chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration on 30Jan2021 09:30 (at the age of 76-years) as 2nd dose, single dose in left buttocks for covid-19 immunization. Medical history included: slight high blood pressure and unspecified allergies. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included carvedilol 12.5 mg, vitamin d [vitamin d nos], pantoprazole sodium. The patient received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration on 09Jan2021 at 10:30 as 1st dose, single dose in Left buttocks for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 31Jan2021 at 05:00, the patient experienced fever 102.6, chills and aches, headache, soreness at site of injection with a 3 inch red circle. The patient underwent lab tests and procedures which included body temperature: 102.6 on 31Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration on 30Jan2021 09:30 (at the age of 76-years) as 2nd dose, single dose in left buttocks for covid-19 immunization. Medical history included: slight high blood pressure and unspecified allergies. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included carvedilol 12.5 mg, vitamin d [vitamin d nos], pantoprazole sodium. The patient received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration on 09Jan2021 at 10:30 as 1st dose, single dose in Left buttocks for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 31Jan2021 at 05:00, the patient experienced fever 102.6, chills and aches, headache, soreness at site of injection with a 3 inch red circle. The patient underwent lab tests and procedures which included body temperature: 102.6 on 31Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Tremor
Clinical narrative: Headache; dizziness; feeling shakiness of hands; This is a spontaneous report from a contactable Pharmacist. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El8982), via intramuscularly in left arm on 02Feb2021 at 10:00 AM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: El1283), via intramuscularly in left arm on 12Jan2021 as 1st dose, single for COVID-19 immunization. Medical history was not reported. Concomitant medications included multivitamins [vitamins nos] (MULTIVITAMIN) received within 2 weeks of vaccination. Patient had no allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 10:00 AM, patient experienced headache and dizziness reported immediately after vaccine. Patient also reported feeling shakiness of hands. No treatment was received for the adverse events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever  102,5 F and higher; Chilles; Headache; Nausa; This is a spontaneous report from a contactable consumer reported for himself that: A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9262 and expiry date were not reported, Solution for injection) via an unspecified route of administration, administered in arm left on 22Jan2021 at 08:45 AM (at the age of 71-year-old) as single dose for COVID-19 immunization. The medical history included a type 2 diabetes, sleep apnea, hypertension, Coronary artery bypass graft, Post-traumatic stress disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received another vaccine NA (sodium) on the same day of vaccination for unknown indication on 22Jan2021. Patient had no known allergies. The concomitant medications were not reported. On 22Jan2021 at 01:00 PM (same day of vaccination), the patient experienced a fever 102.5 f and higher, chills, nausea, headache. The reporter assessed all the events as non-serious. No treatment was received for events. The outcome of events is recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Diarrhoea, Nausea, Pain
Clinical narrative: High fever; Body aches; Stomach upset; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration on 25Jan2021 at 18:30, Unknown, SINGLE dose for COVID-19 immunisation. The patient medical history included epilepsy, asthma, migraines, diabetes. The patient was allergic to tetracycline and cinnamon. The patient's concomitant medication (s) included topiramate (TROKENDI), oxcarbazepine (TRILEPTAL), verapamil (VERAPAMIL), fluoxetine hydrochloride (PROZAC), Pentobarbital sodium (NEMBUTAL). The patient did not received any other vaccines within four weeks prior to COVID vaccine. The patient did not have COVID before vaccine and no COVID test was done after COVID vaccine. On 27Jan2021 at 13:00, the patient experienced high fever, body aches, stomach upset, nausea, diarrhea. The patient did not received any treatment for this events. All the events were non-serious. The outcome of all the events were recovering.   Follow-up attempts have been completed and no further information is expected.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; Body aches; Stomach upset; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration on 25Jan2021 at 18:30, Unknown, SINGLE dose for COVID-19 immunisation. The patient medical history included epilepsy, asthma, migraines, diabetes. The patient was allergic to tetracycline and cinnamon. The patient's concomitant medication (s) included topiramate (TROKENDI), oxcarbazepine (TRILEPTAL), verapamil (VERAPAMIL), fluoxetine hydrochloride (PROZAC), Pentobarbital sodium (NEMBUTAL). The patient did not received any other vaccines within four weeks prior to COVID vaccine. The patient did not have COVID before vaccine and no COVID test was done after COVID vaccine. On 27Jan2021 at 13:00, the patient experienced high fever, body aches, stomach upset, nausea, diarrhea. The patient did not received any treatment for this events. All the events were non-serious. The outcome of all the events were recovering.   