chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain, Feeding disorder, Gastric emptying study, Impaired gastric emptying
Clinical narrative: it started with abdominal cramping then severe stabbing pain all over my right and left abdomen.; my stomach is either partially or fully paralyzed; Unable to eat; Nausea; Painful bloating; This is a spontaneous report from a contactable Consumer (patient, self-reporting). A 24-year-old (non-pregnant) female patient received a first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), dose 1 via unspecified route of administration in left arm on 09Apr2021 (at the age of 24-year-old) as single dose for COVID-19 immunization in Hospital. The patient medical history includes COVID-19 on an unspecified onset an unknown stop date and concomitant medications were not reported. On 16May2021, after the vaccination, the patient experienced abdominal cramping then severe stabbing pain all over her right and left abdomen. Painful bloating and unable to eat without getting extremely full paired with nausea. Gastric emptying study came back abnormal thus finding out her stomach is either partially or fully paralysed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) dose 2 via an unspecified route of administration on 27Jul2021 as single dose for COVID-19 immunization. Patient was diagnosed with COVID prior vaccination. No known allergies reported. No other vaccines were taken in four weeks of vaccination and no other medications were taken in two weeks of vaccination. The patient lab data includes Gastric emptying study on an unspecified date which showed abnormal results stomach is either partially or fully paralysed. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: it started with abdominal cramping then severe stabbing pain all over my right and left abdomen.; my stomach is either partially or fully paralyzed; Unable to eat; Nausea; Painful bloating; This is a spontaneous report from a contactable Consumer (patient, self-reporting). A 24-year-old (non-pregnant) female patient received a first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), dose 1 via unspecified route of administration in left arm on 09Apr2021 (at the age of 24-year-old) as single dose for COVID-19 immunization in Hospital. The patient medical history includes COVID-19 on an unspecified onset an unknown stop date and concomitant medications were not reported. On 16May2021, after the vaccination, the patient experienced abdominal cramping then severe stabbing pain all over her right and left abdomen. Painful bloating and unable to eat without getting extremely full paired with nausea. Gastric emptying study came back abnormal thus finding out her stomach is either partially or fully paralysed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) dose 2 via an unspecified route of administration on 27Jul2021 as single dose for COVID-19 immunization. Patient was diagnosed with COVID prior vaccination. No known allergies reported. No other vaccines were taken in four weeks of vaccination and no other medications were taken in two weeks of vaccination. The patient lab data includes Gastric emptying study on an unspecified date which showed abnormal results stomach is either partially or fully paralysed. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash macular, Throat tightness
Clinical narrative: throat feeling like it was clogged.; Itchy and blotchy skin; Itchy and blotchy skin; This is a spontaneous report from a contactable consumer (Patient). A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0173), via an unspecified route of administration 06Sep2021 00:15 (at the age of 15-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included allergies to cephalosporin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cephalosporin nos and experienced allergy. On 06Sep2021 at 00:30 AM, the patient experienced Itchy and blotchy skin, throat feeling like it was clogged. Therapeutic measures were taken as a result of the events and treatment included Benadryl, Epinephrine, Prednisone. The adverse event did result Emergency room/department or urgent care. The seriousness criteria was assessed as Medically significant for Throat tightness. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter
Clinical narrative: Fluttering heart off and on; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 03Sep2021 17:00 at 36 years (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Patient was not pregnant and was not pregnant at time of vaccination. The patient did not experience COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive other vaccine in four weeks. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced fluttering heart off and on (medically significant) on 03Sep2021 18:30 with outcome of recovered in Sep2021 (several hours after). No therapeutic measures were taken as a result of the event. Patient has not been tested for COVID-19 after vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: Patient passed away on 09/10/2021
