chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: they put the shot in it and they did not squeeze or anything and it hurt going in; my arm feels weird; My hands specially feels swollen; some tightness in my hand; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: Not provided)), for COVID-19 immunisation. The following information was reported: INJECTION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "they put the shot in it and they did not squeeze or anything and it hurt going in"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "my arm feels weird"; PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "My hands specially feels swollen"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Apr2021, outcome "unknown", described as "some tightness in my hand".  Additional Information: The patient received the second dose of the Pfizer vaccine about 1 hour ago (Apr2021) and was okay. The patient was not having any horrible reaction but the concern was that when the patient got the first dose, they held patient's arm and gave it a squeeze a little bit but this person made the patient's arm hang down and said to just relax the arm, hang it down, then they put the shot in it and they did not squeeze or anything and it hurt going in and told them that and then the patient's arm felt weird. The patient didn't have that the first time. It's not numb because the patient tested with a needle but the patient's hands specially felt swollen like tight inside. The patient's hand was swollen and there was some tightness in the hand and didn't know if it's because of the way the shot was administered. The patient asked if to squeeze the arm first or if it's like important. He did it in the upper arm and the patient didn't know whom to call and asked if to call primary health care doctor about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Concussion, Illness, Nervous system disorder
Clinical narrative: sick; vaccine was affecting neurologically/any neurological damaging the path was attacking the nervous system; something like concussion; This is a spontaneous report received from contactable reporter (Consumer).  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: ILLNESS (non-serious), outcome "unknown", described as "sick"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "vaccine was affecting neurologically/any neurological damaging the path was attacking the nervous system"; CONCUSSION (non-serious), outcome "unknown", described as "something like concussion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021449118 Same reporter/drug, different patient/event.
Sex: U
Vaccine: COVID19
Symptoms: Concussion, Malaise, Nervous system disorder
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a nervous system disorder/vaccine had neurological affect/neurological damaging/attacking the nervous system,  concussion (had something like concussion) and malaise (sick), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 07Apr2021 (Lot number: EP7533, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6208), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional Information: The patient was asking if he was supposed to be feeling the event. The patient reported was shy 2 days of 2 weeks of the second vaccination, and was thinking why the patient was feeling the effects."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: "I got my vaccine earlier and my arm has not stopped shaking.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset 19Apr2021, outcome "unknown", described as ""I got my vaccine earlier and my arm has not stopped shaking.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea; Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: ER8730) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot number =EN62085,, administration date =03/03/2021,, administration time =03:45 PM,, vaccine location =Right arm,), administration date: 03Mar2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 17Apr2021 08:00, outcome "not recovered", described as "Nausea "; DIZZINESS (non-serious) with onset 17Apr2021 08:00, outcome "not recovered", described as "Dizziness". The events "nausea " and "dizziness" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of nausea, dizziness.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452255 same drug/event, different patient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Headache; neck pain; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 10:15 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: FLUOXETINE; NECON 7/7/7; CLARITIN [LORATADINE]. The following information was reported: HEADACHE (non-serious) with onset 28Mar2021 20:00, outcome "recovered" (Apr2021), described as "Headache"; NECK PAIN (non-serious) with onset 28Mar2021 20:00, outcome "recovered" (Apr2021), described as "neck pain". Therapeutic measures were not taken as a result of headache, neck pain.  Additional Information: The patient experienced headache and neck pain that lasted for 1 week after first shot. The patient did not receive other vaccine in four weeks, was not diagnosed with COVID prior vaccination, was not tested for COVID post vaccination, and had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021452300 Same patient and drug; Different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: it bothered her where the shot was put in her arm.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 17Mar2021 (Lot number: EN6208) 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 "it bothered her where the shot was put in her arm.".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021441732 same patient/product, different dose/event.
