chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash from her face to the bottom of torso/so severe that he had to be put on a dose pack; This is a spontaneous report from a contactable nurse. A 58-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on right arm on 18Dec2020 06:00 (lot number: EL1284), then via an unspecified route of administration on 18Dec2020 (lot number: EL1248), both at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]). It was reported that on "Cupid" days (as reported) after vaccine, she broke out in huge whips and rash from her face to the bottom of torso. It did this twice so severe that he had to be put on a dose pack [steroids the first time nothing for yesterday but took diphenhydramine (BENADRYL)]. She then received her second dose on 08Jan2021 and woke up at around 3 am with severe itching on her legs and this time, a huge rash on her legs front and back but not on torso only, but on neck on 08Jan2021. Therapeutic measures were taken as a result of rash from her face to the bottom of torso. The outcome of the event was recovered on Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Nausea, Pain
Clinical narrative: the symptoms as "having Covid all over again"; the symptoms as "having Covid all over again"; headache; nausea; severe joint and body pain; body pain; coughing; fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient just got the Covid vaccine and was experiencing side effects. She described the symptoms as "having Covid all over again", mentioned headache, nausea, severe joint and body pain, coughing and fever on an unknown date. Want to see how long these side effects last. The outcome of the events was unknown. Information regarding lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: the symptoms as "having Covid all over again"; the symptoms as "having Covid all over again"; headache; nausea; severe joint and body pain; body pain; coughing; fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient just got the Covid vaccine and was experiencing side effects. She described the symptoms as "having Covid all over again", mentioned headache, nausea, severe joint and body pain, coughing and fever on an unknown date. Want to see how long these side effects last. The outcome of the events was unknown. Information regarding lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded. Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive
Clinical narrative: caller was rushed to the emergency room and was tested positive for COVID-19; caller was rushed to the emergency room and was tested positive for COVID-19; caller became symptomatic and experienced headaches; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first dose on 18Dec2020 and is scheduled for the second dose today, 09Jan2021. However, on 24Dec2020, she became symptomatic and experienced headaches. On Saturday, she was rushed to the emergency room and was tested positive for COVID-19. Her physician told her that she could get the COVID-19 vaccine if she has no symptoms anymore. She wanted to know the guidance per Pfizer. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 09Jan2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Flushing, Heart rate, Heart rate increased
Clinical narrative: flushing; heart rate went up to 150 or 180; intense/hot temperature for 5-7 minutes; This is a spontaneous report from a contactable Nurse.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 24Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. Five minutes after she received the vaccine on 24Dec2020, she experienced flushing and her "heart rate went up to 150 or 180". She explained that she tested her heart rate because she was a nurse. After 5 minutes, the symptoms went away and it didn't return. She described her flushing as having an intense/hot temperature for 5-7 minutes. The outcome was recovered on 24Dec2020.   The events were assessed non-serious.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Low-grade fever; Severe joint/muscle aches; Severe joint/muscle aches; Moderate headache; Moderate fatigue; This is a spontaneous report from a contactable nurse. A 53-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, via an unspecified route of administration on 08Jan2021 12:15 at single dose on right arm for COVID-19 immunization. Medical history included hypertension, anxiety and penicillin allergy. Historical vaccine included bnt162b2 for covid-19 immunization. Concomitant medication included acetylsalicylic acid (ASPIRIN), escitalopram, famotidine, losartan and prazosin. The patient experienced low-grade fever, severe joint/muscle aches, moderate headache, moderate fatigue, all on 08Jan2021 17:00 with outcome of recovering. Patient did not receive any treatment. Patient did not experience COVID prior vaccination and did not have COVID tested post vaccination.  Information on Lot/Batch has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low-grade fever; Severe joint/muscle aches; Severe joint/muscle aches; Moderate headache; Moderate fatigue; This is a spontaneous report from a contactable nurse. A 53-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, via an unspecified route of administration on 08Jan2021 12:15 at single dose on right arm for COVID-19 immunization. Medical history included hypertension, anxiety and penicillin allergy. Historical vaccine included bnt162b2 for covid-19 immunization. Concomitant medication included acetylsalicylic acid (ASPIRIN), escitalopram, famotidine, losartan and prazosin. The patient experienced low-grade fever, severe joint/muscle aches, moderate headache, moderate fatigue, all on 08Jan2021 17:00 with outcome of recovering. Patient did not receive any treatment. Patient did not experience COVID prior vaccination and did not have COVID tested post vaccination.  Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: a little sicky on and off mostly in his stomach but overall feels okay; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for himself that a male patient of unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included blood thinner. Patient received the first dose of the COVID-19 vaccine yesterday (08Jan2021). He stated that he has been feeling "a little sicky on and off mostly in his stomach but overall feels okay." He stated that he forgot to mention to facility that he is on a blood thinner and saw this on the sheet he received after his shot. He would like to know if this will be an issue when he goes for his second dose. He also would like to know if he has any immunity to COVID-19. Specifically he stated that he wants to visit a friend who has cancer and he wants to know if there is a possibility of getting his friend sick since he has received the vaccine now. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: At the injection site, she had a quarter sized welt that is hot to the touch; At the injection site, she had a quarter sized welt that is hot to the touch; She said that it hurts to the fingers, arm, and shoulder; She said that it hurts to the fingers, arm, and shoulder; The injection site is red and swollen; The injection site is red and swollen; She also has a 103F fever; This is a spontaneous report from a non-contactable nurse (patient). This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. At the injection site, she had a quarter sized welt that was hot to the touch. She said that it hurts to the fingers, arm, and shoulder. The injection site was red and swollen. She also had a 103F fever. She asked if this was expected from the vaccine. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: At the injection site, she had a quarter sized welt that is hot to the touch; At the injection site, she had a quarter sized welt that is hot to the touch; She said that it hurts to the fingers, arm, and shoulder; She said that it hurts to the fingers, arm, and shoulder; The injection site is red and swollen; The injection site is red and swollen; She also has a 103F fever; This is a spontaneous report from a non-contactable nurse (patient). This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. At the injection site, she had a quarter sized welt that was hot to the touch. She said that it hurts to the fingers, arm, and shoulder. The injection site was red and swollen. She also had a 103F fever. She asked if this was expected from the vaccine. The outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: tingling on tongue tip; Metallic taste in the mouth; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 (date lot number: EK9231; expiration date: unknown) at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received his first dose of (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Dec2020 13:45 (lot number: EH9899; expiration date: unknown) at a single dose for covid-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced tingling on tongue tip and metallic taste in the mouth on 09Jan2021 09:45 AM. The patient did not received treatment for the adverse event. The patient was tested for COVID-19 post vaccination (saliva) which was negative on 04Jan2021. The outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Mild photophobia; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 18Dec2020 (19:15) at a single dose on the left arm for COVID-19 immunization at the hospital. Medical history included allergic rhinitis and cashew allergy. Concomitant medications included fexofenadine, ergocalciferol (VIT D) and cyanocobalamin (VITAMIN B12). On 06Jan2021 (17:45), the patient had mild photophobia within 5 to 10 minutes of the first dose of vaccination. The patient did not recognize the symptom at the time. The patient had self-administered over-the-counter (OTC) oral analgesics as treatment for the event. The outcome of the event, mild photophobia, was recovering. The patient did not have COVID-19 prior to the vaccination, and had not been tested positive for COVID-19 since the vaccination.  Information regarding lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: got a positive test on 31Dec2020. Her 2nd dose is due on Wed and she is currently symptomatic.; got a positive test on 31Dec2020. Her 2nd dose is due on Wed and she is currently symptomatic.; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 31Dec2020, the patient got a positive test. Her 2nd dose was due on wed and she was currently symptomatic. Patent would to know if she should get second dose on her scheduled date even though she still was feeling unwell. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Left arm injection site mild itching and redness; Left arm injection site mild itching and redness; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELD142; Expiration date was not reported) on 06Jan2021 (14:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the nursing home. Medical history included atrial fibrillation (AF). Concomitant medications included metoprolol and paracetamol (TYLENOL). On 08Jan2021 (13:00), the patient had mild itching and redness on the left arm injection site. The patient did not receive any treatment for the reported events. The outcome of the events, mild itching and redness on the left arm injection site, was not recovered. The patient had no COVID-19 prior to vaccination, and had been tested post-vaccination. The patient's nasal swab COVID-19 test was negative on 07Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Lip swelling
Clinical narrative: tip of tongue numb; Metallic taste; lower left lip felt swollen; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284 and expiration date not provided), via an unspecified route of administration (Right arm) first dose on 02Jan2021 10:30 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 02Jan2021, the patient experienced metallic taste, lower left lip felt swollen, and tip of tongue numb. The patient was treated with Injection 50 mg Benadryl L thigh. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not tested for COVID-19.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Migraine
