chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: bloody nose on Thursday morning upon waking; body aches; chills; fever throughout the day; chest pains; had left underarm lymph node swelling; swelling on the right side of her top lip; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Restylane kysse, start date: Sep2020, notes: Her lips were previously injected; Restylane dyfyne, start date: Mar2021, notes: Her lips were previously injected. Vaccination history included: Bnt162b2 (First Dose), administration date: 2021, for Covid-19 Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "bloody nose on Thursday morning upon waking"; PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "body aches"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "fever throughout the day"; CHEST PAIN (non-serious) with onset 16Sep2021, outcome "unknown", described as "chest pains"; LYMPHADENOPATHY (non-serious) with onset Sep2021, outcome "unknown", described as "had left underarm lymph node swelling"; LIP SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "swelling on the right side of her top lip".  Additional information: Patient received 2nd Pfizer Covid-19 Vaccine on Wednesday, 15Sep in the left arm. Patient experienced  a bloody nose on Thursday morning upon waking and body aches, chills, and fever throughout the day. She had chest pains that evening and a bloody nose upon waking Friday morning. Patient had left underarm lymph node swelling and swelling on the right side of her top lip.   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 in extremity, Peripheral swelling
Clinical narrative: arm is real sore; Under the arm is like a swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (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 (Dose number: 1), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm is real sore"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Under the arm is like a swelling".  Additional information: Reporter inquired for her niece regarding the Pfizer Vaccine, second dose. The reporter needs a question answered. The reporter states the arm is real sore and under the arm is like a swelling. Is the swelling supposed to go down or should the patient go to the emergency room?. NDC number of Unknown Pfizer Vaccine and Expiry Date of Unknown Pfizer Vaccine was not provided.   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 in extremity
Clinical narrative: arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Lot number: 301558A, Expiration Date: 31Dec2021) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, single, No events reported), for Covid-19 immunization, reaction(s): "No adverse events"; Bnt162b2 (Dose 1, single, No events reported), for Covid-19 immunization, reaction(s): "No adverse events".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "arm is sore".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced abdominal pain (intermittent abdominal pain), with outcome of unknown. Additional information: Patient and his son were experiencing intermittent abdominal pain, which "comes and goes." He asked if he should go to the emergency room, or it was a commonly reported adverse event. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Renal disorder
Clinical narrative: kidney disease; heart condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 86 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 (Dose: 1), administration date: Jan2021, when the patient was 86 years old, for COVID-19 immunization. The following information was reported: RENAL DISORDER (non-serious), outcome "unknown", described as "kidney disease"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Menstrual disorder
Clinical narrative: Route of administration: Consumer stated, "Intravenous like just on my arm, not through my veins.; Was supposed to get my period by September 5th and I still haven''t have my period yet, I have never gone so long without having my periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intravenous, administered in arm left, administration date 27Aug2021 (Lot number: FC3130) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herniated disc" (unspecified if ongoing), notes: Lab test: Consumer stated, Yeah, for my back I have to do both MRI and X-RAY. The patient took concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Was supposed to get my period by September 5th and I still haven''t have my period yet, I have never gone so long without having my periods"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Aug2021, outcome "unknown", described as "Route of administration: Consumer stated, "Intravenous like just on my arm, not through my veins.".  Additional information: I got my first dose of the Pfizer vaccine on 27Aug2021 and I was like I was supposed to get my period by 05Sep2021 and I still have like I still haven't have my period yet and yesterday when I went to take my second dose, I told the nurse over there and she said to call and report this because I have never gone so long without having my periods. The patient was on unspecified antidepressant therapy and was taking unspecified medication for sleep. When probed if consumer had any other vaccination within 4 weeks prior to the administration of the COVID vaccine, consumer stated, "No, I mean not recently obviously but yeah".   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: B-lymphocyte count, Fatigue, SARS-CoV-2 antibody test
Clinical narrative: fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergies to plants" (unspecified if ongoing); "allergies to dogs, allergies to cats" (unspecified if ongoing), notes: allergies to dogs, allergies to cats; "balance issues" (unspecified if ongoing), notes: balance issues; "Lhermitte's Sign" (unspecified if ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: On an unspecified date, the patient underwent the laboratory tests and procedures which showed no COVID antibodies, CD19 B cells 0L, Absolute CD19+ cells less than 20L.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Loss of personal independence in daily activities
