chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: Lime sized swelling in armpit on side of most recently administered vaccine; Dose received: 3; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 17Dec2021 at 10:00 (Lot number: unknown) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: FLU, administered in left arm, taken for immunisation, start date: 03Dec2021, stop date: 03Dec2021; PROPRANOLOL ER; OMEPRAZOLE; VITAMIN D; VITAMIN C and TURMERIC. Past drug history included: Codeine, reaction: "Drug allergy", notes: known allergies: Codeine. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, vaccine location: left arm), administration date: 07Jan2021, when the patient was 37 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown, vaccine location: right arm), administration date: 27Jan2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 10:00, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious) with onset 18Dec2021 at 23:00, outcome "unknown", described as "Lime sized swelling in armpit on side of most recently administered vaccine". Therapeutic measures were not taken as a result of swelling.  Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Herpes simplex, Immunisation
Clinical narrative: Herpes outbreak on nose, near left nostril.; Fatigue; Nausea; Chills; Headache; Sore left arm; Swollen left armpit lymph node; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Dec2021 at 12:45 (Lot number: FF8839) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Left arm), administration date: 23Feb2021, when the patient was 55 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Anatomical location: Left arm), administration date: 16Mar2021, when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 12:45, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 17Dec2021, outcome "recovering", described as "Fatigue"; NAUSEA (non-serious) with onset 17Dec2021, outcome "recovering", described as "Nausea"; CHILLS (non-serious) with onset 17Dec2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 17Dec2021, outcome "recovering", described as "Sore left arm"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021, outcome "recovering", described as "Swollen left armpit lymph node"; HERPES SIMPLEX (non-serious) with onset 19Dec2021, outcome "recovering", described as "Herpes outbreak on nose, near left nostril". Therapeutic measures were not taken as a result of fatigue, nausea, chills, headache, pain in extremity, lymphadenopathy and herpes simplex.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the 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 events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: Herpes outbreak on nose, near left nostril.; Fatigue; Nausea; Chills; Headache; Sore left arm; Swollen left armpit lymph node; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 16Dec2021 at 12:45 (Lot number: FF8839) at the age of 56 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Left arm), administration date: 23Feb2021, when the patient was 55 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Anatomical location: Left arm), administration date: 16Mar2021, when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021 at 12:45, outcome "unknown", described as "Dose received: 3"; FATIGUE (non-serious) with onset 17Dec2021, outcome "recovering", described as "Fatigue"; NAUSEA (non-serious) with onset 17Dec2021, outcome "recovering", described as "Nausea"; CHILLS (non-serious) with onset 17Dec2021, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 17Dec2021, outcome "recovering", described as "Sore left arm"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021, outcome "recovering", described as "Swollen left armpit lymph node"; HERPES SIMPLEX (non-serious) with onset 19Dec2021, outcome "recovering", described as "Herpes outbreak on nose, near left nostril". Therapeutic measures were not taken as a result of fatigue, nausea, chills, headache, pain in extremity, lymphadenopathy and herpes simplex.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the 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 events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Burning sensation, Fatigue, Immunisation
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 at 17:00 (Lot number: FJ1620) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included None. There were no concomitant medications. Vaccination history included Bnt162b2 (DOSE 1, SINGLE; Lot number: CR8731, Route of administration: Unknown), administration date: 14Apr2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FW0167; Anatomical site: left arm, Route of administration: Unknown), administration date: 05May2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported IMMUNISATION (non-serious) with onset 19Dec2021 at 17:00, outcome unknown, described as Dose number 3; FATIGUE (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; MYALGIA (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; BURNING SENSATION (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; AXILLARY MASS (non-serious) and AXILLARY PAIN (non-serious), all with onset 20Dec2021 at 17:00, outcome not recovered. Therapeutic measures were not taken as a result of fatigue, myalgia, burning sensation, axillary mass, and axillary pain.  