chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Malaise, Myalgia, Pancytopenia, Platelet count decreased
Clinical narrative: Pancytopenia; Malaise; Muscle aches; Fever; A spontaneous report was received from a physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pancytopenia, fever, malaise, and muscle aches.   There was no medical history provided. There were no concomitant medications provided.  On 16 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Batch # unknown), for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced the serious event of pancytopenia. Additionally, on an unspecified date in Jan 2021, following in jection, the patient experienced the non-serious events of fever, malaise, and muscle aches. Relevant laboratory result included platelet count of 1000 and hemoglobin was decreased on 22 Jan 2021. There was no treatment information provided.  Action taken with mRNA-1273 in response to the events of pancytopenia, fever, malaise, and muscle aches, was not provided.  The event of pancytopenia was unknown. The outcome for the events fever, malaise, and muscle aches, was unknown at the time of this report.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of pancytopenia and non-serious unexpected event of malaise, non-serious expected events of myalgia, and pyrexia. The event of pancytopenia occurred 7 days after first dose of mRNA-1273, lot # unknown.  The event of myalgia and pyrexia occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment was not specified. Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pancytopenia; Malaise; Muscle aches; Fever; A spontaneous report was received from a physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pancytopenia, fever, malaise, and muscle aches.   There was no medical history provided. There were no concomitant medications provided.  On 16 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Batch # unknown), for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced the serious event of pancytopenia. Additionally, on an unspecified date in Jan 2021, following in jection, the patient experienced the non-serious events of fever, malaise, and muscle aches. Relevant laboratory result included platelet count of 1000 and hemoglobin was decreased on 22 Jan 2021. There was no treatment information provided.  Action taken with mRNA-1273 in response to the events of pancytopenia, fever, malaise, and muscle aches, was not provided.  The event of pancytopenia was unknown. The outcome for the events fever, malaise, and muscle aches, was unknown at the time of this report.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of pancytopenia and non-serious unexpected event of malaise, non-serious expected events of myalgia, and pyrexia. The event of pancytopenia occurred 7 days after first dose of mRNA-1273, lot # unknown.  The event of myalgia and pyrexia occurred on an unspecified date after first dose of mRNA-1273, lot # unknown. Treatment was not specified. Very limited information regarding this event has been provided at this time.  Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site mass
Clinical narrative: Subcutaneous Injection; lump at injection site; A spontaneous report was received from a nurse concerning a 65-year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) via subcutaneous injection and experienced lump at injection site.   No relevant medical history and concomitant medications were reported.   On 20-Jan-2021, prior to the onset of the events, the patient received a dose of mRNA-1273 (lot number 032L20A) subcutaneously for prophylaxis of COVID-19 infection.  On 20-Jan-2021, the patient developed a lump at the injection site when vaccine was given to her subcutaneously. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The event subcutaneous injection was considered to be resolved on 20-Jan-2021. The outcome of event lump at injection site was unknown.; Reporter's Comments: This report refers to a case of incorrect route of product administration  for mRNA-1273, lot #: 032L20A.  There were no reported AEs associated with this case of incorrect route of product administration.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthma, Back pain, Blood cholesterol increased, Blood test normal
Clinical narrative: Lungs congested; Trouble breathing; Trouble speaking/Trouble breathing; When she would speak she would cough hard; A spontaneous report was received from a consumer concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced trouble breathing, trouble speaking, lungs congested and when she would speak she would cough hard.   The patient's medical history included back pain being treated by a pain management doctor, high blood pressure, high cholesterol, asthma and diabetes. Medications reported by the patient, within two weeks prior to the event, included albuterol inhaler.  On 18 Jan 2021, in the morning, the patient received their first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Jan 2021, in the evening on the same day of vaccination, the patient went to the ER (emergency room) due to trouble breathing and speaking, lungs congested, and cough when she would speak. While in the ER she had a blood test, chest x-ray, and an EKG which all came back normal. She stated that she did not think that the symptoms were related to an environmental change.   Treatment for the event included steroid and nebulizer treatment, and the symptoms resolved after treatment on the same day.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 028L20A), and who experienced the serious unlisted event of lungs congested, and the non-serious unlisted events of trouble breathing, trouble speaking, and cough.  The events occurred on the day of vaccination. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Diabetes mellitus, Dyspnoea, Electrocardiogram normal
