chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: joint pain in his shoulders, fingers and knees; overall pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0151, expiration date unknown) via an unspecified route of administration in the arm right on 04May2021 at 13:00 at age of 63-year-old for COVID-19 immunization. Medical history included depression. Patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0170, expiration date unknown) via an unspecified route of administration in the right arm on 15Apr2021 at 02:00 PM at age of 63-year-old for COVID-19 immunisation. Patient previously received acetylsalicylic acid (ASPIRIN ) and experienced stomach reaction. There was no other vaccine in four weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT). After the second dose, patient had about 3 days of muscle pain and overall pain. Then within 10 days, patient started having joint pain in his shoulders, fingers and knees. Knees got better after a week or two but shoulder pain in his left side and fingers got more severe for 2 month afterwards. Then gradually lessened to a tolerable level. And now, 5 months later he still had pain in his fingers and shoulders. Patient never had shoulder pain or hand pain before. His right hand got the worst of it and his left shoulder after that. Most of the pain in his fingers were concentrated in the first joints from the tip of fingers. The events didn't result in emergency room visit or physician office visit. Onset date of the events was reported as 20May2021 at 12:00AM. No treatment received for the events. Outcome of the events was recovered with sequel. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Bone pain, Feeling cold
Clinical narrative: joint pain in his shoulders, fingers and knees; overall pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0151, expiration date unknown) via an unspecified route of administration in the arm right on 04May2021 at 13:00 at age of 63-year-old for COVID-19 immunization. Medical history included depression. Patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0170, expiration date unknown) via an unspecified route of administration in the right arm on 15Apr2021 at 02:00 PM at age of 63-year-old for COVID-19 immunisation. Patient previously received acetylsalicylic acid (ASPIRIN ) and experienced stomach reaction. There was no other vaccine in four weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT). After the second dose, patient had about 3 days of muscle pain and overall pain. Then within 10 days, patient started having joint pain in his shoulders, fingers and knees. Knees got better after a week or two but shoulder pain in his left side and fingers got more severe for 2 month afterwards. Then gradually lessened to a tolerable level. And now, 5 months later he still had pain in his fingers and shoulders. Patient never had shoulder pain or hand pain before. His right hand got the worst of it and his left shoulder after that. Most of the pain in his fingers were concentrated in the first joints from the tip of fingers. The events didn't result in emergency room visit or physician office visit. Onset date of the events was reported as 20May2021 at 12:00AM. No treatment received for the events. Outcome of the events was recovered with sequel. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: joint pain in his shoulders, fingers and knees; overall pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0151, expiration date unknown) via an unspecified route of administration in the arm right on 04May2021 at 13:00 at age of 63-year-old for COVID-19 immunization. Medical history included depression. Patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0170, expiration date unknown) via an unspecified route of administration in the right arm on 15Apr2021 at 02:00 PM at age of 63-year-old for COVID-19 immunisation. Patient previously received acetylsalicylic acid (ASPIRIN ) and experienced stomach reaction. There was no other vaccine in four weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT). After the second dose, patient had about 3 days of muscle pain and overall pain. Then within 10 days, patient started having joint pain in his shoulders, fingers and knees. Knees got better after a week or two but shoulder pain in his left side and fingers got more severe for 2 month afterwards. Then gradually lessened to a tolerable level. And now, 5 months later he still had pain in his fingers and shoulders. Patient never had shoulder pain or hand pain before. His right hand got the worst of it and his left shoulder after that. Most of the pain in his fingers were concentrated in the first joints from the tip of fingers. The events didn't result in emergency room visit or physician office visit. Onset date of the events was reported as 20May2021 at 12:00AM. No treatment received for the events. Outcome of the events was recovered with sequel. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Off label use, Vaccination site bruising, Vaccination site erythema
