chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Fever 100.5; chills; joint pain; nausea; headache; tachycardia; shortness of breath; dizziness; pain & swelling at injection site and up my neck; pain & swelling at injection site and up my neck; worst patient have ever felt, felt like body had been poisoned; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), via an unspecified route of administration on the left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included heart disease, diabetes and allergies to sulfa antibiotics. Patient's concomitant medications were not reported. The patient received the first dose on 21Dec2020 (lot number: EH9899) on the left arm. The patient experienced fever 100.5, chills, joint pain, nausea, headache, tachycardia, shortness of breath, dizziness, chills, pain & swelling at injection site and up my neck, inability to lift even a water bottle without having pain on 10Jan2021. In summary it was the worst patient have ever felt, felt like body had been poisoned. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy
Clinical narrative: entire body joint pain; axillary lymph node pain; same enlarged supraclavical lymph node; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 5730 and expiry date: unknown), intramuscular on 08Jan2021 11:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. There were no concomitant medications. Patient received the 1st dose on 21Dec2020 13:30 on the left arm. After the initial dose enlarged supraclavical lymph node enlargement on same side as vaccine dose-24 hour later-lasted 17 days after 2nd dose, same enlarged supraclavical lymph node within 2 hours of administration on 08Jan2021, followed by axillary lymph node pain starting at 8 hours (19:30)  after dose, then groin lymph node pain and entire body joint pain at 12 hours (23:30) after 2nd dose, then ILI like symptoms for 36 hours. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: High fevers; chills; sweating; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; This is a spontaneous report from a contactable other hcp (patient).    A 42-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) on 09Jan2021 08:00b for Covid-19 immunisation, administered at hospital.   Medical history included Crohn's disease, allergies to sulfa drugs. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 19Dec2020 14:30 for Covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced high fevers, chills, sweating and extreme knee joint and calf muscle pain on 09Jan2021 20:30. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about Lot/Batch number is requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fevers; chills; sweating; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; Extreme knee joint and calf muscle pain; This is a spontaneous report from a contactable other hcp (patient).    A 42-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) on 09Jan2021 08:00b for Covid-19 immunisation, administered at hospital.   Medical history included Crohn's disease, allergies to sulfa drugs. The patient had not experienced Covid-19 prior vaccination. Patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 19Dec2020 14:30 for Covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced high fevers, chills, sweating and extreme knee joint and calf muscle pain on 09Jan2021 20:30. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.  Information about Lot/Batch number is requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: experience feeling of swelling in the back of her sinuses; This is a spontaneous report from a contactable pharmacist. A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular in the right arm, on 11Jan2021 at 12:00 A.M., at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular in the left arm on 21Dec2020 for COVID-19 immunization. It was unknown if patient is pregnant at the time of vaccination, and if she was tested for COVID prior/after vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient was given the Pfizer vaccination in the right deltoid muscle. On 11Jan2021, at 12:00 P.M., after the injection and during her 15-minute waiting period, the patient began to experience feeling of swelling in the back of her sinuses again. She denied difficulty breathing, difficulty swallowing, throat tightness and facial swelling. The provider was notified of patient reaction and she was then assessed in the emergency bay area. She was monitored for severe reaction symptoms, including but not limited to increased swelling and rapid progression of symptoms. The patient received an unspecified antihistamine as treatment for the event. The patient recovered from the event on an unspecified date.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Sinus disorder
Clinical narrative: felt swelling at the back of her sinus; This is a spontaneous report from a contactable pharmacist. A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) intramuscular on 21Dec2020 at a single dose in the left arm for COVID vaccine. Medical history and concomitant medications were not reported. She had no other vaccine received in four weeks. It was reported that on an unspecified date, the patient felt swelling at the back of her sinus after having her last COVID vaccination. Lab data included prior allergy testing with unknown results on an unspecified date. Treatment for the event was noted as antihistamine. It was unknown if the patient had COVID prior vaccination and also unknown if she had COVID tested post vaccination. The outcome of the event was recovered on an unspecified date.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Feeling abnormal, Headache