The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 at 17:00 (Lot number: FJ1620) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included None. There were no concomitant medications. Vaccination history included Bnt162b2 (DOSE 1, SINGLE; Lot number: CR8731, Route of administration: Unknown), administration date: 14Apr2021, when the patient was 45 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: FW0167; Anatomical site: left arm, Route of administration: Unknown), administration date: 05May2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported IMMUNISATION (non-serious) with onset 19Dec2021 at 17:00, outcome unknown, described as Dose number 3; FATIGUE (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; MYALGIA (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; BURNING SENSATION (non-serious) with onset 20Dec2021 at 17:00, outcome not recovered; AXILLARY MASS (non-serious) and AXILLARY PAIN (non-serious), all with onset 20Dec2021 at 17:00, outcome not recovered. Therapeutic measures were not taken as a result of fatigue, myalgia, burning sensation, axillary mass, and axillary pain.  The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Muscle twitching, Myalgia, Neuropathy peripheral
Clinical narrative: Neuropathy; muscle twitching; muscle pain; fatigue; numbness (whole body); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 18:30 (Lot number: FF2590) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; Intramuscular, Left arm, administration time 06:00 PM.), administration date: 15Oct2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 22Nov2021 18:00, outcome "not recovered", described as "Neuropathy"; MUSCLE TWITCHING (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "muscle twitching"; MYALGIA (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "muscle pain"; FATIGUE (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "fatigue"; HYPOAESTHESIA (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "numbness (whole body)". The events were evaluated at the physician office visit. Therapeutic measures were not taken as a result of the events. The patient had not COVID-19 prior to vaccination; he did not perform a COVID-19 test after the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jan2021 17:45 (Lot number: EL1284) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sjogrens syndrome" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Known allergies: Salicylates" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE.  The following information was reported: FATIGUE (non-serious) with onset 05Jan2021 20:45, outcome "recovered", described as "fatigued". Therapeutic measures were not taken as a result of fatigue.  Additional Information: The patient received the vaccine at the hospital and did not receive other vaccine within four weeks prior to vaccination. The patient was very fatigued for 12-24 hours after each dose of vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient received the second dose on 26Jan2021 (Lot number: EL3302) in the left arm for COVID-19 immunization.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021494997 Same reporter, patient, and product; Different dose and events
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: Since receiving the vaccine on 05Mar2021 I've been feeling discomfort pressure in my brain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported HEAD DISCOMFORT (non-serious) with onset 05Mar2021 23:00, outcome not recovered. Therapeutic measures were not taken as a result of head discomfort. The patient has no known allergies. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Movement disorder, Pain in extremity
Clinical narrative: pain in her arm that shoots all the way down to her fingers; swollen wrist; can hardly lift her arm up; This is a spontaneous report received from a contactable reporter (consumer) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm that shoots all the way down to her fingers"; JOINT SWELLING (non-serious), outcome "unknown", described as "swollen wrist"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "can hardly lift her arm up".  Additional information: Caller is a 70-year-old female who received her first dose of the Pfizer BioNTech COVID-19 vaccine on 4Mar2021 and is now experiencing pain in her arm that shoots all the way down to her fingers and a swollen wrist. She states that she can hardly lift her arm up. Caller would like to know if this is normal. She is concerned about how long it may last because she does not know if she should go see her doctor about it yet or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Malaise
Clinical narrative: This is a spontaneous report received from a contactable reporter from medical information team. The reporter is the patient. A 70-year-old female patient received BNT162B2 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: malaise, lethargy and diarrhea, outcome unknown. Additional information: The patient received the second dose on a Saturday, then felt sick on Monday but was better and able to go to yoga class by Tuesday. The patient wanted to know how to get proof of immunization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 10Feb2021 at 10:00 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes 2" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PAIN (non-serious), outcome "recovered", described as "soreness". Therapeutic measures were not taken as a result of pain.  Additional information: The patient did not have COVID prior vaccination. The patient had not been tested for COVID post-vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Vaccination site haemorrhage, Wrong technique in product usage process
