chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Paraesthesia oral, SARS-CoV-2 test negative, Throat tightness
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (HCP) (parent). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The other HCP called on behalf of her 27-year-old daughter requesting an urgent callback. On an unspecified date, the daughter had an anaphylactic reaction, continuing on medications that cannot be tapered and was hospitalized. She has an appointment on 11Jan2021 with a general practitioner. It was asked what happens when you become allergic to the spike protein? How long does it continue to make the spike protein? Do "we" have any ideas if she is exposed to the virus/spike protein would she experience another adverse reaction as she works in healthcare? Is there a way to break the cycle? The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on an implied chronological association and known BNT162B2 vaccine safety profile, a causal relationship between event Anaphylactic reaction and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (HCP) (parent). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The other HCP called on behalf of her 27-year-old daughter requesting an urgent callback. On an unspecified date, the daughter had an anaphylactic reaction, continuing on medications that cannot be tapered and was hospitalized. She has an appointment on 11Jan2021 with a general practitioner. It was asked what happens when you become allergic to the spike protein? How long does it continue to make the spike protein? Do "we" have any ideas if she is exposed to the virus/spike protein would she experience another adverse reaction as she works in healthcare? Is there a way to break the cycle? The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on an implied chronological association and known BNT162B2 vaccine safety profile, a causal relationship between event Anaphylactic reaction and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Nausea
Clinical narrative: severe pain in the middle of her chest that was acid reflux/bad GERD; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ1686, expiry date: 31Mar2021), intramuscular in the left arm on 04Jan2021 11:00 (also reported as 12:00) at a single dose for COVID-19 immunisation. The patient's medical history included Gastrooesophageal reflux disease (GERD) which she has not had this since she was pregnant 36 years ago. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The caller stated she had the COVID vaccine on Monday (04Jan2021) at 11:00am. Later that day at 6:00pm she had severe pain in the middle of her chest that was acid reflux/bad GERD. She has not had this since she was pregnant 36 years ago. She stated that the sharp pain in her chest was really really bad, she thought she was having a heart attack. She stated the pain went away, but she has really bad acid. The caller asked if this is this normal? Additionally, how long do side effects in general last? She wanted to go lay down because her stomach was hurting. The outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: severe pain in the middle of her chest that was acid reflux/bad GERD; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EJ1686, expiry date: 31Mar2021), intramuscular in the left arm on 04Jan2021 11:00 (also reported as 12:00) at a single dose for COVID-19 immunisation. The patient's medical history included Gastrooesophageal reflux disease (GERD) which she has not had this since she was pregnant 36 years ago. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The caller stated she had the COVID vaccine on Monday (04Jan2021) at 11:00am. Later that day at 6:00pm she had severe pain in the middle of her chest that was acid reflux/bad GERD. She has not had this since she was pregnant 36 years ago. She stated that the sharp pain in her chest was really really bad, she thought she was having a heart attack. She stated the pain went away, but she has really bad acid. The caller asked if this is this normal? Additionally, how long do side effects in general last? She wanted to go lay down because her stomach was hurting. The outcome of the event was not recovered.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Flushing, Pruritus, Scratch, Sleep disorder
Clinical narrative: Coughing; Under my arm and my groin area it's all itching and now my whole body is itching; Under my arm and my groin area it's all  sore; Under my arm and my groin area it's all sore; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received bnt162b2 (BNT162B2 reported as COVID-19 Vaccine Pfizer; unknown lot number and expiration date), via an unspecified route of administration on 31Dec2020 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that "I just started coughing, I got the vaccine 31Dec2020". The patient doesn't know can the patient has a side effect like starting maybe couple of days ago. The patient's whole body was like it was itching and the patient don't know what the patient was dealing with and like under patient's arm and patient's groin area, it's all itching and sore, so the patient doesn't know and now the patient's whole body is itching. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Age: 62.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cough, Groin pain, Pain in extremity, Pruritus
