chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Dizzy when standing; arm pain; fever; This is a spontaneous report from a non-contactable consumer (patient).   A 25-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3247), via an unspecified route of administration, in right arm on 10Feb2021 at 10:45 (at the age of 25 years old) as a dose 2 single for COVID-19 immunization. Patient had medical history of shellfish allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC). Patient doesnt had a COVID prior vaccination. Patient had not tested to COVID post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247) in left arm on 20Jan2021 at 10:45 as a dose 1 single for covid-19 immunization. On 11Feb2021 the patient experienced headache, dizzy when standing, arm pain and fever. The patient did not receive any treatment for the events. The outcome of the events was recovered on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Lymphadenopathy, Malaise
Clinical narrative: Swollen lymph node; Headache; Nausea; Feeling unwell; Dizziness; Weakness; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had headache, nausea, feeling unwell, swollen lymph node, dizziness and weakness. Reporter (Husband) stated that he had a question regarding the, regarding the side effects she (wife) is having from her first dose (COVID 19 Vaccine). Primarily a headache but also some nausea and feeling unwell, and swollen lymph node. She also had some dizziness and weakness which is continuing. Question was, with those side effects, we have heard that the side effects are even worst with the second dose and we are wondering about the safety of her getting a second dose or not. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Swollen lymph node; Headache; Nausea; Feeling unwell; Dizziness; Weakness; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had headache, nausea, feeling unwell, swollen lymph node, dizziness and weakness. Reporter (Husband) stated that he had a question regarding the, regarding the side effects she (wife) is having from her first dose (COVID 19 Vaccine). Primarily a headache but also some nausea and feeling unwell, and swollen lymph node. She also had some dizziness and weakness which is continuing. Question was, with those side effects, we have heard that the side effects are even worst with the second dose and we are wondering about the safety of her getting a second dose or not. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling jittery, Headache, Pain in extremity
Clinical narrative: Light grade headache; Diarrhea, the loose bowels; Jittery feeling/the jitteriness; Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. When she got her first shot she had quite a few side effects that was listed. When probed for side effects, consumer stated, just the normal one that had listed, On an unspecified date patient had light grade headache, the diarrhea, the loose bowels, the jitteriness, the jittery feeling and of course the sore arm but that she know everybody got that sore arm (further clarification unknown). But she was just wondering if that was all natural to get all of those. The outcome of events was unknown.  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: Chills, Pain, Pyrexia, Somnolence
Clinical narrative: became a boss ass bitch fever; chills; sleepy; sore; This is a spontaneous report from a non-contactable consumer or other non-Health Care Professional. A adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient received any other vaccines within 4 weeks prior to the Covid vaccine was unknown.The patient received other medications of vaccination was unknown. Patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) on an unspecified date for Covid-19 immunization. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. On 11Feb2021 the patient experienced became a boss ass bitch fever, chills, sleepy, sore. On an unspecified date FEB2021 the outcome of event was recovered.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: moderate pain at injection site after 12 hrs; fatigue after 12 hours; This is a spontaneous report from a non-contactable consumer (patient) received via COVAES. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 20Jan2021 at 06:15 PM (Batch/Lot Number: EL1283) (at the age of 20 years old) as dose 1, single for COVID-19 immunisation in a hospital. The patient has no relevant medical history. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cefdinir. On 21Jan2021 at 06:15 AM, 12 hours after the first dose vaccination, the patient experienced moderate pain at injection site and fatigue. The patient did not receive treatment for the events. The patient was recovering from the events on the time of the report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Severe headaches; Difficulty maintaining thoughts or focus/Cloudy head; Sweats; Sweats/chills; Severe sudden onset exhaustion; This is a spontaneous report from a non-contactable other healthcare professional.     A 34-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none and concomitant medications was reported as no. The patient previously took cefixime (BIOXIN) and experienced allergies. On an unspecified date, the patient experienced severe headaches, difficulty maintaining thoughts or focus/cloudy head, and sweats/chills, severe sudden onset exhaustion. It was reported unknown if patient had COVID prior vaccination and the patient did not test for COVID post vaccination. The facility type vaccine was reported as hospital. No other vaccine in four weeks and no other medications in two weeks. There was no treatment received for the events. The patient recovered from all the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mumps, Swelling face