Follow-up attempts have been completed and no further information is expected.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; Sore arm; Felt little sore; This is a spontaneous report from a contactable consumer (patient herself). Follow-up (03Feb2021) information was processed together with initial information:  A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264,), via an unspecified route of administration, administered in Arm on 12Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. It was reported that, After her 1st dose of the covid vaccine about 3 weeks ago patient experienced a low grade fever, a sore arm and Felt little sore on an unspecified date in 2021. The caller enquired on symptoms she is experiencing post covid vaccination and how long to hold off before she is concerned about the symptoms she is experiencing post covid vaccination. Upon Follow up (03Feb2021), it was reported that, When told about the Pfizer medical information department, consumer stated, "That would be really helpful and because I just need to speak to someone to make sure that I mean, my friend had terrible hallucinations. He had a lot of problem. (Further not clarified) I would give it to you. I do not know if I want to have answers to the questions, 10 minutes questions. I am just letting you know." The patient stated, "I would like to because I just do not feel well that is severe. "Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. The outcome of the events was unknown. QR comment: It was not further clarified as the hallucination occurred after taking the Covid 19 vaccine. Hence split case not made.   Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Depressed mood, Fatigue
Clinical narrative: not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/feeling so bad; weak/weakness; miserable; nausea/nauseous; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration (administered in arm Left) on 29Jan2021 at 11:30 AM (at the time of 76-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that her first dose of Pfizer vaccine on 29Jan2021. first dose of the vaccine by injection. Stated having side effects yesterday. Today patient has headache, chills, tired, just not feeling good, weak and miserable. Then all of the sudden yesterday she felt really bad. She was very tired with cold, chills, nausea and weakness. she received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 11:30 AM in the left arm. She was not sure of the time because she was feeling so bad and adds she has not gotten up out of the chair today. Then on 2Feb2021 in the afternoon, she started to felt really bad. Mentions that she thought she was nauseous because she was so nervous about getting the vaccine. Adds it wasn't really just like nausea but more like not wanting to eat. She stopped having chills last night. She was scheduled to get the second dose of the vaccine 19Feb2021. Patient mentioned she was shrinking due to natural aging. The outcome of chills was recovered on 02Feb2021 for tired/very tired and malaise (PT) was not recovered for weak/weakness and nausea (PT) was recovering while for other events was unknown. The reported events felt really bad, tired, nausea and weak were considered as related to suspect product. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nasopharyngitis, Nausea
Clinical narrative: not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/feeling so bad; weak/weakness; miserable; nausea/nauseous; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration (administered in arm Left) on 29Jan2021 at 11:30 AM (at the time of 76-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that her first dose of Pfizer vaccine on 29Jan2021. first dose of the vaccine by injection. Stated having side effects yesterday. Today patient has headache, chills, tired, just not feeling good, weak and miserable. Then all of the sudden yesterday she felt really bad. She was very tired with cold, chills, nausea and weakness. she received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 11:30 AM in the left arm. She was not sure of the time because she was feeling so bad and adds she has not gotten up out of the chair today. Then on 2Feb2021 in the afternoon, she started to felt really bad. Mentions that she thought she was nauseous because she was so nervous about getting the vaccine. Adds it wasn't really just like nausea but more like not wanting to eat. She stopped having chills last night. She was scheduled to get the second dose of the vaccine 19Feb2021. Patient mentioned she was shrinking due to natural aging. The outcome of chills was recovered on 02Feb2021 for tired/very tired and malaise (PT) was not recovered for weak/weakness and nausea (PT) was recovering while for other events was unknown. The reported events felt really bad, tired, nausea and weak were considered as related to suspect product. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; fatigue; This is a spontaneous report was received from a non-contactable consumer or other non-HCP (Patient). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on 01Feb2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had taken 1st dose of vaccine and had no side effects. On 01Feb2021, after second dose, the patient had experienced fever, chills, body aches and fatigue. Symptoms lasted 24 hours and she is now feeling well. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Feb2021, the patient had recovered from the events.  