chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Pain
Clinical narrative: Prominent hematoma in her hand, fingers, in her palm, in between fingers and on thumb. Few days later she developed it in her pinky; Severe pain; This is a spontaneous report from a contactable physician for herself . A 47-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date (after the dose), the patient developed prominent hematoma in her hand, fingers, in her palm, in between fingers and on thumb. Few days later she developed it in her pinky for which the patient needed to go to emergency room due to severe pain. It was reported that patient developed hematoma after the vaccine only and did not had this before. The reporter considered the event as non-serious. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: Latissimus Dorsi Hematoma; This is a spontaneous report from a contactable physician. A 68-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 06Apr2021 (at the age of 68-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included known allergies: NSAID, Sulfates. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 2 weeks of vaccination. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID-19 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 experienced latissimus dorsi hematoma on 09Apr2021. The event resulted in emergency and physician room visit. The patient did not receive any treatment. The clinical outcome for the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pain
Clinical narrative: in 2-7 days: 2 inch red spot, pain and burningin 8-17 days: 6 inch red spot, pain and burning.; in 2-7 days: 2 inch red spot, pain and burningin 8-17 days: 6 inch red spot, pain and burning.; in 2-7 days: 2 inch red spot, pain and burningin 8-17 days: 6 inch red spot, pain and burning.; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0153; Expiration Date: on an unspecified date in Jul2021), via an unspecified route of administration, administered in Arm Left on 06Apr2021 18:30 as dose 1, single for COVID-19 immunization (Age at vaccination was 48-year-old). The patient medical history included malignant Melanoma, Mitral valve prolapse and Scoliosis. The patient concomitant medications were not reported. It was reported that, she was not allergic to medications, food, or other products. She was not a pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications the patient received within 2 weeks of vaccination. She was not diagnosed with COVID-19 prior to vaccination and not tested with COVID-19 since the vaccination. On 08Apr2021 12:00, the patient experienced in 2-7 days: 2-inch red spot, pain and burning, in 8-17 days: 6-inch red spot, pain and burning. Her doctor prescribed allergy relief (Diphenhydramine hydrochloride) and Antibiotics which made the situation worse. Patient has visited emergency room as a result of events. Therapeutic measures were taken as a result of events include allergy relief (Diphenhydramine hydrochloride) and Antibiotics. The outcome of the events was not recovered.  No follow-up attempts are needed. Iinformation about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Pruritus, Psoriasis, Rash
Clinical narrative: large painful lump in the my right armpit of the arm the shot was given; itchy; scaly rash outbreak on my shins, calves elbows, genital and anal areas, arms, thighs, inside left ear, back of left shoulder, lower back; scaly rash outbreak on my shins, calves elbows, genital and anal areas, arms, thighs, inside left ear, back of left shoulder, lower back; large painful lump in the my right armpit of the arm the shot was given; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 56-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12Jan2021 as dose 2, single (at the age of 56-years-old) for covid-19 immunization. Patient was not pregnant at time of vaccination. Previously the patient received first dose of BNT162B2, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administered in Arm right on 17Dec2020 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. There were no concomitant medications. No Other vaccines received in four and two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. There were no allergies. On 14Jan2021, the patient experienced large painful lump in her right armpit of the arm the shot was given, itchy, scaly rash outbreak on her shins, calves elbows, genital and anal areas, arms, thighs, inside left ear, back of left shoulder, lower back. New outbreaks were still appearing. It was not going away. Her dermatologist diagnosed it as psoriasis which was an overactive immune system. Therapeutic measures were taken as a result of all events; treatment included steroid and hydrocortisone creams were prescribed. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Fatigue, Loss of personal independence in daily activities
