chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic
Clinical narrative: atopic dermatitis; This is a spontaneous report based on the information received by Pfizer from  Laboratorie (Case number: GL-090321-21301). A contactable 36-year-old female consumer (patient) reported. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 15Mar2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took tacrolimus for dermatitis atopic. No other vaccines, illnesses, or dental procedures in the last 6-12 months. Patient was injected with a total of 1 ml of what she believes to be Restylane Kysse (Lot and exp Unknown) to tear troughs and upper and lower lips on 20Apr2021. She reported that she developed swelling under her right eye one day in Aug-2021 and the next day she woke up with swelling to both upper and lower eyelids and upper and lower lips, she reported they were very inflamed. She saw the HCP who administered certisone injections to both eyes and lips and prescribed her with a 5-day course of oral prednisone, swelling resolved. After finishing the oral prednisone, the swelling returned (02Sep2021). She contacted the HCP by phone and sent him photos of the swelling and he prescribed her lisinopril 5 mg daily and advised she take cetirizine dihydrochloride and fexofenadine. She reported that she is reluctant to take the lisinopril because its for high blood pressure. Event has not resolved, still has swelling and inflammation both eyes and upper and lower lips. The patient was diagnosed with atopic dermatitis around the eyes 6 weeks prior to injections, she was treated with Tacrolimus ointment which she had stopped about 2 weeks prior to injections. No other medical history, allergies, or medications. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: She has had a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low; she started feeling light headed like she is gonna pass out; No energy; This is a spontaneous report from a contactable Nurse(daughter). A 17 year old female patient first dose of received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 05Aug2021 (age at vaccination 17 years) as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported . It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination. On 19 Aug2021 the patient had experienced a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low,No energy and feeling light headed like she is gonna pass out. On an unspecified date the patient underwent lab test and procedures which had included Blood test,Holter monitor , had echocardiogram for heart and EKG for her heart with diagnosis of unknown results for all tests. The clinical outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Heart rate decreased
Clinical narrative: She has had a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low; she started feeling light headed like she is gonna pass out; No energy; This is a spontaneous report from a contactable Nurse(daughter). A 17 year old female patient first dose of received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 05Aug2021 (age at vaccination 17 years) as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported . It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination. On 19 Aug2021 the patient had experienced a low heart rate; she did not had a low heart rate prior to the vaccine; heart rate it was in 40 and now she runs 30's 40's it does go up but it stay significantly low,No energy and feeling light headed like she is gonna pass out. On an unspecified date the patient underwent lab test and procedures which had included Blood test,Holter monitor , had echocardiogram for heart and EKG for her heart with diagnosis of unknown results for all tests. The clinical outcome of the events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diabetes mellitus, Eating disorder, Fatigue
Clinical narrative: she is diabetic; Fever; Chills; Upset stomach; Fatigue; couldn't eat; Sick for two days; couldn't go to work; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, upset stomach, fatigue, couldn't eat, sick for two days and couldn't go to work on an unspecified date. The patient also reported that she is diabetic on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: she is diabetic; Fever; Chills; Upset stomach; Fatigue; couldn't eat; Sick for two days; couldn't go to work; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, upset stomach, fatigue, couldn't eat, sick for two days and couldn't go to work on an unspecified date. The patient also reported that she is diabetic on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Palpitations
Clinical narrative: Have not been able to sleep through the night since vaccine; Fatigued; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Sep2021 at 12:00 (Batch/Lot Number: FC3181) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at age of 51 years old. Medical history included hashimotos disease, thrombocytosis, hemochromatosis, anxiety. Concomitant medications included escitalopram oxalate (LEXAPRO); levothyroxine sodium (SYNTHROID); bupropion hydrobromide (APLENZIN); liraglutide (SAXENDA). The patient experienced have not been able to sleep through the night since vaccine, fatigued, and heart palpitations on 08Sep2021. The report was non-serious. No treatment received for the events. The patient did not have covid prior vaccination, and did not test covid post vaccination. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site haemorrhage, Pain in extremity
