chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Rash, Vaccination site papule, Vaccination site rash
Clinical narrative: Rash on right side of neck; Rash of bumps on the left arm where injection happened; Rash of bumps on the left arm where injection happened; Some difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 22Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included asthma, allergies and migraine. Concomitant medication included ibuprofen, albuterol [salbutamol] and sumatriptan. The patient previously took clindamycin and experienced drug allergy. The patient experienced rash of bumps on the left arm where injection happened, rash on right side of neck some difficulty breathing on 22Jan2021 19:30. The patient received treatment Benadryl and albuterol to treat symptoms. The outcome of events was recovered in Jan2021.  Information on the Lot/Batch number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Eye swelling, Feeling abnormal
Clinical narrative: My left eye was pretty well swollen and puffy, it hurts to blink and stuff and it was pretty tender; My left eye was pretty well swollen and puffy, it hurts to blink and stuff and it was pretty tender; My left eye was pretty well swollen and puffy, it hurts to blink and stuff and it was pretty tender; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3247, expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mood disorder or attention deficit hyperactivity disorder (ADHD). Concomitant medications included aripiprazole (ABILIFY), and gabapentin, both for mood or ADHD. The patient reported that he got the shot on his left arm last Thursday, 21Jan2021 and woke up the next morning, 22Jan2021, and his left eye was pretty well swollen and puffy, it hurts to blink, and stuff and it was pretty tender. The patient stated that he believe he took acetaminophen or the tylenol. Outcome of events was unknown.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Eye swelling, Periorbital swelling
Clinical narrative: My left eye was pretty well swollen and puffy, it hurts to blink and stuff and it was pretty tender; My left eye was pretty well swollen and puffy, it hurts to blink and stuff and it was pretty tender; My left eye was pretty well swollen and puffy, it hurts to blink and stuff and it was pretty tender; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3247, expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included mood disorder or attention deficit hyperactivity disorder (ADHD). Concomitant medications included aripiprazole (ABILIFY), and gabapentin, both for mood or ADHD. The patient reported that he got the shot on his left arm last Thursday, 21Jan2021 and woke up the next morning, 22Jan2021, and his left eye was pretty well swollen and puffy, it hurts to blink, and stuff and it was pretty tender. The patient stated that he believe he took acetaminophen or the tylenol. Outcome of events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Pruritus, Rash, Urticaria
Clinical narrative: raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took my temperature and it was 97.4; My heart rate jumped to 93bpm; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via an unspecified route of administration on 22Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. The patient medical history included hypothyroidism, inflammation and sensitive to grains. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient was not pregnant at the time of vaccination. Approximately 4 hours after patient received the vaccination (22Jan2021 21:45), she felt very warm, and she started itching. Patient developed a rash all over the trunk. Patient took her temperature and it was 97.4. Patient heart rate jumped to 93bpm. Patient took a diphenhydramine hydrochloride (BENADRYL). As soon as the diphenhydramine hydrochloride took effect, her heart lowered pretty quickly. When patient woke up this morning (23Jan2021), she was still itching mildly and raised welts if is scratched. More diphenhydramine hydrochloride four hours ago. Treatment received for the adverse event included diphenhydramine hydrochloride (self administered). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovering. The events were reported as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature abnormal, Feeling hot, Heart rate, Heart rate increased
Clinical narrative: raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took my temperature and it was 97.4; My heart rate jumped to 93bpm; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via an unspecified route of administration on 22Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. The patient medical history included hypothyroidism, inflammation and sensitive to grains. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient was not pregnant at the time of vaccination. Approximately 4 hours after patient received the vaccination (22Jan2021 21:45), she felt very warm, and she started itching. Patient developed a rash all over the trunk. Patient took her temperature and it was 97.4. Patient heart rate jumped to 93bpm. Patient took a diphenhydramine hydrochloride (BENADRYL). As soon as the diphenhydramine hydrochloride took effect, her heart lowered pretty quickly. When patient woke up this morning (23Jan2021), she was still itching mildly and raised welts if is scratched. More diphenhydramine hydrochloride four hours ago. Treatment received for the adverse event included diphenhydramine hydrochloride (self administered). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovering. The events were reported as non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: raised welts if is scratched; felt very warm; itching; developed a rash all over the trunk; I took my temperature and it was 97.4; My heart rate jumped to 93bpm; This is a spontaneous report from a contactable consumer (patient). This 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via an unspecified route of administration on 22Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. The patient medical history included hypothyroidism, inflammation and sensitive to grains. Patient received other medications within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient was not pregnant at the time of vaccination. Approximately 4 hours after patient received the vaccination (22Jan2021 21:45), she felt very warm, and she started itching. Patient developed a rash all over the trunk. Patient took her temperature and it was 97.4. Patient heart rate jumped to 93bpm. Patient took a diphenhydramine hydrochloride (BENADRYL). As soon as the diphenhydramine hydrochloride took effect, her heart lowered pretty quickly. When patient woke up this morning (23Jan2021), she was still itching mildly and raised welts if is scratched. More diphenhydramine hydrochloride four hours ago. Treatment received for the adverse event included diphenhydramine hydrochloride (self administered). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of the event was recovering. The events were reported as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip pruritus, Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: lower lip became swollen; throat began feeling irritated/scratchy; lips started tingling, then itching; lips started tingling, then itching; This is a spontaneous report from a contactable Nurse (also the patient). A 63-year-old male patient (also the age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK4176, expiry date: Not available/provided by the reporter at the time of report), via an unspecified route of administration in left arm from 21Jan2021 10:00 AM at single dose for covid-19 immunization. The patient is vaccinated in a hospital. Medical history included bilateral iliac aneurysms on an unspecified and inferior wall MI in 2004. No other vaccine was administered in four weeks. The patient had no known allergies. No covid prior vaccination and not covid tested post vaccination. Concomitant medication included (reported as other medications in two weeks): aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), simvastatin, metoprolol succinate (TOPROL), alfuzosin, colecalciferol (D3), zinc gluconate (ZINC (GLUCONATE).  It was reported that at home, approximately 45 minutes after shot (reported start time: 10:45 AM), lips started tingling, then itching. Around 10 minutes later (10:55 AM; 55 minutes), throat began feeling irritated/scratchy. Approximately 10 minutes (11:05 AM; 65 minutes) later lower lip became swollen. The patient took half a Benadryl. Never had any difficulty breathing or swallowing. The presentation never got any worse. Tingling of lips lasted most of day, but milder than initial reaction - other symptoms gone in approximately an hour after taking the Benadryl (reported also as: No treatment was received for the events; pending clarification). The outcome of the event lips started tingling was recovered on 21Jan2021; and for all other events was recovered on an unspecified date.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: lower lip became swollen; throat began feeling irritated/scratchy; lips started tingling, then itching; lips started tingling, then itching; This is a spontaneous report from a contactable Nurse (also the patient). A 63-year-old male patient (also the age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK4176, expiry date: Not available/provided by the reporter at the time of report), via an unspecified route of administration in left arm from 21Jan2021 10:00 AM at single dose for covid-19 immunization. The patient is vaccinated in a hospital. Medical history included bilateral iliac aneurysms on an unspecified and inferior wall MI in 2004. No other vaccine was administered in four weeks. The patient had no known allergies. No covid prior vaccination and not covid tested post vaccination. Concomitant medication included (reported as other medications in two weeks): aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), simvastatin, metoprolol succinate (TOPROL), alfuzosin, colecalciferol (D3), zinc gluconate (ZINC (GLUCONATE).  It was reported that at home, approximately 45 minutes after shot (reported start time: 10:45 AM), lips started tingling, then itching. Around 10 minutes later (10:55 AM; 55 minutes), throat began feeling irritated/scratchy. Approximately 10 minutes (11:05 AM; 65 minutes) later lower lip became swollen. The patient took half a Benadryl. Never had any difficulty breathing or swallowing. The presentation never got any worse. Tingling of lips lasted most of day, but milder than initial reaction - other symptoms gone in approximately an hour after taking the Benadryl (reported also as: No treatment was received for the events; pending clarification). The outcome of the event lips started tingling was recovered on 21Jan2021; and for all other events was recovered on an unspecified date.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Body temperature increased, Chills, Lymphadenopathy, Pain
Clinical narrative: Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Pain, Swelling, Tremor
