chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 101 temp for two days.; Chills; sweats; muscle aches and joint all over; muscle aches and joint; headache; severe fatigue; diarrhea; Dizziness; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: unknown), via an unspecified route of administration, administered in left right on 29Jan2021 02:15 pm at the age of 70 years old as single dose for COVID-19 immunization. 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. There were no allergies to medications, food, or other products. On 30Jan2021, at 03:00am, the patient experienced 101 temp for two days, Chills, sweats, muscle aches and joint all over, headache, severe fatigue, diarrhea, Dizziness and it my weakness. Reporter considered the events as non-serious. No treatment was received for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 30Jan2021 and result was 101 temp for two days. The outcome of the events was recovered on 30Jan2021.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache; Muscle pain; Chills; Joint pain; Tiredness; Injection sight soreness; Nausea; This is a spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP letter. This 71-year-old non-pregnant female consumer reported that the patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the right arm, on 28Jan2021 at 09:30 (age at the time of vaccination 71-year-old), as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient's allergies were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 09Jan2021 at 09:15 (age at the time of vaccination 71-year-old), as single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks prior. On 29Jan2021 at 03:00, the patient experienced headache, muscle pain, chills, joint pain, tiredness, injection sight soreness, and nausea. The event did not require the initiation of new medication and other treatment and procedure. The patient's treatment medications were not reported. The patient underwent lab tests and procedures were not reported. The outcome of the events was recovered on an unknown date in2021.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Headache; Muscle pain; Chills; Joint pain; Tiredness; Injection sight soreness; Nausea; This is a spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP letter. This 71-year-old non-pregnant female consumer reported that the patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the right arm, on 28Jan2021 at 09:30 (age at the time of vaccination 71-year-old), as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient's allergies were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 09Jan2021 at 09:15 (age at the time of vaccination 71-year-old), as single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks prior. On 29Jan2021 at 03:00, the patient experienced headache, muscle pain, chills, joint pain, tiredness, injection sight soreness, and nausea. The event did not require the initiation of new medication and other treatment and procedure. The patient's treatment medications were not reported. The patient underwent lab tests and procedures were not reported. The outcome of the events was recovered on an unknown date in2021.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: She got her vaccine, felt a little pain at the injection site, waited the 15 minutes and walked home.  Once she got home she noticed her arm was sore, but didn't think much of it.   Around 4 hours later around 6:00 PM she went to make dinner and her neck was so stiff she could not move it to the right.  When she was able to move her neck it hurt a lot.  The arm started to hurt more, and the whole left side of her body started to hurt from her neck down to her stomach.  Then when she was in the bed around 9:00 and she likes to sleep on her left side, and the pain was so bad that she could not sleep on her left arm and put her head on top of the pillow and sleep at all.  When she woke up the next day everything was still very stiff, her neck was and could not really move it or move the left arm to the right due to severe pain.  That night she was finally able to sleep on her left side.  Then probably by the 3rd day it was getting a lot better.  No fever, chills, or any other reactions, just the arm pain and neck stiffness.   She was in pretty bad pain.    She then got her 2nd vaccine and was okay at that time, and had no reaction at all to that one and actually thought that she did not get it at all.  She had told the nurse about the reaction and the 2nd nurse was very gentle with her.   She did not go home right away and felt just a little bit of a prick in her left arm.   She then went to 2 stores as she felt well.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: She got her vaccine, felt a little pain at the injection site, waited the 15 minutes and walked home.  Once she got home she noticed her arm was sore, but didn't think much of it.   