Clinical narrative: dizziness; my head is like bouncing; fatigue,tired and unable to work; fatigue,tired and unable to work; 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 (COMIRNATY), administration date 22Sep2021 (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: DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "dizziness"; HEAD DISCOMFORT (non-serious) with onset Sep2021, outcome "not recovered", described as "my head is like bouncing"; FATIGUE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "fatigue,tired and unable to work".  Additional information: Caller received her 1st dose of the Pfizer BT Covid Vaccine last wednesday,22Sep2021, and she is still having side effects like dizziness ,"my head is like bouncing", fatigue, tired and unable to work. What should I take to treat my symptoms. The patient don't have any insurance to go to a doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Fatigue, Headache
Clinical narrative: Pt had mild tactile temp; fatigue; mild headache symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 17Aug2021 15:54 (Lot number: EW0185) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild intermittent asthma" (ongoing), notes: Verbatim: Mild intermittent asthma. The patient took concomitant medications. Vaccination history included: Hpv 9 (Lot:T029522, Route: Intramuscular, Anatomical site: Left deltoid), administration date: 12Aug2021, when the patient was 12 years old. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "Pt had mild tactile temp"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "mild headache symptoms".  Additional information: Follow up call made after 24 patient had mild tactile temperature, fatigue, mild headache, Symptoms were not different from what he experienced after first dose.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; CALCIUM; BIOTIN; VITAMIN D3; LUTEIN. The following information was reported: VERTIGO (non-serious) with onset 19Feb2021, outcome "not recovered", described as "Vertigo". The event "vertigo" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo.  Additional information: Facility where the most recent COVID-19 vaccine was administered:Pharmacy or Drug Store. Patient other vaccine  4weeks details: [other vaccine 4weeks product=Pfizer-Bio, other vaccine 4weeks vaccine date=10Mar2021, other vaccine 4weeks lot number=EN6202, other vaccine 4weeks dose number=2, other vaccine 4weeks vaccine location=left arm.AE treatment:: Medicine (Meclizine) and physical therapy. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination the patient was not tested for Covid-19.Patient had no allergies.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Tenderness
Clinical narrative: red itchy very sore area near the injection sight, but not the injection sight; very sore area near the injection sight/but not the injection sight.; red itchy very sore area near the injection sight, but not the injection sight; tender; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 16:00 (Lot number: 301308a) at the age of 60 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Bp" (unspecified if ongoing), notes: Bp; "asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 27Sep2021, outcome "not recovered" and all described as "red itchy very sore area near the injection sight, but not the injection sight"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021, outcome "not recovered", described as "very sore area near the injection sight/but not the injection sight."; TENDERNESS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "tender". Therapeutic measures were not taken as a result of pruritus, pain in extremity, erythema, tenderness.  Additional information: 3 days post injection I have red itchy very sore area near the injection sight, but not the injection sight. It had been 5 days now and it is still red, and very tender. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination: Many but this was my 3rd injection. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Sleep disorder
Clinical narrative: Dizzy; feels crappy now; Sweaty; Up half of the night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: Her niece is remission from Crohn's disease. She had it really bad since a teenager and had all sorts of fusion therapy a long time a ago. She has been in remission for a few years now. There were no concomitant medications. Vaccination history included: Bnt162b2 (received the first dose a few weeks ago and was fine after that), for Covid-19 immunization, reaction(s): "was fine after that". The following information was reported: DIZZINESS (non-serious) with onset 28Sep2021, outcome "recovered" (28Sep2021), described as "Dizzy"; FEELING ABNORMAL (non-serious) with onset Sep2021, outcome "not recovered", described as "feels crappy now"; HYPERHIDROSIS (non-serious) with onset Sep2021, outcome "not recovered", described as "Sweaty"; SLEEP DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "Up half of the night". Additional information: The reporter is the Patient's aunt. Batch/lot, NDC number and Expiry Date were Unknown, Reason for no lot number is her niece would have that information on her card. The Vaccination Facility Type was Pharmacy/drug store. Her niece is remission from Crohn's disease. She had it really bad since a teenager and had all sorts of fusion therapy a long time ago. She has been in remission for a few years now. The reporter is a consumer reported that she got a text from her niece who got her second shot of the Pfizer Covid-19 Vaccine, and she was so dizzy that she could not drive home. The patient's mother reported it to the pharmacy. The patient is in bed at home. She does not know if her niece should go to the hospital. Her niece had to leave her car at the pharmacy and her mother had to go pick her up. The reporter said that her niece received the Pfizer Covid-19 Vaccine. The reporter said that her niece was fine after a half hour with the dizziness. Her niece was up half the night and feels crappy now and is taking a nap. Her niece was sweaty but had no fever. Her niece received the first dose a few weeks ago and was fine after that. Caller said that she wanted to get this reported because she is afraid of Guillain Barre because she knows you can get that from vaccines. After listening to the recording, reporter states that she thinks the patient received the vaccine the day before on 28Sep2021, and the dizziness occurred immediately after receiving 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: Abdominal pain upper, Decreased appetite, Lethargy, Vomiting