Clinical narrative: Lungs congested; Trouble breathing; Trouble speaking/Trouble breathing; When she would speak she would cough hard; A spontaneous report was received from a consumer concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced trouble breathing, trouble speaking, lungs congested and when she would speak she would cough hard.   The patient's medical history included back pain being treated by a pain management doctor, high blood pressure, high cholesterol, asthma and diabetes. Medications reported by the patient, within two weeks prior to the event, included albuterol inhaler.  On 18 Jan 2021, in the morning, the patient received their first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Jan 2021, in the evening on the same day of vaccination, the patient went to the ER (emergency room) due to trouble breathing and speaking, lungs congested, and cough when she would speak. While in the ER she had a blood test, chest x-ray, and an EKG which all came back normal. She stated that she did not think that the symptoms were related to an environmental change.   Treatment for the event included steroid and nebulizer treatment, and the symptoms resolved after treatment on the same day.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 028L20A), and who experienced the serious unlisted event of lungs congested, and the non-serious unlisted events of trouble breathing, trouble speaking, and cough.  The events occurred on the day of vaccination. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pulmonary congestion, Speech disorder
Clinical narrative: Lungs congested; Trouble breathing; Trouble speaking/Trouble breathing; When she would speak she would cough hard; A spontaneous report was received from a consumer concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced trouble breathing, trouble speaking, lungs congested and when she would speak she would cough hard.   The patient's medical history included back pain being treated by a pain management doctor, high blood pressure, high cholesterol, asthma and diabetes. Medications reported by the patient, within two weeks prior to the event, included albuterol inhaler.  On 18 Jan 2021, in the morning, the patient received their first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Jan 2021, in the evening on the same day of vaccination, the patient went to the ER (emergency room) due to trouble breathing and speaking, lungs congested, and cough when she would speak. While in the ER she had a blood test, chest x-ray, and an EKG which all came back normal. She stated that she did not think that the symptoms were related to an environmental change.   Treatment for the event included steroid and nebulizer treatment, and the symptoms resolved after treatment on the same day.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 028L20A), and who experienced the serious unlisted event of lungs congested, and the non-serious unlisted events of trouble breathing, trouble speaking, and cough.  The events occurred on the day of vaccination. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Cardioversion, Heart rate abnormal, Pain in extremity
Clinical narrative: Bad heart rate; sore arm; A spontaneous report was received from a nurse who was also a 77-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and bad heart rate.  The patient's medical history was not provided. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient developed a sore arm. No treatment was administered.  On 10 Jan 2021, the patient experienced bad heart rate and had to go to the emergency room (ER).   On 21 Jan 2021, the patient had a second visit to the ER, where she required a cardioversion for the bad heart rate.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, sore arm, was resolved on an unknown date. The outcome for the event, bad heart rate, was resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient, who experienced a medically significant unexpected event of Heart rate abnormal and unexpected non-serious event of Pain in extremity. The medical history is not provided. The event of Pain in extremity occurred on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). The event of Heart rate abnormal occurred approximately five days after receiving their first of two planned doses of mRNA-1273 (Lot # 025L20A). Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Vaccine positive rechallenge
Clinical narrative: Angioedema both times, the second time was a little bit worse; A spontaneous report was received from a healthcare facility staff member concerning an unknown patient who received Moderna's COVID-19 Vaccine, and who experienced angioedema after both doses.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the symptoms, the patient received their two planned doses of mRNA-1273 unknown batch number intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the patient experienced angioedema both times after vaccination. The second time was a little bit worse and lasted for three days. Treatment for the event included prednisolone, Pepcid and Benadryl.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the event angioedema both times not reported.; Reporter's Comments: This case concerns a patient who received their two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of angioedema after both doses.  Based on the current available information, including reoccurrence of event after second dose and temporal association between the use of the product and the onset of event after vaccination, a causal relationship cannot be excluded and the event of angioedema is considered possibly related to the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Death, Dyspnoea, Hypertension, Intracranial aneurysm
Clinical narrative: Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed, shortness of breath, loss of consciousness, massive anaphylactic reaction, and brain aneurysm.    The patient's medical history, as provided by the reporter, included high blood pressure and arthritis. Products known to have been used by the patient, within two weeks prior to the event, included an antihypertensive.   On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath, blood pressure skyrocketed, and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided.   The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old, female patient with a medical history of hypertension, who experienced fatal, serious, unexpected events of Anaphylactic reaction, hypertension, dyspnea, loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed, shortness of breath, loss of consciousness, massive anaphylactic reaction, and brain aneurysm.    The patient's medical history, as provided by the reporter, included high blood pressure and arthritis. Products known to have been used by the patient, within two weeks prior to the event, included an antihypertensive.   On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath, blood pressure skyrocketed, and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided.   The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old, female patient with a medical history of hypertension, who experienced fatal, serious, unexpected events of Anaphylactic reaction, hypertension, dyspnea, loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Feeding disorder, Pelvic pain, Weight decreased
