chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: "tingling" in face; face felt numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer reported similar events for three patients. This is the third of three reports.  A patient (no qualifiers provided) 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: PARAESTHESIA (non-serious), outcome "unknown", described as ""tingling" in face"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "face felt numb". The reporter spoke with two of her colleagues who reported feeling the same thing.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021258997 same reporter, drug, similar events, and different patient;US-PFIZER INC-202101257695 same reporter, drug, similar events, and different patient
Sex: F
Vaccine: COVID19, UNK
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Got her menstrual cycle back again; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administration date Apr2021 (Lot number: unknown) as dose 2, single for COVID-19 immunization; estrogens conjugated, medroxyprogesterone acetate (PREMPRO; Tablet), via an unspecified route of administration on an unspecified date (Lot number: unknown) as relief for menopause. Relevant medical history included: "Menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; lot number: unknown), administration date: Apr2021, for COVID-19 immunization. The following information was reported: The patient mentioned that the medication is estrogens conjugated, medroxyprogesterone acetate and she had been on it for about a month already at the time of the report. For some reason she got her menstrual cycle back again on an unspecified date. She used the medication from relief for menopause. The patient wanted to know is it normal to have a menstrual cycle again how long the bleeding will last. The patient mentioned that she got two shots of the Pfizer vaccine last Apr2021. She underwent routine vaccination and had no side effect. She wants to have the third shot and asked when will she get the approval to get the third Pfizer shot. The action taken for estrogens conjugated, medroxyprogesterone acetate was unknown. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: After second dose I had a bad period with huge bleeding.; Menstruation stopped; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 17:00 (Lot number: EW0173) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot unknown: EW0157, Administrator route: Intramuscular, Administration time: 14:30, Vaccine location: Left arm), administration date: 13Apr2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "not recovered", described as "After second dose I had a bad period with huge bleeding."; AMENORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Menstruation stopped". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, amenorrhoea.  Additional information: Patient medical history and concomitant medications reported as none. Patient had no known allergies. The patient did not take other vaccine in four weeks and did not administer other medications in two weeks. After second dose she had a bad period with huge bleeding. And then her menstruation stopped. She did not have any problem before and she went on period on time on each month. The patient was not diagnosed with covid-19 prior vaccination. The patient has been tested with covid-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 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).  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu, reaction(s): "cold sweats", "diarrhea", "sick", "vomiting". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I had severe swelling of lymph nodes under the arm across my chest; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 16:00 (Lot number: EW0186) at the age of 50 years as dose 1, single and administered in arm left, administration date 10Jun2021 (Lot number: EW0180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergies - penicillin" (unspecified if ongoing); "Known Allergies - contrast dye" (unspecified if ongoing). There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "I had severe swelling of lymph nodes under the arm across my chest". Therapeutic measures were taken as a result of lymphadenopathy. Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported event: I had severe swelling of lymph nodes under the arm across my chest and was placed on two doses of steroids to help bring down the baseball size swelling. Device date was reported as 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Headache, Inappropriate schedule of product administration
Clinical narrative: I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep; pain; upset stomach; Leg and neck and shoulder pain; cramping; Back and neck pains; Bad headache; Leg and neck and shoulder pain; Leg and neck and shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Sep2021 14:30 (Lot number: FC3184) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01 of covid vaccine, Time: 01:30, Site and route of injection: , Anatomical site if injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EW0151 Covid-19 Pfizer,withheld), administration date: 08Apr2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "pains", "stiffness", "really sick", "my shoulder, still hurt and do does my legs", "I wake with pain all through my body disoriented".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Sep2021 14:30, outcome "unknown" and all described as "I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep"; PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "pain"; ABDOMINAL DISCOMFORT (non-serious) with onset 08Sep2021, outcome "not recovered", described as "upset stomach"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 08Sep2021, outcome "not recovered" and all described as "Leg and neck and shoulder pain"; MUSCLE SPASMS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "cramping"; BACK PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Back and neck pains"; HEADACHE (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Bad headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, neck pain, back pain, headache, pain in extremity, arthralgia.  Additional information: On an unspecified date in 2021, patient undergone unspecified test and it was negative. On 04Aug2021 and 09Aug2021, patient had Covid-19 test and the result was negative.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Muscle spasms, Neck pain, Pain, Pain in extremity
