chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: I have a lump under my armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY MASS (non-serious), outcome "unknown", described as "I have a lump under my armpit". Additional information: Patient reported to have received the first shot on the 25th (not specified). The patient has not received the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Stomatitis
Clinical narrative: Swelling in lymph nodes from my left arm up; sore throat on the left side; sores in mouth on the left side; 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 (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Feb2021 (Batch/Lot number: EM9810) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing); "Allergy to penicillin" (unspecified if ongoing); "High cholesterol" (ongoing); "Sulfa allergy" (ongoing). Concomitant medication(s) included: GLIMEPIRIDE; ATORVASTATIN. Past drug history included: Levaquin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: EL1283, Anatomical Site of injection: Left arm, Route of administration: Intramuscular), administration date: 23Jan2021, when the patient was 77 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "Swelling in lymph nodes from my left arm up"; OROPHARYNGEAL PAIN (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "sore throat on the left side"; STOMATITIS (non-serious) with onset 15Feb2021, outcome "recovered" (19Feb2021), described as "sores in mouth on the left side". The events "swelling in lymph nodes from my left arm up", "sore throat on the left side" and "sores in mouth on the left side" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, oropharyngeal pain, stomatitis.  Additional information: The patient had not received any other vaccines within 4 weeks. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since the vaccination. Antibiotics (unspecified) for 3 days were received as treatments for the events.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: dizziness; nausea; He says the room was spinning around; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EL9264) at the age of 78 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: DIZZINESS (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 03Mar2021, outcome "recovered" (04Mar2021), described as "nausea"; VERTIGO (non-serious) with onset 03Mar2021, outcome "recovering", described as "He says the room was spinning around".  Additional information: Reporter confirmed patient received the first dose on 03Mar2021 and the dizziness began the same day. She said it is resolved now. Patient said the room was spinning around he got nauseous with it too but it got better as the night went on. Reporter said it was after midnight ,so it was on 04Mar2021 when the dizziness recovered completely. Reporter said patient's nausea was recovered now as well. It was just nausea it was not vomiting and that was better now.  No follow-up attempts are possible.  No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Injection site pain; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 12:45 (Lot number: EL3247) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "CT scan dye allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; CALCIUM CITRATE; VIT D; CENTRUM SILVER +50. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 17:00, outcome "recovering", described as "Injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 03Mar2021 17:00, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site/ Injection site soreness (in left arm) overnight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 12:15 (Lot number: EL3248) at the age of 34 years as dose 1, single and administered in arm left, administration date 24Mar2021 12:00 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic rhinitis" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D [COLECALCIFEROL]; MULTIVIT [VITAMINS NOS]; ALIGN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 19:00, outcome "recovered", described as "Pain at injection site/ Injection site soreness (in left arm) overnight". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The facility where the most recent COVID-19 vaccine was administered in a workplace clinic. The patient has no allergies to medications, food, or other products and prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant therapy included birth control. The patient also experienced injection site soreness (in left arm) overnight after the second dose on 24Mar2021 at 18:00 which resolved within 24 hours of receiving shot. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: mild sore arm; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 14:30 (Batch/Lot number: EN6205) at the age of 60 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: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "recovered", described as "mild sore arm"; NAUSEA (non-serious) with onset 03Mar2021, outcome "recovered", described as "mild nausea". Therapeutic measures were not taken as a result of pain in extremity, nausea.  Additional information: The patient had not received any other vaccines within 4 weeks. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. The events were considered as non-serious by the reporter.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms both arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arms both arms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site discomfort, Vaccination site pain
