chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Menstruated cycle that was not scheduled to occur for another 1.5 weeks; Menstrual cycle is accompanied with heavy bleeding and intense cramps; Menstrual cycle is accompanied with heavy bleeding and intense cramps; Vaginal spotting; Soreness at the injection site; Soreness at the injection site and in the shoulder of the arm that was injected; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3303080 [as reported]) via an unspecified route of administration in the left arm on 17Nov2021 at 18:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. Concomitant medications taken within two weeks of vaccination included multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient experienced vaginal spotting for five days beginning on 18Nov2021, the day after immunization followed by a menstrual cycle on 23Nov2021 that was not scheduled to occur for another 1.5 weeks. Menstrual cycle was accompanied with heavy bleeding and intense cramps, more than normal. The patient also experienced soreness at the injection site and in the shoulder of the arm that was injected on an unknown date in Nov2021. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal spotting was resolved on 23Nov2021; while that of the events menstruated cycle that was not scheduled to occur for another 1.5 weeks, menstrual cycle was accompanied with heavy bleeding and intense cramps, more than normal was not resolved; soreness at the injection site and in the shoulder of the arm that was injected was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Feeling hot, Flushing
Clinical narrative: Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Fever; Nausea; Malaise; Body aches; Joint pain; Headache; Chills; Painful left arm; This is a spontaneous report from a non-contactable nurse, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FJ1611), via an unspecified route of administration in the left arm on 22Nov2021 at 15:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis, irritable bowel syndrome, anxiety, depression, mononucleosis, reoccurring strep infection, COVID-19 and known allergies to egg and fin fish. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included eluxadoline (VIBERZI), risankizumab (SKYRIZI) and venlafaxine hydrochloride (EFFEXOR); all for unknown indication from unknown date and unknown if ongoing. On 22Nov2021 at 15:45, the patient was flushed/dizzy/warm 30-60 min following injection, experienced fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flushed/dizzy/warm 30-60 min following injection, fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Fever; Nausea; Malaise; Body aches; Joint pain; Headache; Chills; Painful left arm; This is a spontaneous report from a non-contactable nurse, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FJ1611), via an unspecified route of administration in the left arm on 22Nov2021 at 15:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis, irritable bowel syndrome, anxiety, depression, mononucleosis, reoccurring strep infection, COVID-19 and known allergies to egg and fin fish. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included eluxadoline (VIBERZI), risankizumab (SKYRIZI) and venlafaxine hydrochloride (EFFEXOR); all for unknown indication from unknown date and unknown if ongoing. On 22Nov2021 at 15:45, the patient was flushed/dizzy/warm 30-60 min following injection, experienced fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flushed/dizzy/warm 30-60 min following injection, fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Flushed/dizzy/warm 30-60 min following injection; Fever; Nausea; Malaise; Body aches; Joint pain; Headache; Chills; Painful left arm; This is a spontaneous report from a non-contactable nurse, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FJ1611), via an unspecified route of administration in the left arm on 22Nov2021 at 15:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included psoriasis, irritable bowel syndrome, anxiety, depression, mononucleosis, reoccurring strep infection, COVID-19 and known allergies to egg and fin fish. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included eluxadoline (VIBERZI), risankizumab (SKYRIZI) and venlafaxine hydrochloride (EFFEXOR); all for unknown indication from unknown date and unknown if ongoing. On 22Nov2021 at 15:45, the patient was flushed/dizzy/warm 30-60 min following injection, experienced fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flushed/dizzy/warm 30-60 min following injection, fever, nausea, malaise, body aches, joint pain, headache, chills and painful left arm was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Feeling dizzy; Nauseous; Headache; Body aches; Fatigue; started to get chills / had chills; Fever/ Fever 102/ I had  99.2 fever; dose received: 3/dose number = 3; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Nov2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination was not reported. The patient received other vaccines within four weeks prior to the COVID vaccine which included influenza vaccine (FLU) in the left arm on 04Nov2021 for immunisation. The patient previously received first 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 16:00 (at the age of 43-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 16:00 (at the age of 43-years-old) both as  single dose for COVID-19 immunisation. On 18Nov2021 at 17:00, the patient started to get chills and a fever and 19Nov2021 to 21Nov2021, the patient had chills, headache, fever 102 (unspecified units), body aches and fatigue. On 22Nov2021 (reported as MON and also as "now"), patient had a 99.2 (unspecified units) fever, felt dizzy and nauseous. It was reported that the patient was still feeling the affects a week after the booster and enquired if that was normal. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the events started to get chills, had chills, headache, body aches, fatigue was resolved on 21Nov2021, however the events fever/ fever 102/  had a 99.2 fever, feeling dizzy and nauseous was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Feeling dizzy; Nauseous; Headache; Body aches; Fatigue; started to get chills / had chills; Fever/ Fever 102/ I had  99.2 fever; dose received: 3/dose number = 3; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received third (booster) dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Nov2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination was not reported. The patient received other vaccines within four weeks prior to the COVID vaccine which included influenza vaccine (FLU) in the left arm on 04Nov2021 for immunisation. The patient previously received first 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 16:00 (at the age of 43-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 16:00 (at the age of 43-years-old) both as  single dose for COVID-19 immunisation. On 18Nov2021 at 17:00, the patient started to get chills and a fever and 19Nov2021 to 21Nov2021, the patient had chills, headache, fever 102 (unspecified units), body aches and fatigue. On 22Nov2021 (reported as MON and also as "now"), patient had a 99.2 (unspecified units) fever, felt dizzy and nauseous. It was reported that the patient was still feeling the affects a week after the booster and enquired if that was normal. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the events started to get chills, had chills, headache, body aches, fatigue was resolved on 21Nov2021, however the events fever/ fever 102/  had a 99.2 fever, feeling dizzy and nauseous was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Severe vomiting; nausea; bodyaches; fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 17 year-old female patient received bnt162b2 (BNT162B2) (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: VOMITING (non-serious), outcome "unknown", described as "Severe vomiting"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; PAIN (non-serious), outcome "unknown", described as "bodyaches"; PYREXIA (non-serious), outcome "unknown", described as "fever".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Vomiting
Clinical narrative: vomiting; body ache; fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PAIN (non-serious), outcome "unknown", described as "body ache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Influenza like illness, Pain in extremity
Clinical narrative: Sore arm; Flu like symptoms; too tired; Fever off and on; Vertigo; Severe fatigue/chronic fatigue; scary; Dizzy spells; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Mar2021 (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 (First Dose), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore arm"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Flu like symptoms"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "too tired"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Fever off and on"; VERTIGO (non-serious) with onset Mar2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizzy spells"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe fatigue/chronic fatigue"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "scary".  Additional information: Additional information: The reporter stated that the symptoms were coming and going but seemed to be getting more frequent and persist for longer periods, getting worse rather than better and patient never had these symptoms prior to the vaccination. Prior to the second vaccine the patient was doing fairly rigorous workouts, walking and biking daily. The patient was too tired to go for just a walk at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Sore arm; Flu like symptoms; too tired; Fever off and on; Vertigo; Severe fatigue/chronic fatigue; scary; Dizzy spells; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Mar2021 (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 (First Dose), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore arm"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Flu like symptoms"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "too tired"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Fever off and on"; VERTIGO (non-serious) with onset Mar2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizzy spells"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe fatigue/chronic fatigue"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "scary".  Additional information: Additional information: The reporter stated that the symptoms were coming and going but seemed to be getting more frequent and persist for longer periods, getting worse rather than better and patient never had these symptoms prior to the vaccination. Prior to the second vaccine the patient was doing fairly rigorous workouts, walking and biking daily. The patient was too tired to go for just a walk at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non HCP) from the Medical Information Team. The reporter is the patient.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 11Feb2021 (Lot number: EL9267) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "bad aortic valve" (ongoing), notes: the patient has a bad aortic valve and will have surgery for it. The patient's concomitant medications were not reported. The following information was reported: TOOTHACHE (non-serious) with onset 2021, outcome "unknown", described as "Dental pain". Additional information: The patient's second dose was scheduled on 04Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness and mild soreness at the injection site; Redness and mild soreness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 10:45 (Lot number: EL3247) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "sensitivity to neomycin" (unspecified if ongoing), notes: not an allergy per se. Concomitant medication(s) included: CALCIUM VITAMIN D; ARIPIPRAZOLE; LAMOTRIGINE. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 02Mar2021 12:00, outcome "not recovered" and all described as "Redness and mild soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pain.  Additional information: The patient had not received any other vaccines within 4 weeks. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since the vaccination. "BUPOPRION" received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: just a little ache in left arm when the patient raise it; 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) (Batch/Lot number: unknown) as dose 1, single and administration date 02Mar2021 (Lot number: EL9267) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "just a little ache in left arm when the patient raise it".  Additional Information: Age was reported as 80, (unit: unknown). The reporter/ patient experienced the event after each dose. After dose 2, event experienced 4 hours after the vaccination. The reporter/ patient was asking if she is to expect more side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neck pain, Vaccination site pain
Clinical narrative: it (arm) just got sore a little bit / left arm was hurting; it (neck) was so painful; just like a spasm in my neck / it is like a spasm; could not move her neck to the right / still very stiff / like a stiff neck/ just like a spasm in my neck / it is like a spasm / her arm on the left side is stiff; 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 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Batch/Lot number: EN6198) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Interstitial Cystitis" (unspecified if ongoing); "stiffness in her arm" (unspecified if ongoing), notes: has happened to her before with the shingles vaccine. Concomitant medication(s) included: CLONAZEPAM; TESTOSTERONE; ESTROGEN; PROGESTERONE. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 03Mar2021, outcome "not recovered", described as "could not move her neck to the right / still very stiff / like a stiff neck/ just like a spasm in my neck / it is like a spasm / her arm on the left side is stiff"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "it (arm) just got sore a little bit / left arm was hurting"; NECK PAIN (non-serious) with onset 03Mar2021, outcome "unknown", described as "it (neck) was so painful"; MUSCLE SPASMS (non-serious) with onset 03Mar2021, outcome "unknown", described as "just like a spasm in my neck / it is like a spasm". Therapeutic measures were taken as a result of musculoskeletal stiffness, vaccination site pain, neck pain, muscle spasms.  Additional information: The patient was vaccinated at around 10:20am or 9 o' clock. Anatomical location was also described as "left arm, upper, the shoulder". It was reported that the patient had have other vaccines like shingles and stuff. Other concomitant medications of the patient included: Hormone Palette. It was reported that the patient could barely get up like it was hard for her to even get up. The patient took three Advil as treatment for the events. It was reported that the patient was due for the second dose on 23Mar2021. The patient was querying if this was a common side effect.  No follow up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness and swelling to her arm at the injection site; soreness and swelling to her arm at the injection site; 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 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "auto immune system/a weak immune system" (unspecified if ongoing); "cancer" (unspecified if ongoing); "low melatonin count" (unspecified if ongoing), notes: because of the cancer she has no melatonin; "insomnia" (unspecified if ongoing), notes: takes Xanax for sleep because she has insomnia. Concomitant medication(s) included: XANAX taken for insomnia. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 02Mar2021, outcome "unknown" and all described as "soreness and swelling to her arm at the injection site". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling.  Additional information: TYLENOL every 6 hours was taken as treatment for the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore arm post vaccination/ injection arm soreness; fatigue; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 01Mar2021 (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: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm post vaccination/ injection arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  Additional information: Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19; and since the vaccination, it was also unknown if patient has been tested for COVID-19. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Events took place after use of product.  No follow-up activities are possible; information on the batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Vaccination site pain
Clinical narrative: the patient fell and slightly hurt her left arm (same arm she got the first shot in); the patient fell and slightly hurt her left arm (same arm she got the first shot in); 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 (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Feb2021 (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: FALL (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "the patient fell and slightly hurt her left arm (same arm she got the first shot in)".  Additional Information: The patient reported that her arm was still a little bit sensitive because of the slight hurt and she wanted to know if she has to get the second shot in this arm. The patient's second dose was scheduled on 04Mar2021  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: Fatigue, Pain in extremity