Around 4 hours later around 6:00 PM she went to make dinner and her neck was so stiff she could not move it to the right.  When she was able to move her neck it hurt a lot.  The arm started to hurt more, and the whole left side of her body started to hurt from her neck down to her stomach.  Then when she was in the bed around 9:00 and she likes to sleep on her left side, and the pain was so bad that she could not sleep on her left arm and put her head on top of the pillow and sleep at all.  When she woke up the next day everything was still very stiff, her neck was and could not really move it or move the left arm to the right due to severe pain.  That night she was finally able to sleep on her left side.  Then probably by the 3rd day it was getting a lot better.  No fever, chills, or any other reactions, just the arm pain and neck stiffness.   She was in pretty bad pain.    She then got her 2nd vaccine and was okay at that time, and had no reaction at all to that one and actually thought that she did not get it at all.  She had told the nurse about the reaction and the 2nd nurse was very gentle with her.   She did not go home right away and felt just a little bit of a prick in her left arm.   She then went to 2 stores as she felt well.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: She got her vaccine, felt a little pain at the injection site, waited the 15 minutes and walked home.  Once she got home she noticed her arm was sore, but didn't think much of it.   Around 4 hours later around 6:00 PM she went to make dinner and her neck was so stiff she could not move it to the right.  When she was able to move her neck it hurt a lot.  The arm started to hurt more, and the whole left side of her body started to hurt from her neck down to her stomach.  Then when she was in the bed around 9:00 and she likes to sleep on her left side, and the pain was so bad that she could not sleep on her left arm and put her head on top of the pillow and sleep at all.  When she woke up the next day everything was still very stiff, her neck was and could not really move it or move the left arm to the right due to severe pain.  That night she was finally able to sleep on her left side.  Then probably by the 3rd day it was getting a lot better.  No fever, chills, or any other reactions, just the arm pain and neck stiffness.   She was in pretty bad pain.    She then got her 2nd vaccine and was okay at that time, and had no reaction at all to that one and actually thought that she did not get it at all.  She had told the nurse about the reaction and the 2nd nurse was very gentle with her.   She did not go home right away and felt just a little bit of a prick in her left arm.   She then went to 2 stores as she felt well.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Ocular discomfort, Pain in extremity
Clinical narrative: headache for 18 days; vision problems where her eyes were glassy; her muscles of her legs the first day bothered her; chills on and off; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Jan2021 as single dose for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on an unknown date in 2021 on Thursday at 02:00 PM as single dose for COVID-19 immunization. Patient's medical history was reported as none. The patient concomitant medication included unspecified flu vaccine (NDC/LOT/EXP unknown) on an unknown date at the end of Oct2020. She stated that she was lucky to be so healthy, she was active. An unknown date, after receiving the first dose of vaccine, the patient experienced headache for 18 days; described as the headache was not a pounding headache, it was a sickly headache at the back of her neck, like we would get when had a temperature. She did not had temperature. She also experienced vision problems where her eyes were glassy and bothered her and could not do her reading. The patient also experienced chills which were on and off and her muscles of legs the first day bothered her. The reporter stated that her doctor told her that the cases and deaths of COVID-19 are high and it would be better for her to receive the second dose despite her reactions. The reporter wanted to know if the Pfizer COVID vaccine dosage is weight based. The reporter stated that her friend mentioned that a 400 pound man may be given the same dose, so she wanted to know if the vaccine can be given based on weight. The reporter stated that she was not sure of lot number as it was hand written and says Pfizer COVID-19 LOT EL or EC, 3247. The reporter stated that her brother and two of her friends had the Pfizer vaccine and they do not have any side effects. Therapeutic measures were taken as a result of headache and the patient received treatment with ibuprofen IB tablets (UPC: 09661988088-1, EXP: Oct2021). The reporter stated that she was ecstatic or thrilled that she does not have headache at the time of report. She also stated that since even her muscles of her legs the first day bothered her, though it subsided after that. The outcome of the events vision problems where her eyes were glassy and chills on and off was reported as unknown whereas headache was reported as recovered. The outcome of the event muscles of her legs the first day bothered her was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Muscle discomfort, Visual impairment