Clinical narrative: Colitis; A spontaneous report was received from a 52-year-old, female consumer, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed colitis.  The patient's medical history was not provided. Concomitant product reported included ogmentin.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) in the right arm for prophylaxis of COVID-19 infection.  The patient experienced weight loss and was unable to eat after receiving the first dose.  On 15 Jan 2021, the patient reported that she started to experience lower pelvic pain and was diagnosed with colitis.  On 21 Jan 2021, she had a follow up with PCP (primary care physician) and the PCP advised not to get second dose until 29 Jan 2021.   On an unspecified date, she started her new antibiotic treatments.  Treatment for the event included levosloxacin.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, colitis, was not reported.; Reporter's Comments: This case concerns a 52 year-old, female patient, who experienced event of colitis. The event of colitis occurred 16 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: A spontaneous report was received from a pharmacist concerning 43-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administered with a 5/8-inch (subcutaneous) needle. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) for prophylaxis of COVID-19 infection. On an unknown date, the patient was administered a vaccine using a 5/8-inch (subcutaneous) needle. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, vaccine administered with a 5/8-inch (subcutaneous) needle, was considered recovered/resolved.; Reporter's Comments: This report refers to a 43-year old, female patient who received their first of two planned doses of mRNA-1273 (lot # 026L20A), reporting Product administration error.  There were no reported AEs associated with this case of Product administration error.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Livedo reticularis, Urticaria
Clinical narrative: My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling, Oral pruritus, Pruritus, Swollen tongue
Clinical narrative: my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of  the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus, Urticaria
Clinical narrative: my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; my lips and tongue started itching and got swollen; itching and got hives; itching and got hives; This is a spontaneous report from a contactable Nurse reported for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 16:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included Asthma, food and environmental allergies, allergy to PCN and Sulfa. Concomitant medications included montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), loratadine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of BNT162B2 on an unknown date for covid-19 immunization. The patient previously took acetylsalicylic acid (ASA), levofloxacin (LEVAQUIN), codeine and azithromycin (ZITHROMAX) and experienced allergy. 8 minutes after the vaccine was given on 22Jan2021 16:08, patient started itching and got hives. She was given Benadryl. About 5 minutes after that on 22Jan2021 16:13, her lips and tongue started itching and got swollen. At that time she was given an injection of Epinephrine and transferred to the Emergency Department. The outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Pfizer comment: Based on the information currently available, a possible contributory role of the BNT162B2 in the reported events lip and tongue itching and got swollen cannot be excluded in this 56 years old female patient, who with medical history of allergy to food, environment and multiple medications. This impact of this report on the benefit/risk profile of  the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing problems/continued breathing issues; pressure on chest; This is a spontaneous report from a contactable Other Health Professional (patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 21Jan2021 16:15 at single dose in Right arm for COVID-19 immunisation. Medical history included asthma, anxiety, and depression, all from an unknown date. Concomitant medication included duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol, norethisterone acetate (JUNEL) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Dec2020 02:30 PM in Right arm at single dose for COVID -19 immunisation and was tested positive for COVID on 01Jan2021; took cefdinir and experienced drug hypersensitivity. The patient reported symptoms began 12 hours after second COVID vaccine (5am on 22Jan2021). Mild breathing problems and pressure on chest. At 7am on 22Jan2021, mild dizziness started and continued breathing issues. At 12pm (noon) dizziness turned severe, was stumbling walking. Took pulse and it was 152 on 22Jan2021, checked several times. The patient went to the ER (Emergency room) and was determined it was a reaction to the vaccine. After receiving medication and fluids, pulse returned to normal after about seven or eight hours. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid-19 tested Positive on 01Jan2021, Pulse rate: 152 on 22Jan2021, Pulse rate returned to normal in Jan2021, heart ultrasound and EKG (Electrocardiogram) with unknown results in Jan2021. The patient received Fluids and medication as treatment. COVID was not tested post vaccination. The outcome of event Took pulse and it was 152 was recovered on an unspecified date in Jan2021. The outcome of the other events was recovering.