Clinical narrative: Much Swelling on left side of face - in lymph node area below ear; Looks like having the mumps on one side of the face; This is a spontaneous report from a contactable consumer (patient). A non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Em9810), via an unspecified route of administration, administered in the left arm on 06Feb2021 09:00 as dose 1, single for COVID-19 immunisation. The patient' s medical history included Acid reflux. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced allergy. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in four weeks and other medications in two weeks was Pantoprozole. Patient did not have COVID prior vaccination and COVID was not tested post vaccination. On 12Feb2021 16:00, the patient experienced much swelling on left side of face in lymph node area below ear, looks like having the mumps on one side of the face. Patient did not receive treatment for adverse events. The outcome of events was unknown.   Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Vomiting
Clinical narrative: I feel weak; I throw up two times; Dizzy; Headache; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection; Lot number not reported) via unspecified route of administration on 09Feb2021 (at age of 66-years-old) as dose1, single for Covid-19 immunisation. Medical history and concomitant medication were not reported. On 10Feb2021 (1 day after vaccination), patient was dizzy and had headache. On 11Feb2021 (2 days after vaccination), patient throw up two times. On 12Feb2021 (3 days after vaccination) patient feel weak. Consumer stated that he got his first shot this past Tuesday(09Feb2021) and was fine, don't have any side effects or anything and everything was fine. Wednesday(10Feb2021) woke up and was dizzy for weeks and have slight headache. So, Wednesday passes he ate regular dinner and Wednesday night threw up two times and today Thursday saw the same problem. Patient was dizzy, feel weak and a slight headache. He drunk five glasses of the water, 1 tea and a bottle of nutrients nos (ENSURE). It was like a vitamin thing that was taken, a drink that taken and then took cracker. This seems like patient threw up at 1 o'clock last night and 3 o'clock. So, have not thrown up since then but still feeling very dizzy, that goes hanging around with him. The outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Chills; slight headache; Tiredness; stiff arm; soreness at injection site; swelling in left arm; nausea which was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL8982, Expiration date: Unknown) via unspecified route of administration on Left arm on an 04Feb2021 at 10:47 (80-year-old vaccination) as a Dose 2, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. Vaccination Facility Type was reported as Clinic and not military facility. The patient had not history of all previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302) via unspecified route of administration on an 14Jan2021 (80-year-old vaccination) as a Dose 1, single for COVID-19 immunization. The reporter mentioned that she took Covid-19 vaccine just to prevent from the virus. She had been having symptoms. On 05Feb2021, the patient had experienced soreness at injection site, swelling in left arm, stiff arm. On 06Feb2021, the patient had experienced tiredness, slight headache. On an unknown date in 2021, the patient had experienced nausea which was reported as worsened. On 09Feb2021, the patient had experienced chills. She was asking how long these symptoms would last. The tiredness was ongoing. If she was still and relaxed, she felt fine. When she started moving the tiredness comes back. She was unable to take her dog for a walk. She still had bouts of chills. Putting on socks or using a blanket abates it. It was not significant. It was only minor. No investigation assessment was performed. No relevant test was reported. These adverse events did not result emergency room or physician visit. The outcome of the events soreness at injection site, stiff arm was recovered on 06Feb2021, swelling in left arm on 07Feb2021 and the outcome of other events not recovered.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: Chills; slight headache; Tiredness; stiff arm; soreness at injection site; swelling in left arm; nausea which was reported as worsened; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL8982, Expiration date: Unknown) via unspecified route of administration on Left arm on an 04Feb2021 at 10:47 (80-year-old vaccination) as a Dose 2, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. Vaccination Facility Type was reported as Clinic and not military facility. The patient had not history of all previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302) via unspecified route of administration on an 14Jan2021 (80-year-old vaccination) as a Dose 1, single for COVID-19 immunization. The reporter mentioned that she took Covid-19 vaccine just to prevent from the virus. She had been having symptoms. On 05Feb2021, the patient had experienced soreness at injection site, swelling in left arm, stiff arm. On 06Feb2021, the patient had experienced tiredness, slight headache. On an unknown date in 2021, the patient had experienced nausea which was reported as worsened. On 09Feb2021, the patient had experienced chills. She was asking how long these symptoms would last. The tiredness was ongoing. If she was still and relaxed, she felt fine. When she started moving the tiredness comes back. She was unable to take her dog for a walk. She still had bouts of chills. Putting on socks or using a blanket abates it. It was not significant. It was only minor. No investigation assessment was performed. No relevant test was reported. These adverse events did not result emergency room or physician visit. The outcome of the events soreness at injection site, stiff arm was recovered on 06Feb2021, swelling in left arm on 07Feb2021 and the outcome of other events not recovered.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Heart rate, Heart rate increased