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient passed away on 09/10/2021
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Dysarthria, Dysstasia, Fatigue
Clinical narrative: Seizures; Fever; feeling really bad; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 15:15 (at the age of 71-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included ongoing seizure from an unknown date Patient states that she has not had a seizure in months. These seizures came out of the blue. Even when she had seizures she never gets that many in a row. The patient's concomitant medications were not reported. The patient did not had covid. She had a lot of medical problems. It was re-ported that the night of the vaccine she started feeling really bad and had three seizures on Wednesday afternoon up until the time she went to bed. She had a temperature of 100.4 and 100.6 on Wednesday and then it stopped and only had a temperature through the night, the fever started at 6 in the afternoon before she went to bed. This morning when she tried to get out of bed she had another seizure. She had a total of 4 seizures since Wednesday. She had a 99 temperature a couple of times today. Her seizures are in here left temporal lobe. She has medication that she takes for seizures since she gets seizures. She takes the seizure medication called Topiramate 200mg at night. The patient visited neurologist for the treatment. The patient did not visited the emergency room. The patient did not had any adverse events prior to vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient underwent lab tests and procedures which included body temperature: 100.4 and 100.6 on an unspecified date, body temperature: 99 on an unspecified date, body temperature: 98.7 on an unspecified date. The out-come of all the events was unknown.   The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Pyrexia, Seizure
Clinical narrative: Seizures; Fever; feeling really bad; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 15:15 (at the age of 71-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included ongoing seizure from an unknown date Patient states that she has not had a seizure in months. These seizures came out of the blue. Even when she had seizures she never gets that many in a row. The patient's concomitant medications were not reported. The patient did not had covid. She had a lot of medical problems. It was re-ported that the night of the vaccine she started feeling really bad and had three seizures on Wednesday afternoon up until the time she went to bed. She had a temperature of 100.4 and 100.6 on Wednesday and then it stopped and only had a temperature through the night, the fever started at 6 in the afternoon before she went to bed. This morning when she tried to get out of bed she had another seizure. She had a total of 4 seizures since Wednesday. She had a 99 temperature a couple of times today. Her seizures are in here left temporal lobe. She has medication that she takes for seizures since she gets seizures. She takes the seizure medication called Topiramate 200mg at night. The patient visited neurologist for the treatment. The patient did not visited the emergency room. The patient did not had any adverse events prior to vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient underwent lab tests and procedures which included body temperature: 100.4 and 100.6 on an unspecified date, body temperature: 99 on an unspecified date, body temperature: 98.7 on an unspecified date. The out-come of all the events was unknown.   The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Malaise, Pyrexia, Seizure
Clinical narrative: Seizures; Fever; feeling really bad; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 15:15 (at the age of 71-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included ongoing seizure from an unknown date Patient states that she has not had a seizure in months. These seizures came out of the blue. Even when she had seizures she never gets that many in a row. The patient's concomitant medications were not reported. The patient did not had covid. She had a lot of medical problems. It was re-ported that the night of the vaccine she started feeling really bad and had three seizures on Wednesday afternoon up until the time she went to bed. She had a temperature of 100.4 and 100.6 on Wednesday and then it stopped and only had a temperature through the night, the fever started at 6 in the afternoon before she went to bed. This morning when she tried to get out of bed she had another seizure. She had a total of 4 seizures since Wednesday. She had a 99 temperature a couple of times today. Her seizures are in here left temporal lobe. She has medication that she takes for seizures since she gets seizures. She takes the seizure medication called Topiramate 200mg at night. The patient visited neurologist for the treatment. The patient did not visited the emergency room. The patient did not had any adverse events prior to vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient underwent lab tests and procedures which included body temperature: 100.4 and 100.6 on an unspecified date, body temperature: 99 on an unspecified date, body temperature: 98.7 on an unspecified date. The out-come of all the events was unknown.   