Clinical narrative: 2nd shot- Arm bled quite a bit after injection; Headache lasting a few days; Sore Arm; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in Left arm on 27Aug2021 at the age of 34-years-old as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concurrent conditions were none. The patient was not pregnant at the time of vaccination. There was no relevant past drug history. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FA7484), via an unspecified route of administration, administered in Left arm on 03Aug2021 (at the age of 34-years-old) as single dose for covid-19 immunisation and experienced Horrible headache lasting 6 days, Chills, Nausea and Sore arm. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 19Sep2021. On an unspecified date in 2021, the patient experienced Arm bled quite a bit after injection, Headache lasting a few days and Sore Arm. Adverse events resulted in none of the above. No treatment was received for adverse events. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of Headache lasting a few days was recovered on an unspecified date in 2021 and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Feeling abnormal, Urine analysis
Clinical narrative: I feel as outer gas; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient) via . A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 11Feb2021 11:00  (at 58 years old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation. Patient has no relevant medical history. The patient's concomitant medications were not reported. The patient underwent lab tests and procedures which included blood test: normal on 2021, urine analysis: normal on 2021. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme fatigue on 12Feb2021 05:00 with outcome of not recovered. Since taking the vaccine have an increased to extreme amount of fatigued by the end of the day. Patient felt as outer gas and just can't so anymore. It is nearly everyday. No treatment given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The adverse event resulted in visit to Doctor or other healthcare professional office. Dose 2 was given on 03Mar2021,intramuscular Left arm; Lot number: EL1686.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Migraine, Myalgia
Clinical narrative: Myalgia; Fever 100.6; Chills; Migraine; Nausea; Severe fatigue; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular, administered in Deltoid Left on 22Dec2020 10:00 (Lot Number: EJ1685) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered at a hospital. Medical history included lupus (prior to vaccination), HPTN (hypertension) (prior to vaccination), and sleep (disorder). Concomitant medication(s) included trazodone (TRAZODONE) taken for sleep (disorder), start and stop date were not reported; losartan (LOSARTAN) taken for HPTN, start and stop date were not reported. The patient previously took ibuprofen and experienced allergy (allergic to ibuprofen). It was reported that the patient experienced myalgia, fever 100.6, chills, migraines, nausea and severe fatigue on 23Dec2020 00:30 (resolved with sequelae on 24Dec2020), then on 13Jan2021 21:00 (resolved with sequelae on 15Jan2021). It was reported that patient was allergic to ibuprofen, thus, she took Tylenol for symptoms. Therapeutic measures were taken as a result of the adverse events which included paracetamol (TYLENOL), taken from 22Dec2020 (as reported) to 24Dec2020, then from 13Jan2021 to 15Jan2021. Outcome of the events was first resolved with sequelae on 24Dec2020. The reporting nurse assessed the events as non-serious. It was reported that the patient received the second dose of (BNT162B2), intramuscular, administered in Deltoid Left on 21Jan2021 11:00 (Lot Number: EJ1686) as DOSE 2, SINGLE for COVID-19 immunisation. The patient also received a third dose on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Myalgia; Fever 100.6; Chills; Migraine; Nausea; Severe fatigue; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular, administered in Deltoid Left on 22Dec2020 10:00 (Lot Number: EJ1685) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered at a hospital. Medical history included lupus (prior to vaccination), HPTN (hypertension) (prior to vaccination), and sleep (disorder). Concomitant medication(s) included trazodone (TRAZODONE) taken for sleep (disorder), start and stop date were not reported; losartan (LOSARTAN) taken for HPTN, start and stop date were not reported. The patient previously took ibuprofen and experienced allergy (allergic to ibuprofen). It was reported that the patient experienced myalgia, fever 100.6, chills, migraines, nausea and severe fatigue on 23Dec2020 00:30 (resolved with sequelae on 24Dec2020), then on 13Jan2021 21:00 (resolved with sequelae on 15Jan2021). It was reported that patient was allergic to ibuprofen, thus, she took Tylenol for symptoms. Therapeutic measures were taken as a result of the adverse events which included paracetamol (TYLENOL), taken from 22Dec2020 (as reported) to 24Dec2020, then from 13Jan2021 to 15Jan2021. Outcome of the events was first resolved with sequelae on 24Dec2020. The reporting nurse assessed the events as non-serious. It was reported that the patient received the second dose of (BNT162B2), intramuscular, administered in Deltoid Left on 21Jan2021 11:00 (Lot Number: EJ1686) as DOSE 2, SINGLE for COVID-19 immunisation. The patient also received a third dose on an unspecified date.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate, Heart rate increased, Sleep disorder