Clinical narrative: Coughing; Under my arm and my groin area it's all itching and now my whole body is itching; Under my arm and my groin area it's all  sore; Under my arm and my groin area it's all sore; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received bnt162b2 (BNT162B2 reported as COVID-19 Vaccine Pfizer; unknown lot number and expiration date), via an unspecified route of administration on 31Dec2020 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that "I just started coughing, I got the vaccine 31Dec2020". The patient doesn't know can the patient has a side effect like starting maybe couple of days ago. The patient's whole body was like it was itching and the patient don't know what the patient was dealing with and like under patient's arm and patient's groin area, it's all itching and sore, so the patient doesn't know and now the patient's whole body is itching. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Back pain, Dizziness, Lymphadenopathy, Myalgia
Clinical narrative: have myopathy under my armpit, it's so sore and its very tender; 101 fever; Lymphatic adenopathy in my left armpit/noticed like a marble within my arm pit; Myalgia all over my body/My muscle hurts; My spine hurts; My bones hurt; Nauseous; Dizzy; Headache; My lungs feel achy; My chest feels achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine (unspecified date). On 06Jan2021, the patient got the Pfizer COVID vaccine number 2; and 16 hours later (Jan2021); the patient had a 101 fever, lymphatic adenopathy in the patient's left armpit, myalgia all over the patient's body, the patient's spine hurts, the patient's muscle hurts, the patient's bones hurt, nauseous, dizzy, severe headache, the patient's lungs felt achy, and the patient's chest felt achy. yesterday, the patient noticed like a marble within the patient's arm pit and now today (08Jan2021), the patient woke and now the patient thought had "myopathy under the armpit, it's so sore and its very tender"; the patient didn't have fever this morning but the patient needed to know if need to go in an urgent care clinic. The outcome of the event "101 fever" was recovered on 08Jan2021; while unknown for other events.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Pyrexia, Spinal pain
Clinical narrative: have myopathy under my armpit, it's so sore and its very tender; 101 fever; Lymphatic adenopathy in my left armpit/noticed like a marble within my arm pit; Myalgia all over my body/My muscle hurts; My spine hurts; My bones hurt; Nauseous; Dizzy; Headache; My lungs feel achy; My chest feels achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine (unspecified date). On 06Jan2021, the patient got the Pfizer COVID vaccine number 2; and 16 hours later (Jan2021); the patient had a 101 fever, lymphatic adenopathy in the patient's left armpit, myalgia all over the patient's body, the patient's spine hurts, the patient's muscle hurts, the patient's bones hurt, nauseous, dizzy, severe headache, the patient's lungs felt achy, and the patient's chest felt achy. yesterday, the patient noticed like a marble within the patient's arm pit and now today (08Jan2021), the patient woke and now the patient thought had "myopathy under the armpit, it's so sore and its very tender"; the patient didn't have fever this morning but the patient needed to know if need to go in an urgent care clinic. The outcome of the event "101 fever" was recovered on 08Jan2021; while unknown for other events.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood electrolytes normal, Full blood count, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: have myopathy under my armpit, it's so sore and its very tender; 101 fever; Lymphatic adenopathy in my left armpit/noticed like a marble within my arm pit; Myalgia all over my body/My muscle hurts; My spine hurts; My bones hurt; Nauseous; Dizzy; Headache; My lungs feel achy; My chest feels achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine (unspecified date). On 06Jan2021, the patient got the Pfizer COVID vaccine number 2; and 16 hours later (Jan2021); the patient had a 101 fever, lymphatic adenopathy in the patient's left armpit, myalgia all over the patient's body, the patient's spine hurts, the patient's muscle hurts, the patient's bones hurt, nauseous, dizzy, severe headache, the patient's lungs felt achy, and the patient's chest felt achy. yesterday, the patient noticed like a marble within the patient's arm pit and now today (08Jan2021), the patient woke and now the patient thought had "myopathy under the armpit, it's so sore and its very tender"; the patient didn't have fever this morning but the patient needed to know if need to go in an urgent care clinic. The outcome of the event "101 fever" was recovered on 08Jan2021; while unknown for other events.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Bone pain, Chest pain, Dizziness, Headache