Clinical narrative: very severe joint and bone pain especially on her back and her spine area; very severe joint and bone pain especially on her back and her spine area; very severe joint and bone pain especially on her back and her spine area; very fragile health; wheelchair and her movements are limited; This is a spontaneous report from a contactable consumer (patients daughter) or other non-health care professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient experienced very severe joint and bone pain especially on her back and her spine area, the pain was kind of on the bottom part near patient's tail area just a little bit above that. The reporter was just wondering if this was one of side effects of the COVID 19 vaccine. Patient was very fragile health, wheelchair and her movements were limited. when she was in pain she can't move at all, she has a hard time going to the bathroom. It was a hassle and it was very hard on her. Reporter stated that her mother said that there was no way she was going to get the second dose with all of that pain. The reporter just wanted to know what will happen if they dont get the second dose. The outcome of the events was unknown.   No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) and physician. A 50-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Apr 24, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration on Apr 3, 2021, single dose, for COVID-19 immunization. On an unspecified date in 2021, patient experienced chills, fever and headache. Verbatim event description: Patient received both the 1st and 2nd dose of the Pfizer COVID-19 vaccines on Apr 3, 2021 and Apr 24, 2021, respectively. Patient called to report adverse events (such as chills, fever and headache) after taking the 2nd dose. The patient wanted to know if it is okay to take OTC pain relievers. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 19Apr2021 as dose 1, single for COVID-19 immunization. The patient relevant medical history and concomitant medications were not reported. On 20Apr2021 morning, the patient had chest pain. The patient wanted to know if she should panic and if chest pain was a side effect of the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Swelling
Clinical narrative: had two little bumps on her collar bone; Swelling on collar bone; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an unspecified route of administration in left arm on 18Apr2021 (age at vaccination 54-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing asthma. Concomitant medications were not reported. Had an inhaler but she was not using it because she was taking care of herself when she goes outside. No further details provided. On 19Apr2021, the patient experienced swelling and two little bumps on her left collarbone. The patient reported that she had two little bumps on her collar bone that started at 12:30 at night. Patient stated that on Sunday she had the vaccine on her left arm and two days after she has swelling and two little bumps on her left collarbone. Stated that she was scared. Stated that she did not know if the swelling was going to go or if it will be increasing. Did not know what to do. Clarified vaccine as Pfizer Covid vaccine and it was her first dose. No treatment was taken for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information was expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Took shot Friday afternoon and Saturday night Sunday morning started to get rash on my neck and on both arms.; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 31-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 16Apr2021 at 13:45 (at the age of 32 years old, not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient took shot on 16Apr2021, friday afternoon and on 17Apr2021 at 01:00 AM saturday night, sunday morning started to get rash on my neck and on both arms. Therapeutic measures were taken as a result of took shot friday afternoon and saturday night sunday morning started to get rash on my neck and on both arms with methyl prednisolone. The event resulted in emergency room/department or urgent care visit. No hospitalization required. Reporter considered events as non-serious. The outcome of event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity, Urticaria
Clinical narrative: lightheaded; developed hives on my legs; dizzy; My arm hurt extremely badly; fatigued; This is a spontaneous report from a non-contactable consumer. A 39-years-old female patient received bnt162b2 (Formulation; Solution for injection; Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 17Apr2021 10:30 as dose 2, single for covid-19 immunisation (at the age of 39 years). Medical history included fibromyalgia from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC), amitriptyline (AMITRIPTYLINE), cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa 12, Levaquin, scopolamine [hyoscine] for unspecified indication and experienced drug hypersensitivity. The patient was previously received first dose of bnt162b2 on 27Mar2021 at 10:30 HR for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Consumer stated that on 17Apr2021 04:00 PM after my second shot I was lightheaded and dizzy. This has lasted into the 3rd day after the shot. My arm hurt extremely badly, and I was fatigued. I have also developed hives on my legs. The outcome of the events was recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: I had some bad cough; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received BNT162b2 (CONMINTARY, Solution for injection, Lot No: was not reported, NDC, UPC number and expiry date was not provided), via an unspecified route of administration on an unspecified date as 1stdose, single for covid-19 immunisation. The patient medical history and Concomitant medication were not reported. The patient experienced i had some bad cough (cough) (non-serious) on an unspecified date. The clinical 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: Chills, Dizziness, Illness, Pain, Pain in extremity
