chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Blood cholesterol, Full blood count, Gait disturbance
Clinical narrative: Cyst behind left knee has gotten more painful; arthritis pain became worse, had back pain, and an increased in difficulty with walking; She couldn't walk, and she had to walk with a cane.; back pain; She has arthritis, and she noticed her leg was getting swollen.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Jun2021 13:30 at 66-years-old (Batch/Lot Number: FA6780) as dose 1, single for COVID-19 immunisation. Medical history included ongoing Asthma (She has had asthma for maybe 39 years), ongoing Diabetes mellitus (She has had diabetes for a year and a half), Breast cancer from Jul2014, ongoing Depression (It started 37 years ago), Knee surgery from Jan2017, arthritis, cyst. Concomitant medication not reported. It was reported that patient had pneumonia vaccine in early Jun.  She previously had a shot for Polio. The caller has arthritis, and she discovered that she had a cyst behind her left knee. She had her first Covid Vaccine and it has gotten more painful. She wanted to know how the second shot will affect her knee with the cyst. She is due to get her second vaccine today (09Jul2021). Cyst behind left knee has gotten more painful: She doesn't know how long she has had the cyst. She has arthritis, and she noticed her leg was getting swollen. It was just very painful the last few weeks she thought. She couldn't take the pain. The pain got worse after the vaccine. She couldn't walk, and she had to walk with a cane. She managed to get an appointment yesterday with her knee doctor. the pain became so bad that she scheduled an appointment with her Orthopedic doctor and was able to see her HCP on 08Jul2021. HCP noted that her left calf was swollen and ordered an MRI; the HCP found a cyst, not a blood clot per Caller. After her first dose her arthritis pain became worse, had back pain, and an increased in difficulty with walking. States that she starting using a cane and she has never used a cane before. She had a CBC, RBC, WBC, cholesterol, and other things she can't recall right now. The outcome of the event cyst behind left knee has gotten more painful was not recovered, while other events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain, Peripheral swelling, Red blood cell count, White blood cell count
Clinical narrative: Cyst behind left knee has gotten more painful; arthritis pain became worse, had back pain, and an increased in difficulty with walking; She couldn't walk, and she had to walk with a cane.; back pain; She has arthritis, and she noticed her leg was getting swollen.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Jun2021 13:30 at 66-years-old (Batch/Lot Number: FA6780) as dose 1, single for COVID-19 immunisation. Medical history included ongoing Asthma (She has had asthma for maybe 39 years), ongoing Diabetes mellitus (She has had diabetes for a year and a half), Breast cancer from Jul2014, ongoing Depression (It started 37 years ago), Knee surgery from Jan2017, arthritis, cyst. Concomitant medication not reported. It was reported that patient had pneumonia vaccine in early Jun.  She previously had a shot for Polio. The caller has arthritis, and she discovered that she had a cyst behind her left knee. She had her first Covid Vaccine and it has gotten more painful. She wanted to know how the second shot will affect her knee with the cyst. She is due to get her second vaccine today (09Jul2021). Cyst behind left knee has gotten more painful: She doesn't know how long she has had the cyst. She has arthritis, and she noticed her leg was getting swollen. It was just very painful the last few weeks she thought. She couldn't take the pain. The pain got worse after the vaccine. She couldn't walk, and she had to walk with a cane. She managed to get an appointment yesterday with her knee doctor. the pain became so bad that she scheduled an appointment with her Orthopedic doctor and was able to see her HCP on 08Jul2021. HCP noted that her left calf was swollen and ordered an MRI; the HCP found a cyst, not a blood clot per Caller. After her first dose her arthritis pain became worse, had back pain, and an increased in difficulty with walking. States that she starting using a cane and she has never used a cane before. She had a CBC, RBC, WBC, cholesterol, and other things she can't recall right now. The outcome of the event cyst behind left knee has gotten more painful was not recovered, while other events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear infection
Clinical narrative: HEARING LOSS; INFECTION IN BOTH EARS; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8733 (reported as 7/21 ER8733)), via an unspecified route of administration, administered in left arm on 01Apr2021 17:00 (at 64-year-old, non-pregnant) as dose 2, single for COVID-19 immunization. The patient's medical history was none. No known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261), via an unspecified route of administration, administered in left arm on 09Mar2021 10:00 AM (at 64-year-old) as dose 1, single for COVID-19 immunization. On 19Apr2021 at 13:00 the patient experienced infection in both ears, hearing loss. The events resulted doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included antibiotics. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died in his sleep; This is a follow-up spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported a 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that a 16-year-old boy died in his sleep after receiving his Covid-19 vaccine per Caller. Caller thinks it was the Pfizer Covid-19 vaccine. States that people died and adverse events happen after receiving the Pfizer Covid-19 vaccine.  Regarding the 16 -ear-old male, caller is asking how could that happen to a young man that seems to be healthy? The patient died on an unspecified date. It was unknown if an autopsy was performed.  information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868538 same reporter/ drug, different AE/ patient; Reported Cause(s) of Death: Died in his sleep
