chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, SARS-CoV-2 test
Clinical narrative: bladder infection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 10:45 (Batch/Lot Number: Ew0153), at the age of 52 years old, as single dose for covid-19 immunisation. Medical history included haemolytic anaemia from an unknown date and unknown if ongoing. Concomitant medication included amoxicillin taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. On 08Apr2021, by 15:00, the patient felt genital burning. The next morning by 11:00 (09Apr2021), she saw blood in urine and saw that she has a bladder infection. The patient undwerwent Covid test post vaccination (Nasal Swab) on 22Mar2021 with negative result. The event was reported as non-serious. The patient received nitrofurantoin as treatment for events. Outcome of the event was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypoaesthesia oral, Sinus congestion, Somnolence
Clinical narrative: lips went numb; hard to breathe; upper respiratory system was clogged; sinuses was clogged; tired; she went to bed a couple of hours before she usually does; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection, Lot number: ER8727, Expiration date: unknown) via an unspecified route of administration in left arm on 07Apr2021 at 11:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history of the patient included arthritis (hip arthritis), allergies (week prior to vaccine) and shellfish reaction; all from an unknown date. Concomitant medications included Loratadine (MANUFACTURER UNKNOWN) [24-hour tablet, sold over the counter], acetylsalicylic acid [ASPIRIN 500 mg] taken for arthritis in her hip. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, expiration: unknown) via an unspecified route of administration in left shoulder, upper arm on 17Mar2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. On 07Apr2021, right after second dose of vaccination patient was tired and went to bed a couple of hours before she usually does. On 08Apr2021, almost 24 hours after second dose, while patient was doing a low impact exercise routine at home, she noticed it was harder to breathe and her upper respiratory system was clogged, sinuses was clogged, and her lips went numb which was similar to her shellfish reaction she has had in the past. Patient asked if her symptoms are normal and if it was safe for her to go back to work as she works at a deli and asked if she was contagious to her coworkers. Patient had allergies the week prior, so she was unsure if her symptoms are from her allergies or the vaccine. Patient took benadryl and Robitussin with guaifenesin to help with the symptoms. Outcome of all events was resolving.  No follow-up attempts are needed; No further information is expected
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract congestion
Clinical narrative: lips went numb; hard to breathe; upper respiratory system was clogged; sinuses was clogged; tired; she went to bed a couple of hours before she usually does; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection, Lot number: ER8727, Expiration date: unknown) via an unspecified route of administration in left arm on 07Apr2021 at 11:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Medical history of the patient included arthritis (hip arthritis), allergies (week prior to vaccine) and shellfish reaction; all from an unknown date. Concomitant medications included Loratadine (MANUFACTURER UNKNOWN) [24-hour tablet, sold over the counter], acetylsalicylic acid [ASPIRIN 500 mg] taken for arthritis in her hip. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6207, expiration: unknown) via an unspecified route of administration in left shoulder, upper arm on 17Mar2021 (at the age of 60-year-old) as single dose for COVID-19 immunization. On 07Apr2021, right after second dose of vaccination patient was tired and went to bed a couple of hours before she usually does. On 08Apr2021, almost 24 hours after second dose, while patient was doing a low impact exercise routine at home, she noticed it was harder to breathe and her upper respiratory system was clogged, sinuses was clogged, and her lips went numb which was similar to her shellfish reaction she has had in the past. Patient asked if her symptoms are normal and if it was safe for her to go back to work as she works at a deli and asked if she was contagious to her coworkers. Patient had allergies the week prior, so she was unsure if her symptoms are from her allergies or the vaccine. Patient took benadryl and Robitussin with guaifenesin to help with the symptoms. Outcome of all events was resolving.  No follow-up attempts are needed; No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: numb arm; headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization and she was fine. The patient experienced numb arm for a little while, twenty to thirty minutes or so after the second shot and had slight headache. The events were reported as non-serious. No pain at all on the site, which was incredible, but she worked it out by doing kind of exercise like crazy. She expected much more problems. She knew some people with Moderna had muscle aches, chills, high fever. Anyone she had talked, who's taken Pfizer vaccine had no issues. The volunteer checked her notes and read that people can have a numb arm up to 30 mins after the shot. Caller inquired about her daughter who had allergy to aldehydes, she had an EpiPen. Her daughter works in a medical lab and was dealing with formaldehyde and got allergic to all aldehydes. She had a life-threatening reaction and was scheduled to take her first shot soon. The mother wanted to know about the ingredients and was wondering if there are any aldehydes in the Pfizer covid19 vaccine. She got a response that there was no formaldehyde in allergen VR. She was also wondering what 95% efficacy means. There were unaddressed medical questions referred or forwarded to medical information. The outcome of the event numbness was recovered and for the event headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Stress
