chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Injection site pain & systemic arthritic; Injection site pain & systemic arthritic pain; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN9581) via an unspecified route of administration, administered on the right arm on 18Feb2021 11:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on 28Jan2021 for COVID-19 immunisation (first dose on the right arm, lot number: EL8982); NSAIDs and sporins experienced allergies. On 18Feb2021 17:45 the patient experienced injection site pain & systemic arthritic pain. No treatment was received for the events. 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. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Middle ear disorder, Rhinorrhoea, Sneezing
Clinical narrative: dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced dizziness in Feb2021 more than 24 hours after received her 2nd shot. The outcome of event was unknown.   Information about lot/batch number requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced dizziness in Feb2021 more than 24 hours after received her 2nd shot. The outcome of event was unknown.   Information about lot/batch number requested.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head normal, Contusion, Culture urine negative, Epistaxis, Full blood count
Clinical narrative: blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin normal, Influenza virus test negative, Metabolic function test, Metabolic function test normal, Petechiae
Clinical narrative: blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, SARS-CoV-2 test negative, Urine analysis normal, White blood cell count normal
Clinical narrative: blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Body temperature, Chills, Epistaxis, Illness
Clinical narrative: blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Petechiae, Platelet count, Platelet count decreased, Pyrexia
Clinical narrative: blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: blood blisters; nose bleed; I had petichiae all over legs and arms; showed platelets at 7000/showed zero platelets; very sick; fever and chills; fever and chills; achy all over; This is a spontaneous report from a contactable consumer (patient).  This 89-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unspecified route, on 12Feb2021 (at 12:15) at a single dose on right arm for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) administered on right (R) arm on 22Jan2021 at 10:15 AM. No other vaccine was received in four weeks. Relevant medical history includes acute myeloid leukemia, allergy to fish and NSAIDS. Past drug history included allergy to penicillin and erythromycin. Relevant concomitant medications included aciclovir (ACYCLOVIR), amiodarone, fluconazole, furosemide (LASIX) and oxitriptan (LEVOTHYM). The patient became very sick after vaccine with fever and chills and achy all over for 4 days, then on the 7th day her blood test showed platelets at 7000. On 19Feb2021 (at 17:00), she had petichiae all over legs and arms and blood blisters and nosebleed for 2 hours. She visited emergency room (ER) were blood tests showed zero platelets so she was hospitalized on 19Feb2021 for 3 days. She was infused with 5 units of plasma and she received also dexamethasone. The events were considered serious because requiring hospitalization on 19Feb2021 and also as life-threatening conditions. On 20Feb2021, the patient underwent a COVID test which resulted negative. The patient had not recovered from the events.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Headache, Inappropriate schedule of product administration, May-Thurner syndrome
Clinical narrative: Localized discomfort where they gave her injection of first dose; both of her feet were only slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the upper left arm on 05Jan2021 around 11:00-11:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks prior to the first administration of the vaccine. Medical history included ongoing thyroid condition (Over 25-30 years ago. Ongoing controlled with Synthroid), breast cancer (2019 treatment and surgery. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 Vaccine. Has no history of blood clots. She had full genetic testing for breast cancer and the results came back unremarkable for everything; every gene they could test they tested and they had nothing come back), lyme disease from 2002 (20 years ago; Has some suppressed immunity from Lyme Disease). The patient had no family medical history. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) taken for thyroid condition. In the evening on 05Jan2021, the patient experienced localized discomfort where they gave her injection of first dose. The event lasted maybe a day. It was also reported that about 3 or 4 days (Jan2021) after she was administered her first dose of Pfizer COVID-19 Vaccine both of her feet were only slightly swollen. She considered this event insignificant at the time. She drank water and this event went away after about 2 days. Event was not uncomfortable. Recovered completely to her awareness at that time. On 06Jan2021, the patient recovered from localized discomfort where they gave her injection of first dose and recovered on an unspecified date from the event both of her feet were only slightly swollen.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Off label use, Peripheral swelling, Vaccination site discomfort
Clinical narrative: Localized discomfort where they gave her injection of first dose; both of her feet were only slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the upper left arm on 05Jan2021 around 11:00-11:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks prior to the first administration of the vaccine. Medical history included ongoing thyroid condition (Over 25-30 years ago. Ongoing controlled with Synthroid), breast cancer (2019 treatment and surgery. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 Vaccine. Has no history of blood clots. She had full genetic testing for breast cancer and the results came back unremarkable for everything; every gene they could test they tested and they had nothing come back), lyme disease from 2002 (20 years ago; Has some suppressed immunity from Lyme Disease). The patient had no family medical history. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) taken for thyroid condition. In the evening on 05Jan2021, the patient experienced localized discomfort where they gave her injection of first dose. The event lasted maybe a day. It was also reported that about 3 or 4 days (Jan2021) after she was administered her first dose of Pfizer COVID-19 Vaccine both of her feet were only slightly swollen. She considered this event insignificant at the time. She drank water and this event went away after about 2 days. Event was not uncomfortable. Recovered completely to her awareness at that time. On 06Jan2021, the patient recovered from localized discomfort where they gave her injection of first dose and recovered on an unspecified date from the event both of her feet were only slightly swollen.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, May-Thurner syndrome, Thrombectomy