No follow-up attempts are possible; No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Severe headache making it hard to even move head/neck; constant vomiting and nausea; constant vomiting and nausea; chills/trembling; chills/trembling; sweating/night sweats; sweating/night sweats; lightheadedness; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL3248), dose 2 intramuscular, administered in right arm on 02Feb2021 at 07:45 (at the age of 24 years old) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included iron (IRON); fish oil (OMEGA 3 [FISH OIL]); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL0142) dose 1 intramuscular, administered in right arm on 09Jan2021 07:45 for COVID-19 immunization. No Allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 23:45, the patient experienced severe headache making it hard to even move head/neck, constant vomiting and nausea, chills/trembling, sweating/night sweats and lightheadedness. The events assessed as non-serious. The patient was not received treatment for the adverse event. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Tremor, Vomiting
Clinical narrative: Severe headache making it hard to even move head/neck; constant vomiting and nausea; constant vomiting and nausea; chills/trembling; chills/trembling; sweating/night sweats; sweating/night sweats; lightheadedness; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL3248), dose 2 intramuscular, administered in right arm on 02Feb2021 at 07:45 (at the age of 24 years old) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included iron (IRON); fish oil (OMEGA 3 [FISH OIL]); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL0142) dose 1 intramuscular, administered in right arm on 09Jan2021 07:45 for COVID-19 immunization. No Allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 23:45, the patient experienced severe headache making it hard to even move head/neck, constant vomiting and nausea, chills/trembling, sweating/night sweats and lightheadedness. The events assessed as non-serious. The patient was not received treatment for the adverse event. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pyrexia
Clinical narrative: She has been running a low grade fever off and on; has had an eczema outbreak; This is a spontaneous report from a contactable consumer (mother reported for her daughter). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that my daughter got the Pfizer vaccine a week ago yesterday. She has been running a low-grade fever off and on and has had an eczema outbreak. caller states her daughter has already reported her symptoms. She was asking that whether it was normal or not. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she was running a low grade fever 2 days after; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Unknown, Batch/Lot number: Unknown), via an unspecified route of administration on 30Jan2021 as a, 1st dose single for covid-19 immunization. The patient's Medical History and concomitant medications were not reported. Patient reported that she received the 1st dose of the vaccine last Saturday morning and experienced no side effects other than she thought she was running a low-grade fever 2 days after on 01Feb2021. The Outcome event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Fever up to 101.1F; chills; full body aches; headaches; stiffness/pain in neck/back; exhaustion; inappropriate schedule of vaccine administered; This is a spontaneous report received from a non-contactable physician (patient).  A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/lot number: EL3247; Expiration date not reported) via an unspecified route of administration, in right arm on 01Feb2021 (at the age of 30 years) as a single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/lot number: EL3249 and Expiration date not reported) via an unspecified route of administration, in right arm on 13Jan2021 as a single dose for COVID-19 immunization. The concomitant medications included Tylenol (PRN), Empresse OCP, Vitamin D and fish oil. The Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was allergic to Tylenol cold and flu liquid. On 02Feb2021, the patient had experienced Fever up to 101.1F, chills, full body aches, headaches, stiffness/pain in neck/back, exhaustion. The laboratory tests and procedures include Body temperature with results 101.1 F. The treatment received included Tylenol. The clinical outcome for the events Fever up to 101.1F, chills, full body aches, headaches, stiffness/pain in neck/back, exhaustion was reported as recovering. The outcome for inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Fever up to 101.1F; chills; full body aches; headaches; stiffness/pain in neck/back; exhaustion; inappropriate schedule of vaccine administered; This is a spontaneous report received from a non-contactable physician (patient).  A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/lot number: EL3247; Expiration date not reported) via an unspecified route of administration, in right arm on 01Feb2021 (at the age of 30 years) as a single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/lot number: EL3249 and Expiration date not reported) via an unspecified route of administration, in right arm on 13Jan2021 as a single dose for COVID-19 immunization. The concomitant medications included Tylenol (PRN), Empresse OCP, Vitamin D and fish oil. The Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was allergic to Tylenol cold and flu liquid. On 02Feb2021, the patient had experienced Fever up to 101.1F, chills, full body aches, headaches, stiffness/pain in neck/back, exhaustion. The laboratory tests and procedures include Body temperature with results 101.1 F. The treatment received included Tylenol. The clinical outcome for the events Fever up to 101.1F, chills, full body aches, headaches, stiffness/pain in neck/back, exhaustion was reported as recovering. The outcome for inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Headache, Hot flush, Nausea
