chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in right arm for COVID-19 immunisation at the age of 81-year-old. Medical history included hypertension, atrial fibrillation. Concomitant medications included losartan, amlodipine, metoprolol, apixaban (ELIQUIS). Historical vaccine included first administration of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunization. On unknown date, blood cholesterol resulted a little bit high. On unknown date, the patient experienced little spot on arm got bigger and started to swell, It got worse, patient had red splotches down my arm, down my wrist, underarm, and then even on side of body; on the other arm a few spots, he had soreness in that arm, the patient might have shingles, doctor gave the patient medication (Unspecified Medication); it did not do anything, the splotches actually got a little bit worse, right arm has 3 splotches on it, one in muscle area on upper arm, down elbow is another red spot, right down the elbow another one; other one has a lot of them; It was getting a little bit itchy. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: she developed an infection on her ankle; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on 15Mar2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller said that she received the first dose on Monday, 15Mar2021, but she developed an infection on her ankle and she needed to take antibiotics. Outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: broke out with cold sores; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as 1st Dose, Single Dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had first dose (she confirmed it was Pfizer-BioNTech COVID-19 Vaccine) almost 3 weeks ago, when I probed for the date, she did not specify the date of first nor the second dose, only stated she is scheduled for second dose in the next few days. The patient broke out with cold sores. She just want to know if I should go get second dose and wanted to know if taking it could weaken the vaccine. Therapeutic measures were taken as a result of broke out and being using topical Abreva. The outcome for the events was Unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Angular cheilitis, Arthralgia, Blood uric acid, Body temperature, C-reactive protein
Clinical narrative: Five day development of swollen joints primarily in the feet; oral lesions; lichens Planus; Angular Chelitus including superficial sores; Angular Chelitus including superficial sores and fungal infection; headache; low grade temps; Severe joint pain; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201) via an unspecified route of administration, administered in arm right on 22Feb2021 at 03:00 (at the age of 67-year-old) as 2nd dose, single dose for Covid-19 immunization. Medical history included Blood pressure high, prostate, anterior cruciate ligament reconstruction repair, tonsillectomy and hay fever. Concomitant medication included metoprolol, lisinopril, amlodipine and finasteride. The patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL9265) on 02MAR2021 at 04:00 administered in arm left for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 22Feb2021, the patient experienced five-day development of swollen joints primarily in the feet, oral lesions, lichens planus, angular chelitus including superficial sores, fungal infection, headache and low-grade temperature. The patient Sed rate (sedimentation rate) was normal, C-Reactive protein: 10* nl (32.3), uric acid: NL, aspirate of left great toe joint had no crystals, polymorphic cells, and cultures: negative. Severe joint pain relieved by aspiration, but pain continued slightly better over three weeks. Resumed walking more than a couple thousand steps a day yesterday. The patient started treatment of oral lesions today, used Motrin 600 QID for first week after second injection. The patient was receiving treatment for the adverse event. The outcome of events was of not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Culture, Fungal infection, Headache, Investigation, Joint swelling
Clinical narrative: Five day development of swollen joints primarily in the feet; oral lesions; lichens Planus; Angular Chelitus including superficial sores; Angular Chelitus including superficial sores and fungal infection; headache; low grade temps; Severe joint pain; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201) via an unspecified route of administration, administered in arm right on 22Feb2021 at 03:00 (at the age of 67-year-old) as 2nd dose, single dose for Covid-19 immunization. Medical history included Blood pressure high, prostate, anterior cruciate ligament reconstruction repair, tonsillectomy and hay fever. Concomitant medication included metoprolol, lisinopril, amlodipine and finasteride. The patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL9265) on 02MAR2021 at 04:00 administered in arm left for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 22Feb2021, the patient experienced five-day development of swollen joints primarily in the feet, oral lesions, lichens planus, angular chelitus including superficial sores, fungal infection, headache and low-grade temperature. The patient Sed rate (sedimentation rate) was normal, C-Reactive protein: 10* nl (32.3), uric acid: NL, aspirate of left great toe joint had no crystals, polymorphic cells, and cultures: negative. Severe joint pain relieved by aspiration, but pain continued slightly better over three weeks. Resumed walking more than a couple thousand steps a day yesterday. The patient started treatment of oral lesions today, used Motrin 600 QID for first week after second injection. The patient was receiving treatment for the adverse event. The outcome of events was of not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Lichen planus, Oral disorder, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Five day development of swollen joints primarily in the feet; oral lesions; lichens