chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye haemorrhage, Headache, Hypersensitivity, Rhinorrhoea
Clinical narrative: pain at the injection site; the area turned red.; experiencing allergies; running nose; sneezing; a stuffy nose; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Ten minutes after vaccination on 30Mar2021, the patient experienced pain at the injection site, the area turned red. On the same day, 30Mar2021, she was also experiencing allergies, running nose, sneezing, and a stuffy nose, and they were still continuing today. Patient wanted to know what she can do about her side effects. Outcome of the events pain at the injection site, the area turned red was unknown. Outcome of the other events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Nasal congestion, Rhinorrhoea, Sneezing, Vaccination site erythema
Clinical narrative: pain at the injection site; the area turned red.; experiencing allergies; running nose; sneezing; a stuffy nose; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Ten minutes after vaccination on 30Mar2021, the patient experienced pain at the injection site, the area turned red. On the same day, 30Mar2021, she was also experiencing allergies, running nose, sneezing, and a stuffy nose, and they were still continuing today. Patient wanted to know what she can do about her side effects. Outcome of the events pain at the injection site, the area turned red was unknown. Outcome of the other events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; the area turned red.; experiencing allergies; running nose; sneezing; a stuffy nose; This is a spontaneous report from a Pfizer-sponsored program, via a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Ten minutes after vaccination on 30Mar2021, the patient experienced pain at the injection site, the area turned red. On the same day, 30Mar2021, she was also experiencing allergies, running nose, sneezing, and a stuffy nose, and they were still continuing today. Patient wanted to know what she can do about her side effects. Outcome of the events pain at the injection site, the area turned red was unknown. Outcome of the other events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Following 3 days after my second dose on Wednesday April 14th, "I" discovered hives in between "my" toes, on the arches of each foot, and along the outer sides of each foot as well.; "My" toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy.; "My" toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy.; "My" toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: WN6203) via an unspecified route of administration in the right arm on 14Apr2021 at 08:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, following 3 days after the second dose, the patient discovered hives in between her toes, on the arches of each foot and along the outer sides of each foot as well. The toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy. The patient reported that she discovered the events at around 23:00 on Saturday April 17th. Therapeutic measures were taken as a result of the reported events and included treatment with topical diphenhydramine hydrochloride (BENADRYL) and unspecified allergy pill. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives in between the toes, on the arches of each foot and along the outer sides of each foot, toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Skin discolouration, Swelling, Urticaria
Clinical narrative: Following 3 days after my second dose on Wednesday April 14th, "I" discovered hives in between "my" toes, on the arches of each foot, and along the outer sides of each foot as well.; "My" toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy.; "My" toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy.; "My" toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy.; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: WN6203) via an unspecified route of administration in the right arm on 14Apr2021 at 08:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 24Mar2021 at 09:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 23:00, following 3 days after the second dose, the patient discovered hives in between her toes, on the arches of each foot and along the outer sides of each foot as well. The toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy. The patient reported that she discovered the events at around 23:00 on Saturday April 17th. Therapeutic measures were taken as a result of the reported events and included treatment with topical diphenhydramine hydrochloride (BENADRYL) and unspecified allergy pill. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives in between the toes, on the arches of each foot and along the outer sides of each foot, toes and the areas around the hives were slightly purple in color and puffy and they were a little bit itchy was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Intermittent numbness and tingling in lips; Intermittent numbness and tingling in lips; Red itchy rash under left eye.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 13Apr2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and known allergy to crab. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone (NORLYDA) taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced intermittent numbness and tingling in lips and red itchy rash under left eye. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intermittent numbness and tingling in lips and red itchy rash under left eye were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Rash erythematous
