chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever of 100.2; Blood sugar keeps dropping; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male adult patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Right on 28Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunization. No Known allergies. Facility type Vaccine was Workplace clinic. No other vaccine in four weeks. No covid prior vaccination, No covid tested post vaccination. Medical history included hypertension, diabetic. Concomitant medications in two weeks included metformin (METFORMIN); nebivolol hydrochloride (BYSTOLIC). On 28Jan2021, the patient experienced sore arm, fever of 100.2, blood sugar keeps dropping. No treatment provided for the events. The patient underwent lab tests and procedures which included blood sugar keeps dropping, body temperature was 100.2. The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff and sore neck; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:00 as unknown, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included infliximab (REMICADE), omeprazole (OMEPRAZOLE), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) taken for an unspecified indication, start and stop date were not reported. On 27Jan2021, the patient experienced stiff and sore neck. The treatment was not received for the adverse event. The outcome of event was recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen left Armpit and left neck.; Swollen left Armpit and left neck.; This is a spontaneous report from a contactable consumer or other non HCP. A 41-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Left on 23Jan2021 13:30 (age at vaccination 41-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. Facility type for vaccination was hospital. The patient's medical history and concomitant medications were not reported. On 25Jan2021 08:00 the patient experienced swollen left armpit and left neck. Treatment was not received by the patient. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: After my first Pfizer vaccine it had facial numbness for about 30 minutes or so.; This is a spontaneous report from a contactable Other Health Professional (patient). A 41 -year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Solution for injection, lot number EL8982 and expiration date 29Jan2021) via unspecified route on Left arm on 29Jan2021 at single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications included Hormone therapy medication prescribed. Historical vac-cine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: Ek9231), via an unspecified route of administration in the on Left arm on 07Jan2021 at 02:00 PM at un-known time as a single dose for COVID-19 immunization. The patient did not have allergies to medica-tions, food or other products. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 07Jan2021 at 02:30 PM, the patient after her first Pfizer vaccine it had facial numbness for about 30 minutes or so. The patient did not receive any treatment for the adverse events. The seriousness of the event was non-serious. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site pain
Clinical narrative: Injection site pain; lethargy; This is a spontaneous report from a contactable Other Health Professional. A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: Solution for injection, Lot Number: Unknown), dose 1 intramuscular, administered in arm left on 28Jan2021 13:15 PM as 1st dose, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. And also reported that any other medications the patient did not received within 2 weeks of vaccination. The patient experienced injection site pain and lethargy on 28Jan2021 at 21:00. No treatment was given for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The clinical outcome of events were recovering.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Heart rate increased
Clinical narrative: all of a sudden my heart started to beat really fast; anxiety; This is a spontaneous report from a contactable consumer(patient) reported for herself. An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number and expiration date was not reported), via an unspecified route of administration, on 22Jan2021 as UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On 29Jan2021 the patient had experienced that the heart started to beat fast and took an anxiety pill because patient do have anxiety at times. The patient underwent lab tests and procedures which included heart rate: really fast. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: I had tiredness, muscle ache  and chills for about 20 hours; I had tiredness, muscle ache  and chills for about 20 hours; I had tiredness, muscle ache  and chills for about 20 hours; This is a spontaneous report from a contactable physician.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EK5730), via an unspecified route of administration on 21Dec2020 as 1st dose single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  he patient received 2nd dose of (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021.  Patient have concerns about the Pfizer Covid vaccines effectiveness.  patient had an antibody testing with SARS-CoV-2 antibody kit with a reported IgG antibody test that has 99.63% specificity and 100% sensitivity that was completely negative at 16 days following the second dose of Pfizer COVID-19 vaccine, and had the first dose exactly three weeks prior. After the first of shot on 21Dec, patient had tiredness, muscle ache and chills for about 20 hours. Following the second shot on 11Jan no adverse reactions were experienced. Patient have read information from Pfizer indicating that its vaccine exhibits a robust induction of antibody response. The lot numbers of the vaccines I received were EK 5730 (1st Dose) and EL 3246 (2nd Dose). The patient said appreciated advice on how to proceed with concern as a health care provider who was constantly exposed to the virus. The patient wonder if the mRNA already degraded in these lots making the vaccine ineffective.  