Clinical narrative: redness / redness all above the upper arm; there was a little bruise at the site where injected; she has swelling on her upper arm, near the injection site about two inches by 2 inches; a little tired; sore arm; she received the booster dose on Sunday, 26Sep2021; she received the booster dose on Sunday, 26Sep2021; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Sep2021 (Batch/Lot Number: 301358A) (at the age of 70 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 04Feb2021 (Lot: EL9269, Expiration: Unknown) (at the age of 69 years old) via an unspecified route of administration, administered in left arm for Covid-19 immunisation and experienced a little tiredness and soreness in arm. The second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26Feb2021 (Lot: EN6203, Expiration: Unknown) (at the age 69 years old) via an unspecified route of administration, administered in left arm and experienced a little tired and had little bit like had the flu. The patient also had a second dose of Pneumonia vaccine 2 years ago for immunization and arm became swollen. The patient's concomitant medications were not reported. The patient received the booster dose on Sunday, 26Sep2021 and felt a little tired and had sore arm. On 29Sep2021, the patient experienced she has swelling on her upper arm, near the injection site about two inches by 2 inches. There was also some redness. Redness all above the upper arm and there was a little bruise at the site where injected. She noted that she just started experiencing this today (29Sep2021). She had taken Benadryl to reduce the swelling. The patient recovered from tiredness on 27Sep2021. Outcome of the other events was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: redness / redness all above the upper arm; there was a little bruise at the site where injected; she has swelling on her upper arm, near the injection site about two inches by 2 inches; a little tired; sore arm; she received the booster dose on Sunday, 26Sep2021; she received the booster dose on Sunday, 26Sep2021; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Sep2021 (Batch/Lot Number: 301358A) (at the age of 70 years old) as single dose for Covid-19 immunisation. The patient medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 04Feb2021 (Lot: EL9269, Expiration: Unknown) (at the age of 69 years old) via an unspecified route of administration, administered in left arm for Covid-19 immunisation and experienced a little tiredness and soreness in arm. The second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26Feb2021 (Lot: EN6203, Expiration: Unknown) (at the age 69 years old) via an unspecified route of administration, administered in left arm and experienced a little tired and had little bit like had the flu. The patient also had a second dose of Pneumonia vaccine 2 years ago for immunization and arm became swollen. The patient's concomitant medications were not reported. The patient received the booster dose on Sunday, 26Sep2021 and felt a little tired and had sore arm. On 29Sep2021, the patient experienced she has swelling on her upper arm, near the injection site about two inches by 2 inches. There was also some redness. Redness all above the upper arm and there was a little bruise at the site where injected. She noted that she just started experiencing this today (29Sep2021). She had taken Benadryl to reduce the swelling. The patient recovered from tiredness on 27Sep2021. Outcome of the other events was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Hot flush, Joint stiffness
Clinical narrative: Severe tiredness/Fatigue; Red face; Hot face/Hot; Swollen glands on face; Pinching quick pains in lymph areas of body; Joint stiffness; Muscle soreness for days/Muscle pain; Hot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Sep2021 13:00 at the age of 60-years-old (Lot Number: FC3182) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included Known allergies: Sulfa, Sulfates. There were no concomitant medications. On 12Sep2021 13:15, the patient experienced adverse events: "Red face. Hot face. Swollen glands on face. Pinching quick pains in lymph areas of body. Joint stiffness. Muscle pain. Fatigue. Hot. Severe tiredness. Muscle soreness for days." AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for AE. The outcome of events was recovered with sequelae.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Severe tiredness/Fatigue; Red face; Hot face/Hot; Swollen glands on face; Pinching quick pains in lymph areas of body; Joint stiffness; Muscle soreness for days/Muscle pain; Hot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Sep2021 13:00 at the age of 60-years-old (Lot Number: FC3182) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included Known allergies: Sulfa, Sulfates. There were no concomitant medications. On 12Sep2021 13:15, the patient experienced adverse events: "Red face. Hot face. Swollen glands on face. Pinching quick pains in lymph areas of body. Joint stiffness. Muscle pain. Fatigue. Hot. Severe tiredness. Muscle soreness for days." AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for AE. The outcome of events was recovered with sequelae.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Feeling hot, Hyperaesthesia