Clinical narrative: felt sluggish the next morning/early afternoon; soreness & feeling in heaviness in arm where vaccine was injected the evening of the vaccination; soreness & feeling in heaviness in arm where vaccine was injected the evening of the vaccination; This is a spontaneous report received from a contactable reporter. The reporter is the patient.   A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 10:30 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies_Environmental" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOMFORT (non-serious) all with onset 03Mar2021 20:00, outcome "recovered" and all described as "soreness & feeling in heaviness in arm where vaccine was injected the evening of the vaccination"; SLUGGISHNESS (non-serious) with onset 04Mar2021, outcome "recovered", described as "felt sluggish the next morning/early afternoon". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site discomfort, sluggishness.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. Events did not result in physician office visit or emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Headache, Nausea
Clinical narrative: Nausea; stomach pain; headache; Diarrhea; shaking; body ache; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  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. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; TREMOR (non-serious), outcome "unknown", described as "shaking"; PAIN (non-serious), outcome "unknown", described as "body ache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  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, Tremor
Clinical narrative: Nausea; stomach pain; headache; Diarrhea; shaking; body ache; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  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. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain"; HEADACHE (non-serious), outcome "unknown", described as "headache"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; TREMOR (non-serious), outcome "unknown", described as "shaking"; PAIN (non-serious), outcome "unknown", described as "body ache"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen armpit lymph node on same side as vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: EL3247) 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen armpit lymph node on same side as vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Arm soreness; headache; bodyache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 10:00 (Lot number: EL3247) at the age of 34 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: PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "recovering", described as "Arm soreness"; HEADACHE (non-serious) with onset 02Mar2021, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 02Mar2021, outcome "recovering", described as "bodyache". Therapeutic measures were taken as a result of pain in extremity, headache, pain.  Additional information: Treatment with Advil was taken as a result of the events. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: her arm was very sore; felt bad; nauseous; dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Some allergies" (unspecified if ongoing), notes: not aware of specifics. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered", described as "her arm was very sore"; FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "recovered", described as "felt bad"; NAUSEA (non-serious) with onset Feb2021, outcome "recovered", described as "nauseous"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovered", described as "dizzy". Therapeutic measures were not taken as a result of pain in extremity, feeling abnormal, nausea, dizziness. Additional information: Patient reported that her arm was very sore the next day after vaccine administration. She said she felt bad and took a 2 hour nap the day after her vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is sore but I've had worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Feb2021 (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: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "Arm is sore but I've had worse".  Additional Information: The report is from Pfizer Sponsored Program   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: arm pain next day; lightheadedness and fogginess about 1 hr post vaccine which resolved within 15 min; lightheadedness and fogginess about 1 hr post vaccine which resolved within 15 min; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 86 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 15:15 (Batch/Lot number: unknown) at the age of 86 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: DIZZINESS (non-serious), FEELING ABNORMAL (non-serious) all with onset 03Mar2021 16:30, outcome "recovered" (03Mar2021 16:45) and all described as "lightheadedness and fogginess about 1 hr post vaccine which resolved within 15 min"; PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "recovered", described as "arm pain next day". Therapeutic measures were not taken as a result of dizziness, feeling abnormal, pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Muscle spasms, Nausea
Clinical narrative: Chills; Aching from head to feet; severe headache; leg cramps; Nausea; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: En6204) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "headaches" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: Bnt162b2 (Dose number: 1, Brand: Pfizer, Lot number: EN6023, Administration date: 26Feb2021, Administration time: 06:30 PM, Vaccine location: Right arm), administration date: 26Feb2021, when the patient was 67 years old, for COVID-19 Immunisation, reaction(s): "Chills", "Aching from head to feet", "severe headache", "leg cramps".  The following information was reported: CHILLS (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Chills"; PAIN (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Aching from head to feet"; HEADACHE (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "severe headache"; MUSCLE SPASMS (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "leg cramps"; NAUSEA (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Nausea"; DIARRHOEA (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Diarrhea ".  