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea
Clinical narrative: Decrease in amount of menstruation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOMENORRHOEA (non-serious), outcome "unknown", described as "Decrease in amount of menstruation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021450627 same reporter, drug, event/different patients
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea
Clinical narrative: Decrease in amount of menstruation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HYPOMENORRHOEA (non-serious), outcome "unknown", described as "Decrease in amount of menstruation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021450627 same reporter, drug, event/different patients
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Muscle pain; Charlie horse/Cramp in leg; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Apr2021 (Lot number: EW0153) 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: MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; MUSCLE SPASMS (non-serious), outcome "unknown", described as "Charlie horse/Cramp in leg".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain
Clinical narrative: Chills; Body aches; Sweating; 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 male patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: EW0170) 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; Lot: ER8733), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Body aches"; HYPERHIDROSIS (non-serious) with onset Apr2021, outcome "unknown", described as "Sweating".  Additional information: Patient experienced chills, body aches and sweating. No fever was experienced. Symptoms started about 14 hours after second vaccine dose. No symptoms were experienced after first dose.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: This is a spontaneous report received from contactable patient (case identifier: 4308546#9265-2013929268). A 51-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 51, on Apr 19, 2021, single dose, for COVID-19 immunisation. Medical history included multiple sclerosis (ongoing). The patient's concomitant medications not reported. The patient had fatigue (very tired), and nausea (a little nauseous), onset Apr 19, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer (patient). A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included epilepsy (unspecified if ongoing). The patient's concomitant medications not reported. The patient had pain in extremity/sore arm and fatigue/tired, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (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 Apr2021, outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Aches; Chills; This is a spontaneous report from a contactable consumer. A 23-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Apr2021 the patient experienced fever, aches and chills. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever, aches and chills were recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Narrative "The patient did not have any relevant medical history" updated to "The patient's relevant medical history was not reported".
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Fever; Cold like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 25Apr2021 at 00:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Apr2021 the patient experienced fever and cold like symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever and cold like symptoms was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Regulatory Authority deleted from Intermediary.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). An 82-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0151), at the age of 82, on Apr 10, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), on Mar 20, 2021, for COVID-19 immunization. The patient experienced rhinorrhea (runny nose), fatigue (felt tired) and pain (body aches), with outcome of  unknown. No follow-up attempts possible. No further information expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm from first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 16Mar2021 (Lot number: EP7534) at the age of 82 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 17Mar2021, outcome "recovered" (17Mar2021), described as "sore arm from first vaccine". Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor, Vision blurred
Clinical narrative: appears slightly pale; feeling lightheaded; blurry vision; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Mar2021 (Lot number: EN6208) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Patient usually takes Zoloft daily for anxiety but missed her dose that day. Concomitant medication(s) included: ZOLOFT taken for anxiety, stop date: 10Mar2021. Vaccination history included: Bnt162b2 (Product: COVID 19 , Brand: Pfizer, Lot number: EN6201, Lot unknown: False, Administration date: 16Feb2021, Administration route: Intramuscular, Vaccine location: Left arm, Dose number: 1, she always feels lightheaded after getting vaccines), administration date: 16Feb2021, when the patient was 29 years old, for Covid-19 immunisation, reaction(s): "she always feels lightheaded after getting vaccines". The following information was reported: DIZZINESS (non-serious) with onset 10Mar2021, outcome "recovering", described as "feeling lightheaded"; VISION BLURRED (non-serious) with onset 10Mar2021, outcome "recovering", described as "blurry vision"; PALLOR (non-serious), outcome "recovering", described as "appears slightly pale". Therapeutic measures were not taken as a result of dizziness, vision blurred, pallor.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; HEADACHE (non-serious), outcome "unknown", described as "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: Illness, Vomiting
Clinical narrative: Throw up; i got sick; 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 01Apr2021 (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: VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "Throw up"; ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "i got sick".  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: Chills, Dizziness, Fatigue, Headache, Maternal exposure during pregnancy
