chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Diarrhoea, Faeces discoloured, Full blood count, Inflammatory bowel disease
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history included had the COVID-19 Virus in Mar2020, and it took her to May2020 to feel better, C-Diff in 2016 was caused by antibiotics that killed off her good bacteria in her intestines. She said she then had to take a very expensive antibiotic for months to treat her C-Diff. She said nothing helped, so she did her own research, and got a fecal implant.  The patient's concomitant medications were not reported.  The patient said the COVID-19 Vaccine was giving her C-Diff symptoms, and she was losing intestinal lining along with having fecal matter mixed in. She said she can't control her bowels. She said if she eats something, it goes completely through her system and out the other end. She said her symptoms started Saturday (20Mar2021), where she noticed she was shedding her intestinal lining, and by Sunday (21Mar2021) she was oozing fecal matter, it is getting worse. She reported her symptoms were very nasty. The events outcome was not recovered. Information on batch / Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history included had the COVID-19 Virus in Mar2020, and it took her to May2020 to feel better, C-Diff in 2016 was caused by antibiotics that killed off her good bacteria in her intestines. She said she then had to take a very expensive antibiotic for months to treat her C-Diff. She said nothing helped, so she did her own research, and got a fecal implant.  The patient's concomitant medications were not reported.  The patient said the COVID-19 Vaccine was giving her C-Diff symptoms, and she was losing intestinal lining along with having fecal matter mixed in. She said she can't control her bowels. She said if she eats something, it goes completely through her system and out the other end. She said her symptoms started Saturday (20Mar2021), where she noticed she was shedding her intestinal lining, and by Sunday (21Mar2021) she was oozing fecal matter, it is getting worse. She reported her symptoms were very nasty. The events outcome was not recovered. Information on batch / Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Ear infection, Hypoacusis, Sinusitis, Tinnitus
Clinical narrative: she couldn't hear out of her right ear; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jan2021 the patient got the injection, 2 hours later the patient she couldn't hear out of her right ear, she has a bugging sound to this day she still is like that. She's gone to urgent care twice, to the ER once, and she went to 2 specialists. Her ear became like this due to the injection to the vaccine. The outcome of the event was not recovered.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: she couldn't hear out of her right ear; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jan2021 the patient got the injection, 2 hours later the patient she couldn't hear out of her right ear, she has a bugging sound to this day she still is like that. She's gone to urgent care twice, to the ER once, and she went to 2 specialists. Her ear became like this due to the injection to the vaccine. The outcome of the event was not recovered.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Fatigue, Neck pain, Pyrexia
Clinical narrative: CHILLS; FEVER; DULL PAIN-BACK OF HEAD; NAUSEA; VERTIGO; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included low iron, sickle cell trait, and domestic violence survivor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered on 22-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. Concomitant medications included iron for monthly cycle, and tranexamic acid for monthly cycle. On MAR-2021, the subject experienced vertigo. On MAR-2021, the subject experienced dull pain-back of head. On MAR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Unknown. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 24-MAR-2021, and had not recovered from dull pain-back of head, vertigo, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: CHILLS; FEVER; DULL PAIN-BACK OF HEAD; NAUSEA; VERTIGO; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included low iron, sickle cell trait, and domestic violence survivor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered on 22-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. Concomitant medications included iron for monthly cycle, and tranexamic acid for monthly cycle. On MAR-2021, the subject experienced vertigo. On MAR-2021, the subject experienced dull pain-back of head. On MAR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Unknown. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 24-MAR-2021, and had not recovered from dull pain-back of head, vertigo, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; DULL PAIN-BACK OF HEAD; NAUSEA; VERTIGO; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included low iron, sickle cell trait, and domestic violence survivor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, administered on 22-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. Concomitant medications included iron for monthly cycle, and tranexamic acid for monthly cycle. On MAR-2021, the subject experienced vertigo. On MAR-2021, the subject experienced dull pain-back of head. On MAR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) Unknown. On 22-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 24-MAR-2021, and had not recovered from dull pain-back of head, vertigo, and nausea. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Diarrhoea, Dyskinesia, Hyperhidrosis, Loss of consciousness