Clinical narrative: Severe headache; nausea; Kidney and back pain; Kidney and back pain; Palpitations; Hot flashes; Whole body pain; Cough; This is a spontaneous report from a contactable other health care professional (patient).  An adult female patient of an unspecified age (age: 58, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EL8982), via an unspecified route of administration, administered in right arm on 15Jan2021 as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included known allergies to nuts, drug allergy to metronidazole [FLAGYL] and hashimotos disease. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) and vitamins. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021, the patient experienced headache, nausea, kidney and back pain, palpitations, hot flashes, whole body pain, cough. The patient not received treatment for the adverse events. The body back and kidney pain lasted 4 days and the rest has lasted over 2 weeks. The patient reported that she was on due for Second dose of COVID vaccine on 06Feb2021. The events were reported as non-serious. The outcome of the events were recovering.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Renal pain
Clinical narrative: Severe headache; nausea; Kidney and back pain; Kidney and back pain; Palpitations; Hot flashes; Whole body pain; Cough; This is a spontaneous report from a contactable other health care professional (patient).  An adult female patient of an unspecified age (age: 58, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EL8982), via an unspecified route of administration, administered in right arm on 15Jan2021 as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included known allergies to nuts, drug allergy to metronidazole [FLAGYL] and hashimotos disease. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) and vitamins. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Jan2021, the patient experienced headache, nausea, kidney and back pain, palpitations, hot flashes, whole body pain, cough. The patient not received treatment for the adverse events. The body back and kidney pain lasted 4 days and the rest has lasted over 2 weeks. The patient reported that she was on due for Second dose of COVID vaccine on 06Feb2021. The events were reported as non-serious. The outcome of the events were recovering.  Follow-up attempts are completed. No further information was expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Underdose
Clinical narrative: patient doesn't think she got the second dose completely; a little muscle pain; 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, lot number: CZ8982 Expiration date was not reported), via an unspecified route of administration on 27Jan2021 as a 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously took first dose of BNT162B2 (lot number: EL3246) on 06Jan2021 at 71-years on the upper left arm for COVID-19 immunization and with the first dose she felt the little warmth or gush of the medication going in, not pain. It was reported that the patient got the second dose. The person who gave the shot seemed very frail which is ok, but she did not feel any heat or anything to say it went in. The patient doesn't think she got the second dose completely. She stated that "the administrator touched my arm and then dropped the needle so without soreness or reaction. I could not feel if it was even administered which was concerning until the next day when I did have a little muscle pain on 27Jan2021". Where it should have gone. Nothing else. Outcome of the events was unknown.  Follow-up (23Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP follow-up letter sent which included New information that: Drug lot number CZ8982, Country of occurrence unknown, and mentioned that No issues with Pfizer product.  Follow-up (10May2021): Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Headache; Injection site soreness; General malaise; This is a spontaneous report received from a contactable consumer (Patient herself). A 25-year-old non pregnant female patient previously received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in arm left on 11Jan2021 at 07:00 as first single dose for covid-19 immunisation and second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in arm right on 01Feb2021 at 07:00 as second single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported, and concomitant medication included insulin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for covid-19 since the vaccination. On 02Feb2021 at 12:00, the patient experienced fever, chills, headache, injection site soreness and general malaise. The case classified as non-serious. No treatment was received for adverse events. The events were recovered on 02Feb2021.  No follow-up attempts are possible. No further information is expected.  Follow-up (09Feb2021) and (09Feb2021): New follow up spontaneous report received in response to mail trail sent for query regarding confirmation of Pfizer receipt date. This report included that: the receipt date would have been Tuesday 02Feb2021.  Follow-up (09Feb2021): This follow-up contains no new medically significant information.