Clinical narrative: slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; joint pain in elbows; extreme chills; migraine was at a level of intractable pain; maybe a low grade fever of 99F; This is a spontaneous report from a contactable other hcp (Anesthesiology, patient).  A 49-years-old male patient received second dose of bnt162b2  (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 07Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines headaches. This was migraine plus; extreme pain which he took  migraine pain medicine.  The patient's concomitant medications were not reported. The patient previous received 1st dose of  bnt162b2.The other HCP reported: On Thursday 07Jan2021, he received the 2nd shot at 8:30am, then about 3-4pm he had symptoms of slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts.  Throughout the evening into the next day, he suffered chills that went away, joint pain in elbows; headache pain, which he had to do migraine medicine again. Saturday morning he felt better, he don't have a headache, but for a good 36 hours, migraine was at a level of intractable pain since Jan2021. He never had a fever, well maybe a low grade fever of 99F in Jan2021.  The even outcome of chills  was recovered Jan2021, headache was recvoered on 09Jan2021; outcome of other events were unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts; joint pain in elbows; extreme chills; migraine was at a level of intractable pain; maybe a low grade fever of 99F; This is a spontaneous report from a contactable other hcp (Anesthesiology, patient).  A 49-years-old male patient received second dose of bnt162b2  (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 07Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. Medical history included migraines headaches. This was migraine plus; extreme pain which he took  migraine pain medicine.  The patient's concomitant medications were not reported. The patient previous received 1st dose of  bnt162b2.The other HCP reported: On Thursday 07Jan2021, he received the 2nd shot at 8:30am, then about 3-4pm he had symptoms of slight headache and muscle ache, during the evening it progressed to extreme chills, achiness, headache off the charts.  Throughout the evening into the next day, he suffered chills that went away, joint pain in elbows; headache pain, which he had to do migraine medicine again. Saturday morning he felt better, he don't have a headache, but for a good 36 hours, migraine was at a level of intractable pain since Jan2021. He never had a fever, well maybe a low grade fever of 99F in Jan2021.  The even outcome of chills  was recovered Jan2021, headache was recvoered on 09Jan2021; outcome of other events were unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Flushing, Tachycardia, Urticaria
Clinical narrative: Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation.  The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies.  On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body height, Body temperature, Electrocardiogram
Clinical narrative: Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation.  The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies.  On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Eye swelling, Heart rate, Investigation, Laboratory test, Oxygen saturation
Clinical narrative: Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation.  The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies.  On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Respiratory rate, Scan, Urticaria, Weight
Clinical narrative: Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation.  The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies.  On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation.  The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies.  On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Erythema, Oedema, Swelling face, Urticaria
Clinical narrative: Tachycardia; Itching hives on the trunk and bilateral arms with 15 minutes; Facial Flush; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (Arm Right) first dose on 08Jan2021 at single dose for covid-19 immunisation.  The patient's medical history included known allergies: Bee Venom, Coconut, and Shellfish. The patient's concomitant medication included vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), metoprolol, zolpidem tartrate (AMBIEN), and dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]). The patient previously took Fenofibrate and experienced allergies.  On 08Jan2021, the patient experienced Itching hives on the trunk and bilateral arms with 15 minutes, Facial Flush, Tachycardia, Elevated. The patient was treated with Benadryl. The patient went Emergency room/department or urgent care due to the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination and was not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Pyrexia
Clinical narrative: reported to be cold one day; had a very low grade fever (97.6 Fahrenheit); some headaches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included pancreatic condition which happens every 6 months. The patient's concomitant medications were not reported. The patient reported to be cold one day, had a very low grade fever (97.6 Fahrenheit) and had some headaches on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Swelling at injection site; inflammation around injection site; This is a spontaneous report from a contactable physician, the patient. This 29 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1 , single dose via intramuscular route of administration in the left arm on 23Dec2020 at 02:15 PM (at the age of 29 years-old) for COVID-19 vaccination. It was unknown if the patient was pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  There was no relevant medical history reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown) dose 2, single dose via  intramuscular route of administration in the left arm on 08Jan2021 at 11:00 AM and experienced headache, nausea, pain at the injection site, fever/chills, bodyache, fatigue, tingling/numbness at injection site, shoulder stiffness, altered taste and inappropriate schedule of vaccine. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient experienced swelling at injection site and inflammation around injection site. The events were reported as non-serious. The patient was not treated for swelling at injection site and inflammation around injection site. The clinical outcome of swelling at injection site and inflammation around injection site was unknown.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information of lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Vaccination site pain