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events are possibly related to suspect vaccine BNT162B2 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Took pulse and it was 152; stumbling walking; mild dizziness/dizziness turned severe; Mild breathing problems/continued breathing issues; pressure on chest; This is a spontaneous report from a contactable Other Health Professional (patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 9231), via an unspecified route of administration on 21Jan2021 16:15 at single dose in Right arm for COVID-19 immunisation. Medical history included asthma, anxiety, and depression, all from an unknown date. Concomitant medication included duloxetine, lamotrigine, buspirone hydrochloride (BUSPAR), etonogestrel (NEXPLANON), ethinylestradiol, norethisterone acetate (JUNEL) in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Dec2020 02:30 PM in Right arm at single dose for COVID -19 immunisation and was tested positive for COVID on 01Jan2021; took cefdinir and experienced drug hypersensitivity. The patient reported symptoms began 12 hours after second COVID vaccine (5am on 22Jan2021). Mild breathing problems and pressure on chest. At 7am on 22Jan2021, mild dizziness started and continued breathing issues. At 12pm (noon) dizziness turned severe, was stumbling walking. Took pulse and it was 152 on 22Jan2021, checked several times. The patient went to the ER (Emergency room) and was determined it was a reaction to the vaccine. After receiving medication and fluids, pulse returned to normal after about seven or eight hours. The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Covid-19 tested Positive on 01Jan2021, Pulse rate: 152 on 22Jan2021, Pulse rate returned to normal in Jan2021, heart ultrasound and EKG (Electrocardiogram) with unknown results in Jan2021. The patient received Fluids and medication as treatment. COVID was not tested post vaccination. The outcome of event Took pulse and it was 152 was recovered on an unspecified date in Jan2021. The outcome of the other events was recovering.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events are possibly related to suspect vaccine BNT162B2 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Maternal exposure before pregnancy
Clinical narrative: half after the shot patient was pregnant 7 months besides; flu; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case via social media, consumer or non-health care professional (Patient).  This case involves adult female patient who experienced flu (influenza) after the INFLUENZA VACCINE [Flu shot] maternal exposure before pregnancy.  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date was not reported.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 1957, the patient developed a non-serious flu (influenza) a month and a half following the administration of INFLUENZA VACCINE.  It was the case of vaccine exposure before pregnancy (maternal exposure before pregnancy) [Latency : unknown].  It was reported that, that was patients first in 1957 and last one after that and never had the flu since.   Pregnancy outcome was unknown at the time of report.  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  At the time of reporting, the event outcome reported as unknown for influenza.  Information on the batch number was requested.
Sex: U
Vaccine: FLUX
Symptoms: Hair growth abnormal
Clinical narrative: Hair coming out toes took 6 months then boom; Initial information received on 24-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a patient (age and gender not reported) who experienced hair coming out toes took 6 months then boom (hair growth abnormal), while he/she received INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious hair coming out toes took 6 months then boom (hair growth abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient was sick; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case from social media via consumer or non-health care professional.  This case involves adult female patient who was sick (illness), while she received vaccine INFLUENZA VACCINE [Flu shot].   It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, she had the flu shot every year and she was sick every year no shot for her husband never had never would.   There were no lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got the shot was never so sick patient in life; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case from social media. Via consumer or non-health care professional (Patient).  This case involves adult patient (gender not specified) who got the INFLUENZA VACCINE [shot] was never so sick patient in life (illness).  It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the shot was never so sick patient in life (illness) (non-serious) unknown latency following the administration of INFLUENZA VACCINE.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Age: 9.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A nine year old girl received Flublok Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Global Medical Information (GMI) (Reference number- 00440411) and transmitted to Sanofi on 21-Jan-2021.  This case involves a 9 years old female patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA, expiry date: 17-Mar-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 11-Oct-2020 (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other concomitant vaccines.   It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  On 11-Oct-2020, both the 9-year-old patient and her mother came into the clinic for their flu shot. It is possible that the Flublok was inadvertently given to the 9-year-old instead of to the mother, but that is not certain. It could have been a mix-up in the paperwork. Reporting nurse stated that she always double-checks for this, just before administering the flu vaccine, which is why she thinks it could just have been recorded incorrectly.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: head ache, nausea, fever, chills, body aches
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 9 days after vaccine was received in the left arm , there was swelling , redness , warmth and pain at the site . I took 600mg Ibuprofen every 6 hours for about 30 hours and I placed ice at the site frequently. I saw my PA next day and I was prescribed a Medrol pack , which helped resolve all those symptoms after first day of taking the medication.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pruritus, Pyrexia, Restlessness
Clinical narrative: Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form!  Can I take Benadryl? I had none of these adverse effects with 1st dose!
