chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Completed a course of Vivotif, which was never refrigerated; Spontaneous report received on 14FEB2020.  A pharmacist reported that a consumer "completed a course of Vivotif, which was never refrigerated" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. The consumer had completed a course of Vivotif in October but the consumer had never refrigerated it. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer completed vivotif course but vivotif was never refrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as possible.; Sender's Comments: A consumer completed vivotif course but vivotif was never refrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as possible.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fall, Fatigue, Headache
Clinical narrative: Jaw pain; Syncopal episode/Syncope; Fell; Dizziness; Nausea; Felt flu-like; Injection site pain; Fatigue; Headache; Muscle pain; Chills; Fever; Felt unwell; A spontaneous report was received from a nurse concerning a female 28 year old, patient who experienced same day injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. .    The patient's medical history was not provided.  Concomitant product use was unknown by the reporter.     The patient received their second dose of mRNA-1273 lot 028L20A on 28-JAN-2021.  On 28-JAN-2021 approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 Lot number 028L20A intramuscularly for prophylaxis of COVID-19 infection.    A patient received her second dose of Moderna vaccine on 28/Jan/2021 at 8 AM, lot 028L20A. Same day at 17:00, she experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed pain. She was seen in the emergency room (ER) and released with a diagnosis of syncope and jaw pain. Resolution dates not reported. Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; Reporter's Comments: This report concerns a 28--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and within 2 days, experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like, dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD21-024340:Crosslinked: Same Reporter MOD21-024360:Crosslinked: Same Reporter MOD21-024368:Crosslinked: Same Reporter MOD21-024387:Crosslinked: Same Reporter MOD21-024396:Crosslinked: Same Reporter MOD21-024411:Crosslinked: Same Reporter
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Malaise, Myalgia, Nausea
Clinical narrative: Jaw pain; Syncopal episode/Syncope; Fell; Dizziness; Nausea; Felt flu-like; Injection site pain; Fatigue; Headache; Muscle pain; Chills; Fever; Felt unwell; A spontaneous report was received from a nurse concerning a female 28 year old, patient who experienced same day injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. .    The patient's medical history was not provided.  Concomitant product use was unknown by the reporter.     The patient received their second dose of mRNA-1273 lot 028L20A on 28-JAN-2021.  On 28-JAN-2021 approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 Lot number 028L20A intramuscularly for prophylaxis of COVID-19 infection.    A patient received her second dose of Moderna vaccine on 28/Jan/2021 at 8 AM, lot 028L20A. Same day at 17:00, she experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed pain. She was seen in the emergency room (ER) and released with a diagnosis of syncope and jaw pain. Resolution dates not reported. Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; Reporter's Comments: This report concerns a 28--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and within 2 days, experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like, dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD21-024340:Crosslinked: Same Reporter MOD21-024360:Crosslinked: Same Reporter MOD21-024368:Crosslinked: Same Reporter MOD21-024387:Crosslinked: Same Reporter MOD21-024396:Crosslinked: Same Reporter MOD21-024411:Crosslinked: Same Reporter
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Syncope
Clinical narrative: Jaw pain; Syncopal episode/Syncope; Fell; Dizziness; Nausea; Felt flu-like; Injection site pain; Fatigue; Headache; Muscle pain; Chills; Fever; Felt unwell; A spontaneous report was received from a nurse concerning a female 28 year old, patient who experienced same day injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. .    The patient's medical history was not provided.  Concomitant product use was unknown by the reporter.     The patient received their second dose of mRNA-1273 lot 028L20A on 28-JAN-2021.  On 28-JAN-2021 approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 Lot number 028L20A intramuscularly for prophylaxis of COVID-19 infection.    A patient received her second dose of Moderna vaccine on 28/Jan/2021 at 8 AM, lot 028L20A. Same day at 17:00, she experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like. On 29/Jan/2021, she developed dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed pain. She was seen in the emergency room (ER) and released with a diagnosis of syncope and jaw pain. Resolution dates not reported. Treatment information was not provided/unknown.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; Reporter's Comments: This report concerns a 28--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and within 2 days, experienced injection site pain, fatigue, headache, muscle pain, chills, fever, felt unwell and flu-like, dizziness, nausea, a syncopal episode and fell and hit her jaw, which developed into pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  MOD21-024340:Crosslinked: Same Reporter MOD21-024360:Crosslinked: Same Reporter MOD21-024368:Crosslinked: Same Reporter MOD21-024387:Crosslinked: Same Reporter MOD21-024396:Crosslinked: Same Reporter MOD21-024411:Crosslinked: Same Reporter
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Chills, Headache, Heart rate increased, Nausea
Clinical narrative: arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills.  The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies.   On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection.  On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot.  Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported.  The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age and prior history of irregular heart beat are considered risk factors for arrhythmias.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills.  The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies.   On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection.  On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot.  Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported.  The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age and prior history of irregular heart beat are considered risk factors for arrhythmias.