Clinical narrative: headache for 18 days; vision problems where her eyes were glassy; her muscles of her legs the first day bothered her; chills on and off; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Jan2021 as single dose for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on an unknown date in 2021 on Thursday at 02:00 PM as single dose for COVID-19 immunization. Patient's medical history was reported as none. The patient concomitant medication included unspecified flu vaccine (NDC/LOT/EXP unknown) on an unknown date at the end of Oct2020. She stated that she was lucky to be so healthy, she was active. An unknown date, after receiving the first dose of vaccine, the patient experienced headache for 18 days; described as the headache was not a pounding headache, it was a sickly headache at the back of her neck, like we would get when had a temperature. She did not had temperature. She also experienced vision problems where her eyes were glassy and bothered her and could not do her reading. The patient also experienced chills which were on and off and her muscles of legs the first day bothered her. The reporter stated that her doctor told her that the cases and deaths of COVID-19 are high and it would be better for her to receive the second dose despite her reactions. The reporter wanted to know if the Pfizer COVID vaccine dosage is weight based. The reporter stated that her friend mentioned that a 400 pound man may be given the same dose, so she wanted to know if the vaccine can be given based on weight. The reporter stated that she was not sure of lot number as it was hand written and says Pfizer COVID-19 LOT EL or EC, 3247. The reporter stated that her brother and two of her friends had the Pfizer vaccine and they do not have any side effects. Therapeutic measures were taken as a result of headache and the patient received treatment with ibuprofen IB tablets (UPC: 09661988088-1, EXP: Oct2021). The reporter stated that she was ecstatic or thrilled that she does not have headache at the time of report. She also stated that since even her muscles of her legs the first day bothered her, though it subsided after that. The outcome of the events vision problems where her eyes were glassy and chills on and off was reported as unknown whereas headache was reported as recovered. The outcome of the event muscles of her legs the first day bothered her was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: severe itching; swelling; 'significant reaction' in legs; felt like a severe sunburn; This is a spontaneous report from a contactable consumer (patient).   A 66-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 12Feb2021 (at the age of 65-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included heart tx patient (as reported), on immunosuppressant drugs. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of the Pfizer covid vaccine on 12Feb2021 and that that night he had a 'significant reaction' in legs; reported severe itching and swelling. He stated it felt like a severe sunburn. Reports it resolved 4 days later (16Feb2021).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Pruritus, Sunburn, Swelling
Clinical narrative: severe itching; swelling; 'significant reaction' in legs; felt like a severe sunburn; This is a spontaneous report from a contactable consumer (patient).   A 66-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 12Feb2021 (at the age of 65-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included heart tx patient (as reported), on immunosuppressant drugs. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of the Pfizer covid vaccine on 12Feb2021 and that that night he had a 'significant reaction' in legs; reported severe itching and swelling. He stated it felt like a severe sunburn. Reports it resolved 4 days later (16Feb2021).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: fever; chills; headache; muscle aches; I wasn't able to move for 48 hours/I was non functional; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 30Jan2021 as 1ST DOSE, SINGLE for a covid-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. It was reported that, the patient experienced quite severe reaction that consisted of fever, chills, headache, muscle aches and it was reported that she was not able to move for 48 hours. The patient was taking 500mg acetaminophen for this reaction and the patient reported that this reaction sent over the top and she was nonfunctional. The patient was walking and biking daily, and she is not on any medication. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: fever; chills; headache; muscle aches; I wasn't able to move for 48 hours/I was non functional; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 30Jan2021 as 1ST DOSE, SINGLE for a covid-19 immunization. Medical history included covid-19. The patient's concomitant medications were not reported. It was reported that, the patient experienced quite severe reaction that consisted of fever, chills, headache, muscle aches and it was reported that she was not able to move for 48 hours. The patient was taking 500mg acetaminophen for this reaction and the patient reported that this reaction sent over the top and she was nonfunctional. The patient was walking and biking daily, and she is not on any medication. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Approximately 4 hours after recieving the vaccine, I developed the worse, one sided headache; extreme exhaustion; This is a spontaneous report from a contactable Nurse. A 60-years-old female patient (not pregnant at the time of vaccination) received 1st dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9265), via unspecified route of administration in left arm on 30Jan2021 at 11:00 am as 1st dose, single for covid-19 immunization. The patient medical history included known allergies to sulfa, and other medical history included none. The concomitant medications included HRT, calcium supplement, turmeric, leutin. The patient had not received 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 had not been tested for COVID-19. The patient had received the vaccine in the hospital. On 30Jan2021 at 03:00 PM approximately 4 hours after the had received the vaccine, and patient had developed the worse, one sided headache that patient ever had. The next day, the severe headache continued as well as extreme exhaustion and fatigue. These 2 symptoms lasted 7 days. The patient had received the treatment of the OTC medications. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Malaise, Pain in extremity
Clinical narrative: mild rash on my one cheek; soreness and swelling of left arm; swelling of left arm; This is spontaneous report received from contactable consumer, the patient. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM6203), via an unspecified route of administration in the left arm on 24Feb2021 at 09:30 as a single dose for COVID-19 immunization. Medical history included sensitive skin (the patient was fair skinned, did not tan and used sunscreen 25 times daily), allergy to pollen grains and grass from 1959 for which the patient took antihistamines very frequently, allergy to penicillin (hives over upper torso) in 2020. Concomitant medication included rosuvastatin, chondroitin sulfate sodium/glucosamine (GLUCOSAMINE AND CHONDROITIN) from 2005 and ongoing, ascorbic acid/betacarotene/cupric oxide/manganese sulfate/selenium/tocopheryl acetate/ubidecarenone/zinc oxide (COQ10) from 2009 and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9242) on 03Feb2021 at 11:30 (at the age of 71-years-old) for COVID-19 immunization and experienced a red raised rash on face- cheek, chin and forehead which was itchy (2-3 days later) for which the patient was prescribed hydrocortisone cream 2.5 gm and diphenhydramine (BENADRYL) as well as soreness and swelling of left arm. On an unspecified date, after the 2nd vaccination, the patient experienced a mild rash on one cheek. The patient used hydrocortisone cream for 2-3 days. It was reported that this reaction was less dramatic and did not last as long as the reaction after the first shot. On 25Feb2021, the patient experienced soreness and swelling of the left arm - for which the patient received unspecified treatment. The clinical outcome of mild rash on one cheek was unknown, and of soreness and swelling of left arm was resolved on an unspecified date.   Information on Lot/Batch number was available. Further information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138308 same patient/drug, different dose
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling
Clinical narrative: mild rash on my one cheek; soreness and swelling of left arm; swelling of left arm; This is spontaneous report received from contactable consumer, the patient. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM6203), via an unspecified route of administration in the left arm on 24Feb2021 at 09:30 as a single dose for COVID-19 immunization. Medical history included sensitive skin (the patient was fair skinned, did not tan and used sunscreen 25 times daily), allergy to pollen grains and grass from 1959 for which the patient took antihistamines very frequently, allergy to penicillin (hives over upper torso) in 2020. Concomitant medication included rosuvastatin, chondroitin sulfate sodium/glucosamine (GLUCOSAMINE AND CHONDROITIN) from 2005 and ongoing, ascorbic acid/betacarotene/cupric oxide/manganese sulfate/selenium/tocopheryl acetate/ubidecarenone/zinc oxide (COQ10) from 2009 and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9242) on 03Feb2021 at 11:30 (at the age of 71-years-old) for COVID-19 immunization and experienced a red raised rash on face- cheek, chin and forehead which was itchy (2-3 days later) for which the patient was prescribed hydrocortisone cream 2.5 gm and diphenhydramine (BENADRYL) as well as soreness and swelling of left arm. On an unspecified date, after the 2nd vaccination, the patient experienced a mild rash on one cheek. The patient used hydrocortisone cream for 2-3 days. It was reported that this reaction was less dramatic and did not last as long as the reaction after the first shot. On 25Feb2021, the patient experienced soreness and swelling of the left arm - for which the patient received unspecified treatment. The clinical outcome of mild rash on one cheek was unknown, and of soreness and swelling of left arm was resolved on an unspecified date.   Information on Lot/Batch number was available. Further information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138308 same patient/drug, different dose
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: mild rash on my one cheek; soreness and swelling of left arm; swelling of left arm; This is spontaneous report received from contactable consumer, the patient. A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM6203), via an unspecified route of administration in the left arm on 24Feb2021 at 09:30 as a single dose for COVID-19 immunization. Medical history included sensitive skin (the patient was fair skinned, did not tan and used sunscreen 25 times daily), allergy to pollen grains and grass from 1959 for which the patient took antihistamines very frequently, allergy to penicillin (hives over upper torso) in 2020. Concomitant medication included rosuvastatin, chondroitin sulfate sodium/glucosamine (GLUCOSAMINE AND CHONDROITIN) from 2005 and ongoing, ascorbic acid/betacarotene/cupric oxide/manganese sulfate/selenium/tocopheryl acetate/ubidecarenone/zinc oxide (COQ10) from 2009 and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9242) on 03Feb2021 at 11:30 (at the age of 71-years-old) for COVID-19 immunization and experienced a red raised rash on face- cheek, chin and forehead which was itchy (2-3 days later) for which the patient was prescribed hydrocortisone cream 2.5 gm and diphenhydramine (BENADRYL) as well as soreness and swelling of left arm. On an unspecified date, after the 2nd vaccination, the patient experienced a mild rash on one cheek. The patient used hydrocortisone cream for 2-3 days. It was reported that this reaction was less dramatic and did not last as long as the reaction after the first shot. On 25Feb2021, the patient experienced soreness and swelling of the left arm - for which the patient received unspecified treatment. The clinical outcome of mild rash on one cheek was unknown, and of soreness and swelling of left arm was resolved on an unspecified date.   Information on Lot/Batch number was available. Further information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138308 same patient/drug, different dose
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 6 pea-sized, itchy welts on anterior neck; 6 pea-sized, itchy welts on anterior neck; This is a spontaneous report from a contactable nurse (patient). A 61-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in left arm (Lot Number: EN6204, expiration date: not reported) on 04Mar2021 16:30 (age at vaccination: 61 years) as Single dose for covid-19 immunisation. The patient's medical history included true medical depression, breast cancer and known allergies sulfa drugs. The patient did not test positive for covid-19 before and after the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), lorazepam (ATIVAN); vitamin d nos; zinc; magnesium sulfate, paracetamol (TYLEN) and amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS). The patient did not receive any other vaccine in four weeks. On 04Mar2021 at 16:30, the patient experienced 6 pea-sized, itchy welts on anterior neck. The patient did not receive any treatment for the adverse events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 6 pea-sized, itchy welts on anterior neck; 6 pea-sized, itchy welts on anterior neck; This is a spontaneous report from a contactable nurse (patient). A 61-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in left arm (Lot Number: EN6204, expiration date: not reported) on 04Mar2021 16:30 (age at vaccination: 61 years) as Single dose for covid-19 immunisation. The patient's medical history included true medical depression, breast cancer and known allergies sulfa drugs. The patient did not test positive for covid-19 before and after the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), lorazepam (ATIVAN); vitamin d nos; zinc; magnesium sulfate, paracetamol (TYLEN) and amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS). The