Clinical narrative: stomach pains; loss of appetite; vomiting; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pains"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; LETHARGY (non-serious), outcome "unknown", described as "lethargy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: All of us started experiencing headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "All of us started experiencing headaches". Therapeutic measures were taken as a result of headache. No follow-up attempts are possible. No further information is expected.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: all of us started experiencing headaches; he couldn't go to work, exercise or anything because he would kind of like fainting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: HEADACHE (non-serious), outcome "recovering", described as "all of us started experiencing headaches"; DIZZINESS (non-serious), outcome "recovering", described as "he couldn't go to work, exercise or anything because he would kind of like fainting". Therapeutic measures were taken as a result of headache, dizziness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: a little swelling of her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2)  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), for COVID-19 immunization.  The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "a little swelling of her arm".  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ovulation disorder
Clinical narrative: ovulated after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "seizures" (unspecified if ongoing). Family history included: "little swelling of her arm" (unspecified if ongoing), notes: Mother fine for second vaccine, just a little swelling of her arm. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 2021, for COVID-19 Immunization, reaction(s): "inflammation", "Facial swelling". The following information was reported: OVULATION DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "ovulated after second vaccine".  Additional information: The reporter stated that her daughter (patient) took second vaccination around 02Sep2021, she takes birth control because of seizures around ovulation. She ovulated after second vaccine, causing her birth control to not work properly.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Face felt numb for an hour and went away; Metal taste in mouth so much that tongue was salivating; Left arm soreness; Left leg cramping and muscle pain; Left leg cramping and muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 (Lot number: FC3184) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious), MYALGIA (non-serious) all with onset 23Aug2021, outcome "recovering" and all described as "Left leg cramping and muscle pain"; DYSGEUSIA (non-serious) with onset 23Aug2021 19:00, outcome "recovering", described as "Metal taste in mouth so much that tongue was salivating"; PAIN IN EXTREMITY (non-serious) with onset 23Aug2021 14:30, outcome "recovering", described as "Left arm soreness"; HYPOAESTHESIA (non-serious) with onset 24Aug2021 11:30, outcome "recovering", described as "Face felt numb for an hour and went away". Additional Information: She took first vaccine and had couple of minor symptoms that were normal and passed within hours.  With the second one, the 1st day, she had soreness in arm. The next day, she had really severe lower back pain and it gradually moved around to both hips to front like it was wrapping around like a belt to her ovaries.  It radiates to both sides of hips and goes down into groin/ovary area and is the same type of pain. It is very painful.  She had been living on Ibuprofen for 1 1/2 for weeks. She just wanted an answer and if there is something to wash it out of her body. She wanted to know if anyone else had ever experienced this. Taking Ibuprofen every day and getting better.No manufacturer, lot or expiration, dose is unknown. 600mg maybe. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: experienced one day of not feeling well; 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 parent.  A 39 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FN5318) as dose 1, single and (Lot number: EL9266) 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: MALAISE (non-serious), outcome "recovered", described as "experienced one day of not feeling well".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Fear, Impaired driving ability, Loss of personal independence in daily activities
Clinical narrative: feels very dizzy; can not drive; can not go to work; sleepy; tiredness; She is scared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "feels very dizzy"; IMPAIRED DRIVING ABILITY (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot drive"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot go to work"; SOMNOLENCE (non-serious) with onset Sep2021, outcome "not recovered", described as "sleepy"; FATIGUE (non-serious) with onset Sep2021, outcome "not recovered", described as "tiredness"; FEAR (non-serious) with onset Sep2021, outcome "not recovered", described as "She is scared".  Additional information: she took the vaccine last week, Wednesday, and still has side effects. She cannot go to work because she feels dizzy, very dizzy and does not know what to do.  The patient stated she cannot drive; she was just so sleepy and cannot work because she was just sleeping.  She was just having tiredness. She was scared.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: feels very dizzy; can not drive; can not go to work; sleepy; tiredness; She is scared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Sep2021, outcome "not recovered", described as "feels very dizzy"; IMPAIRED DRIVING ABILITY (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot drive"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot go to work"; SOMNOLENCE (non-serious) with onset Sep2021, outcome "not recovered", described as "sleepy"; FATIGUE (non-serious) with onset Sep2021, outcome "not recovered", described as "tiredness"; FEAR (non-serious) with onset Sep2021, outcome "not recovered", described as "She is scared".  