Clinical course: Chills that lasted for hours Aching from head to feet, severe headache, leg cramps, after the first vaccine this started on Saturday around 6:15 pm and lasted all day on Sunday. The second vaccine I had the same symptoms along with Nausea and diarrhea. this started at 11:30 pm on 19Mar2021 and lasted through 21Mar2021. I called my pharmacist and she suggested I take Tylenol and stay in bed. Patient has not taken any other vaccine in four weeks. Medication in two weeks reported as yes. Patient was not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills; Aching from head to feet; severe headache; leg cramps; Nausea; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: En6204) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "headaches" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". Vaccination history included: Bnt162b2 (Dose number: 1, Brand: Pfizer, Lot number: EN6023, Administration date: 26Feb2021, Administration time: 06:30 PM, Vaccine location: Right arm), administration date: 26Feb2021, when the patient was 67 years old, for COVID-19 Immunisation, reaction(s): "Chills", "Aching from head to feet", "severe headache", "leg cramps".  The following information was reported: CHILLS (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Chills"; PAIN (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Aching from head to feet"; HEADACHE (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "severe headache"; MUSCLE SPASMS (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "leg cramps"; NAUSEA (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Nausea"; DIARRHOEA (non-serious) with onset 19Mar2021 23:30, outcome "recovered" (21Mar2021), described as "Diarrhea ".  Clinical course: Chills that lasted for hours Aching from head to feet, severe headache, leg cramps, after the first vaccine this started on Saturday around 6:15 pm and lasted all day on Sunday. The second vaccine I had the same symptoms along with Nausea and diarrhea. this started at 11:30 pm on 19Mar2021 and lasted through 21Mar2021. I called my pharmacist and she suggested I take Tylenol and stay in bed. Patient has not taken any other vaccine in four weeks. Medication in two weeks reported as yes. Patient was not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Nasal congestion, Vertigo
Clinical narrative: slight earache in the left ear along with mild vertigo; slight earache in the left ear along with mild vertigo; a slightly stuffy nose the next morning; felt fatigued; This is a spontaneous report received from a contactable consumer who is also a Pfizer colleague. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Mar2021 11:30 (Lot number: EN6203) at the age of 53 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergies to latex" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medications included: OMEPRAZOLE; ZOLOFT; D3 VITAMIN; EXCEDRIN MIGRAINE. Past drug history included: Betadine, reaction(s): "allergy". The following information was reported: NASAL CONGESTION (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "a slightly stuffy nose the next morning"; FATIGUE (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "felt fatigued"; EAR PAIN (non-serious), VERTIGO (non-serious) all with onset 03Mar2021 16:30, outcome "recovered" (05Mar2021) and all described as "slight earache in the left ear along with mild vertigo". Therapeutic measures were not taken as a result of nasal congestion, fatigue, ear pain, vertigo.  Additional information: The patient woke up with a slightly stuffy nose the next morning after the first dose vaccination (03Mar2021) and felt fatigued. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination. The patient also received the second dose of BNT162B2, administered in the left arm, administration date 26Mar2021 11:30 (Lot number: EL3248) for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)  (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Caller wants to know if she can take Tylenol Medical Information, no: Customer and/or medical inquiry was NOT forwarded.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint range of motion decreased, Vaccination site pain
Clinical narrative: Pain at injection site; Limited range of motion of arm without pain; severe headache; This is a spontaneous report from a contactable consumer. This 63-year-old (age at vaccination)  non- pregnant female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6202) via an unspecified route of administration on 11Mar2021 at 11:00 am in left arm at dose 1, single for covid-19 immunisation. Patient's medical; history included hypothyroidism, Asthma, osteoarthritis, high blood pressure, known allergies; wheat, sulfa and Covid-19. Patient also received second dose of BNT162B2, lot number: EW0151 via an unspecified route of administration on 09Apr2021 at 11:00 am in left arm for covid-19 immunisation. No other vaccines were administered in four weeks. Other medications in two weeks: Fluticasone propionate/salmeterol; Albuterol Sulfa. Adverse event 1st dose - severe headache; Pain at injection site; limited range of motion of arm without pain. 2nd dose - Fever of 99.4 usu. 97.5; Pain at injection site; Limited range of motion of arm without pain; tiredness. Adverse event start date was 09Apr2021 at 5:00 pm. AE did not result in ER or physician's office. Treatment was given for the AEs. ae treatment acetaminophen; Biofreeze spray. Patient was not pregnant at the time of vaccination. Patient had covid prior vaccination. Patient was not tested for covid post vaccination. Vaccine Facility information available. Ethnicity information is available. Race information is available. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nasopharyngitis