Clinical narrative: low grade fever of 99.4; sore joint pain on my knuckles and my wrist; felt kind of off and weak; felt kind of off and weak; Arm was a bit sore for 3 days; mild headache; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 20Dec2020 16:15 at a single dose for covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient is not pregnant. Concomitant medication included fluoxetine taken from an unspecified date for an unspecified indication. On the second day of the vaccine (21Dec2020 10:00), the patient had a low grade fever of 99.4 (no unit reported), had sore joint pain on her knuckles and her wrist, felt kind of off and weak, her arm was a bit sore for 3 days and she also had a mild headache that would come and go. No treatment was received for the reported events. The outcome of the events was recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: low grade fever of 99.4; sore joint pain on my knuckles and my wrist; felt kind of off and weak; felt kind of off and weak; Arm was a bit sore for 3 days; mild headache; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 20Dec2020 16:15 at a single dose for covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient is not pregnant. Concomitant medication included fluoxetine taken from an unspecified date for an unspecified indication. On the second day of the vaccine (21Dec2020 10:00), the patient had a low grade fever of 99.4 (no unit reported), had sore joint pain on her knuckles and her wrist, felt kind of off and weak, her arm was a bit sore for 3 days and she also had a mild headache that would come and go. No treatment was received for the reported events. The outcome of the events was recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Feeling hot, Neck pain, Swelling
Clinical narrative: Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Severe swelling of left upper arm, left anterior chest wall; Severe swelling of left upper arm, left anterior chest wall; Underarm and neck with pain; Underarm and neck with pain; Heat; Redness; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686; Expiration date was not reported) on 08Jan2021 (15:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. On 10Jan2021 (15:00), the patient had severe swelling on the left upper arm and left anterior chest wall; underarm and neck were with pain; was in heat; and had redness. The adverse events resulted in the patient having a visit on the doctor or other healthcare professional office/clinic. The patient had received treatment for the reported adverse events. The outcome of the events, 'severe swelling on the left upper arm and left anterior chest wall', 'underarm and neck were with pain', 'heat' and 'redness', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very strong jaw tightness with lightheadedness/muscles feel so tight; Right away very strong jaw tightness with lightheadedness; the tight jaw with Very tight full deep ache all over body/whole body hurts/feeling more pain; Headache lasting over 59 hours; Very very fatigued/feeling more fatigue; Chills worse at night; her hands feel swollen and cramping but they do not look swollen; her hands feel swollen and cramping but they do not look swollen; On and off lip/face tingling; On and off lip/face tingling; she felt like her lymph nodes were swollen; shaking; This is a spontaneous report from a contactable nurse (reported for herself). This nurse reported information for both mother and baby. This is the maternal report. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ec1284), via an unspecified route of administration on 11Jan2021 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included low vitamin d and patient is currently breastfeeding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc (PRENATAL S), vitamin d [vitamin d nos] (VITAMIN D), and calcium. The patient was administered with first dose of bnt162b2 (Pfizer brand) on 21Dec2020 at 10:00 on her left arm (lot number: EJ1685) for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 10:15, the patient experienced right away, very strong jaw tightness with lightheadedness. The lightheadedness feeling improved 2 hours later, but the tight jaw with very tight full deep ache all over her body. She had headache  lasting over 59 hours. Her whole body hurt. Her muscles felt so tight and she was "very very" fatigued. She had chills (worse at night). She was shaking both nights after 2nd vaccine. Her hands felt swollen and cramping, but they did not look swollen. She also had on and off lip/face tingling. She felt like her lymph nodes were swollen. She can't even do a load of laundry without feeling more pain and fatigue. It was unknown if treatment was given for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious. The patient was not hospitalized due to the events. The patient has not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021038485 baby case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Off label use, Pain, Paraesthesia