Clinical narrative: I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep; pain; upset stomach; Leg and neck and shoulder pain; cramping; Back and neck pains; Bad headache; Leg and neck and shoulder pain; Leg and neck and shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Sep2021 14:30 (Lot number: FC3184) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01 of covid vaccine, Time: 01:30, Site and route of injection: , Anatomical site if injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EW0151 Covid-19 Pfizer,withheld), administration date: 08Apr2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "pains", "stiffness", "really sick", "my shoulder, still hurt and do does my legs", "I wake with pain all through my body disoriented".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Sep2021 14:30, outcome "unknown" and all described as "I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep"; PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "pain"; ABDOMINAL DISCOMFORT (non-serious) with onset 08Sep2021, outcome "not recovered", described as "upset stomach"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 08Sep2021, outcome "not recovered" and all described as "Leg and neck and shoulder pain"; MUSCLE SPASMS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "cramping"; BACK PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Back and neck pains"; HEADACHE (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Bad headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, neck pain, back pain, headache, pain in extremity, arthralgia.  Additional information: On an unspecified date in 2021, patient undergone unspecified test and it was negative. On 04Aug2021 and 09Aug2021, patient had Covid-19 test and the result was negative.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep; pain; upset stomach; Leg and neck and shoulder pain; cramping; Back and neck pains; Bad headache; Leg and neck and shoulder pain; Leg and neck and shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Sep2021 14:30 (Lot number: FC3184) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01 of covid vaccine, Time: 01:30, Site and route of injection: , Anatomical site if injection: Right arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EW0151 Covid-19 Pfizer,withheld), administration date: 08Apr2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "pains", "stiffness", "really sick", "my shoulder, still hurt and do does my legs", "I wake with pain all through my body disoriented".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Sep2021 14:30, outcome "unknown" and all described as "I took my first pfizer vaccine on 08Apr2021/ took the second vaccine 08Sep"; PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "pain"; ABDOMINAL DISCOMFORT (non-serious) with onset 08Sep2021, outcome "not recovered", described as "upset stomach"; NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 08Sep2021, outcome "not recovered" and all described as "Leg and neck and shoulder pain"; MUSCLE SPASMS (non-serious) with onset 08Sep2021, outcome "not recovered", described as "cramping"; BACK PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Back and neck pains"; HEADACHE (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Bad headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, neck pain, back pain, headache, pain in extremity, arthralgia.  Additional information: On an unspecified date in 2021, patient undergone unspecified test and it was negative. On 04Aug2021 and 09Aug2021, patient had Covid-19 test and the result was negative.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: swelling on her Knees/joint swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: JOINT SWELLING (non-serious) with onset 27Sep2021, outcome "unknown", described as "swelling on her Knees/joint swelling".  Additional information: Reporter wanted to know if swelling on patient's knees was normal from the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: I am having lot of Menstrual Bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 (Lot number: FC3182) as dose 1, single and administered in arm left, administration date 27Sep2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset Sep2021, outcome "unknown", described as "I am having lot of Menstrual Bleeding". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient age at the time of vaccination: Consumer stated, No. It was 47 at the time of vaccination because patient birth date, and patient got the first dose on 01Sep2021. Patient had the first dose on 01Sep2021 and then the second dose on 27Sep2021 and It started 2 weeks ago.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Heavy period; A normal period for me last 3 days and I typically have higher than 28 day cycles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Aug2021 17:00 (Lot number: 0733847-10389) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product-COVID 19, brand-Pfizer, lot number: 0729293-10389,, administration time: 04:00 PM,, vaccine location: Right arm,, dose number: 1), administration date: 10Aug2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Heavy period"; MENSTRUATION IRREGULAR (non-serious) with onset 08Sep2021, outcome "not recovered", described as "A normal period for me last 3 days and I typically have higher than 28 day cycles". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular.  Adverse event: I have had a heavy period almost every single day since a week after getting the second vaccine on 31Aug2021. It started around 08Sep2021 and it's still persisting today (30Sep2021). On 08Sep2021 it lasted till 15Sep2021. Spotted a little and started back up 17Sep2021 and lasted until 26Sep2021 and started again today at on 30Sep2021. I am very concerned. As this has never happened to me. A normal period for me last 3 days and I typically have higher than 28 day cycles.  Follow-Up (08 OCT2021): Follow-up attempts are completed. No further information is expected
