chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: nausea; headache; low-grade fever; fatigue; Sore injection site; This is a spontaneous report from a non-contactable consumer or other non hcp. A 48-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:45 (at the age of 48-year-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. No concomitant medications. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 18:00, the patient experienced nausea, headache, low-grade fever, fatigue, sore injection site. Therapeutic measures were taken as a result of events included advil. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Headache, Myalgia, Pain in extremity
Clinical narrative: rash on the face; feels like sunburn/ feels like she has a sunburn; spots on both arm more intense on the left arm, spots on chest; muscle pain; arm pain; headache; She is experiencing redness in her face; feels very flushed; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team reported that:  A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 14Apr2021 11:30 (at the age of 27 years old) as dose 1, single for covid-19 immunisation. Medical history included cardiac disorder, peripheral swelling and allergy to arthropod sting from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Prior to vaccination the Patient had heart problem and consulted with her cardiologist, fluid and swelling of the feet, blood stay on the feet. On an unspecified date, the patient experienced rash on the face, feels like sunburn/ feels like she has a sunburn, spots on both arm more intense on the left arm, spots on chest, muscle pain, arm pain, headache, she is experiencing redness in her face and feels very flushed. The outcome of the events was unknown.  Follow-up #1(14Apr2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that:   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Sunburn
Clinical narrative: rash on the face; feels like sunburn/ feels like she has a sunburn; spots on both arm more intense on the left arm, spots on chest; muscle pain; arm pain; headache; She is experiencing redness in her face; feels very flushed; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team reported that:  A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 14Apr2021 11:30 (at the age of 27 years old) as dose 1, single for covid-19 immunisation. Medical history included cardiac disorder, peripheral swelling and allergy to arthropod sting from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Prior to vaccination the Patient had heart problem and consulted with her cardiologist, fluid and swelling of the feet, blood stay on the feet. On an unspecified date, the patient experienced rash on the face, feels like sunburn/ feels like she has a sunburn, spots on both arm more intense on the left arm, spots on chest, muscle pain, arm pain, headache, she is experiencing redness in her face and feels very flushed. The outcome of the events was unknown.  Follow-up #1(14Apr2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that:   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on left arm above his wrist on forearm; itching all over the body after rash formed; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 19Mar2021(at the age of 60-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included blood pressure increased from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril taken for blood pressure increased, start and stop date were not reported; cyanocobalamin (B12 1000 SR) taken for supplementation therapy, start and stop date were not reported. On an unspecified date, the patient experienced itching all over the body after rash formed was reported as worsened, rash on left arm above his wrist on forearm. He had both doses of his Pfizer COVID vaccine, states he is trying to report a delayed side effect, that 17-18 days after his first dose was administered on 19Mar2021, he developed a rash on his arm, states it was above his wrist on his forearm o his left arm. States he did get the second dose on 09Apr2021, states the rash came before, about 4-5 days before, maybe the weekend of 03Apr2021, exact dates unknown. States he was gardening and doing yard work so he was unsure if it had to do with that. No additional Vaccines were administered on Same Date of the Pfizer Suspect. The adverse event did not result Emergency Room and Physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering for rash on left arm above his wrist on forearm and not recovered for another event.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Itchy rash; Tiredness; Headache; Chills; Joint pain; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), dose 2 via an unspecified route of administration on 05Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine was that patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267; Expiration Date: 31MAY2021), dose 1 via an unspecified route of administration on 12FEB2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included, from an unknown date and unknown if ongoing. Concomitant medications included methotrexate METHOTREXATE taken for rheumatoid arthritis, start and stop date were not reported; adalimumab (HUMIRA) taken for rheumatoid arthritis, start and stop date were not reported. Caller stated after her first vaccine, her arm hurt