Planus; Angular Chelitus including superficial sores; Angular Chelitus including superficial sores and fungal infection; headache; low grade temps; Severe joint pain; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201) via an unspecified route of administration, administered in arm right on 22Feb2021 at 03:00 (at the age of 67-year-old) as 2nd dose, single dose for Covid-19 immunization. Medical history included Blood pressure high, prostate, anterior cruciate ligament reconstruction repair, tonsillectomy and hay fever. Concomitant medication included metoprolol, lisinopril, amlodipine and finasteride. The patient previously took first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL9265) on 02MAR2021 at 04:00 administered in arm left for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 22Feb2021, the patient experienced five-day development of swollen joints primarily in the feet, oral lesions, lichens planus, angular chelitus including superficial sores, fungal infection, headache and low-grade temperature. The patient Sed rate (sedimentation rate) was normal, C-Reactive protein: 10* nl (32.3), uric acid: NL, aspirate of left great toe joint had no crystals, polymorphic cells, and cultures: negative. Severe joint pain relieved by aspiration, but pain continued slightly better over three weeks. Resumed walking more than a couple thousand steps a day yesterday. The patient started treatment of oral lesions today, used Motrin 600 QID for first week after second injection. The patient was receiving treatment for the adverse event. The outcome of events was of not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Malaise
Clinical narrative: It has lasted so long and gotten worse after the second shot.; not feeling well; This is a spontaneous report from a contactable consumer (patient).  A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 23Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation and pregabalin (LYRICA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 300 mg for neuropathy peripheral.  Medical history included neuropathy peripheral. Patient received the first vaccination dose on 02Mar2021. There were no concomitant medications.  The patient started not feeling well on 25Mar2021. It has lasted so long and gotten worse after the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She was tested positive after the 1st dose; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced she was tested positive after the 1st dose. The caller (patient) called in to ask if she can still get the COVID-19 vaccine or she needs to reschedule because she received her 1st dose last 10Mar2021 and will get the 2nd dose on 31Mar2021. The seriousness of the event was reported as non-serious. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on an unspecified date. The clinical outcome of the event was unknown.   No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got tested positive a week after the vaccine; This is a spontaneous report from a non-contactable consumer (patient).   A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, a week after the vaccination, the patient got tested positive for COVID-19. It was reported that the patient was supposed to get next vaccine on tomorrow (31Mar2021, next day of this report). The patient was asking whether to received next vaccine or not. The event was reports as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: almost like on top of my hand loses feeling; hand is partially.. like a numbness, tingling or needles sensation; hand is partially.. like a numbness, tingling or needles sensation/hands felt like pins and needles; She could still feel pain in her forearm; injection site pain; the pain was going down her elbow; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number; unknown), via an unspecified route of administration on 05Apr2021 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Apr2021 patient received the covid vaccine two days ago. The first day, she felt injection site pain. She felt it from her arm down to her forearm, elbow area. Her arm feels better today. The injection site feels better today. She woke up today and her hand was partially.. like a numbness, tingling or needles sensation, almost like on top of her hand loses feeling. Since she has woken up, her hands feel like she has been sitting on them. Clarified that her hands felt like pins and needles. She felt this on her wrist and hands. She kept moving her hands around, sticking them up in the air, and making a ball with her hands. She would say it was about a 25 percent loss. She could still feel pain in her forearm, which was weird to her. The injection site feels much better. She was concerned about the nerve issue. She was asking if this was a reported side effect. The outcome of the event injection site pain was recovering and unknown for other events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: almost like on top of my hand loses feeling; hand is partially.. like a numbness, tingling or needles sensation; hand is partially.. like a numbness, tingling or needles sensation/hands felt like pins and needles; She could still feel pain in her forearm; injection site pain; the pain was going down her elbow; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number; unknown), via an unspecified route of administration on 05Apr2021 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Apr2021 patient received the covid vaccine two days ago. The first day, she felt injection site pain. She felt it from her arm down to her forearm, elbow area. Her arm feels better today. The injection site feels better today. She woke up today and her hand was partially.. like a numbness, tingling or needles sensation, almost like on top of her hand loses feeling. Since she has woken up, her hands feel like she has been sitting on them. Clarified that her hands felt like pins and needles. She felt this on her wrist and hands. She kept moving her hands around, sticking them up in the air, and making a ball with her hands. She would say it was about a 25 percent loss. She could still feel pain in her forearm, which was weird to her. The injection site feels much better. She was concerned about the nerve issue. She was asking if this was a reported side effect. The outcome of the event injection site pain was recovering and unknown for other events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Inflammation, Pain
