chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Gait disturbance, Illness
Clinical narrative: body pain/he can't even lift his arms up due to the pain; severe fatigue; achy shoulder, neck; achy shoulder, neck; not sleeping well; he can't even lift his arms up due to the pain; sick; had no energy; very lethargic; if paitent walks a mile, that's a long walk for patient; lost four to five pounds in the last couple of months; the bottom of feet started to grab and cramp up and hurt; the bottom of feet started to grab and cramp up and hurt; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is fifth of five reports. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced body pain/he can't even lift his arms up due to the pain; severe fatigue; achy shoulder, neck; not sleeping well, can't even lift arms up due to the pain, got sick, had no energy, very lethargic, lost four to five pounds in the last couple of months, the bottom of patient feet started to grab and cramp up and hurt. It was reported if patient walks a mile, that's a long walk for patient. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Mobility decreased, Muscle spasms, Neck pain, Pain
Clinical narrative: body pain/he can't even lift his arms up due to the pain; severe fatigue; achy shoulder, neck; achy shoulder, neck; not sleeping well; he can't even lift his arms up due to the pain; sick; had no energy; very lethargic; if paitent walks a mile, that's a long walk for patient; lost four to five pounds in the last couple of months; the bottom of feet started to grab and cramp up and hurt; the bottom of feet started to grab and cramp up and hurt; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is fifth of five reports. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced body pain/he can't even lift his arms up due to the pain; severe fatigue; achy shoulder, neck; not sleeping well, can't even lift arms up due to the pain, got sick, had no energy, very lethargic, lost four to five pounds in the last couple of months, the bottom of patient feet started to grab and cramp up and hurt. It was reported if patient walks a mile, that's a long walk for patient. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep, Weight decreased
Clinical narrative: body pain/he can't even lift his arms up due to the pain; severe fatigue; achy shoulder, neck; achy shoulder, neck; not sleeping well; he can't even lift his arms up due to the pain; sick; had no energy; very lethargic; if paitent walks a mile, that's a long walk for patient; lost four to five pounds in the last couple of months; the bottom of feet started to grab and cramp up and hurt; the bottom of feet started to grab and cramp up and hurt; This is a spontaneous report from a contactable consumer. This consumer reported similar events for five patients. This is fifth of five reports. This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. On unspecified date, patient experienced body pain/he can't even lift his arms up due to the pain; severe fatigue; achy shoulder, neck; not sleeping well, can't even lift arms up due to the pain, got sick, had no energy, very lethargic, lost four to five pounds in the last couple of months, the bottom of patient feet started to grab and cramp up and hurt. It was reported if patient walks a mile, that's a long walk for patient. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541547 Same reporter/drug/event, different patients
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cardiomegaly, Cough, Echocardiogram, Nasal congestion
Clinical narrative: Echocardiogram results moderate circumferential pericardial effusion; Fever; stomach pain; congestion; cough; Xray showed enlarged heart.; This is a spontaneous report from from a non-contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Apr2021 (Batch/Lot Number: 7533) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included down syndrome. The patient also reported sulfa drugs (unspecified). Prior to vaccination, the patient diagnosed with COVID-19, however since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (reported as other medications the patient received within 2 weeks of vaccination) includes: Topiramate, Buspirone, Mirtazapine, Synthroid, all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Fever, stomach pain, congestion, cough, Xray showed enlarged heart and Echocardiogram results moderate circumferential pericardial effusion, all on 09Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included echocardiogram: pericardial effusion (moderate circumferential pericardial effusion) and x-ray: showed enlarged heart, both on 09Apr2021. The outcome of the events was recovering. Treatment include: antibiotic, prednisone.   No follow-up attempts are possible. No further information expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Pyrexia, X-ray
Clinical narrative: Echocardiogram results moderate circumferential pericardial effusion; Fever; stomach pain; congestion; cough; Xray showed enlarged heart.; This is a spontaneous report from from a non-contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Apr2021 (Batch/Lot Number: 7533) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included down syndrome. The patient also reported sulfa drugs (unspecified). Prior to vaccination, the patient diagnosed with COVID-19, however since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (reported as other medications the patient received within 2 weeks of vaccination) includes: Topiramate, Buspirone, Mirtazapine, Synthroid, all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Fever, stomach pain, congestion, cough, Xray showed enlarged heart and Echocardiogram results moderate circumferential pericardial effusion, all on 09Apr2021. The events resulted in Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included echocardiogram: pericardial effusion (moderate circumferential pericardial effusion) and x-ray: showed enlarged heart, both on 09Apr2021. The outcome of the events was recovering. Treatment include: antibiotic, prednisone.   No follow-up attempts are possible. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Oedema peripheral