Clinical narrative: fatigue; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:15 (Lot number: EL3247) at the age of 37 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: FATIGUE (non-serious) with onset 03Mar2021 21:30, outcome "recovering", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 03Mar2021 21:30, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of fatigue, pain in extremity.  Additional information: Patient had no known allergies. 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 did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: Fatigue/Tiredness; Headache; Nausea; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the medical information team for a Pfizer-sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 23Feb2021 (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: FATIGUE (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Fatigue/Tiredness"; HEADACHE (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 02Mar2021, outcome "not recovered", described as "Not feeling well". Additional information: The patient's age was reported 28 (unit not specified) who stated that it has been a week from the report and the symptoms were still going on.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastric disorder, Nausea, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; poorly timed stomach bug; 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 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 13:30 (Lot number: EN6205) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Diagnosed at least 15 years ago; "allergies" (ongoing). Concomitant medication(s) included: PROAIR HFA taken for asthma (ongoing); ALLEGRA taken for hypersensitivity, start date: Jan2021 (ongoing). The following information was reported: NAUSEA (non-serious) with onset 03Mar2021 05:15, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 03Mar2021 05:15, outcome "recovered" (03Mar2021 11:30), described as "vomiting"; DIARRHOEA (non-serious) with onset 03Mar2021 05:15, outcome "not recovered", described as "diarrhea"; GASTRIC DISORDER (non-serious) with onset 03Mar2021 05:15, outcome "not recovered", described as "poorly timed stomach bug".  Additional information: Patient received other unspecified concomitant medications (reported as other products). The patient did not receive any other vaccines on same date of the Pfizer Suspect. It was also reported that some of the symptoms had stopped such as vomiting (vomited twice) but nausea and diarrhea continued. Patient was trying to understand if this was a result of the shot or a poorly timed stomach bug. All events did not result to physician or emergency room visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: "COVID arm" - redness about 2 inch in the diameter, swelling like she just got a shot; "COVID arm" - redness about 2 inch in the diameter, swelling like she just got a shot; sore injection site; tingling arm; tingling in the lips and her tongue; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm, administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "tingling in the lips and her tongue"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 28Feb2021, outcome "unknown" and all described as ""COVID arm" - redness about 2 inch in the diameter, swelling like she just got a shot"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "unknown", described as "sore injection site"; PARAESTHESIA (non-serious) with onset 28Feb2021, outcome "unknown", described as "tingling arm".  Additional information: The patient's age was reported as 78 (unit unspecified). The patient said she had breast cancer and can use only one arm for shots and she read on the CDC site that the arm needed to be rotated for the second dose. She was wondering if it's safe to receive the 2nd dose of the vaccine on 10Mar. The patient also said her sister also got tingling after the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: sciatic pain in the back; the patient is in such pain; 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 65 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL9269) 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: SCIATICA (non-serious) with onset 02Mar2021, outcome "unknown", described as "sciatic pain in the back; the patient is in such pain". The event "sciatic pain in the back; the patient is in such pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sciatica.  Additional Information: The patient was treated with methylprednisolone steroid, hydrocodone/acetaminophen and receiving "something" for nerve pain/sciatic pain. The patient was advised by her doctor not to take the 2nd dose on 10Mar2021 as she will be taking steroids through 07Mar2021. The reporter/patient was concerned with the second dose because she was taking steroids.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood sodium, Blood sodium decreased
Clinical narrative: blood pressure issues; sodium level that dropped to 126; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Feb2021 08:30 (Batch/Lot number: EN6198) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BLOOD SODIUM DECREASED (non-serious) with onset 02Mar2021 13:40, outcome "not recovered", described as "sodium level that dropped to 126"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure issues". The events "sodium level that dropped to 126" and "blood pressure issues" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood sodium decreased, blood pressure abnormal.  Additional information: It was reported that the doctor wanted the patient to go to ER because her sodium level had dropped to 126. It was also reported that the patient has a follow up for her blood pressure and had to get blood work done. The patient stated that she felt fine and she read on the paper what the side effects were and didn't know if it had to do with her sodium with her blood pressure issues. The events did not result in an emergency room visit. The patient has no prior vaccinations within 4 weeks. The patient has no family medical history relevant to adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise
Clinical narrative: chills; headache; felt extremely tired; felt lousy and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Medical Information Team. The reporter is the patient.  An 80 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 17Feb2021 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Congestive heart failure" (unspecified if ongoing); "COVID-19", start date: Mar2021 (unspecified if ongoing), notes: had COVID last March. Concomitant medications included: BISOPROLOL taken for cardiac failure congestive; LISINOPRIL taken for cardiac failure congestive; SPIRONOLACTONE taken for cardiac failure congestive; CALCIUM; and Vitamins.  The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "felt extremely tired"; MALAISE (non-serious), outcome "unknown", described as "felt lousy and tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: severe body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female (Age: 34, unit: Unknown) patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: unknown) via unspecified route on an unspecified date as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced severe body aches. It was reported that the first dose patient had severe body aches, she take hardcore pain medications, the body aches were so bad her medications didn't touch it, they lasted 8 days. Therapeutic measures were taken as a result of pain. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaccination site pain
Clinical narrative: Mild sore arm; Severe back muscle spasms lasted about 36 hours also; This is a spontaneous report from a contactable consumer (patient).    A 56 years-old (non-pregnant) female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Lot number: EN6208) via an unspecified route of administration at left arm on 17Mar2021 at 17.00 (at the age of 56 years) as dose 2, single for COVID-19 immunization. The patient medical history included asthma from an unknown date and unknown if ongoing, high blood pressure from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. The patient had seafood and environmental 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 4 weeks prior to the COVID vaccine. Concomitant medications included BUSPAR (buspirone hydrochloride) taken for unknown date, start and stop date were not reported, trazodone taken for unknown date, start and stop date were not reported, alprazolam taken for unknown date, start and stop date were not reported, PRISTIQ (desvenlafaxine succinate) taken for unknown date, start and stop date were not reported and losartan taken for unknown date, start and stop date were not reported (two weeks). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration at right arm on 24Feb2021 at 17.00 (at the age of 56 years) as dose 1, single for COVID-19 immunization and the patient experienced moderate sore arm, fatigue lasted for about 36 hours and chills for about 12 hours. On 17Mar2021, the patient experienced mild sore arm and severe back muscle spasms with lasted about 36 hours also. The patient called nurse and was advised to apply ice and take ibuprofen. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304436 same patient/drug, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Muscle spasms, Myalgia, Nausea, Retching
Clinical narrative: dehydration; muscle spasms; dry heaving; muscle aches and pains; nausea; 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 24 year-old female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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, SINGLE), for COVID-19 Immunization. The following information was reported: DEHYDRATION (non-serious), outcome "unknown", described as "dehydration"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle spasms"; RETCHING (non-serious), outcome "unknown", described as "dry heaving"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches and pains"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  Additional information: the patient was a physical therapy student who received second dose on Monday and had some muscle aches and pains which she expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Product dose omission issue
Clinical narrative: Consumer was refused his second dose of the Pfizer BioNTech covid-19 vaccine; about a week and a half before his second, dose he had a fall; This is a spontaneous report from a contactable consumer (patient reported for self). A 74-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EN6201), via an unspecified route of administration, administered in arm right on 24Feb2021 (at the age of 74-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included artificial heart valve. Concomitant medications included isosorbide dinitrate, sotalol, nitroglycerin, warfarin deanol, atorvastatin calcium and tramadol. On an unspecified date, the patient reported that before his second dose (of Covid19 vaccine), he had a fall and had to go to the ER and they gave him a tetanus booster and he was refused his second dose of the Pfizer BioNTech covid-19 vaccine. When patient went in for his first dose and was scheduled for his second dose and about a week and a half before his second, dose he had a fall and had to go to the ER and they gave him a tetanus booster and so when second dose appointment arrived, the pharmacist said "you had another vaccination within 2 weeks. We can't give you this dose". Adverse event (fall) required a visit to the emergency room. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.