Clinical narrative: Localized discomfort where they gave her injection of first dose; both of her feet were only slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the upper left arm on 05Jan2021 around 11:00-11:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks prior to the first administration of the vaccine. Medical history included ongoing thyroid condition (Over 25-30 years ago. Ongoing controlled with Synthroid), breast cancer (2019 treatment and surgery. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 Vaccine. Has no history of blood clots. She had full genetic testing for breast cancer and the results came back unremarkable for everything; every gene they could test they tested and they had nothing come back), lyme disease from 2002 (20 years ago; Has some suppressed immunity from Lyme Disease). The patient had no family medical history. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) taken for thyroid condition. In the evening on 05Jan2021, the patient experienced localized discomfort where they gave her injection of first dose. The event lasted maybe a day. It was also reported that about 3 or 4 days (Jan2021) after she was administered her first dose of Pfizer COVID-19 Vaccine both of her feet were only slightly swollen. She considered this event insignificant at the time. She drank water and this event went away after about 2 days. Event was not uncomfortable. Recovered completely to her awareness at that time. On 06Jan2021, the patient recovered from localized discomfort where they gave her injection of first dose and recovered on an unspecified date from the event both of her feet were only slightly swollen.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cytogenetic analysis, Peripheral swelling, Vaccination site discomfort
Clinical narrative: Localized discomfort where they gave her injection of first dose; both of her feet were only slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the upper left arm on 05Jan2021 around 11:00-11:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks prior to the first administration of the vaccine. Medical history included ongoing thyroid condition (Over 25-30 years ago. Ongoing controlled with Synthroid), breast cancer (2019 treatment and surgery. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 Vaccine. Has no history of blood clots. She had full genetic testing for breast cancer and the results came back unremarkable for everything; every gene they could test they tested and they had nothing come back), lyme disease from 2002 (20 years ago; Has some suppressed immunity from Lyme Disease). The patient had no family medical history. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) taken for thyroid condition. In the evening on 05Jan2021, the patient experienced localized discomfort where they gave her injection of first dose. The event lasted maybe a day. It was also reported that about 3 or 4 days (Jan2021) after she was administered her first dose of Pfizer COVID-19 Vaccine both of her feet were only slightly swollen. She considered this event insignificant at the time. She drank water and this event went away after about 2 days. Event was not uncomfortable. Recovered completely to her awareness at that time. On 06Jan2021, the patient recovered from localized discomfort where they gave her injection of first dose and recovered on an unspecified date from the event both of her feet were only slightly swollen.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Dizziness, Erythema, Headache
Clinical narrative: Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg.  The patient's medical history included cellulitis in left leg. No concomitant medications were reported.  On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not.   Patient did not take anything to treat symptoms but contacted her doctor and pharmacist.   The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine.  Seriousness criteria for the event of swelling and edema was medically important.  Action taken with mRNA-1273 was unknown.  The outcome for all the events was considered as recovered/resolved.  No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Paraesthesia, Paraesthesia oral
Clinical narrative: Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg.  The patient's medical history included cellulitis in left leg. No concomitant medications were reported.  On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not.   Patient did not take anything to treat symptoms but contacted her doctor and pharmacist.   The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine.  Seriousness criteria for the event of swelling and edema was medically important.  Action taken with mRNA-1273 was unknown.  The outcome for all the events was considered as recovered/resolved.  No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Headache, Hypoaesthesia oral, Muscular weakness