Clinical narrative: hot and swollen red arm; hot and swollen red arm; hot and swollen red arm; Swelling radiating down to elbow; severe sensitivity to touch; pressure in arm; fever 103; body aches; fatigue; This is a spontaneous report from a contactable healthcare professional.   A non-pregnant 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 30Aug2021 (Batch/Lot Number: EW0171) as dose 1, single for COVID-19 immunisation.  Patient had no medical history (None, otherwise healthy).   There were no concomitant medications.  The patient previously took CECLOR and experienced allergies.  The patient experienced 5 days post-vaccine 03Sep2021 17:00, hot and swollen red arm. Swelling radiating down to elbow, severe sensitivity to touch or pressure in arm, unresolved.  24-48h maintain post-vaccine fever 103, body aches, fatigue, resolved after 2 days. Patient received topical biofreeze;  otc NSAIDs. No COVID prior to vaccination and has not been tested for COVID-19. The outcome of fever 103, body aches, fatigue  was recovered on 05Sep2021 and other events was recovering.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Limb discomfort, Pain, Peripheral swelling, Pyrexia
Clinical narrative: hot and swollen red arm; hot and swollen red arm; hot and swollen red arm; Swelling radiating down to elbow; severe sensitivity to touch; pressure in arm; fever 103; body aches; fatigue; This is a spontaneous report from a contactable healthcare professional.   A non-pregnant 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 30Aug2021 (Batch/Lot Number: EW0171) as dose 1, single for COVID-19 immunisation.  Patient had no medical history (None, otherwise healthy).   There were no concomitant medications.  The patient previously took CECLOR and experienced allergies.  The patient experienced 5 days post-vaccine 03Sep2021 17:00, hot and swollen red arm. Swelling radiating down to elbow, severe sensitivity to touch or pressure in arm, unresolved.  24-48h maintain post-vaccine fever 103, body aches, fatigue, resolved after 2 days. Patient received topical biofreeze;  otc NSAIDs. No COVID prior to vaccination and has not been tested for COVID-19. The outcome of fever 103, body aches, fatigue  was recovered on 05Sep2021 and other events was recovering.   No follow up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 101.1 fever; headache; body ache; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Sep2021 at 17:45, at the age of 39 years, as the second single dose, in left arm, for COVID-19 immunization. Medical history included COVID prior vaccination. Known allergies no. Other medical history: no. The patient received the first dose of BNT162B2 vaccine on 01Sep2021 at 17:30, in left arm, at the age of 39 years. No other vaccine was administered in four weeks. Concomitant medications were not reported. The morning after, on 29Sep2021 at 08:00, the patient had 101.1 fever, also headache and body ache. The events were resolving without any treatment. COVID was not tested post vaccination. No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Inappropriate schedule of product administration, SARS-CoV-2 antibody test
Clinical narrative: Aankylosing spondylitis; second vaccine dose on 06May2021 and third booster dose on 16Sep2021; This is a spontaneous report from a contactable consumer.  A 51-year-old patient of unknown gender received third dose booster of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EW0179), intramuscular into the Right Arm on 16Sep2021 at 18:30 (at the age of 51-years-old) at single dose for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot EP7533) in the Right Arm on 15Apr2021 and the second dose of BNT162B2 (lot ER8735) in the Right Arm on 06May2021. No Prior Vaccinations Within 4 Weeks. Medical history included Underactive thyroid, Bi-Polar with Psychotic Episodes, Osteo/ Rheumatoid arthritis and Chondritis, Scoliosis. Concomitant Drugs included Synthroid 15 mg oral daily for Thyroid,  Aleve oral for Joint pain/ Arthritis, Tylenol oral for  Pain and Miralax oral. On 17Sep2021 the patient was newly diagnosed with ankylosing spondylitis following ongoing symptoms and requested a lab test to check antibodies to rule out any concern that she was also suffering from COVID. The patient was concerned that she has been vaccinated and on 06Jun2021 the antibodies were not found. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: daily severe headaches, debilitating at times; This is a spontaneous report from a non-contactable nurse (patient). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Apr2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There is no other vaccine in four weeks, no other medications in two weeks. The patient experienced daily severe headaches, debilitating at times on an unspecified date. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information in the case, a contributory role of BNT162B2 to the reported event Headache 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.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Immunisation, Off label use, Pain, Wrong product administered
