chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disorientation, Feeling of body temperature change, Headache, Joint range of motion decreased
Clinical narrative: nausea; headache; body ache "all over"; chills; very drowsy; disoriented; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On Feb2021, the patient experienced nausea, headache, body ache "all over", chills and was very drowsy and disoriented. The patient questioned the efficacy of the vaccine after the first dose. The clinical outcome of nausea, headache, body ache "all over", chills, very drowsy and disoriented was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Somnolence
Clinical narrative: nausea; headache; body ache "all over"; chills; very drowsy; disoriented; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On Feb2021, the patient experienced nausea, headache, body ache "all over", chills and was very drowsy and disoriented. The patient questioned the efficacy of the vaccine after the first dose. The clinical outcome of nausea, headache, body ache "all over", chills, very drowsy and disoriented was unknown.  Information on the lot/batch number has been requested.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Malaise, Nausea
Clinical narrative: Feeling unwell; nauseated; loss of appetite; sleeping; chills; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 1515), via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:30 at 0.3 mL, single for covid-19 immunisation. Medical history included Congestive heart failure (CHF), Defibrillator, Diabetes, Peripheral Neuropathy, hard of hearing, Aged Macular degeneration. No Known allergies. The patient received unspecified other medications in two weeks. On 06Feb2021, the patient was feeling unwell, nauseated, loss of appetite, sleeping, chills, extreme fatigue. No treatment was received for the events. The patient did not have covid tested post vaccination. The outcome of events was recovered.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Feeling unwell; nauseated; loss of appetite; sleeping; chills; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 1515), via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:30 at 0.3 mL, single for covid-19 immunisation. Medical history included Congestive heart failure (CHF), Defibrillator, Diabetes, Peripheral Neuropathy, hard of hearing, Aged Macular degeneration. No Known allergies. The patient received unspecified other medications in two weeks. On 06Feb2021, the patient was feeling unwell, nauseated, loss of appetite, sleeping, chills, extreme fatigue. No treatment was received for the events. The patient did not have covid tested post vaccination. The outcome of events was recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chest pain, Confusional state, Dizziness
Clinical narrative: Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Pain in extremity, Somnolence
Clinical narrative: Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe chest pain; Severe headache; Racing Heartbeat; Vomit; Pain in my left side of my arm; Pain in my left side of my arm, Shoulder; Dizziness; Very tired; Sleepy; Anxiety; Not knowing where she was; This is a spontaneous report from a contactable healthcare professional (patient). This 53-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) on 22Jan2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history included anemia, gastritis, and peptic ulcer. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received penicillin from an unknown date for an unknown indication and experienced allergy. On 23Jan2021 at 21:00 the patient experienced severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month. The patient went to a doctor or other healthcare professional office/clinic visit as a result of the events. The patient did not receive any treatment for the events. The outcomes of severe chest pain, racing heartbeat, vomit, pain in the left side of her arm, shoulder, and chest, dizziness, very tired and sleepy, severe headache, not knowing where she was, and anxiety coming and going for more than a month were recovered with lasting effects. It was also reported that since the vaccine the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Hypertension, Loss of consciousness
Clinical narrative: things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dementia, Diarrhoea, Fatigue, Feeling of body temperature change
Clinical narrative: dementia; chilled with cold and hot; eating very little; tired; Diarrhea; He is peeing his pants; This is an initial spontaneous report from a contactable consumer. An 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for Injection, Batch/Lot Number: Unknown, Expiration date: unknown), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced dementia, feeling of body temperature change, decreased appetite, fatigue, diarrhea, micturition disorder on 12Mar2021. Clinical course reported as Caller, a wife calling for her husband who got the COVID shot on 01Feb2021 and got sick about the 6 day later until yesterday. He has been chilled with cold and hot, eating very little, tired, and had diarrhea. The diarrhea started again today. Now he is supposed to get the second shot on 22Feb2021 but she doesn't think he can take it. She wants to cancel the appointment. The caller is going to call the location he got it at and cancel the appointment, she tried before, but she got no answer. She is just going to leave a message. Her husband has dementia and she heard people will get very sick if the get it. It has been 2 weeks. He is peeing his pants and he never did that before, this is making it her crazy. She would like to get one, a shot but she doesn't want to go through what he has gone through. The outcome of events was unknown.   No follow-up attempts are possible. Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Micturition disorder