Clinical narrative: Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to open eyes and focus; unable to open eyes and focus; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number: EN6204), via an unspecified route of administration in the Left Arm on 20Mar2021 09:30 AM (received at the age of 69-years-old) at a single dose for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to receiving BNT162B2. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus. She had no known allergies. The patient had no prior history of COVID-19. Concomitant medications included dulaglutide (TRULICITY), insulin degludec (TRESIBA), atorvastatin calcium trihydrate (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), and losartan potassium (LOSARTIN). On 21Mar2021 07:30 AM, the patient experienced vertigo, nausea, vomiting, diarrhea, loss of consciousness, inability to control limbs, unable to open eyes and focus. The reported adverse events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for one day. Therapeutic measures were received as a result of reported adverse events; Medicine for nausea, CT scan, IV. Outcome of the events was recovering. The patient was tested for COVID post vaccination on 21Mar2021 through nasal swab with result of negative.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metamorphopsia, Vertigo, Vomiting
Clinical narrative: Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to open eyes and focus; unable to open eyes and focus; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number: EN6204), via an unspecified route of administration in the Left Arm on 20Mar2021 09:30 AM (received at the age of 69-years-old) at a single dose for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to receiving BNT162B2. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus. She had no known allergies. The patient had no prior history of COVID-19. Concomitant medications included dulaglutide (TRULICITY), insulin degludec (TRESIBA), atorvastatin calcium trihydrate (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), and losartan potassium (LOSARTIN). On 21Mar2021 07:30 AM, the patient experienced vertigo, nausea, vomiting, diarrhea, loss of consciousness, inability to control limbs, unable to open eyes and focus. The reported adverse events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for one day. Therapeutic measures were received as a result of reported adverse events; Medicine for nausea, CT scan, IV. Outcome of the events was recovering. The patient was tested for COVID post vaccination on 21Mar2021 through nasal swab with result of negative.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Diarrhoea, Eyelid function disorder, Loss of consciousness, Motor dysfunction
Clinical narrative: Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to open eyes and focus; unable to open eyes and focus; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number: EN6204), via an unspecified route of administration in the Left Arm on 20Mar2021 09:30 AM (received at the age of 69-years-old) at a single dose for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to receiving BNT162B2. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus. She had no known allergies. The patient had no prior history of COVID-19. Concomitant medications included dulaglutide (TRULICITY), insulin degludec (TRESIBA), atorvastatin calcium trihydrate (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), and losartan potassium (LOSARTIN). On 21Mar2021 07:30 AM, the patient experienced vertigo, nausea, vomiting, diarrhea, loss of consciousness, inability to control limbs, unable to open eyes and focus. The reported adverse events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for one day. Therapeutic measures were received as a result of reported adverse events; Medicine for nausea, CT scan, IV. Outcome of the events was recovering. The patient was tested for COVID post vaccination on 21Mar2021 through nasal swab with result of negative.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vertigo, Vision blurred, Vomiting