Clinical narrative: have myopathy under my armpit, it's so sore and its very tender; 101 fever; Lymphatic adenopathy in my left armpit/noticed like a marble within my arm pit; Myalgia all over my body/My muscle hurts; My spine hurts; My bones hurt; Nauseous; Dizzy; Headache; My lungs feel achy; My chest feels achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine (unspecified date). On 06Jan2021, the patient got the Pfizer COVID vaccine number 2; and 16 hours later (Jan2021); the patient had a 101 fever, lymphatic adenopathy in the patient's left armpit, myalgia all over the patient's body, the patient's spine hurts, the patient's muscle hurts, the patient's bones hurt, nauseous, dizzy, severe headache, the patient's lungs felt achy, and the patient's chest felt achy. yesterday, the patient noticed like a marble within the patient's arm pit and now today (08Jan2021), the patient woke and now the patient thought had "myopathy under the armpit, it's so sore and its very tender"; the patient didn't have fever this morning but the patient needed to know if need to go in an urgent care clinic. The outcome of the event "101 fever" was recovered on 08Jan2021; while unknown for other events.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Myalgia, Myopathy, Nausea, Pulmonary pain
Clinical narrative: have myopathy under my armpit, it's so sore and its very tender; 101 fever; Lymphatic adenopathy in my left armpit/noticed like a marble within my arm pit; Myalgia all over my body/My muscle hurts; My spine hurts; My bones hurt; Nauseous; Dizzy; Headache; My lungs feel achy; My chest feels achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine (unspecified date). On 06Jan2021, the patient got the Pfizer COVID vaccine number 2; and 16 hours later (Jan2021); the patient had a 101 fever, lymphatic adenopathy in the patient's left armpit, myalgia all over the patient's body, the patient's spine hurts, the patient's muscle hurts, the patient's bones hurt, nauseous, dizzy, severe headache, the patient's lungs felt achy, and the patient's chest felt achy. yesterday, the patient noticed like a marble within the patient's arm pit and now today (08Jan2021), the patient woke and now the patient thought had "myopathy under the armpit, it's so sore and its very tender"; the patient didn't have fever this morning but the patient needed to know if need to go in an urgent care clinic. The outcome of the event "101 fever" was recovered on 08Jan2021; while unknown for other events.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Spinal pain
Clinical narrative: have myopathy under my armpit, it's so sore and its very tender; 101 fever; Lymphatic adenopathy in my left armpit/noticed like a marble within my arm pit; Myalgia all over my body/My muscle hurts; My spine hurts; My bones hurt; Nauseous; Dizzy; Headache; My lungs feel achy; My chest feels achy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of Pfizer COVID vaccine (unspecified date). On 06Jan2021, the patient got the Pfizer COVID vaccine number 2; and 16 hours later (Jan2021); the patient had a 101 fever, lymphatic adenopathy in the patient's left armpit, myalgia all over the patient's body, the patient's spine hurts, the patient's muscle hurts, the patient's bones hurt, nauseous, dizzy, severe headache, the patient's lungs felt achy, and the patient's chest felt achy. yesterday, the patient noticed like a marble within the patient's arm pit and now today (08Jan2021), the patient woke and now the patient thought had "myopathy under the armpit, it's so sore and its very tender"; the patient didn't have fever this morning but the patient needed to know if need to go in an urgent care clinic. The outcome of the event "101 fever" was recovered on 08Jan2021; while unknown for other events.  Information about batch/lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Decreased appetite, Fatigue
Clinical narrative: Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; started with slight headache by that evening migraine level headache; started with slight headache by that evening migraine level headache; Fatigue; This is a spontaneous report from a contactable other-HCP (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was hospital. Medical history included degenerative disc disease, obesity, high cholesterol, high blood pressure, migraines. The known allergies included adhesive, mango, banana, compazine, demerol, codeine. Concomitant medication included gabapentin and meloxicam. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 29Dec2020 with outcome of recovered, started with slight headache by that evening migraine level headache on 31Dec2020 with outcome of recovered, fever on 01Jan2021 early am with outcome of recovered, severe chills on 01Jan2021 with outcome of recovered, severe aches low back, legs, hips, joints on 01Jan2021 with outcome of recovered. The outcome of event was recovered in 03Jan2021, other events were recovered in 02Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Migraine, Pain, Pyrexia