Clinical narrative: both arms started shaking like having seizures on the outside; could not breathe good; heart rate high like 140; Headache; has been sleeping a lot ever since; This is a spontaneous report from a contactable nurse. A 56-years-old female patient (sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC318), dose 2 via an unspecified route of administration, administered in right arm on 20Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing asthma which was diagnosed years ago. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number of FCJ183) via an unspecified route of administration, administered in right arm on 30Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. On 21Sep2021, the patient's both arms started shaking like having seizures on the outside which started at 01:00 to 02:00, could not breathe good, heart rate high like 140, headache and was sleeping a lot ever since. They had to call her doctor and they did some things that helped. She took Ibuprofen for headache and did breathing treatment. The patient underwent lab tests and procedures which included heart rate was 140 and heart rate high like 140 on 21Sep2021. The outcome of sleep disorder was not recovered; headache was recovering and all the other events wee recovered on 21Sep2021. There was product quality complaint (PQC) present. Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: both arms started shaking like having seizures on the outside; could not breathe good; heart rate high like 140; Headache; has been sleeping a lot ever since; This is a spontaneous report from a contactable nurse. A 56-years-old female patient (sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC318), dose 2 via an unspecified route of administration, administered in right arm on 20Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing asthma which was diagnosed years ago. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number of FCJ183) via an unspecified route of administration, administered in right arm on 30Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. On 21Sep2021, the patient's both arms started shaking like having seizures on the outside which started at 01:00 to 02:00, could not breathe good, heart rate high like 140, headache and was sleeping a lot ever since. They had to call her doctor and they did some things that helped. She took Ibuprofen for headache and did breathing treatment. The patient underwent lab tests and procedures which included heart rate was 140 and heart rate high like 140 on 21Sep2021. The outcome of sleep disorder was not recovered; headache was recovering and all the other events wee recovered on 21Sep2021. There was product quality complaint (PQC) present. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Erythema, Fatigue, Feeling abnormal
Clinical narrative: some oral issues; she got a golf ball size on her arm; she got a golf ball size on her arm with itching; redness somewhat there and it's going down; back of her tongue is now white with patches; 3rd shot felt a little different on the arm.; fatigue; pain in her joints; brain fog; papules on her mouth; This is a spontaneous report from a contactable other HCP (Patient). A 75-year-old immunocompromised female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included immunocompromised, chronic lyme and Low Antibodies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported and other products was not provided. Historical vaccine included first dose and second dose of bnt162b2 on an unknown date for covid-19 immunisation. It was reported that the patient antibodies were very low and her doctor was very concerned and told her to get the third dose as soon as she could as she was at high risk. The patient experienced some oral issues, she got a golf ball size on her arm with itching and redness somewhat there and it's going down, back of her tongue was now white with patches, 3rd shot felt a little different on the arm, fatigue, pain in her joints, brain fog and papules on her mouth on an unknown date. The patient got the third dose because the vaccine didn't give her the immunity as her doctor expected. The patient wanted to know if oral issues have been reported to see if the side effect she experienced was just a coincidence because she's also on a lot of different things and have a lot of other issues. The patient stated that her mouth isn't irritated. The patient glad that there were no major issues that popped up with the Comirnaty vaccine. The patient asked as anyone had oral issues with the 3rd shot, she didn't have it with the first 2 or was there a study saying people having this. The patient battling chronic Lyme (medical history) and was on a regime and was on natural things at the moment. The patient had different reaction than she did with the first 2 dose. The patient stated, she had fatigue and pain in her joints already so it's hard to tell if it's one thing or something else. Patient stated her mouth was something different and she had some irritation due to a change of one thing. States she needs to go to the dentist or if she was having problems not to go today. The patient stated its confusing right now. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Oral papule, Peripheral swelling, Pruritus, Tongue discolouration