Clinical narrative: dementia; chilled with cold and hot; eating very little; tired; Diarrhea; He is peeing his pants; This is an initial spontaneous report from a contactable consumer. An 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for Injection, Batch/Lot Number: Unknown, Expiration date: unknown), via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced dementia, feeling of body temperature change, decreased appetite, fatigue, diarrhea, micturition disorder on 12Mar2021. Clinical course reported as Caller, a wife calling for her husband who got the COVID shot on 01Feb2021 and got sick about the 6 day later until yesterday. He has been chilled with cold and hot, eating very little, tired, and had diarrhea. The diarrhea started again today. Now he is supposed to get the second shot on 22Feb2021 but she doesn't think he can take it. She wants to cancel the appointment. The caller is going to call the location he got it at and cancel the appointment, she tried before, but she got no answer. She is just going to leave a message. Her husband has dementia and she heard people will get very sick if the get it. It has been 2 weeks. He is peeing his pants and he never did that before, this is making it her crazy. She would like to get one, a shot but she doesn't want to go through what he has gone through. The outcome of events was unknown.   No follow-up attempts are possible. Information about batch/lot number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Limb injury, Oral mucosal blistering, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown.      No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: fever; constant diarrhea; chills; This is a spontaneous report from a sponsored program. This is a report from a contactable consumer (patient's wife).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced fever on an unspecified date with outcome of unknown, constant diarrhea on an unspecified date with outcome of unknown and chills on an unspecified date with outcome of unknown.    Information about lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: a little dizzy after the first vaccine; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer, the patient. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. On an unknown date the patient was a little dizzy after the first vaccine. The patient reported the dizziness passed after about an hour.  The clinical outcome of the dizziness was recovered on an unknown date.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell; This is a spontaneous report based on the information received by Pfizer (Mfr Report# UNT-2021-002835). A non-contactable female consumer reported an 82 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date.  Co-suspect medication included treprostinil sodium (REMODULIN, Lot# 937303, Exp. Date: 31May2022) 10 mg/ml Subcutaneous  at 0.070 ug/kg for secondary pulmonary arterial hypertension since 09Sep2010. Relevant medical history included secondary pulmonary arterial hypertension (ongoing). Concomitant medications included apixaban (ELIQUIS) and tadalafil (ADCIRCA). On 18Jan2021, 10 years 4 months 10 days after initiating SQ Remodulin, the patient fell after receiving the COVID vaccine and was hospitalized.  Action taken with SQ Remodulin was not reported for the event of fall. At the time of reporting, the event of fall was considered as resolved on 18Jan2021. The patient was discharged from the hospital on 22Jan2021. The reporter did not provide causality for the event of fall.  Case Comment/Senders Comment: The company has assessed the event of fall as not related to SQ treprostinil considering that the patient has been on drug for more than 10 years. Fall was likely an accidental event in this elderly patient or could be caused by a syncopal episode associated with the underlying PAH or could also be associated with the administration of COVID vaccine. Additional information has been requested.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for covid 19; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a male patient (unknown age) received the first dose of at single dose for COVID-19 IMMUNISATION. Relevant history and concomitant drugs were unknown.  Physician stated four days after receiving the first dose of the COVID vaccine the patient tested positive for COVID-19. He was hospitalized and treated with plasma. Doctor was wondering how long his patient had to wait before receiving the second dose.  Outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, the event COVID-19 most likely represents an intercurrent infection as it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chills, Headache, Muscular weakness, Pyrexia
Clinical narrative: Fever; Chills; Bell's Palsy; Swelling and muscle weakness on the left side of the face; Swelling and muscle weakness on the left side of the face; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6198, first dose) solution for injection intramuscular in the left arm on 06Mar2021 at 08:45 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with Covid-19 on 26Jul2020 and penicillin allergy. Family medical history included diabetes. There were no concomitant medications. Past drug history included known allergies to codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced Bell's Palsy, swelling and muscle weakness on the left side of the face on 07Mar2021 at 05:00. It started with left arm swelling and muscle weakness on the left side of the face, left face pain diagnosed as Bell's palsy and developed headache (07Mar2021). The next day (08Mar2021) at 1pm started with fever and chills. The was no emergency room or physician office visit. No treatment was provided for the events Bell's Palsy, swelling and muscle weakness on the left side of the face. The outcome of the events Bell's Palsy, swelling and muscle weakness on the left side of the face was recovering. The outcome of the events headache, fever and chills was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Fever; Chills; Bell's Palsy; Swelling and muscle weakness on the left side of the face; Swelling and muscle weakness on the left side of the face; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6198, first dose) solution for injection intramuscular in the left arm on 06Mar2021 at 08:45 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with Covid-19 on 26Jul2020 and penicillin allergy. Family medical history included diabetes. There were no concomitant medications. Past drug history included known allergies to codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced Bell's Palsy, swelling and muscle weakness on the left side of the face on 07Mar2021 at 05:00. It started with left arm swelling and muscle weakness on the left side of the face, left face pain diagnosed as Bell's palsy and developed headache (07Mar2021). The next day (08Mar2021) at 1pm started with fever and chills. The was no emergency room or physician office visit. No treatment was provided for the events Bell's Palsy, swelling and muscle weakness on the left side of the face. The outcome of the events Bell's Palsy, swelling and muscle weakness on the left side of the face was recovering. The outcome of the events headache, fever and chills was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Musculoskeletal stiffness, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Delusion, Dementia