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Fever and chills starting 12 hours after injection. Temperature 101.7 then and now 5 hours later! Unable to sleep, restlessness! Lower legs itch. Site is sore! Had been to to not take ibuprofen or Tylenol to help antibodies form!  Can I take Benadryl? I had none of these adverse effects with 1st dose!
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: I had some swelling and pain the first two days following the vaccine, then all was fine.  On day 8 I awoke to a large (2.5 inch) hard, red, itchy, hot welt at the injection site.  There is mild pain when I touch it.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: I had some swelling and pain the first two days following the vaccine, then all was fine.  On day 8 I awoke to a large (2.5 inch) hard, red, itchy, hot welt at the injection site.  There is mild pain when I touch it.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Pruritus, Urticaria
Clinical narrative: Large red welt that was itchy but not anymore.  Slight burning on site
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pyrexia
Clinical narrative: Body aches, muscle weakness around midnight Fever at 6am
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Tongue pruritus
Clinical narrative: Patient stated her lips and tongue feel itchy.  Patient stated she is allergic to shellfish and gets anxious every time she gets a vaccine.  Vital signs within normal limits.  BP 128/74, HR 68, O2 sat 96%.  Patient took her own Benedryl PO.  Patient stated she is feeling better, and she wants to go home.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Vision blurred
Clinical narrative: Pt complaint of dizziness 2 minutes after getting the vaccine.  Pt the stated her vision was blurry. BP 200/130  Pt stated she was feeling better.   Medic rechecked BP 247-200/130.  Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER.  Pt doesn't want to go by squad.  States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived.  Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen.  Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dysstasia, Hypersomnia, Nausea
Clinical narrative: Dizziness, nausea and inability to sit up 5-minutes following injection. BP rose to 200/100 (normally 80/60). BP declined over two hours of observation. Expected sleepiness a few hours later; slept for 18-hours.   Ongoing dizziness and nausea still present 7-days post vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Felt like CoVid.  I had CoVid about 6 months ago.  Fever (104 F)  Chills Total body ache
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site inflammation
Clinical narrative: Headache, growing inflammation under injection site-bottom of muscle
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: headache, rapid heart rate for several hours (160s), nausea, joint aches, chills, dizziness, weakness. Worst part lasted 48 hours. The nearest ER is an hour away so just pushed thru it.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tachycardia
Clinical narrative: headache, rapid heart rate for several hours (160s), nausea, joint aches, chills, dizziness, weakness. Worst part lasted 48 hours. The nearest ER is an hour away so just pushed thru it.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose increased, Dizziness
Clinical narrative: 15 minutes after client received vaccine client stated that she felt dizzy and weak.  Vital signs obtained by EMS  BP 119/72, Pulse 72, Temp 99, O2 sat 96%  Blood Sugar 107 at 1:43 pm.  Client was wearing 2 face masks.  She removed the mask and stated she feels better.  States she was hungry.  After EMS obtained 2 sets of vitals within normal limits, patient stated she felt better and was discharged home by EMS at 1:45 pm.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 6 days post second vaccine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Monitor 9RN) checked on pt at 15 min check.  Pt stated to RN that she was feeling warm, lightheaded and slightly dizzy.  POD leader + supervisor was informed.  Supervisor informed EMS staff of current situation.  Pt was monitored for 15 min more at that time water was given + vitals were taken. BP 140/75, HR 105,SPO2 94% RA & 20 respirations.  09:15 Pt reassessed by (RN) & (EMS), pt showed no changes, and stated that she felt the same.  Pt was removed to a private area to be further evaluated and await until squad arrived.   Pt. also stated to staff that she typically experiences these symptoms whenever she takes in any form of nuts.  Pt stated she does have an epipen injection. 0922 squad arrived. BP 148/90, HR 83, SPO2 99% RA, RR 20.  Pt lung sounds were clear stated by EMS staff.  Pt refused to be rescue by squad/ EMS but instead taken by her husband.  Pt was informed that if anything went wrong on her way to TCH to call 911 right away.  Pt agreed and was discharged at 0921AM.