Clinical narrative: Vertigo; nausea; vomiting; diarrhea; loss of consciousness; inability to control limbs; unable to open eyes and focus; unable to open eyes and focus; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, lot number: EN6204), via an unspecified route of administration in the Left Arm on 20Mar2021 09:30 AM (received at the age of 69-years-old) at a single dose for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store. The patient did not receive any other vaccine within four weeks prior to receiving BNT162B2. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus. She had no known allergies. The patient had no prior history of COVID-19. Concomitant medications included dulaglutide (TRULICITY), insulin degludec (TRESIBA), atorvastatin calcium trihydrate (ATORVASTATIN [ATORVASTATIN CALCIUM TRIHYDRATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), and losartan potassium (LOSARTIN). On 21Mar2021 07:30 AM, the patient experienced vertigo, nausea, vomiting, diarrhea, loss of consciousness, inability to control limbs, unable to open eyes and focus. The reported adverse events resulted in emergency room/department or urgent care and hospitalization. The patient was hospitalized for one day. Therapeutic measures were received as a result of reported adverse events; Medicine for nausea, CT scan, IV. Outcome of the events was recovering. The patient was tested for COVID post vaccination on 21Mar2021 through nasal swab with result of negative.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Patient arrived with EMS to hospital and states she developed a sudden onset of hoarseness to her voice after receiving the COVID-19 vaccine at 9:45 am. Patient reports of tongue swelling and tingling to face. Also describes an intermittent sinking feeling to the chest. She also reported nausea and her symptoms did not improve prompting her visit to ED. Per EMS note, patient tested negative 3 weeks prior and received COVID shot at 9:45 am and was monitored and released.  While in ED, patient received Benadryl IV, Pepcid IV, solumedrol IV, and epinephrine IM. MD assessed her twice and patient was observed until 14:50, impression of MD was allergic reaction.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Dysphonia, Nausea, Palpitations, Paraesthesia, Swollen tongue
Clinical narrative: Patient arrived with EMS to hospital and states she developed a sudden onset of hoarseness to her voice after receiving the COVID-19 vaccine at 9:45 am. Patient reports of tongue swelling and tingling to face. Also describes an intermittent sinking feeling to the chest. She also reported nausea and her symptoms did not improve prompting her visit to ED. Per EMS note, patient tested negative 3 weeks prior and received COVID shot at 9:45 am and was monitored and released.  While in ED, patient received Benadryl IV, Pepcid IV, solumedrol IV, and epinephrine IM. MD assessed her twice and patient was observed until 14:50, impression of MD was allergic reaction.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Amnesia, Angina pectoris, Aphonia, Diarrhoea, Disorientation
Clinical narrative: Patient arrived with EMS to hospital and states she developed a sudden onset of hoarseness to her voice after receiving the COVID-19 vaccine at 9:45 am. Patient reports of tongue swelling and tingling to face. Also describes an intermittent sinking feeling to the chest. She also reported nausea and her symptoms did not improve prompting her visit to ED. Per EMS note, patient tested negative 3 weeks prior and received COVID shot at 9:45 am and was monitored and released.  While in ED, patient received Benadryl IV, Pepcid IV, solumedrol IV, and epinephrine IM. MD assessed her twice and patient was observed until 14:50, impression of MD was allergic reaction.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Dysphagia, Dyspnoea, Feeling abnormal, Gait inability, Gastrointestinal disorder
Clinical narrative: Patient arrived with EMS to hospital and states she developed a sudden onset of hoarseness to her voice after receiving the COVID-19 vaccine at 9:45 am. Patient reports of tongue swelling and tingling to face. Also describes an intermittent sinking feeling to the chest. She also reported nausea and her symptoms did not improve prompting her visit to ED. Per EMS note, patient tested negative 3 weeks prior and received COVID shot at 9:45 am and was monitored and released.  While in ED, patient received Benadryl IV, Pepcid IV, solumedrol IV, and epinephrine IM. MD assessed her twice and patient was observed until 14:50, impression of MD was allergic reaction.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Inadequate diet, Malaise, Mast cell activation syndrome
Clinical narrative: Patient arrived with EMS to hospital and states she developed a sudden onset of hoarseness to her voice after receiving the COVID-19 vaccine at 9:45 am. Patient reports of tongue swelling and tingling to face. Also describes an intermittent sinking feeling to the chest. She also reported nausea and her symptoms did not improve prompting her visit to ED. Per EMS note, patient tested negative 3 weeks prior and received COVID shot at 9:45 am and was monitored and released.  While in ED, patient received Benadryl IV, Pepcid IV, solumedrol IV, and epinephrine IM. MD assessed her twice and patient was observed until 14:50, impression of MD was allergic reaction.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Sensation of foreign body, Symptom recurrence, Syncope