The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizures; Fever; feeling really bad; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Sep2021 15:15 (at the age of 71-years-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included ongoing seizure from an unknown date Patient states that she has not had a seizure in months. These seizures came out of the blue. Even when she had seizures she never gets that many in a row. The patient's concomitant medications were not reported. The patient did not had covid. She had a lot of medical problems. It was re-ported that the night of the vaccine she started feeling really bad and had three seizures on Wednesday afternoon up until the time she went to bed. She had a temperature of 100.4 and 100.6 on Wednesday and then it stopped and only had a temperature through the night, the fever started at 6 in the afternoon before she went to bed. This morning when she tried to get out of bed she had another seizure. She had a total of 4 seizures since Wednesday. She had a 99 temperature a couple of times today. Her seizures are in here left temporal lobe. She has medication that she takes for seizures since she gets seizures. She takes the seizure medication called Topiramate 200mg at night. The patient visited neurologist for the treatment. The patient did not visited the emergency room. The patient did not had any adverse events prior to vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient underwent lab tests and procedures which included body temperature: 100.4 and 100.6 on an unspecified date, body temperature: 99 on an unspecified date, body temperature: 98.7 on an unspecified date. The out-come of all the events was unknown.   The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, Computerised tomogram abnormal, Infection
Clinical narrative: I received the vaccination and within 24 hours started having extreme stomach pain and a fever with NO prior history of any stomach pains or issues before the vaccine. By the next day my pain was so extreme that I could not walk. I went to the hospital and was diagnosed with acute appendicitis and had an infection. Following my diagnosis I underwent surgery to have an emergency appendix removal.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: I received the vaccination and within 24 hours started having extreme stomach pain and a fever with NO prior history of any stomach pains or issues before the vaccine. By the next day my pain was so extreme that I could not walk. I went to the hospital and was diagnosed with acute appendicitis and had an infection. Following my diagnosis I underwent surgery to have an emergency appendix removal.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicectomy, Appendicitis, Gait inability, Infection
Clinical narrative: I received the vaccination and within 24 hours started having extreme stomach pain and a fever with NO prior history of any stomach pains or issues before the vaccine. By the next day my pain was so extreme that I could not walk. I went to the hospital and was diagnosed with acute appendicitis and had an infection. Following my diagnosis I underwent surgery to have an emergency appendix removal.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I received the vaccination and within 24 hours started having extreme stomach pain and a fever with NO prior history of any stomach pains or issues before the vaccine. By the next day my pain was so extreme that I could not walk. I went to the hospital and was diagnosed with acute appendicitis and had an infection. Following my diagnosis I underwent surgery to have an emergency appendix removal.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Previously submitted VAERS report on this pt E report # 640946  updating with pts death 9/20/2021
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Previously submitted VAERS report on this pt E report # 640946  updating with pts death 9/20/2021
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac flutter, Heart rate increased, Hypoaesthesia oral, Mouth swelling
Clinical narrative: Patient reports rash, swelling of my mouth, headache, rapid heart beat and fluttering heart rate and pounding headache
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Headache, Heart rate increased, Mouth swelling, Rash
Clinical narrative: Patient reports rash, swelling of my mouth, headache, rapid heart beat and fluttering heart rate and pounding headache