Clinical narrative: Transient b/l LE edema 2d after 2nd dose with neuropathy; Transient b/l LE edema 2d after 2nd dose with neuropathy; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received (COVID 19 PFIZER), dose 2 intramuscular, administered in right arm on 13Apr2021 17:00 as single dose for COVID-19 immunization. Medical history included type 2 (DM) diabetes mellitus, obesity, vitamin D deficiency and was diagnosed with COVID-19 prior to vaccination; all from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported. The patient previously received 1st dose of (COVID 19 PFIZER), intramuscular, administered in left arm on 23Mar2021 05:00 PM  for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced transient (bilateral) b/l lower extremities (LE) edema 2d after 2nd dose with neuropathy. Outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken were NSAID and muscle relaxant. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: face went numb as well as her tongue and hands; face went numb as well as her tongue and hands; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients. This is one for two reports.  A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient's mother reported that her daughter had the same vaccine, and had the same exact reaction (face went numb as well as her tongue and hands) but received it at the hospital. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541836 Same reporter/ drug/ event for different patients
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Menstruation irregular
Clinical narrative: The feeling is different than what she had before; Period advanced/Usually has period every 30-35 days. This time it started in 19 days.; Dizziness; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE, Batch/Lot Number: ER8729; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 28Apr2021 (26-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Vaccination Facility Type: Stadium at college campus. The patient took first dose of bnt162b2 (Lot: EP7534, Expiration: 30Jun2021) on 07Apr2021, administered in the left arm for COVID-19 Immunization. Patient received the second dose of the Pfizer Covid-19 vaccine on 28Apr2021. Shortly afterwards, her period advanced on 08May2021. Usually she has her period around every 30-35 days. This time it started in 19 days. She is unsure if it is really a period or abnormal bleeding. The feeling is different than what she had before. Today is the 6th day of bleeding. She is unsure how long it will last. She does not have health insurance. She is asking if she should purchase health insurance. If she continues to bleed she may have to go to the doctor. She was asking if there was anything that can protect her. She will be moving at the end of the month because she graduated. She provides the address of a friend. She also experienced dizziness on 30Apr2021 (or 03May 2021) which lasted 20-30 minutes, she had to lay down and rest at the time, she felt good now; and she also experienced shortness of breath from 30Apr2021 (or 03May2021) which lasted a few minutes, unsure if related because she was working in the sunshine in the garden. She thinks she maybe was exposed to Atrazine while in the garden. She is unsure if this was related or not. She pulled weeds up where this had been spray a month ago. The half life of chemical is half of a year. She asked if she goes for a screening or clinic for any diagnosis or treatment for breathing will Pfizer be able to help with the cost of expenses? The outcome of the event period advanced/usually has period every 30-35 days. this time it started in 19 days was not recovered, dizziness and short of breath was recovered on 30Apr2021, while other event was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Migraine, Neck pain, Pain
Clinical narrative: Migraine headache/ gets worse every day; Body aches and pain; Neck, shoulder and upper back pain; Neck, shoulder and upper back pain; Neck, shoulder and upper back pain; This is a spontaneous report from a contactable other healthcare professional (hcp; patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0175, expiry date not reported), via an unspecified route of administration, administered in right arm on 07May2021 14:30 (at the age of 36 years old) as second dose, single dose for covid-19 immunisation. Medical history included migraine and known allergies to sulfa, both from an unknown date and unknown if ongoing.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medications included amitriptyline at 20 mg, and estrogens conjugated (PREMARIN) at 0.3 mg, daily; both taken for an unspecified indication, start and stop date were not reported. The patient previously took gabapentin, Compazine, SSRIs  (Selective Serotonin Reuptake Inhibitor), oxitriptan (TRIPTAN, reported as Triptans) and promethazine, and experienced known allergy to all of them. Patient received the first dose of COVID-19 Immunization, BNT162B2 (brand=Pfizer, lot number ER8731) on 15Apr2021 14:30 PM, administered in the right arm (at the age of 36 years old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Following dose 2 of the Covid vaccine, on 07May2021 23:45 patient had severe body aches and pain, and a migraine headache (also reported that this migraine headache started 12hr after the shot). Migraine headache has lasted 6 and a half days so far with no break, and gets worse every day. It started as a 5 on the scale and progressed to a 9 (May2021). On 07May2021 23:45, the patient was also having neck, shoulder and upper back pain the same as the initial body aches. The event migraine headache was reported as serious medically significant. Therapeutic measures were taken as a result of the events reported which included: Advil Dual Action, Caffeine, Zofran, Antihistamines, which were reported to have all failed to treat it. Patient had to contact neurologist for a short term prescription to try and break the cluster.  