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19  Information on the lot/batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of dysphagia  due to temporal relationship  The clinical presentation, along with the treatment measures, is suggestive of a significant allergic reaction. There is limited information provided in this report.   This case will be reassessed once additional 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.