Clinical narrative: BP has been quite high and hard to control; Stress; This is a spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955), via an unspecified route of administration in right arm, on 05Mar2021 at 01:30 PM (13:30) (at the age of 62 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included ongoing high blood pressure (BP) and supraventricular tachycardia (SVT) under control with medicine; allergies to almonds; and multivitamin. The patient's concomitant medications included metoprolol tartrate for high blood pressure and SVT; and an unspecified multivitamin. 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-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store. The patient had high BP and SVT in the past which was under control with only metoprolol tartrate. On 10Mar2021 at 07:00 AM (after the vaccine), the patient's BP has been quite high and hard to control. The patient had now added lisinopril and actually tried an anxiety pill because of the stress of the high BP (10Mar2021 at 07:00 AM). The patient was also wearing an HR event monitor now (since an unspecified date in 2021). Treatment to the events included more BP medicine and anxiety pill. The adverse events resulted in doctor or other healthcare professional office or clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Paraesthesia, Paraesthesia oral, Physical examination
Clinical narrative: Patient is presenting with shortness of breath/decreased air entry; chest pain began 30 minutes after injection as leaving site to her car; Arm tingling; lip tingling; This is a spontaneous report from a contactable physician. A 47-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), dose 1 via intramuscular route of administration in arm right on 09Apr2021 (at the age of 47-years-old) as single dose for COVID-19 immunisation at other facility. The patient was not pregnant at the time of vaccination. Lot number was not available/provided to reporter at the time of report completion. Medical history included allergies (peanuts) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination stated as not applicable. 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 was presenting with shortness of breath, decreased air entry, chest pain began 30 minutes after injection as leaving site to her car, arm tingling, lip tingling on 09Apr2021. Decreased air entry on exam no overt bronchospasm but improved with albuterol no asthma history for her. The events were not serious and seriousness criteria included none. Events resulted in Emergency room/ department or urgent care. Therapeutic measures were taken which included treatment with Aspirin and Albuterol for chest pain and tightness and decreased air entry or dyspnea. Clinical outcome of the events recovered on unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Waves of extreme nausea, along with chills; Waves of extreme nausea, along with chills; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old female patient (unknown if pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration in left arm on 07Apr2021 at 11:00 (at the age of 35-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 18:00, the patient experienced waves of extreme nausea, along with chills. Terrible for first 24 hours. It was reported that the second 24 hours had been milder, but still nauseated. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the reported events. The clinical outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, HIV antibody, Headache, Hepatitis B surface antigen
Clinical narrative: Pregnant at the time of vaccination?: Yes; headaches; fatigue; chills; body aches; This is a spontaneous report from a contactable other hcp. This other hcp reported information for both mother and fetus/baby. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261, Expiry date: unknown, Last menstrual date: 30Oct2020, Delivery date: 08May2021, Gestational period: 17), dose 1 intramuscular administered in Arm Left on 24Feb2021 08:15 as dose 1, single for covid-19 immunisation administered at Doctor's office/urgent care. Medical history included ongoing dermatitis atopic Since childhood, hypersensitivity. No other vaccine in four weeks. Concomitant medication(s) included ongoing crisaborole (EUCRISA) taken for dermatitis atopic; loratadine taken for hypersensitivity; minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously took ibuprofen and experienced drug hypersensitivity, aspirin (e.c.) and experienced drug hypersensitivity, nuvaring and experienced drug hypersensitivity. The patient reported, she went into preterm labor on 29Mar2021 which was 12 days after my second Pfizer vaccine and delivered on 30Mar2021 at 21 weeks and 5 days. She was diagnosed with chorioamnioitis due to a staph aureus infection. Her baby did not survive. Leading up to the hospital admission and after my first and second vaccines she had frequent headaches, fatigue which she related to the vaccine. She also had chills and body aches. On admission she had a fever. She said she was very healthy and developed an unusual uterine infection after the vaccine. She felt that her immune system was affected post vaccine which may have contributed to my ability to fight off infection. Outcome of events was unknown.   