Clinical narrative: Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; started with slight headache by that evening migraine level headache; started with slight headache by that evening migraine level headache; Fatigue; This is a spontaneous report from a contactable other-HCP (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was hospital. Medical history included degenerative disc disease, obesity, high cholesterol, high blood pressure, migraines. The known allergies included adhesive, mango, banana, compazine, demerol, codeine. Concomitant medication included gabapentin and meloxicam. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 29Dec2020 with outcome of recovered, started with slight headache by that evening migraine level headache on 31Dec2020 with outcome of recovered, fever on 01Jan2021 early am with outcome of recovered, severe chills on 01Jan2021 with outcome of recovered, severe aches low back, legs, hips, joints on 01Jan2021 with outcome of recovered. The outcome of event was recovered in 03Jan2021, other events were recovered in 02Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue
Clinical narrative: Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; started with slight headache by that evening migraine level headache; started with slight headache by that evening migraine level headache; Fatigue; This is a spontaneous report from a contactable other-HCP (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was hospital. Medical history included degenerative disc disease, obesity, high cholesterol, high blood pressure, migraines. The known allergies included adhesive, mango, banana, compazine, demerol, codeine. Concomitant medication included gabapentin and meloxicam. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 29Dec2020 with outcome of recovered, started with slight headache by that evening migraine level headache on 31Dec2020 with outcome of recovered, fever on 01Jan2021 early am with outcome of recovered, severe chills on 01Jan2021 with outcome of recovered, severe aches low back, legs, hips, joints on 01Jan2021 with outcome of recovered. The outcome of event was recovered in 03Jan2021, other events were recovered in 02Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Migraine, Pain in extremity, Pyrexia
Clinical narrative: Fever; Severe chills; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; severe aches low back, legs, hips, joints,; started with slight headache by that evening migraine level headache; started with slight headache by that evening migraine level headache; Fatigue; This is a spontaneous report from a contactable other-HCP (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was hospital. Medical history included degenerative disc disease, obesity, high cholesterol, high blood pressure, migraines. The known allergies included adhesive, mango, banana, compazine, demerol, codeine. Concomitant medication included gabapentin and meloxicam. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 29Dec2020 with outcome of recovered, started with slight headache by that evening migraine level headache on 31Dec2020 with outcome of recovered, fever on 01Jan2021 early am with outcome of recovered, severe chills on 01Jan2021 with outcome of recovered, severe aches low back, legs, hips, joints on 01Jan2021 with outcome of recovered. The outcome of event was recovered in 03Jan2021, other events were recovered in 02Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Laboratory test, Tachycardia, Tremor
Clinical narrative: tachycardia which continues to persist; intermittent violent shaking; This is a spontaneous report from a contactable healthcare professional (patient).  This 44-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Eh9899, expiry date: unknown, vaccine location: left arm, dose number: 1), via an unspecified route of administration on 21Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included dermatomyositis (not receiving any treatment). The patient had no known allergies. The patient's concomitant medications were not reported. Shortly after vaccination on 24Dec2020, the patient developed tachycardia which continues to persist. Also, on 24Dec2020, the patient developed intermittent violent shaking. Treatment was received for the adverse events. EKG and lab work were done. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. The events did not result in death, were not life-threatening, did not cause or prolong hospitalization, were not disabling or incapacitating, and did not result to a congenital anomaly or birth defect. Outcome of the events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Chest X-ray, Computerised tomogram head, Facial paresis
Clinical narrative: Loss of vision left eye, numbness  left side of face left arm and left leg, weakness left side of body, headache pressure, it was difficult to answer some questions like numbers example couldn't remember my number or my zip code