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Clot and bleed in brain causing stroke; Clot and bleed in brain causing stroke; Clot and bleed in brain causing stroke; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old male patient received BNT162B2 (Lot Number: EW0186), dose 2 via an unspecified route of administration, administered in arm left on 20May2021 11:30 as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). No known allergies. Concomitant medication included paracetamol (TYLENOL). The patient previously received first dose of BNT162B2 (lot number: ER8735) in left arm on 29Apr2021 17:15 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced clot and bleed in brain causing stroke on 06Jul2021 17:00. The events were reported as serious due to hospitalization. Events resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Treatment received for the adverse events: Current hospitalization in PICU, rehabilitation, and pending further follow up actions. Prior to vaccination, was the patient diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 06Jul2021. The outcome of events was recovering.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neuropathy peripheral
Clinical narrative: neuropathy in feet; Weakness in legs; This is a spontaneous report from a non-contactable physician. A 90-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EL9262) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date. There was unspecified concomitant medications in two weeks. The patient previously received the first dose of bnt162b2 intramuscularly on 23Jan2021 (lot number: el8982) for covid-19 immunization at age of 89 years old. The patient experienced neuropathy in feet and weakness in legs on an unspecified date. No treatment received for the events. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of BNT162B2 to the development of neuropathy in feet and weakness in legs cannot be excluded. 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm has been sore since vaccination. Has not gone away; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 at age of 59-year-old (Lot Number: EP7533) at single dose for COVID-19 immunisation at Health Clinic. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other vaccine in four weeks. The patient previously took bnt162b2 (Lot number: EN6204) dose 1 via an unspecified route of administration in left arm on 12Mar2021 03:00 PM at age of 59-year-old in left arm for COVID-19 immunisation. The patient experienced left arm had been sore since vaccination on 07Apr2021. It had not gone away. The event resulted in disability or permanent damage. There was no treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not resolved.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Skin disorder, Urticaria
Clinical narrative: Skin patches; Developed into hives/ big red blotches; This is a spontaneous report from two contactable consumers calling on behalf of father in law. A 78-year-old male patient received bnt162b2, via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included bnt161b2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The first reporter is calling on behalf of father in law, 78 years old who received the second dose of the Pfizer vaccine 3 months ago. Patient developed skin patches and then developed into hives. He was admitted to the hospital and was seen by a dermatologist while in there, who performed a biopsy for allergies, and all tests came back negative. He has an appointment today (09Jul2021) to see his doctor. None of the doctors want to commit into saying it is caused by the vaccine. It was also reported that a few months after the patient received the vaccine, the patient started experiencing hives that won't go away, they look like big red blotches. Patient went to his doctor, but the doctor doesn't know what is causing the hives. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant, SARS-CoV-2 antibody test
Clinical narrative: This was a cancer patient and they would need a third dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The pharmacist reported that this was a cancer patient and they would need a third dose with outcome of unknown. Patient had a negative antibody test following Pfizer vaccine series. Serious: No.   Information on lot/batch number has been requested.; Sender's Comments: Based on no temporal relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be assessed for the reported event of neoplasm malignant. 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Joint swelling, Nausea, Off label use, Pain in extremity