Follow-up attempts completed. No further information expected.  Amendment: This follow up is being submitted to amend previously reported information: Amendment (PSSR): Events "off label use", product use in unapproved population" deleted, event "pregnant at the time of vaccination?: yes" recoded to "Maternal exposure during pregnancy, second trimester", narrative updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392328 Mother/Fetus baby case
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain, Rubella antibody test, Treponema test
Clinical narrative: Pregnant at the time of vaccination?: Yes; headaches; fatigue; chills; body aches; This is a spontaneous report from a contactable other hcp. This other hcp reported information for both mother and fetus/baby. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261, Expiry date: unknown, Last menstrual date: 30Oct2020, Delivery date: 08May2021, Gestational period: 17), dose 1 intramuscular administered in Arm Left on 24Feb2021 08:15 as dose 1, single for covid-19 immunisation administered at Doctor's office/urgent care. Medical history included ongoing dermatitis atopic Since childhood, hypersensitivity. No other vaccine in four weeks. Concomitant medication(s) included ongoing crisaborole (EUCRISA) taken for dermatitis atopic; loratadine taken for hypersensitivity; minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously took ibuprofen and experienced drug hypersensitivity, aspirin (e.c.) and experienced drug hypersensitivity, nuvaring and experienced drug hypersensitivity. The patient reported, she went into preterm labor on 29Mar2021 which was 12 days after my second Pfizer vaccine and delivered on 30Mar2021 at 21 weeks and 5 days. She was diagnosed with chorioamnioitis due to a staph aureus infection. Her baby did not survive. Leading up to the hospital admission and after my first and second vaccines she had frequent headaches, fatigue which she related to the vaccine. She also had chills and body aches. On admission she had a fever. She said she was very healthy and developed an unusual uterine infection after the vaccine. She felt that her immune system was affected post vaccine which may have contributed to my ability to fight off infection. Outcome of events was unknown.   Follow-up attempts completed. No further information expected.  Amendment: This follow up is being submitted to amend previously reported information: Amendment (PSSR): Events "off label use", product use in unapproved population" deleted, event "pregnant at the time of vaccination?: yes" recoded to "Maternal exposure during pregnancy, second trimester", narrative updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392328 Mother/Fetus baby case
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Oropharyngeal pain, Pain in extremity
Clinical narrative: After approximately 6 hours I startedto feel a sore throat; After 12 hours couldn't fall asleep; Pain in my arm; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date. The patient did not receive any concomitant medications. The patient had no known allergies. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 19:15, approximately 6 hours after vaccination, the patient started to feel a sore throat and after 12 hours, she could not fall asleep because of the pain in the arm and the sore throat on an unknown date in Apr2021. The events did not result in a visit to doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events sore throat, could not fall asleep and pain in the arm were not recovered at the time of this report.  No follow-up attempts are needed ; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Fever; chills; fatigue; headache; loss of appetite; nausea; general malaise; neck pain; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK8734) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 02:00, the patient experienced fever of 101.5, sustained fever over 101F after taking acetaminophen, chills, fatigue, headache, loss of appetite, nausea, general malaise and neck pain, after all other side effects were gone. On 08Apr2021, the patient underwent body temperature measurement and the result was found to be 101.5 degree farenheit (degF). On 08Apr2021 after taking acetaminophen again the body temperature was sustained to be 101 degree farenheit (degF). The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse event fever and included treatment with acetaminophen and no therapeutic measures were taken as the result of other adverse events. The clinical outcome of the events fever chills, fatigue, headache, loss of appetite, nausea, general malaise and neck pain were recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Neck pain, Pyrexia