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Hypoaesthesia, International normalised ratio, Magnetic resonance imaging, Metabolic function test
Clinical narrative: Loss of vision left eye, numbness  left side of face left arm and left leg, weakness left side of body, headache pressure, it was difficult to answer some questions like numbers example couldn't remember my number or my zip code
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Prothrombin time, Visual field defect
Clinical narrative: Loss of vision left eye, numbness  left side of face left arm and left leg, weakness left side of body, headache pressure, it was difficult to answer some questions like numbers example couldn't remember my number or my zip code
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Pyrexia, Rash
Clinical narrative: Loss of vision left eye, numbness  left side of face left arm and left leg, weakness left side of body, headache pressure, it was difficult to answer some questions like numbers example couldn't remember my number or my zip code
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Computerised tomogram head, Differential white blood cell count, Full blood count, Haematology test
Clinical narrative: Loss of vision left eye, numbness  left side of face left arm and left leg, weakness left side of body, headache pressure, it was difficult to answer some questions like numbers example couldn't remember my number or my zip code
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Headache, Hemiparesis, Hypoaesthesia, Intensive care
Clinical narrative: Loss of vision left eye, numbness  left side of face left arm and left leg, weakness left side of body, headache pressure, it was difficult to answer some questions like numbers example couldn't remember my number or my zip code
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging brain, Memory impairment
Clinical narrative: Loss of vision left eye, numbness  left side of face left arm and left leg, weakness left side of body, headache pressure, it was difficult to answer some questions like numbers example couldn't remember my number or my zip code
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: SOB and abdominal pain 2 hours after vaccine was administered. O2 started 3 hours after, Bi PAP 5 hours later, intubation 30 hours later.   DEATH 4 days after vaccine was given.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Bilevel positive airway pressure, Computerised tomogram, Death, Dialysis
Clinical narrative: SOB and abdominal pain 2 hours after vaccine was administered. O2 started 3 hours after, Bi PAP 5 hours later, intubation 30 hours later.   DEATH 4 days after vaccine was given.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Endotracheal intubation, SARS-CoV-2 test negative
Clinical narrative: SOB and abdominal pain 2 hours after vaccine was administered. O2 started 3 hours after, Bi PAP 5 hours later, intubation 30 hours later.   DEATH 4 days after vaccine was given.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea, Mechanical ventilation, Medical induction of coma, Multiple organ dysfunction syndrome
Clinical narrative: SOB and abdominal pain 2 hours after vaccine was administered. O2 started 3 hours after, Bi PAP 5 hours later, intubation 30 hours later.   DEATH 4 days after vaccine was given.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: SOB and abdominal pain 2 hours after vaccine was administered. O2 started 3 hours after, Bi PAP 5 hours later, intubation 30 hours later.   DEATH 4 days after vaccine was given.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Discomfort, Fatigue
Clinical narrative: Watery loose stools for 2 days
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea
Clinical narrative: Watery loose stools for 2 days
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Malaise, Myalgia, Nasopharyngitis, Pain in extremity
Clinical narrative: muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like having a fever/fever of 101.4F; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm, on 08Jan2021 at 09:15, at single dose, for COVID-19 immunization.  Medical history included palpitations and COVID-19 on 26Mar2020 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes).  On 26Mar2020, the patient had nasal swab for COVID-19 which is positive. The patient has no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), metoprolol, and unspecified multivitamins. The patient felt cold in the evening of 08Jan2021 at 20:00, feels like having a fever. The next morning (09Jan2021), the patient had a fever of 101.4F, muscle aches, headache and soreness on left arm. The patient took Tylenol, lots of fluids and bed rest. The patient started feeling better on 10Jan2021. COVID-19 vaccine was administered in a hospital. The patient is not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On unspecified date, the patient was tested for COVID post vaccination (COVID-19 PCR) with unknown result. The patient did not receive other vaccine in four weeks. The patient recovered from the events in Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like having a fever/fever of 101.4F; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm, on 08Jan2021 at 09:15, at single dose, for COVID-19 immunization.  