Clinical narrative: some oral issues; she got a golf ball size on her arm; she got a golf ball size on her arm with itching; redness somewhat there and it's going down; back of her tongue is now white with patches; 3rd shot felt a little different on the arm.; fatigue; pain in her joints; brain fog; papules on her mouth; This is a spontaneous report from a contactable other HCP (Patient). A 75-year-old immunocompromised female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included immunocompromised, chronic lyme and Low Antibodies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported and other products was not provided. Historical vaccine included first dose and second dose of bnt162b2 on an unknown date for covid-19 immunisation. It was reported that the patient antibodies were very low and her doctor was very concerned and told her to get the third dose as soon as she could as she was at high risk. The patient experienced some oral issues, she got a golf ball size on her arm with itching and redness somewhat there and it's going down, back of her tongue was now white with patches, 3rd shot felt a little different on the arm, fatigue, pain in her joints, brain fog and papules on her mouth on an unknown date. The patient got the third dose because the vaccine didn't give her the immunity as her doctor expected. The patient wanted to know if oral issues have been reported to see if the side effect she experienced was just a coincidence because she's also on a lot of different things and have a lot of other issues. The patient stated that her mouth isn't irritated. The patient glad that there were no major issues that popped up with the Comirnaty vaccine. The patient asked as anyone had oral issues with the 3rd shot, she didn't have it with the first 2 or was there a study saying people having this. The patient battling chronic Lyme (medical history) and was on a regime and was on natural things at the moment. The patient had different reaction than she did with the first 2 dose. The patient stated, she had fatigue and pain in her joints already so it's hard to tell if it's one thing or something else. Patient stated her mouth was something different and she had some irritation due to a change of one thing. States she needs to go to the dentist or if she was having problems not to go today. The patient stated its confusing right now. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chapped lips, Computerised tomogram, Lip dry, Muscular weakness
Clinical narrative: Cracked and dry lips that will not healDry; Cracked and dry lips that will not healDry; Swollen tongue; dry tongue; Weakened muscle; Burning and affecting glands; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in the arm on 13Mar2021 12:45 (at the age of 69-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included minor COPD. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cracked and dry lips that will not heal, dry and swollen tongue, weakened muscle, burning and affecting glands. The patient underwent lab tests and procedures which included CATSCAN and sars-cov-2 test: negative in Jun2021. Therapeutic measures were taken as a result of the events. The outcome of all events was not recovered.   Information on lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swollen tongue, Tongue dry
Clinical narrative: Cracked and dry lips that will not healDry; Cracked and dry lips that will not healDry; Swollen tongue; dry tongue; Weakened muscle; Burning and affecting glands; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in the arm on 13Mar2021 12:45 (at the age of 69-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included minor COPD. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced cracked and dry lips that will not heal, dry and swollen tongue, weakened muscle, burning and affecting glands. The patient underwent lab tests and procedures which included CATSCAN and sars-cov-2 test: negative in Jun2021. Therapeutic measures were taken as a result of the events. The outcome of all events was not recovered.   Information on lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dysarthria, Electric shock sensation, Electromyogram
Clinical narrative: EMG revealed nerve damage/sensation of nervous system experiencing electricity/vibrations throughout body; Confusion; slurred speech; severe muscle spasms; tremors; sudden episodes of numbness in arms and legs; severe pressure in head; dizziness; tinnitus; heart palpitations; increased heart rate; shallow breathing; disturbance in menstrual cycle; sensation of nervous system experiencing electricity/vibrations throughtout body; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 36 years, administered in arm left on 07Aug2021 12:30 (Lot Number: EW0183) as single dose for covid-19 immunisation. Medical history included allergies to Almonds. No covid prior vaccination. The patient's concomitant medications were none. No other vaccine in four weeks, no other medications in two weeks. The