Clinical narrative: More pronounced pain from IM site; chills after more than 12 hrs; body malaise; This is a spontaneous report from a contactable nurse (patient). A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Jan2021 12:00 at single dose (Lot:EK9231) on left arm for covid-19 immunisation. Medical history included none. No Known allergies. No COVID prior vaccination. Concomitant medication included VITAMIN C and multi vitamin. No other vaccine in four weeks.  The patient experienced More pronounced pain from IM site, chills after more than 12 hrs, body malaise, all on 09Jan2021. 01:00 Outcome of events was recovering. No COVID tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: fever; muscle and body aches; muscle and body aches; cannot smell; tastebuds going haywire; described as "flu-y"; This is a spontaneous report from a contactable consumer(patient). A 65 years-old male patient received first dose BNT162B2, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization.  The medical history included the patient had Covid 5-6 weeks ago in 2020. The patient received first dose of the vaccine yesterday on 08Jan2021. He had Covid 5-6 weeks ago in 2020 and after getting vaccine experienced similar symptoms. In Jan2021 the patient specified fever, muscle and body aches, cannot smell, taste buds going haywire, and described as "flu-y". He wanted to know how long these symptoms would last. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: fever; muscle and body aches; muscle and body aches; cannot smell; tastebuds going haywire; described as "flu-y"; This is a spontaneous report from a contactable consumer(patient). A 65 years-old male patient received first dose BNT162B2, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization.  The medical history included the patient had Covid 5-6 weeks ago in 2020. The patient received first dose of the vaccine yesterday on 08Jan2021. He had Covid 5-6 weeks ago in 2020 and after getting vaccine experienced similar symptoms. In Jan2021 the patient specified fever, muscle and body aches, cannot smell, taste buds going haywire, and described as "flu-y". He wanted to know how long these symptoms would last. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, SARS-CoV-2 test positive
Clinical narrative: COVID test result as positive; COVID test result as positive; Chills; Body aches; Headache; Weakness; This is a spontaneous report from a contactable nurse (patient).  A 46-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: 49899, unknown expiration), intramuscular in right arm, in Dec2020 at 09:00 AM, at single dose, for COVID-19 immunization.  Medical history included asthma, hypothyroid, and interstitial cystitis.  The patient has no known allergies. Concomitant medication included influenza vaccine in right arm (lot number: US47SAA) on 08Dec2020 for immunization. Patient also received other unspecified medication within two weeks of vaccination. COVID-19 vaccine was administered in a hospital. On 23Dec2020 at 01:30 AM, the patient woke up with chills, body aches, headache and weakness. On 31Dec2020, the patient had nasal swab for COVID with COVID test result as positive post vaccination. Patient is not pregnant at the time of vaccination.  The patient did not have COVID prior to vaccination.  The patient received ibuprofen for the events chills, body aches, headache and weakness. The patient recovered from the events chills, body aches, headache and weakness on unspecified date; while unknown outcome for the remaining events.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and nasal swab for COVID-19 test positive on 31Dec2020.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents the pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Malaise
Clinical narrative: feeling dizzy; feeling chilled and achy; feeling chilled and achy; fever (39.0C and 40.0C); felt unwell; head and body aches; This is a spontaneous report from a contactable nurse (patient).  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at left arm on 06Jan2021 at 16:30 at single dose for COVID-19 immunization. The patient medical history included hypothyroid, PCOS (polycystic ovaries), chronic idiopathic urticaria (resolved with XOLAIR), depression and environmental allergy (unaware of exact trigger), each from an unknown date and unknown if ongoing. The patient concomitant medication included escitalopram (CIPRALEX), levothyroxine sodium (SYNTHROID) and omalizumab (XOLAIR). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 16Dec2020 at 09:15 at single dose for COVID-19 immunization.  The patient reported that she woke up on 07Jan2020 feeling dizzy. Went back to bed feeling chilled and achy, fever developed around 9:00, temperature of 39.0 C. Headache, chills, body aches, fever increased to 40.0 C. She felt unwell until approximately 16:00 when temperature went down to normal. Remained achy and chilled. On 08Jan2020, she had ongoing head and body aches, fatigue. 09Jan2020 feeling back to normal. The patient outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: feeling dizzy; feeling chilled and achy; feeling chilled and achy; fever (39.0C and 40.0C); felt unwell; head and body aches; This is a spontaneous report from a contactable nurse (patient).  A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at left arm on 06Jan2021 at 16:30 at single dose for COVID-19 immunization. The patient medical history included hypothyroid, PCOS (polycystic ovaries), chronic idiopathic urticaria (resolved with XOLAIR), depression and environmental allergy (unaware of exact trigger), each from an unknown date and unknown if ongoing. The patient concomitant medication included escitalopram (CIPRALEX), levothyroxine sodium (SYNTHROID) and omalizumab (XOLAIR). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at left arm on 16Dec2020 at 09:15 at single dose for COVID-19 immunization.  The patient reported that she woke up on 07Jan2020 feeling dizzy. Went back to bed feeling chilled and achy, fever developed around 9:00, temperature of 39.0 C. Headache, chills, body aches, fever increased to 40.0 C. She felt unwell until approximately 16:00 when temperature went down to normal. Remained achy and chilled. On 08Jan2020, she had ongoing head and body aches, fatigue. 09Jan2020 feeling back to normal. The patient outcome of the events was recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swelling to left axillary lymph node; This is a spontaneous report from a contactable nurse (patient) reported for herself that a 60-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) via an unspecified route of administration at left arm, on 17Dec2020 16:30 at single dose for COVID-19 immunization. Medical history included cherries and peach allergies. Patient was not pregnant at the time of this report. Concomitant medications were not reported. The nurse received the vaccine at Hospital. She reported swelling to left axillary lymph node since 17Dec2020, no treatment received, event was not recovered at the time of this report (09Jan2021). Nurse denied having COVID prior vaccination.  She had tested COVID through nasal swab post vaccination which revealed negative on an unspecified date. She did not receive other vaccine in four weeks, she had the second dose of BNT162B2 (Lot number EK9231) via intramuscular at left arm on 06Jan2021 01:45 PM at single dose for COVID-19 immunization. Outcome of the event was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: Bouts of profuse perspiration; Nausea; Slight headache; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Fever of 101.0 at 12 hours post vaccination; Body aches; Malaise; Chills; Dizziness; Loss of appetite; second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), via an unspecified route of administration at Left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included hypothyroidism. No known allergies. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE) 50mcg. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number=EJ1685) via an unspecified route of administration at arm right on 21Dec2020 07:15 at single dose for COVID-19 immunization. The patient experienced nausea, slight headache, extreme left arm soreness with some tingling and numbness spreading to hand, fever of 101.0 at 12 hours post vaccination, body aches, malaise, chills, dizziness, loss of appetite. Adverse events start time reported as 08Jan2021 19:00. 24 hours after 2nd dose, the patient had body aches and bouts of profuse perspiration on 09Jan2021 07:15. No treatment received for these events. No COVID prior and COVID was not tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.0 on 08Jan2021 at 19:15. The outcome of the events "second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15" was unknown, of other events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Inappropriate schedule of product administration, Malaise, Nausea
Clinical narrative: Bouts of profuse perspiration; Nausea; Slight headache; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Fever of 101.0 at 12 hours post vaccination; Body aches; Malaise; Chills; Dizziness; Loss of appetite; second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), via an unspecified route of administration at Left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included hypothyroidism. No known allergies. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE) 50mcg. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number=EJ1685) via an unspecified route of administration at arm right on 21Dec2020 07:15 at single dose for COVID-19 immunization. The patient experienced nausea, slight headache, extreme left arm soreness with some tingling and numbness spreading to hand, fever of 101.0 at 12 hours post vaccination, body aches, malaise, chills, dizziness, loss of appetite. Adverse events start time reported as 08Jan2021 19:00. 24 hours after 2nd dose, the patient had body aches and bouts of profuse perspiration on 09Jan2021 07:15. No treatment received for these events. No COVID prior and COVID was not tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.0 on 08Jan2021 at 19:15. The outcome of the events "second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15" was unknown, of other events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Bouts of profuse perspiration; Nausea; Slight headache; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Fever of 101.0 at 12 hours post vaccination; Body aches; Malaise; Chills; Dizziness; Loss of appetite; second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), via an unspecified route of administration at Left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included hypothyroidism. No known allergies. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE) 50mcg. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number=EJ1685) via an unspecified route of administration at arm right on 21Dec2020 07:15 at single dose for COVID-19 immunization. The patient experienced nausea, slight headache, extreme left arm soreness with some tingling and numbness spreading to hand, fever of 101.0 at 12 hours post vaccination, body aches, malaise, chills, dizziness, loss of appetite. Adverse events start time reported as 08Jan2021 19:00. 24 hours after 2nd dose, the patient had body aches and bouts of profuse perspiration on 09Jan2021 07:15. No treatment received for these events. No COVID prior and COVID was not tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.0 on 08Jan2021 at 19:15. The outcome of the events "second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15" was unknown, of other events was recovering.