Medical history included palpitations and COVID-19 on 26Mar2020 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes).  On 26Mar2020, the patient had nasal swab for COVID-19 which is positive. The patient has no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), metoprolol, and unspecified multivitamins. The patient felt cold in the evening of 08Jan2021 at 20:00, feels like having a fever. The next morning (09Jan2021), the patient had a fever of 101.4F, muscle aches, headache and soreness on left arm. The patient took Tylenol, lots of fluids and bed rest. The patient started feeling better on 10Jan2021. COVID-19 vaccine was administered in a hospital. The patient is not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On unspecified date, the patient was tested for COVID post vaccination (COVID-19 PCR) with unknown result. The patient did not receive other vaccine in four weeks. The patient recovered from the events in Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Feeling cold, Headache, Myalgia, Pain in extremity
Clinical narrative: muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like having a fever/fever of 101.4F; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm, on 08Jan2021 at 09:15, at single dose, for COVID-19 immunization.  Medical history included palpitations and COVID-19 on 26Mar2020 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes).  On 26Mar2020, the patient had nasal swab for COVID-19 which is positive. The patient has no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), metoprolol, and unspecified multivitamins. The patient felt cold in the evening of 08Jan2021 at 20:00, feels like having a fever. The next morning (09Jan2021), the patient had a fever of 101.4F, muscle aches, headache and soreness on left arm. The patient took Tylenol, lots of fluids and bed rest. The patient started feeling better on 10Jan2021. COVID-19 vaccine was administered in a hospital. The patient is not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On unspecified date, the patient was tested for COVID post vaccination (COVID-19 PCR) with unknown result. The patient did not receive other vaccine in four weeks. The patient recovered from the events in Jan2021.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like having a fever/fever of 101.4F; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm, on 08Jan2021 at 09:15, at single dose, for COVID-19 immunization.  Medical history included palpitations and COVID-19 on 26Mar2020 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes).  On 26Mar2020, the patient had nasal swab for COVID-19 which is positive. The patient has no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), metoprolol, and unspecified multivitamins. The patient felt cold in the evening of 08Jan2021 at 20:00, feels like having a fever. The next morning (09Jan2021), the patient had a fever of 101.4F, muscle aches, headache and soreness on left arm. The patient took Tylenol, lots of fluids and bed rest. The patient started feeling better on 10Jan2021. COVID-19 vaccine was administered in a hospital. The patient is not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On unspecified date, the patient was tested for COVID post vaccination (COVID-19 PCR) with unknown result. The patient did not receive other vaccine in four weeks. The patient recovered from the events in Jan2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: Bad fatigue; low grade temperature, then got real hot, it went back and forth. went over 103F/fever/lingering fever; chills; body looked like it was sunburned, extreme fatigue, sunburn rash/ red rash over my body/rash; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 18:15 (Wednesday) at SINGLE DOSE for covid-19 immunization. Patient took the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the 2nd vaccine on Wednesday at 6:15pm and she did ok until Thursday. She woke up with bad fatigue, mid morning hours she had low grade temperature, chills, then got real hot, it went back and forth. Patient's temperature kept increasing. That evening, it went over 103F she rechecked it. She had taken nothing. She read it was best not to take anything, temperature over 102 and best not to take any. But then decided to take Tylenol. It went down to 101.7F; that was on Thursday evening. Then yesterday (08Jan2021) patient still had a temperature she hasn't taken anything else. Temperature was 101 or greater. It was 101.7F when she woke up. Patient's body looked like it was sunburned, extreme fatigue, sunburn rash. 100.6 highest today (09Jan2021). It's going down. She related it to the vaccine; 12-15 hours after receiving the vaccine, but then patient wondered how long it's going to last, red rash over her body. It's definitely an