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Immunisation
Clinical narrative: After severe nosebleed unexpected and unusual twenty four hours after shot; Immunization; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (Batch/Lot number: unknown) at the age of 70 years 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: IMMUNISATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "Immunization"; EPISTAXIS (non-serious) with onset 30Sep2021, outcome "unknown", described as "After severe nosebleed unexpected and unusual twenty four hours after shot". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. A patient (no qualifiers provided) 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: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "I know two patients of mine that reported neurological issues". Additional information: Caller stated "nothings updated on there. Even the vaers was not 100% accurate because they know two patients that reported neurological issues and one a blood clot. And they filled it out. It was never even reported on there.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Head discomfort, Headache, Hyperhidrosis
Clinical narrative: I have had a headache with sinus pressure and pressure on the back of my head; I have had a headache with sinus pressure and pressure on the back of my head; I have had a headache with sinus pressure and pressure on the back of my head; EXTREME DIZZINESS AND BLURRED VISION; EXTREME DIZZINESS AND BLURRED VISION; It is accompanied by sweating and feeling faint; It is accompanied by sweating and feeling faint; It is making it hard to concentrate; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 07:30 (Formulation: solution for injection, Lot number: EW0191) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Pineapples" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious), PARANASAL SINUS DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "I have had a headache with sinus pressure and pressure on the back of my head"; DIZZINESS (non-serious), VISION BLURRED (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "EXTREME DIZZINESS AND BLURRED VISION"; HYPERHIDROSIS (non-serious), DIZZINESS (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "It is accompanied by sweating and feeling faint"; DISTURBANCE IN ATTENTION (non-serious) with onset 04Oct2021 09:00, outcome "not recovered", described as "It is making it hard to concentrate". Therapeutic measures were not taken as a result of headache, paranasal sinus discomfort, head discomfort, dizziness, vision blurred, hyperhidrosis, dizziness, disturbance in attention.  Additional information: The patient received the vaccine in a hospital. The patient did not have any other vaccine in four weeks or had any other medication in two weeks. She had a headache with sinus pressure and pressure on the back of head with EXTREME DIZZINESS AND BLURRED VISION. It was accompanied by sweating and feeling faint. It was making hard to concentrate on whatever task she was trying to complete at the time. The patient did not have covid prior to vaccination nor was tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Vision blurred
Clinical narrative: I have had a headache with sinus pressure and pressure on the back of my head; I have had a headache with sinus pressure and pressure on the back of my head; I have had a headache with sinus pressure and pressure on the back of my head; EXTREME DIZZINESS AND BLURRED VISION; EXTREME DIZZINESS AND BLURRED VISION; It is accompanied by sweating and feeling faint; It is accompanied by sweating and feeling faint; It is making it hard to concentrate; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 07:30 (Formulation: solution for injection, Lot number: EW0191) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Pineapples" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious), PARANASAL SINUS DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "I have had a headache with sinus pressure and pressure on the back of my head"; DIZZINESS (non-serious), VISION BLURRED (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "EXTREME DIZZINESS AND BLURRED VISION"; HYPERHIDROSIS (non-serious), DIZZINESS (non-serious) all with onset 04Oct2021 09:00, outcome "not recovered" and all described as "It is accompanied by sweating and feeling faint"; DISTURBANCE IN ATTENTION (non-serious) with onset 04Oct2021 09:00, outcome "not recovered", described as "It is making it hard to concentrate". Therapeutic measures were not taken as a result of headache, paranasal sinus discomfort, head discomfort, dizziness, vision blurred, hyperhidrosis, dizziness, disturbance in attention.  Additional information: The patient received the vaccine in a hospital. The patient did not have any other vaccine in four weeks or had any other medication in two weeks. She had a headache with sinus pressure and pressure on the back of head with EXTREME DIZZINESS AND BLURRED VISION. It was accompanied by sweating and feeling faint. It was making hard to concentrate on whatever task she was trying to complete at the time. The patient did not have covid prior to vaccination nor was tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: My next period was only 2 days early, however it has lasted 8 days now. I have never had a period continue this many days; my period started 7 days early with many clots (also abnormal for me).; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 (Lot number: FA7485) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE. Past drug history included: No. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left), administration date: 06Aug2021, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 04Sep2021, outcome "not recovered", described as "My next period was only 2 days early, however it has lasted 8 days now. I have never had a period continue this many days"; MENSTRUAL DISORDER (non-serious) with onset 04Sep2021, outcome "not recovered", described as "my period started 7 days early with many clots (also abnormal for me).". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, menstrual disorder.  Additional information: Patient have had regular periods for years. However, following her 2ND dose of the vaccine, her period started 7 days early with many clots (also abnormal for me). The period lasted only 3 days. Typically, her periods last 5 days. Patient's next period was only 2 days early, however it has lasted 8 days now. Patient never had a period continued these many days. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility where the most recent COVID-19 vaccine was administered was Clinic facility.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Heavy menstrual bleeding, Migraine
Clinical narrative: fever; chills; body aches; nausea; joint pain; headache; cluster like migraine headaches; Also had severely heavy period which is not normal for me.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 (Lot number: 30135BA) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Interstitial Cystitis" (unspecified if ongoing), notes: other medical history: Interstitial Cystitis, IBS; "IBS" (unspecified if ongoing), notes: other medical history: Interstitial Cystitis, IBS. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DYMISTA; KARIVA. Vaccination history included: Bnt162b2 (Previous Dose dose number=1, Previous dose Lot number: EC3180, Previous dose Administration date= 19Aug2021, Previous dose Administration time: 11:00 AM, Previous dose Vaccine location= Left arm), administration date: 19Aug2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fever"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "chills"; PAIN (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "body aches"; NAUSEA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "nausea"; ARTHRALGIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "joint pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "headache"; MIGRAINE (non-serious) with onset 10Sep2021, outcome "not recovered", described as "cluster like migraine headaches"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Also had severely heavy period which is not normal for me.". Therapeutic measures were not taken as a result of pyrexia, chills, pain, nausea, arthralgia, headache, migraine, heavy menstrual bleeding.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; nausea; joint pain; headache; cluster like migraine headaches; Also had severely heavy period which is not normal for me.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 (Lot number: 30135BA) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Interstitial Cystitis" (unspecified if ongoing), notes: other medical history: Interstitial Cystitis, IBS; "IBS" (unspecified if ongoing), notes: other medical history: Interstitial Cystitis, IBS. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; DYMISTA; KARIVA. Vaccination history included: Bnt162b2 (Previous Dose dose number=1, Previous dose Lot number: EC3180, Previous dose Administration date= 19Aug2021, Previous dose Administration time: 11:00 AM, Previous dose Vaccine location= Left arm), administration date: 19Aug2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "fever"; CHILLS (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "chills"; PAIN (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "body aches"; NAUSEA (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "nausea"; ARTHRALGIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "joint pain"; HEADACHE (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "headache"; MIGRAINE (non-serious) with onset 10Sep2021, outcome "not recovered", described as "cluster like migraine headaches"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Sep2021, outcome "recovered with sequelae", described as "Also had severely heavy period which is not normal for me.". Therapeutic measures were not taken as a result of pyrexia, chills, pain, nausea, arthralgia, headache, migraine, heavy menstrual bleeding.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: that the first shot is still sitting in her arm; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 08Sep2021 (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: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "that the first shot is still sitting in her arm".  Additional information: The course of the event was as follows: The patient who was having an issue with her first dose of the Pfizer Biontech COVID-19 vaccine which she received on 08Sep2021 and wanted to get the second dose but her medical technician, pharmacist, and primary HCP stated that her body was encapsulating the vaccine and was uncomfortable on giving the second dose. The patient stated that the first shot was still sitting in her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Poor quality sleep
Clinical narrative: booster; up all night; her arm just hurt and that's it; 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 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06Oct2021 (Lot number: FF8841) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "she needs to put her glasses on to read his card" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (1st dose, Lot no. EI8982), administration date: 23Jan2021, for COVID-19 immunisation; BNT162B2 (Second Dose, Lot no. EN6201), administration date: 13Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 06Oct2021, outcome "unknown", described as "booster"; POOR QUALITY SLEEP (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "up all night"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "her arm just hurt and that's it".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nodule