Clinical narrative: Intermittent numbness and tingling in lips; Intermittent numbness and tingling in lips; Red itchy rash under left eye.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 13Apr2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and known allergy to crab. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone (NORLYDA) taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced intermittent numbness and tingling in lips and red itchy rash under left eye. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intermittent numbness and tingling in lips and red itchy rash under left eye were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Flushing, Skin warm
Clinical narrative: Face flushed and was bright red and extremely warm to the touch; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, high cholesterol and seasonal allergy (for which the patient took injections every 2 to 3 weeks). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), drospirenone (SLYND), rosuvastatin calcium (CRESTOR) and daily vitamin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 17Apr2021, at 15:30 the patient's face flushed and was bright red and extremely warm to the touch. This happened about 20 to 25 minutes after the vaccine and lasted not more than 30 minutes total. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event face flushed and was bright red and extremely warm to the touch was on 17Apr2021 at 16:00, after a duration of 30 minutes.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing
Clinical narrative: Face flushed and was bright red and extremely warm to the touch; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, high cholesterol and seasonal allergy (for which the patient took injections every 2 to 3 weeks). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), drospirenone (SLYND), rosuvastatin calcium (CRESTOR) and daily vitamin (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 17Apr2021, at 15:30 the patient's face flushed and was bright red and extremely warm to the touch. This happened about 20 to 25 minutes after the vaccine and lasted not more than 30 minutes total. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event face flushed and was bright red and extremely warm to the touch was on 17Apr2021 at 16:00, after a duration of 30 minutes.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Pain in extremity, X-ray limb normal
Clinical narrative: left foot right now is swollen bad, he can hardly walk on it; left foot hurts it is throbbing and swollen and sore; left foot hurts it is throbbing and swollen and sore; the bottom of his left foot was itching; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727, expiration date were not reported) via an unspecified route of administration on 24Mar2021 at 13:30 (at the age of 63-years-old) as dose 2, single for covid-19 immunization. Medical history included ongoing Fatty liver disease and Type II Diabetes, Surgery remove left colon from 2014 to unknown date. The patient's concomitant medications were not reported. On 25Mar2021, patient experienced left foot right now is swollen bad, he can hardly walk on it, left foot hurts it is throbbing and swollen and sore, the bottom of his left foot was itching. On an unspecified date patient underwent lab tests and procedures which included x-ray unknown result. Patient took treatment for the events. Therapeutic measures were taken as a result of left foot right now is swollen bad, he can hardly walk on it (swelling). It was reported that patient went to the doctor and doctor told the patient had left foot right now is swollen bad, he can hardly walk on it, hyperactive nerves and muscles, the doctor put him on steroids. The outcome of events left foot right now is swollen bad, he can hardly walk on it and the bottom of his left foot was itching was not recovered rest all events was unknown.  No follow-up attempts are possible; no further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pruritus, Swelling, X-ray
Clinical narrative: left foot right now is swollen bad, he can hardly walk on it; left foot hurts it is throbbing and swollen and sore; left foot hurts it is throbbing and swollen and sore; the bottom of his left foot was itching; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727, expiration date were not reported) via an unspecified route of administration on 24Mar2021 at 13:30 (at the age of 63-years-old) as dose 2, single for covid-19 immunization. Medical history included ongoing Fatty liver disease and Type II Diabetes, Surgery remove left colon from 2014 to unknown date. The patient's concomitant medications were not reported. On 25Mar2021, patient experienced left foot right now is swollen bad, he can hardly walk on it, left foot hurts it is throbbing and swollen and sore, the bottom of his left foot was itching. On an unspecified date patient underwent lab tests and procedures which included x-ray unknown result. Patient took treatment for the events. Therapeutic measures were taken as a result of left foot right now is swollen bad, he can hardly walk on it (swelling). It was reported that patient went to the doctor and doctor told the patient had left foot right now is swollen bad, he can hardly walk on it, hyperactive nerves and muscles, the doctor put him on steroids. The outcome of events left foot right now is swollen bad, he can hardly walk on it and the bottom of his left foot was itching was not recovered rest all events was unknown.  No follow-up attempts are possible; no further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Colonoscopy normal, Constipation, Free prostate-specific antigen, Irritable bowel syndrome