The events resulted in doctor or other healthcare professional office/clinic visit. Patient then had Toradol 10mg PO TID 4 days, and added steroid if needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the strong temporal relation between the vaccine administration and the onset of the event migraine, the association between them cannot be completely ruled out with the available information
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment
Clinical narrative: Migraine headache/ gets worse every day; Body aches and pain; Neck, shoulder and upper back pain; Neck, shoulder and upper back pain; Neck, shoulder and upper back pain; This is a spontaneous report from a contactable other healthcare professional (hcp; patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0175, expiry date not reported), via an unspecified route of administration, administered in right arm on 07May2021 14:30 (at the age of 36 years old) as second dose, single dose for covid-19 immunisation. Medical history included migraine and known allergies to sulfa, both from an unknown date and unknown if ongoing.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medications included amitriptyline at 20 mg, and estrogens conjugated (PREMARIN) at 0.3 mg, daily; both taken for an unspecified indication, start and stop date were not reported. The patient previously took gabapentin, Compazine, SSRIs  (Selective Serotonin Reuptake Inhibitor), oxitriptan (TRIPTAN, reported as Triptans) and promethazine, and experienced known allergy to all of them. Patient received the first dose of COVID-19 Immunization, BNT162B2 (brand=Pfizer, lot number ER8731) on 15Apr2021 14:30 PM, administered in the right arm (at the age of 36 years old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Following dose 2 of the Covid vaccine, on 07May2021 23:45 patient had severe body aches and pain, and a migraine headache (also reported that this migraine headache started 12hr after the shot). Migraine headache has lasted 6 and a half days so far with no break, and gets worse every day. It started as a 5 on the scale and progressed to a 9 (May2021). On 07May2021 23:45, the patient was also having neck, shoulder and upper back pain the same as the initial body aches. The event migraine headache was reported as serious medically significant. Therapeutic measures were taken as a result of the events reported which included: Advil Dual Action, Caffeine, Zofran, Antihistamines, which were reported to have all failed to treat it. Patient had to contact neurologist for a short term prescription to try and break the cluster.  The events resulted in doctor or other healthcare professional office/clinic visit. Patient then had Toradol 10mg PO TID 4 days, and added steroid if needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the strong temporal relation between the vaccine administration and the onset of the event migraine, the association between them cannot be completely ruled out with the available information
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: she did have a little bit of burst of an allergy with the first shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 14Jan2021 14:30 as 1st dose, single dose for COVID-19 immunization in an public health department. Family history for the patient's dad had 5 heart bypass surgery and a stroke about 7-9 years after. Then 9 years later another stroke that was fatal and the patient's mother had a whole bunch stents but no open heart surgery. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. No tests were done. On 18Jan2021, 4 days after the first dose, the patient had little bit of burst of an allergy, she stated she had a rash all over her body, it was not really heavy but was there. The patient visited the emergency room and the doctor told her that it would last 3-4 days and should go away with Benadryl and it cleared up. No physician's office visit was done. The outcome of the events was recovered in 2021.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: she did have a little bit of burst of an allergy with the first shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 14Jan2021 14:30 as 1st dose, single dose for COVID-19 immunization in an public health department. Family history for the patient's dad had 5 heart bypass surgery and a stroke about 7-9 years after. Then 9 years later another stroke that was fatal and the patient's mother had a whole bunch stents but no open heart surgery. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. No tests were done. On 18Jan2021, 4 days after the first dose, the patient had little bit of burst of an allergy, she stated she had a rash all over her body, it was not really heavy but was there. The patient visited the emergency room and the doctor told her that it would last 3-4 days and should go away with Benadryl and it cleared up. No physician's office visit was done. The outcome of the events was recovered in 2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Hypertension, Migraine