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Laboratory test normal, Magnetic resonance imaging head normal, Seizure
Clinical narrative: Migraine, drowsiness, light headed Injection arm hot - stiff-hard and bump.  Chills Nausea Stinging feeling from injection area up to neck
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chest X-ray, Chills, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: Migraine, drowsiness, light headed Injection arm hot - stiff-hard and bump.  Chills Nausea Stinging feeling from injection area up to neck
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Full blood count, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Migraine, drowsiness, light headed Injection arm hot - stiff-hard and bump.  Chills Nausea Stinging feeling from injection area up to neck
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Magnetic resonance imaging head, Migraine, Nausea, Pain
Clinical narrative: Migraine, drowsiness, light headed Injection arm hot - stiff-hard and bump.  Chills Nausea Stinging feeling from injection area up to neck
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Somnolence, Urine analysis
Clinical narrative: Migraine, drowsiness, light headed Injection arm hot - stiff-hard and bump.  Chills Nausea Stinging feeling from injection area up to neck
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Balance disorder, Chills, Decreased appetite
Clinical narrative: PAIN IN THROAT ON RIGHT SIDE; LITTLE COUGH; PAIN ON RIGHT SIDE OF FACE FROM EYE TO THE CHIN; PAIN IN RIGHT EAR; PAIN IN BOTH EYES; SWEATING CONTINUOUSLY; TINGLING IN FACE; HEADACHE WITH PAIN IN FRONT OF HEAD WHEN BENDS OVER; FEVER OF 100.5F; COLD; PAIN IN BACK OF LEGS AT EVERY JOINT AT BACK OF KNEES, HIP AND ANKLES; CHILLS; TINGLING IN RIGHT HAND; DIZZY AND ALMOST FELL AND LAID DOWN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced dizzy and almost fell and laid down. On 13-SEP-2021, the patient experienced tingling in right hand. On 14-SEP-2021, the patient experienced cold. On 14-SEP-2021, the patient experienced pain in back of legs at every joint at back of knees, hip and ankles. On 14-SEP-2021, the patient experienced chills. On 14-SEP-2021, the patient experienced headache with pain in front of head when bends over. On 14-SEP-2021, the patient experienced fever of 100.5f. On 15-SEP-2021, the patient experienced pain in both eyes. On 15-SEP-2021, the patient experienced sweating continuously. On 15-SEP-2021, the patient experienced tingling in face. Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 16-SEP-2021, the patient experienced pain on right side of face from eye to the chin. On 16-SEP-2021, the patient experienced pain in right ear. On 16-SEP-2021, the patient experienced pain in throat on right side. On 16-SEP-2021, the patient experienced little cough. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right hand on 13-SEP-2021, had not recovered from tingling in face, and dizzy and almost fell and laid down, and the outcome of cold, headache with pain in front of head when bends over, pain in back of legs at every joint at back of knees, hip and ankles, fever of 100.5f, pain on right side of face from eye to the chin, pain in both eyes, pain in right ear, pain in throat on right side, little cough, sweating continuously and chills was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Head discomfort, Headache
Clinical narrative: PAIN IN THROAT ON RIGHT SIDE; LITTLE COUGH; PAIN ON RIGHT SIDE OF FACE FROM EYE TO THE CHIN; PAIN IN RIGHT EAR; PAIN IN BOTH EYES; SWEATING CONTINUOUSLY; TINGLING IN FACE; HEADACHE WITH PAIN IN FRONT OF HEAD WHEN BENDS OVER; FEVER OF 100.5F; COLD; PAIN IN BACK OF LEGS AT EVERY JOINT AT BACK OF KNEES, HIP AND ANKLES; CHILLS; TINGLING IN RIGHT HAND; DIZZY AND ALMOST FELL AND LAID DOWN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced dizzy and almost fell and laid down. On 13-SEP-2021, the patient experienced tingling in right hand. On 14-SEP-2021, the patient experienced cold. On 14-SEP-2021, the patient experienced pain in back of legs at every joint at back of knees, hip and ankles. On 14-SEP-2021, the patient experienced chills. On 14-SEP-2021, the patient experienced headache with pain in front of head when bends over. On 14-SEP-2021, the patient experienced fever of 100.5f. On 15-SEP-2021, the patient experienced pain in both eyes. On 15-SEP-2021, the patient experienced sweating continuously. On 15-SEP-2021, the patient experienced tingling in face. Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 16-SEP-2021, the patient experienced pain on right side of face from eye to the chin. On 16-SEP-2021, the patient experienced pain in right ear. On 16-SEP-2021, the patient experienced pain in throat on right side. On 16-SEP-2021, the patient experienced little cough. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right hand on 13-SEP-2021, had not recovered from tingling in face, and dizzy and almost fell and laid down, and the outcome of cold, headache with pain in front of head when bends over, pain in back of legs at every joint at back of knees, hip and ankles, fever of 100.5f, pain on right side of face from eye to the chin, pain in both eyes, pain in right ear, pain in throat on right side, little cough, sweating continuously and chills was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Dizziness