patient experienced Confusion/slurred speech, severe muscle spasms, tremors, sudden episodes of numbness in arms and legs, severe pressure in head, dizziness, tinnitus, heart palpitations, increased heart rate, shallow breathing, disturbance in menstrual cycle, and sensation of nervous system experiencing electricity/vibrations throughout body post vaccination. EMG (20Aug2021) revealed nerve damage of questionable clinical significance thirteen days post vaccination. MRI (2021) revealed no underlying condition. Covid test via nasal swab on 13Aug2021 and negative. The pharmacy does not recommend that patient receive the 2nd shot after her adverse reaction to the Pfizer Covid-19 vaccine. The pharmacy also guided she to the Pfizer website to report adverse reaction event. Adverse events start date was 07Aug2021 13:30 and resulted in Doctor or other healthcare professional office/clinic visit, no treatment was received. The outcome of the events was Recovered/Resolved with Sequel in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Heart rate, Heart rate increased, Hypoaesthesia, Hypopnoea
Clinical narrative: EMG revealed nerve damage/sensation of nervous system experiencing electricity/vibrations throughout body; Confusion; slurred speech; severe muscle spasms; tremors; sudden episodes of numbness in arms and legs; severe pressure in head; dizziness; tinnitus; heart palpitations; increased heart rate; shallow breathing; disturbance in menstrual cycle; sensation of nervous system experiencing electricity/vibrations throughtout body; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 36 years, administered in arm left on 07Aug2021 12:30 (Lot Number: EW0183) as single dose for covid-19 immunisation. Medical history included allergies to Almonds. No covid prior vaccination. The patient's concomitant medications were none. No other vaccine in four weeks, no other medications in two weeks. The patient experienced Confusion/slurred speech, severe muscle spasms, tremors, sudden episodes of numbness in arms and legs, severe pressure in head, dizziness, tinnitus, heart palpitations, increased heart rate, shallow breathing, disturbance in menstrual cycle, and sensation of nervous system experiencing electricity/vibrations throughout body post vaccination. EMG (20Aug2021) revealed nerve damage of questionable clinical significance thirteen days post vaccination. MRI (2021) revealed no underlying condition. Covid test via nasal swab on 13Aug2021 and negative. The pharmacy does not recommend that patient receive the 2nd shot after her adverse reaction to the Pfizer Covid-19 vaccine. The pharmacy also guided she to the Pfizer website to report adverse reaction event. Adverse events start date was 07Aug2021 13:30 and resulted in Doctor or other healthcare professional office/clinic visit, no treatment was received. The outcome of the events was Recovered/Resolved with Sequel in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Menstruation irregular, Muscle spasms, Nerve injury, Palpitations
Clinical narrative: EMG revealed nerve damage/sensation of nervous system experiencing electricity/vibrations throughout body; Confusion; slurred speech; severe muscle spasms; tremors; sudden episodes of numbness in arms and legs; severe pressure in head; dizziness; tinnitus; heart palpitations; increased heart rate; shallow breathing; disturbance in menstrual cycle; sensation of nervous system experiencing electricity/vibrations throughtout body; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 36 years, administered in arm left on 07Aug2021 12:30 (Lot Number: EW0183) as single dose for covid-19 immunisation. Medical history included allergies to Almonds. No covid prior vaccination. The patient's concomitant medications were none. No other vaccine in four weeks, no other medications in two weeks. The patient experienced Confusion/slurred speech, severe muscle spasms, tremors, sudden episodes of numbness in arms and legs, severe pressure in head, dizziness, tinnitus, heart palpitations, increased heart rate, shallow breathing, disturbance in menstrual cycle, and sensation of nervous system experiencing electricity/vibrations throughout body post vaccination. EMG (20Aug2021) revealed nerve damage of questionable clinical significance thirteen days post vaccination. MRI (2021) revealed no underlying condition. Covid test via nasal swab on 13Aug2021 and negative. The pharmacy does not recommend that patient receive the 2nd shot after her adverse reaction to the Pfizer Covid-19 vaccine. The pharmacy also guided she to the Pfizer website to report adverse reaction event. Adverse events start date was 07Aug2021 13:30 and resulted in Doctor or other healthcare professional office/clinic visit, no treatment was received. The outcome of the events was Recovered/Resolved with Sequel in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus, Tremor