Clinical narrative: dementia; Delusions; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient (not pregnant) received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9269), via an unspecified route of administration (left arm) on 06Feb2021 10:45, (at the age of vaccination70 -years-old) single dose for COVID-19 immunisation.  Medical history included Early-onset Alzheimer's, high blood pressure, allergies: fire ants. Concomitant medications included memantine hydrochloride (NAMENDA), amlodipine, clopidogrel, atorvastatin. The patient previously had first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 16Jan2021 at 70 years old for covid-19 immunisation and experienced delusions and dementia. The patient experienced Delusions. Believing that people are trying to get into home. Belief that people on TV are in her home and speaking with her. Frequency and severity has increased since second dose. Also wandering (attempting to leave the home with no purpose). No COVID prior vaccination,no COVID tested post vaccination. No treatment for the events. The patient had not recovered from the events.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity vasculitis, Rash pruritic
Clinical narrative: allergic vasculitis; Joint pain; body rash to his torso and part of his legs/ Itchy body rash/ itching; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9266), via an unspecified route of administration, administered in Arm Left on 26Feb2021 15:00 as SINGLE DOSE for covid-19 immunisation, at 66 years old. Medical history included hypertension (Verbatim: Blood pressure high, takes blood thinner), Heart issue (Verbatim: stents), cholesterol, and sinus disorder from an unknown date. Concomitant medication included olmesartan medoxomil (BENICAR); metoprolol succinate (TOPROL); dexlansoprazole (DEXILANT); eluxadoline (VIBERZI); and acetylsalicylic acid (BABY ASPIRIN), taken for an unspecified indication; and clopidogrel bisulfate (PLAVIX) for blood pressure high, takes blood thinner, start and stop date were not reported. Patient had no new medications or recent vaccinations. The patient reported that his side effect on an unspecified date in Mar2021, is a body rash (itchy body rash) to his torso and part of his legs. His doctor called it allergic vasculitis, and she put him on an unspecified steroid (cortisone to be picked up), antibiotic, an antihistamine to help control the itching, and an unspecified treatment. The rash was described as about the same, it is getting crusty in some of the rash area, and there was new popping up, and also experienced unexplained joint pain. Patient stated he started notice some issues maybe on 01Mar2021 (not specified). Treatment was given for hypersensitivity vasculitis and itchy body rash. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Prostate cancer
Clinical narrative: prostate cancer; diabetes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on 07Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the vaccine on 07Feb2021, and the pharmacy did not receive the 2nd dose vaccine as promised. It reported the patient was with prostate cancer and diabetes. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: Body aches; Head pounding; muscle joints hurt; This may have been a bad Batch or something; flu like symptoms; felt sick; fever; felt like beat with baseball bat; vomited; Very loose stool; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EM9809; Expiration date: Jun2021), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm, on 22Jan2021 at 10:00 (at the age of 59-years-old) for COVID-19 immunisation and experienced body aches, head pounding, muscle joints hurt, flu like symptoms, felt sick, fever, felt like beat with a baseball bat, vomited, very loose stools, and reported this may have been a bad batch or something. The patient experienced body aches, head pounding, and muscle joints hurt on 13Feb2021, which were reported to have caused hospitalization. The patient also experienced flu like symptoms, felt sick, fever, felt like beat with baseball bat, vomited, and very loose stool on 13Feb2021. It was also reported that the patient felt this may have been a bad batch or something on an unspecified date. The patient did not receive any treatment for any of the events. The clinical outcome of all of body aches, head pounding, muscle joints hurt, flu like symptoms, felt sick, fever, felt like beat with baseball bat, vomited, and very loose stool was recovered on an unspecified date and of this may have been a bad batch or something was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain, Product quality issue, Pyrexia, Vomiting
Clinical narrative: Body aches; Head pounding; muscle joints hurt; This may have been a bad Batch or something; flu like symptoms; felt sick; fever; felt like beat with baseball bat; vomited; Very loose stool; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EM9809; Expiration date: Jun2021), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm, on 22Jan2021 at 10:00 (at the age of 59-years-old) for COVID-19 immunisation and experienced body aches, head pounding, muscle joints hurt, flu like symptoms, felt sick, fever, felt like beat with a baseball bat, vomited, very loose stools, and reported this may have been a bad batch or something. The patient experienced body aches, head pounding, and muscle joints hurt on 13Feb2021, which were reported to have caused hospitalization. The patient also experienced flu like symptoms, felt sick, fever, felt like beat with baseball bat, vomited, and very loose stool on 13Feb2021. It was also reported that the patient felt this may have been a bad batch or something on an unspecified date. The patient did not receive any treatment for any of the events. The clinical outcome of all of body aches, head pounding, muscle joints hurt, flu like symptoms, felt sick, fever, felt like beat with baseball bat, vomited, and very loose stool was recovered on an unspecified date and of this may have been a bad batch or something was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: patient had taken the flu shot and a few weeks later and had gotten sick but patient was not saying it was from the shot but patient had been hospitalized; Initial information was received on 11-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional (patient).  