Clinical narrative: Like a little cold but no fever; fatigue/weakness; fatigue/weakness; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (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, for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Apr2021, outcome "not recovered", described as "severe headache"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Like a little cold but no fever"; FATIGUE (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "fatigue/weakness". Clinical course: Patient stated that he got the Pfizer second dose 30Mar2021 and today (16Apr2021), the day of this report) has been one week patient has had a severe headache and thought it was a cold, but he had not runny nose or fever, nothing. Like a little cold but no fever. Patient was asking if this was a side effect of Pfizer. Caller was asking what Pfizer suggest for the headache as it was not going away after a few days, it has been more than 7 days, does Pfizer suggest a Covid test. Patient stated that he was fine on 30Mar2021 and Saturday (10Apr2021) he started getting the headache and thought about getting a Covid test, but he did not have a fever, not even 99-100 and it had been off and on and he was feeling good and sometimes it was severe. Stated it was like the cold is suppressed to his head and he had been doing hot water steam and whatever was coming out of his nose he gets out but it's not running. Since vaccination, he has experienced headaches and some fatigue/weakness that attributes to the headaches. He wanted to know if there was some over-the-counter pain medication that he could take that would not be detrimental and undermine the efficacy of the vaccine or the antibodies it should ultimately produce. Caller was asking what remedies Pfizer would suggest and stated it was the Pfizer Covid Vaccine. This report was not related to a study or program. Reason for no lot number of Covid vaccine stated as Caller unwilling to complete the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Malaise, Myalgia, Nausea
Clinical narrative: arm pain; didn't feel well; flushing hot; Exhaustion; severe nausea; Muscle ache; 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 Lot number: EN6207),administration date 18Mar2021 as dose 1 single for covid-19 immunization.The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 18Mar2021, outcome "unknown", described as "flushing hot"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Exhaustion"; NAUSEA (non-serious) with onset 18Mar2021, outcome "unknown", described as "severe nausea"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; MALAISE (non-serious), outcome "unknown", described as "didn't feel well".The patient received her 2nd dose of bnt162b2 on 15Apr2021, lot EW0161.   No Follow-up attempts are needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; didn't feel well; flushing hot; Exhaustion; severe nausea; Muscle ache; 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 Lot number: EN6207),administration date 18Mar2021 as dose 1 single for covid-19 immunization.The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 18Mar2021, outcome "unknown", described as "flushing hot"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Exhaustion"; NAUSEA (non-serious) with onset 18Mar2021, outcome "unknown", described as "severe nausea"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Muscle ache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; MALAISE (non-serious), outcome "unknown", described as "didn't feel well".The patient received her 2nd dose of bnt162b2 on 15Apr2021, lot EW0161.   No Follow-up attempts are needed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: Next day Chills; extremely tender arm at injection site; hot sweats; achy body; nausea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received bnt162b2 (BNT162B2) solution for injection, (Batch/Lot number: unknown) dose 2 via unspecified route of administration in arm right, administration date 21Apr2021 12:00 at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, pregnant; "pregnant" (unspecified if ongoing), notes: Other medical history: Asthma, pregnant. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30May2021. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". Vaccination history included: Bnt162b2 (Dose number: 1) solution for injection, (Batch/Lot number: unknown) dose 1 via unspecified route of administration on an unspecified date, when the patient was 31 years old, for Covid-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "Next day Chills"; INJECTION SITE PAIN (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "extremely tender arm at injection site"; HYPERHIDROSIS (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "hot sweats"; PAIN (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "achy body"; NAUSEA (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "nausea"; DECREASED APPETITE (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "loss of appetite". Therapeutic measures were not taken as a result of chills, injection site pain, hyperhidrosis, nausea, decreased appetite.