Clinical narrative: in a lot of pain; Inadvertently, she was given 2 COVID vaccines instead.; Inadvertently received dose 3 and 4 the same day; Inadvertently received dose 3 and 4 the same day; Received  Pfizer Covid  vaccine instead of flu vaccine; This is a spontaneous report from a contactable consumer (the patient) .    A female patient of an unspecified age received bnt162b2 (BNT162B2) dose number three, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included knee arthroplasty.     The patient's concomitant medications were not reported.  The patient experienced in a lot of pain (non-serious) on Sep2021 with outcome of unknown , inadvertently, she was given 2 covid vaccines instead.  (non-serious) on Sep2021 with outcome of unknown , inadvertently received dose 3 and 4 the same day  (non-serious) on Sep2021 with outcome of unknown ,  received  Pfizer Covid vaccine instead of flu vaccine  (non-serious) on Sep2021 with outcome of unknown.  Course of the event The caller was supposed to get the flu vaccine and the Covid 19 vaccine booster or third dose but the pharmacy gave the caller 2 Covid 19 booster vaccines. She wants to know what to do. Caller states she is recovering from a knee replacement surgery and is in a lot of pain.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lips became swollen; This is a spontaneous report from a contactable consumer (patient). A 98-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) (at the age of 98-years-old) as DOSE 1,SINGLE for covid-19 immunisation.  Medical history included she had a history of allergies her whole life, lips became swollen years ago after taking a blood pressure medicine from an unknown date.  The patient's concomitant medications were not reported. The patient stated she had a history of allergies her whole life. On 20Jan2021, she was given the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. An hour after, she said her lips became swollen. She said she had the same reaction years ago after taking a blood pressure medicine. She was told to take Benadryl, and it went away after. However, that night, her lips swelled again so she took another Benadryl and it went away. She was told not to get the 2nd dose so she didn't. She said it had been 8 months and she wanted to socialize. She said that her daughter read something about taking Benadryl or steroids prior to receiving the booster. The patient would like to know if that was advisable. Therapeutic measures were taken as a result of lips became swollen included Benadryl. The outcome of the event was resolved on an unspecified date.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4090213-00) received from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular on 08Mar2021 (at the age of 70 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 intramuscular on 15Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. Patient with an event of non-serious Rheumatoid arthritis flare up after the second Covid shot with Humira (Adalimumab). The patient experienced rheumatoid arthritis flare up in 2021 with outcome of recovered in 2021. In 2021, the patient experienced Rheumatoid arthritis flare up after the second Covid shot. In 2021, the Rheumatoid arthritis flare up after the second Covid shot resolved. Pfizer BionTech COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event for adalimumab was unknown. The reporter's causality for the event of rheumatoid arthritis flare up and BNT162B2 as possible and not provided for adalimumab.  No follow-up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported event.  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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoacusis
Clinical narrative: chest pain; tunnel hearing/partial hearing loss; This is a spontaneous report from a contactable consumer.  A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 05Aug2021 13:00 (Batch/Lot Number: FA7484) (at the age of 36-years-old ) as single dose for covid-19 immunisation.  Medical history included cough from 30May2021 to 06Sep2021.  There were no concomitant medications.  The patient had received the first dose of bnt162b2 (lot EW0181) on 13Jul2021 Intramuscular Left arm and experienced prolonged period as well as late period.  On 05Aug2021 at 22:00 the patient experienced tunnel hearing, partial hearing loss happens about 1-2 days out of the week since the second Pfizer vaccine was given. On 11Aug2021 at 03:00 chest pain started a week after second Pfizer vaccine given . Chest pain got so severe that the patient had to go to the ER. Medication at ER helped with further severe pain (so far). The event tunnel hearing, partial hearing loss were considered serious as Persistent/Significant disability and Important medical event. The outcome of the event was not recovered, the outcome of the chest pain was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021892717 Same reporter/ patient, different dose/ AEs.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cystoid macular oedema, Inappropriate schedule of product administration, SARS-CoV-2 test, Uveitis
Clinical narrative: Uveitis; Cystoid Macular Edema; dose 1 on 03Jun2021 11:00/dose 2 on 03Jun2021; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm, on 03Jun2021 11:00, at the age of 55-year-old (not pregnant), (Lot Number: FC2336) as dose 1, single; and dose 2 via an unspecified route of administration in left arm, on 03Jun2021 at the age of 55-year-old (not pregnant), (Lot Number: EW0181) as dose 2, single; for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks, no other medications in two weeks. Patient did not have COVID prior vaccination. Patient had no known allergies. The patient's concomitant medications were not reported. On 28Jun2021 06:00, the patient experienced uveitis and cystoid macular edema. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient tested COVID post vaccination included COVID test (Nasal Swab) was negative on 02Jun2021; was negative on 10Jun2021; was negative on 21Aug2021; and was negative on 25Sep2021. Therapeutic measures were taken as a result of uveitis and cystoid macular edema included "call me/15 visits and still no cure". The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting into the second day.; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FF8839), via an unspecified route of administration on 27Sep2021 at 16:30(at the age of 69-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 27Sep2021 to 27Sep2021; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient had previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 28Sep2021 at 12:00 PM, Vomiting into the second day. This was her booster. She had no special adverse events with her first two doses. No treatment was given for the event. The outcome of the event was not recovered.    Follow-Up (05Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid 19 infection on 24Aug2021/had the Covid virus 24Aug2021; tested positive for covid 19 infection on 24Aug2021/had the Covid virus 24Aug2021; This is a spontaneous report from a Program from a contactable other healthcare professional (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date as single dose, first dose via an unspecified route of administration on Jan2021 as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that he was fully vaccinated with Pfizer BioNtech covid 19 vaccine back in Jan2021. He tested positive for covid 19 infection on 24Aug2021. Patient stated that he was still having some side effects from decreased lung capacity however he had completed his required isolation and was back to work. Patient stated that he would like to know when it was safe for him to get his booster dose of the Pfizer Biontech covid 19 vaccine? Patient had the Covid virus 24Aug2021 and was asking how long to take the booster and what was the recommended month to get the booster shot. Patient stated that was what he really wanted to know and no one can answer. Patient stated it was too soon as he was still having side effects with his lung capacity, he was over the Covid for a little bit now. Patient was asking when it was safe for him to get it. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up. Based on the temporal association, a causal relationship between the events and BNT162B2 cannot be completely excluded. Of note, the efficacy of a drug varies from patient to patient and can be affected by different factors, and the mutated coronavirus strains would also alter the efficacy of the vaccine. The case will be reassessed when additional information becomes available.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fatigue, Muscle twitching, Sleep disorder, Tremor
Clinical narrative: shaky; my hands having a slight twitch; tired; slept all day; sustained readings of "signs of atrial fib."; This is a spontaneous report from a contactable consumer. A 68-year-old male consumer (patient) reported that received the third dose (booster dose) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 26Sep2021 at 12:30 (at the age of 68-years-old) at single dose for COVID-19 immunization. The patient had received another dose of BNT162B2 on 15Feb2021 at 12:45 PM in the Left arm. Within 4 weeks prior the booster dose on 13Sep2021, the patient had received flu vaccine - left arm. Medical history: included atrial fib; mild asthma; high blood pressure; high cholesterol; thoracic aortic aneurysm. No known allergies. Concomitant drugs included eliquis; montelukast; amlodipine; melatonin, budes. Prior to vaccination, the patient was not diagnosed with COVID-19. On 26Sep2021 04:30 PM approximately four hours after the shot the patient's Apple Watch showed sustained readings of "signs of atrial fib."  On the next morning he was shaky, with his hands having a slight twitch.  He was tired and slept all day. On the subsequent day (i.e. day 2) he was fine. The event resulted in Doctor or other healthcare professional office/clinic visit. no treatment was given. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the event was recovered on 28Sep2021.  The Lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Blister, Erythema, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: started having a reaction and started w/itching; large hives like blisters on neck and face; Face was all red like a sunburn/red face palms and bottom of feet red; large hives like blisters on neck and face; This is a spontaneous report from a contactable consumer (patient). This 61-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number EL9269), intramuscularly on the right upper arm on 12Feb2021 at 3:00 PM (at the age of 61-year old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were none. On 12Feb2021 at 17:00, 10 hours after vaccination the patient started having reaction and started with itching, large hives like blister on neck and face. Face was all red like a sunburn. The patient took diphenhydramine (BENADRYL) 25 mg, waited 30 minutes took another diphenhydramine 25 mg. "A prednisone pill (left over from poison IVY 2019) patient called Pfizer and talked to someone to repeat. Went to bed and the next morning it took like nothing happened. On 05feb2021 the patient had a nasal swap the was negative. Patient's work required to be tested every week, all results were negative. The outcome of the events was recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021259921 same patient/drug, different dose/AE