Clinical narrative: lot of rumbling and cramps in lower GI tract and loose bowel movements; loose bowel movements; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202, expiry date 30Jun2021), via an unspecified route of administration, administered in arm on 01Mar2021 14.00 (at the age of 68-years) as DOSE 1, SINGLE for covid-19 immunization. No relevant medical history and concomitant medications were not reported. The patient stated that she got both of the pfizer covid vaccines, her first dose was on 01Mar2021. The patient experienced a lot of rumbling and cramps in lower GI tract and loose bowel movements. Caller stated the symptoms started after the first dose and had continued for the last 2.5 weeks and continuing now. Caller wanted to know was these reported side effects and how long will they last and to make a report of these symptoms. Caller stated the patient already reported to facility. The patient will be 69 this year. The second dose of pfizer covid vaccines received on 22Mar2021, lot ER2613, expiration 31Jul2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit emergency room and in physician's office not yet, but the patient thinks she will go to a walk-in clinic tomorrow. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any relevant tests. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Rectal examination normal
Clinical narrative: lot of rumbling and cramps in lower GI tract and loose bowel movements; loose bowel movements; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202, expiry date 30Jun2021), via an unspecified route of administration, administered in arm on 01Mar2021 14.00 (at the age of 68-years) as DOSE 1, SINGLE for covid-19 immunization. No relevant medical history and concomitant medications were not reported. The patient stated that she got both of the pfizer covid vaccines, her first dose was on 01Mar2021. The patient experienced a lot of rumbling and cramps in lower GI tract and loose bowel movements. Caller stated the symptoms started after the first dose and had continued for the last 2.5 weeks and continuing now. Caller wanted to know was these reported side effects and how long will they last and to make a report of these symptoms. Caller stated the patient already reported to facility. The patient will be 69 this year. The second dose of pfizer covid vaccines received on 22Mar2021, lot ER2613, expiration 31Jul2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit emergency room and in physician's office not yet, but the patient thinks she will go to a walk-in clinic tomorrow. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any relevant tests. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Gastrointestinal pain
Clinical narrative: lot of rumbling and cramps in lower GI tract and loose bowel movements; loose bowel movements; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202, expiry date 30Jun2021), via an unspecified route of administration, administered in arm on 01Mar2021 14.00 (at the age of 68-years) as DOSE 1, SINGLE for covid-19 immunization. No relevant medical history and concomitant medications were not reported. The patient stated that she got both of the pfizer covid vaccines, her first dose was on 01Mar2021. The patient experienced a lot of rumbling and cramps in lower GI tract and loose bowel movements. Caller stated the symptoms started after the first dose and had continued for the last 2.5 weeks and continuing now. Caller wanted to know was these reported side effects and how long will they last and to make a report of these symptoms. Caller stated the patient already reported to facility. The patient will be 69 this year. The second dose of pfizer covid vaccines received on 22Mar2021, lot ER2613, expiration 31Jul2021. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit emergency room and in physician's office not yet, but the patient thinks she will go to a walk-in clinic tomorrow. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any relevant tests. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: body aches; low grade fever; chills/shivering; headache; lymph nodes were swelling in underarm where I had the shot.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8734), via an unspecified route of administration, administered in Arm left on 10Apr2021 12:45 PM (at the age of 55-year-old) as single dose for covid-19 immunization. Medical history included known allergies to hornets, yellow jackets, mold, yeast, hops, chocolate, kiwi fruit, ragweed. The patient had no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included phenylephrine, methscopolamine bromide (Methscscop/Phenylep 2.5/20); Multi-Vitamin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7534), via an unspecified route of administration, administered in Arm left on 20Mar2021 12:45 PM (at the age of 55-year-old) as single dose for covid-19 immunization. The patient also took sulfa antibiotics before and had allergy. On 10Apr2021 23.45, about 12 hours after shot the patient had body aches, low grade fever, chills/shivering, headache. About 2 days after the shot (Apr2021) the patient noticed lymph nodes were swelling in underarm where he had the shot. The patient did not receive any treatment for AE. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Chills, Dyspnoea, Fatigue, Movement disorder