Clinical narrative: Fever; chills; fatigue; headache; loss of appetite; nausea; general malaise; neck pain; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK8734) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 02:00, the patient experienced fever of 101.5, sustained fever over 101F after taking acetaminophen, chills, fatigue, headache, loss of appetite, nausea, general malaise and neck pain, after all other side effects were gone. On 08Apr2021, the patient underwent body temperature measurement and the result was found to be 101.5 degree farenheit (degF). On 08Apr2021 after taking acetaminophen again the body temperature was sustained to be 101 degree farenheit (degF). The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse event fever and included treatment with acetaminophen and no therapeutic measures were taken as the result of other adverse events. The clinical outcome of the events fever chills, fatigue, headache, loss of appetite, nausea, general malaise and neck pain were recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Brain hypoxia, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: at times brain almost feels like a limited oxygen level to it; Having brain fog issues/strange feelings; forgetful; have no motivation to exercise; Very tired; hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Er8737) at the age of 45-year-old, via an unspecified route of administration in the left arm on 03Apr2021 at 10:45, as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, cutaneous lupus erythematosus (cutaneous lupus), and sulfonamide allergy (known allergies: sulfa (rashes, heated)). The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and hydroxychloroquine. The patient previously received the first dose of BNT162B2 (Lot Number: EN6208), via an unspecified route of administration in the left arm on 13Mar2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation and thought something was wrong with lympnodes in neck area or thyroid but went for ultrasound, very small nodule, this started after first vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 13:00, the patient experienced having brain fog issues, forgetful, at times brain almost feels like a limited oxygen level to it, no motivation to exercise, very tired, hard to concentrate and strange feelings. It was reported that patient experienced brain "fog" issues, forgetful and at times brain almost felt like a limited oxygen level to it, never had this prior to vaccine, the patient was healthy and active yet had no motivation to exercise since vaccine, very tired, hard to concentrate yet there were moments of clarity where patient felt that was so keen of thinking almost OCD perfect, very strange feelings, this started after second vaccine. No therapeutic measures were taken for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was not recovered at the time of report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Ultrasound scan
Clinical narrative: at times brain almost feels like a limited oxygen level to it; Having brain fog issues/strange feelings; forgetful; have no motivation to exercise; Very tired; hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Er8737) at the age of 45-year-old, via an unspecified route of administration in the left arm on 03Apr2021 at 10:45, as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, cutaneous lupus erythematosus (cutaneous lupus), and sulfonamide allergy (known allergies: sulfa (rashes, heated)). The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and hydroxychloroquine. The patient previously received the first dose of BNT162B2 (Lot Number: EN6208), via an unspecified route of administration in the left arm on 13Mar2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation and thought something was wrong with lympnodes in neck area or thyroid but went for ultrasound, very small nodule, this started after first vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 13:00, the patient experienced having brain fog issues, forgetful, at times brain almost feels like a limited oxygen level to it, no motivation to exercise, very tired, hard to concentrate and strange feelings. It was reported that patient experienced brain "fog" issues, forgetful and at times brain almost felt like a limited oxygen level to it, never had this prior to vaccine, the patient was healthy and active yet had no motivation to exercise since vaccine, very tired, hard to concentrate yet there were moments of clarity where patient felt that was so keen of thinking almost OCD perfect, very strange feelings, this started after second vaccine. No therapeutic measures were taken for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was not recovered at the time of report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations every couple of hours. After the patient drink 16oz of water or more it calms down after 30 minutes but will start back up again.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and endometriosis. The patient did not have any allergies to food, medications, or other products. Concomitant medications included iron (MANUFACTURER UNKNOWN), potassium (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID), ibuprofen (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 18:30, the patient experienced heart palpitations every couple of hours. After the patient drank 16oz of water or more it calmed down after 30 minutes but would start back up again. The patient did not receive treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event heart palpitations every couple of hours. After the patient drink 16oz of water or more it calms down after 30 minutes but will start back up again was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Hyperhidrosis, Illness