Clinical narrative: When the needle was retracted, blood came out then a clear stream of fluid; When the needle was retracted, blood came out then a clear stream of fluid / concerned he did not get the full dose; When the needle was retracted, blood came out; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "When the needle was retracted, blood came out then a clear stream of fluid"; UNDERDOSE (non-serious) with onset 05Mar2021, outcome "unknown", described as "When the needle was retracted, blood came out then a clear stream of fluid / concerned he did not get the full dose"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 05Mar2021, outcome "unknown", described as "When the needle was retracted, blood came out". Additional information: The reporter wanted to know what to do and was querying if there was any harm in getting a third dose of the vaccine. Reporter was also querying if there was any protection with only getting one dose if you don't get a second injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I had an enlarged lymph node located on top of my clavicle bone that moved independently; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 09:00 (Lot number: EL 3247) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Feb2021, outcome "not recovered", described as "I had an enlarged lymph node located on top of my clavicle bone that moved independently". The event "i had an enlarged lymph node located on top of my clavicle bone that moved independently" was evaluated at the physician office visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received birth control within 2 weeks of vaccination. It was also reported that patient visited her primary care physician on Monday 22Feb2021 to make sure she was ok receiving her second vaccine on 24Feb2021. Physician said patient was safe to receive it and that they would self-monitor the lymph node for 4-6 weeks after the second vaccine. Patient also reported that physician stated it felt to be as big as 1 millimeter.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Headache
Clinical narrative: slight headache, fuzziness and heaviness afterward; slight headache, fuzziness and heaviness afterward; slight headache, fuzziness and heaviness afterward; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 10Feb2021, for Covid-19 Immunisation, reaction(s): "heaviness in the forehead; couldn't even consider it a headache". The following information was reported: HEADACHE (non-serious), FEELING ABNORMAL (non-serious), HEAD DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "slight headache, fuzziness and heaviness afterward". Additional information: Patient's age was "85" (unit not specified). The events went away then came back a few days later. The patient was asking if it was normal to have a headache, go away and come back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site scab
Clinical narrative: injection site was itchy; she scratched off the scab from the site in her sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 06Mar2021, outcome "unknown", described as "injection site was itchy"; VACCINATION SITE SCAB (non-serious) with onset 06Mar2021, outcome "unknown", described as "she scratched off the scab from the site in her sleep".  Additional Information: The patient was asking if she can receive the second dose of Pfizer-Biontech Covid19 vaccine in the same arm as she received the first.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness
Clinical narrative: sudden leg weakness, finding it very difficult to walk; sudden leg weakness, finding it very difficult to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), GAIT DISTURBANCE (non-serious), outcome "unknown" and all described as "sudden leg weakness, finding it very difficult to walk". Additional information: The consumer was reporting for his wife. The events happened within 5 weeks of receiving the first dose. On the second dose, the symptoms has increased.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: he had the worst diarrhea ever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIARRHOEA (non-serious) with onset 07Mar2021, outcome "unknown", described as "he had the worst diarrhea ever."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Middle insomnia, Tinnitus
Clinical narrative: woke up a couple of nights with perspirations soaked undershirt, but no fever and nothing; woke up a couple of nights; bilateral ears are ringing/ had tinnitus in the past, it was stabilized and realized, this caused it to be aggravated / mild humming; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 27Feb2021, outcome "unknown", described as "bilateral ears are ringing/ had tinnitus in the past, it was stabilized and realized, this caused it to be aggravated / mild humming"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "woke up a couple of nights with perspirations soaked undershirt, but no fever and nothing"; MIDDLE INSOMNIA (non-serious), outcome "unknown", described as "woke up a couple of nights". Additional information: The age of the patient was reported as: Age:71, Unit: Unknown. The patient wanted to know if event ears were ringing was a normal side effect and if he should get the second dose. It was reported that the first dose caused mild humming and patient was worried the second dose may cause a worsened effect. Event was also described as: the tinnitus came from sound, the patient used to work with sheet metal, even noise can cause it to become aggravated. The patient stated that he doesn't know how Pfizer could have overlooked this, nothing mentioned in the data that this was something to consider. He wouldn't have taken Pfizer; he would have taken this can qualify for long term disability. People need to be told about this. He can tell right away that the vaccine caused it, it had to be the vaccine. Tinnitus was disabling, he may have to pursue disability. The patient was querying on how long it was going last and said that he has read online or maybe in the news that 40% of people who had the vaccine it created it or made it worse. Patient also said that he has read that Moderna, it does not do that; and said that the problem was, you don't have all of the data, you need to have some idea of what to take or what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Laboratory test, Muscle spasms, Paraesthesia