Clinical narrative: Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; Body aches; Injection arm began to hurt; Body tremble; Armpit very painful; Arm pit swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 23Jan2021 (11:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included early diabetes and high blood pressure. Concomitant medications included valsartan, sitagliptin (JANUVIA) and rosuvastatin. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on 02Jan2021 (when the patient was 53 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 23Jan2021 (19:00), the patient had chills; body aches; injection arm had begun to hurt; body tremble; armpit was very painful; and armpit was swelling. The patient had no fever. The patient had taken paracetamol (TYLENOL) as treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'injection arm had begun to hurt', 'body tremble', 'armpit was very painful' and 'armpit was swelling', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Pruritus, Vertigo
Clinical narrative: Itching; Pain in elbows, shoulders and knees; Pain in stomach; Vertigo; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number not provided), via an unspecified route of administration on the left arm on 22Jan2021 08:30 at SINGLE DOSE for COVID-19 immunization at the Public Health Department.  Medical history reported as none.  The patient's concomitant medications were not reported. On 23Jan2021 23:45, the patient experienced itching, pain in elbows, shoulders and knees; pain in stomach and vertigo. The patient was not diagnosed with COVID-19 prior and not tested since vaccination. No treatment was received for the events. The patient had not recovered from the events.  Information about lot and batch number was requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted  for over 18 hours; Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted  for over 18 hours; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL1284, intramuscular at left arm on 04Jan2021 11:45 at a single dose for COVID-19 immunisation. Medical history included asthma. The patient was not pregnant. Concomitant medications were not reported. On 04Jan2021, the patient experienced tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted for over 18 hours. The patient tested negative on COVID test by nasal swab on 12Jan2021. The patient did not receive any treatment. The outcome of the events was recovered on an unspecified date.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted  for over 18 hours; Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted  for over 18 hours; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL1284, intramuscular at left arm on 04Jan2021 11:45 at a single dose for COVID-19 immunisation. Medical history included asthma. The patient was not pregnant. Concomitant medications were not reported. On 04Jan2021, the patient experienced tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted for over 18 hours. The patient tested negative on COVID test by nasal swab on 12Jan2021. The patient did not receive any treatment. The outcome of the events was recovered on an unspecified date.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: sore upper left arm for 48 hours; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date was not reported), via an unspecified route of administration in the left arm on 21Jan2021 11:00 AM at a single dose for COVID-19 immunization. Medical history included being lactose intolerant and known allergies: poultry. Concomitant medication in two weeks included famotidine. The patient did not receive any other vaccine in four weeks. He was not diagnosed with COVID prior to vaccination. The patient experienced a sore upper left arm for 48 hours on 21Jan2021 07:00 AM (pending clarification). The patient did not receive treatment for the event and was not COVID tested post vaccination. The outcome of the event was recovered.    Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore upper left arm for 48 hours; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date was not reported), via an unspecified route of administration in the left arm on 21Jan2021 11:00 AM at a single dose for COVID-19 immunization. Medical history included being lactose intolerant and known allergies: poultry. Concomitant medication in two weeks included famotidine. The patient did not receive any other vaccine in four weeks. He was not diagnosed with COVID prior to vaccination. The patient experienced a sore upper left arm for 48 hours on 21Jan2021 07:00 AM (pending clarification). The patient did not receive treatment for the event and was not COVID tested post vaccination. The outcome of the event was recovered.    Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever (highest 102..8); Body aches; Chills; This is a spontaneous report from a contactable Pharmacist, the patient. This 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL1283), via an unspecified route of administration in the left arm on 22Jan2021 at 09:15 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN) and fexofenadine (FEXOFENADINE). The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EL1284), dose #1, via an unspecified route of administration in the left arm on 30Dec2020 as a single dose for COVID-19 vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 23Jan2021 at 01:00, the patient experienced fever (highest 102.8), body aches and chills. Therapeutic measures taken included ibuprofen to reduce the fever. The clinical outcomes of the fever (highest (102.8), body aches and chills were resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Fever (highest 102..8); Body aches; Chills; This is a spontaneous report from a contactable Pharmacist, the patient. This 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL1283), via an unspecified route of administration in the left arm on 22Jan2021 at 09:15 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN) and fexofenadine (FEXOFENADINE). The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EL1284), dose #1, via an unspecified route of administration in the left arm on 30Dec2020 as a single dose for COVID-19 vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 23Jan2021 at 01:00, the patient experienced fever (highest 102.8), body aches and chills. Therapeutic measures taken included ibuprofen to reduce the fever. The clinical outcomes of the fever (highest (102.8), body aches and chills were resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears; This is a spontaneous report received from a contactable consumer (patient). This 73-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261 and expiry date unknown), via an unspecified route of administration on 20Jan2021 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included lymphoma, hypertension (HTN), and hypothyroid. Concomitant medications included zanubrutinib (BRUKINSA), lisinopril, apixaban (ELIQUIS), and pantoprazole. Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 18:00, the patient experienced ringing in the ears. No treatment was received. Outcome of the event was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (BNT162B2; lot number=EL8982) second dose, via an unspecified route of administration on 20Jan2021 10:30 AM at SINGLE DOSE left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) 75 mg for hot flasjes. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot number=EL1284) on 30Dec2020 10:00 AM at left arm for covid-19 immunisation. The patient experienced headache, chills, fever, vomiting and exhaustion, all on 20Jan2021 20:00 with outcome of recovered with sequelae (recovered with lasting effects). Reported as headache, chills, fever, vomiting, and exhaustion the exhaustion lasted more than 3 days and it was severe. Patient had reactions after each short. No treatment received for the adverse event. All events reported as non-serious. Patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (BNT162B2; lot number=EL8982) second dose, via an unspecified route of administration on 20Jan2021 10:30 AM at SINGLE DOSE left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) 75 mg for hot flasjes. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot number=EL1284) on 30Dec2020 10:00 AM at left arm for covid-19 immunisation. The patient experienced headache, chills, fever, vomiting and exhaustion, all on 20Jan2021 20:00 with outcome of recovered with sequelae (recovered with lasting effects). Reported as headache, chills, fever, vomiting, and exhaustion the exhaustion lasted more than 3 days and it was severe. Patient had reactions after each short. No treatment received for the adverse event. All events reported as non-serious. Patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Headache; chills; fever; Vomiting; exhaustion; This is a spontaneous report from a contactable other healthcare professional. A 65-years-old female patient received bnt162b2 (BNT162B2; lot number=EL8982) second dose, via an unspecified route of administration on 20Jan2021 10:30 AM at SINGLE DOSE left arm for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) 75 mg for hot flasjes. Historical vaccine included first dose of Pfizer COVID 19 vaccine (lot number=EL1284) on 30Dec2020 10:00 AM at left arm for covid-19 immunisation. The patient experienced headache, chills, fever, vomiting and exhaustion, all on 20Jan2021 20:00 with outcome of recovered with sequelae (recovered with lasting effects). Reported as headache, chills, fever, vomiting, and exhaustion the exhaustion lasted more than 3 days and it was severe. Patient had reactions after each short. No treatment received for the adverse event. All events reported as non-serious. Patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Palpitations, Throat tightness
Clinical narrative: her throat closed-up and anaphylactic and she couldn't breathe; her throat closed-up and anaphylactic and she couldn't breathe; her throat closed-up and anaphylactic and she couldn't breathe; had a heart problem/ still have the heart palpitation/made her heart worse; Dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 22Jan2021 at single dose in right arm inside her muscle for COVID-19 immunization, co-suspect drug included hydroxyzine hcl (ATARAX), via an unspecified route of administration from an unspecified date to an unspecified date at 25 mg for an unspecified indication. Medical history reported as none. There were no concomitant medications. The patient did not get the other vaccine. Consumer stated, she was calling to report a reaction to the vaccine. She had a reaction on Friday (22Jan2021), she went to the hospital (further hospitalization details not clarified/confirmed). She had an incident where her throat closed-up and anaphylactic and she couldn't breathe and then she went to the hospital and she got out and also she had a heart problem and dizziness and all this was very scary. She had to go to the doctor today (25Jan2021) and find out if she was okay to go back to work or when she could go back because I can't work today. It was reported that they gave her a prescription to took but she haven't picked it up because that medicine they gave her at the emergency room made her heart worse and she was not going to take it again. She said they gave me the medication at the pharmacy but she was not going to pick it up because they gave her that medicine (ATARAX) at hospital and it made her worse and she didn't want to take it. The one they gave her at the hospital was ATARAX 25 mg, that was the pill they gave her at the hospital. The action taken in response to the events for hydroxyzine was permanently withdrawn on an unspecified date. The outcome of the event had a heart problem/ still have the heart palpitation/made her heart worse was not recovered; of the rest events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Palpitations, Throat tightness