Clinical narrative: Patient arrived with EMS to hospital and states she developed a sudden onset of hoarseness to her voice after receiving the COVID-19 vaccine at 9:45 am. Patient reports of tongue swelling and tingling to face. Also describes an intermittent sinking feeling to the chest. She also reported nausea and her symptoms did not improve prompting her visit to ED. Per EMS note, patient tested negative 3 weeks prior and received COVID shot at 9:45 am and was monitored and released.  While in ED, patient received Benadryl IV, Pepcid IV, solumedrol IV, and epinephrine IM. MD assessed her twice and patient was observed until 14:50, impression of MD was allergic reaction.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anal incontinence, Hypopnoea, Loss of consciousness, Pulse abnormal
Clinical narrative: sat unresponsive in a sleep like state stopped breathing no pulse no heart beat for about 4-5 minutes  Guardsman popped an ammonia capsule under the nostril for a few seconds transported via ambulance to ER transferred from one hospital to another due to needing to be admitted to a cardiac unit
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Pulse absent, Respiratory arrest, SARS-CoV-2 test
Clinical narrative: sat unresponsive in a sleep like state stopped breathing no pulse no heart beat for about 4-5 minutes  Guardsman popped an ammonia capsule under the nostril for a few seconds transported via ambulance to ER transferred from one hospital to another due to needing to be admitted to a cardiac unit
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: sat unresponsive in a sleep like state stopped breathing no pulse no heart beat for about 4-5 minutes  Guardsman popped an ammonia capsule under the nostril for a few seconds transported via ambulance to ER transferred from one hospital to another due to needing to be admitted to a cardiac unit
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: SWEATING; DRY MOUTH; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; FEVER; This spontaneous report received from a patient concerned a 17 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced sweating. On 31-MAR-2021, the subject experienced dry mouth. On 31-MAR-2021, the subject experienced inappropriate age at vaccine administration. On 31-MAR-2021, the subject experienced off label use. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from off label use, and the outcome of sweating, fever, dry mouth and inappropriate age at vaccine administration was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Hyperhidrosis, Off label use, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: SWEATING; DRY MOUTH; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; FEVER; This spontaneous report received from a patient concerned a 17 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced sweating. On 31-MAR-2021, the subject experienced dry mouth. On 31-MAR-2021, the subject experienced inappropriate age at vaccine administration. On 31-MAR-2021, the subject experienced off label use. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from off label use, and the outcome of sweating, fever, dry mouth and inappropriate age at vaccine administration was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Disorientation, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: After Vaccine Administration  pt pulled to observation lot to wait 15 minutes for observation of adverse reaction. He lost consciousness after becoming confused for 1 minute. He was assessed by a guardsman and EMS staff regaining conciseness within a few minutes
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea
Clinical narrative: After Vaccine Administration  pt pulled to observation lot to wait 15 minutes for observation of adverse reaction. He lost consciousness after becoming confused for 1 minute. He was assessed by a guardsman and EMS staff regaining conciseness within a few minutes
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Loss of consciousness
Clinical narrative: After Vaccine Administration  pt pulled to observation lot to wait 15 minutes for observation of adverse reaction. He lost consciousness after becoming confused for 1 minute. He was assessed by a guardsman and EMS staff regaining conciseness within a few minutes
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle spasms, Myalgia, Nausea
Clinical narrative: TEMPERATURE INCREASED  TO 102 F AND NEXT DAY WAS IN RANGE OF 99-100F; BODY ACHES; CHILLS, FEELING COULD NOT GET WARM; Headache; Nausea; This spontaneous report received from a consumer concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805023 and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 at approximately 22:00, the subject experienced body aches. On 30-MAR-2021 at approximately 22:00, the subject experienced chills, feeling could not get warm. On 30-MAR-2021 at approximately 22:00, the subject experienced headache. On 30-MAR-2021 at approximately 22:00, the subject experienced nausea. On 30-MAR-2021 22:00, the subject experienced temperature increased to 102 f and next day was in range of 99-100f. On 30-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 102 F. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99-100 F. On an unspecified date, the subject experienced body temperature increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling could not get warm, headache, nausea, body aches, and temperature increased to 102 f and next day was in range of 99-100f. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: TEMPERATURE INCREASED  TO 102 F AND NEXT DAY WAS IN RANGE OF 99-100F; BODY ACHES; CHILLS, FEELING COULD NOT GET WARM; Headache; Nausea; This spontaneous report received from a consumer concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805023 and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 at approximately 22:00, the subject experienced body aches. On 30-MAR-2021 at approximately 22:00, the subject experienced chills, feeling could not get warm. On 30-MAR-2021 at approximately 22:00, the subject experienced headache. On 30-MAR-2021 at approximately 22:00, the subject experienced nausea. On 30-MAR-2021 22:00, the subject experienced temperature increased to 102 f and next day was in range of 99-100f. On 30-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 102 F. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99-100 F. On an unspecified date, the subject experienced body temperature increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling could not get warm, headache, nausea, body aches, and temperature increased to 102 f and next day was in range of 99-100f. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Nausea
Clinical narrative: TEMPERATURE INCREASED  TO 102 F AND NEXT DAY WAS IN RANGE OF 99-100F; BODY ACHES; CHILLS, FEELING COULD NOT GET WARM; Headache; Nausea; This spontaneous report received from a consumer concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805023 and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 at approximately 22:00, the subject experienced body aches. On 30-MAR-2021 at approximately 22:00, the subject experienced chills, feeling could not get warm. On 30-MAR-2021 at approximately 22:00, the subject experienced headache. On 30-MAR-2021 at approximately 22:00, the subject experienced nausea. On 30-MAR-2021 22:00, the subject experienced temperature increased to 102 f and next day was in range of 99-100f. On 30-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 102 F. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99-100 F. On an unspecified date, the subject experienced body temperature increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling could not get warm, headache, nausea, body aches, and temperature increased to 102 f and next day was in range of 99-100f. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: TEMPERATURE INCREASED  TO 102 F AND NEXT DAY WAS IN RANGE OF 99-100F; BODY ACHES; CHILLS, FEELING COULD NOT GET WARM; Headache; Nausea; This spontaneous report received from a consumer concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805023 and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 at approximately 22:00, the subject experienced body aches. On 30-MAR-2021 at approximately 22:00, the subject experienced chills, feeling could not get warm. On 30-MAR-2021 at approximately 22:00, the subject experienced headache. On 30-MAR-2021 at approximately 22:00, the subject experienced nausea. On 30-MAR-2021 22:00, the subject experienced temperature increased to 102 f and next day was in range of 99-100f. On 30-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 102 F. On 31-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99-100 F. On an unspecified date, the subject experienced body temperature increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feeling could not get warm, headache, nausea, body aches, and temperature increased to 102 f and next day was in range of 99-100f. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Intensive care, Swollen tongue
Clinical narrative: Throat tightening, dyspnea, lip paresthesias, tachycardia
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Intensive care, Swelling face, Tongue pruritus
Clinical narrative: Throat tightening, dyspnea, lip paresthesias, tachycardia
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Paraesthesia oral, Tachycardia, Throat tightness
Clinical narrative: Throat tightening, dyspnea, lip paresthesias, tachycardia
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Throat tightening, dyspnea, lip paresthesias, tachycardia
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emergency Room but I did not get seen thinking it would pass  nest couple days blood pressure mildly high and then extremely low, dizziness,  nausea with vomiting (vomiting started 3 days) and then i stoped eating 6 days later started Zofran to combat the nausea; blood pressure less variable
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Decreased appetite, Dizziness, Hypertension, Hypotension
Clinical narrative: shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emergency Room but I did not get seen thinking it would pass  nest couple days blood pressure mildly high and then extremely low, dizziness,  nausea with vomiting (vomiting started 3 days) and then i stoped eating 6 days later started Zofran to combat the nausea; blood pressure less variable
