chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Exposed to Covid positive on 25Apr2021; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program.   A 43-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 19Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that in between the doses, she was exposed to Covid positive on 25Apr2021 and she did not had any symptoms. She was exposed to COVID and was quarantin until this Sunday 09May2021. She will be done quarantining this Sunday and did not mention the exact dates of when she had her first dose and when the infection started. She only stated that she was exposed to a person who had COVID and she did not necessarily say she had COVID per say and had no symptoms of COVID whatsoever. She had shown no symptoms and was supposed to be scheduled for her second dose next Tuesday which was due on 11May2021 and was asking if she can proceed with her schedule and was referred to healthcare professional. She wanted if there were any guidelines with regards to her concern or if she needed to extend the date of her second dose (second dose schedule was more than 21 days). Unaddressed medical questions were referred or forwarded to Medical Information. Report was not related to a study or programme. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received 1st dose COVID-19 Vaccine and experienced COVID-19; COVID-19; This is a solicited report from a non-Pfizer sponsored program based on the information received by Pfizer. A contactable consumer (patient) reported that a 65-year-old female patient received bnt162b2, intramuscularly in 2021 (Batch/Lot number was not reported) as first dose, single for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from Jan2021 (Batch/Lot number was not reported) to 2021, at 40 mg, cyclic, (1 in 2 week) for moderate to severe adult crohn's disease. The patient medical history and concomitant medications were not reported. The patient received 1st dose COVID-19 Vaccine and experienced COVID-19. It was also reported that the patient experienced an event of non-serious COVID-19 with ADALIMUMAB (HUMIRA). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number and expiration date was unknown. In 2021, the patient experienced COVID-19. In 2021, the COVID-19 resolved. On 2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number and expiration date was unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: covid-19 on 2021. The action taken in response to the event(s) for adalimumab was permanently withdrawn in 2021. The reporter's causality for the event(s) of COVID-19 with adalimumab and bnt162b2 was not provided. The outcome of the events was recovered in 2021.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  No follow-up attempts are possible. information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information, a causal relationship between events Drug ineffective / COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Repetitive headache; Body ache; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 05Apr2021, second dose on 27Apr2021, both at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. She experienced adverse events such as repetitive headache, body ache and chills. She wanted to seek medical advice with regards to this experience. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Experienced cold after the first dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. Patient experienced cold after 1st dose. Patient was scheduled for the second dose on 03May2021. He was asking if he can get the vaccine on 03May2021. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Burning sensation, Ear discomfort, Tinnitus, Vaccination site pain
Clinical narrative: swelling in brain; tinnitus; pressure in her right ear; feeling a burning sensation that traveled from the injection site to the back of her neck and then to the other side to her other arm in same location then down her spine and top of her head; feeling a burning sensation that traveled from the injection site to the back of her neck and then to the other side to her other arm in same location then down her spine and top of her head; This is spontaneous report from a contactable consumer (the patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 15Apr2021 as a single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller states she would like to know if the reactions she experienced with the first dose of the Pfizer COVID vaccine are considered an allergic reaction and if she should receive the second dose. Caller states she received the first dose on 15Apr2021 and her side effects persisted until 21Apr2021. Caller states within the first fifteen minutes after the vaccine she started feeling a burning sensation that traveled from the injection site to the back of her neck and then to the other side to her other arm in same location then down her spine and top of her head. Caller states she also experienced pressure with the burning. Caller states the burning sensation persisted mostly behind her neck and top of her head. Caller states she felt like she had some swelling in brain because she also had tinnitus and pressure in the right ear. Caller describes this as almost how you feel when you have an ear infection and it felt uncomfortable. On 21Apr2021, all the event was recovered. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Caller states the Medical Information line should be able to give medical advice regarding whether or not a reaction is considered an allergic reaction or not.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: had a heart condition who also received the Pfizer Covid-19 vaccine; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer reported on behalf of her husband and her sister in law. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Caller called on behalf of her husband who is due to get the second dose on 06May2021. Caller's husband received the first dose of the Pfizer Covid-19 vaccine on 15Apr2021 and will have an emergency on 06May2021 so she wants to know if her husband can take the second dose earlier than the given schedule and Caller's sister-in law had a heart condition who also received the Pfizer Covid-19 vaccine. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Full body aches; This is a spontaneous report from a contactable consumer (company representative). A 50-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 2 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's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for covid-19 immunisation and no reaction. In the 2-3 days that followed the second shot, the patient experienced very strong full body aches. According to the reporter, the patient's symptoms subsided after 3 days or so. The outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She got infected with currently raging Indian variant of the coronavirus few days back/symptoms were mild; She got infected with currently raging Indian variant of the coronavirus few days back/symptoms were mild; This is a spontaneous report from a Pfizer-sponsored program, Pfizer RxPathways from a contactable consumer (patient's daughter). A female patient of an unspecified age received BNT162B2, dose 2 and dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 2 doses of COVID vaccine in February and got infected with currently raging Indian variant of the coronavirus few days back. Luckily because of the vaccine, her symptoms were mild and she only got cough for 2 days. Outcome of the events was unknown. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date  (Indian variant).  Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Malaise, Pyrexia
Clinical narrative: testicles swelling; experienced a rash three hours after the vaccine; fever; chills; diarrhea; Malaise; they gave him a quick test that said he had covid; This is a spontaneous report from a contactable consumer (patient). A 63 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 15Apr2021 at 10:30 (at the age of 63 years old) as single dose for COVID-19 immunization. Patient's medical history included asthma and it was diagnosed years ago. Concomitant medications were not reported. On 15Apr2021, the patient experienced fairly, fever, chills, testicles swelling, and diarrhea, malaise, COVID-19 and rash three hours after the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported symptoms went on for several days and began on 15Apr2021 about three hours after he was administered the 1st dose of the Pfizer COVID vaccine and the symptoms resolved probably 7 days later. Patient do not have prior vaccine side effects. Patient did not require treatment but for one thing he did call to HCP and was sent for a COVID test and it came back negative, and it was the one that takes three days, states patient still did not feel good so that same day patient first COVID test on 23Apr2021 patient went to another COVID test at and they gave him a quick test in that result patient had COVID. Outcome of the events fever, chills, diarrhea, malaise was recovered and testicular swelling, rash, COVID-19 was unknown.    Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Testicular swelling