Clinical narrative: My upper right arm still hurts. I did not have arthritis like this my hands are becoming crippled; joints swollen; nausea; I have on and off random unexplained fevers; second dose 02Mar2021; second dose 02Mar2021; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received bnt162b2 (PFIZER -BIONTECH COVID-19 VACCINE), dose 1 at the age of 58-year-old on 02Mar2021 (lot number: El3302) as single dose in Right arm, second dose at the age of 58-year-old 02Mar2021 (lot number: Ew6w2) as single dose Left arm, both for COVID-19 immunisation. The patient was not pregnant. No covid prior vaccination. Known allergies was No. Other medical history included Chronic back pain. No other vaccine in four weeks. No other medications in two weeks. Her upper right arm still hurts. She did not have arthritis like this her hands was becoming crippled and joints swollen. She had been nausea every single day at some point since getting the vaccine and she had on and off random unexplained fevers. Adverse event start date was 03Mar2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and was serious due to Disability or permanent damage. Adverse event treatment included patient was on otezla and it was not helping. There was no covid tested post vaccination. The outcome of the event was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My upper right arm still hurts. I did not have arthritis like this my hands are becoming crippled; joints swollen; nausea; I have on and off random unexplained fevers; second dose 02Mar2021; second dose 02Mar2021; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received bnt162b2 (PFIZER -BIONTECH COVID-19 VACCINE), dose 1 at the age of 58-year-old on 02Mar2021 (lot number: El3302) as single dose in Right arm, second dose at the age of 58-year-old 02Mar2021 (lot number: Ew6w2) as single dose Left arm, both for COVID-19 immunisation. The patient was not pregnant. No covid prior vaccination. Known allergies was No. Other medical history included Chronic back pain. No other vaccine in four weeks. No other medications in two weeks. Her upper right arm still hurts. She did not have arthritis like this her hands was becoming crippled and joints swollen. She had been nausea every single day at some point since getting the vaccine and she had on and off random unexplained fevers. Adverse event start date was 03Mar2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and was serious due to Disability or permanent damage. Adverse event treatment included patient was on otezla and it was not helping. There was no covid tested post vaccination. The outcome of the event was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiomegaly, Computerised tomogram, Headache, Hypersomnia
Clinical narrative: Enlarged Heart; sleeping too much; headache; Haven't been able to get her energy back; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 27Feb2021 (at the age of 71-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included arthritis, osteoarthritis, lump in her lung, and underwent hip replacement. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9264), via an unspecified route of administration, administered in arm Left on 06Feb2021 (at the age of 71-years-old) as dose 1, single for covid-19 immunisation. The patient had a horrible experience with the second shot, she mean it, it wasn't just of a couple of days of sleeping too much and a headache. She meant that she slept 15 hours straight, have excruciating headache amongst other things and for 9 days and she just haven't felt the same, she haven't been able to get her energy back to normal, she still get an 10 to 12 thousand steps a day but she knew there was something going on with her heart. She was a VA patient and she had to go in for as they have been checking a lump that she had on her lung to make sure that it hasn't grown, and yet it had been (before vaccination), but what they found was that she had an enlarged heart. And she saw today they were showing that there was a co-relation between Moderna and Pfizer and the information of the heart and she was getting ready to go and see a Cardiologist, but what she was wondering, what do, does it was ever go back to normal. She just don't understand, if she had it to do it over again there was no way she would take any of this medication, any of this shot, she mean it was that horrible. The patient had a CT test and that's how she found out she have an enlarge heart and she have never had anything to do with her heart. There was no treatment, the patient just laid on bed for 9 days. The outcome of enlarged heart was not recovered; and the rest of the events was unknown. The reported event 'enlarged heart' was considered as serious, disabling.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Mass
Clinical narrative: I got bumps. All over both arms; This is a spontaneous report from a contactable other HCP (patient). This 50-year-old male patient received bnt162b2 (COMIRNATY) at the age of 50-year-old on 20May2021 (Lot: unknown) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included Known allergies: Penalisan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination was on record but unspecified. After the covid 19 vaccine given, patient got bumps on 27May2021 at 12:00 PM. That need to be biopsy now. All over both arms. The event was serious due to Disabling/Incapacitating/Disability or permanent damage. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Biopsy bloodwork creame. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event bumps with COMIRNATY use can not be fully excluded.  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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal vein occlusion
Clinical narrative: Central Retinal Vein Occlusion; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 26Jan2021 (Batch/Lot Number: EL-1283) at the age of 62 years as single dose for covid-19 immunisation. Medical history included osteopenia. Concomitant medications included alendronate sodium (FOSAMAX); levothyroxine; meloxicam; atorvastatin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced central retinal vein occlusion on 12Feb2021. Adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received included injections in left eye, ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were not recovered.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Facial paralysis, Headache, Tongue blistering