Clinical narrative: severe body aches/pains; Next morning temp 101; fatigued; shivering uncontrollably; couldn't feel or move feet or legs; couldn't feel or move feet or legs; difficulty breathing; couldn't speak but aware; Up about 1 hour later, somewhat confused; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number: EP7533) via an unspecified route of administration on 02Apr2021 at 09:00 (at the age of 60-years-old) in left arm as dose 1, single for covid-19 immunization in hospital. Medical history included hypertension, asthma, gastroesophageal reflux disease, blood cholesterol increased, slight allergy to shellfish all from an unknown date and unknown if ongoing, diverticulum and intestinal resection from 2005 to an unknown date, patient had covid-19 for 4 weeks from Oct2020 to Nov2020 and experienced 2 weeks of 101 fever and pneumonia. The patient did not receive any other vaccine in four weeks. Concomitant medications received in two weeks included valsartan (VALSARTAN); omeprazole (OMEPRAZOLE); meclozine hydrochloride (BONINE) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all taken for an unspecified indication, start and stop date were not reported. It was reported that on 02Apr2021, the patient went to bed on 10:30, awoke at 11:30 and he couldn't feel or move feet or legs, shivering uncontrollably, difficulty breathing, couldn't speak but aware. Wife to BR, light on and looked over, he tried to say help me, but she thought he was just dry so tried water. He got up, drank water, and went back to bed. He was up about 1 hour later, somewhat confused. He saw his son in hall and drank 1 and half of Gatorades, fell asleep. Next morning on 03Apr2021, temp was 101, severe body aches, pains and fatigued. Post vaccination, the patient had not been tested for covid-19. The patient underwent lab tests and procedures which included body temperature: 101 on 03Apr2021. The patient did not receive any treatment. The outcome of all the events was resolved with lasting effects in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: severe body aches/pains; Next morning temp 101; fatigued; shivering uncontrollably; couldn't feel or move feet or legs; couldn't feel or move feet or legs; difficulty breathing; couldn't speak but aware; Up about 1 hour later, somewhat confused; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number: EP7533) via an unspecified route of administration on 02Apr2021 at 09:00 (at the age of 60-years-old) in left arm as dose 1, single for covid-19 immunization in hospital. Medical history included hypertension, asthma, gastroesophageal reflux disease, blood cholesterol increased, slight allergy to shellfish all from an unknown date and unknown if ongoing, diverticulum and intestinal resection from 2005 to an unknown date, patient had covid-19 for 4 weeks from Oct2020 to Nov2020 and experienced 2 weeks of 101 fever and pneumonia. The patient did not receive any other vaccine in four weeks. Concomitant medications received in two weeks included valsartan (VALSARTAN); omeprazole (OMEPRAZOLE); meclozine hydrochloride (BONINE) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all taken for an unspecified indication, start and stop date were not reported. It was reported that on 02Apr2021, the patient went to bed on 10:30, awoke at 11:30 and he couldn't feel or move feet or legs, shivering uncontrollably, difficulty breathing, couldn't speak but aware. Wife to BR, light on and looked over, he tried to say help me, but she thought he was just dry so tried water. He got up, drank water, and went back to bed. He was up about 1 hour later, somewhat confused. He saw his son in hall and drank 1 and half of Gatorades, fell asleep. Next morning on 03Apr2021, temp was 101, severe body aches, pains and fatigued. Post vaccination, the patient had not been tested for covid-19. The patient underwent lab tests and procedures which included body temperature: 101 on 03Apr2021. The patient did not receive any treatment. The outcome of all the events was resolved with lasting effects in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Confusional state, Dyspnoea, Fatigue