Clinical narrative: testicles swelling; experienced a rash three hours after the vaccine; fever; chills; diarrhea; Malaise; they gave him a quick test that said he had covid; This is a spontaneous report from a contactable consumer (patient). A 63 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 15Apr2021 at 10:30 (at the age of 63 years old) as single dose for COVID-19 immunization. Patient's medical history included asthma and it was diagnosed years ago. Concomitant medications were not reported. On 15Apr2021, the patient experienced fairly, fever, chills, testicles swelling, and diarrhea, malaise, COVID-19 and rash three hours after the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported symptoms went on for several days and began on 15Apr2021 about three hours after he was administered the 1st dose of the Pfizer COVID vaccine and the symptoms resolved probably 7 days later. Patient do not have prior vaccine side effects. Patient did not require treatment but for one thing he did call to HCP and was sent for a COVID test and it came back negative, and it was the one that takes three days, states patient still did not feel good so that same day patient first COVID test on 23Apr2021 patient went to another COVID test at and they gave him a quick test in that result patient had COVID. Outcome of the events fever, chills, diarrhea, malaise was recovered and testicular swelling, rash, COVID-19 was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The patient's medical history and concomitant medications were not reported. On 19Apr2021, patient got Covid-19 symptoms and he tested Covid-19 positive on 21Apr2021. He said that he missed the 2nd dose and the vaccination facility called him for a follow-up. Patient also mentioned that he got a clearance letter and he is not contagious anymore. The outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Dysphagia, Headache, Rheumatoid arthritis
Clinical narrative: Swallowing difficult; Heartburn; Headache; Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer, (Mfr. Control No.: 21K-163-3863221-00). Solicited report by a consumer of a 70 year old female with events  of non-serious heartburn, headaches since had covid-19 vaccine, rheumatoid arthritis flare ups on on HANDS/FEET and difficult swallowing with Rinvoq (upadacitinib). In 2021, the patient experienced rheumatoid arthritis flare ups on on hands/feet. In Feb2021, the patient experienced heartburn, headaches since had COVID-19 vaccine and difficult swallowing. COVID-19 vaccine was also considered suspect. Patient had a flare up on her hands and feet from time to time. In 2021, she had last one after moving furniture. She stated that Rinvoq helped her a lot with her rheumatoid arthritis. In Feb2021, she had been having headaches since she had her vaccine. They really put her down when she gets them. She had been having  heartburn also experienced difficulty of swallowing and she was not sure if it was Rinvoq or Chili that was the cause. Her headache and heartburn was on and off. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number EL9261. On 16Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number EM9810. The patient was treated with TYLENOL.  Causality for RINVOQ (UPADACITINIB) The reporter's causality for the event(s) of heartburn, headaches since had covid-19 vaccine, Rheumatoid arthritis flare ups on on hands/feet and difficult swallowing with RINVOQ(UPADACITINIB) was a reasonable possibility.  Change History On 26Apr2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information and narrative description. The event of "Difficult Swallowing" was added. The event of "Headaches" was amended to "Headaches Since Had Covid-19 Vaccine".  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: I get the shot which I'm allergic/ended up in the hospital with a severe reaction it was bad; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (reported as Covid vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated when she got the Covid vaccine she ended up in the hospital with a severe reaction it was bad, she was in the hospital now. The covid vaccine the way it was developed was using the H1N1 strand of virus and every time she called to get ingredients they show some but not all the components both Pfizer and Moderna they both don't show. Patient stated "My mom has severe dementia and my sister got sick with covid she was full time caregiver for my mom and my mom needs 24 hour care I went to all facilities and I won't be able to see my mother unless I get the shot which I'm allergic or she lives with me". The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site swelling
Clinical narrative: lymph swelling in arm pit so large that it hurt to apply deodorant; swelling at injection site; Redness too. Size of a golf ball.; This is a spontaneous report from a non-contactable consumer reporting for herself. This report was received via a sales representative.     A 38-years-old female patient received bnt162b2 (BNT162B2), dose 2 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 was not reported.   The patient's concomitant medications were not reported.  