Clinical narrative: Chills; Mild Fever; Sore all over; Sick; like she had the flu; Arm Hurts; Dizzy; This is a spontaneous report from a contactable consumer. A 44-year-old female consumer (Patient) reported for that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 17:21 (at the age of 44 years) as dose 2, single for covid-19 immunisation. Patient had no medical history. Family medical history relevant to AE(s) was none. Denied any medications, medical conditions, labs, testing, or treatments relevant to the report. Caller mentioned that her 83 year old mother had the vaccine with no effects. No further information provided by caller. The patient's concomitant medications were not reported. Past drug included flu vaccine (No NDC, Lot Number, or Expiration date known) on an unspecified date and experienced sore arm on unspecified date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730, Expiry Date, NDC number: not reported), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient took Covid vaccine as she did not want to be really sick and wanted to get on with life. Vaccine was not administered at military facility. No investigation assessment done. Prior Vaccinations (within 4 weeks) was none. Additional vaccines administered on same date of the Pfizer suspect was none. Caller stated that she had the vaccine on 17Apr2021 and her symptoms began the next day on 18Apr2021. The patient experienced chills, mild fever, sore all over, sick like she had the flu, arm hurts and dizzy on 18Apr2021. Caller stated that she wanted to ensure she was not contacted any further about the report. Stated that she felt her reaction was standard. Patient did not visited emergency room or physician office. Stated that she took Tylenol three times a day to help with her symptoms; had not taken any yet till the time of report. The outcome of events chills and mild fever was recovered on 19Apr2021 while the outcome of other events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021459170 same reporter/vaccine different patient/event
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Mild Fever; Sore all over; Sick; like she had the flu; Arm Hurts; Dizzy; This is a spontaneous report from a contactable consumer. A 44-year-old female consumer (Patient) reported for that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 17:21 (at the age of 44 years) as dose 2, single for covid-19 immunisation. Patient had no medical history. Family medical history relevant to AE(s) was none. Denied any medications, medical conditions, labs, testing, or treatments relevant to the report. Caller mentioned that her 83 year old mother had the vaccine with no effects. No further information provided by caller. The patient's concomitant medications were not reported. Past drug included flu vaccine (No NDC, Lot Number, or Expiration date known) on an unspecified date and experienced sore arm on unspecified date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730, Expiry Date, NDC number: not reported), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient took Covid vaccine as she did not want to be really sick and wanted to get on with life. Vaccine was not administered at military facility. No investigation assessment done. Prior Vaccinations (within 4 weeks) was none. Additional vaccines administered on same date of the Pfizer suspect was none. Caller stated that she had the vaccine on 17Apr2021 and her symptoms began the next day on 18Apr2021. The patient experienced chills, mild fever, sore all over, sick like she had the flu, arm hurts and dizzy on 18Apr2021. Caller stated that she wanted to ensure she was not contacted any further about the report. Stated that she felt her reaction was standard. Patient did not visited emergency room or physician office. Stated that she took Tylenol three times a day to help with her symptoms; had not taken any yet till the time of report. The outcome of events chills and mild fever was recovered on 19Apr2021 while the outcome of other events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021459170 same reporter/vaccine different patient/event
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Terrible deep cough started 24 hours after each shot. The cough was just going away when I got the 2nd shot and it started all over again; fever; awful headache; sore throat; This is a spontaneous report from contactable 63-year-old female consumer (patient) reported for herself. A 63-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731), via an unspecified route of administration in left arm on 18Apr2021 (at the age of 63 years old, not pregnant at the time of vacciantion) as dose 2, single for covid-19 immunisation. Medical history included she had covid a year ago on 14 Mar2020 to 14 Mar2020 and was tested 4 times in the past year for antibodies and they were still present right before she got dose 1. She don't think doctors and Pfizer should have been recommending she get the covid shots. The patient was allergies to medications, food, or other products included sulfa drugs. Concomitant medications the patient received within 2 weeks of vaccination included simvastatin 10 mg; calcium citrate; vitamin b complex. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 26Mar2021 at 01:00 PM (at the age of 63 years old) for covid-19 immunisation and patient experienced terrible deep cough started 24 hours after each shot. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced terrible deep cough started 24 hours after each shot. The cough was just going away when she got the 2nd shot and it started all over again. In addition she have a fever of 101.8, awful headache and sore on an unspecified date. Therapeutic measures were taken as a result all the events with benzonatate 200 MG 3 times a day. The outcome of events was not recovered.  No follow up attempts are needed. No further information is expected
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: She just had this red, splotchy rash on her ankle/legs are more red and splotchy/Little red rash on right pinky; Really itchy rash on her ankle. Super itchy. There are other places she may not see and it is very itchy; Rash is on both of her arms, legs and other parts of her body. The rash is a little on her lower back, but mostly on legs and both arms.; This is spontaneous report from contactable consumer. A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170; Expiration Date: 01Aug2021) via an unspecified route of administration, administered in Arm Left on 20Apr2021 13:30 (age at vaccination 32-years-old) as dose 1, 0.3ml single for covid-19 immunisation. Medical history included ongoing anxiety, ongoing sleep and stuff, ongoing attention deficit hyperactivity disorder, migraine from an unknown date and unknown if ongoing. Concomitant medication included galcanezumab (EMGALITY [GALCANEZUMAB]) taken for migraine she took it Saturday, so she was not sure if there was any relation to the reaction she is having after the vaccine; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder Usually takes 15mg. She is supposed to take every day, but she does not take on her days off. She takes it maybe 4 to 5 days a week. She has been taking more than 10 years, clonazepam (KLONOPIN) taken for anxiety, sleep disorder from an unspecified start date and ongoing. On 20Apr2021, patient experienced she just had this red, splotchy rash on her ankle/legs are more red and splotchy/little red rash on right pinky, itchy rash on her ankle. super itchy there are other places she may not see, and it is very itchy, rash is on both of her arms, legs and other parts of her body, the rash is a little on her lower back, but mostly on legs and both arms. Consumer stated that, that it was about an hour or hour and a half later, she wondered if she had a bug bite at first because she just had this red, splotchy rash on her ankle. It feels like she has been bitten by a bunch of ants. But the rash is on both of her arms, legs, and other parts of her body. The rash is a little on her lower back, but mostly on legs and both arms. The legs are more red and splotchy. There are other places she may not see, and it is very itchy. There is a little red rash on her right pinky. For the treatment she took Benadryl she stated that her boyfriend took the vaccine at the same time and had no reaction. The pharmacist told her to monitor this and if it gets worse, go ahead, and go to the emergency room. Prior vaccination within 4 week was no. consumer was not allergic to anything. The only thing was an antibiotic in the early 90's that they stopped making. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Mass excision, Pruritus, Swelling, Urticaria, Vaccination site pain
Clinical narrative: Raised area, lump in the arm; Hives both arms; Itching; Swelling; Hurt as the vaccination site; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, (lot number: EN6206)) via unknown route of administration at right arm on 06Mar2021 at 14:00 (age at the time of vaccination was 58-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on Same Date of the Pfizer Suspect was no. There was no family medical history relevant to adverse events. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had hurt at the vaccine site on 06Mar2021, the swelling did itch unknown if from skin stretching or actual reaction on 07Mar2021, hives on the wrist of her right arm inside the forearm the upper bicep that they mostly stayed on her upper body. The next day the hives raised area went away, She stated 3-4 days later she noticed her upper bicep swelling like a bee sting started spreading and had blew up like a very large pork chop. She stated her daughter took pictures and outlined the area and dated it with a pen in case it got bigger as the width of her bicep and raised and that she had very big biceps. She stated she would put Benadryl, cool water on it and also alcohol for the itching and it seems to take the itch off on 08Mar2021 and raised area, lump in the arm like a Nickle in her arm and she could move it on 03Apr2021. The patient received treatment included benadryl cool water and alcohol for itching. The adverse events do not resulted to visit the emergency room and physician office. The event hurt at the vaccine site was recovered on 09Mar2021. The outcome of the other events was unknown. The patient received second dose of vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dry mouth, Dyspnoea, Eye pruritus, Fatigue