the next day really bad and she was tired and wanted to sleep and lounge around all day so she slept and then the next day her arm was a little sore on Sunday and then it was gone the next day. Caller stated after her second vaccine she has an itchy rash, tiredness, headaches, chills, joint pain, and diarrhea that came and went.Clarified the itchy rash started on her spine and went up her spine to her shoulder blades to her chest and to her face. Stated they are telling her it was not from the vaccine and stated she still had the itching, and it was terrible. Treatment: Caller states none because they are telling her she is not have any side effects. States he just sent her to an allergist, and he said it is not from the vaccine. On 08Mar2021 the patient experienced itchy rash, tiredness, headache, chills, joint pain, diarrhea. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash; Tiredness; Headache; Chills; Joint pain; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), dose 2 via an unspecified route of administration on 05Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine was that patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267; Expiration Date: 31MAY2021), dose 1 via an unspecified route of administration on 12FEB2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included, from an unknown date and unknown if ongoing. Concomitant medications included methotrexate METHOTREXATE taken for rheumatoid arthritis, start and stop date were not reported; adalimumab (HUMIRA) taken for rheumatoid arthritis, start and stop date were not reported. Caller stated after her first vaccine, her arm hurt the next day really bad and she was tired and wanted to sleep and lounge around all day so she slept and then the next day her arm was a little sore on Sunday and then it was gone the next day. Caller stated after her second vaccine she has an itchy rash, tiredness, headaches, chills, joint pain, and diarrhea that came and went.Clarified the itchy rash started on her spine and went up her spine to her shoulder blades to her chest and to her face. Stated they are telling her it was not from the vaccine and stated she still had the itching, and it was terrible. Treatment: Caller states none because they are telling her she is not have any side effects. States he just sent her to an allergist, and he said it is not from the vaccine. On 08Mar2021 the patient experienced itchy rash, tiredness, headache, chills, joint pain, diarrhea. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Difficulty breathing; His chest still hurt; This is a spontaneous report from a contactable consumer. An 18-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EP7533), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 as DOSE 1, SINGLE for covid-19 immunisation (at the age of 18 years). The patient medical history was not reported. Concomitant medication included somatropin (OMNITROPE) taken for an unspecified indication, start and stop date were not reported. On 08Apr2021 patient experienced His chest still hurt, on an unspecified date patient experienced He had difficulty breathing. Reporter stated that his chest still hurt, but it's easier for him to breath. He feels it's not a hundred percent, but it is better. The adverse events resulted in emergency room visit. The patient was not received treatment. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Respiratory disorder
Clinical narrative: Respiratory disorder; muscle aches; feeling like death; This is a follow up spontaneous report received from a non-contactable consumer or other non-HCP via Company Representative. A 40-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient experienced respiratory disorder, muscle aches and feeling like death, as she stated after second dose of Covid vaccine. Event took place after use of product. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever; I feel terrible, I had body ache everything; I feel terrible, I had body ache everything; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).     A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported; Expiry date: unknown) dose 1 via an unspecified route of administration on 26Mar2021 as dose 1, single (at the age of 46-year-old) for covid-19 immunization.The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, Consumer stated, that she had side effects from the vaccine, she took pfizer vaccine yesterday after which she felt terrible, she had a fever and body ache everything. 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: Arthralgia, Chills, Cough, Feeling of body temperature change, Irritability
Clinical narrative: Irritated; joint pain; nauseous overnight; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced irritated, joint pain, nauseous overnight, had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: Irritated; joint pain; nauseous overnight; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced irritated, joint pain, nauseous overnight, had symptoms like colds, coughing,chills, hot and cold all night,sore on the arm and pain in her knee after the first dose. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis; This is a spontaneous report from a Pfizer sponsored program regulatory authority. A contactable male consumer (husband) reported for a female patient (reporter's wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: not reported, Expiry date: not reported), dose 1 via an unspecified route of administration on 16Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Ear pain, Headache, Hyperhidrosis