Clinical narrative: funny feeling; muscle cramping, muscle spasms; paresthesia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "funny feeling"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "not recovered", described as "muscle cramping, muscle spasms"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "paresthesia". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient received the 1st dose last Sunday, 28Feb2021. Patient got a funny feeling, tingling in her leg and then it shoots up to her arm and she clenched her fist. It only lasted about 15-20 seconds. Patient then went to the hospital on Sunday. They ran tests and everything came back good. But, it happened again to her today. She reported that this was happening on the left side of her body. She stated that she got the vaccine in her right arm. MD put down muscle cramping, muscle spasm and paresthesia as a diagnosis. Patient also reported that she have to keep stretching out her muscles. She stated that a few friends of hers have had different side effects from the vaccine. She then asked if this was a side effect associated with the vaccine and if she should get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: tension headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Mar2021 14:20 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENSION HEADACHE (non-serious) with onset 08Mar2021, outcome "unknown", described as "tension headache".  Additional information: The patient wanted to know if he can take Tylenol for a tension headache after the first dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: a little bit of soreness in the arm; injection site pain; This is a spontaneous report received from contactable nurse.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Mar2021 (Lot number: EN6202) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "he had a stent put in a year ago" (unspecified if ongoing); "prostate cancer" (not ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, Lot number: EL9265), administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (08Mar2021), described as "a little bit of soreness in the arm"; VACCINATION SITE PAIN (non-serious) with onset 05Mar2021, outcome "recovered" (08Mar2021), described as "injection site pain ". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain.  Additional information: The reporter was reporting about her husband (patient). The patient thought that since he didn't have the swelling under the arm that it (vaccine) was not working that his immune system was not working. Another problem the patient was having was that he took a Metformin and he felt like it was stuck in his throat. He was coughing and screaming and hollering and talking and drinking a lot of water and he still felt like it was stuck. The reporter said that didn't sound like an emergency dose it If he could talk and cough and walk around and complain about it and holler. The reporter said that was bugging her more than the lump under her arm. The patient finally cleared his throat.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Sore muscles just in the arm and shoulder where the vaccine injection was given; Sore muscles just in the arm and shoulder where the vaccine injection was given; Really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Oct2020 (unspecified if ongoing); "Surgery", start date: Jan2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "Sore muscles just in the arm and shoulder where the vaccine injection was given"; FATIGUE (non-serious), outcome "unknown", described as "Really tired".  Additional information: It was reported that the patient's symptoms were very mild.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported CHILLS (non-serious), outcome unknown. The patient got chills after both of her shots.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-2021252736 Same reporter and drug, similar event, and different patient.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "all kinds of injuries over the years, including martial arts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired after the first dose".  Additional Information: The patient received his first dose in the latter part of January and he is not sure of the exact date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vomiting