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Sep2021 at around 09:00, as the first single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced breaking out in rash on her arm. The patient stated that from time to time, without thinking about it, she pulled weeds when they grew up and she did that a couple of days before, but she washed her arms. She was not sure if she came into contact with poison ivy or if this was one of the side effects. Event outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a solicited report based on information received by Pfizer (Control No: 21K-163-4090627-00). A contactable consumer (patient) reported that a 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly in May2021 (Batch/Lot number was not reported) at age of 36 years old as a single dose, 2nd dose intramuscularly in Jun2021 (Batch/Lot number was not reported) at age of 36 years old as a single dose for covid-19 immunisation. HUMIRA, subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 in Sep2021 with outcome resolving. The action taken in response to the event for HUMIRA was unknown.  Solicited report by a consumer of a 36 years old female with an event of non-serious COVID-19 with HUMIRA. There was no reported medical history. In Sep2021, the patient experienced COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On May2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On Jun2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The reporter's causality for the event of COVID-19 with HUMIRA was no reasonable possibility. Causality as per reporter for the event COVID-19 with BNT162B2 was possible.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. The efficacy of a drug varies from patient to patient and can be affected by different factors, however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dermatitis, Rash
Clinical narrative: looks like acne but she said it's painful on her forehead./Broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead; The forehead was little bit, some of it is inflamed and she said it looks like white head all over her forehead actually on her cheeks and even on her chin like more dominant on her forehead; broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead; This is a spontaneous report from a contactable physician. A 15-year-old female patient received bnt162b2, intramuscular, administered in Arm Left on 27Sep2021 17:45 (Batch/Lot Number: 301458A) as DOSE 1, SINGLE at age of 15-year-old for covid-19 immunization. Patient History was No. No Other medical Conditions and Drugs taken, she doesn't have any medical problems or allergies. The patient's concomitant medications were no. Patient is a 15 year old female (15 Years 11 months, almost 16) who received the first dose of the vaccine on Monday (27Sep2021). One day later on Tuesday (28Sep2021) she got a rash like acne and painful all over her face. It looks like white heads and is more on her forehead. She has had no changes in detergents, lotions or anything. On Tuesday (28Sep2021) the patient broke out in a rash that looks like acne or white heads on her face and it is more prominent on the forehead. The reporter said the patient has had no change in detergent or lotions or anything like that and she wanted to know if there any other reports of rashes like that has been reported and she said she is not sure how to treat it. It looks like acne but she said it's painful on her forehead. The forehead was little bit, some of it is inflamed and she said it looks like white head all over her forehead actually on her cheeks and even on her chin like more dominant on her forehead. Yesterday (28Sep2021) and today (29Sep2021) things are a little bit worse. She got a couple more on the chin that she didn't have before. Patient feels it's a little worse from yesterday. She got a couple of new ones. She got the COVID shot on the 27th and then she said on the 28th she got this rash on her face. It was also reported that the patient got the painful looks like almost like white head acne lesion all on her face and this develop yesterday (28Sep2021), painful all over her face, did not notice anything anybody else reporting something like that, white head. Scheduled Date and Time of second shot was on 18Oct2021 at 17:45 PM. No Prior vaccination(4 weeks). Causality was no, the reporter hasn't seen anything like this. No Lab tests, haven't done any lab tests. Treatment for adverse events included Benadryl, she took it one time. The outcome of the events was not recovered.; Sender's Comments: Based on known disease pathophysiology, the events of rash, acne and dermatitis are assessed as not related to BNT162B2 and more likely due to underlying hormonal imbalances.