Clinical narrative: Chills; sweat; hurting inside the ears; Headache/a massive head ache; Neck pain; Muscle ache; Fever/a fever of 106 Fahrenheit; my arm was sore; This is a spontaneous report from a contactable consumer (patient herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number ER38730), 1 via an unspecified route of administration on 27Mar2021 03:00 (at the age of 63 years old)as dose 1, single for COVID-19 immunization .Medical history included fibromyalgia Start date: 1985, lymphoedema Consumer stated, It was diagnosed 2-3 years ago, depression, panic disorder. Concomitant medication(s) included CLONAZEPAM taken for panic disorder, DULOXETINE taken for depression, HYDROCHLOROTHIAZIDE Consumer stated, It is a water pill, SPIRONOLACTONE taken for lymphoedema, TOPIRAMATE, it is for Closter Headache, patient was not sure, REQUIP taken for an Ii is for involuntary leg and arm twitching. The patient stated, Called to report an adverse event with Pfizer COVID vaccine. The patient took Pfizer Covid Vaccine first shot on 27 Mar (27Mar2021) and at 3 in the morning her arm was sore and at 5 am she was hit with a massive head ache, Neck pain, muscle pain and had a fever of 106 Fahrenheit. On 28Mar2021 the fever was 102.5 Fahrenheit with massive chills and sweat and it was hurting inside the ears. On 29Mar she was a bit better and after 1 hour after she woke up with the fever was 101.1 Fahrenheit. Yesterday she was a bit better and fever wasn't there. When probed for doctor details, consumer stated, It was not prescribed by anyone, it is just for COVID prevention. When probed for Laboratory tests, consumer stated, had some year ago but she do not remember. It was reported all events are improving. When probed for treatment, consumer stated, she took Acetaminophen and Tylenol. The patient did not went to the hospital. Consumer asked, What are the chances that when she take the second shot and will have the same problems. And will she get some paper work that reported the adverse event. The patient was scheduled for 2nd Shot on 17Apr2021. The outcome of the events my arm was sore, sweat, hurting inside the ears was unknown and rest all events were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Chills; sweat; hurting inside the ears; Headache/a massive head ache; Neck pain; Muscle ache; Fever/a fever of 106 Fahrenheit; my arm was sore; This is a spontaneous report from a contactable consumer (patient herself). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number ER38730), 1 via an unspecified route of administration on 27Mar2021 03:00 (at the age of 63 years old)as dose 1, single for COVID-19 immunization .Medical history included fibromyalgia Start date: 1985, lymphoedema Consumer stated, It was diagnosed 2-3 years ago, depression, panic disorder. Concomitant medication(s) included CLONAZEPAM taken for panic disorder, DULOXETINE taken for depression, HYDROCHLOROTHIAZIDE Consumer stated, It is a water pill, SPIRONOLACTONE taken for lymphoedema, TOPIRAMATE, it is for Closter Headache, patient was not sure, REQUIP taken for an Ii is for involuntary leg and arm twitching. The patient stated, Called to report an adverse event with Pfizer COVID vaccine. The patient took Pfizer Covid Vaccine first shot on 27 Mar (27Mar2021) and at 3 in the morning her arm was sore and at 5 am she was hit with a massive head ache, Neck pain, muscle pain and had a fever of 106 Fahrenheit. On 28Mar2021 the fever was 102.5 Fahrenheit with massive chills and sweat and it was hurting inside the ears. On 29Mar she was a bit better and after 1 hour after she woke up with the fever was 101.1 Fahrenheit. Yesterday she was a bit better and fever wasn't there. When probed for doctor details, consumer stated, It was not prescribed by anyone, it is just for COVID prevention. When probed for Laboratory tests, consumer stated, had some year ago but she do not remember. It was reported all events are improving. When probed for treatment, consumer stated, she took Acetaminophen and Tylenol. The patient did not went to the hospital. Consumer asked, What are the chances that when she take the second shot and will have the same problems. And will she get some paper work that reported the adverse event. The patient was scheduled for 2nd Shot on 17Apr2021. The outcome of the events my arm was sore, sweat, hurting inside the ears was unknown and rest all events were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasopharyngitis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Cold; Cough; Fever; Tiredness; This is a spontaneous report from a contactable adult female consumer reported for her Husband.   