Clinical narrative: Hypertension (160); Intense migraine; hot arms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 05May2021 at 17:45 at 44 years (Lot Number: EW0170), as single dose, for COVID-19 immunisation. The patient's medical history was not reported. Patient did not have known allergies, did not have COVID-19 prior to vaccination, was not pregnant and was not pregnant at time of vaccination. Concomitant medication included unspecified birth control. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 10Apr2021 at 14:45 at 44 years (lot# EP7533) in left arm. Patient did not receive other vaccines in four weeks. The patient experienced hypertension (160) (medically significant) on 06May2021 at 06:00 with outcome of not recovered, intense migraine (medically significant) on 06May2021 at 06:00 with outcome of not recovered, hot arms (medically significant) on 06May2021 at 06:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure: hypertension (160) on 06May2021. Therapeutic measures were taken as a result of the events and included treatment with lisinopril 20 mg. Patient did not tested for COVID-19 post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Erythema, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: Itching; Hives; Redness; Begun to stutter; This is a spontaneous report received via COVAES from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 07Apr2021 02:00 PM (Batch/Lot Number: SN6206) as single dose for covid-19 immunisation. Patient is not pregnancy at time of vaccination. Medical history included known allergies to Dilaudid, Percocet, Eggs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced itching, redness and hives within 5 days of getting the first shot on 10Apr2021. Patient also have begun to stutter on 10Apr2021, but doctor did not think it was a side effect. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event including a shot to stop the itching and hives. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 with nasal swab negative on 12Apr2021. The event outcome for all events was recovering.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeling abnormal, Hypoaesthesia, Nasopharyngitis, Pain in extremity
Clinical narrative: numbness on the side of the face and on top of the head; fever; felt like he was catching cold; sore arm; He felt like he was having a stroke; still not feeling right; This is spontaneous report from contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12May2021 16:38 (Lot Number: EW0182, at the age of 72-year-old) as single dose for covid-19 immunization. Medical history included diabetes, heart bypass from 1989. Concomitant medications included glimepiride taken for diabetes from 2020; acetylsalicylic acid (ASPIRIN 81) taken for heart bypass from 1989; metoprolol; metoprolol succinate (TOPROL XL) from 1989. Patient got the 1st dose of the vaccine on 12May2021 at 16:38 and got the reaction of a sore arm and knew that he would have that and then the next day on 13May2021 got a fever and the feeling of catching a cold or something. Stated he also had numbness of his face on 14May2021 and thought what was this and he did not have that before and the numbness feels like it was on the side of his face and the top of his head. He felt like he was having a stroke. The numbness was gone. He was still not feeling right. The sore arm began overnight and was a little better and the fever and feeling like he had a cold began the morning of 13May2021 and was now gone; stated the numbness began this morning of 14May2021 it seemed like and he woke up with it and did not notice it until this morning and it was ongoing and better but he did not know it just affected him and he did not know what was going on and it scared him. Patient had not required treatment or a visit to his healthcare professional (HCP) or the emergency room (ER) for the reported events. There was no prior vaccinations (within 4 weeks). The outcome of the events stroke and "still not feeling right" was unknown, for event "numbness on the side of the face and on top of the head" was recovering, for events "sore arm", fever and "felt like he was catching cold" was recovered on May2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: numbness on the side of the face and on top of the head; fever; felt like he was catching cold; sore arm; He felt like he was having a stroke; still not feeling right; This is spontaneous report from contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12May2021 16:38 (Lot Number: EW0182, at the age of 72-year-old) as single dose for covid-19 immunization. Medical history included diabetes, heart bypass from 1989. Concomitant medications included glimepiride taken for diabetes from 2020; acetylsalicylic acid (ASPIRIN 81) taken for heart bypass from 1989; metoprolol; metoprolol succinate (TOPROL XL) from 1989. Patient got the 1st dose of the vaccine on 12May2021 at 16:38 and got the reaction of a sore arm and knew that he would have that and then the next day on 13May2021 got a fever and the feeling of catching a cold or something. Stated he also had numbness of his face on 14May2021 and thought what was this and he did not have that before and the numbness feels like it was on the side of his face and the top of his head. He felt like he was having a stroke. The numbness was gone. He was still not feeling right. The sore arm began overnight and was a little better and the fever and feeling like he had a cold began the morning of 13May2021 and was now gone; stated the numbness began this morning of 14May2021 it seemed like and he woke up with it and did not notice it until this morning and it was ongoing and better but he did not know it just affected him and he did not know what was going on and it scared him. Patient had not required treatment or a visit to his healthcare professional (HCP) or the emergency room (ER) for the reported events. There was no prior vaccinations (within 4 weeks). The outcome of the events stroke and "still not feeling right" was unknown, for event "numbness on the side of the face and on top of the head" was recovering, for events "sore arm", fever and "felt like he was catching cold" was recovered on May2021.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated that she received the Pfizer-Biontech Covid19 on 27Apr2021 and "was crazy sick" for 4 to 5 days afterward. She reported that her "whole body hurt" and she "couldn't find a comfortable position to lay in".   The patient indicated that her symptoms have resolved, but she was  nervous about receiving the second dose.  The outcome of event was resolved on unknown date.   No follow-up is possible. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Delirium, Dysarthria, Headache, Inappropriate schedule of product administration