The patient experienced lymph swelling in arm pit so large that it hurt to apply deodorant on 2021 with outcome of unknown , swelling at injection site  on 2021 with outcome of unknown , redness too size of a golf ball on 2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine; second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine; Covid19; Covid19; This is a spontaneous report from Pfizer program. A contactable consumer (herself as patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Mar2021 (Batch/Lot number: Unknown) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Mar2021, she had Covid19 virus after getting the first dose. On an unspecified date, the patient missed the second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine. The patient got the first dose of the vaccine 27Mar2021 and was scheduled on 17Apr2021 to get the second dose. However, she had Covid19 virus after getting the first dose. The patient missed the second dose appointment and she's asking if there is a walking center where she can get the second dose vaccine. The events drug ineffective and Covid19 were assessed as serious as medically significant and remaining events were assessed as non-serious. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had COVID symptoms one and a half weeks after the first dose; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date at a single dose (1ST DOSE, SINGLE) for covid-19 immunization. Medical history included breast cancer (Ten year). Concomitant medication included letrozole. The patient had covid symptoms one and a half weeks after the first dose on an unspecified date. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Blood uric acid normal, C-reactive protein increased
Clinical narrative: 2nd dose given 3/26/2021.  Three days after the 2nd vaccine dose, patient had severe fatigue and some joint aches, this got much worse one week later with severe right hand synovitis, diffuse muscle and joint aches. He tried ibuprofen on 4/7/2021. this did not help. He came to see me 4/19 with severe pains. CBC, CMP, ESR, and CK levels were normal. CRP was elevated at 123. and I put him on a 12-days prednisone taper which made him feel better. He stopped that taper on May 1 and within one week his symptoms had returned in full force, this time with fever. I saw him again 5/14 and again he had elevated CRP level and also elevated ferritin level. other rheumatologic labs were normal. he still had right hand swelling and synovitis. He is miserable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Metabolic function test normal, Myalgia
Clinical narrative: 2nd dose given 3/26/2021.  Three days after the 2nd vaccine dose, patient had severe fatigue and some joint aches, this got much worse one week later with severe right hand synovitis, diffuse muscle and joint aches. He tried ibuprofen on 4/7/2021. this did not help. He came to see me 4/19 with severe pains. CBC, CMP, ESR, and CK levels were normal. CRP was elevated at 123. and I put him on a 12-days prednisone taper which made him feel better. He stopped that taper on May 1 and within one week his symptoms had returned in full force, this time with fever. I saw him again 5/14 and again he had elevated CRP level and also elevated ferritin level. other rheumatologic labs were normal. he still had right hand swelling and synovitis. He is miserable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Serum ferritin increased
Clinical narrative: 2nd dose given 3/26/2021.  Three days after the 2nd vaccine dose, patient had severe fatigue and some joint aches, this got much worse one week later with severe right hand synovitis, diffuse muscle and joint aches. He tried ibuprofen on 4/7/2021. this did not help. He came to see me 4/19 with severe pains. CBC, CMP, ESR, and CK levels were normal. CRP was elevated at 123. and I put him on a 12-days prednisone taper which made him feel better. He stopped that taper on May 1 and within one week his symptoms had returned in full force, this time with fever. I saw him again 5/14 and again he had elevated CRP level and also elevated ferritin level. other rheumatologic labs were normal. he still had right hand swelling and synovitis. He is miserable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Synovitis
Clinical narrative: 2nd dose given 3/26/2021.  Three days after the 2nd vaccine dose, patient had severe fatigue and some joint aches, this got much worse one week later with severe right hand synovitis, diffuse muscle and joint aches. He tried ibuprofen on 4/7/2021. this did not help. He came to see me 4/19 with severe pains. CBC, CMP, ESR, and CK levels were normal. CRP was elevated at 123. and I put him on a 12-days prednisone taper which made him feel better. He stopped that taper on May 1 and within one week his symptoms had returned in full force, this time with fever. I saw him again 5/14 and again he had elevated CRP level and also elevated ferritin level. other rheumatologic labs were normal. he still had right hand swelling and synovitis. He is miserable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Burning sensation, Contusion, Hallucination, Injection site rash