Clinical narrative: Sneezing; extremely congestion; breathing out by my mouth because hard for me to breath; Itchy eyes; Severe runny nose; Sneezing; extremely congestion; breathing out by my mouth because hard for me to breath; Sneezing; extremely congestion; breathing out by my mouth because hard for me to breath; I was tired I could not get out of the bed, I had no energy; Allergy; Tiredness/Feeling so exhausted; Dry mouth; Arm pain; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0171), via an unspecified route of administration, administered in arm right on 21Apr2021 (at the age of 47-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included ergocalciferol/retinol palmitate (VITAMINS A and D) taken for an unspecified indication. On an unspecified date in Apr2021, the patient experienced allergy, arm pain, tiredness/feeling so exhausted, dry mouth, I was tired I could not get out of the bed, I had no energy. On 24Apr2021, the patient experienced sneezing; extremely congestion; breathing out by my mouth because hard for me to breath, itchy eyes, severe runny nose. Patient stated, she got the shot the COVID shot on Wednesday 21Apr2021, and it was her first. She had allergy go and on pass on a week after the shot, sneezing, congestion and itchy eyes on 24Apr2021, but before the shot she was fine, after receiving the Covid shot she had arm pain for 2 days, for her congestion clear up on second day, her arm pain went away on the third day, she does not had fever. Congestion came back on Friday 23Apr2021 each of these days since she had been taken her first shot. On Saturday 24Apr2021, she woke up extremely congestion and severe runny nose like she used whole toilet paper. She took my Zyrtec (treatment) but she was feeling a little better and she was very tired she could not get out of the bed, she just had no energy, very congested runny nose dry mouth because she was breathing out by my mouth and she had this on and it's hard for her to breathe in. she was breathing but not out of her nose and right now her right nose was little clear but left was till congested, so dry mouth she was breathing out of my mouth but she don't have fever, it's 4 days later, she was feeling it so exhausted. she remembered the first day, it is like a too mild, and then she gets extremely get tired. Patient stated as far as the congestion, I am not feeling that much right now. The patient received Zyrtec as treatment for the events sneezing, extremely congestion. Outcome of all the events was unknown.  No follow up attempts are needed, no further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: Sneezing; extremely congestion; breathing out by my mouth because hard for me to breath; Itchy eyes; Severe runny nose; Sneezing; extremely congestion; breathing out by my mouth because hard for me to breath; Sneezing; extremely congestion; breathing out by my mouth because hard for me to breath; I was tired I could not get out of the bed, I had no energy; Allergy; Tiredness/Feeling so exhausted; Dry mouth; Arm pain; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0171), via an unspecified route of administration, administered in arm right on 21Apr2021 (at the age of 47-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included ergocalciferol/retinol palmitate (VITAMINS A and D) taken for an unspecified indication. On an unspecified date in Apr2021, the patient experienced allergy, arm pain, tiredness/feeling so exhausted, dry mouth, I was tired I could not get out of the bed, I had no energy. On 24Apr2021, the patient experienced sneezing; extremely congestion; breathing out by my mouth because hard for me to breath, itchy eyes, severe runny nose. Patient stated, she got the shot the COVID shot on Wednesday 21Apr2021, and it was her first. She had allergy go and on pass on a week after the shot, sneezing, congestion and itchy eyes on 24Apr2021, but before the shot she was fine, after receiving the Covid shot she had arm pain for 2 days, for her congestion clear up on second day, her arm pain went away on the third day, she does not had fever. Congestion came back on Friday 23Apr2021 each of these days since she had been taken her first shot. On Saturday 24Apr2021, she woke up extremely congestion and severe runny nose like she used whole toilet paper. She took my Zyrtec (treatment) but she was feeling a little better and she was very tired she could not get out of the bed, she just had no energy, very congested runny nose dry mouth because she was breathing out by my mouth and she had this on and it's hard for her to breathe in. she was breathing but not out of her nose and right now her right nose was little clear but left was till congested, so dry mouth she was breathing out of my mouth but she don't have fever, it's 4 days later, she was feeling it so exhausted. she remembered the first day, it is like a too mild, and then she gets extremely get tired. Patient stated as far as the congestion, I am not feeling that much right now. The patient received Zyrtec as treatment for the events sneezing, extremely congestion. Outcome of all the events was unknown.  No follow up attempts are needed, no further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling on the right arm on the lower part of his armpit; This is a spontaneous report from a contactable consumer (patient, reported for himself).  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot: Not provided), via an unspecified route of administration on unspecified date as dose number unknown, single for COVID-19 immunization. The patients Medical history and Concomitant medication were not reported. On unspecified date patient took COVID-19 Vaccine last Saturday. Sunday, he experienced swelling underneath right arm on the lower part of his armpit on unspecified date. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Mobility decreased, Pain