Clinical narrative: It was scary for a while, and he felt awful; Hot fevers; wet the bed in sweat; Shaking; Chills; muscles, arms, legs, and back were hurting; muscles, arms, legs, and back were hurting; muscles, arms, legs, and back were hurting; he was was so sick.; This is a spontaneous report received from a contactable consumer (patient himself). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 on 13Dec2020. The patient's concomitant medications were not reported. The patient previously took Bamlanivimab infusion of antibodies on 21Dec2020. Patient stated that, he could not receive the COVID vaccine for at least 90 days after this infusion. He received the first COVID vaccine 91 days later on 22Mar2021. He is supposed to have the second dose next Tuesday. After the first vaccine, he was so sick (illness). Early the next morning (23Mar2021) he thought he was going to die. On 23Mar2021, patient stated that he had experienced hot fevers, wet the bed in sweat, shaking, chills, his muscles, arms, legs, and back were hurting terribly. It was scary for a while, and he felt awful the entire next day. He also stated that, the following day he felt better. The outcome of all the events was unknown.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: It was scary for a while, and he felt awful; Hot fevers; wet the bed in sweat; Shaking; Chills; muscles, arms, legs, and back were hurting; muscles, arms, legs, and back were hurting; muscles, arms, legs, and back were hurting; he was was so sick.; This is a spontaneous report received from a contactable consumer (patient himself). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 on 13Dec2020. The patient's concomitant medications were not reported. The patient previously took Bamlanivimab infusion of antibodies on 21Dec2020. Patient stated that, he could not receive the COVID vaccine for at least 90 days after this infusion. He received the first COVID vaccine 91 days later on 22Mar2021. He is supposed to have the second dose next Tuesday. After the first vaccine, he was so sick (illness). Early the next morning (23Mar2021) he thought he was going to die. On 23Mar2021, patient stated that he had experienced hot fevers, wet the bed in sweat, shaking, chills, his muscles, arms, legs, and back were hurting terribly. It was scary for a while, and he felt awful the entire next day. He also stated that, the following day he felt better. The outcome of all the events was unknown.   Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Entire body aches; joint aches; muscle aches; chills; exhaustion; headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 at 13:15 (at the age of 61-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 13:45 (at the age of 61-year-old) both as a single dose for COVID-19 immunisation. Medical history included corneal ulcers. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), medroxyprogesterone (MANUFACTURER UNKNOWN) and progesterone (PROGESTIN) from an unknown date for an unknown indication. The patient previously took aspirin and experienced a drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00 the patient experienced entire body aches, joint aches, muscle aches, chills, exhaustion and headache. The clinical course was as follows: Entire body aches (joints and muscles) and it began a week before the 2nd shot but had intensified the day after the 2nd shot. Chills, exhaustion and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, exhaustion, headache, body aches, joint aches and muscle aches was not resolved at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Entire body aches; joint aches; muscle aches; chills; exhaustion; headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 at 13:15 (at the age of 61-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 at 13:45 (at the age of 61-year-old) both as a single dose for COVID-19 immunisation. Medical history included corneal ulcers. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), medroxyprogesterone (MANUFACTURER UNKNOWN) and progesterone (PROGESTIN) from an unknown date for an unknown indication. The patient previously took aspirin and experienced a drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00 the patient experienced entire body aches, joint aches, muscle aches, chills, exhaustion and headache. The clinical course was as follows: Entire body aches (joints and muscles) and it began a week before the 2nd shot but had intensified the day after the 2nd shot. Chills, exhaustion and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, exhaustion, headache, body aches, joint aches and muscle aches was not resolved at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Insomnia, Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes in underarm of injection site swelled andbecame very sore; Lymph nodes in underarm of injection site swelled andbecame very sore; The soreness hasradiated to the outer edge of mybreast.; am having trouble sleepingon that side (my usual positioning).; Chills; Low-grade fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 13:45(at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory bowel disease, allergy to PCN, sulfa and latex. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC); all for unknown indication and start date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 as a single dose for COVID-19 immunisation and also experienced drug allergy from cefaclor (CECLOR), albuterol (MANUFACTURER UNKNOWN) and ciprofloxacin lactate (CIPRO). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 13:45, patient experienced chills, low-grade fever that started 24hours after vaccination and abated within few hours. More significant beginning about 30 hours post injection, on 08Apr2021 at 19:45, patient lymph nodes in underarm of injection site swelled and became very sore and it hurt when she put her arm down. The soreness radiated to the outer edge of her breast and had trouble sleeping on that side (her usual positioning). Patient stated that she did not believe medical intervention was necessary, but she wanted to report the event. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event chills and low-grade fever were recovered on 08Apr2021. The clinical outcome of lymph nodes in underarm of injection site swelled and became very sore, soreness radiated to the outer edge of her breast and had trouble sleeping on that side were recovering at the time of this report.  No follow up attempts needed; no further information can be expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lymph nodes in underarm of injection site swelled andbecame very sore; Lymph nodes in underarm of injection site swelled andbecame very sore; The soreness hasradiated to the outer edge of mybreast.; am having trouble sleepingon that side (my usual positioning).; Chills; Low-grade fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 13:45(at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory bowel disease, allergy to PCN, sulfa and latex. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC); all for unknown indication and start date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 as a single dose for COVID-19 immunisation and also experienced drug allergy from cefaclor (CECLOR), albuterol (MANUFACTURER UNKNOWN) and ciprofloxacin lactate (CIPRO). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 13:45, patient experienced chills, low-grade fever that started 24hours after vaccination and abated within few hours. More significant beginning about 30 hours post injection, on 08Apr2021 at 19:45, patient lymph nodes in underarm of injection site swelled and became very sore and it hurt when she put her arm down. The soreness radiated to the outer edge of her breast and had trouble sleeping on that side (her usual positioning). Patient stated that she did not believe medical intervention was necessary, but she wanted to report the event. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event chills and low-grade fever were recovered on 08Apr2021. The clinical outcome of lymph nodes in underarm of injection site swelled and became very sore, soreness radiated to the outer edge of her breast and had trouble sleeping on that side were recovering at the time of this report.  No follow up attempts needed; no further information can be expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: Three swollen lymphs in the left side spread between armpit, chest, clavicle; Body aches; First day after vaccination experienced extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: PFIZER ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 17:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:00, first day after vaccination, the patient experienced extreme fatigue and body aches. On 09Apr2021 Second day after vaccination, the patient developed three swollen lymphs in the left side spreaded between armpit, chest and clavicle. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events body ache, extreme fatigue and swollen lymphs were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Eye pain, Ocular hyperaemia, Vision blurred
Clinical narrative: left eye started to have severe pressure on it; The following day at approximately 7:30 PM, my left eye started to have severe pressure on it, turned red,; The following day at approximately 7:30 PM, my left eye started to have severe pressure on it, turned red, was painful when I tried to move it,; The following day at approximately 7:30 PM, my left eye started to have severe pressure on it, turned red, was painful when I tried to move it, and vision was blurred.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) in the left arm on 02Apr2021 at 17:15 as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), acetylsalicylic acid (ASPIRIN) and vitamins nos (MANUFACTURER UNKNOWN); all for unknown indications since an unknown duration. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) in the left arm on 05Mar2021 at 17:15 as a single dose for COVID-19 immunisation. On 03Apr2021 at 19:30, the patient had experienced severe pressure on left eye, it turned red, was painful when he tried to move it and the vision was blurred. The next day it was less severe but was present. Later, there was no pain anymore. The patient thought that the vision wasn't quite as good as before but had not validated it with an eye appointment. It just felt like the treatment might be a little different then. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse event. The clinical outcome of the events severe pressure on left eye, eye turned red, painful when tried to move it and vision was blurred was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.