Clinical narrative: 15 hours after - onset massive body and skin aches, tingling/burning skin, migraine-level headache.   25 hours after: swelling and rash at injection site radiating to elbow and around entire upper arm.   48 hours after: swelling and bruising through lymph nodes under left arm. Less than 5 hours? sleep, skin sensitivity lasted through first 48 hours. Became reliant on inhaler for minor exertion or activity.   72 hours after: insomnia continued, pain & swelling  & rash through lymph nodes continued. Bruising in upper arm continued. By Sunday evening (3rd day), began having hallucinations and uncontrollable feelings of rage, led to contacting suicide hotline.  Feelings were not resolved  with 2 1mg doses of clonipin over 5 hours. Couldn?t reach a live person at suicide hotline and ended up driving to ER for dose of Atavan, where I finally slept.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Migraine, Pain, Paraesthesia
Clinical narrative: 15 hours after - onset massive body and skin aches, tingling/burning skin, migraine-level headache.   25 hours after: swelling and rash at injection site radiating to elbow and around entire upper arm.   48 hours after: swelling and bruising through lymph nodes under left arm. Less than 5 hours? sleep, skin sensitivity lasted through first 48 hours. Became reliant on inhaler for minor exertion or activity.   72 hours after: insomnia continued, pain & swelling  & rash through lymph nodes continued. Bruising in upper arm continued. By Sunday evening (3rd day), began having hallucinations and uncontrollable feelings of rage, led to contacting suicide hotline.  Feelings were not resolved  with 2 1mg doses of clonipin over 5 hours. Couldn?t reach a live person at suicide hotline and ended up driving to ER for dose of Atavan, where I finally slept.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Sleep disorder
Clinical narrative: 15 hours after - onset massive body and skin aches, tingling/burning skin, migraine-level headache.   25 hours after: swelling and rash at injection site radiating to elbow and around entire upper arm.   48 hours after: swelling and bruising through lymph nodes under left arm. Less than 5 hours? sleep, skin sensitivity lasted through first 48 hours. Became reliant on inhaler for minor exertion or activity.   72 hours after: insomnia continued, pain & swelling  & rash through lymph nodes continued. Bruising in upper arm continued. By Sunday evening (3rd day), began having hallucinations and uncontrollable feelings of rage, led to contacting suicide hotline.  Feelings were not resolved  with 2 1mg doses of clonipin over 5 hours. Couldn?t reach a live person at suicide hotline and ended up driving to ER for dose of Atavan, where I finally slept.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Rash pruritic
Clinical narrative: Dry, itchy rash on left arm several days after receiving vaccine
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash
Clinical narrative: Patient developed lip tingling and a rash within 15 minutes after receiving vaccination.   Patient received 25mg PO Benadryl with improvement in her symptoms.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Feeling abnormal, Memory impairment, Nausea
Clinical narrative: Extreme anxiety that will not subside. Extreme forgetfulness. Brain fog loss of appetite nausea
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test abnormal
Clinical narrative: tested positive for PAT test after having both vaccines.  5/17/2021
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received first and second doses of BNT162B2; tested positive for COVID-19; Received first and second doses of BNT162B2; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, in Dec2020 as first dose, single, and then in Jan2021 as second dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine, the first dose in Dec2020 and the second dose in Jan2021. It is now May2021. On 01May2021, the patient tested positive for COVID-19. The patient was not sure where he/she should report this, but the patient believed this is important for further development for the science. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavier than normal menstrual blessing.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Myalgia, Nausea, Pyrexia
Clinical narrative: Blistering rash on scalp, forehead nose. Currently treating with Hydrocortizone  cream. Body temperature 99.8. which lowered to 98.8 within 1 hour  then 98.6 the next hour (5/18). ( I'm usually at 97.5)  Chills, muscle aches, a massive migraine ( I never have migraines), limited nausea.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: Blistering rash on scalp, forehead nose. Currently treating with Hydrocortizone  cream. Body temperature 99.8. which lowered to 98.8 within 1 hour  then 98.6 the next hour (5/18). ( I'm usually at 97.5)  Chills, muscle aches, a massive migraine ( I never have migraines), limited nausea.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient felt fine, noticed slight rash and mild itching. pt took 25 mg of benadryl immedietly. After 30 minutes patient improved and felt fine. pt requested to leave after 30 minutes and stated she would follow up with her primary care doctor.