Clinical narrative: Extreme joint pain in arms & legs; Continued pain 10 to 12 on pain scale; Can't lift arms and hard to move legs to walk; Can't lift arms and hard to move legs to walk; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 68-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number and Expiration date was not reported) (at the age of 68-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included: blood pressure high, thyroid and drug allergy (Penicillin family drugs). Concomitant medications included losartan, levothyroxine, amlodipine and acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination, the patient has not been tested for COVID-19. On 05Apr2021 11:15 the patient experienced extreme joint pain in arms & legs, can't lift arms and hard to move legs to walk and continued pain 10 to 12 on pain scale. It was reported that after shot arm sore. Then body aches and chills with night sweats. Went to Urgent Care, ER, and physician office. Received meds to pacify problem. Did not work. The problem continued to intensify. Was told it was not vaccine so did the 2nd shot which made symptoms worse. Extreme joint pain in arms & legs. Can't lift arms and hard to move legs to walk. Continued pain 10 to 12 on pain scale. The events resulted in Emergency room/department or urgent care/physician office visit. The patient received treatment with Pain medications and muscle relaxer and MRI (magnetic resonance imaging) was requested. The outcome of the events was not recovered.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash papular, Rash pruritic, Swelling
Clinical narrative: general area around where the shot was given looked a little discolored; red swollen itchy bumps; it has been very painful; inside of my left arm broke out in a patch of red swollen itchy bumps; red swollen itchy bumps; red swollen itchy bumps; general area around where the shot was given looked a little discolored for some days and felt swore to the touch for some days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (age at vaccination: 57 Years) as DOSE 2, SINGLE for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included known allergies of BIAXON, and rest other history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took bnt162b2 (Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in arm left on Mar2021 15:00 (age at vaccination: 57 Years) as DOSE 1, SINGLE for covid-19 immunisation. On 21Apr2021 16:00, the patient experienced general area around where the shot was given looked a little discolored, inside of my left arm broke out in a patch of red swollen itchy bumps, red swollen itchy bumps; and it had been very painful. Clinical course was as follow: the patient at first noticed the general area around where the shot was given looked a little discolored for some days and felt swore to the touch for some days. On 21Apr2021 (Wednesday), the patient noticed the inside of her left arm broke out in a patch of red swollen itchy bumps. She put hydrocortisone (therapeutic measures were taken for red itchy bumps and painful) on it, and it seemed to relieve the itching, it had been very painful, but the hydrocortisone seems to help. Still patchy and not completely clear yet. Reportedly, the case was non-serious. Outcome for all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: general area around where the shot was given looked a little discolored; red swollen itchy bumps; it has been very painful; inside of my left arm broke out in a patch of red swollen itchy bumps; red swollen itchy bumps; red swollen itchy bumps; general area around where the shot was given looked a little discolored for some days and felt swore to the touch for some days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534), dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (age at vaccination: 57 Years) as DOSE 2, SINGLE for covid-19 immunisation at Public Health Clinic/Veterans Administration facility. Medical history included known allergies of BIAXON, and rest other history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took bnt162b2 (Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in arm left on Mar2021 15:00 (age at vaccination: 57 Years) as DOSE 1, SINGLE for covid-19 immunisation. On 21Apr2021 16:00, the patient experienced general area around where the shot was given looked a little discolored, inside of my left arm broke out in a patch of red swollen itchy bumps, red swollen itchy bumps; and it had been very painful. Clinical course was as follow: the patient at first noticed the general area around where the shot was given looked a little discolored for some days and felt swore to the touch for some days. On 21Apr2021 (Wednesday), the patient noticed the inside of her left arm broke out in a patch of red swollen itchy bumps. She put hydrocortisone (therapeutic measures were taken for red itchy bumps and painful) on it, and it seemed to relieve the itching, it had been very painful, but the hydrocortisone seems to help. Still patchy and not completely clear yet. Reportedly, the case was non-serious. Outcome for all events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Disturbance in attention, Fatigue