Clinical narrative: patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very strong jaw tightness with lightheadedness/muscles feel so tight; Right away very strong jaw tightness with lightheadedness; the tight jaw with Very tight full deep ache all over body/whole body hurts/feeling more pain; Headache lasting over 59 hours; Very very fatigued/feeling more fatigue; Chills worse at night; her hands feel swollen and cramping but they do not look swollen; her hands feel swollen and cramping but they do not look swollen; On and off lip/face tingling; On and off lip/face tingling; she felt like her lymph nodes were swollen; shaking; This is a spontaneous report from a contactable nurse (reported for herself). This nurse reported information for both mother and baby. This is the maternal report. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ec1284), via an unspecified route of administration on 11Jan2021 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included low vitamin d and patient is currently breastfeeding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc (PRENATAL S), vitamin d [vitamin d nos] (VITAMIN D), and calcium. The patient was administered with first dose of bnt162b2 (Pfizer brand) on 21Dec2020 at 10:00 on her left arm (lot number: EJ1685) for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 10:15, the patient experienced right away, very strong jaw tightness with lightheadedness. The lightheadedness feeling improved 2 hours later, but the tight jaw with very tight full deep ache all over her body. She had headache  lasting over 59 hours. Her whole body hurt. Her muscles felt so tight and she was "very very" fatigued. She had chills (worse at night). She was shaking both nights after 2nd vaccine. Her hands felt swollen and cramping, but they did not look swollen. She also had on and off lip/face tingling. She felt like her lymph nodes were swollen. She can't even do a load of laundry without feeling more pain and fatigue. It was unknown if treatment was given for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious. The patient was not hospitalized due to the events. The patient has not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021038485 baby case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Peripheral swelling, Product use issue, Tremor
Clinical narrative: patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very strong jaw tightness with lightheadedness/muscles feel so tight; Right away very strong jaw tightness with lightheadedness; the tight jaw with Very tight full deep ache all over body/whole body hurts/feeling more pain; Headache lasting over 59 hours; Very very fatigued/feeling more fatigue; Chills worse at night; her hands feel swollen and cramping but they do not look swollen; her hands feel swollen and cramping but they do not look swollen; On and off lip/face tingling; On and off lip/face tingling; she felt like her lymph nodes were swollen; shaking; This is a spontaneous report from a contactable nurse (reported for herself). This nurse reported information for both mother and baby. This is the maternal report. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ec1284), via an unspecified route of administration on 11Jan2021 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included low vitamin d and patient is currently breastfeeding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc (PRENATAL S), vitamin d [vitamin d nos] (VITAMIN D), and calcium. The patient was administered with first dose of bnt162b2 (Pfizer brand) on 21Dec2020 at 10:00 on her left arm (lot number: EJ1685) for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 10:15, the patient experienced right away, very strong jaw tightness with lightheadedness. The lightheadedness feeling improved 2 hours later, but the tight jaw with very tight full deep ache all over her body. She had headache  lasting over 59 hours. Her whole body hurt. Her muscles felt so tight and she was "very very" fatigued. She had chills (worse at night). She was shaking both nights after 2nd vaccine. Her hands felt swollen and cramping, but they did not look swollen. She also had on and off lip/face tingling. She felt like her lymph nodes were swollen. She can't even do a load of laundry without feeling more pain and fatigue. It was unknown if treatment was given for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious. The patient was not hospitalized due to the events. The patient has not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021038485 baby case
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Hypersensitivity, Urticaria
Clinical narrative: minor allergic reaction; small hives on her thumb; skin was sensitive; This is a spontaneous report from a contactable consumer reported for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration at the right arm on 12Jan2021 15:15 at single dose for Covid-19 immunization in a hospital. Medical history included hyperthyroidism, allergies to medication, allergies to food. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021 07:30, the patient thought she was having a minor allergic reaction, she had some small hives on her thumb earlier and her skin was sensitive. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment due to the events. The outcome of the events minor allergic reaction, small hives on her thumb, and skin was sensitive was recovering. The reporter considered the events non-serious which did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pruritus, SARS-CoV-2 test