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Severe shingles; Severe shingles rash about 10 days out from vaccine; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6204; Expiration date: not provided) via an intramuscular route of administration on 11Sep2021 (age at vaccination 77-year-old) as dose 2, single for Covid-19 immunization at hospital. The patients medical history included antisynthetase syndrome and hypertension. The patients known allergies was statins. The patients concomitant medication included mycophenolate mofetil (CELLCEPT [MYCOPHENOLATE MOFETIL]); hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIZIDE); metoprolol; metformin; isosorbide mononitrate (IMDUR); aspirin [acetylsalicylic acid] and allopurinol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9269; Expiration date: not provided) via an unspecified route of administration on an unspecified date (age at vaccination 77-year-old) as dose 1, single for Covid-19 immunization. The patient had not received any other vaccine within 4 weeks. The patient was not diagnosed with Covid-19 prior to vaccination. The patient was not tested for Covid since the vaccination. On 21Sep2021, 10 days after vaccination the patient experienced severe shingles rash. An adverse events resulted into physicians office visit. Therapeutic measures were taken for the events was valtrex, prednisone and gabapentin. The reporter assessed the events as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Device breakage, Discomfort, Dyspnoea
Clinical narrative: right breast implant completely ruptured; sharp pain in chest; pain that caused insomnia; pain that caused insomnia; chest tightness; discomfort; shortness of breath; Other vaccine same date vaccine date: 10Aug2021; Other vaccine same date vaccine date: 10Aug2021; This is a spontaneous report from a contactable other hcp (patient).   A 36-years-old female patient (not pregnant) received bnt162b2 (Brand: Pfizer) intramuscularly administered in Arm Left on 10Aug2021 (vaccination age was 36 years old) (Batch/Lot Number: Fc3180) as DOSE 1, SINGLE for covid-19 immunisation. Other unspecified Pfizer vaccine administered via an unspecified route of administration in Arm Left on 10Aug2021 (Batch/Lot Number: Fc3181) as DOSE 2, SINGLE for immunization. Facility type vaccine was in Pharmacy or Drug Store. Medical history included generalized dystonia and covid-19 (prior vaccination), no known allergies. There is no other vaccine in four weeks. Concomitant medication(s) included amantadine; carbidopa monohydrate, levodopa (SINEMET); amfetamine (ADZENYS ER); vitamin d nos (VITAMIN D); ascorbic acid (VITAMIN C); zinc; all taken for an unspecified indication, start and stop date were not reported.  The patient experienced right sharp pain in chest that started the night of the second vaccination that lasted for 48 hours, pain that caused insomnia, followed by 2 weeks of chest tightness, discomfort and shortness of breath. 2 1/2 weeks later right breast implant completely ruptured. Patient will now have to have breast revision surgery. Adverse events start date was reported as on 31Aug2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of right sharp pain in chest, pain that caused insomnia, chest tightness, discomfort and shortness of breath, right breast implant completely ruptured was not recovered with unknown treatment received. No covid tested post vaccination.; Sender's Comments: Based on the information in the case report, a possible causal association between the event device breakage and suspect drug BNT162B2 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Off label use, Pain, Product use issue
Clinical narrative: right breast implant completely ruptured; sharp pain in chest; pain that caused insomnia; pain that caused insomnia; chest tightness; discomfort; shortness of breath; Other vaccine same date vaccine date: 10Aug2021; Other vaccine same date vaccine date: 10Aug2021; This is a spontaneous report from a contactable other hcp (patient).   A 36-years-old female patient (not pregnant) received bnt162b2 (Brand: Pfizer) intramuscularly administered in Arm Left on 10Aug2021 (vaccination age was 36 years old) (Batch/Lot Number: Fc3180) as DOSE 1, SINGLE for covid-19 immunisation. Other unspecified Pfizer vaccine administered via an unspecified route of administration in Arm Left on 10Aug2021 (Batch/Lot Number: Fc3181) as DOSE 2, SINGLE for immunization. Facility type vaccine was in Pharmacy or Drug Store. Medical history included generalized dystonia and covid-19 (prior vaccination), no known allergies. There is no other vaccine in four weeks. Concomitant medication(s) included amantadine; carbidopa monohydrate, levodopa (SINEMET); amfetamine (ADZENYS ER); vitamin d nos (VITAMIN D); ascorbic acid (VITAMIN C); zinc; all taken for an unspecified indication, start and stop date were not reported.  The patient experienced right sharp pain in chest that started the night of the second vaccination that lasted for 48 hours, pain that caused insomnia, followed by 2 weeks of chest tightness, discomfort and shortness of breath. 2 1/2 weeks later right breast implant completely ruptured. Patient will now have to have breast revision surgery. Adverse events start date was reported as on 31Aug2021. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of right sharp pain in chest, pain that caused insomnia, chest tightness, discomfort and shortness of breath, right breast implant completely ruptured was not recovered with unknown treatment received. No covid tested post vaccination.; Sender's Comments: Based on the information in the case report, a possible causal association between the event device breakage and suspect drug BNT162B2 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.