Clinical narrative: her throat closed-up and anaphylactic and she couldn't breathe; her throat closed-up and anaphylactic and she couldn't breathe; her throat closed-up and anaphylactic and she couldn't breathe; had a heart problem/ still have the heart palpitation/made her heart worse; Dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 22Jan2021 at single dose in right arm inside her muscle for COVID-19 immunization, co-suspect drug included hydroxyzine hcl (ATARAX), via an unspecified route of administration from an unspecified date to an unspecified date at 25 mg for an unspecified indication. Medical history reported as none. There were no concomitant medications. The patient did not get the other vaccine. Consumer stated, she was calling to report a reaction to the vaccine. She had a reaction on Friday (22Jan2021), she went to the hospital (further hospitalization details not clarified/confirmed). She had an incident where her throat closed-up and anaphylactic and she couldn't breathe and then she went to the hospital and she got out and also she had a heart problem and dizziness and all this was very scary. She had to go to the doctor today (25Jan2021) and find out if she was okay to go back to work or when she could go back because I can't work today. It was reported that they gave her a prescription to took but she haven't picked it up because that medicine they gave her at the emergency room made her heart worse and she was not going to take it again. She said they gave me the medication at the pharmacy but she was not going to pick it up because they gave her that medicine (ATARAX) at hospital and it made her worse and she didn't want to take it. The one they gave her at the hospital was ATARAX 25 mg, that was the pill they gave her at the hospital. The action taken in response to the events for hydroxyzine was permanently withdrawn on an unspecified date. The outcome of the event had a heart problem/ still have the heart palpitation/made her heart worse was not recovered; of the rest events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Breast pain, Breast tenderness, Lymph node pain, Neck pain
Clinical narrative: Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes under the right arm, and the right side of the neck; Tender lymph nodes under the right arm, and the right side of the neck; tender right breast; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) via an unspecified route of administration in right arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included HTN (hypertension) hereditary. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), verapamil hydrochloride (VERAPAMIL). The patient previously received the first dose of bnt162b2 (Lot number: EK5730) on 22Dec2020 11:00 in right arm for COVID-19 immunization. Events started from 12Jan2021 18:00 included very sore right arm, right underarm, and right breast pain onset the evening of the second dose, tender lymph nodes under the right arm, and the right side of the neck, also, tender right breast. All symptoms still present 13 days later, but better. The adverse event result in Doctor or other healthcare professional office/clinic visit. This is a non-serious report per reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes under the right arm, and the right side of the neck; Tender lymph nodes under the right arm, and the right side of the neck; tender right breast; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) via an unspecified route of administration in right arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included HTN (hypertension) hereditary. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), verapamil hydrochloride (VERAPAMIL). The patient previously received the first dose of bnt162b2 (Lot number: EK5730) on 22Dec2020 11:00 in right arm for COVID-19 immunization. Events started from 12Jan2021 18:00 included very sore right arm, right underarm, and right breast pain onset the evening of the second dose, tender lymph nodes under the right arm, and the right side of the neck, also, tender right breast. All symptoms still present 13 days later, but better. The adverse event result in Doctor or other healthcare professional office/clinic visit. This is a non-serious report per reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore right arm; Very sore right arm, right underarm; right breast pain; Tender lymph nodes under the right arm, and the right side of the neck; Tender lymph nodes under the right arm, and the right side of the neck; tender right breast; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL3248) via an unspecified route of administration in right arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included HTN (hypertension) hereditary. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN HCTZ), verapamil hydrochloride (VERAPAMIL). The patient previously received the first dose of bnt162b2 (Lot number: EK5730) on 22Dec2020 11:00 in right arm for COVID-19 immunization. Events started from 12Jan2021 18:00 included very sore right arm, right underarm, and right breast pain onset the evening of the second dose, tender lymph nodes under the right arm, and the right side of the neck, also, tender right breast. All symptoms still present 13 days later, but better. The adverse event result in Doctor or other healthcare professional office/clinic visit. This is a non-serious report per reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Injection-site pain days 2 and 3.; Nausea at 3 hours post-injection.; Mild headache surrounding event of nausea; This is a spontaneous report from a contactable Other HCP (patient). A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular at left arm on 20Jan2021 12:30 at single dose for COVID-19 immunization. Concomitant medications were not reported. The patient was not pregnant. The patient previously took cefzil and experienced drug hypersensitivity. No other medical history. The patient experienced injection-site pain days 2 and 3, nausea at 3 hours post-injection, mild headache surrounding event of nausea. All events started on 20Jan2021 15:00 (as reported). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Injection-site pain days 2 and 3.; Nausea at 3 hours post-injection.; Mild headache surrounding event of nausea; This is a spontaneous report from a contactable Other HCP (patient). A 23-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular at left arm on 20Jan2021 12:30 at single dose for COVID-19 immunization. Concomitant medications were not reported. The patient was not pregnant. The patient previously took cefzil and experienced drug hypersensitivity. No other medical history. The patient experienced injection-site pain days 2 and 3, nausea at 3 hours post-injection, mild headache surrounding event of nausea. All events started on 20Jan2021 15:00 (as reported). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Nasal congestion
Clinical narrative: Fever/fever that has been as high as 102 degrees Fahrenheit; Terrible headache; Achy; Stuffy nose; Sleep-she slept almost the whole weekend; This is a spontaneous report from a contactable consumer, the patient. A 59-years-old  female patient (consumer) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249, Expiration Date May2021), via an unspecified route of administration  0.3mL injection to right arm  on 22Jan2021 at 15:45 as a single dose, for COVID-19 vaccination. The vaccination was administered at a Hospital. Medical History includes Severe allergic reaction to bee sting (At 14 years of age, stepped on a beehive received 50+ bee stings. Had to use an Epi-pen in response to this possible severe allergic reaction to bees) There were no concomitant medications. No other vaccines were given within 4 weeks. On 23Jan2021 at  08:00 , the patient experienced Terrible side effects,  fever that has been as high as 102 degrees fahrenheit; terrible headache; achy; stuffy nose; and sleep-she slept almost the whole weekend.   The patient underwent lab tests  which included body temperature: 'as high as 102 degrees Fahrenheit' on 23Jan2021. Fever has come down but she still has one. Consumer  had no physician office visits, no emergency room visits and no hospitalizations were involved. Caller inquired how long do the side effects generally last, should  she get the second dose of the vaccine and should she have a COVID test before she goes back to work? The patient's second dose was scheduled for 12Feb2021 but  no dose change made at this time. The clinical outcome of the event fever was recovering, while  headache, achy, stuffy nose, slept most of the weekend was unknown .
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Fever/fever that has been as high as 102 degrees Fahrenheit; Terrible headache; Achy; Stuffy nose; Sleep-she slept almost the whole weekend; This is a spontaneous report from a contactable consumer, the patient. A 59-years-old  female patient (consumer) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249, Expiration Date May2021), via an unspecified route of administration  0.3mL injection to right arm  on 22Jan2021 at 15:45 as a single dose, for COVID-19 vaccination. The vaccination was administered at a Hospital. Medical History includes Severe allergic reaction to bee sting (At 14 years of age, stepped on a beehive received 50+ bee stings. Had to use an Epi-pen in response to this possible severe allergic reaction to bees) There were no concomitant medications. No other vaccines were given within 4 weeks. On 23Jan2021 at  08:00 , the patient experienced Terrible side effects,  fever that has been as high as 102 degrees fahrenheit; terrible headache; achy; stuffy nose; and sleep-she slept almost the whole weekend.   The patient underwent lab tests  which included body temperature: 'as high as 102 degrees Fahrenheit' on 23Jan2021. Fever has come down but she still has one. Consumer  had no physician office visits, no emergency room visits and no hospitalizations were involved. Caller inquired how long do the side effects generally last, should  she get the second dose of the vaccine and should she have a COVID test before she goes back to work? The patient's second dose was scheduled for 12Feb2021 but  no dose change made at this time. The clinical outcome of the event fever was recovering, while  headache, achy, stuffy nose, slept most of the weekend was unknown .