extreme reaction. She was trying to determine, if she should take Benadryl, any other cases. Effects could last a few days. She didn't know what to do. No other symptoms besides fever and rash. Patient asked if it's an inflammatory reaction. Fatigue is still there, lingering fever and sunburn rash. If she should go to the ER, get looked at. It's a weird inflammatory responses. She know a lot is not known, if she should get medical attention. The outcome of event Chills was unknown, other events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Bad fatigue; low grade temperature, then got real hot, it went back and forth. went over 103F/fever/lingering fever; chills; body looked like it was sunburned, extreme fatigue, sunburn rash/ red rash over my body/rash; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 18:15 (Wednesday) at SINGLE DOSE for covid-19 immunization. Patient took the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the 2nd vaccine on Wednesday at 6:15pm and she did ok until Thursday. She woke up with bad fatigue, mid morning hours she had low grade temperature, chills, then got real hot, it went back and forth. Patient's temperature kept increasing. That evening, it went over 103F she rechecked it. She had taken nothing. She read it was best not to take anything, temperature over 102 and best not to take any. But then decided to take Tylenol. It went down to 101.7F; that was on Thursday evening. Then yesterday (08Jan2021) patient still had a temperature she hasn't taken anything else. Temperature was 101 or greater. It was 101.7F when she woke up. Patient's body looked like it was sunburned, extreme fatigue, sunburn rash. 100.6 highest today (09Jan2021). It's going down. She related it to the vaccine; 12-15 hours after receiving the vaccine, but then patient wondered how long it's going to last, red rash over her body. It's definitely an extreme reaction. She was trying to determine, if she should take Benadryl, any other cases. Effects could last a few days. She didn't know what to do. No other symptoms besides fever and rash. Patient asked if it's an inflammatory reaction. Fatigue is still there, lingering fever and sunburn rash. If she should go to the ER, get looked at. It's a weird inflammatory responses. She know a lot is not known, if she should get medical attention. The outcome of event Chills was unknown, other events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Rash erythematous
Clinical narrative: Bad fatigue; low grade temperature, then got real hot, it went back and forth. went over 103F/fever/lingering fever; chills; body looked like it was sunburned, extreme fatigue, sunburn rash/ red rash over my body/rash; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 18:15 (Wednesday) at SINGLE DOSE for covid-19 immunization. Patient took the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the 2nd vaccine on Wednesday at 6:15pm and she did ok until Thursday. She woke up with bad fatigue, mid morning hours she had low grade temperature, chills, then got real hot, it went back and forth. Patient's temperature kept increasing. That evening, it went over 103F she rechecked it. She had taken nothing. She read it was best not to take anything, temperature over 102 and best not to take any. But then decided to take Tylenol. It went down to 101.7F; that was on Thursday evening. Then yesterday (08Jan2021) patient still had a temperature she hasn't taken anything else. Temperature was 101 or greater. It was 101.7F when she woke up. Patient's body looked like it was sunburned, extreme fatigue, sunburn rash. 100.6 highest today (09Jan2021). It's going down. She related it to the vaccine; 12-15 hours after receiving the vaccine, but then patient wondered how long it's going to last, red rash over her body. It's definitely an extreme reaction. She was trying to determine, if she should take Benadryl, any other cases. Effects could last a few days. She didn't know what to do. No other symptoms besides fever and rash. Patient asked if it's an inflammatory reaction. Fatigue is still there, lingering fever and sunburn rash. If she should go to the ER, get looked at. It's a weird inflammatory responses. She know a lot is not known, if she should get medical attention. The outcome of event Chills was unknown, other events was not recovered.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: fatigue; Severe fever (104.6); chills; nausea; muscle soreness; first dose of BNT162B2 on 22Dec2020, second dose on 09Jan2021; This is a spontaneous report from a contactable nurse. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 09Jan2021 at 07:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other product. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) on 22Dec2020 at 02:00 pm on the right arm for COVID-19 immunization. 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. On 09Jan2021 at 20:00, the patient experienced fatigue, severe fever (104.6), chills, nausea, and muscle soreness. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.