Clinical narrative: Soreness in left arm; vomiting; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2020 09:45 (Lot number: EKS730) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 31Dec2020 16:00, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 31Dec2020 18:00, outcome "unknown", described as "vomiting"; VACCINATION SITE PAIN (non-serious) with onset 02Jan2021, outcome "unknown", described as "Soreness in left arm". The events "nausea", "vomiting" and "soreness in left arm" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of nausea, vomiting.  Additional information: The patient took ondansetron (ZOFRAN) for nausea and vomiting.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only symptoms after 1st dose was arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in deltoid right, administration date 22Dec2020 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rash of mostly arms,leg, back,chest increase with itchiness/ intermitent rash with itchiness", start date: Sep2020 (ongoing), notes: rash approx. 4 month prior to vaccination but never face swelling, possible hives according to MD; "birth control", start date: 2007 (unspecified if ongoing); "overactive bladder", start date: Jan2020 (unspecified if ongoing). Concomitant medication(s) included: CETRIZINE taken for rash pruritic, start date: Sep2020 (ongoing); OXYBUTYNIN CHLORIDE taken for hypertonic bladder, start date: Jan2020 (ongoing); NORTREL [ETHINYLESTRADIOL;NORETHISTERONE] taken for contraception, start date: 2007 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Only symptoms after 1st dose was arm pain".  Additional information: The patient had not use antipyretic. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in deltoid left, administration date 11Jan2021 09:30 (Batch/Lot number: EJ1686) for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: has not felt well since last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "has other health problems" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "has not felt well since last night".  Additional Information: It was reported that the patient could not go to the vaccination appointment because she has not felt well. Furthermore, the reporter mentioned that the patient's condition is not related to the Pfizer-BioNTech COVID-19 vaccine. The reporter was not sure if it would be advisable to receive the first vaccine again, in case the second dose of the COVID-19 vaccine was not administered 3 weeks later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Inappropriate schedule of product administration, Vaccination site extravasation
Clinical narrative: 3rd dose administered; 2nd dose given on 09Jan2021, third dose given on 29Jan2021; vaccine leaking out; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Jan2021 (Lot number: EL9261, Expiration Date: May2021) at the age of 37 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included autoimmune disorder (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose 1, 0.3 ml, single, Lot number: EJ1685, Expiration date: Mar2021, Route of administration: Intramuscular), administration date: 18Dec2020, when the patient was 37 years old, for COVID-19 immunisation; Bnt162b2 (Dose 2, 0.3 ml, single, Lot number: EK9231, Expiration date: Apr2021, Route of administration: Intramuscular), administration date: 09Jan2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported IMMUNISATION (non-serious) with onset 29Jan2021, outcome unknown; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 29Jan2021, outcome unknown; VACCINATION SITE EXTRAVASATION (non-serious) with onset 29Jan2021, outcome unknown. Therapeutic measures were not taken as a result of vaccination site extravasation. Upset due to vaccine leaking out, administered by student nurse. No Z-Track method and/or sensation of skin preparation evaporation.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Lower Back Pain; Right Leg Extremely Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 27Feb2021 18:00 (Lot number: EN6203) at the age of 73 years as dose 1, 0.3 ml single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Feb2021 03:00, outcome "recovered" (02Mar2021), described as "Right Leg Extremely Sore"; BACK PAIN (non-serious) with onset 02Mar2021 08:00, outcome "not recovered", described as "Lower Back Pain". Additional information: The vaccine was administered on the "Left upper arm shoulder". The patient did not receive any other vaccines within 4 weeks and on the same date of vaccination. The patient had no family medical history relevant to AEs or AEs following prior vaccinations. The events did not result in an emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Tremor
Clinical narrative: Chills; Cold; Having tremors, his hands and his feet were shaking; This is a spontaneous report received from a contactable consumer.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 07Mar2021, outcome "unknown", described as "Having tremors, his hands and his feet were shaking"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vein disorder
Clinical narrative: veins in her arm have become pronounced/ also the veins in her other arm and a little bit on her throat; Orange spot appeared on my hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Lot number: EL9267) at the age of 91 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN; BABY ASPIRIN. The following information was reported: VEIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "veins in her arm have become pronounced/ also the veins in her other arm and a little bit on her throat"; SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "Orange spot appeared on my hands". Therapeutic measures were not taken as a result of vein disorder, skin discolouration. Additional information: The course of events was described as follows: The patient had the first Pfizer COVID vaccine shot about three weeks ago and was due to have second shot on 04Mar2021. She was just within the last 4-5 days; she developed the veins in her arm have become pronounced and also the veins in her other arm and a little bit on her throat. The patient was querying if she should have the second shot. The patient hasn't treated the events since it didn't bother.  No follow-up attempts are possible. No further information is expected.