chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Myalgia, Pain, Pain in extremity
Clinical narrative: third dose; Suffered terrible pain that radiates in the area where i receive the shot; Suffered terrible pain that radiates in the area where i receive the shot up into my shoulder; painful that i can barely raise my arm; Suffered terrible pain that radiates in the area where i receive the shot up; Suffered terrible pain that radiates in the area where i receive the shot up into my shoulder but primarily down into my muscle; This is a spontaneous report from a non-contactable consumer (reported for himself). A 85-years old elderly male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 19Aug2021 (at the age of 85-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of COVID-19 vaccine (at the age of 85-years-old) of unknown manufacturer as single for COVID-19 immunisation. After receiving his third dose he was suffering terrible pain that radiates in the area where he received the shot up into his shoulder but primarily down into his muscle towards his elbow it is so painful that, he can barely raise his arm in a certain direction, third dose on 19Aug2021. The reporter stated that the events resulted in physician office visit. The patient underwent lab tests and procedures which included x-ray: did not show anything to the bones, he read an article that said that this had happened in other instances and the only thing to do is to wait, well he waited a long time oh forget it on an unspecified date in 2021. The outcome of events was recovered in 08Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, X-ray
Clinical narrative: third dose; Suffered terrible pain that radiates in the area where i receive the shot; Suffered terrible pain that radiates in the area where i receive the shot up into my shoulder; painful that i can barely raise my arm; Suffered terrible pain that radiates in the area where i receive the shot up; Suffered terrible pain that radiates in the area where i receive the shot up into my shoulder but primarily down into my muscle; This is a spontaneous report from a non-contactable consumer (reported for himself). A 85-years old elderly male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 19Aug2021 (at the age of 85-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of COVID-19 vaccine (at the age of 85-years-old) of unknown manufacturer as single for COVID-19 immunisation. After receiving his third dose he was suffering terrible pain that radiates in the area where he received the shot up into his shoulder but primarily down into his muscle towards his elbow it is so painful that, he can barely raise his arm in a certain direction, third dose on 19Aug2021. The reporter stated that the events resulted in physician office visit. The patient underwent lab tests and procedures which included x-ray: did not show anything to the bones, he read an article that said that this had happened in other instances and the only thing to do is to wait, well he waited a long time oh forget it on an unspecified date in 2021. The outcome of events was recovered in 08Nov2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Immunisation, Menstruation irregular
Clinical narrative: The patient received the third/booster dose of BNT162b2; The most current period a week after my 3rd booster has been a lot heavier than usual and started early as well; The most current period a week after my 3rd booster has been a lot heavier than usual and started early as well; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 03Nov2021 at 16:45 (at the age of 35-years-old) as a dose 3 (booster), single for COVID-19 immunisation. Medical history included Irregular menstruation, have noticed changes in periods/They have been starting a day or 2 earlier than usual,medical device removal from an unknown date and unknown if ongoing Had a nexplanon implant removed at the end of May, mild asthma, seasonal allergies from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received etonogestrel (NEXPLANON) implant. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 35-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation, experienced hormone imbalance. The patient had received the third/booster dose of BNT162b2 on 03Nov2021 at 16:45, a week after the most current period a week after her 3rd booster has been a lot heavier than usual and started early as well on Nov2021. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event the most current period had been a lot heavier than usual and started early as well was unknown at the time of this report.  Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Vomiting
Clinical narrative: dry heaving; Got the COVID booster shot Thursday, 04Nov2021; She sees by the Booster dose is Pfizer, expiration 04Apr2021; she started to feel bad; muscle pain on her back near shoulder/ feels like a sore muscle; lymph nodes are under the arm; Vomiting/throwing up.; This is a spontaneous report from a contactable consumer. This 83-year-old female consumer (patient) reported for herself that:  A 83-years-old female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 85441937, Expiration Date: 04Apr2021), via an unspecified route of administration in left arm on 04Nov2021 at 13:00 (at the age of 83 years old) as single dose for COVID-19 immunisation. The patient received expired product. The patient's medical history included blood pressure high. The patient's concomitant medications included losartan and amlodipine taken for hypertension from an unspecified start date and ongoing. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 8753), via an unspecified route of administration, administered in arm left on 30Mar2021 as single dose for COVID-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in left arm on 20Apr2021 (at the age of 82 years old) as single dose for COVID-19 immunisation. No investigation assessment. On 04nov2021, the patient got the booster dose then came home and was okay. Then on Thursday night, the patient started to feel bad. The patient did not remember Friday and experienced vomiting and was terrible. On 05Nov2021, the patient had dry heaving. The patient felt like underneath where her bone was on her left side is black and blue, but it was not. Previous day (at the time of reporting), the patient first time had food. The patient could not keep anything down and found the paper. The patient wondered if it was her lymph nodes, but her daughter said that the lymph nodes were under the arm. It was more like where the chicken bone was and experienced muscle pain. It was right where she hooks her bra on her back, but toward the lung on the left side. She finally tried Pepto Bismol, and that helped a little, but then it came up. The Pepto lot number is 123417195U and expiration of 20Jul2023. Last night, 07Nov2021, she had a small slice the size of her finger of meat and mashed potatoes. She has improved. The pain may be because she slept wrong. It is on her left side. Her daughter thinks it is a side effect. It feels like a sore muscle. She can move her arms, but if she lifts up it catches. The outcome of the event she started to feel bad was recovering and muscle pain on her back near shoulder/ feels like a sore muscle, vomiting/throwing up and dry heaving were not recovered. Other events outcome were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: BOOSTER; rash; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional based on information received by the company from other company (manufacturer control number: EC-2021-094942), for bnt162b2. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included COVID-19 Vaccine (solution for injection) via unspecified route of administration, administered on an unspecified date as dose 1, single and COVID-19 Vaccine (solution for injection) via unspecified route of administration, administered on an unspecified date as dose 2, single for COVID-19 immunization, Primary Immunization series completed but unknown manufacturer. Patient reported had fatigue, joint pain, hypothyroidism, and rash. She attributed the rash to the covid booster. Patient reported missing one dose due to forgetting to take it. On an unspecified date the patient experienced booster and rash. Outcome of the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use
Clinical narrative: 3rd Pfizer COVID-19 Booster; 3rd Pfizer COVID-19 Booster; fatigue; This is a spontaneous report received from a contactable consumer. This contactable consumer reported for a female patient that. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunisation. It was reported that a colleague had fatigue after her 3rd Pfizer COVID-19 Booster. The patient had 3rd pfizer covid-19 booster on an unspecified date and patient experienced fatigue on an unspecified date. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Back pain, Breast pain, Chest pain, Decreased appetite
Clinical narrative: loss of appetite; Migraines; Nausea; Body aches and pain; Swollen lymph node under right armpit; Skin on the right breast started peeling to the white; Fatigue; Pain in right breast; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right arm/right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Dose number: 3; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FH8028), via intramuscular, administered in arm right on 28Oct2021 at 19:00 (age at vaccination was 41 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE, Batch/Lot number was not reported), via an unspecified route, administered in upper right arm on 28Oct2021 as DOSE NUMBER UNKNOWN, SINGLE for immunization. The patient was not pregnant at the time of vaccination. The facility where most recent covid-19 vaccine administered was pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of Covid vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had known allergies to Codeine. The patient previously took first dose of bnt162b2 (Batch/Lot Number: EN6202), via intramuscular, administered in arm right on 24Feb2021 (age at vaccination was 40 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: ER8730), via intramuscular, administered in arm right on 24Mar2021 (age at vaccination was 40 years) as DOSE 1, SINGLE for covid-19 immunization. On 28Oct2021 19:00, booster was administered. On 29Oct2021 at 12:00 am, the patient experienced migraines; nausea; body aches and pain; swollen lymph node under right armpit; fatigue; loss of appetite; pain in right breast, right shoulder, right arm, right back, right chest and right hand and skin on the right breast started peeling to the white. The events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The case was non-serious. Therapeutic measures were taken as a result of the events. Treatment was ongoing for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Immunisation, Lymphadenopathy, Migraine, Nausea
