chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Rash papular
Clinical narrative: 3 days after the vaccine I woke up with a hives-like rash.; This consists of raised red bumps, ranging is size from about 1 cm to 1/4 cm in diameter. They are specifically concentrated over both my knee caps and both my elbows. From each of these concentrated locations, they continue up and down the limb; This consists of raised red bumps, ranging is size from about 1 cm to 1/4 cm in diameter. They are specifically concentrated over both my knee caps and both my elbows. From each of these concentrated locations, they continue up and down the limb; I also have redness around the edge of my ears.; All bumps are itchy when touched, but not unbearable otherwise; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 08:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient previously has had a photosensitivity allergic reaction (reported as sun allergy). Concomitant medications taken within two weeks prior to vaccination included Birth control (unspecified), paracetamol (manufacturer: TYLENOL), ibuprofen (manufacturer: ADVIL) and amoxicillin (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. Prior to the 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 four weeks prior to the vaccination. On 10Apr2021 at 04:00, three days after the vaccine, the patient woke up with a hives-like rash. This consisted of raised red bumps, ranging in size from about 1 centimeter to 1/4 centimeter in diameter. They were specifically concentrated over both her knee caps and both her elbows. From each of these concentrated locations, they continued up and down the limb. The patient also had redness around the edge of her ears. All bumps were itchy when touched, but not unbearable otherwise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events three days after the vaccine, the patient woke up with a hives-like rash that consisted of raised red bumps, ranging in size from about 1 cm to 1/4 cm in diameter and were specifically concentrated over both her knee caps and both her elbows; from each of these concentrated locations, they continued up and down the limb and redness around the edge of her ears, all bumps were itchy when touched, but not unbearable otherwise was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Weakness in arms and legs. Couldn't get up; Somewhat disoriented.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient 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 08Apr2021 at 00:00 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included testicular cancer since 2016, hypertension, arthritis COVID-19 and two mini strokes. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced weakness in arms and legs, couldn't get up and somewhat disoriented. Lasted a few hours. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events weakness in arms and legs, couldn't get up and somewhat disoriented were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Muscular weakness
Clinical narrative: Weakness in arms and legs. Couldn't get up; Somewhat disoriented.; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient 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 08Apr2021 at 00:00 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included testicular cancer since 2016, hypertension, arthritis COVID-19 and two mini strokes. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced weakness in arms and legs, couldn't get up and somewhat disoriented. Lasted a few hours. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events weakness in arms and legs, couldn't get up and somewhat disoriented were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Hypersensitivity, Periorbital swelling
Clinical narrative: Worse migraines; Vertigo (altered proprioception); Periorbital swelling; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 29Apr2021 at 09:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. Concomitant medications included ethinylestradiol, levonorgestrel (LO/OVRAL), ibuprofen (MOTRIN) and paracetamol (TYLENOL); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. Prior to the 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. On 07May2021 at 04:00, 8 days post dose, the patient woke up with periorbital swelling, it was stated that lasted 3-4 days. On 10May2021 (On days 11 and 13 post-dose) the patient experienced worse migraines ever accompanied by vertigo (altered proprioception). Therapeutic measures were taken as a result of periorbital swelling and included treatment with Benadryl and Zyrtec. The events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events periorbital swelling, worse migraines and vertigo (altered proprioception) was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Periorbital swelling, Vertigo
Clinical narrative: Worse migraines; Vertigo (altered proprioception); Periorbital swelling; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the arm left on 29Apr2021 at 09:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. Concomitant medications included ethinylestradiol, levonorgestrel (LO/OVRAL), ibuprofen (MOTRIN) and paracetamol (TYLENOL); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. Prior to the 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. On 07May2021 at 04:00, 8 days post dose, the patient woke up with periorbital swelling, it was stated that lasted 3-4 days. On 10May2021 (On days 11 and 13 post-dose) the patient experienced worse migraines ever accompanied by vertigo (altered proprioception). Therapeutic measures were taken as a result of periorbital swelling and included treatment with Benadryl and Zyrtec. The events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events periorbital swelling, worse migraines and vertigo (altered proprioception) was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Felt trouble breathing/ hard to breathe; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0186) via an unspecified route of administration in the left arm on 12May2021 at 10:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mango (fruit allergy) and allergy to carbs (seafood allergy). It was unknown if the patient was pregnant at the time of reporting. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the left arm on 21Apr2021 at 9:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the COVID-19 vaccination. On 13May2021 at 14:00, after the second shot of Pfizer vaccine the patient felt trouble breathing, hard to breathe. When she stayed "chill" she felt little better, but still needed a hard hold of longer breathe, when she had a talk, she would have to breathe more to feel better. 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 the event. The clinical outcome of the event felt trouble breathing/ hard to breathe was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Breast swelling, Submaxillary gland enlargement
Clinical narrative: Swelling in underarms; Discomfort in underarms; Swollen breast on side of injection; typical fever/chills; typical fever/chills; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 11May2021 at 13:45(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included raynaud's disease and allergy to lemon peels. The patient did not receive any medications within two weeks of vaccination. The patient previously took ciprofloxacin(CIPRO) on an unknown date  and experienced allergy. Prior to the 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 four weeks prior to the vaccination. On 13May2021, the patient experienced swollen breast on side of injection, typical fever, chills, swelling and discomfort in underarms. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling in underarms, discomfort in underarms, swollen breast on side of injection, typical fever and chills were not recovered at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast swelling, Chills, Discomfort, Lymphadenopathy, Pyrexia
Clinical narrative: Swelling in underarms; Discomfort in underarms; Swollen breast on side of injection; typical fever/chills; typical fever/chills; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 11May2021 at 13:45(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included raynaud's disease and allergy to lemon peels. The patient did not receive any medications within two weeks of vaccination. The patient previously took ciprofloxacin(CIPRO) on an unknown date  and experienced allergy. Prior to the 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 four weeks prior to the vaccination. On 13May2021, the patient experienced swollen breast on side of injection, typical fever, chills, swelling and discomfort in underarms. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling in underarms, discomfort in underarms, swollen breast on side of injection, typical fever and chills were not recovered at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Hypoaesthesia oral
Clinical narrative: Allergic reaction; Wheezing; My taste is off; fatigue; red bump where injection was given; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0183), via an unspecified route of administration, administered in left arm, on 15May2021 at 11:30 (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0151) via unspecified route of administration, administered in left arm, on 02Apr2021 at 11:00 AM (at the age of 60 years old) as dose 1, single for COVID-19 immunization, wherein the patient experienced funny metal taste, top/Bottom Lips became Numb, tongue became numb and the patient couldn't swallow, and the patient spent 6 hours in the emergency room (ER) with 2 shots plus 1 bag of IV. The patient saw an allergist consulting allergy testing to determine if the patient could receive the 2nd dosage due to the previous allergic reaction to the vaccine. On 15May2021 at 11:30, it was reported that the patient experienced the same reaction as the first allergic reaction but worse (medically significant); the patient was taken to the ER for 5 hours. The event required visit to the ER and physician's office. The allergy department did allergy testing two weeks prior to the second vaccine on 15May2021, wherein the allergist cleared the patient to receive 2nd Pfizer dosage. The patient had allergic reaction to testing and received 3 treatments, 2 shots for testing. It was also reported that the patient still has a red bump where the injection was given, still feel fatigue, wheezing and the patient's taste was off. The outcome of the event wheezing was unknown, while for the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Allergy test, Fatigue, Hypersensitivity, Vaccination site erythema
Clinical narrative: Allergic reaction; Wheezing; My taste is off; fatigue; red bump where injection was given; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0183), via an unspecified route of administration, administered in left arm, on 15May2021 at 11:30 (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0151) via unspecified route of administration, administered in left arm, on 02Apr2021 at 11:00 AM (at the age of 60 years old) as dose 1, single for COVID-19 immunization, wherein the patient experienced funny metal taste, top/Bottom Lips became Numb, tongue became numb and the patient couldn't swallow, and the patient spent 6 hours in the emergency room (ER) with 2 shots plus 1 bag of IV. The patient saw an allergist consulting allergy testing to determine if the patient could receive the 2nd dosage due to the previous allergic reaction to the vaccine. On 15May2021 at 11:30, it was reported that the patient experienced the same reaction as the first allergic reaction but worse (medically significant); the patient was taken to the ER for 5 hours. The event required visit to the ER and physician's office. The allergy department