Clinical narrative: EMG revealed nerve damage/sensation of nervous system experiencing electricity/vibrations throughout body; Confusion; slurred speech; severe muscle spasms; tremors; sudden episodes of numbness in arms and legs; severe pressure in head; dizziness; tinnitus; heart palpitations; increased heart rate; shallow breathing; disturbance in menstrual cycle; sensation of nervous system experiencing electricity/vibrations throughtout body; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 36 years, administered in arm left on 07Aug2021 12:30 (Lot Number: EW0183) as single dose for covid-19 immunisation. Medical history included allergies to Almonds. No covid prior vaccination. The patient's concomitant medications were none. No other vaccine in four weeks, no other medications in two weeks. The patient experienced Confusion/slurred speech, severe muscle spasms, tremors, sudden episodes of numbness in arms and legs, severe pressure in head, dizziness, tinnitus, heart palpitations, increased heart rate, shallow breathing, disturbance in menstrual cycle, and sensation of nervous system experiencing electricity/vibrations throughout body post vaccination. EMG (20Aug2021) revealed nerve damage of questionable clinical significance thirteen days post vaccination. MRI (2021) revealed no underlying condition. Covid test via nasal swab on 13Aug2021 and negative. The pharmacy does not recommend that patient receive the 2nd shot after her adverse reaction to the Pfizer Covid-19 vaccine. The pharmacy also guided she to the Pfizer website to report adverse reaction event. Adverse events start date was 07Aug2021 13:30 and resulted in Doctor or other healthcare professional office/clinic visit, no treatment was received. The outcome of the events was Recovered/Resolved with Sequel in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: mild case of covid on August/ tested positive; mild case of covid on August; This is a spontaneous report received from a contactable consumer (spouse of patient) from a Pfizer-sponsored program. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 on Feb2021 (Batch/Lot number was not reported), and dose 2 via on Mar2021 (Batch/Lot number was not reported), both as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the 1st and 2nd doses on February and March. He got a mild case of COVID in August (24Aug2021, tested positive). He tested negative in 17Sep2021. The patient had an appointment to get the booster "today" (report date: 27Sep2021). The reporter was interested in knowing if it was not dangerous for the patient to get the booster. The reporter thought that maybe the patient's antibodies were still too high.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Deafness unilateral, Magnetic resonance imaging, X-ray
Clinical narrative: lost my balance for 2 to 3 weeks; complete hearing loss in his left ear; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 73-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EN6201) as DOSE 2, SINGLE for covid-19 immunisation at the age of 73-year-old. Medical history included ongoing high cholesterol (this was diagnosed in 1997 to 1998), suspected covid-19 at the very end of 2019 to beginning of 2020, he says there wasn't a lot of information back then when it hit this area. He says he was sick 2.5 days then he got out of bed and saw the doctor and he told him you have something bronchial, your lungs sound clear, and that they no idea what it was. He says they gave him antibiotic pills for cough treatment for it, then in the ensuing 3 months when COVID information came out he had had classic COVID symptoms. He says he recovered from that, it took quite a while, and it was almost a year before the vaccine was available to him. He says he had gone to the hospital 06 Jan 2020, and then he didn't get his first COVID vaccine until 21Jan2021. Historical vaccine included dose 1 of bnt162b2 (Batch/Lot Number: EL9261) on 21Jan2021 at the age of 73-year-old. The concomitants included three primary cardio related primary medications that he has been taking for a long time, including one for high cholesterol. The patient experienced complete hearing loss in his left ear on 11Mar2021 with outcome of recovering, lost the balance for 2 to 3 weeks on an unspecified date with outcome of not recovered. The clinical course was reported as: the patient received the second dose of the Pfizer Covid-19 vaccine on 11Feb2021 and experienced complete hearing loss in his left ear 30 days after the dose on 11Mar2021. He went to sleep 11Mar2021 and then woke up 12Mar2021 with no hearing in his left ear. He says this has improved somewhat, he has had two hearing tests, and is scheduled to take the third test 01Oct2021 to prepare for getting a hearing aid. He says prior to this he had no decline in hearing in his left ear, it just went out like a light. He says he has talked to four ENTs and had x-rays and MRIs (Magnetic resonance imaging) and they can't nail it down. He says he understands there is some other hearing loss associated with the vaccine. Along with the hearing problem on that particular day, he lost the balance for 2 to 3 weeks it was difficult to get up and go to the bathroom and to this day still have some balance issues.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via a Regulatory Authority. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in Mar2021 (lot number not reported), as dose 1, single; then via an unspecified route of administration, in Mar2021 (lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 01Aug2021, the patient developed COVID-19 after being fully vaccinated. It was reported that the patient had a breakthrough (as reported) and the reporter asked if there is a waiting period after recovery before getting the booster shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Incorrect product storage (unknown if vaccine was administered); This case is considered invalid as it is unknown if any patient received the incorrectly stored vaccine, no specified event reported.   