Clinical narrative: My body no effect, my body is bad, very bad. Similar I have a Covid.; inflammation; Terrible, I felt so bad.; Fever; headache; pain and pain in my arm.; I got pain in my body, in my shoulder, in my arm; I got pain in my body, in my shoulder, in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Solution for injection; Lot Number: unknown) via an unspecified route of administration on 03Apr2021 as a single dose for covid-19 immunization. The patient's medical history included Covid (last year in June) and concomitant medications were not reported. On an unspecified date, the patient stated, "I take the first vaccine in April 3 and I effect, secondary effect last and no finish. Fever, headache, pain and pain in my arm. Pain and inflammation. Today is fourth day that they gave me the vaccine. Terrible, I felt so bad, all my body my hair. I am waiting everyday for stay fine, I know that's no good for me the vaccine in my body." When confirmed the vaccine as Pfizer's Covid vaccine, consumer stated, No, the first. I am having second effect. When probed for the effects, consumer stated, "I got the second effect from the vaccine. No reaction, no good. I got pain in my body, in my shoulder, in my arm." When probed if consumer had a query, consumer stated, "I called and respond a report second effect because no finish the second effect continue 5 days. Days today 5 days." Nobody respond It's just terrible, don't know what happen. My body no effect, my body was bad, very bad. Similar I have a Covid, I have Covid last year in June, was the similar." as reported by reporter. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Suspected COVID-19
Clinical narrative: My body no effect, my body is bad, very bad. Similar I have a Covid.; inflammation; Terrible, I felt so bad.; Fever; headache; pain and pain in my arm.; I got pain in my body, in my shoulder, in my arm; I got pain in my body, in my shoulder, in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Solution for injection; Lot Number: unknown) via an unspecified route of administration on 03Apr2021 as a single dose for covid-19 immunization. The patient's medical history included Covid (last year in June) and concomitant medications were not reported. On an unspecified date, the patient stated, "I take the first vaccine in April 3 and I effect, secondary effect last and no finish. Fever, headache, pain and pain in my arm. Pain and inflammation. Today is fourth day that they gave me the vaccine. Terrible, I felt so bad, all my body my hair. I am waiting everyday for stay fine, I know that's no good for me the vaccine in my body." When confirmed the vaccine as Pfizer's Covid vaccine, consumer stated, No, the first. I am having second effect. When probed for the effects, consumer stated, "I got the second effect from the vaccine. No reaction, no good. I got pain in my body, in my shoulder, in my arm." When probed if consumer had a query, consumer stated, "I called and respond a report second effect because no finish the second effect continue 5 days. Days today 5 days." Nobody respond It's just terrible, don't know what happen. My body no effect, my body was bad, very bad. Similar I have a Covid, I have Covid last year in June, was the similar." as reported by reporter. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Hypersensitivity, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 71-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) dose 1 intramuscular on 25 Mar 2021 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to unspecified medications, food, or other products. The patient's concomitant medications were not provided. No other vaccine in four weeks and no other medication in two weeks. No COVID-19 prior vaccination and no COVID-19 tested post vaccination. On 27Mar2021 11:00, the patient experienced allergic/toxic feeling, tight throat and lungs. The patient further reported that concerning symptoms with the thought if this gets any worse, she was in trouble. Regarding the Pfizer COVID-19 vaccine. States she already reported online. States she had side effects and lived through it, but it was unpleasant enough for the first vaccine that you are supposed to report it, and they won't take her back for the second dose without a letter from her doctor. She was ultra sensitive, one of those. As she understands it was 80% effective at one dose, she questioned was that true. Treatment for adverse events was provided with various preventive remedies, detox session, etc (as reported). The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Pain in extremity, Vaccination site pain
Clinical narrative: the first shot only thing I had with the first shot was a sore arm; the first one or the second one I had allergic reaction to; first shot was a sore arm and next day right in the area where the injection site was; This is spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in arm left on 20Mar2021 (age at the time of vaccination is 41-year-old) as single dose for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included triamterene (TRIAMTERENE) taken at 37.5mg; hydrochlorothiazide (HCTZ) taken at 25mg, once daily; methylprednisolone (METHYLPREDNISOLONE) all the concomitant medications are taken for an unspecified indication, start and stop date were not reported. It was reported that with the first shot only thing she had with the first shot was a sore arm and next day right in the area where the injection site and the first one or the second one she had allergic reaction to. Outcome of the events was unknown.   No Follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021467210 same patient/drug, different vaccine dose/AE