A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 25Mar2021 at 08:30 AM (at the age of 32-years-old) at dose 1, single for COVID-19 immunisation. Medical history included asthma (asthma did not continue and did not experience at the time of report, but he had experienced it earlier). Concomitant medications were none. On 25Mar2021, same day of vaccination, in the evening, the patient experienced cold, cough, fever and tiredness. It was reported that after the patient got vaccine in the day, from night onwards he got fever and tiredness (exact time was not known but in the evening). The fever stayed for 3 continuous days and he was fine a bit after that, and the fever stayed for till like Saturday, and Sunday he was fine and Monday also he was fine a bit. But today he is (incomplete sentence). Side effects like fever and cough, a bit of cold were still present at the time of report. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Negative on an unspecified date in 2021. The patient did not receive treatment for the events. The outcome of events cold, cough and fever was not recovered, and unknown for tiredness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over my legs, back, thighs, the upper legs and my arms; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration on 10Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing Verbatim: Cholesterol. The patient's concomitant medications were not reported. Nurse practitioner said to take Benadryl (treatment) which patient did and said it makes you sleepy. She worked part time. So she took it for 3 days Tuesday, Wednesday Thursday and Friday and then she went to take something different. She had to take the weekend off. So the initial Saturday and got a week and a half. Nurse practitioner told patient that you are going to take the vaccine on 31st start taking Claritin. She started taking Claritin last week for 7 days because she was going to get that tomorrow. The patient experienced rash all over my legs, back, thighs, the upper legs and my arms on 14Mar2021. The outcome of the events was recovered. Therapeutic measures were taken as a result of rash all over my legs, back, thighs, the upper legs and my arms (as patient said she was taking Claritin to avoid reaction) No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Oxygen saturation, Spirometry, Yawning
Clinical narrative: Chest tightness; Shortness of breath; Yawning a lot; This is a spontaneous report from a contactable other hcp. A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8729) intramuscular, on 12Apr2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient may have taken some over the counter congestion medication. Investigation assessment was performed. On 12Apr2021, the patient was waiting the 20 minutes after receiving the vaccine and he was yawning a lot. On 13Apr2021, the patient experienced chest tightness and shortness of breath. Chest tightness was reported as worsened. The patient was having a harder time catching his breath, no need for an emergency room visit, it was not severe. The patient yawned a lot but was fine 2 hours later because he went to football practice. The patient's oxygen saturation was 97 percent and spirometer was normal. The patient underwent lab tests and procedures which included oxygen saturation: 97 percent and spirometry was normal on Jul2021. The outcome of the event yawning a lot was unknown. The outcome of the events chest tightness and shortness of breath was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic, Rash vesicular, Vaccination site rash, Vaccination site vesicles
Clinical narrative: Red bumps, Blistery, itchy generalized rash; Red bumps, Blistery, itchy generalized rash; crazy itching all over; At the site of the injection now has all red bumps all around it; It started red bumps then the blister end loose yellow; At the site of the injection now has all red bumps all around it; It started red bumps then the blister end loose yellow; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7533) via an unspecified route of administration, administered in the left arm on 11Apr2021 at 10:30 (at the age of 64-year-old) as dose 2, single for COVID-19 immunization at hospital. Medical history included hypothyroidism and Allergies to medications, food, or other products included PCN, ASA, NSAIDS. Concomitant medications included levothyroxine sodium (SYNTHROID); cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID), Vitamin D; all taken for an unspecified indications, start and stop dates were not reported. Historical vaccine included first dose of BNT162B2 (Lot Number: ER8727) via an unspecified route of administration, administered in the left arm on 21Mar2021 at 15:15 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, the patient was not tested for COVID-19. It was reported that, Patient received vaccine on 11Apr2021 (Sunday). The following Wednesday on an unspecified date in Apr2021, patient started developing to a look like a blistery rash on his arm, the opposite arm of the injection site. The patient experienced red bumps, blistery, itchy generalized rash. And at the site of the injection now had all red bumps all around it, It started with red bumps then the blister end loose yellow. He was suffering with crazy itching all over. And it was thought to be poison Ivy. Since then or since Wednesday, It was not generalized at that time, It was growing. So the only thing that it could be is the vaccine. So, now it was generalized at the time of report. Patient received treatment for the events with Calamine lotion. Outcome of the events was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Nausea; Diarrhea; Fever; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing,.thyroid issues, anaemia, vitamin b12 deficiency from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced nausea on an unspecified date with outcome of unknown, diarrhoea on an unspecified date with outcome of unknown and fever on an unspecified date with outcome of unknown.    