Clinical narrative: Is pregnant: Yes; arm pain; fever; chills; headache; dizziness; muscle aches; exhaustion; 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), administered in arm left, administration date 22Apr2021 14:00 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Date of last menstrual period: 20Dec2020. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 17 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Sep2021. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Covid-19 vaccine (Product: COVID 19, brand: Pfizer, administration date: 01Apr2021, administration time: 10:00 AM, vaccine location: Left arm, After dose 1: arm pain for 2 days), administration date: 01Apr2021, when the patient was 31 years old, for COVID-19 immunisation, reaction(s): "Arm pain".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "arm pain"; PYREXIA (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "dizziness"; MYALGIA (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "muscle aches"; FATIGUE (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "exhaustion"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "is pregnant Yes". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, headache, dizziness, myalgia, fatigue.  Additional information: Adverse event: After dose 2: fever, chills, headache, dizziness, muscle aches, exhaustion, arm pain, Adverse event start date:  23Apr2021, Adverse event start time: 02:00 AM, other medical history: Hypothyroid.  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: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Is pregnant: Yes; arm pain; fever; chills; headache; dizziness; muscle aches; exhaustion; 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), administered in arm left, administration date 22Apr2021 14:00 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Date of last menstrual period: 20Dec2020. The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 17 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Sep2021. Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Covid-19 vaccine (Product: COVID 19, brand: Pfizer, administration date: 01Apr2021, administration time: 10:00 AM, vaccine location: Left arm, After dose 1: arm pain for 2 days), administration date: 01Apr2021, when the patient was 31 years old, for COVID-19 immunisation, reaction(s): "Arm pain".  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "arm pain"; PYREXIA (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "dizziness"; MYALGIA (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "muscle aches"; FATIGUE (non-serious) with onset 23Apr2021 02:00, outcome "not recovered", described as "exhaustion"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "is pregnant Yes". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, chills, headache, dizziness, myalgia, fatigue.  Additional information: Adverse event: After dose 2: fever, chills, headache, dizziness, muscle aches, exhaustion, arm pain, Adverse event start date:  23Apr2021, Adverse event start time: 02:00 AM, other medical history: Hypothyroid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: have a bad neck; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (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: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "have a bad neck".  Additional Information: The patient asked if they could take a steroid after taking the vaccine. The patient had the vaccine on Wednesday (Apr2021) and also had a bad neck.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Nerve injury, Pain in extremity
Clinical narrative: arm pain; bursitis; hit a nerve in his arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101211084 (Pfizer).  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 49 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, Lot: EP7533, Expiration 31Jul2021, both injections were in the left arm.), administration date: 10Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01May2021, outcome "not recovered", described as "arm pain"; BURSITIS (non-serious) with onset 2021, outcome "unknown", described as "bursitis"; NERVE INJURY (non-serious) with onset 2021, outcome "unknown", described as "hit a nerve in his arm". The events "arm pain", "bursitis" and "hit a nerve in his arm" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, bursitis, nerve injury.  Additional information: Patient stated he did not experience bothersome side effects after his first dose, but after his second dose he experienced arm pain that has persisted for greater than 2.5 months and radiates to the bone and into the upper muscle of the arm into his back. Patient stated his doctor diagnosed him with bursitis and informed him this could be due to injection technique, and the needle could have hit a nerve in his arm. Patient asking if this was a known side effect from the Pfizer BioNTech Covid-19 Vaccine or if this was likely to be caused by poor injection technique. Patient asking, since people seem to have stronger reactions to the second dose of the vaccine, if the second dose of the Pfizer BioNTech Covid-19 Vaccine was stronger or different than the first dose. He waited the time that he thought would be normal for most people of hurting for about 3-4 days to a week. It kept getting worse. It hurt the same day. It never stopped hurting after that. Six weeks later he went to the doctor, and it could have worsened into that bursitis feeling. It was pain when you wake up. He felt like vaccine shot was a menace some days and other days it was stiffness, and the bursitis pushes through. They recommend physical therapy.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: diarrhea; chills; nausea; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 72-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right, administration date 06Mar2021 13:15 (Lot number: EN6205) at the age of 72 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, Single, Batch/Lot Number: EN6201, Time: 4:00 PM, Anatomical Site of Injection: Right Arm, Route of Administration: Intramuscular), administration date: 13Feb2021, for COVID-19 immunization, reaction(s): "felt faint", "chills", "tired", "diarrhea". The following information was reported: DIARRHOEA (non-serious) with onset 06Mar2021 09:30, outcome "recovered", described as "diarrhea"; CHILLS (non-serious) with onset 06Mar2021 09:30, outcome "recovered", described as "chills"; NAUSEA (non-serious) with onset 06Mar2021 09:30, outcome "recovered", described as "nausea". Additional Information: The patient has no prior vaccination. Concomitant drugs, patient medical history and relevant tests were unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360023 same patient, drug, different dose/events.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Pfizer vaccines and the temparature fallsoutside of the ranges; controllant monitor that automatically stops 2 days ago; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "Pfizer vaccines and the temparature fallsoutside of the ranges"; PRODUCT STORAGE ERROR (non-serious), outcome "unknown", described as "controllant monitor that automatically stops 2 days ago".  Additional information: The vials in the freezer w/ are currently at -22 degrees Fahrenheit w/c is -9 degrees cooler than what is stated w/c is -13.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer-sponsored program (159558). A 71-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730, expiration date: Jul 2021), at the age of 71, on Mar 25, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had vaccination site pain (a little soreness on the injection site), with outcome of unknown. Additional information: The patient mentioned she didn't have a reaction, only a little soreness on the injection site. She was scheduled to return on Apr 15, 2021 for her second shot. However, she missed it. She wanted to have her second dose rescheduled, and wanted to know where she can get her second shot. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: fell down after the Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious), outcome "unknown", described as "fell down after the pfizer vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Pain, Vaccination site pain