Clinical narrative: loss of appetite; Migraines; Nausea; Body aches and pain; Swollen lymph node under right armpit; Skin on the right breast started peeling to the white; Fatigue; Pain in right breast; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right arm/right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Dose number: 3; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FH8028), via intramuscular, administered in arm right on 28Oct2021 at 19:00 (age at vaccination was 41 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE, Batch/Lot number was not reported), via an unspecified route, administered in upper right arm on 28Oct2021 as DOSE NUMBER UNKNOWN, SINGLE for immunization. The patient was not pregnant at the time of vaccination. The facility where most recent covid-19 vaccine administered was pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of Covid vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had known allergies to Codeine. The patient previously took first dose of bnt162b2 (Batch/Lot Number: EN6202), via intramuscular, administered in arm right on 24Feb2021 (age at vaccination was 40 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: ER8730), via intramuscular, administered in arm right on 24Mar2021 (age at vaccination was 40 years) as DOSE 1, SINGLE for covid-19 immunization. On 28Oct2021 19:00, booster was administered. On 29Oct2021 at 12:00 am, the patient experienced migraines; nausea; body aches and pain; swollen lymph node under right armpit; fatigue; loss of appetite; pain in right breast, right shoulder, right arm, right back, right chest and right hand and skin on the right breast started peeling to the white. The events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The case was non-serious. Therapeutic measures were taken as a result of the events. Treatment was ongoing for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain, Pain in extremity, Skin exfoliation
Clinical narrative: loss of appetite; Migraines; Nausea; Body aches and pain; Swollen lymph node under right armpit; Skin on the right breast started peeling to the white; Fatigue; Pain in right breast; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right arm/right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Pain in right breast, right shoulder, right arm, right back, right chest and right hand; Dose number: 3; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FH8028), via intramuscular, administered in arm right on 28Oct2021 at 19:00 (age at vaccination was 41 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization; influenza vaccine (INFLUENZA VACCINE, Batch/Lot number was not reported), via an unspecified route, administered in upper right arm on 28Oct2021 as DOSE NUMBER UNKNOWN, SINGLE for immunization. The patient was not pregnant at the time of vaccination. The facility where most recent covid-19 vaccine administered was pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of Covid vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had known allergies to Codeine. The patient previously took first dose of bnt162b2 (Batch/Lot Number: EN6202), via intramuscular, administered in arm right on 24Feb2021 (age at vaccination was 40 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: ER8730), via intramuscular, administered in arm right on 24Mar2021 (age at vaccination was 40 years) as DOSE 1, SINGLE for covid-19 immunization. On 28Oct2021 19:00, booster was administered. On 29Oct2021 at 12:00 am, the patient experienced migraines; nausea; body aches and pain; swollen lymph node under right armpit; fatigue; loss of appetite; pain in right breast, right shoulder, right arm, right back, right chest and right hand and skin on the right breast started peeling to the white. The events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The case was non-serious. Therapeutic measures were taken as a result of the events. Treatment was ongoing for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: her sister also had the Pfizer Covid booster shot; She is still hurting too; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of an unspecified age received bnt162b2 (COMIRNATY Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Oct2021 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of COVID-19 vaccine on an unknown date (Primary Immunization series complete but unknown manufacturer) for covid-19 immunisation. Other product was not provided. It was stated that her sister also had the pfizer covid booster shot on 26Oct2021 and the patient was still hurting too on an unknown date of Oct2021. The outcome of event reported as not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Tinnitus
Clinical narrative: off label use; Dose: 3; Date: 29Oct2021; Tinnitus in the right ear, still ongoing after 1 week; This is a spontaneous report from a non-contactable consumer (patient).   A 48-years-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 29Oct2021 (at the age of 48-Years-old) (Lot Number: FG3529) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. (Booster and off label use). The patient's medical history and concomitant medications were not reported. 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. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 (at the age of 47-Years-old) (Batch/Lot Number: ER2613) as DOSE 1, SINGLE for covid-19 immunisation and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (at the age of 47-Years-old) (Batch/Lot Number: E0102) as DOSE 2, SINGLE for covid-19 immunisation and experienced Migraine headaches on day 2 and Severe vertigo approximately 5 days after. On an unknown date in 2021, the patient experienced tinnitus in the right ear, still ongoing after 1 week. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Seriousness was reported as non-serious. At the time of this report, the outcome of event tinnitus was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable nurse (patient). A female patient, of an unspecified age, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Patient previously received the first and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date; single dose, for COVID-19 immunisation. Reportedly, 2 weeks ago a guy said he was having  a side effect from the COVID-19 vaccine. The caller highly doubts it was true because she thinks the guy was an anti-vaxxer. He was spreading disinformation. There was nothing on Pfizer's website that says about where to report people who are disinforming the public. During the original report, she mentioned she had her 3rd shot of the Pfizer COVID-19 vaccine on an unspecified date and experienced sore arm and tiredness on an unspecified date. The outcome of events: unknown. The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Immunisation, Lacrimation increased, Therapeutic response unexpected