Sex: M
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: Cataract; This is a spontaneous report from a Pfizer-sponsored program Support from a contactable consumer (patient). A male patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unknown date. The patient had both doses of the vaccine. He had the second dose 26Dec2020. However, the caller will have a Cataract operation on 07May2021. His doctor asked him to prove that he already got both doses of the vaccine but he went to the facility to get the records, the facility was already closed. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Faeces discoloured, Somnolence, Stool DNA test
Clinical narrative: he had bowel movement and it came out red; feeling drowsy from the shot; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0171) via an unspecified route of administration on 01May2021 13:00 at first dose, single for covid-19 immunisation. Medical history included Diabetes mellitus, High blood pressure, Blood cholesterol increased, back disorder. Concomitant medications included fenofibrate; metformin; gabapentin for his back; losartan; empagliflozin (JARDIANCE); sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); atorvastatin; fish oil; glimepiride, acetylsalicylic acid (ASPIRIN CHILDREN) (St. Joseph Children Aspirin) and multivitamin once a day. patient stated he went to get the first vaccine shot yesterday around 1 O'clock in the afternoon and then late at night on around 8 O'clock he had bowel movement and it came out red and that's never happened to him before. And he have been feeling kind of, every time he sit up for he go for a walk he feel drowsy. He was still, its the next day and he was still feeling drowsy from the shot. He went through this pamphlet they gave him after the shot and it didn't say anything about having any effects on his bowel movement. he want to know if there is something he should worry about. Consumer stated, Blood work was couple of months before. He had a Cologuard test recently. And the test came back positive. He called last night when he was on the phone for like almost two hours and nobody picked up and he felt asleep. No treatment received for the events. Outcome of feeling drowsy from the shot was not recovered and outcome of the other event was unknown.  No Follow-up needed; information about lot/batch no. cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Lip swelling, Pruritus, Swelling face, Throat irritation
Clinical narrative: allergic reaction; throat felt scratchy; she felt itchy; lips swelled; face swelled; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first COVID 19 vaccine and had an allergic reaction. Her doctor advised her not to receive the second COVID 19 vaccine. She clarified she received her first COVID-19 vaccine and two days later her lips and face swelled. Her throat felt scratchy and she felt itchy. She took Benadryl. A few days later the swelling went down. Her doctor told her not to get the second COVID-19 vaccine. The caller is asking if she only receives one Covid 19 vaccine then she is only 50% protected. She is calling for information only. The patient was recovering from lips swelled and face swelled; while outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient who received first CoVax 10Apr2021, was later diagnosed with COVID-19; Patient who received first 10Apr2021, was later diagnosed with COVID-19; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for a female patient of an unspecified age received bnt162b2 (reported as Covid-19 Vaccine), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first 10Apr2021, was later diagnosed with COVID-19, asked if we can provide any medical advice in regard to receiving second dose. The event outcome was unknown.  Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Pain
Clinical narrative: Chills; Fever; Bad Headache; Vomiting; Diarrhea; Body aches; Loss of appetite; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-Years-old female (No Pregnancy) patient received 2nd dose of BNT162B2 (lot number= EW0179) on 30Apr2021 03:15 PM on Right arm for Covid-19 Immunization. Medical history was allergies: Penicillin. No other vaccine in four weeks. Other medications in two weeks was Daily Multi Vitamins. Historical Vaccine was 1st dose of BNT162B2 (lot number= ER8729) on 09Apr2021 01:30 PM on Right arm for Covid-19 Immunization. Patient experienced Chills, Fever, Bad Headache, Vomiting, Diarrhea, Body aches, Loss of appetite from 01May2021 03:00 AM with outcome was Recovering. Treatment: Tylenol and Ibuprofen. No covid prior vaccination, no covid test post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills; Fever; Bad Headache; Vomiting; Diarrhea; Body aches; Loss of appetite; This is a spontaneous report from a contactable Other Health Professional (patient). A 50-Years-old female (No Pregnancy) patient received 2nd dose of BNT162B2 (lot number= EW0179) on 30Apr2021 03:15 PM on Right arm for Covid-19 Immunization. Medical history was allergies: Penicillin. No other vaccine in four weeks. Other medications in two weeks was Daily Multi Vitamins. Historical Vaccine was 1st dose of BNT162B2 (lot number= ER8729) on 09Apr2021 01:30 PM on Right arm for Covid-19 Immunization. Patient experienced Chills, Fever, Bad Headache, Vomiting, Diarrhea, Body aches, Loss of appetite from 01May2021 03:00 AM with outcome was Recovering. Treatment: Tylenol and Ibuprofen. No covid prior vaccination, no covid test post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: Vomiting; joint pain; muscle pain; nausea; feeling unwell; tiredness; kidney and lung pain; kidney and lung pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (lot number: EW0107), via an unspecified route of administration in right arm on 30Apr2021 13:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estrogens conjugated (ESTROCON), colecalciferol (VITAMIN D), oenothera biennis oil (EVENING PRIMROSE), and fish oil (O3 OMEGA 3). The patient previously received the first dose of BNT162B2 (lot number: EW0158) in left arm on 09Apr2021 13:15 for COVID-19 immunisation. The most recent COVID-19 vaccine was administered in workplace clinic. Patient experienced vomiting, joint pain, muscle pain, nausea, feeling unwell, tiredness, kidney and lung pain on 01May2021 01:00. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for these events. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain, Renal pain, Vomiting