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia oral, Vomiting
Clinical narrative: shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emergency Room but I did not get seen thinking it would pass  nest couple days blood pressure mildly high and then extremely low, dizziness,  nausea with vomiting (vomiting started 3 days) and then i stoped eating 6 days later started Zofran to combat the nausea; blood pressure less variable
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Fatigue, Pain, Rash
Clinical narrative: FLU LIKE SYMPTOMS; RED SPOTS (BLOTCHES) ON FOREHEAD, UNDER AM,  SHOULDER; REDNESS ON CHEST AND UNDER CHEST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 27-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced flu like symptoms. On 28-MAR-2021, the subject experienced red spots (blotches) on forehead, under am, shoulder. On 28-MAR-2021, the subject experienced redness on chest and under chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, red spots (blotches) on forehead, under am, shoulder, and redness on chest and under chest. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Condition aggravated, Myalgia, Neuropathy peripheral
Clinical narrative: FLU LIKE SYMPTOMS; RED SPOTS (BLOTCHES) ON FOREHEAD, UNDER AM,  SHOULDER; REDNESS ON CHEST AND UNDER CHEST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 27-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced flu like symptoms. On 28-MAR-2021, the subject experienced red spots (blotches) on forehead, under am, shoulder. On 28-MAR-2021, the subject experienced redness on chest and under chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, red spots (blotches) on forehead, under am, shoulder, and redness on chest and under chest. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Rash, Skin warm
Clinical narrative: FLU LIKE SYMPTOMS; RED SPOTS (BLOTCHES) ON FOREHEAD, UNDER AM,  SHOULDER; REDNESS ON CHEST AND UNDER CHEST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 27-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced flu like symptoms. On 28-MAR-2021, the subject experienced red spots (blotches) on forehead, under am, shoulder. On 28-MAR-2021, the subject experienced redness on chest and under chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, red spots (blotches) on forehead, under am, shoulder, and redness on chest and under chest. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Influenza like illness, Rash macular
Clinical narrative: FLU LIKE SYMPTOMS; RED SPOTS (BLOTCHES) ON FOREHEAD, UNDER AM,  SHOULDER; REDNESS ON CHEST AND UNDER CHEST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 27-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced flu like symptoms. On 28-MAR-2021, the subject experienced red spots (blotches) on forehead, under am, shoulder. On 28-MAR-2021, the subject experienced redness on chest and under chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, red spots (blotches) on forehead, under am, shoulder, and redness on chest and under chest. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Erythema, Inflammation, Oedema
Clinical narrative: Normal redness, swelling and itching first 72 hours, cleared up and returned 8 days later on March 31, joint swelling in elbow of Left arm, bruise showed up next to injection site, arm developed red swollen,itchy rash 1.5 inches below and right of the injection site, sore throat and ache in chest, mild fever 99.8, aches and pain in ears, joints, hands, knees over the next 72 hours. All mild, recurring and now resolved.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Ear pain, Erythema, Injection site bruising
Clinical narrative: Normal redness, swelling and itching first 72 hours, cleared up and returned 8 days later on March 31, joint swelling in elbow of Left arm, bruise showed up next to injection site, arm developed red swollen,itchy rash 1.5 inches below and right of the injection site, sore throat and ache in chest, mild fever 99.8, aches and pain in ears, joints, hands, knees over the next 72 hours. All mild, recurring and now resolved.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Joint swelling, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Normal redness, swelling and itching first 72 hours, cleared up and returned 8 days later on March 31, joint swelling in elbow of Left arm, bruise showed up next to injection site, arm developed red swollen,itchy rash 1.5 inches below and right of the injection site, sore throat and ache in chest, mild fever 99.8, aches and pain in ears, joints, hands, knees over the next 72 hours. All mild, recurring and now resolved.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Rash erythematous, Swelling
Clinical narrative: Normal redness, swelling and itching first 72 hours, cleared up and returned 8 days later on March 31, joint swelling in elbow of Left arm, bruise showed up next to injection site, arm developed red swollen,itchy rash 1.5 inches below and right of the injection site, sore throat and ache in chest, mild fever 99.8, aches and pain in ears, joints, hands, knees over the next 72 hours. All mild, recurring and now resolved.