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm/ pain in the arm/I woke up in the middle of the night and I had pain in the arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 69-year-old male patient received second dose of BNT162B2 (Pfizer-BioNtech Covid-19 vaccine, Lot number: unknown, Expiration date: 31May2021), via an unspecified route on 03Feb2021 at 16:00 (at the age of 69-years) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient took first dose of BNT162B2 (Pfizer-BioNtech Covid-19 vaccine) on an unspecified date, as a single dose for COVID-19 immunization. On 04Feb2021 (one day after vaccination), patient woke up in the middle of the night and had pain in the arm and headache. Nurse and doctor told him that if he experienced any post-vaccination symptoms, he could take ibuprofen or Tylenol. Therapeutic measure taken as a result of events included Advil which he took on 04Feb2021 morning. Patient enquired if he could take ibuprofen or Tylenol or if this will affect the effectiveness of the vaccine. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever; Chills; Body aches; Extreme fatigue; Terrible headache for 24 hours; This is a spontaneous report from a contactable Nurse (patient). A 30-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265) via an unspecified route of administration, administered in left arm on 03Feb2021 at 14:00 (at the age of 30-years-old) as a SINGLE DOSE for covid-19 immunization. Not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Allergies to medications, food, or other products: Penicillin. Patient previously received first dose of BNT162B2 lot number: EL3249, at left arm on13Jan2021 at 01:00 PM for covid-19 immunization. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient has not tested for COVID-19. On 03Feb2021 at 06:00pm, 4hrs after the administration of vaccine the patient experienced Fever, chills, body aches, extreme fatigue and terrible headache for 24 hours. On 03Feb2021 Lab test included Body temperature: Fever. No treatment received for the adverse event. The seriousness criteria reported as non-serious. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Body aches; Extreme fatigue; Terrible headache for 24 hours; This is a spontaneous report from a contactable Nurse (patient). A 30-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265) via an unspecified route of administration, administered in left arm on 03Feb2021 at 14:00 (at the age of 30-years-old) as a SINGLE DOSE for covid-19 immunization. Not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Allergies to medications, food, or other products: Penicillin. Patient previously received first dose of BNT162B2 lot number: EL3249, at left arm on13Jan2021 at 01:00 PM for covid-19 immunization. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient has not tested for COVID-19. On 03Feb2021 at 06:00pm, 4hrs after the administration of vaccine the patient experienced Fever, chills, body aches, extreme fatigue and terrible headache for 24 hours. On 03Feb2021 Lab test included Body temperature: Fever. No treatment received for the adverse event. The seriousness criteria reported as non-serious. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Ear pain, Headache, Hypertension
Clinical narrative: This is a spontaneous report from a contactable Other HCP (patient, self-reported). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL8982 and expiry date was not reported), via intramuscularly, in Arm Left, on 25Jan2021 at 04:45 PM, as a single dose for COVID-19 immunization at hospital. The patient received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via intramuscularly, in Arm Right, on 04Jan2021 at 04:45 PM, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included known allergies: mushrooms, Levaquin and cipro, hypertension, and thyroid cancer. The patient received medications Amlodipine, Levothyroxine, and fenofibrate in two weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that in first 36 hrs, she was fine but by 06Feb2021 at 06:00 AM, she had the worst headache ever focused on her left temple. She happened to have an eye exam scheduled for that day and was told that her IOP was 21 in her left eye. She experienced photosensitivity for the following 2 days. Then she ended up in the ER from the headache and pressure she felt in her eye. Her blood pressure was 162/125. She was now 11 days post vaccine and currently still had a headache and experiencing light sensitivity focused in her left temple into her scalp and now had inner ear pain and jaw pain. At times, she felt short of breath as well. The events resulted in emergency room/department or urgent care. The patient received cocktail Compazine, Benadryl and Tylenol as treatment for the event headache. The patient also received unknown treatment for other events. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Intraocular pressure test, Intraocular pressure test abnormal, Pain in jaw, Photosensitivity reaction