Sex: U
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: I have lost significant range of motion in my arm/shoulder; vaccine was given to high in my shoulder; Pain; A spontaneous report was received from a paramedic who was also a male patient of unknown age, who was administered Moderna's COVID-19 vaccine and experienced that the vaccine was given to high in shoulder (vaccine administered at inappropriate site), pain and lost significant range of motion in my arm/shoulder (injected limb mobility decreased).  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 02 Feb 2021, the patient received the second dose of mRNA-1273 through an unknown route in an unknown arm for COVID-19 infection prophylaxis.  On 02 Feb 2021, the patient reported that  the vaccine was given to high in his shoulder and was injected into the bursa space and he had lost significant range of motion in his arm/shoulder and the pain was severe. The patient immediately obtained medical care within six hours of receiving the vaccine. The patient was admitted to an emergency room after the initial care in less than twenty-four hours and then eventually to the hospital floor. The patient's treatment  included medical care.  The action taken for Moderna COVID-19 vaccine was not applicable.  The outcome of the events, lost significant range of motion in arm/shoulder and the pain were considered as unknown.The outcome of the event vaccine was given to high in shoulder was resolved.; Reporter's Comments: This case report concerns a male patient of unknown age who vaccine was given to high in shoulder (vaccine administered at inappropriate site) and experienced pain and  lost significant range of motion in arm/shoulder for mRNA-1273, lot # unknown. The event of pain and lost significant range of motion in arm/shoulder are temporarily associated with the product use and a causal association cannot be excluded. The event of vaccine was given to high in shoulder is assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Haematemesis, Vomiting
Clinical narrative: Vomiting and vomit had blood in it; Bloody nose; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, female patient who received Moderna's COVID-19 vaccine and experienced bloody nose/epistaxis, vomiting and the vomit had blood in it/ hematemesis.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 10 FEB 2021, the patient received her second planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly in the left arm and administered by medical center for prophylaxis of COVID-19 infection.  On 11 FEB 2021, in the morning the patient woke up with a bloody nose, vomiting and the vomit had blood in it. The treatment information for the events, were not provided. The patient had other medicine for her blood pressure and toe fungus.  The action taken with the second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the events, bloody nose, vomiting and the vomit had blood in it were considered as unknown.; Reporter's Comments: This report concerns a 61-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273, Lot number: 032L20A) and experienced bloody nose/epistaxis, vomiting and the vomit had blood in it/ hematemesis. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Foaming at mouth, Pallor, Somnolence, Unresponsive to stimuli
Clinical narrative: Unresponsive/laying in bed still; Sleepy and stayed in bed after getting vaccine; pale; eyes half open and foam coming from mouth; A spontaneous report was received from Pfizer concerning a 66 year old male who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being unresponsive/laying in bed, sleepy and stayed in bed after getting vaccine, pale, and eyes half open and foam coming from mouth.  The patient's medical history was not provided. Concomitant medication use was not provided.   On an unknown date, the patient received unknown dose number of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection.   On an unknown date, the patient, who resided in a senior home, stayed in bed the dat after getting the vaccine. Early the next morning, he was observed in bed lying still, pale, eyes half open and foam coming from the mouth. He was unresponsive. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of unresponsive/laying in bed still, sleepy and stayed in bed after getting vaccine, pale, and eyes half open and foam coming from mouth/ was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: Lock down for dementia after first dose; A spontaneous report was received from a consumer concerning a female patient was participating in the mRNA-1273 Emergency Use Program and experienced lock down for dementia after first dose / dementia.  The patient's medical history not provided. The patient's concomitant not provided.  On 30th JAN 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    On unknown date, the patient was in lock down for dementia.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.     The outcome of the event, lock down for dementia after first dose, was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hot flush