Clinical narrative: Booster dose of the Pfizer Covid vaccine; Watery eye; Burning sensation; Her dry eyes is much better and she is experiencing tears; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: 30145BA), via an unspecified route of administration on 12Oct2021 as dose 3 (booster), single for covid-19 immunization. Medical history included bone dry eyes, conjunctivitis, rosea, all in her eyes severely for the last 4 years, and not as severe issues before that. The patient concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6202), via unspecified route of administration on 24Feb2021 as dose 1, single and dose 2 via unspecified route of administration on 17Mar2021 (Lot number: Lot: ER8727 or EC8727) as dose 2, single both taken for covid-19 immunization. It was reported that the patient received the booster dose of the Pfizer Covid vaccine 2 to 3 weeks ago and was reported a positive side effect. After the booster dose last month, she noticed she was at work and noticed she had not put drops in and the afternoon would go by and she did not need the drops. In the past she would have to stop working and put her drops in her eyes in the afternoon. Stated that dry eyes were so painful, and she would be watched to see what happened with her eye. Her eyes felt good and if she could help someone by reporting this. The patient had severe dry eye condition, where it was very itchy. The only reaction patient ever had to the vaccine was watery eyes, a burning sensation, nothing else, patient felt that was probably where her inflammation was from in 2021. The patient went to her eye doctor for which he had been treated her for years, and said her dry eyes, her condition was controlled. The patient wondered if the vaccine had an effect on it, because patient used everything, 5 kinds of eye drops, and now she had down to over the counter as of yesterday, and wanted to pass it along, that if there was something in the Pfizer shot that caused that. The patient did not usually have tears, and runny nose after the shot but hardly nothing else, and that was not usually associated with dry eyes. So many people had dry eyes, and she never of it getting better. The patient stated if there was something in the vaccine that helps with dry eyes, she wanted to report this. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
Clinical narrative: Swelling under my left arm pit the size of a lemon  assumed lymph node; Pfizer:Dose Number: 1 Batch/Lot No: .03/  Moderna Dose Number: 2 Batch/Lot No: 65081186-1221; Pfizer:Dose Number: 1 Batch/Lot No: .03/  Moderna Dose Number: 2 Batch/Lot No: 65081186-1221; Pfizer:Dose Number: 1 Batch/Lot No: .03/  Moderna Dose Number: 2 Batch/Lot No: 65081186-1221; This is a spontaneous report from a contactable Other Health Professional(patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Left on 05Nov2021 13:00(at the age of 57-years-old) (Batch/Lot Number: EA6780) as single dose for covid-19 immunisation in Pharmacy or Drug Store. The patient was not pregnant. The patient was not pregnant at time of vaccination. Medical history included psoriasis from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no Known allergies.Concomitant medications included vitamin d, fish oil and vitamin c (ASCORBIC ACID) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unspecified date(Batch/Lot Number: 03) as single dose for covid-19 immunisation and Moderna as dose 2 via an unspecified route of administration on unspecified date(Batch/Lot Number: 65081186-1221) as single dose for covid-19 immunisation and experienced Interchange of vaccine products. The patient experienced swelling under my left arm pit the size of a lemon assumed lymph node on 07Nov2021, pfizer: dose number: 1 batch/lot no: .03/ moderna dose number: 2 batch/lot no: 65081186-1221 on an unspecified date. No treatment received for the event. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Tremor
Clinical narrative: Booster; experiencing tremors to his right hand; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-year-old male patient received bnt162b2 (COMIRNATY Formulation: Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of bnt162b2 on an unknown date (Batch/lot number: Unknown) for covid-19 immunisation. The patient experienced tremors to his right hand on an unspecified date. The reporter would like to know if this was a reported side effect of the Pfizer Covid vaccine. The patient wife wanted to know if they still need to continue to wear masks and social distance, since they were fully vaccinated. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Confusional state, Decreased appetite, Disorientation