Additional information: she took the vaccine last week, Wednesday, and still has side effects. She cannot go to work because she feels dizzy, very dizzy and does not know what to do.  The patient stated she cannot drive; she was just so sleepy and cannot work because she was just sleeping.  She was just having tiredness. She was scared.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Second dose: was a little tired was similar to how to caller felt after receiving the second dose; little bit like had the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Lot number: EN6203) at the age of 69 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 (First dose of covid vaccine, Lot: EL9269, NDC: Unknown , Expiration: Unknown , Route of administration: left arm), administration date: 04Feb2021, when the patient was 70 years old, for COVID-19 immunization; Pneumonia vaccine (Reaction the caller had to the second dose Pneumonia vaccine, where arm became swollen: Pneumonia Vaccine: NDC/lot/expiration: The caller is unable to provide this information, states this was over 2 years ago., where arm became swollen), for Immunization, reaction(s): "where arm became swollen"; Pneumonia vaccine (1st dose of pneumonia vaccine), for Immunization. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Second dose: was a little tired was similar to how to caller felt after receiving the second dose"; INFLUENZA LIKE ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "little bit like had the flu".  Additional information: The patient was a little tired after receiving the second dose. The patient does not remember when the tiredness began after the second dose, patient states this was in Feb2021. The patient states after the first dose Pfizer Vaccine the caller did not feel anything. The patient also felt a little bit like had the flu and tired maybe for a day and it went away. Reaction the patient had to the second dose of Pneumonia vaccine, where arm became swollen. The patient was unable to provide the information, as this was over 2 years ago.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: He reports after the second Covid 19 vaccine he and his wife were both down for the afternoon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (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, start date: Jan2021, tolerated the first Covid 19 vaccine very easy), administration date: Jan2021, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "He reports after the second Covid 19 vaccine he and his wife were both down for the afternoon".  Additional information: Reporter reported that his wife tolerated the first Covid 19 vaccine very easy. He reported after the second Covid 19 vaccine he and his wife were both down for the afternoon, then they both picked up. number of covid-19 vaccine was not provided. Consumer stated that his wife was doing fine.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: The swelling in his foot and ankle, he is not sure if this pre-dates the the first doses of the Covid vaccine.; The swelling in his foot and ankle, he is not sure if this pre-dates the the first doses of the Covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2021 (Lot number: EK9231) at the age of 79 years as dose 1, single and administered in arm left, administration date 16Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "increase in weight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "The swelling in his foot and ankle, he is not sure if this pre-dates the the first doses of the Covid vaccine.". Therapeutic measures were taken as a result of joint swelling, peripheral swelling.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): none provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect:  none. Other Products, Patient History and Investigation Assessment was reported as No. Prior Vaccinations (within 4 weeks) and Patients Medical History (including any illness at time of vaccination): none. Weight- he states he has an increase in weight in but this was before the last dose, it started more than a year this has been going on before any of the vaccines. medication change- he had a problem with swelling in his left foot and ankle. when it gets really swollen his cardiologist has him take a half a pill of furosemide, he was on this for about a week and stopped 2 days ago but is not sure when started it. The swelling in his foot and ankle, he is not sure if this pre-dates the the first doses of the Covid vaccine. Adverse events did not result in Emergency room visit or physician office visit. Relevant tests was reported as none.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281330 similar report from same reporter
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nasopharyngitis
Clinical narrative: Swollen lymph node under right armpit; common cold; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 28Sep2021 16:00 (Lot number: FF2588) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression", start date: 2007 (ongoing); "anxiety", start date: 2007 (ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM taken for anxiety, start date: 2007 (ongoing); SPIRONOLACTONE taken for acne, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Time: 11.00, Anatomical site: R Deltoid, Route of administration: Intramuscular, Batch/lot number: 3248), administration date: 25Jan2021, when the patient was 29 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, Time: 15.30, Anatomical site: R Deltoid, Route of administration: Intramuscular, Batch/lot no: 9266), administration date: 15Feb2021, when the patient was 29 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "Swollen lymph node under right armpit"; NASOPHARYNGITIS (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "common cold". Therapeutic measures were not taken as a result of lymphadenopathy. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: issues with her right arm having really bad pain; 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 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: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "issues with her right arm having really bad pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: feeling unwell; diarrhea; tiredness; headache; chills; nausea; 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), administered in arm left, administration date 28Sep2021 10:00 (Lot number: 3013598) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Diabetes, She has been diabetic for the past couple of years. Her sugars are controlled. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: MALAISE (non-serious) with onset 29Sep2021, outcome "unknown", described as "feeling unwell"; DIARRHOEA (non-serious) with onset 29Sep2021, outcome "not recovered", described as "diarrhea"; FATIGUE (non-serious) with onset 29Sep2021, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 29Sep2021, outcome "recovered" (29Sep2021), described as "headache"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovered" (29Sep2021), described as "chills"; NAUSEA (non-serious) with onset 29Sep2021, outcome "recovered" (29Sep2021), described as "nausea". Therapeutic measures were taken as a result of diarrhoea, fatigue, headache.  Additional information: Clinical course: It was reported that patient was still tired and diarrhea she is drinking water and apple Juice and wants to know if she can take Imodium. She has a doctor's appointment on the 07October. She has been drinking a lot of water and apple juice. Her doctor didn't prescribe the vaccine. She doesn't see her doctor until the 7th. When she got it she was fine. She was training at a withheld yesterday, and that is when she started feeling tired. She developed all of the side effects yesterday. She developed tiredness, headache, chills, diarrhea, and nausea yesterday. Today she just feels tired and has consistent diarrhea. Yesterday, she was tired with headache, nausea, and diarrhea. She has constant diarrhea. She is diabetic, but her sugar is controlled. She has been diabetic for the past couple of years. Her sugars are controlled though so she doesn't always take her Metformin. She talked to her doctor about it, and he agreed to only take it when needed. If she takes it every day her sugar will drop too low. She puts all of her metformin into a big bottle. So she doesn't have the normal prescription bottle. The big bottle is a pharmacy bottle from pharmacy. She took Tylenol for her headache yesterday.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: feeling unwell; diarrhea; tiredness; headache; chills; nausea; 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), administered in arm left, administration date 28Sep2021 10:00 (Lot number: 3013598) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Diabetes, She has been diabetic for the past couple of years. Her sugars are controlled. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: MALAISE (non-serious) with onset 29Sep2021, outcome "unknown", described as "feeling unwell"; DIARRHOEA (non-serious) with onset 29Sep2021, outcome "not recovered", described as "diarrhea"; FATIGUE (non-serious) with onset 29Sep2021, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 29Sep2021, outcome "recovered" (29Sep2021), described as "headache"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovered" (29Sep2021), described as "chills"; NAUSEA (non-serious) with onset 29Sep2021, outcome "recovered" (29Sep2021), described as "nausea". Therapeutic measures were taken as a result of diarrhoea, fatigue, headache.  Additional information: Clinical course: It was reported that patient was still tired and diarrhea she is drinking water and apple Juice and wants to know if she can take Imodium. She has a doctor's appointment on the 07October. She has been drinking a lot of water and apple juice. Her doctor didn't prescribe the vaccine. She doesn't see her doctor until the 7th. When she got it she was fine. She was training at a withheld yesterday, and that is when she started feeling tired. She developed all of the side effects yesterday. She developed tiredness, headache, chills, diarrhea, and nausea yesterday. Today she just feels tired and has consistent diarrhea. Yesterday, she was tired with headache, nausea, and diarrhea. She has constant diarrhea. She is diabetic, but her sugar is controlled. She has been diabetic for the past couple of years. Her sugars are controlled though so she doesn't always take her Metformin. She talked to her doctor about it, and he agreed to only take it when needed. If she takes it every day her sugar will drop too low. She puts all of her metformin into a big bottle. So she doesn't have the normal prescription bottle. The big bottle is a pharmacy bottle from pharmacy. She took Tylenol for her headache yesterday.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 51-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0176), at the age of 51, in left arm, on May 14, 2021, at 09:00; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0182), in left arm, on Jun 3, 2021, at 17:00; both single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed blisters (sores on both hands), onset Jun 15, 2021, with outcome of not recovered; and pain in extremity (painful to the touch), onset 2021, with outcome of unknown. No therapeutic measures taken. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm was a little sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2), for covid-19 Immunization; Bnt162b2 (Dose:1), for covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his arm was a little sore".  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness/had complete numbness in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Batch/Lot number: unknown) at the age of 39 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: HYPOAESTHESIA (non-serious) with onset Sep2021, outcome "unknown", described as "Numbness/had complete numbness in right arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.