Clinical narrative: delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Off label use, Overdose, Peripheral swelling
Clinical narrative: delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: delerium; Severe myalgia; full body rash; swollen legs; facial swelling; slurred speech; stomach pain and cramping; nausea; headache; injection for vaccine received same date; injection for vaccine received same date; injection for vaccine received same date; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EP7533, at the age of 16-year-old) as single dose, and second dose via an unspecified route of administration, administered in right arm on 15Apr2021 (Lot Number: EW0171, at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included post streptococcal reactive arthritis and bee sting allergy. The patient's concomitant medications were not reported. On 16Apr2021, the patient experienced severe myalgia, full body rash, swollen legs, facial swelling, slurred speech, delerium, stomach pain and cramping, nausea, headache. Headache and stomach pain have lasted 7 days. Rash and myalgia lasted 5 days. Delerium, facial swelling, leg swelling and slurred speech lasted 12-24 hours and were relieved by Benedryl. The treatment for the event included Ibuprofen, Acetaminophen, diphenhydramine. The injection for vaccine received same date on 15Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant. The outcome of the events severe myalgia and full body rash was recovered on 21Apr2021, for events stomach pain and cramping and headache was recovered on 23Apr2021, for other events delirium, swollen legs, facial swelling, slurred speech, nausea was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Loss of personal independence in daily activities
Clinical narrative: severe dizziness that did not allow her to work or perform her daily tasks; severe dizziness that did not allow her to work or perform her daily tasks; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 for COVID-19 immunisation in 2021. On an unspecified date in 2021, the patient experienced: severe dizziness that did not allow her to work or perform her daily tasks (medically significant) and could not sleep (non-serious). The patient called requesting information about the symptoms she experienced after administering the second dose of Pfizer's COVID-19 vaccine. The patient reported that the second dose of Pfizer's COVID-19 vaccine was administered two weeks ago (at the time of the initial report) and from that date, she suffered from severe dizziness that did not allow her to work or perform her daily tasks. The patient reported that due to dizziness she could not sleep. The patient reported that she had not visited her doctor. The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Apnoea, Confusional state, Feeling abnormal, Loss of consciousness, Pain in extremity
Clinical narrative: passed out; not breathing; shaking; not awake; not coherent; not feeling good; arm was aching a little bit/her arm was hurting and her arm was achy; This is a spontaneous report from a contactable consumer (patient) and patient's mother.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13May2021 20:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got to work on 14May2021 at 08:00 and the manager let her go home because her arm was hurting and her arm was achy, and she was not feeling good, but she was feeling fine when she got home. At 11:00 AM, she came home and went into the house and came back outside. The patient's mom said that they were on the front porch and her daughter passed out and looked like she was having a seizure kind of thing (shaking really bad), she was not awake, not coherent and not breathing. They got her into the house once she came to, they cooled her off and let her sleep for about 45 minutes. Patient said that she felt like she went to sleep and what she remembered next she felt like she was waking up. She said that she slept and nowshe feels fine. Outcome of events was recovered.    Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: passed out; not breathing; shaking; not awake; not coherent; not feeling good; arm was aching a little bit/her arm was hurting and her arm was achy; This is a spontaneous report from a contactable consumer (patient) and patient's mother.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13May2021 20:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got to work on 14May2021 at 08:00 and the manager let her go home because her arm was hurting and her arm was achy, and she was not feeling good, but she was feeling fine when she got home. At 11:00 AM, she came home and went into the house and came back outside. The patient's mom said that they were on the front porch and her daughter passed out and looked like she was having a seizure kind of thing (shaking really bad), she was not awake, not coherent and not breathing. They got her into the house once she came to, they cooled her off and let her sleep for about 45 minutes. Patient said that she felt like she went to sleep and what she remembered next she felt like she was waking up. She said that she slept and nowshe feels fine. Outcome of events was recovered.    Information about Lot/Batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bipolar disorder, Brain oedema, Mania