Clinical narrative: small cell lymphoma; increasingly poor appetite/taste; increasingly poor appetite/taste; poor intake; weight loss/30 weight loss overall cachectic; short breath; Poor sleeping but extreme fatigue and sleeping day and night; extreme fatigue/lassitude; periods of shivering; disorientation; finally confusion; grouchy; tremor; mumbling; Parkinsonian gait; This is a spontaneous case from a contactable physician. This physician reported similar events under different doses. This is the first report of two reports for dose 2.   An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular in left arm on 25Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL9262) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included heart transplant with immunosuppression tacrolimus stable. The patient had none known allergies. The patient concomitant medications were reported yes, but unspecified. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular in left arm on 04Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL3246) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. By mid-Feb if not sooner, after the first 2 vaccines in Jan, the patient experienced increasingly poor appetite/taste, poor intake, weight loss, short breath, poor sleeping but extreme fatigue and sleeping day and night, periods of shivering, lassitude, disorientation, and finally confusion, grouchy, tremor, mumbling, Parkinsonian gait. 30# weight loss overall cachectic. Overlay on stable health 12-year post heart transplant on stable immunosuppression regimen. Workup above symptoms found small cell lymphoma. Prior to CA oral med begun 5 months after first two vaccines, symptoms abruptly reversed and slowly regaining all usual physical and cognitive abilities, gait, demeanor, sensorium and weight up 10 pounds over 2 months. The event start date were reported as 10Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Lymphoma cannot be ruled out. 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.,Linked Report(s) : US-PFIZER INC-202101550380 as same reporter/patient/drug, different dose/event.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypophagia, Investigation, Irritability
Clinical narrative: small cell lymphoma; increasingly poor appetite/taste; increasingly poor appetite/taste; poor intake; weight loss/30 weight loss overall cachectic; short breath; Poor sleeping but extreme fatigue and sleeping day and night; extreme fatigue/lassitude; periods of shivering; disorientation; finally confusion; grouchy; tremor; mumbling; Parkinsonian gait; This is a spontaneous case from a contactable physician. This physician reported similar events under different doses. This is the first report of two reports for dose 2.   An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular in left arm on 25Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL9262) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included heart transplant with immunosuppression tacrolimus stable. The patient had none known allergies. The patient concomitant medications were reported yes, but unspecified. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular in left arm on 04Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL3246) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. By mid-Feb if not sooner, after the first 2 vaccines in Jan, the patient experienced increasingly poor appetite/taste, poor intake, weight loss, short breath, poor sleeping but extreme fatigue and sleeping day and night, periods of shivering, lassitude, disorientation, and finally confusion, grouchy, tremor, mumbling, Parkinsonian gait. 30# weight loss overall cachectic. Overlay on stable health 12-year post heart transplant on stable immunosuppression regimen. Workup above symptoms found small cell lymphoma. Prior to CA oral med begun 5 months after first two vaccines, symptoms abruptly reversed and slowly regaining all usual physical and cognitive abilities, gait, demeanor, sensorium and weight up 10 pounds over 2 months. The event start date were reported as 10Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Lymphoma cannot be ruled out. 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.,Linked Report(s) : US-PFIZER INC-202101550380 as same reporter/patient/drug, different dose/event.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphoma, Parkinsonian gait, Sleep disorder, Speech disorder, Tremor
Clinical narrative: small cell lymphoma; increasingly poor appetite/taste; increasingly poor appetite/taste; poor intake; weight loss/30 weight loss overall cachectic; short breath; Poor sleeping but extreme fatigue and sleeping day and night; extreme fatigue/lassitude; periods of shivering; disorientation; finally confusion; grouchy; tremor; mumbling; Parkinsonian gait; This is a spontaneous case from a contactable physician. This physician reported similar events under different doses. This is the first report of two reports for dose 2.   An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular in left arm on 25Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL9262) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included heart transplant with immunosuppression tacrolimus stable. The patient had none known allergies. The patient concomitant medications were reported yes, but unspecified. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular in left arm on 04Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL3246) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. By mid-Feb if not sooner, after the first 2 vaccines in Jan, the patient experienced increasingly poor appetite/taste, poor intake, weight loss, short breath, poor sleeping but extreme fatigue and sleeping day and night, periods of shivering, lassitude, disorientation, and finally confusion, grouchy, tremor, mumbling, Parkinsonian gait. 30# weight loss overall cachectic. Overlay on stable health 12-year post heart transplant on stable immunosuppression regimen. Workup above symptoms found small cell lymphoma. Prior to CA oral med begun 5 months after first two vaccines, symptoms abruptly reversed and slowly regaining all usual physical and cognitive abilities, gait, demeanor, sensorium and weight up 10 pounds over 2 months. The event start date were reported as 10Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Lymphoma cannot be ruled out. 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.,Linked Report(s) : US-PFIZER INC-202101550380 as same reporter/patient/drug, different dose/event.