Clinical narrative: Pain in arm pit on injection side; racing heart rate at random intervals; headache; This is a spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 11:30 (at the age of 48-years) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included hypertension, high cholesterol, Generalized anxiety disorder (GAD) from an unknown date. The patient had no allergies. Concomitant medication(s) included lisinopril; atenolol and citalopram all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pain in arm pit on injection side, racing heart rate at random intervals, headache on 10Feb2021 18:30. The patient did not receive any treatment for the events. The outcome for all events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in her right wrist/pain in her left wrist; This is a spontaneous report from a contactable consumer (reported for herself). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, administered in arm left on 19Jan2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Jan2021, the patient experienced pain in her right wrist/pain in her left wrist. Therapeutic measures were taken as a result of event with included treatment with Tylenol and Tylenol arthritis. Dose 2 was scheduled on 09Feb2021. The outcome of the event was not resolved.  Description of Product Complaint: Description of complaint: She said that she had the first vaccine, and she plays tennis and had a pain in the right hand and wrist. She was getting it in the left wrist too playing tennis. She said that she wondered if it was arthritis. She said that she took Tylenol and Tylenol arthritis, and it was not really doing anything to help it. She stated that the pain was not alleviated with the Tylenol for arthritis. By process of elimination, she thought it was the vaccine. , Lot, or expiration date for the Tylenol or Tylenol Arthritis. She thinks she bought it a year ago and said that it all should've been ok.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This is a spontaneous report from a contactable consumer.This is report 2 of 2. This consumer (wife) reported for a 62-year-old male patient (husband) that: A 62-years-old male patient received bnt162b2 (Solution injection; Lot Number: EM9810), intramuscular, administered in Arm Left on 02Feb2021 at 10:00 am (at the age of 62-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included follicular b cell lymphoma from 2006 to an unknown date and cancer from 2006 to an unknown date. Patient did not receive any other vaccine with 4 weeks prior to vaccination. The patient's concomitant medications were not reported. The patient experienced sore left arm on 02Feb2021. Caller stated that her husband did not have any side effects aside from a sore arm. He had a sore left arm but it was not bad and the soreness recovered two days later. He did really good. AE(s) did not require a visit to Emergency Room or Physician Office. The outcome of the event was recovered on unspecified date in Feb2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: right inside armpit, had large lymphnode last week, it is now smaller. Then new large behind lymphnode behind left ear started two days ago, today small lymphnode on left side neck 4 inch; This is a spontaneous report from a contactable Other HCP. This 51-year-old non-pregnant female patient/ Other HCP reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in Jan2021 at 02:00 PM in right arm as dose 1, single for COVID-19 immunization. The medical history of the patient included allergy to chemicals, was overweight, neck and back injury, gout and neck and back injury. It was mentioned that patient did not receive other vaccine in four week and was prescribed other medications in two weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination. On an unknown date in Jan2021 the patient experienced right inside armpit, had large lymphnode last week, it was now smaller. Then new large behind lymphnode behind left ear started two days ago, today small lymphnode on left side neck 4 inch below the left ear (lymphadenopathy). It was unknown if any treatment was received. The patient had not recovered.  Information about Batch/Lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain
Clinical narrative: after first dose, very mild side effects like body aches and stomach upset; after first dose, very mild side effects like body aches and stomach upset; This is a spontaneous report from a contactable consumer (patient herself).  A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247; Expiration Date: May2021) via an unspecified route of administration on 17Jan2021 as DOSE 1, SINGLE (age at vaccination was 39 years old) for covid-19 immunisation. Medical history was none. There were no concomitant medications. On an unknown date in 2021, after first dose, patient experienced very mild side effects like body aches and stomach upset that subsided within 36 hours. The outcome of both the events was resolving.   Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: fever of 101F; severe pain at injection site after 1 hr; fatigue after 24 hours/fatigue after 36 hours; extreme nausea; This is a spontaneous report from a non-contactable consumer (patient herself). A 20-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9264; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 10Feb2021 18:30 (at age of 20-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history reported as none. Concomitant medication included cefdinir (CEFDINIR) taken for an unspecified indication. Patient had not any known allergies. Patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1283; Expiration date: unknown) via an unspecified route of administration, administered in Arm left on 20Jan2021 18:15 (at age of 20-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 19:30 after 1 hour of vaccination patient experienced severe pain at injection site, fever of 101F on 11Feb2021 18:30 after 24 hours of vaccination. Fatigue after 24 hours/fatigue after 36 hours and extreme nausea on 2021. Patient did not receive any treatment for adverse events. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on an unspecified date in 2021; fever of 101F. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 78-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection), at the age of 78, intramuscularly, in upper left arm, on Feb 9, 2021, single dose, for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, formulation solution for injection), intramuscularly, in upper left arm, on Jan 19, 2021, single dose, for COVID-19 immunization; patient experienced pain in her right wrist/left wrist. Family medical history relevant to AE included both of her parents had arthritis. The patient 's medical history and concomitant medications not reported. On Feb 9, 2021, patient experienced pain in her ankle and patient experienced little bit more pain on an unspecified date. Patient said she got the second vaccine yesterday afternoon Feb 9, 2021 and had a little bit more pain. She was in bed last night and started having pain in her ankle. She said that it is tolerable. She read that joint pain was a side effect. She inquired regarding how long it takes before that clears up and if this permanent damage or will this go away. The outcome of pain in her ankle was recovered last night on Feb 9, 2021. The outcome of little bit more pain: unknown. Information on the lot/batch number requested. Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Neck pain
Clinical narrative: Headache; Back aches-lower back; Back aches-lower back and shoulders/neck; Back aches-lower back and shoulders/neck; Chills; night sweats; Slight throat discomfort; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL9261; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 03Feb2021 01:15 PM (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation at a Hospital. The patient's medical history was not reported. Concomitant medications included biotin, bifidobacterium lactis (PROBIOTIC), vitamin b and an unspecified oral contraceptive; all taken for an unknown indication, stop and start dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL3249; Expiration date was not reported), administered in the left arm on 13Jan2021 10:30 AM (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced headache, back aches-lower back and shoulders/neck, chills, night sweats and slight throat discomfort on 05Feb2021 01:00 PM. No treatment was taken for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Oropharyngeal discomfort
Clinical narrative: Headache; Back aches-lower back; Back aches-lower back and shoulders/neck; Back aches-lower back and shoulders/neck; Chills; night sweats; Slight throat discomfort; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL9261; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 03Feb2021 01:15 PM (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation at a Hospital. The patient's medical history was not reported. Concomitant medications included biotin, bifidobacterium lactis (PROBIOTIC), vitamin b and an unspecified oral contraceptive; all taken for an unknown indication, stop and start dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL3249; Expiration date was not reported), administered in the left arm on 13Jan2021 10:30 AM (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient experienced headache, back aches-lower back and shoulders/neck, chills, night sweats and slight throat discomfort on 05Feb2021 01:00 PM. No treatment was taken for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from contactable consumer. This 60-year-old male consumer (patient) reported for himself. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine Solution for injection Lot number was not reported) via an unspecified route of administration on 10Feb2021 14:00 as dose number unknown, single (age at vaccination: 60 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Feb2021 16:30, the patient experienced headache. It was reported by the patient that he was a senior, living by himself in a senior community, took the shot at 2'oclock and then at 04:30, experienced a headache. Also, he was reading a paper and it says he was not the only one, but people are also complaining about headache, took Tylenol 500 mg as treatment, it became little better and asked what he should take, it goes if I take the Tylenol and queried that does it go or stays and for how many days it stays. The clinical outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Face, arm and neck rash; Red around nail beds of fingers; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 62-year-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 19:45 (Batch/Lot Number: En6201) as DOSE 1, SINGLE (at the age of 62-year-old) for covid-19 immunisation. Medical history included Et (platelets disorder) and Known allergies to Mangos, walnuts, red peppers and Latex from an unknown date and unknown if ongoing. Concomitant medications included interferon alfa-2b and acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had face, arm and neck rash and red around nail beds of fingers on 10Feb2021 at 20:45. It was reported that this event lasted about an hour then went away. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events reported as recovered on 10Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: She also reported that her neighbor had her first shot recently and complained of temporary wrist pain in the inject arm as well; This is a spontaneous report from a contactable Consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date s dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. it was unknown whether patient had any known allergies. the patient was not pregnant at the time of vaccination. Facility type vaccine was public health clinic/veterans administration facility. No other vaccine in four weeks was administered. It was unknown whether any medications patient took in two weeks. On an unspecified date, patient experienced soreness at injection site and achy feeling in left wrist. She also reported that her neighbor had her first shot recently and complained of temporary wrist pain in the inject arm as well. "Feels like just before your hand goes to sleep". She also stated another neighbor had the injection previously and was "very" bruised in the injection site "looks like I was beat up". No treatment was given for the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was unknown.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Tired; Muscle pain on shoulder; Joint pain on knee; Fatigue; Follow-up attempts are completed. No further information is expected.  This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 01Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a vaccine on 01Feb2021 at Hospital in "PRIVACY" and on 05Feb2021, last Friday, the patient had the fatigue and muscle pain and joint pain and today, it was the fifth or sixth day from vaccination. When clarified the concern, consumer stated, "Today (10Feb2021), I had fatigue and I am tired and muscle pain on shoulder and joint pain on knee and I am 87 years old. I need to know is that normal or what I need to do". The outcome of the events was unknown.  Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Lymphadenopathy
Clinical narrative: Lymph nodes in neck blown up to where it is swollen to his temple; Feel punky; Headache; This is a spontaneous report from a contactable Consumer. This male Consumer (patient) reported that: A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 at 16:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that he received Pfizer COVID-19 Vaccine second dose yesterday at 4PM Pacific coast time. Was feeling great when he got up. Started to feel punky, had a headache, and those kinds of things. Then his left lymph nodes in his neck had blown up to the point where it is swollen to his temple. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: Approximately 30 hours after vaccination I felt sick; I had a fever of 101.2 and chills; I had a fever of 101.2 and chills; I felt incredibly nauseous and lost my appetite; I felt incredibly nauseous and lost my appetite; I was pale and felt weak; I had a severe headache; I'm left with a sore right arm; I was pale and felt weak; Approximately 2 hours after vaccination I was very tired and slept about 6 hours; This is a spontaneous report received from a contactable Other Health Professional. A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 00:45 as (At the age of 21-year) DOSE 1, SINGLE for covid-19 immunisation. Medical history included granuloma annulare, migraine and autoimmune thyroiditis from an unknown date. The patient's concomitant medications were not reported. Patient had No known allergies. No covid tested post vaccination. No covid prior vaccination. Patient did not receive Other medications in two weeks. It was unknown if patient was pregnant at the time of vaccination. Patient took Other vaccine 4 weeks include HPV vaccine dose number 2 in Left arm on 15Jan2021 and Tdap booster in Right arm on 15Jan2021. It was reported that Approximately 2 hours after vaccination patient was very tired on 09Feb2021 and slept about 6 hours. Patient felt great afterwards. Approximately 30 hours after vaccination patient felt sick. Patient had a fever of 101.2 and chills. Patient felt incredibly nauseous and lost his appetite. patient was pale and felt weak. Patient had a severe headache. Approximately 48 hours after vaccination most side effects have been resolved and I'm left with a sore right arm on 10Feb2021. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 101.2 on 10Feb2021. The outcome of event i'm left with a sore right arm was not recovered, and outcome of all other events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Pain in extremity, Pallor
Clinical narrative: Approximately 30 hours after vaccination I felt sick; I had a fever of 101.2 and chills; I had a fever of 101.2 and chills; I felt incredibly nauseous and lost my appetite; I felt incredibly nauseous and lost my appetite; I was pale and felt weak; I had a severe headache; I'm left with a sore right arm; I was pale and felt weak; Approximately 2 hours after vaccination I was very tired and slept about 6 hours; This is a spontaneous report received from a contactable Other Health Professional. A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 00:45 as (At the age of 21-year) DOSE 1, SINGLE for covid-19 immunisation. Medical history included granuloma annulare, migraine and autoimmune thyroiditis from an unknown date. The patient's concomitant medications were not reported. Patient had No known allergies. No covid tested post vaccination. No covid prior vaccination. Patient did not receive Other medications in two weeks. It was unknown if patient was pregnant at the time of vaccination. Patient took Other vaccine 4 weeks include HPV vaccine dose number 2 in Left arm on 15Jan2021 and Tdap booster in Right arm on 15Jan2021. It was reported that Approximately 2 hours after vaccination patient was very tired on 09Feb2021 and slept about 6 hours. Patient felt great afterwards. Approximately 30 hours after vaccination patient felt sick. Patient had a fever of 101.2 and chills. Patient felt incredibly nauseous and lost his appetite. patient was pale and felt weak. Patient had a severe headache. Approximately 48 hours after vaccination most side effects have been resolved and I'm left with a sore right arm on 10Feb2021. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 101.2 on 10Feb2021. The outcome of event i'm left with a sore right arm was not recovered, and outcome of all other events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Approximately 30 hours after vaccination I felt sick; I had a fever of 101.2 and chills; I had a fever of 101.2 and chills; I felt incredibly nauseous and lost my appetite; I felt incredibly nauseous and lost my appetite; I was pale and felt weak; I had a severe headache; I'm left with a sore right arm; I was pale and felt weak; Approximately 2 hours after vaccination I was very tired and slept about 6 hours; This is a spontaneous report received from a contactable Other Health Professional. A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 00:45 as (At the age of 21-year) DOSE 1, SINGLE for covid-19 immunisation. Medical history included granuloma annulare, migraine and autoimmune thyroiditis from an unknown date. The patient's concomitant medications were not reported. Patient had No known allergies. No covid tested post vaccination. No covid prior vaccination. Patient did not receive Other medications in two weeks. It was unknown if patient was pregnant at the time of vaccination. Patient took Other vaccine 4 weeks include HPV vaccine dose number 2 in Left arm on 15Jan2021 and Tdap booster in Right arm on 15Jan2021. It was reported that Approximately 2 hours after vaccination patient was very tired on 09Feb2021 and slept about 6 hours. Patient felt great afterwards. Approximately 30 hours after vaccination patient felt sick. Patient had a fever of 101.2 and chills. Patient felt incredibly nauseous and lost his appetite. patient was pale and felt weak. Patient had a severe headache. Approximately 48 hours after vaccination most side effects have been resolved and I'm left with a sore right arm on 10Feb2021. Patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 101.2 on 10Feb2021. The outcome of event i'm left with a sore right arm was not recovered, and outcome of all other events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Fatigue, Migraine
Clinical narrative: sore arm; tired; low grade fever 99.1; vomiting; sore neck; migraine; chills; body aches; upset bowels; This is a spontaneous report from a non-contactable consumer (patient herself).  A 43-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 12:00 PM (at the age of 43-years-old) as dose number unknown, single for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included osteoarthritis, low vitamin D, migraine and bulge disk in neck. Patient had no known allergies. Concomitant medications included zolpidem (ZOLPIDEM), tizanidine (TIZANIDINE) and oxycodone (OXYCODONE). Patient did not receive any other vaccine in 4 weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 09Feb2021 16:00 PM, patient experienced tired and sore arm, low grade fever 99.1, vomiting, sore neck, migraine, chills, body aches and upset bowels. Therapeutic measures were not taken due to the events. The patient underwent lab tests and procedures which included body temperature which was 99.1. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: sore arm; tired; low grade fever 99.1; vomiting; sore neck; migraine; chills; body aches; upset bowels; This is a spontaneous report from a non-contactable consumer (patient herself).  A 43-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 12:00 PM (at the age of 43-years-old) as dose number unknown, single for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included osteoarthritis, low vitamin D, migraine and bulge disk in neck. Patient had no known allergies. Concomitant medications included zolpidem (ZOLPIDEM), tizanidine (TIZANIDINE) and oxycodone (OXYCODONE). Patient did not receive any other vaccine in 4 weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 09Feb2021 16:00 PM, patient experienced tired and sore arm, low grade fever 99.1, vomiting, sore neck, migraine, chills, body aches and upset bowels. Therapeutic measures were not taken due to the events. The patient underwent lab tests and procedures which included body temperature which was 99.1. The outcome of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain
Clinical narrative: Severe armpit and breast pain; Severe armpit and breast pain; This is a spontaneous report from a contactable consumer (patient herself). A 52-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262, Expiry date were not reported) via an unspecified route of administration, administered in arm left on 08Feb2021 12:59 (age at the vaccination 52-year-old) as dose 2, single for COVID-19 immunization. Medical history included, severe asthmatic and have aspirin induced asthma and cannot take any NSAIDs from an unknown date and unknown if ongoing, while getting her vaccination card she says that she needs her glasses because she cannot see anything anymore from an unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 between 8:10-8:20 as dose 1, single for COVID-19 immunization and had no new medications and had not done anything else. The patient's concomitant medications were not reported. On 09Feb2021 12:30 PM, the patient had experienced severe armpit and breast pain started 24 hours after her vaccination. It was on the same side as she received the dose the left side and had worsened. She cannot even turn her steering wheel and she confirms that is on the left side. She had been using lotion on her arm and it hurts so bad she can barely move her arm. The patient did not receive treatment for the adverse event. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.