This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that:  Patient characteristics: Patient: Unknown  Reaction(s)/Event(s): Reaction/event as reported by primary source: Excursion go from frozen to the core and we put in less then 30 minutes and then we put the vaccine back to the freezer  Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Covid-19 vaccine Batch/Lot number: Unknown Action(s) taken with drug: Unknown  Narrative case summary and further information: Case narrative: Submitted by Call Centre  Selected Report Type: Initial  Is the patient also the reporter? No  Reporter type: Pharmacist Reporter telephone: #  Primary / Prescribing Healthcare Professional Info HCP postal address:  Dates for Excursion go from frozen to the core and we put in less then 30 minutes and then we put the vaccine back to the freezer: (From: Unspecified To: Unspecified)  Is COVID 19 VACCINE a Pfizer product? Yes COVID 19 VACCINE manufacturer: Unspecified Dates for COVID 19 VACCINE: (Start: Unspecified Stop: Unspecified) NDC number of COVID 19 VACCINE: Unknown UPC number of COVID 19 VACCINE: Unknown  Reason for no lot number: of COVID 19 VACCINE: Caller unwilling to complete the report  Expiry Date of COVID 19 VACCINE: Unknown  Additional Context: Concern: Pharmacist stated "Yeah. I am calling to get some information about the Pfizer product excursion."  When asked that, Is the vaccine administered to anyone: Pharmacist stated, "Yes. So, this is Pfizer excursion go from frozen to the core and we put in less then 30 mins and then we put the vaccine back to the freezer so, what are we able to give that vaccine still."  LOT NO: Pharmacist stated "No. Thank you. I will call you back."  Pharmacist was informed about Pfizer Medical Information and telephone number was shared.  Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed as Pharmacist hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Pain in extremity
Clinical narrative: shingles appeared on and around right thigh; pain in the right forearm; felt shoulder joint pain until now; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0170; Expiration date: not provided) via an unspecified route of administration on 16Apr2021 in left arm age at vaccination 53-year-old as dose 2, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8734; Expiration date: not provided) via an unspecified route of administration on 26Mar2021 in left arm age at vaccination 53-year-old as dose 1, single for Covid-19 immunization at hospital. 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 26Apr2021, 10 days after vaccination, shingles appeared on and around right thigh. He visited urgent care for both arm pain and thigh pain after shingles pain appeared on 26Apr2021 and told the doctor he recently got COVID19 vaccine. The doctor said that the arm pain was due to the problem with my working gesture, like using computer for long time, so there was no treatment for the arm pain. The thigh pain was caused by the sciatic nerve, so no treatment for it either. Four days later he visited the urgent care/ emergency room again, and told the doctor that his thigh pain might be due to the shingles. An adverse events resulted into emergency room visit. Therapeutic measures were taken as a result of shingles appeared on and around right thigh, pain in the right forearm, and felt shoulder joint pain until now. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Swollen tongue, Urticaria
Clinical narrative: allergic reaction; swelling of the tongue; hives; itching; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program  support. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced allergic reaction, swelling of the tongue, hives, itching. Therapeutic measures were taken as a result of events. Events resulted in physician office visit. Pharmacist would like to know in the wake of the allergic reaction her patient had to the first dose of the Pfizer Covid 19 vaccine is there any information on interchangeability and could the patient get a dose of the Johnson and Johnson Covid 19 vaccine to complete the series? Patient actually ended up getting an Epi Pen. Patient got their first dose and afterwards ended up having allergic reaction. Is the patient able to get the Pfizer COVID-19 Vaccine again? Or can the patient receive a COVID-19 Vaccine from a different manufacturer? Patient got hives, itching, and swelling of the tongue right after the Pfizer COVID-19 vaccine. Patient's breathing was ok, just had the tongue swelling. Received treatment at an urgent care, not the ER. Patient went to see an allergist, who advised her she can get the Johnson and Johnson as a second dose. Patient received Benadryl at the Urgent Care. Is it ok for patient to receive the Johnson and Johnson COVID-19 Vaccine after the Pfizer COVID-19 Vaccine? Patient received the Pfizer COVID-19 Vaccine at a different facility. Patient wanted to receive the Johnson and Johnson COVID-19 vaccine at caller's facility. The outcome of events was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.