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, Pruritus
Clinical narrative: my lower legs felt like were getting itchy/lower legs were itchy; with any kind of exertion and heart jumping out of chest; heart pounding; trouble breathing/Difficulty breathing with any kind of exertion; with minimal walking she had to sit and take it easy; This is spontaneous report received from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8729), via an unspecified route of administration in left arm on 08Apr2021 at 10:00 AM as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included ongoing autoimmune breathing issue (started 6 years ago). No family medical history relevant to adverse events. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. She had her first shot 3 weeks ago, on 08Apr2021 and she was due to second shot on 29Apr2021 this Thursday. She had the first shot on a Thursday and she was fine Thursday through Sunday. Did not have any symptoms until 4 days afterwards on 11Apr2021. She started having trouble breathing/difficulty breathing for the next several days with any kind of exertion and her heart was jumping out of chest with exertion, heart pounding a lot that lasted a good week probably 8 days and then it subsided. It lasted every day, for 4 days it was really difficult to breathe and then on 23Apr2021, then probably 2 weeks into started at night her lower legs felt like were getting itchy and scratching it didn't make a difference because it was on the inside. With minimal walking she had to sit and take it easy. It lasted about a week and she is feeling better. She put some topical itch cream that seemed to help and took a Benadryl and it made it better, it seemed to dissipate. She is concerned about the second shot, would her breathing and heart issue would be worse. She called her breathing doctor and he said he thinks it was still better to take the second vaccine because of the seriousness of the COVID-19 disease. The patient did not visit emergency room or physician office. The patient received treatment due to the events with topical itch cream and Benadryl. The outcome of my lower legs felt like were getting itchy/lower legs were itchy was recovered on 26Apr2021, while with other events trouble breathing/Difficulty breathing with any kind of exertion; with minimal walking she had to sit and take it easy and with any kind of exertion and heart jumping out of chest; heart pounding was recovered on 21Apr2021. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Bone pain, Ear discomfort, Fatigue
Clinical narrative: Had a severe allergic reaction after a previous dose; ringing in the ear; feeling of pressure in the ear; arm hurt; joint pain; armpits hurt; muscle pain; bones hurt; super tired and fatigued; This is a spontaneous report from a contactable consumer or other non hcp.   A 36-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 12:30 PM as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, patient reported that got his first dose of the Pfizer COVID-19 vaccine April 13th and was due for his follow up second dose on May 4th. Stated that vaccine card information was handwritten and the NDC/EXP were not provided on there. Caller stated that got a lot of the normal things, like his arm hurt, he had joint pain, his armpits hurt, he had muscle pain, and his bones hurt a little bit and reported that 5-6 hours after getting the vaccine he had ringing in his ears and that lasted a bit but then it went away, then the next day it came back, and not had the ringing since then. Stated that had slight pressure in his ears that is still there, but the ringing only happened the first two days. The pressure feels like an ear infection, no treatment for the ear ringing or pressure, but called his primary care provider and they told him to wait a bit and also said he could come in or he could try over the counter ear ringing medications, but they recommended calling to report it to Pfizer and get their opinion on it, she doesn't see any reason he could not get the second dose. Stated that his armpit hurting and things only lasted a couple hours, didn't take anything for the other pains either. Stated arm felt like an anvil for days, was super tired and fatigued. Still muscle and joint pain lasted a couple days after or lasted a day or two, main reason he called was because of the ear ringing and pressure. The outcome of the events was unknown.  Follow-up (PRD 04May2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included the information.  Follow-up actions are closed. No need of further information.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Myalgia, Pain in extremity, Tinnitus
Clinical narrative: Had a severe allergic reaction after a previous dose; ringing in the ear; feeling of pressure in the ear; arm hurt; joint pain; armpits hurt; muscle pain; bones hurt; super tired and fatigued; This is a spontaneous report from a contactable consumer or other non hcp.   