patient did not receive any other vaccine in four weeks. On 04Mar2021 at 16:30, the patient experienced 6 pea-sized, itchy welts on anterior neck. The patient did not receive any treatment for the adverse events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Hives after vaccination near vaccine injection site; Very itchy, raised bumps each similar in size and shape to a bug bite; raised bumps each similar in size and shape to a bug bite; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration on 03Mar2021 10:30 at right arm as a single dose for COVID-19 immunisation. The patient medical history included allergy to penicillin and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medication included labetalol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 18:00, hives beginning about 8 hours after vaccination near vaccine injection site, spreading across entire upper right arm, then right shoulder, left arm and knees over a matter of days. Still experiencing 4 days later. Very itchy, raised bumps each similar in size and shape to a bug bite on 03Mar2021 at 6:00 PM. No therapeutic measures were received for the events. The outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria, Vaccination site mass
Clinical narrative: Hives after vaccination near vaccine injection site; Very itchy, raised bumps each similar in size and shape to a bug bite; raised bumps each similar in size and shape to a bug bite; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206), via an unspecified route of administration on 03Mar2021 10:30 at right arm as a single dose for COVID-19 immunisation. The patient medical history included allergy to penicillin and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medication included labetalol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 18:00, hives beginning about 8 hours after vaccination near vaccine injection site, spreading across entire upper right arm, then right shoulder, left arm and knees over a matter of days. Still experiencing 4 days later. Very itchy, raised bumps each similar in size and shape to a bug bite on 03Mar2021 at 6:00 PM. No therapeutic measures were received for the events. The outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: developed hives to both arms, chest, and back; This is a spontaneous report from a contactable nurse. A 33-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207 and expiration date: not reported), intramuscular, administered in arm right on 11Mar2021 09:30 as first dose, at single for covid-19 immunization (At an age of 33-years and the patient) at the event center. The patient medical history and concomitant medications were not reported. The patient previously took vancomycin and had known allergies. It was reported the patient did not received other vaccine in four weeks. No covid prior vaccination and it was unknown if covid tested post vaccination was done. On 11Mar2021, 09:30 approximately 5 minutes after vaccination, client developed hives to both arms, chest, and back. Lungs and temp were within normal limits (WNL). Patient's mother provided her BENADRYL as therapeutic measure for the hives; the patient was advised to not receive 2nd vaccine and prior to departure, patient's hives had improved. The outcome for the hives to both arms, chest, and back was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, C-reactive protein increased, Cardiac assistance device user, Chest pain, Haemoglobin decreased
Clinical narrative: Patient developed sharp chest pain radiating to the jaw 3 hours after receiving his second COVID vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pain in extremity, Pain in jaw, Pericardial effusion, Pericarditis
Clinical narrative: Patient developed sharp chest pain radiating to the jaw 3 hours after receiving his second COVID vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Pyrexia
Clinical narrative: Patient developed sharp chest pain radiating to the jaw 3 hours after receiving his second COVID vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial flutter, Chest pain, Computerised tomogram abnormal, Computerised tomogram thorax, Implantable cardiac monitor insertion
Clinical narrative: Patient developed sharp chest pain radiating to the jaw 3 hours after receiving his second COVID vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 19Feb2021 at 12:00 (at the age of 71-years-old) as first dose, single (Lot number- EN6200); and via an unspecified route of administration in right arm on 12Mar2021 at 12:00 (at the age of 71-years-old) as second dose, single (Lot number- EN6206), both for COVID-19 immunization. Medical history included primary biliary cholangitis and prostate cancer. Concomitant medications included Ursodiol, hydrochlorothiazide and losartan potassium. The patient did not have any known allergies. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced severe vertigo 13 days after first vaccine, as 04Mar2021 08:00, and again 12 days after second vaccine (24Mar2021). The events were reported as non-serious. Therapeutic measures taken as a result of the event included Meclazine. The outcome of the event was recovered on unspecified date.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Troponin increased