Clinical narrative: hot flashes, below the arm right side of the body, hot sensation on and off comes frequently; right hip pain; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient) reported that a 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 (past Friday night) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24Jan2021 (Sunday), patient experienced hot flashes, below the arm right side of the body, hot sensation on and off comes frequently. She also had right hip pain. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash
Clinical narrative: The rash is up under arm, in armpit and is in the same arm of injection but there is no rash at the injection site.; because there was some itching under the arm.  I went to see a dermatologist who says it has nothing to do with vaccine.  I also had a slight headache; I also had a slight headache a day or two after the shot; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on 14Jan2021 on left arm at a single dose for COVID-19 immunisation. Medical history included chronic kidney disease. The patient had chronic kidney disease and its real important for someone with her disease to get the vaccine, because if she got the actual virus it would hit the kidneys hard. The patient had no positive covid or antibody test prior to the vaccine. Concomitant medications were none. The patient stated that only thing she thinks would be related was that, she noticed this rather after using the hot tub, her husband just cleaned the hot tub and put chemicals in it, maybe she had a reaction to chemicals used to clean the hot tub. On 24Jan2021, the patient was reported after 10 days the patient had rash was up under the arm, near the arm pit, in the same arm of injection but there was no rash at the actual injection site, however her skin was beautiful, there was no spot except under the armpit. She got the injection a week ago Friday, she noticed the rash days later, on Sunday with itching under the arm. The Dermatologist says it has nothing to do with vaccine. The patient also had a slight headache a day or 2 (on 15Jan2021) after the shot, not a migraine, it was a slight dull headache, but went away. The patient went to the dermatologist yesterday, and he said it had nothing to do with the vaccine. She went to the dermatologist on 26Jan2021. Caller again stated that there was no rash at the injection site, but there was a rash underneath the arm in the arm pit. She still has it, she just started to use medicine last night. It's getting better. The Dermatologist prescribed a topical cream and its some kind of cortisone. The patient did not have any severe reaction like head swelling or swelling. The patient was scheduled for her second dose on 05Feb2021. The patient recovered from headache on 16Jan2021, recovering from rash, and for itching it was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: strong headaches; fever around 99.8 - 100 degree F; This is a spontaneous report from a non-contactable consumer.  A female patient (reporter's wife) of an unspecified age receive BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that since Sunday morning, 24Jan2021, the patient has been suffering of strong headaches and fever. The patient experienced fever around 99.8 - 100 degree F and a very strong headache that cannot be controlled with medication. The outcome of the events was unknown. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Nephropathy, Urticaria
Clinical narrative: Facial hives/hives on the face; might have caused a flare of my kidney disease; might have caused a flare of my kidney disease; This is a spontaneous report received from a contactable consumer (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 27Jan2021 09:45 on left arm at single dose for COVID-19 immunisation. Medical history included liver transplant and kidney disease. The patient previously took amoxicillin and had allergies. The patient did not receive other vaccine in four weeks prior to vaccination but received other medications (unspecified) in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Jan2021 12:00, the patient experienced facial hives/hives on the face and reported that it might have caused a flare of my kidney disease. The seriousness of the events was considered as non-serious by the reporter. Therapeutic measures were taken as a result of event facial hives/hives on the face included Benadryl. The outcome of the event hives was recovering, whereas unknown for other events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Sever upper body itching; This is a spontaneous report from contactable nurse (patient). A 37-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital via an unspecified route of administration on 13Jan2021 at 10:00 at a single dose on the right arm for COVID-19 immunization.  The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient previously took erythromycin and Polytrim and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe upper body itching on 13Jan2021. The itching started 7 hours after the vaccine. The patient received Benadryl, Zyrtec and Claritin as treatment. The patient recovered from the event. The event was reported as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness at injection site of 3-4 inches; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness at injection site of 3-4 inches. The reporter wanted to know if there were any recommendations on how to treat this side effect. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient (not pregnant) received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), via an unspecified route of administration on the left arm, on 26Jan2021 13:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The vaccine was administered at the workplace clinic. The patient experienced having a slightly painful swollen lymph node on her left side near the clavicle and it was tender when touched on 27Jan2021 10:00. No treatment was received for the adverse events. The patient had not recovered from the adverse events at the time of the report. The patient has not been COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tiredness; fever; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The first dose was received on an unspecified date. The patient's medical history and concomitant medications were not reported.  The patient experienced tiredness and fever on 28Jan2021 which resulted in a clinic visit. Outcome of the event was unknown. The reporter considered the events non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Night sweats
Clinical narrative: Difficulty lifting arm; horrible night sweats; This is a spontaneous report from a contactable consumer. An elderly female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced difficulty lifting arm and horrible night sweats the night of injection (27Jan2021) and difficulty lifting arm the following morning. The patient was not tested for covid post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain started about 8h after vaccination with the COVID-19 vaccine at the side of vaccination (left arm); This is a spontaneous report from a contactable consumer (patient himself). A 38-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247, expiration date was unknown), via an unspecified route of administration in the left arm on 27Jan2021 at 13:00 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the workplace clinic. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post-vaccination. On 27Jan2021 at 21:00, the patient experienced mild pain started about 8 hours (8h) after vaccination with the COVID-19 vaccine at the side of vaccination (left arm). The patient did not receive any treatment for the adverse event (AE). The patient was recovering from the event.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Palpitations, Pyrexia
Clinical narrative: palpitations; Fever of 101 (Degree)F; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (unknown lot number and expiration) for COVID-19 immunization on unspecified date.  The patient called to report the side effects she experienced after administration of the second dose of the COVID-19 vaccine. She mentioned that 20 minutes after the administration of the second dose of the COVID-19 vaccine, she experienced palpitations and now she has a fever of 101 (Degree) F (unspecified dates).  The patient was recommended by the nurse to manage fever with Tylenol. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Bone swelling, Neck pain, Pain
Clinical narrative: Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; Pain on left side especially in her neck swelling at her left clavicle painful to touch; This is a spontaneous report from a contactable nurse (patient herself). A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3303, expiration date was unknown), intramuscularly in the left arm on 27Jan2021 at 12:30 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiration date was unknown) on 06Jan2021 at 12:45 AM, intramuscularly in the left arm for COVID-19 immunization. The patient had no medical history. The patient had no known drug allergies (NKDA). There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Jan2021 at 06:00 AM, the patient experienced pain on left side especially in her neck swelling at her left clavicle painful to touch, which was assessed as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever/ranging from 100.4F-104.4F; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. It was reported that the patient has had a high fever since the vaccine dose on 27Jan2021, ranging from 100.4F-104.4F. She stated she is taking Tylenol for it and wants to know what else to do. The outcome of the event was unknown. The event was reported as non-serious.  Information on the lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe leg and hip pain; Severe leg and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 22Jan2021 09:00 (at the age of 57years) at single dose for Covid-19 immunization. Medical history included migraine. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen (ADVIL), levothyroxine sodium (SYNTHROID), amitriptyline, rizatriptan benzoate (MAXALT), and butalbital, caffeine, paracetamol (FIORICET); all taken from an unspecified date for an unspecified indication. The patient previously took compazine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 06:00, the patient experienced severe leg and hip pain. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. This case is non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever; headache; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8983) intramuscular on the left arm on 27Jan2021 08:30 at a single dose for Covid-19 immunization. Medical history included allergies, sinus (disorder), hearing loss and allergies: shellfish and sulfa. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (first dose, 04:00 PM Intramuscular on the left arm lot number: EL 0142). Concomitant medication included nigella sativa (black seed oil), turmeric [curcuma longa rhizome] and multivitamins. On 28Jan2021 05:00 AM, the patient experienced fever, headache and body aches. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Eye swelling, Feeling hot, Headache