Clinical narrative: severe body aches/pains; Next morning temp 101; fatigued; shivering uncontrollably; couldn't feel or move feet or legs; couldn't feel or move feet or legs; difficulty breathing; couldn't speak but aware; Up about 1 hour later, somewhat confused; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number: EP7533) via an unspecified route of administration on 02Apr2021 at 09:00 (at the age of 60-years-old) in left arm as dose 1, single for covid-19 immunization in hospital. Medical history included hypertension, asthma, gastroesophageal reflux disease, blood cholesterol increased, slight allergy to shellfish all from an unknown date and unknown if ongoing, diverticulum and intestinal resection from 2005 to an unknown date, patient had covid-19 for 4 weeks from Oct2020 to Nov2020 and experienced 2 weeks of 101 fever and pneumonia. The patient did not receive any other vaccine in four weeks. Concomitant medications received in two weeks included valsartan (VALSARTAN); omeprazole (OMEPRAZOLE); meclozine hydrochloride (BONINE) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all taken for an unspecified indication, start and stop date were not reported. It was reported that on 02Apr2021, the patient went to bed on 10:30, awoke at 11:30 and he couldn't feel or move feet or legs, shivering uncontrollably, difficulty breathing, couldn't speak but aware. Wife to BR, light on and looked over, he tried to say help me, but she thought he was just dry so tried water. He got up, drank water, and went back to bed. He was up about 1 hour later, somewhat confused. He saw his son in hall and drank 1 and half of Gatorades, fell asleep. Next morning on 03Apr2021, temp was 101, severe body aches, pains and fatigued. Post vaccination, the patient had not been tested for covid-19. The patient underwent lab tests and procedures which included body temperature: 101 on 03Apr2021. The patient did not receive any treatment. The outcome of all the events was resolved with lasting effects in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Movement disorder, Pain, Pyrexia, Speech disorder
Clinical narrative: severe body aches/pains; Next morning temp 101; fatigued; shivering uncontrollably; couldn't feel or move feet or legs; couldn't feel or move feet or legs; difficulty breathing; couldn't speak but aware; Up about 1 hour later, somewhat confused; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number: EP7533) via an unspecified route of administration on 02Apr2021 at 09:00 (at the age of 60-years-old) in left arm as dose 1, single for covid-19 immunization in hospital. Medical history included hypertension, asthma, gastroesophageal reflux disease, blood cholesterol increased, slight allergy to shellfish all from an unknown date and unknown if ongoing, diverticulum and intestinal resection from 2005 to an unknown date, patient had covid-19 for 4 weeks from Oct2020 to Nov2020 and experienced 2 weeks of 101 fever and pneumonia. The patient did not receive any other vaccine in four weeks. Concomitant medications received in two weeks included valsartan (VALSARTAN); omeprazole (OMEPRAZOLE); meclozine hydrochloride (BONINE) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) all taken for an unspecified indication, start and stop date were not reported. It was reported that on 02Apr2021, the patient went to bed on 10:30, awoke at 11:30 and he couldn't feel or move feet or legs, shivering uncontrollably, difficulty breathing, couldn't speak but aware. Wife to BR, light on and looked over, he tried to say help me, but she thought he was just dry so tried water. He got up, drank water, and went back to bed. He was up about 1 hour later, somewhat confused. He saw his son in hall and drank 1 and half of Gatorades, fell asleep. Next morning on 03Apr2021, temp was 101, severe body aches, pains and fatigued. Post vaccination, the patient had not been tested for covid-19. The patient underwent lab tests and procedures which included body temperature: 101 on 03Apr2021. The patient did not receive any treatment. The outcome of all the events was resolved with lasting effects in Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: SEVERELY SWOLLEN EYES; HIVES THAT WENT FROM SMALL TO MODERATE AT FIRST TO THE SIZE OF HALF DOLLARS EVERY DAY BETWEEN 4 TO 5 PM; EXTREME ALLERGIC REACTION TO COVID 19 VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced extreme allergic reaction to covid 19 vaccine. On an unspecified date, the patient experienced severely swollen eyes, and hives that went from small to moderate at first to the size of half dollars every day between 4 to 5 pm. Laboratory data (dates unspecified) included: Allergy test (NR: not provided) only reaction to limonene and bees wax (units unspecified). Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme allergic reaction to covid 19 vaccine on JUL-2021, and the outcome of severely swollen eyes and hives that went from small to moderate at first to the size of half dollars every day between 4 to 5 pm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Eye swelling, Hypersensitivity, Urticaria
Clinical narrative: SEVERELY SWOLLEN EYES; HIVES THAT WENT FROM SMALL TO MODERATE AT FIRST TO THE SIZE OF HALF DOLLARS EVERY DAY BETWEEN 4 TO 5 PM; EXTREME ALLERGIC REACTION TO COVID 19 VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced extreme allergic reaction to covid 19 vaccine. On an unspecified date, the patient experienced severely swollen eyes, and hives that went from small to moderate at first to the size of half dollars every day between 4 to 5 pm. Laboratory data (dates unspecified) included: Allergy test (NR: not provided) only reaction to limonene and bees wax (units unspecified). Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme allergic reaction to covid 19 vaccine on JUL-2021, and the outcome of severely swollen eyes and hives that went from small to moderate at first to the size of half dollars every day between 4 to 5 pm was not reported. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Swelling