A 36-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 12:30 PM as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, patient reported that got his first dose of the Pfizer COVID-19 vaccine April 13th and was due for his follow up second dose on May 4th. Stated that vaccine card information was handwritten and the NDC/EXP were not provided on there. Caller stated that got a lot of the normal things, like his arm hurt, he had joint pain, his armpits hurt, he had muscle pain, and his bones hurt a little bit and reported that 5-6 hours after getting the vaccine he had ringing in his ears and that lasted a bit but then it went away, then the next day it came back, and not had the ringing since then. Stated that had slight pressure in his ears that is still there, but the ringing only happened the first two days. The pressure feels like an ear infection, no treatment for the ear ringing or pressure, but called his primary care provider and they told him to wait a bit and also said he could come in or he could try over the counter ear ringing medications, but they recommended calling to report it to Pfizer and get their opinion on it, she doesn't see any reason he could not get the second dose. Stated that his armpit hurting and things only lasted a couple hours, didn't take anything for the other pains either. Stated arm felt like an anvil for days, was super tired and fatigued. Still muscle and joint pain lasted a couple days after or lasted a day or two, main reason he called was because of the ear ringing and pressure. The outcome of the events was unknown.  Follow-up (PRD 04May2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included the information.  Follow-up actions are closed. No need of further information.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Throat tightness
Clinical narrative: Tongue felt tingly/It numbness was in several areas her my mouth; Tongue felt tingly/It numbness was in several areas her my mouth; Her throat was closing; This is a spontaneous report from a contactable consumer reporting same events under the same suspect product for different patient (sister). This is one of three reports.  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported and CBD oil taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with covid 19. Since the vaccination, the patient had not been tested for covid19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient's tongue felt tingly/it numbness was in several areas in her mouth, throat was closing (throat tightness). Therapeutic measures were taken as a result of events. The events were considered as non-serious by the reporter. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Myalgia, Pain in extremity
Clinical narrative: pain in her arm; like a muscle pain; swelling on her tooth; This is a spontaneous report received from a contactable consumer (patient). This 55-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced a little pain in her arm after the first dose that was gone on the second day, like a muscle pain. The patient had a root canal and was taking clindamycin. She had some swelling on her tooth. She wanted to know if she should postpone her second dose of the vaccine. She asked if she could take the vaccine with an infection in her tooth. The outcome of pain in her arm like a muscle pain was recovered. The outcome of swelling on her tooth was unknown.  Follow-up (09JUN2021): Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 2nd vaccine and broke out into a rash all over his body; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as 1st Single Dose for COVID-19 immunisation and experienced a small rash on the arm. It was reported that the patient received the 2nd vaccine and broke out into a rash all over his body. The reporter did not specify any seriousness for event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Peripheral swelling, Rash, Swelling face
Clinical narrative: severe rash head to waist; major migraines; severe swelling in arm, legs and face; severe swelling in arm, legs and face; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration, administered in left arm on 12May2021 09:30 (at the age of 44-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included allergies to tree nuts, shellfish, and lots of medications, fibromyalgia, small fibre neuropathy, brain lesions, asthma, thrombocytopenia, chronic arthritis, nerve damage in elbows and hands, and complex regional pain syndrome (CRPS). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient previously took the first dose of bnt162b2 on 21Apr2021 10:30 (at the age of 44 years old) in the right arm for COVID-19 immunization and experienced extremely sick, affected neurological, and increased pain in fibro with right arm still not fully better left arm same issues neurological wise. On 12May2021, the patient experienced severe rash head to waist, major migraines, and severe swelling in arm, legs and face. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone, diphenhydramine (BENADRYL), and epinephrine (epi). 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: Inflammation, Joint stiffness, Mobility decreased, Pain
Clinical narrative: she lost full motion on being able to reach and bend down.; she lost full motion on being able to reach and bend down.; She says she has pain and inflammation; She says she has pain and inflammation; 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), dose 2 via an unspecified route of administration on 15May2021 16:00 (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. Medical history included some discomfort in her neck/shoulder. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start date not reported. The patient reported she lost full motion on being able to reach and bend down on 15May2021 at 18:30. She said  she has pain and inflammation. She was pretty sure it was unrelated to the vaccine. The outcome of the events was unknown.  The patient has been taking paracetamol and she wanted to know if she can take Aleve after the vaccination.  