Clinical narrative: From f/u note 5/18/21: HPI/Subjective: patient is a 37 y.o. male with above past cardiovascular history who presents today for follow-up.    He was hospitalized at hospital from 4/1/21 to 4/2/21 after presenting to ED with 12 hours of chest pain, found to have markedly elevated troponin (9,142). Of note, he received 2nd COVID vaccine a day before symptoms began. CT coronary scan showed calcium score of 0. Cardiac MRI on 4/2 showed myocarditis, with anterior and lateral subepicardial enhancement as well as abnormal T1 and T2 signal. He was started on colchicine x 6 months.    Today, patient reports improvement in chest pain since discharge. He reports rare episode of chest pain with last episode ~3 weeks ago. He denies participating in very rigorous exercise, but did complete 20 mile bike ride recently. Denies palpitations, dyspnea, orthopnea, PND, abdominal distention, LE edema, fatigue, lightheadedness, dizziness, syncope or near syncope.    Cardiovascular Problem List: #Myocarditis o 4/1/21. Echocardiogram: EF 60% o 4/1/21. CT coronary: Calcium score 0 o 4/2/21. Cardiac MRI: myocarditis, with anterior and lateral subepicardial enhancement as well  as abnormal T1 and T2 signal.    Assessment/Plan:   #Myocarditis:  During admission, echocardiogram was normal with EF 60% and CT coronary angiogram showed Agatston score of 0. Cardiac MRI showed myocarditis, with anterior and lateral subepicardial enhancement as well  as abnormal T1 and T2 signal. Of note, he received the second Moderna COVID-19 vaccine the day prior, so  - Monitor, will consider repeat MRI at follow up (more for activity recommendations given age) - Continue colchicine for total of 6 months (until Oct 2021)
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Blood calcium decreased, Chest pain, Echocardiogram normal, Magnetic resonance imaging heart
Clinical narrative: From f/u note 5/18/21: HPI/Subjective: patient is a 37 y.o. male with above past cardiovascular history who presents today for follow-up.    He was hospitalized at hospital from 4/1/21 to 4/2/21 after presenting to ED with 12 hours of chest pain, found to have markedly elevated troponin (9,142). Of note, he received 2nd COVID vaccine a day before symptoms began. CT coronary scan showed calcium score of 0. Cardiac MRI on 4/2 showed myocarditis, with anterior and lateral subepicardial enhancement as well as abnormal T1 and T2 signal. He was started on colchicine x 6 months.    Today, patient reports improvement in chest pain since discharge. He reports rare episode of chest pain with last episode ~3 weeks ago. He denies participating in very rigorous exercise, but did complete 20 mile bike ride recently. Denies palpitations, dyspnea, orthopnea, PND, abdominal distention, LE edema, fatigue, lightheadedness, dizziness, syncope or near syncope.    Cardiovascular Problem List: #Myocarditis o 4/1/21. Echocardiogram: EF 60% o 4/1/21. CT coronary: Calcium score 0 o 4/2/21. Cardiac MRI: myocarditis, with anterior and lateral subepicardial enhancement as well  as abnormal T1 and T2 signal.    Assessment/Plan:   #Myocarditis:  During admission, echocardiogram was normal with EF 60% and CT coronary angiogram showed Agatston score of 0. Cardiac MRI showed myocarditis, with anterior and lateral subepicardial enhancement as well  as abnormal T1 and T2 signal. Of note, he received the second Moderna COVID-19 vaccine the day prior, so  - Monitor, will consider repeat MRI at follow up (more for activity recommendations given age) - Continue colchicine for total of 6 months (until Oct 2021)
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: From f/u note 5/18/21: HPI/Subjective: patient is a 37 y.o. male with above past cardiovascular history who presents today for follow-up.    He was hospitalized at hospital from 4/1/21 to 4/2/21 after presenting to ED with 12 hours of chest pain, found to have markedly elevated troponin (9,142). Of note, he received 2nd COVID vaccine a day before symptoms began. CT coronary scan showed calcium score of 0. Cardiac MRI on 4/2 showed myocarditis, with anterior and lateral subepicardial enhancement as well as abnormal T1 and T2 signal. He was started on colchicine x 6 months.    Today, patient reports improvement in chest pain since discharge. He reports rare episode of chest pain with last episode ~3 weeks ago. He denies participating in very rigorous exercise, but did complete 20 mile bike ride recently. Denies palpitations, dyspnea, orthopnea, PND, abdominal distention, LE edema, fatigue, lightheadedness, dizziness, syncope or near syncope.    