Clinical narrative: Fevers; chills; fatigue; body aches; headache; diarrhea; loss of apetite; severe inability to focus -brain fog; severe inability to focus -brain fog; This is a spontaneous report from a contactable other hcp (Patient). A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, (Batch/Lot Number: EN6206)), via an unspecified route of administration, administered in the left arm on 02Apr2021(age the time of vaccination was 42-year-old) as dose 2, 0.3 ML Single for COVID-19 immunisation. The patient's medical history included asthma, migraine, urinary tract infection, bronchitis, pneumonia. The patient's concomitant medications were not reported. The patient previously took sulphonamide and experienced drug hypersensitivity. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE solution for injection, Lot number: ER8733) in left arm on12Mar2021 at 10:00 AM (age the time of vaccination was 42-year-old) as dose 1, 0.3 ML Single for COVID-19 immunisation. Patient Received 1st dose 12Mar2021 by late that evening and by 13Mar2021 unable to get out of bed, fever 100F, chills, body aches, difficulty breathing, chest tightness, and abdominal pain. on 15Mar2021 difficulty breathing, flu-like symptoms and given an injection of steroids and CX Ray 17Mar2021 done. Symptoms continued to worsen with increasing difficulty to breathe, gasping for air, 02 stats were btw 88-93 for 3 weeks. Had several telehealth appt w/ pulmonologist. Had second injection 02Apr2021 w/ pre/post dosing of prednisone and Tylenol with little to no relief of symptoms. Fevers persisted for about the last two months. On an unspecified date, the patient had fevers, chills, fatigue, body aches, headache, diarrhoea, loss of appetite, severe inability to focus -brain fog. Had second injection 02Apr2021 w/ pre/post dosing of prednisone and Tylenol with little to no relief of symptoms. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 16Apr2021 Blood test. Therapeutic measures were taken as a result of fevers, chills, fatigue, body aches, headache, diarrhoea, loss of appetite, severe inability to focus -brain fog, severe inability to focus -brain fog. As treatment medication Pre and post dosing of prednisone and Tylenol with little to no relief of symptoms. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Fevers; chills; fatigue; body aches; headache; diarrhea; loss of apetite; severe inability to focus -brain fog; severe inability to focus -brain fog; This is a spontaneous report from a contactable other hcp (Patient). A 42-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, (Batch/Lot Number: EN6206)), via an unspecified route of administration, administered in the left arm on 02Apr2021(age the time of vaccination was 42-year-old) as dose 2, 0.3 ML Single for COVID-19 immunisation. The patient's medical history included asthma, migraine, urinary tract infection, bronchitis, pneumonia. The patient's concomitant medications were not reported. The patient previously took sulphonamide and experienced drug hypersensitivity. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE solution for injection, Lot number: ER8733) in left arm on12Mar2021 at 10:00 AM (age the time of vaccination was 42-year-old) as dose 1, 0.3 ML Single for COVID-19 immunisation. Patient Received 1st dose 12Mar2021 by late that evening and by 13Mar2021 unable to get out of bed, fever 100F, chills, body aches, difficulty breathing, chest tightness, and abdominal pain. on 15Mar2021 difficulty breathing, flu-like symptoms and given an injection of steroids and CX Ray 17Mar2021 done. Symptoms continued to worsen with increasing difficulty to breathe, gasping for air, 02 stats were btw 88-93 for 3 weeks. Had several telehealth appt w/ pulmonologist. Had second injection 02Apr2021 w/ pre/post dosing of prednisone and Tylenol with little to no relief of symptoms. Fevers persisted for about the last two months. On an unspecified date, the patient had fevers, chills, fatigue, body aches, headache, diarrhoea, loss of appetite, severe inability to focus -brain fog. Had second injection 02Apr2021 w/ pre/post dosing of prednisone and Tylenol with little to no relief of symptoms. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 16Apr2021 Blood test. Therapeutic measures were taken as a result of fevers, chills, fatigue, body aches, headache, diarrhoea, loss of appetite, severe inability to focus -brain fog, severe inability to focus -brain fog. As treatment medication Pre and post dosing of prednisone and Tylenol with little to no relief of symptoms. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.