Clinical narrative: PAIN IN THROAT ON RIGHT SIDE; LITTLE COUGH; PAIN ON RIGHT SIDE OF FACE FROM EYE TO THE CHIN; PAIN IN RIGHT EAR; PAIN IN BOTH EYES; SWEATING CONTINUOUSLY; TINGLING IN FACE; HEADACHE WITH PAIN IN FRONT OF HEAD WHEN BENDS OVER; FEVER OF 100.5F; COLD; PAIN IN BACK OF LEGS AT EVERY JOINT AT BACK OF KNEES, HIP AND ANKLES; CHILLS; TINGLING IN RIGHT HAND; DIZZY AND ALMOST FELL AND LAID DOWN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced dizzy and almost fell and laid down. On 13-SEP-2021, the patient experienced tingling in right hand. On 14-SEP-2021, the patient experienced cold. On 14-SEP-2021, the patient experienced pain in back of legs at every joint at back of knees, hip and ankles. On 14-SEP-2021, the patient experienced chills. On 14-SEP-2021, the patient experienced headache with pain in front of head when bends over. On 14-SEP-2021, the patient experienced fever of 100.5f. On 15-SEP-2021, the patient experienced pain in both eyes. On 15-SEP-2021, the patient experienced sweating continuously. On 15-SEP-2021, the patient experienced tingling in face. Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 16-SEP-2021, the patient experienced pain on right side of face from eye to the chin. On 16-SEP-2021, the patient experienced pain in right ear. On 16-SEP-2021, the patient experienced pain in throat on right side. On 16-SEP-2021, the patient experienced little cough. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right hand on 13-SEP-2021, had not recovered from tingling in face, and dizzy and almost fell and laid down, and the outcome of cold, headache with pain in front of head when bends over, pain in back of legs at every joint at back of knees, hip and ankles, fever of 100.5f, pain on right side of face from eye to the chin, pain in both eyes, pain in right ear, pain in throat on right side, little cough, sweating continuously and chills was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Eye pain, Facial pain, Headache, Hyperhidrosis
Clinical narrative: PAIN IN THROAT ON RIGHT SIDE; LITTLE COUGH; PAIN ON RIGHT SIDE OF FACE FROM EYE TO THE CHIN; PAIN IN RIGHT EAR; PAIN IN BOTH EYES; SWEATING CONTINUOUSLY; TINGLING IN FACE; HEADACHE WITH PAIN IN FRONT OF HEAD WHEN BENDS OVER; FEVER OF 100.5F; COLD; PAIN IN BACK OF LEGS AT EVERY JOINT AT BACK OF KNEES, HIP AND ANKLES; CHILLS; TINGLING IN RIGHT HAND; DIZZY AND ALMOST FELL AND LAID DOWN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced dizzy and almost fell and laid down. On 13-SEP-2021, the patient experienced tingling in right hand. On 14-SEP-2021, the patient experienced cold. On 14-SEP-2021, the patient experienced pain in back of legs at every joint at back of knees, hip and ankles. On 14-SEP-2021, the patient experienced chills. On 14-SEP-2021, the patient experienced headache with pain in front of head when bends over. On 14-SEP-2021, the patient experienced fever of 100.5f. On 15-SEP-2021, the patient experienced pain in both eyes. On 15-SEP-2021, the patient experienced sweating continuously. On 15-SEP-2021, the patient experienced tingling in face. Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 16-SEP-2021, the patient experienced pain on right side of face from eye to the chin. On 16-SEP-2021, the patient experienced pain in right ear. On 16-SEP-2021, the patient experienced pain in throat on right side. On 16-SEP-2021, the patient experienced little cough. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right hand on 13-SEP-2021, had not recovered from tingling in face, and dizzy and almost fell and laid down, and the outcome of cold, headache with pain in front of head when bends over, pain in back of legs at every joint at back of knees, hip and ankles, fever of 100.5f, pain on right side of face from eye to the chin, pain in both eyes, pain in right ear, pain in throat on right side, little cough, sweating continuously and chills was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Paraesthesia, Pyrexia