Clinical narrative: Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in right arm, on 21Dec2020 at 19:45, at a single dose, for COVID-19 immunization. The patient's medical history included sciatica. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was a hospital. After the first dose on 21Dec2020 (from the day of injection and for 2 days post), the patient experienced itching, nausea, headache, body ache, and site soreness and swelling. Treatment was received for the adverse events which included paracetamol (TYLENOL) at 500 mg. Since the vaccination, the patient has been tested for COVID-19. Polymerase chain reaction (PCR) nasal swab for COVID-19 that was negative on 04Jan2021. The patient recovered from the events in Dec2020.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in right arm, on 21Dec2020 at 19:45, at a single dose, for COVID-19 immunization. The patient's medical history included sciatica. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was a hospital. After the first dose on 21Dec2020 (from the day of injection and for 2 days post), the patient experienced itching, nausea, headache, body ache, and site soreness and swelling. Treatment was received for the adverse events which included paracetamol (TYLENOL) at 500 mg. Since the vaccination, the patient has been tested for COVID-19. Polymerase chain reaction (PCR) nasal swab for COVID-19 that was negative on 04Jan2021. The patient recovered from the events in Dec2020.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the fourth (4th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified number of patients) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: Typical arm swelling; Headache; Tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the 5th of the 17 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization at the village. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had typical arm swelling; headache; and tiredness. "Multiple friends" (unspecified number of patients) had the regular side effect of soreness in the arm. The outcome of the events, 'typical arm swelling', 'headache' and 'tiredness', was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/product/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: Typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the sixth of the seventeen reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the seventh (7th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the eighth (8th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is 9th of 17 reports. A patient of unspecified age and gender (reporter's friend) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness in Jan2021. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/product, diff AE/patients
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the tenth (10th) of seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not provided) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that they all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The reporter stated that also multiple friends (unspecified) had the regular side effect of soreness in the arm. The outcome of the events arm swelling, headache, and tiredness was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness in the arm; Typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 15 patients. This is 10th of 15 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced soreness in the arm, had the typical arm swelling, headache and tiredness, all on unspecified dates in Jan2021. The outcome of the events were unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026413 same reporter/product/events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the 14th of the 17 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization at the village. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had typical arm swelling; headache; and tiredness. "Multiple friends" (unspecified number of patients) had the regular side effect of soreness in the arm. The outcome of the events, 'typical arm swelling', 'headache' and 'tiredness', was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the fifteenth (15th) of seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not provided) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that they all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The reporter stated that also multiple friends (unspecified) had the regular side effect of soreness in the arm. The outcome of the events arm swelling, headache, and tiredness was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the 16th of the seventeen reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm. The patient got the vaccine shot in the village and had the typical arm swelling, headache, and tiredness in Jan2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/similar event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: Tiredness; Headache; Typical arm swelling; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the 17th of the seventeen reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient got the vaccine shot in the village along with friends and all had the typical arm swelling, headache and tiredness on an unspecified date. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Erythema, Feeling hot, Flushing, Hot flush