Clinical narrative: Do you think it caused my brain to swell?; Bipolar manic episode; She had a manic attack after receiving the first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 13:30 (Lot Number: ER8729) at 64-years-old as 1ST DOSE, SINGLE for covid-19 immunisation  .  Medical history included bipolar 1 from 1972 and ongoing , manic attack, had a spat of anorexia. Concomitant medication included diazepam (VALIUM) taken for anxiety and benzodiazepine.  The patient previously took the measles. The patient asked "do you think it caused my brain to swell", The patient experienced bipolar manic episode, she had a manic attack after receiving the first dose of the vaccine on 25Apr2021. No treatment for the events. The outcome of events was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Hypoaesthesia
Clinical narrative: numbness on his left leg and one time with left arm/His left leg went numb seven or eight times; could not walk; This is a spontaneous report from a contactable consumer (the patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0164, expiry date Aug2021), via an unspecified route of administration on 13Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and allergic to bees. The patient had an EpiPen. He would have to use it if he ever got stung. He has never had to use an EpiPen. Concomitant medications included: hydrochlorothiazide/ lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) taken for hypertension, for maybe 8 years. The patient had other unspecified concomitant medications. After receiving the Pfizer COVID vaccine, the patient experienced numbness on his left leg and one time with left arm. His left leg went numb seven or eight times. His left arm went numb one time. He thought maybe it was just going to sleep. He usually slept on his arm, and it woke up that way. But he was walking, and it went numb; it was very strange. There was no pain. It began about two and a half weeks ago (2021). It has happened twice today, so he thinks it is getting worse. It was also lasting longer. Today (unspecified date 2021), his left leg went numb so much that he could not walk. He was walking, and he had to stop and stand there for 10 minutes before the feeling came back. It was very strange. His leg numbness was the most serious today. After this last episode of leg numbness, he called his insurance company, and made an appointment with his medical provider on Monday. He was reluctant to take the second dose of the COVID vaccine. The patient stated he occasionally took vitamin D, fish oil, vitamin C, and aspirin. The outcome of the event could not walk was unknown. The outcome of the other event was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anything; mouth was very dry; achy body and lower back/felt aches and pains; achy body and lower back; went through was some kind of flu; it was hard to sleep at first; kids are watching over her, clean up stuff and doing laundry and all that; Arm hurt; discomfort; feet hurt; she could not walk; felt weak/she could not push herself up, her arm and legs would not push her up; more off balance/balance got worse; could not almost stand up; terrible stomach pains at went up and down her stomach; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Apr2021 (lot number: ER8731), as 1st dose, single dose, at age 76 years old, for COVID-19 immunisation, at a pharmacy/drug store. The patient medical history and concomitant medications were not reported. Historical vaccine included a flu shot for immunization and experienced hives after. In the evening of 29Apr2021, when the patient was about to go to bed, she experienced terrible stomach pains at went up and down her stomach. She almost called the ambulance. For the next 14 days (dates unspecified), she was very exhausted, was sleeping a lot/sleeping all the time causing the bottom of her neck area to ache, she was not able to eat anything for 2 days (I would just have 'brock' and cheese and crackers something easy), her mouth was very dry she had to keep hydrating, had an achy body and lower back, felt aches and pains, her feet hurt she could not walk, felt weak which made her more off balance/balance got worse (pending clarification) causing her to use a walker just to be careful. The patient stated that what she went through was some kind of flu which knocked her out, she was sleeping all the time and mentioned that it was hard to sleep at first. At one time (unknown date), as she woke up from her nap, she could not push herself up, her arm and legs would not push her up and had to be assisted by her grandson. The patient could not almost stand up. The patient reported that her kids are watching over her, clean up stuff and doing laundry and all that. The patient also experienced discomfort and her arm hurt on an unspecified date. On 13May2021, she had her first real small meal. She stated that she avoided taking medications until she gave in and took Tylenol for "bottom neck area to ache", "achy body and lower back/felt aches and pains", "feet hurt", "arm hurt", and discomfort. She stated, "I was very happy after getting the shot, I felt very good but after some days I felt like I was going to die here, should I call the ambulance, what going on with my stomach, and that's was shocking for me." The patient asked if what she experienced was normal and if she should get the second dose. The patient was recovering from the events (reported as "she was coming out of it").  Follow-up attempts are needed. Further information is expected.