Follow-up (15Apr2021): This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that: Husband and wife both had their 1st shot on 13Apr21. Wife had nausea, diarrhoea and fever. Wants to know if ok to have 2nd dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from non-contactable consumer (patient).   A female patient of an unspecified age BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date: Not reported), via an unspecified route of administration, administered in Arm, on an unknown date in Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Mar2021, after first vaccination (on Saturday) patient experienced a rash on her forearm and wanted to know what to do and how to treat the rash. The clinical outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Limb discomfort, Neck pain
Clinical narrative: her whole left side where her arm all the way to her elbow and around her back its hurting; headaches; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting /Verified that she was referring to injection site; up to her neck it hurts; maybe that's part of the body aches; it's like some weight is on me; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Apr2021(Saturday) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, patient experienced headache and this morning when she woke up her whole left side where her arm all the way to her elbow and around her back its hurting this has been since Saturday and verified that she was referring to injection site, up to her neck it hurts, it was like some weight is on her and maybe that's part of the body aches. Patient wants to know how long side effects will last and stated people say it couple of days, but it has been almost 5 days. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: her whole left side where her arm all the way to her elbow and around her back its hurting; headaches; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting /Verified that she was referring to injection site; up to her neck it hurts; maybe that's part of the body aches; it's like some weight is on me; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Apr2021(Saturday) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, patient experienced headache and this morning when she woke up her whole left side where her arm all the way to her elbow and around her back its hurting this has been since Saturday and verified that she was referring to injection site, up to her neck it hurts, it was like some weight is on her and maybe that's part of the body aches. Patient wants to know how long side effects will last and stated people say it couple of days, but it has been almost 5 days. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Hypoaesthesia
Clinical narrative: Pain at the injection site; Numbness in left arm (location of the immunization); Fatigue; Headache; Full body aches; Intermittent chills; Hot flashes; Possible fever; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 08Apr2021 12:45 (at the age of: 48-years-old) as dose 2, single for covid-19 immunisation. Medical history included depression, insomnia and blood cholesterol increased from an unknown date . The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:15 for covid-19 immunisation. The patient was non pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient received other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Apr2021 08:00 the patient experienced pain at the injection site, numbness in left arm, fatigue, headache, full body aches, intermittent chills, hot flashes and possible fever. Therapeutic measures were taken as a result events with tylenol extra strength. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site; Numbness in left arm (location of the immunization); Fatigue; Headache; Full body aches; Intermittent chills; Hot flashes; Possible fever; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 08Apr2021 12:45 (at the age of: 48-years-old) as dose 2, single for covid-19 immunisation. Medical history included depression, insomnia and blood cholesterol increased from an unknown date . The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 18Mar2021 12:15 for covid-19 immunisation. The patient was non pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to vaccination. The patient received other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Apr2021 08:00 the patient experienced pain at the injection site, numbness in left arm, fatigue, headache, full body aches, intermittent chills, hot flashes and possible fever. Therapeutic measures were taken as a result events with tylenol extra strength. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pruritus