Clinical narrative: Vomiting; joint pain; muscle pain; nausea; feeling unwell; tiredness; kidney and lung pain; kidney and lung pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (lot number: EW0107), via an unspecified route of administration in right arm on 30Apr2021 13:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estrogens conjugated (ESTROCON), colecalciferol (VITAMIN D), oenothera biennis oil (EVENING PRIMROSE), and fish oil (O3 OMEGA 3). The patient previously received the first dose of BNT162B2 (lot number: EW0158) in left arm on 09Apr2021 13:15 for COVID-19 immunisation. The most recent COVID-19 vaccine was administered in workplace clinic. Patient experienced vomiting, joint pain, muscle pain, nausea, feeling unwell, tiredness, kidney and lung pain on 01May2021 01:00. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for these events. Outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Myalgia, Vaccination site pain
Clinical narrative: Muscle aches; tiredness; injection site pain (left arm); swollen and painful lymph nodes in left armpit and left side of neck; painful lymph nodes in left armpit and left side of neck; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), via unspecified route of administration in left arm on 30Apr2021 16:30 at age of 40-year-old at single dose for COVID-19 immunization. Medical history included allergies, arthritis. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0158) in Apr2021 05:45 PM in Left arm for COVID-19 immunization. The patient received medications within 2 weeks of vaccination included ibuprofen. The reported event included muscle aches, tiredness, injection site pain (left arm), swollen and painful lymph nodes in left armpit and left side of neck. Adverse Event start on 30Apr2021 07:00 PM. Seriousness criteria was reported as non-serious. No Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. It was unknown if patient recovered from events.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; Earache; This is a spontaneous report received from a non-contactable consumer (patient). A 32 years old female patient (no pregnant) received BNT162B2 on an unspecific date at single dose for COVID-19 immunization. Medical history was covid prior vaccination. Concomitant drug was not reported. Adverse event reported as Earache and sore throat. No treatment. Outcome of the event was Recovered. Covid test post vaccination: covid test type post vaccination Nasal Swab with unknown result.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient medical history and concomitant medications were not reported. Patient stated, on 07Apr2021, he received his first dose of the COVID vaccine and approximately four days after that, he showed symptoms of having COVID, had cold and tested positive for COVID. He was dealing with that for a couple of weeks and on 28Apr, he was supposed to get the second dose but never did because I was dealing with COVID and its his understanding that once you have COVID, you are basically free from getting it for 90 days. So, somebody recommended not to get the second shot and so, he is not sure when he should be getting that. When questioned whether still experiencing the side effects, patient stated that he did not experience any side effects, he just got COVID and he was just having fever and headache. Patient asked if someone was going to tell him if he needs to get the second shot or when he should. The lab tests included SARS-CoV-2 test on an unspecified date in Apr2021 with result as positive. There is a product complaint component. Patient did not receive any treatment for the events headache and fever. Reporter seriousness for the events was unspecified.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Malaise, Urticaria
Clinical narrative: then broke out into hives on her face, neck and chest on 05May2021; She had malaise and discomfort for about a week and a half; She had malaise and discomfort for about a week and a half; This is a spontaneous report from a contactable consumer. This consumer reported for Family friend that: A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown, patient did not disclose, and expiry date was not reported), via an unspecified route of administration, on 22Apr2021, as a single dose for COVID-19 immunization at Public Health Clinic/facility. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that on 05May2021, the patient had malaise and discomfort for about a week and a half and then broke out into hives on her face, neck and chest. Hives were still present on 06May2021 even with Bendryl. The patient was not on any other medications and had not altered her routine at all. The patient was working from home since the start of the pandemic. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Follow up attempts needed. Further information is expected.