Clinical narrative: Noticed crooked mouth and paralyzed on right side of face in the morning; Major headaches; Blistered tongue and blistered inside and outside of right ear (very painful).; Blistered tongue and blistered inside and outside of right ear (very painful).; This is a spontaneous report received from contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05Jun2021 10:00 AM (Batch/Lot Number: ER8735) at the age of 47 years as single dose for covid-19 immunisation. Patient had no medical history and no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Major headaches started 05Jul2021. Noticed crooked mouth and paralyzed on right side of face in the morning. Blistered tongue and blistered inside and outside of right ear (very painful). Admitted to Emergency room on 08Jul2021. Date of start of reaction/event was 05Jul2021 9:00. Treatment received included valacyclovir hcl and prednisone. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Outcome of events were not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Exophthalmos, Eye pain, Eye swelling, Swelling of eyelid
Clinical narrative: she experienced swelling around and under her left eye which caused it to "bulge out"; she experienced swelling around and under her left eye which caused it to "bulge out"/the tissue around the outer part of my eye is swollen; sharp pain shooting through her eye; swelling around her eyelid; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 13May2021 (Lot Number: ER8736) at the age of 65 years as single dose for covid-19 immunisation. Medical history included glaucoma, dry eye. Concomitant medications included ongoing brimonidine tartrate, brinzolamide (SIMBRINZA) taken for glaucoma; ongoing polyvinyl alcohol, povidone (REFRESH CLASSIC LUBRICANT EYE DROPS) taken for dry eye. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She had never received a flu shot before. She did not take a flu shot and only took natural herbs. She thought she's having a reaction because she only used homeopathic medications, had a specific diet (listed vegetarian, pescatarian, and organic) and bodies weren't used to chemical medicine. After her first dose she experienced swelling around and under her left eye which caused it to "bulge out". The bulging was most notable in the mornings. She reported her eye doctor said the tissue around the outer part of her eye was swollen and had recommended she see a specialist. Patient experienced swelling around her eye and sharp pain shooting through her eye from 14May2021 and ongoing. She reported that after the first dose, she has had a swelling around her eyelid and around her eye that was not there prior to the vaccine. Her left eye started bulging out a little bit and there was swelling all under her eye. There is swelling in the tissue around her eye. It was not doing any of this before the vaccine. She stated that she was having sharp pain shooting through her eye. She said that it was from her eye brow to the corner of her eye by her nose. She went to see her eye doctor about her eye. The sharp pain in her eye was not as constant as it was previously. Treatments were not received. They checked her retina and glaucoma. Eye doctor thought it was swelling of the tissue around the eye. She was seeing an outer eye doctor on the 15Jul2021. She told them it was because of the vaccine. AEs swelling of eye and shooting pain in her eye require a visit to physician office. Outcome of events were not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Wrong technique in product usage process
Clinical narrative: but when it came to administering the shot, the nurse only pulled out 3 doses out of 6 from the vial and missed the step of equalizing the pressure.; but when it came to administering the shot, the nurse only pulled out 3 doses out of 6 from the vial and missed the step of equalizing the pressure.; This is a spontaneous report received from a Pfizer Sponsored Program. A Contactable consumer (Caregiver) reported for a Patient that, A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated she made appointments for family members in receiving the Pfizer COVID vaccine and she saw a nurse mixing it all together and was not sure exactly what happened, but when it came to administering the shot, the nurse only pulled out 3 doses out of 6 from the vial and missed the step of equalizing the pressure (on an unspecified date). reporter was not sure if missing the equalizing pressure step would get the vaccine get wasted. Reporter was asking if there would be a concern. Outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021874401 same reporter/product/event, different patient;US-PFIZER INC-2021874400 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Investigation, Rocky mountain spotted fever
Clinical narrative: rocky mountain fever; having brain fog; she was feeling very fatigued; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program, a Regulatory Authority. A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient got her first dose of the vaccine and was scheduled for her second dose of the vaccine on 13Jul2021. She stated she thought she was having a reaction to the first shot because she was feeling very fatigued. She was also having brain fog. However, her mother thought it could be a tick bite. She went to get tested and it came back today that she had rocky mountain fever. She was currently taking an antibiotic, doxycycline hyclate, and her last day of that was on 18Jul2021. Patient asked about getting the second dose on 20Jul2021 or 22Jul2021. She wanted to know if she could still get her second dose of the vaccine with rocky mountain fever while taking the antibiotics (doxycycline hyclate). Patient was diagnosed with mountain fever after she received the first dose of the Pfizer covid vacccine. Outcome of events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Pulmonary thrombosis, Renal vascular thrombosis