Cardiovascular Problem List: #Myocarditis o 4/1/21. Echocardiogram: EF 60% o 4/1/21. CT coronary: Calcium score 0 o 4/2/21. Cardiac MRI: myocarditis, with anterior and lateral subepicardial enhancement as well  as abnormal T1 and T2 signal.    Assessment/Plan:   #Myocarditis:  During admission, echocardiogram was normal with EF 60% and CT coronary angiogram showed Agatston score of 0. Cardiac MRI showed myocarditis, with anterior and lateral subepicardial enhancement as well  as abnormal T1 and T2 signal. Of note, he received the second Moderna COVID-19 vaccine the day prior, so  - Monitor, will consider repeat MRI at follow up (more for activity recommendations given age) - Continue colchicine for total of 6 months (until Oct 2021)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: TRIAGE NURSE History of Present Illness: brought in by rescue ambulance from covid site clinic, patient received 2nd dose covid vaccine. 15mins post vaccine +sob, chest tightness and throat swelling. one 0 .3mg epi given at site. breathing treatment started by rescue. Female brought in by emergency medical services for allergic reaction. She had second Moderna shot and then felt flushed in the face, slight facial itching and pain in the back and throat tightening. She was given IM diphenhydramine and epinephrine at 1515 and she is feeling better.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest discomfort, Dyspnoea, Flushing, Hypersensitivity
Clinical narrative: TRIAGE NURSE History of Present Illness: brought in by rescue ambulance from covid site clinic, patient received 2nd dose covid vaccine. 15mins post vaccine +sob, chest tightness and throat swelling. one 0 .3mg epi given at site. breathing treatment started by rescue. Female brought in by emergency medical services for allergic reaction. She had second Moderna shot and then felt flushed in the face, slight facial itching and pain in the back and throat tightening. She was given IM diphenhydramine and epinephrine at 1515 and she is feeling better.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Throat tightness
Clinical narrative: TRIAGE NURSE History of Present Illness: brought in by rescue ambulance from covid site clinic, patient received 2nd dose covid vaccine. 15mins post vaccine +sob, chest tightness and throat swelling. one 0 .3mg epi given at site. breathing treatment started by rescue. Female brought in by emergency medical services for allergic reaction. She had second Moderna shot and then felt flushed in the face, slight facial itching and pain in the back and throat tightening. She was given IM diphenhydramine and epinephrine at 1515 and she is feeling better.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Headache starting the same day as the vaccine, after the vaccine and persisting to the present
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Headache, Magnetic resonance imaging head
Clinical narrative: Headache starting the same day as the vaccine, after the vaccine and persisting to the present
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient was hospitalized and died within 60 days of receiving a COVID vaccine series. Patient was also tested positive for COVID on 4/6/2021 during hospitalization
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient was hospitalized and died within 60 days of receiving a COVID vaccine series. Patient was also tested positive for COVID on 4/6/2021 during hospitalization
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Ear pain, Headache, Magnetic resonance imaging
Clinical narrative: Bell paulsy left side of my face paralized
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Tongue paralysis
Clinical narrative: Bell paulsy left side of my face paralized
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Bell paulsy left side of my face paralized
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adenovirus test positive, Angiotensin converting enzyme, Antinuclear antibody negative, Borrelia test negative, C-reactive protein increased
Clinical narrative: Three days after receiving second dose of Moderna vaccine patient began experiencing chest pain presented to ED on 4/9/21 CTE negative for PE, covid negative, respiratory viral panel negative.  Echocardiogram revealed pericardial effusion.  Patient diagnosed with pericarditis patient admitted 4/14/21 with ongoing chest pain due to pericarditis
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cytomegalovirus test negative, Dyspnoea, Echocardiogram abnormal, Epstein-Barr virus antibody positive
Clinical narrative: Three days after receiving second dose of Moderna vaccine patient began experiencing chest pain presented to ED on 4/9/21 CTE negative for PE, covid negative, respiratory viral panel negative.  Echocardiogram revealed pericardial effusion.  Patient diagnosed with pericarditis patient admitted 4/14/21 with ongoing chest pain due to pericarditis