Clinical narrative: Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red blotches mostly to both calves; redness to right leg/redness to right thigh/she had redness, flushed and warmth of face; stated that all the flushed areas were hot to touch; redness to face (flushed)/she had redness, flushed and warmth of face; she had redness, flushed and warmth of face; moderate allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the right arm, on 07Jan2021 at a single dose, for COVID-19 immunization. Relevant medical history included right eye surgery on 06Jan2021, severe allergies, environmental and drug allergies. The patient has no concomitant medications. The patient stated that she had first dose of COVID vaccine on Thursday. Stated that she has sent V-safe reporting updates. Stated that she had a moderate allergic reaction to the vaccine on an unspecified date in Jan2021. She had noticed hives when she woke up on Friday morning (08Jan2021) that her legs were feeling itchy. She stated that she has hives, red blotches on back of thighs, arms and mostly on calves. The area was hot to touch. She then clarified that all the flushed areas were hot to touch. She was feeling a little better. She stated that they looked like they were trying to dry up and she has new ones. She had redness, flushed and warmth of face that started the day of vaccine that night (07Jan2021). She had red blotches to back of thighs Friday evening and they were starting to fade. Stated that the blotches to her left leg started Friday and that evening redness started to right leg and thighs. The blotches to both calves are still warm but starting to improve. The redness to her right thigh is more pink than red now. The patient was Benadryl around the clock and using Aveeno cream as treatment for the events. She has always had severe allergies but has not had an allergic reaction in over year. She also has history of environmental and drug allergies. Patient was trying to determine if should go back for second vaccine due to the reaction. She had asked for a consult from the immunization doctor before receiving the vaccine because she has history of severe allergies. Outcome of the events hives, and redness was not recovered, for events flushing, hot flushes, and red blotches was recovering, while for the remaining events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red blotches mostly to both calves; redness to right leg/redness to right thigh/she had redness, flushed and warmth of face; stated that all the flushed areas were hot to touch; redness to face (flushed)/she had redness, flushed and warmth of face; she had redness, flushed and warmth of face; moderate allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the right arm, on 07Jan2021 at a single dose, for COVID-19 immunization. Relevant medical history included right eye surgery on 06Jan2021, severe allergies, environmental and drug allergies. The patient has no concomitant medications. The patient stated that she had first dose of COVID vaccine on Thursday. Stated that she has sent V-safe reporting updates. Stated that she had a moderate allergic reaction to the vaccine on an unspecified date in Jan2021. She had noticed hives when she woke up on Friday morning (08Jan2021) that her legs were feeling itchy. She stated that she has hives, red blotches on back of thighs, arms and mostly on calves. The area was hot to touch. She then clarified that all the flushed areas were hot to touch. She was feeling a little better. She stated that they looked like they were trying to dry up and she has new ones. She had redness, flushed and warmth of face that started the day of vaccine that night (07Jan2021). She had red blotches to back of thighs Friday evening and they were starting to fade. Stated that the blotches to her left leg started Friday and that evening redness started to right leg and thighs. The blotches to both calves are still warm but starting to improve. The redness to her right thigh is more pink than red now. The patient was Benadryl around the clock and using Aveeno cream as treatment for the events. She has always had severe allergies but has not had an allergic reaction in over year. She also has history of environmental and drug allergies. Patient was trying to determine if should go back for second vaccine due to the reaction. She had asked for a consult from the immunization doctor before receiving the vaccine because she has history of severe allergies. Outcome of the events hives, and redness was not recovered, for events flushing, hot flushes, and red blotches was recovering, while for the remaining events was unknown.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Oedema peripheral, Skin exfoliation
Clinical narrative: Sloughing to the skin on the left arm.; Skin hanging about 3-4 inches due to some sort of fluid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient went for his appointment at 11:40am and then got the vaccine at 12:00pm. Denied getting any other vaccines the same day or 4 weeks prior. Mentioned having the influenza shot and then later clarified it was actually the pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. Went to the clinic and they gave him something and it went away, and he was told not to get another one. The outcome of the event was recovered on an unspecified date.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain in extremity, Vaccination site swelling
Clinical narrative: Sloughing to the skin on the left arm.; Skin hanging about 3-4 inches due to some sort of fluid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient went for his appointment at 11:40am and then got the vaccine at 12:00pm. Denied getting any other vaccines the same day or 4 weeks prior. Mentioned having the influenza shot and then later clarified it was actually the pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. Went to the clinic and they gave him something and it went away, and he was told not to get another one. The outcome of the event was recovered on an unspecified date.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.