Clinical narrative: pneumonia; Blood clots in right lung; had blood clots on her right and left kidneys; This is a spontaneous report from a contactable consumer (patient sister). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm on an unspecified date (Batch/Lot number unknown) as single dose for covid-19 immunisation. Patient had no medical history and concomitant medications. Consumer reported that patient was hospitalized with pneumonia after both doses of product and blood clots in right lung in Apr2021. She was healthy for a while, then had blood clots on her right and left kidneys. She almost died from the blood clots. Her symptoms right after the shot were not fully developed, then it started getting worse and worse and worse and she thought it would dissipate. Stated something about really horrible side effects where she would wither away and it got worse and worse. She was hospitalized for two weeks, they put her on oxygen because she could not breathe, she did not want to be on a respirator since she did not want this to be a prolonged thing. Her sister was young, healthy, and vivacious. Her health declined and she was still struggling. When she talked to her sister it sounded like she was barely breathing. She also stated that her sister almost died from those blood clots back in April. She was hospitalized for 2 weeks then discharged to go home. Outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rectal abscess
Clinical narrative: Rectal abscess; This is spontaneous report from contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Apr2021 (lot number and expiry date: unknown) at the age of 60-years-old, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received amoxicillin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. On 10Apr2021 (3 days after the first jab), at 7:00 AM, the patient had rectal abscess. It peaked in 10 days, and without the surgery it disappeared in about 17-18 days. The event was considered serious, medically significant. The event resulted in healthcare professional office/clinic visit. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on unspecified date in Apr2021.  Information on lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Cough, Dysgeusia, Dyspnoea
Clinical narrative: face started hives; Chest started getting tight; heart rate started elevating; face started burning; started wheezing; started coughing; begging to not breath; Weird taste in mouth; itching all over; whole body was sore; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162B2 (Lot Number: Ewd171), dose 1 via an unspecified route of administration, administered in arm right on 10Jul2021 11:00 at the age of 29-year-old as single dose for covid-19 immunisation. Medical history included asthma. No known allergies. The patient's concomitant medications were none. The patient experienced adverse events on 10Jul2021 at 11:30. Reported Event: Weird taste in mouth, face started hives, chest started getting tight, heart rate started elevating, face started burning. The patient started wheezing then she started coughing she begging to not breath. The patient grabbed her inhaler and took the first pump it did not work, she took another pump it did not work, she took 2 more no luck, 2 more some luck, ambulance assisted. Hour later her whole body was broken out, her chest tight itching all over bumps everywhere, she was wheezing, her whole body was sore and she did not feel good. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 08Jul2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: face started hives; Chest started getting tight; heart rate started elevating; face started burning; started wheezing; started coughing; begging to not breath; Weird taste in mouth; itching all over; whole body was sore; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162B2 (Lot Number: Ewd171), dose 1 via an unspecified route of administration, administered in arm right on 10Jul2021 11:00 at the age of 29-year-old as single dose for covid-19 immunisation. Medical history included asthma. No known allergies. The patient's concomitant medications were none. The patient experienced adverse events on 10Jul2021 at 11:30. Reported Event: Weird taste in mouth, face started hives, chest started getting tight, heart rate started elevating, face started burning. The patient started wheezing then she started coughing she begging to not breath. The patient grabbed her inhaler and took the first pump it did not work, she took another pump it did not work, she took 2 more no luck, 2 more some luck, ambulance assisted. Hour later her whole body was broken out, her chest tight itching all over bumps everywhere, she was wheezing, her whole body was sore and she did not feel good. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 08Jul2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: face started hives; Chest started getting tight; heart rate started elevating; face started burning; started wheezing; started coughing; begging to not breath; Weird taste in mouth; itching all over; whole body was sore; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162B2 (Lot Number: Ewd171), dose 1 via an unspecified route of administration, administered in arm right on 10Jul2021 11:00 at the age of 29-year-old as single dose for covid-19 immunisation. Medical history included asthma. No known allergies. The patient's concomitant medications were none. The patient experienced adverse events on 10Jul2021 at 11:30. Reported Event: Weird taste in mouth, face started hives, chest started getting tight, heart rate started elevating, face started burning. The patient started wheezing then she started coughing she begging to not breath. The patient grabbed her inhaler and took the first pump it did not work, she took another pump it did not work, she took 2 more no luck, 2 more some luck, ambulance assisted. Hour later her whole body was broken out, her chest tight itching all over bumps everywhere, she was wheezing, her whole body was sore and she did not feel good. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 08Jul2021. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a contactable consumer(patient) via Pfizer sponsored program.  A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191, Expiration date was not reported), via an unspecified route of administration, at the age of 15-year-old on 05Jun2021 as single dose for covid-19 immunization. The patient medical history was reported as no. The patient's concomitant medications were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Lot number: EW0182, Expiration date was not reported), via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization. On 09Jun2021, the patient got seizure. The patient reported that he got seizure twice already, which never happened before. 1st time was on 09Jun2021(4 days after 2nd dose), and 2nd time was on 10Jul2021. Each time it was unprovoked grand mal seizure. Patient was hospitalized by 911 on 09Jun2021. Reports revealed no mass/bleed in head, He was given Keppra IV. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The clinical outcome of event was not recovered.   Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, SARS-CoV-2 test, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: I pulled over where I proceeded to pass out and vomited on myself; swelling and itching at injection site.; swelling and itching at injection site.; I felt nauseous while driving; I pulled over where I proceeded to pass out and vomited on myself; This is a spontaneous report from a contactable other healthcare professional. A 29-year-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jul2021 at 15:00 (at the age of 29 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swelling and itching at injection site, felt nauseous while driving and vomited on herself leading to hospitalization on 07Jul2021 10:00. She was taken to the ED by ambulance after monitoring for a few hours decision was taken to discharge but upon standing she passed out again so was admitted and multiple tests were performed. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 nasal swab test: with negative result on 02Jun2021. Therapeutic measures were taken for adverse events with fluids. Outcome of events was not recovered.   Information about batch/lot number has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: loss of consciousness, vaccination site swelling, vaccination site pruritus, nausea and vomiting ;and the administration of the vaccine cannot be excluded.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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I pulled over where I proceeded to pass out and vomited on myself; swelling and itching at injection site.; swelling and itching at injection site.; I felt nauseous while driving; I pulled over where I proceeded to pass out and vomited on myself; This is a spontaneous report from a contactable other healthcare professional. A 29-year-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jul2021 at 15:00 (at the age of 29 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swelling and itching at injection site, felt nauseous while driving and vomited on herself leading to hospitalization on 07Jul2021 10:00. She was taken to the ED by ambulance after monitoring for a few hours decision was taken to discharge but upon standing she passed out again so was admitted and multiple tests were performed. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 nasal swab test: with negative result on 02Jun2021. Therapeutic measures were taken for adverse events with fluids. Outcome of events was not recovered.   Information about batch/lot number has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: loss of consciousness, vaccination site swelling, vaccination site pruritus, nausea and vomiting ;and the administration of the vaccine cannot be excluded.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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Blood triglycerides, Dyspnoea, Loss of consciousness
Clinical narrative: passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old male patient received the second dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0168), via an unspecified route of administration, administered in Arm Left on 27May2021 09:00 as a single dose, and dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 09:15 (Batch/Lot Number: Ew0171) as a single dose for COVID-19 immunization . Medical history included blood cholesterol increased from an unknown date and unknown if ongoing and High cholesterol and triglycerides , blood triglycerides increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On the third day after the second shot the patient did some yard work and then after coming inside passed out and was twitching and gasping for air on the ground for less than a minute. I then sat up took some juice and was fine. The patient experienced passed out (loss of consciousness) , twitching (muscle twitching) and gasping for air on the ground for less than a minute (dyspnoea). patient underwent lab tests and procedures which included blood cholesterol: high on High cholesterol and triglycerides , blood pressure measurement: fine and blood triglycerides. Prior and since the vaccination, patient was not tested for COVID-19. The patient didn't take any other vaccines 4 weeks before the COVID vaccine.   The patient took the covid19 vaccine in hospital. Device date reported to be 11Jul2021.  Follow-up actions are needed. Further information has been requested.  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.