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: small cell lymphoma; increasingly poor appetite/taste; increasingly poor appetite/taste; poor intake; weight loss/30 weight loss overall cachectic; short breath; Poor sleeping but extreme fatigue and sleeping day and night; extreme fatigue/lassitude; periods of shivering; disorientation; finally confusion; grouchy; tremor; mumbling; Parkinsonian gait; This is a spontaneous case from a contactable physician. This physician reported similar events under different doses. This is the first report of two reports for dose 2.   An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular in left arm on 25Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL9262) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history included heart transplant with immunosuppression tacrolimus stable. The patient had none known allergies. The patient concomitant medications were reported yes, but unspecified. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via intramuscular in left arm on 04Jan2021 at patient age of 86-year-old as single dose (Lot Number: EL3246) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. By mid-Feb if not sooner, after the first 2 vaccines in Jan, the patient experienced increasingly poor appetite/taste, poor intake, weight loss, short breath, poor sleeping but extreme fatigue and sleeping day and night, periods of shivering, lassitude, disorientation, and finally confusion, grouchy, tremor, mumbling, Parkinsonian gait. 30# weight loss overall cachectic. Overlay on stable health 12-year post heart transplant on stable immunosuppression regimen. Workup above symptoms found small cell lymphoma. Prior to CA oral med begun 5 months after first two vaccines, symptoms abruptly reversed and slowly regaining all usual physical and cognitive abilities, gait, demeanor, sensorium and weight up 10 pounds over 2 months. The event start date were reported as 10Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.; Sender's Comments: Based on the limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Lymphoma cannot be ruled out. 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.,Linked Report(s) : US-PFIZER INC-202101550380 as same reporter/patient/drug, different dose/event.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immunisation
Clinical narrative: 02Nov2021 her and her husband got the covid vaccine booster; He got a little dizzy; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for old male patient (reporter's husband). A 73-year-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,Batch/Lot number: not reported), via an unspecified route of administration on 02Nov2021 as DOSE 3 (BOOSTER, SINGLE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. 02Nov2021, the patient experienced her and her husband got the covid vaccine booster and On an unspecified date in 2021, he got a little dizzy. Caller reporting on her husband. 02Nov2021 her and her husband got the covid vaccine booster at the doctors office.They both waited the 15 minutes. He got a little dizzy but nothing like what happened to her.The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Lymphadenopathy, Pain
Clinical narrative: Booster dose; Body aches (joints, ankles and feet, mostly on left side); headache; fatigue; swollen lymph nodes (armpit & collarbone); This is a spontaneous report from a contactable consumer (Pfizer colleague). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,), dose 3 intramuscular, administered in Arm Left on 04Nov2021 (at the age of 39-years-old) (Batch/Lot Number: F93527) as single dose for covid-19 immunisation in Pharmacy or Drug Store. The patient was not pregnant. The patient was not pregnant at time of vaccination. Medical history included seafood allergy from an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EP6955) via Intramuscular in the left arm on 26Mar2021, and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EW0162) via Intramuscular in the left arm on 31Jul2021 at single dose for covid-19 immunisation and experienced Dose 1: 26Mar2021, dose 2: 31Jul2021. The patient experienced booster dose on 04Nov2021, body aches (joints, ankles and feet, mostly on left side), headache, fatigue, swollen lymph nodes (armpit & collarbone) on 04Nov2021. Event did not result in Emergency Room Visit nor Physician Office Visit. No Treatment was Received for the events other than booster dose. The outcome of the events other than booster dose was recovering.    Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: The next day i also have swelling in my left lymph node and it still hurts; The next day i also have swelling in my left lymph node and it still hurts; tingling; numbness in both my legs and feet for several hours; booster; booster; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 43-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 07Nov2021 at 12:00 (Batch/Lot Number: FH8020) as DOSE 3 (BOOSTER), SINGLE (at the age of 43-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 01Mar2021 (at the age of 42-year-old) as dose 1, single and second dose of bnt162b2 PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 22Mar2021 (at the age of 42-year-old) as dose 1, single for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 07Nov2021, the patient got all the same symptoms reported from first shot and adverse event plus tingling and numbness in both my legs and feet for several hours. The next day on 08Nov2021, the patient had swelling in left lymph node and it still hurts, that was patient observing. It was unknown if Covid tested post vaccination or not. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date. The outcome of events reported as recovering.  Follow-up attempts are completed. No further information is expected.