Age: 92.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient was hospitalized within 60 days of receiving a COVID vaccine
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Syncopal episode. Positioned patient in trendelenburg position. Patient bp wnl, HR 120. Patient layed down on stretcher and recovered. Sent home
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Cough, Erythema, Gastrointestinal pain, Nausea
Clinical narrative: urticaria, nausea, pelvic cramping, racing heart beat, wheezing, responsive at first to pt's supply of 40 mg prednisone orally, but then recurred within 2 hours and she gave herself an epipen injection as these are her typical prodromal anaphylactic symptoms. Went to ED. Got IV steroid, H2 blocker, another 40 mg oral steroid and discharged home.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rhinorrhoea, Throat tightness, Urticaria, Uterine spasm, Wheezing
Clinical narrative: urticaria, nausea, pelvic cramping, racing heart beat, wheezing, responsive at first to pt's supply of 40 mg prednisone orally, but then recurred within 2 hours and she gave herself an epipen injection as these are her typical prodromal anaphylactic symptoms. Went to ED. Got IV steroid, H2 blocker, another 40 mg oral steroid and discharged home.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Dyspnoea, Nausea, Pruritus
Clinical narrative: urticaria, nausea, pelvic cramping, racing heart beat, wheezing, responsive at first to pt's supply of 40 mg prednisone orally, but then recurred within 2 hours and she gave herself an epipen injection as these are her typical prodromal anaphylactic symptoms. Went to ED. Got IV steroid, H2 blocker, another 40 mg oral steroid and discharged home.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Respiratory tract congestion, Rhinorrhoea, Tachycardia
Clinical narrative: urticaria, nausea, pelvic cramping, racing heart beat, wheezing, responsive at first to pt's supply of 40 mg prednisone orally, but then recurred within 2 hours and she gave herself an epipen injection as these are her typical prodromal anaphylactic symptoms. Went to ED. Got IV steroid, H2 blocker, another 40 mg oral steroid and discharged home.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Nausea, Palpitations, Urticaria, Wheezing
Clinical narrative: urticaria, nausea, pelvic cramping, racing heart beat, wheezing, responsive at first to pt's supply of 40 mg prednisone orally, but then recurred within 2 hours and she gave herself an epipen injection as these are her typical prodromal anaphylactic symptoms. Went to ED. Got IV steroid, H2 blocker, another 40 mg oral steroid and discharged home.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Pancreatitis
Clinical narrative: Severe stomach pain ; hospitalized in emergency; patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous at age of 61 years, at single dose in left arm on 01Apr2021 at 11:15 (Lot number: ER8734) for COVID-19 immunisation. Medical history was not provided. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced severe stomach pain on 01Apr2021 at 11:15 and hospitalized in emergency for it. And it was reported that the adverse event result in "Emergency room/department or urgent care" and it was unknown if treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she was not diagnosed with COVID-19 prior to vaccination or since the vaccination. Event outcome for severe stomach pain  was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Incorrect route of product administration
Clinical narrative: Severe stomach pain ; hospitalized in emergency; patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via subcutaneous at age of 61 years, at single dose in left arm on 01Apr2021 at 11:15 (Lot number: ER8734) for COVID-19 immunisation. Medical history was not provided. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced severe stomach pain on 01Apr2021 at 11:15 and hospitalized in emergency for it. And it was reported that the adverse event result in "Emergency room/department or urgent care" and it was unknown if treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she was not diagnosed with COVID-19 prior to vaccination or since the vaccination. Event outcome for severe stomach pain  was not recovered.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, C-reactive protein normal, Dizziness, Dyskinesia, Fatigue
Clinical narrative: Myalgia, muscle fatigue, paresthesia of the finger tips.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Myalgia, muscle fatigue, paresthesia of the finger tips.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, C-reactive protein normal, Muscle fatigue, Myalgia, Paraesthesia
Clinical narrative: Myalgia, muscle fatigue, paresthesia of the finger tips.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Myalgia, muscle fatigue, paresthesia of the finger tips.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Urticaria
Clinical narrative: 4/3/21  30 seconds after 2nd dose - developed hot flashes, lightheadedness, and dizziness, 1 min later developed tachycardia, felt presyncopal, then crushing chest tightness, dyspnea. Given Epi at the site - symptoms plateaued immediately. Better within 30 mins. EMS - Benadryl 50mg. In ER - Solumedrol. Sent to ER - monitored for 4-6 hrs. D/c'ed home on Prednisone.  4/7/21  Now feeling some chest/abdominal bloating and tightness. Today feeling better. Full body aching.