Clinical narrative: my arm was really itchy; lump; This is a spontaneous report from a consumer (patient) reported for herself that. A 67-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Apr2021, the patient noticed her arm was really itchy and a lump there, not at the injection site, it's 2 inches over from the injection site. It was reported that, she laid on her left side all the time. Not sure if side effect or something else. Outcome of events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed hives within an hour; This is a spontaneous case received from a contactable consumer from a Pfizer-Sponsored Program.   A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. According to the reporter, the patient received second dose of vaccine and developed hives within an hour and has not gone away. The outcome of the event was not recovered.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Right arm is swollen and tingling/Right hand is numb and swollen; Right hand is numb and swollen; Right shoulder hurts; Arm is tingling; Fell on right arm; Hurst to move her right arm, hand, and shoulder; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 12:15 (at the age of 16-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient had no other products. The patient had no history of previous immunizations. No additional vaccines administered on same date. The patient had no prior vaccinations within 4 weeks. The patient received first shot yesterday on 14Apr2021. On the same day, at night, she fell on her right arm when she was playing with her dog. On 15Apr2021, symptoms developed about 22 hours later in the morning. Her arm was experiencing pain, numbness and swelling, her right shoulder also hurts, but the dog jumped on her, so she was not sure if it was from the vaccine or not. She asked are these normal side effects. Her right arm was swollen, right hand was numb and swollen, asked if this could be from the shot. Right Arm was tingling. Hurst to move her right arm, hand, and shoulder. Caller was looking on her paperwork and didn't know if this was a side effect. Was it different in children. The patient did not visit any not yet. The patient had no relevant tests. The outcome of the event Fell on right arm was unknown and outcome of all other events was not recovered.   Information on lot/Batch number has been requested.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Right arm is swollen and tingling/Right hand is numb and swollen; Right hand is numb and swollen; Right shoulder hurts; Arm is tingling; Fell on right arm; Hurst to move her right arm, hand, and shoulder; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 12:15 (at the age of 16-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history and family history. The patient's concomitant medications were not reported. The patient had no other products. The patient had no history of previous immunizations. No additional vaccines administered on same date. The patient had no prior vaccinations within 4 weeks. The patient received first shot yesterday on 14Apr2021. On the same day, at night, she fell on her right arm when she was playing with her dog. On 15Apr2021, symptoms developed about 22 hours later in the morning. Her arm was experiencing pain, numbness and swelling, her right shoulder also hurts, but the dog jumped on her, so she was not sure if it was from the vaccine or not. She asked are these normal side effects. Her right arm was swollen, right hand was numb and swollen, asked if this could be from the shot. Right Arm was tingling. Hurst to move her right arm, hand, and shoulder. Caller was looking on her paperwork and didn't know if this was a side effect. Was it different in children. The patient did not visit any not yet. The patient had no relevant tests. The outcome of the event Fell on right arm was unknown and outcome of all other events was not recovered.   Information on lot/Batch number has been requested.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a rash that has appeared on my extremities (arms and legs); This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i have a rash that has appeared on my extremities (arms and legs) on an unspecified date. Reported as, patient have a rash that has appeared on his extremities (arms and legs) since my first Covid shot. Patient was concerned about receiving the second shot. Patient was concerned about the rash spreading. 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: Chest pain, Headache, Migraine, Neck pain, Pain in extremity
Clinical narrative: Sore arm; Got chest pains; Headache; Chronic migrains; Pain in my neck; This is a spontaneous report from a contactable consumer or other non-HCP (patient) received via  sponsored program. A 68-years-old patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization at Baylor Dallas downtown. Patient medical history included immune system disorder and heart problems. The concomitant medication included rizatriptan benzoate (MAXALT) taken as a 10 mg for unspecified indication start and stop date were not reported. The patient experienced sore arm until the next day it went away, got chest pains, headache, pain in my neck, pain in my left arm and chronic migrains on an unspecified date. The clinical outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Pelvic pain
Clinical narrative: had pelvic pain; spotting; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, exactly 10 days after vaccine administration, the patient experienced pelvic pain and spotting. She stated this was not normal for her and she wants to speak to someone about side effects. Case assessed as non-serious by reporter. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.