Clinical narrative: Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg.  The patient's medical history included cellulitis in left leg. No concomitant medications were reported.  On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not.   Patient did not take anything to treat symptoms but contacted her doctor and pharmacist.   The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine.  Seriousness criteria for the event of swelling and edema was medically important.  Action taken with mRNA-1273 was unknown.  The outcome for all the events was considered as recovered/resolved.  No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Swelling in leg/edema; Facial tingling; numbness in lips; Shortness of breath; Weakness in leg; Weakness in leg and severe headache; A spontaneous report was received from an 86 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced facial tingling, numbness in lips, severe headache, shortness of breath, increased blood pressure, swelling and edema and weakness in leg.  The patient's medical history included cellulitis in left leg. No concomitant medications were reported.  On 21- Feb-2021, the patient received her first doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient reported that that she had facial tingling, numbness in lips, shortness of breath and blood pressure of 210/90 after getting her first Moderna vaccine. Patient also reported weakness in her leg and severe headache. Patient said facial tingling lasted for about 2 hours and lip numbness lasted for about 4 hours(21-FEB-2021). Patient also complained about swelling in her leg/edema but she said she has cellulitis in her left leg and she was not sure if the swelling had something to do with the vaccine or not.   Patient did not take anything to treat symptoms but contacted her doctor and pharmacist.   The patient reported that all other symptoms like weakness in her legs, Shortness of breath, and the headache lasted for about 4 days(25-FEB-2021). Patient said all she wanted the Moderna team to know that she reacted to the vaccine.  Seriousness criteria for the event of swelling and edema was medically important.  Action taken with mRNA-1273 was unknown.  The outcome for all the events was considered as recovered/resolved.  No further information was provided.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache is consistent with the known safety profile of the vaccine.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Dysstasia, Gait inability, Mobility decreased, Vertigo
Clinical narrative: lost control of the body she can't sit, stand straight without any support; She fell on the floor/carpet at least four to five times and can't get up either; lost control of the body she can't sit, stand straight without any support; Can't do her routine thing without support of two people; head is spinning; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL1283), via an unspecified route of administration on 29Jan2021 at 10:30 (at the age of 89-year-old) in right arm as a single dose for COVID-19 immunisation and lorazepam (Manufacturer: unknown, Formulation: unknown, strength: 1mg) via unknown route of administration at a dose of 1mg unknown frequency for an unknown indication. The patient relevant medical history included asthma and She can't even walk with the walker too. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies. The patient concomitant medication included fluticasone propionate, salmeterol xinafoate (COMBITIDE). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. It was reported that on 04Feb2021, at 09:00, she lost control of the body she can't sit, stand straight without any support. She can't even walk with the walker too. Can't do her routine thing without support of two people. Seems like her head is spinning. At 16:00, she fell on the floor/carpet at least four to five times and can't get up either and can't do her routine thing without support of two people. The patient condition resulted in Emergency room, physician office visit. The patient was also hospitalized on an unknown date in Feb2021 for 5 days. The patient received Meclizine HCL Tab as a treatment. It was also reported that the patient adverse events resulted in disability or permanent damage. The seriousness of the events was reported as hospitalization (on an unknown date in Feb2021) and disability. The outcome of the events was not recovered.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Fall, Loss of personal independence in daily activities, Sitting disability, Vertigo
Clinical narrative: lost control of the body she can't sit, stand straight without any support; She fell on the floor/carpet at least four to five times and can't get up either; lost control of the body she can't sit, stand straight without any support; Can't do her routine thing without support of two people; head is spinning; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL1283), via an unspecified route of administration on 29Jan2021 at 10:30 (at the age of 89-year-old) in right arm as a single dose for COVID-19 immunisation and lorazepam (Manufacturer: unknown, Formulation: unknown, strength: 1mg) via unknown route of administration at a dose of 1mg unknown frequency for an unknown indication. The patient relevant medical history included asthma and She can't even walk with the walker too. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies. The patient concomitant medication included fluticasone propionate, salmeterol xinafoate (COMBITIDE). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. It was reported that on 04Feb2021, at 09:00, she lost control of the body she can't sit, stand straight without any support. She can't even walk with the walker too. Can't do her routine thing without support of two people. Seems like her head is spinning. At 16:00, she fell on the floor/carpet at least four to five times and can't get up either and can't do her routine thing without support of two people. The patient condition resulted in Emergency room, physician office visit. The patient was also hospitalized on an unknown date in Feb2021 for 5 days. The patient received Meclizine HCL Tab as a treatment. It was also reported that the patient adverse events resulted in disability or permanent damage. The seriousness of the events was reported as hospitalization (on an unknown date in Feb2021) and disability. The outcome of the events was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: extreme body ache, chills, fever, fever 102, nausea, vomiting, extreme fatigue and headache. It comes in waves about every 3 days for the first 3 weeks. Know the symptoms are not as severe. 2 days ago body aches, nausea, extreme fatigue.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: extreme body ache, chills, fever, fever 102, nausea, vomiting, extreme fatigue and headache. It comes in waves about every 3 days for the first 3 weeks. Know the symptoms are not as severe. 2 days ago body aches, nausea, extreme fatigue.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: extreme body ache, chills, fever, fever 102, nausea, vomiting, extreme fatigue and headache. It comes in waves about every 3 days for the first 3 weeks. Know the symptoms are not as severe. 2 days ago body aches, nausea, extreme fatigue.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; not feeling well; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and medications were not reported. The patient got the first pfizer covid vaccine. She had shingles the first 2 weeks. She was not feeling well. Inquiring if she can get the second dose after these effects. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Malaise