Clinical narrative: PAIN IN THROAT ON RIGHT SIDE; LITTLE COUGH; PAIN ON RIGHT SIDE OF FACE FROM EYE TO THE CHIN; PAIN IN RIGHT EAR; PAIN IN BOTH EYES; SWEATING CONTINUOUSLY; TINGLING IN FACE; HEADACHE WITH PAIN IN FRONT OF HEAD WHEN BENDS OVER; FEVER OF 100.5F; COLD; PAIN IN BACK OF LEGS AT EVERY JOINT AT BACK OF KNEES, HIP AND ANKLES; CHILLS; TINGLING IN RIGHT HAND; DIZZY AND ALMOST FELL AND LAID DOWN; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced dizzy and almost fell and laid down. On 13-SEP-2021, the patient experienced tingling in right hand. On 14-SEP-2021, the patient experienced cold. On 14-SEP-2021, the patient experienced pain in back of legs at every joint at back of knees, hip and ankles. On 14-SEP-2021, the patient experienced chills. On 14-SEP-2021, the patient experienced headache with pain in front of head when bends over. On 14-SEP-2021, the patient experienced fever of 100.5f. On 15-SEP-2021, the patient experienced pain in both eyes. On 15-SEP-2021, the patient experienced sweating continuously. On 15-SEP-2021, the patient experienced tingling in face. Laboratory data included: Body temperature (NR: not provided) 100.5 F. On 16-SEP-2021, the patient experienced pain on right side of face from eye to the chin. On 16-SEP-2021, the patient experienced pain in right ear. On 16-SEP-2021, the patient experienced pain in throat on right side. On 16-SEP-2021, the patient experienced little cough. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right hand on 13-SEP-2021, had not recovered from tingling in face, and dizzy and almost fell and laid down, and the outcome of cold, headache with pain in front of head when bends over, pain in back of legs at every joint at back of knees, hip and ankles, fever of 100.5f, pain on right side of face from eye to the chin, pain in both eyes, pain in right ear, pain in throat on right side, little cough, sweating continuously and chills was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Site of the vaccine began to swell, turned red and severe itch 9 days after vaccination. Tonight, 9/22 at 7:35 PM, severe redness, itch and welts developed spontaneously on booth knees/thighs.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Site of the vaccine began to swell, turned red and severe itch 9 days after vaccination. Tonight, 9/22 at 7:35 PM, severe redness, itch and welts developed spontaneously on booth knees/thighs.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Site of the vaccine began to swell, turned red and severe itch 9 days after vaccination. Tonight, 9/22 at 7:35 PM, severe redness, itch and welts developed spontaneously on booth knees/thighs.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Site of the vaccine began to swell, turned red and severe itch 9 days after vaccination. Tonight, 9/22 at 7:35 PM, severe redness, itch and welts developed spontaneously on booth knees/thighs.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: abnormal, unexplained weight loss without change in behavior, up to 5 pounds (out of 117 pounds); fast beating heart; fatigue for several weeks when performing light tasks; felt like I was weak and thirsty; felt like I was weak and thirsty; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 34-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 20Aug2021 at 02:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none; very healthy. The patient's concomitant medications were not reported. No seriousness criteria were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was not tested for COVID-19. No known allergies were reported. On 25Aug2021, the patient experienced abnormal, unexplained weight loss without change in behavior, up to 5 pounds (out of 117 pounds), fast beating heart, fatigue for several weeks when performing light tasks, felt like i was weak and thirsty, felt like i was weak and thirsty. Reported that not just a fluctuation because I weighed myself at consistent times of the day. The patient underwent lab tests and procedures which included Heartbeat: fast on 25Aug2021. No treatment was received for events. The outcomes of events were not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Heart rate increased, Investigation, Thirst
Clinical narrative: abnormal, unexplained weight loss without change in behavior, up to 5 pounds (out of 117 pounds); fast beating heart; fatigue for several weeks when performing light tasks; felt like I was weak and thirsty; felt like I was weak and thirsty; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 34-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 20Aug2021 at 02:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none; very healthy. The patient's concomitant medications were not reported. No seriousness criteria were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was not tested for COVID-19. No known allergies were reported. On 25Aug2021, the patient experienced abnormal, unexplained weight loss without change in behavior, up to 5 pounds (out of 117 pounds), fast beating heart, fatigue for several weeks when performing light tasks, felt like i was weak and thirsty, felt like i was weak and thirsty. Reported that not just a fluctuation because I weighed myself at consistent times of the day. The patient underwent lab tests and procedures which included Heartbeat: fast on 25Aug2021. No treatment was received for events. The