did allergy testing two weeks prior to the second vaccine on 15May2021, wherein the allergist cleared the patient to receive 2nd Pfizer dosage. The patient had allergic reaction to testing and received 3 treatments, 2 shots for testing. It was also reported that the patient still has a red bump where the injection was given, still feel fatigue, wheezing and the patient's taste was off. The outcome of the event wheezing was unknown, while for the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Allergic reaction; Wheezing; My taste is off; fatigue; red bump where injection was given; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0183), via an unspecified route of administration, administered in left arm, on 15May2021 at 11:30 (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0151) via unspecified route of administration, administered in left arm, on 02Apr2021 at 11:00 AM (at the age of 60 years old) as dose 1, single for COVID-19 immunization, wherein the patient experienced funny metal taste, top/Bottom Lips became Numb, tongue became numb and the patient couldn't swallow, and the patient spent 6 hours in the emergency room (ER) with 2 shots plus 1 bag of IV. The patient saw an allergist consulting allergy testing to determine if the patient could receive the 2nd dosage due to the previous allergic reaction to the vaccine. On 15May2021 at 11:30, it was reported that the patient experienced the same reaction as the first allergic reaction but worse (medically significant); the patient was taken to the ER for 5 hours. The event required visit to the ER and physician's office. The allergy department did allergy testing two weeks prior to the second vaccine on 15May2021, wherein the allergist cleared the patient to receive 2nd Pfizer dosage. The patient had allergic reaction to testing and received 3 treatments, 2 shots for testing. It was also reported that the patient still has a red bump where the injection was given, still feel fatigue, wheezing and the patient's taste was off. The outcome of the event wheezing was unknown, while for the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test, Wheezing
Clinical narrative: Allergic reaction; Wheezing; My taste is off; fatigue; red bump where injection was given; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0183), via an unspecified route of administration, administered in left arm, on 15May2021 at 11:30 (at the age of 60 years old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0151) via unspecified route of administration, administered in left arm, on 02Apr2021 at 11:00 AM (at the age of 60 years old) as dose 1, single for COVID-19 immunization, wherein the patient experienced funny metal taste, top/Bottom Lips became Numb, tongue became numb and the patient couldn't swallow, and the patient spent 6 hours in the emergency room (ER) with 2 shots plus 1 bag of IV. The patient saw an allergist consulting allergy testing to determine if the patient could receive the 2nd dosage due to the previous allergic reaction to the vaccine. On 15May2021 at 11:30, it was reported that the patient experienced the same reaction as the first allergic reaction but worse (medically significant); the patient was taken to the ER for 5 hours. The event required visit to the ER and physician's office. The allergy department did allergy testing two weeks prior to the second vaccine on 15May2021, wherein the allergist cleared the patient to receive 2nd Pfizer dosage. The patient had allergic reaction to testing and received 3 treatments, 2 shots for testing. It was also reported that the patient still has a red bump where the injection was given, still feel fatigue, wheezing and the patient's taste was off. The outcome of the event wheezing was unknown, while for the other events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: thought he was having an allergic reaction after first dose Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number: EW0167) via unspecified route of administration in left arm on 25Apr2021 (at age of 53-years-old) as a dose 1, single for COVID-19 immunization (safety and health reasons). Medical history included heart problems and has had 4 stents. Concomitant Medications included blood pressure pills every day. No additional vaccines administered on same date of suspect. No prior vaccinations within 4 weeks. On 27Apr2021 (2 days after vaccination), patient thought he was having an allergic reaction after first dose Covid 19 vaccine. Reporter seriousness for thought he was having an allergic reaction after first dose Covid 19 vaccine was unspecified. Patient went to the emergency room and did not visited physician office and was not admitted to the hospital. Patient received second dose (Batch/lot number: EW0185) in right arm on 18May2021 and experienced hives. The outcome of event was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: thought he was having an allergic reaction after first dose Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number: EW0167) via unspecified route of administration in left arm on 25Apr2021 (at age of 53-years-old) as a dose 1, single for COVID-19 immunization (safety and health reasons). Medical history included heart problems and has had 4 stents. Concomitant Medications included blood pressure pills every day. No additional vaccines administered on same date of suspect. No prior vaccinations within 4 weeks. On 27Apr2021 (2 days after vaccination), patient thought he was having an allergic reaction after first dose Covid 19 vaccine. Reporter seriousness for thought he was having an allergic reaction after first dose Covid 19 vaccine was unspecified. Patient went to the emergency room and did not visited physician office and was not admitted to the hospital. Patient received second dose (Batch/lot number: EW0185) in right arm on 18May2021 and experienced hives. The outcome of event was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Immediate post-injection reaction, Injection site pain, Lymphadenopathy