Clinical narrative: shingles; not feeling well; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and medications were not reported. The patient got the first pfizer covid vaccine. She had shingles the first 2 weeks. She was not feeling well. Inquiring if she can get the second dose after these effects. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased
Clinical narrative: Bone infection in her finger; Her blood pressure has gone sky high: 167/89, 190/100, 164/89; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 20Feb2021 as single dose for covid-19 immunisation. Medical history included hypertension and was on medication for it, and cholesterol; both ongoing.  Concomitant medication included unspecified medication for hypertension and cholesterol. The day before vaccination on 19Feb2021, patient had a doctor's appointment because she was getting ready to have knee surgery. Her blood pressure there was 147/80 and 134/79 a little later. They did blood work and checked her cholesterol.  She got the results and her cholesterol was 300 so they put her on medication. She also mentioned having a bone infection in her finger on an unspecified date, but did not mention when that was. Since getting the vaccine, her blood pressure has gone sky high: 167/89, 190/100, 164/89. It had never been that high. Patient was asking if vaccine cause high blood pressure. Outcome of the event of bone infection in finger was unknown while for the other event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Hypertension, Osteomyelitis
Clinical narrative: Bone infection in her finger; Her blood pressure has gone sky high: 167/89, 190/100, 164/89; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 20Feb2021 as single dose for covid-19 immunisation. Medical history included hypertension and was on medication for it, and cholesterol; both ongoing.  Concomitant medication included unspecified medication for hypertension and cholesterol. The day before vaccination on 19Feb2021, patient had a doctor's appointment because she was getting ready to have knee surgery. Her blood pressure there was 147/80 and 134/79 a little later. They did blood work and checked her cholesterol.  She got the results and her cholesterol was 300 so they put her on medication. She also mentioned having a bone infection in her finger on an unspecified date, but did not mention when that was. Since getting the vaccine, her blood pressure has gone sky high: 167/89, 190/100, 164/89. It had never been that high. Patient was asking if vaccine cause high blood pressure. Outcome of the event of bone infection in finger was unknown while for the other event was not recovered.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Moderate anaphylactic reaction; Throat swelled up; difficulty swallowing; difficulty breathing; dizzy; weakness; fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 03Jan2021 at 18:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B chronic carrier, hypothyroidism, low blood pressure, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN) and fludrocortisone (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced moderate anaphylactic reaction, throat swelled up, difficulty swallowing, difficulty breathing, dizzy, weakness, and fast heartbeat on 03Jan2021 at 18:45. The patient underwent lab tests and procedures which included heartbeat: fast on 03Jan2021. The patient did not receive any treatment for the events. The clinical outcome of moderate anaphylactic reaction, throat swelled up, difficulty swallowing, difficulty breathing , dizzy, weakness, and fast heartbeat was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pharyngeal swelling
Clinical narrative: Moderate anaphylactic reaction; Throat swelled up; difficulty swallowing; difficulty breathing; dizzy; weakness; fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 03Jan2021 at 18:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B chronic carrier, hypothyroidism, low blood pressure, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN) and fludrocortisone (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced moderate anaphylactic reaction, throat swelled up, difficulty swallowing, difficulty breathing, dizzy, weakness, and fast heartbeat on 03Jan2021 at 18:45. The patient underwent lab tests and procedures which included heartbeat: fast on 03Jan2021. The patient did not receive any treatment for the events. The clinical outcome of moderate anaphylactic reaction, throat swelled up, difficulty swallowing, difficulty breathing , dizzy, weakness, and fast heartbeat was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pharyngeal swelling
Clinical narrative: Moderate anaphylactic reaction; Throat swelled up; difficulty swallowing; difficulty breathing; dizzy; weakness; fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 03Jan2021 at 18:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hepatitis B chronic carrier, hypothyroidism, low blood pressure, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (MANUFACTURER UNKNOWN) and fludrocortisone (MANUFACTURER UNKNOWN). The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced moderate anaphylactic reaction, throat swelled up, difficulty swallowing, difficulty breathing, dizzy, weakness, and fast heartbeat on 03Jan2021 at 18:45. The patient underwent lab tests and procedures which included heartbeat: fast on 03Jan2021. The patient did not receive any treatment for the events. The clinical outcome of moderate anaphylactic reaction, throat swelled up, difficulty swallowing, difficulty breathing , dizzy, weakness, and fast heartbeat was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.