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Next day Chills; extremely tender arm at injection site; hot sweats; achy body; nausea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received bnt162b2 (BNT162B2) solution for injection, (Batch/Lot number: unknown) dose 2 via unspecified route of administration in arm right, administration date 21Apr2021 12:00 at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, pregnant; "pregnant" (unspecified if ongoing), notes: Other medical history: Asthma, pregnant. The patient was 34 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30May2021. There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". Vaccination history included: Bnt162b2 (Dose number: 1) solution for injection, (Batch/Lot number: unknown) dose 1 via unspecified route of administration on an unspecified date, when the patient was 31 years old, for Covid-19 Immunisation. The following information was reported: CHILLS (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "Next day Chills"; INJECTION SITE PAIN (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "extremely tender arm at injection site"; HYPERHIDROSIS (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "hot sweats"; PAIN (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "achy body"; NAUSEA (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "nausea"; DECREASED APPETITE (non-serious) with onset 22Apr2021 02:00, outcome "recovering", described as "loss of appetite". Therapeutic measures were not taken as a result of chills, injection site pain, hyperhidrosis, nausea, decreased appetite.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Diarrhoea, Lower limb fracture, Nausea, Weight decreased
Clinical narrative: lost 7 lbs; Diarrhea; Nausea; broken her ankle and cannot walk right now/ 8 broken bones in her legs and ankles/ patient in a cast; broken her ankle and cannot walk right now/ 8 broken bones in her legs and ankles/ patient in a cast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 01Jan2021, stop date: 14Jan2021, notes: nauseous and had diarrhea; lost 17 pounds and almost went to the emergency room for dehydration; "nauseous" (unspecified if ongoing); "diarrhea" (unspecified if ongoing); "dehydration" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANKLE FRACTURE (medically significant), LOWER LIMB FRACTURE (medically significant) all with onset 2021, outcome "recovering" and all described as "broken her ankle and cannot walk right now/ 8 broken bones in her legs and ankles/ patient in a cast"; DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "Nausea"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 7 lbs". The patient reported that the first shot gave her diarrhea for 24 hours. The patient took promethazine (PHENERGAN) as a treatment for nausea. She was in a cast due to the 8 broken bones in her legs and ankles. The patient does not want to receive the second dose.  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, Illness
Clinical narrative: She got really sick; Severe headache; 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) (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose.), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She got really sick"; HEADACHE (non-serious), outcome "unknown", described as "Severe headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Severe Nausea; Throwing Up; Constant Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart Condition with Stents" (ongoing), notes: Verbatim: Heart Condition with Stents. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Severe Nausea"; VOMITING (non-serious) with onset 2021, outcome "recovered" (2021), described as "Throwing Up"; DIARRHOEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Constant Diarrhea".  Additional information: She stated that she was just wanted to know about side effects happening 2 months after the last Covid Shot and she had no reaction initially to either vaccine.  Two months, almost to the day, after the second one she had severe nausea, throwing up, and constant diarrhea for 2 and a half days. She stated that she had a heart condition with stents. She just wanted to know if this is something other people have experienced with her age and have experienced any people this 2 months after the vaccine. She stated that this past weekend they were feeling okay but the weekend before they were not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging head
Clinical narrative: severe headache; 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 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 09:45 (Batch/Lot number: unknown) at the age of 28 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, location: Right arm, date/time: 16Apr2021 14:00), administration date: 16Apr2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08May2021, outcome "unknown", described as "severe headache". The event "severe headache" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 08May2021 she developed a severe headache which has continued and not resolved. She had an MRI which showed no abnormal findings. She wants to know if this has been reported and how long to expect this side effect to last. Consumer stated that she wanted to report a side effect. She was just actually at the hospital and stated that she was advised by the hospital staff to report this after she had a clear brain MRI. She said that she has had a severe headache going on 6 days now. she stated that it has gotten a little better but is definitely persisting. 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) Covid-19 Vaccine, Right arm, No lot or expiration date info available. The patient visits to emergency room and no physician office. She was sent to get a MRI at the hospital by the physician.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Severe nausea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 12:00 (Lot number: Ew0182) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Antidepressant" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO taken for antidepressant therapy. The following information was reported: NAUSEA (non-serious) with onset 04Jun2021 02:00, outcome "recovering", described as "Severe nausea"; VOMITING (non-serious) with onset 04Jun2021 02:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of nausea, vomiting. Follow-up attempts are completed. No further information is expected.