Information about lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Edema in both hands and feet with 24 hours of second vaccine,has not resolved as of 17May2021; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received her second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Lot number: EN6201) administered on the right arm on 19Feb2021 as 2nd dose, single dose (at the age of 50 years old) for COVID-19 immunization. The vaccine was administered in a hospital. The patient's medical history included DCIS breast cancer on 2018 and known allergies to sulfa and sensitivity to gluten. The patient previously received BNT162B2, administered on right arm on 28Jan2021 (Lot number: EL9264), at the age of 50 years old, as 1st dose, single dose for COVID-19 immunization. The patient's concomitant medication included venlafaxine hydrochloride (VENLAFAXINE XR), propranolol, levothyroxine sodium (LEVOTHYROXINE), and biotin. On 20Feb2021, the patient experienced edema in both hands and feet in 24 hours of the second vaccine. There was no treatment given on the event. The adverse event resulted to Doctor or other healthcare professional office/clinic visit. The patient has not had COVID prior to vaccine. The patient has not been COVID tested post vaccination. The outcome for the event was not recovered/not resolved as of 17May2021.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: patient experienced numbness on his right hand; he started having this sensation when he went to sleep and ended up having it during daytime as well which got worse over time; he developed extreme pain in his arm. He stated that his arm was "killing him" at 3 o'clock that morning; This is a spontaneous report received via Medical Information Team. A contactable consumer (patient) reported a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as unknown, single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness on his right hand. He stated that he started having this sensation when he went to sleep and ended up having it during daytime as well which got worse over time. During the last few weeks, he developed extreme pain in his arm. He stated that his arm was "killing him" at 3 o'clock that morning and diminished at 6 o'clock that morning. Patient used heat pads, vibrators and took paracetamol (TYLENOL) to diminish the pain. He claimed that other people have been reporting the same type of reaction as well. The patient was referred to his physician for treatment recommendations. The patient was recovering from extreme pain in his arm. The outcome of the event numbness on his right hand was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: she woke up with the flu; This is a spontaneous report from a non-contactable consumer. A 38-year-old female patient 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 dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient informed that she was supposed to receive the 2nd dose of the Pfizer-BioNTech Covid-19 vaccine. However, she woke up with the flu. The patient wanted to know if she is allowed to receive the 2nd dose even if she has the flu. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: My Left armpit is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unspecified route of administration, administered in left arm on 14May2021 at second dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was previously administered the first dose of BNT162B2 in left arm on 13Apr2021, single dose for COVID-19 immunization. On an unspecified date, the patient experienced pain under left her arm and stated that it feels sort of like lymph nodes or a pulled hamstring or something. The patient reported that her left armpit was extremely painful and when she lifted it up, it hurt a little bit. The patient added that her left armpit really hurt when she poked the middle of her left armpit with her right finger. She asked if this was normal and how long does it last? (patient received both vaccine doses in her left arm). The outcome of event was unknown.  The following information on the batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: his only thing he had as a side effect from the first dose was tiredness and arm soreness.; his only thing he had as a side effect from the first dose was tiredness and arm soreness.; This is a spontaneous report from a contactable consumer (patient's wife).  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, in right arm on 10Mar2021 at 10:00 (at the age of 74-years-old)  (Batch/Lot Number: EN6199) as 1st dose, single dose for COVID-19 immunization. Medical history included car accident in 1972 and had some injuries from that, and then 2012 slight stroke, and seizure disorder since his car accident in 1972.The patient had no concomitant medications. The patient's wife reported that the only thing he had as a side effect from the first dose was tiredness and arm soreness. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 (Batch/Lot Number: EW0153) (at the age of 67-years-old) as 1st dose, single dose for Covid-19 immunization. Medical history included ongoing hypothyroidism. The patient has known allergies for sulfa and penicillin. Concomitant medications included levothyroxine, liothyronine (NP THYROID 60mg) and "bioidentical hormone compound" both taken for an unknown indication and unknown if ongoing. On 02May2021 at 2:00 am  the patient woke up with shooting pains and on 03May2021 she broke out in shingles rash. The patient received valacyclovir hcl 1 gm as treatment. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for Covid-19 since the vaccination. The outcome of the events was unknown.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: she got some reactions to the first vaccine/ she had to be tested for PG ingredients as an allergy test; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date (at the age of 55 years old) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got some reactions to the first vaccine and ended with cardiologist due to that who indicated that the patient had to be tested for PG ingredients (as reported) as an allergy test. The patient mentioned that she had has not been able to get the test done and had has an appointment to get the second dose this next Wednesday (as reported). The patient would like to know if she can delay the vaccine to a 7th week after the first dose since she has already waited for 6 weeks. The patient had has contacted 2 physicians and the CDC and nobody could give her an answer to this question. Outcome of the event was unknown.  Information about batch/ lot number has been requested.