Clinical narrative: Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Hot red face and neck; Hot red face and neck; possible slight swelling of face and eyes (minor); possible slight swelling of face and eyes (minor); chills; headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 15:15 at a single dose for COVID-19 immunization. Medical history included hypertension and kidney disease, and was allergic to bee stings, penicillin, aluminum chloride. Patient was not pregnant at the of vaccination. There were unspecified medications received within 2 weeks of vaccination, and no other vaccine in 4 weeks prior to. The patient experienced hot red face and neck, possible slight swelling of face and eyes (minor), chills and headache on 29Jan2021 15:30. Outcome of the events was recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Experienced a low grade fever; body aches; This is a spontaneous report from a non-contactable consumer. A 34-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 24Jan2021 at 10:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Last Monday (25Jan2021), the patient experienced a low grade fever and body aches. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 26Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: hands are really itching, palm of hands itching, knee might itch a bit; This is a spontaneous report from a contactable consumer reporting for herself. A 91-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (injection given in left arm) on 27Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. The patient has no medical history. The patient was taking unspecified concomitant medications (takes a lot of mediations but they are the same thing she has taken for a long time. Nothing was new). The patient experienced palm of hands itching, knee might itch a bit on 27Jan2021. Patient reported she walked outside for about a half an hour; she didn't have anything on her hands. However, when she came back inside, her hands were really itching, specifically the palm of her hands. She has never had this happen before. She came back inside and took her mask and coat off and when she started to get warm, her hands started itching. She stated it's like the cold caused the itching or something. The itching has stayed the same. It was just itchy. She stated her knee might itch a bit, but her hands are really itching. She was not given her vaccine record card. Her facility is saving it and will give it to her after her second vaccine. No investigation assessment reported. Event outcome was not recovered.    Information on Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Appetite disorder, Burning sensation, Chills, Flushing, Nausea
Clinical narrative: flushing on the face; burning on the face and on the both arms; skin is burning; Nauseous; Appetite vacillates; Chills; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was stated, "I can tell you side effect I am getting now, so you can't tell me if you ever heard the side effects or not, I am getting flushing on the face and I am getting burning on both arms, I am getting burning on the face and on the both arms, the other one would be normal one's except the extremely nauseous, my appetite vacillates, extremely nauseous this the 3rd day now after the shot and burning on both arms, of course chills you probably heard of chills, I also was getting sore throat and either the body ache you heard of but I think to press option 3 and call but I wanted to you know the burning in the arm and in the face, like skin is burning." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Skin burning sensation
Clinical narrative: flushing on the face; burning on the face and on the both arms; skin is burning; Nauseous; Appetite vacillates; Chills; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was stated, "I can tell you side effect I am getting now, so you can't tell me if you ever heard the side effects or not, I am getting flushing on the face and I am getting burning on both arms, I am getting burning on the face and on the both arms, the other one would be normal one's except the extremely nauseous, my appetite vacillates, extremely nauseous this the 3rd day now after the shot and burning on both arms, of course chills you probably heard of chills, I also was getting sore throat and either the body ache you heard of but I think to press option 3 and call but I wanted to you know the burning in the arm and in the face, like skin is burning." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on her right arm, via an unspecified route of administration on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included thyroid condition and environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and levothyroxine. The patient experienced Chills, Arm Soreness, Malaise, slight sore throat, warm body feeling; all for 05Feb2021 10:00AM. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.