Clinical narrative: Pain at the site of injection; Light body aches; Vivid dreams the night after the shot; This is a spontaneous report received from a contactable Consumer (patient).  A male patient received BNT162B2 (COMIRNATY), administration date 11Apr2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain at the site of injection"; PAIN (non-serious), outcome "recovered", described as "Light body aches"; ABNORMAL DREAMS (non-serious), outcome "recovered", described as "Vivid dreams the night after the shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: nausea; DIARRHEA; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 29 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; bosutinib (BOSULIF) (Batch/Lot number: unknown, Expiration Date: 31Dec2023) at 500 mg (500mg). 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"; DIARRHOEA (non-serious), outcome "unknown", described as "DIARRHEA".  Additional information: Patient received both pfizer covid vaccines. He continues to have nausea and diarrhea as side effects of bosulif(Dose: 500mg, Expiration Date: 31Dec2023)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: did feel terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 16:00 (Lot number: EN6198) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Time (24 hr): 4:50 pm, Site and Route of injection: Left Arm, Route of administration: intramuscular, Batch/Lot number: EN6201), administration date: 13Feb2021, when the patient was 46 years old, for COVID-19 immunization, reaction(s): "Dizzy last night", "Raised bumps on torso from neck to butt/when run finger over them they stung/hot tub rash", "hot tub rash". The following information was reported: FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "did feel terrible".  Additional information: Patient has no allergies to medications, food, or other products. 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. It was reported that after the second vaccine, patient did feel terrible for 2 days but it was manageable.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastric dilatation, Insomnia, Vomiting
Clinical narrative: vomiting; distended stomach; sleeplessness; diarrhea; fatigue; 9 lbs of weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US086466.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; GASTRIC DILATATION (non-serious), outcome "unknown", described as "distended stomach"; INSOMNIA (non-serious), outcome "unknown", described as "sleeplessness"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "9 lbs of weight loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated two weeks after his covid vaccine, he had a distended stomach along with vomiting sleeplessness which has now progressed to diarrhea and fatigue. Illness has resulted in 9 lbs of weight loss.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: vomiting; distended stomach; sleeplessness; diarrhea; fatigue; 9 lbs of weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US086466.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; GASTRIC DILATATION (non-serious), outcome "unknown", described as "distended stomach"; INSOMNIA (non-serious), outcome "unknown", described as "sleeplessness"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "9 lbs of weight loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated two weeks after his covid vaccine, he had a distended stomach along with vomiting sleeplessness which has now progressed to diarrhea and fatigue. Illness has resulted in 9 lbs of weight loss.  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
Clinical narrative: First dose: Tired in the evening of the same day.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 10:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL; VIT D. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021, outcome "recovered", described as "First dose: Tired in the evening of the same day.". Therapeutic measures were not taken as a result of fatigue.  Additional Information: No other vaccine in four weeks. No covid prior vaccination No covid tested post vaccination and also no known allergies.  Query: Please see the attached source document. The Pfizer Drug safety unit recently received the attached report submitted by you. Your awareness date provided as 08Apr2021, while submitted this report on 10May2021. which is a delay per Agency.  This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Please kindly further confirm the PRD and the delay reason for this report.  Response: The delay was due to a) instructions at the first vaccination to not report any side effects if minor within 24 hours so waited a couple of days to monitor any side effects and b) I mistakenly thought I had submitted the report but realized later that I started it but never submitted it.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Don't feel well; Fatigued; Has a heart condition; Nausea; Chills; Throwing up all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0169) at the age of 76 years as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Don't feel well"; FATIGUE (non-serious), outcome "unknown", described as "Fatigued"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has a heart condition"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CHILLS (non-serious), outcome "unknown", described as "Chills"; VOMITING (non-serious), outcome "unknown", described as "Throwing up all night".  Follow-up(14May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  Follow-up(19May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  Follow-up(23May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Don't feel well; Fatigued; Has a heart condition; Nausea; Chills; Throwing up all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0169) at the age of 76 years as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Don't feel well"; FATIGUE (non-serious), outcome "unknown", described as "Fatigued"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has a heart condition"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CHILLS (non-serious), outcome "unknown", described as "Chills"; VOMITING (non-serious), outcome "unknown", described as "Throwing up all night".  Follow-up(14May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  Follow-up(19May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  Follow-up(23May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  No follow-up attempts are possible. No further information is expected.