Clinical narrative: During my second dose of Pfizer, about an hour after I received the vaccine I had swelling in my face. I then developed a rash on my face and arms. It lasted until I was treated by the ER.; During my second dose of Pfizer, about an hour after I received the vaccine I had swelling in my face. I then developed a rash on my face and arms. It lasted until I was treated by the ER.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0165 and expiry date was not reported), via an unspecified route of administration, in right arm on 01Apr2021 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included Allergies: Amoxicillin. Concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8727 and expiry date was not reported), via an unspecified route of administration, in right arm on 01Apr2021 05:00 PM, as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. patient doent had COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient received other unspecified medications in two weeks. During her second dose of Pfizer, about an hour after she received the vaccine she had swelling in her face and then developed a rash on her face and arms on 22Apr2021 05:30 PM. It lasted until she was treated by the emergency room (ER). The AE resulted in Emergency room/department or urgent care. The patient received treatment with Benadryl, Pepcid, Steroid. Outcome of the events were recovering.  No follow-up attempts are required. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: During my second dose of Pfizer, about an hour after I received the vaccine I had swelling in my face. I then developed a rash on my face and arms. It lasted until I was treated by the ER.; During my second dose of Pfizer, about an hour after I received the vaccine I had swelling in my face. I then developed a rash on my face and arms. It lasted until I was treated by the ER.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0165 and expiry date was not reported), via an unspecified route of administration, in right arm on 01Apr2021 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included Allergies: Amoxicillin. Concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8727 and expiry date was not reported), via an unspecified route of administration, in right arm on 01Apr2021 05:00 PM, as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. patient doent had COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient received other unspecified medications in two weeks. During her second dose of Pfizer, about an hour after she received the vaccine she had swelling in her face and then developed a rash on her face and arms on 22Apr2021 05:30 PM. It lasted until she was treated by the emergency room (ER). The AE resulted in Emergency room/department or urgent care. The patient received treatment with Benadryl, Pepcid, Steroid. Outcome of the events were recovering.  No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Vomited; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program. A female patient of (Age: 79 Unit: unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had her last dose on last 10Feb the second one and now she is reporting that she is having an adverse reaction(vomiting)last 14Feb2021 and 19Feb2021. And she is asking if it is because of Covid-19 vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Arthralgia, Chills, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: fatigue/tired; arm pain; chills; fever; malaise; body aches in joints; not feeling well; aches and pains in the joints and knees; difficult to walk; This is a spontaneous report from a contactable consumer (patient) reporting for self. A 65-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955) via an unspecified route of administration administered in left arm on 26Mar2021 05:00 as DOSE 2, SINGLE for covid-19 immunization. Medical history reported as patient had an autoimmune disease 7-8 years ago. It went away in 1-2 years, arthritis, polymyalgia rheumatica, gets prednisone shots in knees, that helps with inflammation because PMR would turn the body on it's joints. surgeries in knee Lifetime abuse on both knees, inflammatory disease of joints and all were managed from an unknown date and unknown if ongoing. Patient had done athletics, multiple sport injuries, surgeries, and osteoarthritis in both his knees. On the first shot it made his knees react badly too, like getting inflammation all over the body and patient theory was that if have a weakness in a joint, it was going to it and exacerbating it. Patient walked with a limp. The patient's concomitant medications were not reported. Historical vaccines included BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Mar021 as DOSE 1, SINGLE for COVID-19 immunization and experienced achy creaky uncomfortable knees, sore arm and fatigue. The patient experienced fatigue/tired, huge arm pain, chills, fever, malaise, body aches in joints, not feeling well, aches and pains in the joints and knees, difficult to walk walking with a limp all on an unspecified date in Mar2021; 18 hours later after receiving the vaccine. These continued for saturday and sunday. By monday, those other symptoms started to dissipate except his joints and knee's continued to ache and it was difficult to walk. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.