outcomes of events were not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: abnormal, unexplained weight loss without change in behavior, up to 5 pounds (out of 117 pounds); fast beating heart; fatigue for several weeks when performing light tasks; felt like I was weak and thirsty; felt like I was weak and thirsty; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 34-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 20Aug2021 at 02:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none; very healthy. The patient's concomitant medications were not reported. No seriousness criteria were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was not tested for COVID-19. No known allergies were reported. On 25Aug2021, the patient experienced abnormal, unexplained weight loss without change in behavior, up to 5 pounds (out of 117 pounds), fast beating heart, fatigue for several weeks when performing light tasks, felt like i was weak and thirsty, felt like i was weak and thirsty. Reported that not just a fluctuation because I weighed myself at consistent times of the day. The patient underwent lab tests and procedures which included Heartbeat: fast on 25Aug2021. No treatment was received for events. The outcomes of events were not recovered.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Burning sensation in lungs; acute inflammation of large airways; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3184), via an unspecified route of administration in left arm on 30Aug2021 at 12:15 PM (at the age of 62 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included sjogren's syndrome, diffuse large b-cell lymphoma (DLBCL-remission). The patient did not have any known allergies. Concomitant medications in two weeks included nadolol; nortriptyline; omeprazole; vitamin c [ascorbic acid]; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On an unspecified date the patient experienced burning sensation in lungs, acute inflammation of large airways, headache, dizziness. The patient underwent lab tests and procedures which included SARS-CoV-2 Ab, Nucleocapsid: negative on 17Aug2021. The patient did not received treatment due to the events. The outcome of events was not recovered.   Follow-Up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Headache, Inflammation, SARS-CoV-2 antibody test
Clinical narrative: Burning sensation in lungs; acute inflammation of large airways; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3184), via an unspecified route of administration in left arm on 30Aug2021 at 12:15 PM (at the age of 62 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included sjogren's syndrome, diffuse large b-cell lymphoma (DLBCL-remission). The patient did not have any known allergies. Concomitant medications in two weeks included nadolol; nortriptyline; omeprazole; vitamin c [ascorbic acid]; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On an unspecified date the patient experienced burning sensation in lungs, acute inflammation of large airways, headache, dizziness. The patient underwent lab tests and procedures which included SARS-CoV-2 Ab, Nucleocapsid: negative on 17Aug2021. The patient did not received treatment due to the events. The outcome of events was not recovered.   Follow-Up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Immunisation, Off label use, Swelling face
Clinical narrative: Burning sensation in lungs; acute inflammation of large airways; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3184), via an unspecified route of administration in left arm on 30Aug2021 at 12:15 PM (at the age of 62 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included sjogren's syndrome, diffuse large b-cell lymphoma (DLBCL-remission). The patient did not have any known allergies. Concomitant medications in two weeks included nadolol; nortriptyline; omeprazole; vitamin c [ascorbic acid]; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On an unspecified date the patient experienced burning sensation in lungs, acute inflammation of large airways, headache, dizziness. The patient underwent lab tests and procedures which included SARS-CoV-2 Ab, Nucleocapsid: negative on 17Aug2021. The patient did not received treatment due to the events. The outcome of events was not recovered.   Follow-Up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: Intense arm pain/Pain in arm was really bad really intense; Earlier I was so cold then hot then cold/body temperature fluctuations; I can't sleep; Tendons are tightening up hands are clawing up; Talking takes up all energy; Feel like laying down; Hands forming claws; extreme fatigue/I am so tired talking is a lot of work, sitting up is hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up) and ASTHENIA (Talking takes up all energy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard) outcome was unknown.            This case was linked to MOD-2021-316009.