Clinical narrative: Day 2, sore arm around injection site; extremely swollen puffy lymph nodes in armpit; Headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 51-years-old female patient received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jun2021 14:00 (Batch/Lot Number: ER8733) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The historical vaccine includes BNT162B2 for COVID-19 immunisation on 14May2021 at 51 years (product=COVID 19, brand=Pfizer, lot number=ER8733,lot unknown=False, administration date=14May2021, administration time=02:00 PM, dose number=1, vaccine location=Left arm). The patient experienced headache on 04Jun2021 14:00, day 2, sore arm around injection site and extremely swollen puffy lymph nodes in armpit on 05Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. No therapeutic treatment was received for events. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: Day 2, sore arm around injection site; extremely swollen puffy lymph nodes in armpit; Headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 51-years-old female patient received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jun2021 14:00 (Batch/Lot Number: ER8733) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The historical vaccine includes BNT162B2 for COVID-19 immunisation on 14May2021 at 51 years (product=COVID 19, brand=Pfizer, lot number=ER8733,lot unknown=False, administration date=14May2021, administration time=02:00 PM, dose number=1, vaccine location=Left arm). The patient experienced headache on 04Jun2021 14:00, day 2, sore arm around injection site and extremely swollen puffy lymph nodes in armpit on 05Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. No therapeutic treatment was received for events. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Day 2, sore arm around injection site; extremely swollen puffy lymph nodes in armpit; Headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 51-years-old female patient received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 04Jun2021 14:00 (Batch/Lot Number: ER8733) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The historical vaccine includes BNT162B2 for COVID-19 immunisation on 14May2021 at 51 years (product=COVID 19, brand=Pfizer, lot number=ER8733,lot unknown=False, administration date=14May2021, administration time=02:00 PM, dose number=1, vaccine location=Left arm). The patient experienced headache on 04Jun2021 14:00, day 2, sore arm around injection site and extremely swollen puffy lymph nodes in armpit on 05Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date. No therapeutic treatment was received for events. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Cough, Gait disturbance, Inflammation
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint swelling, Myalgia, Night sweats, Pain in extremity, Peripheral swelling
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Swelling, Testicular swelling, Ultrasound scan, X-ray
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody negative, Bartonella test negative, Blood culture negative, Bone scan abnormal, C-reactive protein increased
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram abnormal, Computerised tomogram thorax, Cough, Culture urine negative
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Echocardiogram, Electrophoresis protein, Fatigue, Feeling abnormal
Clinical narrative: swelling and tenderness in ankle, groin area, and testicles; swelling and tenderness in ankle, groin area, and testicles; cough; Night Sweats; low grade fever; chills; Inflammation of left calf; severe muscle pain; Pain in calf; swelling of calf; fluid retention in left ankle; Weight bearing is still difficult; swelling and tenderness in ankle, groin area, and testicles; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0176), via an unspecified route of administration, administered in arm right on 26May2021 at 08:45 AM (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing (If COVID prior vaccination: Yes). The patient concomitant medication included celecoxib (OCCASSIONAL CELEBREX) taken for arthritis, start and stop date were not reported. Patient had no allergies. Patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. On 27May2021 at 17:00 (05:00 PM), the patient experienced inflammation of left calf, severe muscle pain, pain in calf, swelling of calf, fluid retention in left ankle, weight bearing is still difficult, swelling and tenderness in ankle, groin area, and testicles, chills; On 28May2021, the patient experienced swelling and tenderness in ankle, groin area, and testicles, cough, night sweats, low grade fever. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Adverse event: Inflammation of left calf: 27May2021 pm began experiencing severe muscle pain and inflammation of left calf on the inside of the leg. Pain in calf, swelling of calf and fluid retention in left ankle has persisted since it began. (now 13 days with no improvement). Weight bearing is still difficult. Using a calf brace. Formerly healthy leg now damaged. Exam by orthopedic provider on 04Jun2021 surmised inflammation in calf not due to injury but a reaction from the vaccine. Other swelling: 28May2021 began experiencing swelling and tenderness in ankle, groin area, and testicles. Experienced persistent slight cough from 28May2021 to present. No sputum or nasal congestion. Night Sweats, chills and fever: Extensive night sweats and low-grade fever 28May2021, 29May2021, 30May2021 ,31May2021. The patient underwent lab tests and procedures which included low grade fever: unknown result on 28May2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  Follow-Up (PRD/SRD 21Jul2021): Follow-up attempts are completed. No further information is expected.