This case involves a patient of unknown age who had taken the flu shot and a few weeks later had gotten sick but patient was not saying it was from the shot but patient had been hospitalized (illness), after she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who had taken the flu shot a few weeks later had gotten sick, patient was not saying it was from the shot but had been hospitalized (illness), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event (seriousness).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a patient of unknown age who presented with sickness (latency: unknown) after vaccination with INFLUENZA VACCINE. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: patient ended up in the hospital from an allergic reaction; Initial information was received on 11-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional (patient) via social media.   This case involves a patient of unknown age and gender who ended up in the hospital from an allergic reaction (hypersensitivity), after patient receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced an allergic reaction (hypersensitivity), (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event (seriousness).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns a patient of unknown age who presented with allergic reaction (latency: unknown) after vaccination with INFLUENZA VACCINE. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: flu like illness; broke out; chills; shaking; fever; sweats; Initial information regarding an unsolicited valid non-serious case was received from Pfizer (non-licensed partner) (Control No: 2021233809) in the form of courtesy via a consumer or non-healthcare professional and transmitted on 10-Mar-2021.   This case involves female patient (age not reported) who experienced broke out (rash), flu like illness (influenza like illness), chills, shaking (tremor) and fever (pyrexia) and sweats (hyperhidrosis), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  In 2016, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination (reported as high dose flu shot but trade was not reported).  In 2016, the patient developed a non-serious broke out (rash), flu like illness/ flu type stuff (influenza like illness), chills, shaking (tremor) and fever (pyrexia) and sweats (hyperhidrosis) and I couldn't get warm within 5-hours following the administration of INFLUENZA VACCINE.  This case report's flu like illness after over 65 year flu shot which lasted the entire nigh. Caller reports that patient looked at the ingredients and the only common thing is the sodium and she want to know, could that have something to do with the reaction she had Caller reports, Since then she have taken the regular flu shot without a problem, and her doctor told her don't take the over 65 flu shot. reporter asks for guidance on getting the coronavirus disease of 2019 (COVID) vaccine. Patient was afraid if she is going to experience an adverse event from the COVID vaccine like she did with the flu vaccine. Reporter says that patient was scheduled to get her COVID vaccine in that afternoon and the reason that she is calling because previous reaction to flu shot. She tried to look up the ingredients of new COVID vaccine versus the ingredients in the flu vaccine and the only thing that the two have in common that she can see is the sodium. She is wondering if that would have anything to do with what she experienced. She is afraid that she is going to experience an adverse event from the COVID vaccine like she did with the flu vaccine. Caller declined to complete a safety report at this time and asked to be transferred for her question to be answered. She says she has to call if she is going to be late to receive her vaccination and she doesn't want to mess it up for her receiving her vaccine. Caller declined to complete a safety report and unable to obtain further information needed for report including lot number, expiry date for previously received flu shot and supplemental form. Investigation assessment: not provided  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Oesophageal varices haemorrhage
Clinical narrative: Varices in his throat ruptured; A spontaneous report was received from a consumer concerning a 55-years-ol male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced varices in his throat ruptured (oesophageal varices haemorrhage).  The patient's medical history included Diabetes 2 and throat varices diagnosed in 2019.  Concomitant medications reported included metformin, glipizide, sitagliptin phosphate, empagliflozin and propranolol.   On 13 Feb 2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (Batch number: unclear) intramuscularly for prophylaxis of COVID-19 infection.    On an unspecified day in Feb 2021, the varices in his throat ruptured. He went to the hospital and was in ICU for 5 days. His physician told him that it has nothing to do with vaccine.Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, varices in his throat ruptured, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea
Clinical narrative: Breathing issues; Death; A spontaneous report was received from a consumer concerning a 78 years old, female patient who experienced breathing issues/dyspnoea.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   The patient experienced breathing difficulty on 12 Mar 2021. The patient died on 12 Mar 2021.  Treatment information was not provided.   Action taken with the drug in response to the events is not applicable.  The patient died on 12 Mar 2021. The cause of death was not reported. The reporter wanted to conduct a autopsy to find out if the death was caused by the vaccine.; Reporter's Comments: This is a case of death in a 78-year-old female subject with unknown medical history, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death