Clinical narrative: This is a spontaneous report from a contactable Other HCP (patient, self-reported). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL8982 and expiry date was not reported), via intramuscularly, in Arm Left, on 25Jan2021 at 04:45 PM, as a single dose for COVID-19 immunization at hospital. The patient received first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via intramuscularly, in Arm Right, on 04Jan2021 at 04:45 PM, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included known allergies: mushrooms, Levaquin and cipro, hypertension, and thyroid cancer. The patient received medications Amlodipine, Levothyroxine, and fenofibrate in two weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The patient reported that in first 36 hrs, she was fine but by 06Feb2021 at 06:00 AM, she had the worst headache ever focused on her left temple. She happened to have an eye exam scheduled for that day and was told that her IOP was 21 in her left eye. She experienced photosensitivity for the following 2 days. Then she ended up in the ER from the headache and pressure she felt in her eye. Her blood pressure was 162/125. She was now 11 days post vaccine and currently still had a headache and experiencing light sensitivity focused in her left temple into her scalp and now had inner ear pain and jaw pain. At times, she felt short of breath as well. The events resulted in emergency room/department or urgent care. The patient received cocktail Compazine, Benadryl and Tylenol as treatment for the event headache. The patient also received unknown treatment for other events. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report was received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported ), via an unspecified route of administration on 03Feb2021 as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported that the patient received first dose of the Pfizer covid vaccine yesterday on 03Feb2021 and was having a bit of a headache. She called her HCP and said it was okay to take Tylenol (paracetamol) and decided to call us to see what information we have on our side. The patient took treatment with Tylenol. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: checked my B/P and it was 165/99/ blood pressure measurement: staying elevated in 140's ever since; his blood pressure was 168/99, and it has been fluctuating ever since; HA/had a really bad headache; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EL8982), via an unspecified route of administration in arm left on 31Jan2021 14:00 as 2nd dose, single for COVID-19 immunisation. Medical history included, cardiac pacemaker insertion from 12Mar2019 to an unknown date, blood pressure abnormal, anticoagulant therapy, blood cholesterol abnormal from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium taken for blood pressure abnormal from an unspecified start date and ongoing, hydrochlorothiazide taken for blood pressure abnormal, start and stop date were not reported, aspirin taken for anticoagulant therapy and ezetimibe taken for blood cholesterol abnormal from an unspecified start date and ongoing. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had events reported as "checked my b/p and it was 165/99" then at 10:00am it was 148/84 and it had been staying elevated in 140's ever since/he took his blood pressure, and it was 165/99. it has been in the 130 to 140 ever since then, had a really bad headache, his blood pressure was 168/99, and it has been fluctuating ever since on 01Feb2021. The patient's blood pressure was recorded as 165/99 on 01Feb2021, 130/71 on 02Feb2021, 168/99 on 03Feb2021, 123/69 on 04Feb2021. On unknown dates, the patient underwent blood pressure measurement and results were reported as 148/84; staying elevated in 140's; 168/99; fluctuating ever since; it has been in the 130 to 140 ever since then. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Description of complaint: Consumer reporting an AE for the second dose of the Pfizer COVID 19 vaccine, while providing concomitant products caller mentions he used to take a statin called Atorvastatin before he switched to Ezetimibe three years ago. He does not have any product or information to provide NDC, lot or expiration date for Atorvastatin he used to take. The outcome for the events was reported as recovered for events Blood Pressure increased and headache. Outcome of the event blood pressure fluctuation was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: Fever; throwing up; heart rate was going up/heart rate from 80 to 150; Shivers; This is a spontaneous report from a contactable consumer or other non-Health Professional. A 25-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 at 01 pm (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021, 1 day after vaccination at 1 am the patient woke up with a fever, and she was throwing up until 1 o clock today, heart rate was going up/heart rate from 80 to 150, shivers. The patient underwent lab tests and procedures which included body temperature as going up, heart rate as 80 to 150, heart rate going up on 04Feb2021. She gave her Tylenol because her fever was going up. She was wondering she could take a Xanax. That way she can see if it is her anxiety or the vaccine that is raising her heart rate. The outcome of events was not recovered.   Follow-up attempts are completed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever; throwing up; heart rate was going up/heart rate from 80 to 150; Shivers; This is a spontaneous report from a contactable consumer or other non-Health Professional. A 25-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 at 01 pm (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021, 1 day after vaccination at 1 am the patient woke up with a fever, and she was throwing up until 1 o clock today, heart rate was going up/heart rate from 80 to 150, shivers. The patient underwent lab tests and procedures which included body temperature as going up, heart rate as 80 to 150, heart rate going up on 04Feb2021. She gave her Tylenol because her fever was going up. She was wondering she could take a Xanax. That way she can see if it is her anxiety or the vaccine that is raising her heart rate. The outcome of events was not recovered.   Follow-up attempts are completed. Information on the lot/batch number has been requested.