Clinical narrative: knot on the arm; Headache; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 08Sep2021 (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: NODULE (non-serious) with onset 08Sep2021, outcome "not recovered", described as "knot on the arm"; HEADACHE (non-serious) with onset 08Sep2021, outcome "unknown", described as "Headache". The events "knot on the arm" and "headache" were evaluated at the physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Circumstance or information capable of leading to medication error, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: knot on the arm; Headache; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 08Sep2021 (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: NODULE (non-serious) with onset 08Sep2021, outcome "not recovered", described as "knot on the arm"; HEADACHE (non-serious) with onset 08Sep2021, outcome "unknown", described as "Headache". The events "knot on the arm" and "headache" were evaluated at the physician office visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: kicked me like a mule; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Batch/Lot number: unknown) at the age of 73 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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "kicked me like a mule".  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: Menstrual disorder, Polymenorrhoea
Clinical narrative: concerned with the size of blood clots that were occurring; I started my menstrual cycle 25 days early; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 12:45 (Lot number: ec3183) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: shell fish" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0169, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM), administration date: 02Sep2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 01Oct2021 16:15, outcome "recovered" (2021), described as "concerned with the size of blood clots that were occurring"; POLYMENORRHOEA (non-serious) with onset 01Oct2021 16:15, outcome "recovered" (2021), described as "I started my menstrual cycle 25 days early". Therapeutic measures were not taken as a result of menstrual disorder, polymenorrhoea.  Additional Information: It was reported that, Two days after my second dose, I started my menstrual cycle 25 days early. I had completed my previous menstrual cycle on 23Sep. This has never happened to me, i was also concerned with the size of blood clots that were occurring, as this was not normal for me. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 after post vaccination. The patient received treatment for adverse events was no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-Up (27Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Abnormal heavy/ clotting period.; Abnormal heavy/ clotting period.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 39 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: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 12Oct2021, outcome "unknown" and all described as "Abnormal heavy/ clotting period.". Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstrual disorder.  Additional information: Facility type Vaccine: Pharmacy or Drug Store. Known allergies: No. Other vaccine in four weeks: No. Other medications in two weeks: No. Covid prior vaccination: No. Covid tested post vaccination: No.  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: Bronchitis chronic, Chronic obstructive pulmonary disease
Clinical narrative: chronic bronchitis; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 21Aug2021, for Covid-19 immunization. The following information was reported: BRONCHITIS CHRONIC (non-serious) with onset 2021, outcome "unknown", described as "chronic bronchitis"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "unknown", described as "COPD". Therapeutic measures were taken as a result of bronchitis chronic, chronic obstructive pulmonary disease.  Additional information: Patient asked about the 100 dollar card they could receive after getting the Pfizer covid-19 vaccine. While reading the isi (unspecified), the patient mentioned that she was on a blood thinner (unspecified), with COPD (chronic obstructive pulmonary disease) and chronic bronchitis.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Investigation, Off label use, Pyrexia
Clinical narrative: I had mild fatigue; Fever; Chills; Fluzone High-Dose Quadrivalent Syringe shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Sep2021 16:00 (Lot number: FF2589) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE HIGH DOSE QUADRIVALENT), administration date 25Sep2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "BPH" (ongoing); "Inflammation" (ongoing); "Anxiety" (unspecified if ongoing); "Shoulder Occusion", start date: 02Jan2005 (unspecified if ongoing), notes: Pertinent details: Fixed; "Shoulder RCT", start date: 02Jan2006 (unspecified if ongoing), notes: Pertinent details: Repaired; "Kidney Stone", start date: 02Jan2017 (unspecified if ongoing), notes: Pertinent details: Removed; "Lymes", start date: 01Aug2020 (unspecified if ongoing), notes: Treated with antibiotics. Concomitant medication(s) included: TERAZOSIN taken for benign prostatic hyperplasia, start date: Jan2016 (ongoing); MELOXICAM taken for inflammation, start date: Jan2018 (ongoing); BUSPIRONE taken for anxiety, start date: Jan2017 (ongoing); IBUPROFEN taken for inflammation, start date: Jan2000 (ongoing). Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "I had mild fatigue"; PYREXIA (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "Fever"; CHILLS (non-serious) with onset 26Sep2021, outcome "recovered" (28Sep2021), described as "Chills"; OFF LABEL USE (non-serious) with onset 25Sep2021, outcome "unknown", described as "Fluzone High-Dose Quadrivalent Syringe shoulder". Relevant laboratory tests and procedures are available in the appropriate section.Therapeutic measures were not taken as a result of fatigue, pyrexia, chills.I had mild fatigue, fever, chills, I did not treat with NSAIDS, wanting the vaccine to take full effect before or after. No follow-up attempts are possible. No further information is expected.