Also, patient wonder if re-vaccination was recommended. The patient underwent lab tests and procedures which included sars-cov-2 test was negative   on Jan2021. The outcome of the event was reported as unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: All-over body hives/ some hives on her thigh, and they spread throughout her body; Had couple of bumps on her body after getting vaccinated/3 bumps on inside of thigh; Felt hot and took temp and had no fever; Nauseous and sickly feeling; Nauseous and sickly feeling; Soreness; Sore and stiffness in muscles; Sore and stiffness in muscles; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer (Patient). A 67-years-old female elderly patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), dose 1 intramuscular, administered in Arm Left on 22Jan2021 09:00 as single dose for covid-19 immunisation. Medical history included allergies, compromised immune status, She takes regular prescriptions for blood pressure , respiratory illness, Genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, She was taking Chemo 5 1/2 years ago but not any more, for breast cancer, high blood pressure, which was prior to getting vaccine; she could not take Taxotere and a CyL one, She later corrected to state it was one Paclitaxel and Docetaxel, she does not have a lot or expiration for either, her body had a severe reaction to them; chronic kidney disease that was diagnosed 3-4 months ago, regular flu vaccine- she gets sick, nausea, lightheaded, warm and want to throw up. The patient family medical history included diabetes, blood pressure, heart issues. Prior to vaccination the patient did not receive any other vaccines within 4 weeks. No additional Vaccines administered on same date of the Pfizer Suspect. The patient's concomitant medications were not reported.  The patient had couple of bumps on her body after getting vaccinated/3 bumps on inside of thigh on 28Jan2021 08:30, all-over body hives/ Hives on whole body including stomach, arms, thighs on 28Jan2021 22:30, soreness, sore and stiffness in muscles on 22Jan2021 09:30, felt hot and took temp and had no fever on 26Jan2021, nauseous and sickly feeling on 26Jan2021. It was reported that after first shot she was fine at first and just had a little soreness. Yesterday, she developed 2 bumps on inside of her thigh. She thought she got bit by a spider. Last night, she noticed her stomach, arms, thighs and whole body had hives. Maybe they turned into hives. The ones on her thighs are now hives. Her whole body is broken out with hives and these bumps. She would like to know if she can still have symptoms from that much time frame after the first injection. The events did not resulted in emergency room visit. The outcome of the events soreness, sore and stiff muscles, Felt hot and took temp and had no fever, Nauseous and sickly feeling were recovering and the outcome of 3 bumps on inside of thigh, hives on whole body including stomach, arms, thighs were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin disorder, Urticaria
Clinical narrative: All-over body hives/ some hives on her thigh, and they spread throughout her body; Had couple of bumps on her body after getting vaccinated/3 bumps on inside of thigh; Felt hot and took temp and had no fever; Nauseous and sickly feeling; Nauseous and sickly feeling; Soreness; Sore and stiffness in muscles; Sore and stiffness in muscles; This is a spontaneous report received from a Pfizer-sponsored program from a contactable consumer (Patient). A 67-years-old female elderly patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), dose 1 intramuscular, administered in Arm Left on 22Jan2021 09:00 as single dose for covid-19 immunisation. Medical history included allergies, compromised immune status, She takes regular prescriptions for blood pressure , respiratory illness, Genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, She was taking Chemo 5 1/2 years ago but not any more, for breast cancer, high blood pressure, which was prior to getting vaccine; she could not take Taxotere and a CyL one, She later corrected to state it was one Paclitaxel and Docetaxel, she does not have a lot or expiration for either, her body had a severe reaction to them; chronic kidney disease that was diagnosed 3-4 months ago, regular flu vaccine- she gets sick, nausea, lightheaded, warm and want to throw up. The patient family medical history included diabetes, blood pressure, heart issues. Prior to vaccination the patient did not receive any other vaccines within 4 weeks. No additional Vaccines administered on same date of the Pfizer Suspect. The patient's concomitant medications were not reported.  The patient had couple of bumps on her body after getting vaccinated/3 bumps on inside of thigh on 28Jan2021 08:30, all-over body hives/ Hives on whole body including stomach, arms, thighs on 28Jan2021 22:30, soreness, sore and stiffness in muscles on 22Jan2021 09:30, felt hot and took temp and had no fever on 26Jan2021, nauseous and sickly feeling on 26Jan2021. It was reported that after first shot she was fine at first and just had a little soreness. Yesterday, she developed 2 bumps on inside of her thigh. She thought she got bit by a spider. Last night, she noticed her stomach, arms, thighs and whole body had hives. Maybe they turned into hives. The ones on her thighs are now hives. Her whole body is broken out with hives and these bumps. She would like to know if she can still have symptoms from that much time frame after the first injection. The events did not resulted in emergency room visit. The outcome of the events soreness, sore and stiff muscles, Felt hot and took temp and had no fever, Nauseous and sickly feeling were recovering and the outcome of 3 bumps on inside of thigh, hives on whole body including stomach, arms, thighs were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chills, Dizziness
Clinical narrative: Nausea; Dizziness; Weakness; Fast heartbeat; High blood pressure; Injection site pain; Low grade fever; Fatigue; Headache; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 09:00 (Batch/Lot Number: EL3249) (at the age of 25-years-old) as single dose for covid-19 immunisation. Medical history included endometriosis, known allergies to most antibiotics, Guaifenesin, Venlafaxine, peanuts and eggplant. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 05Jan2021 09:00 (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Concomitant medication(s) in two weeks included escitalopram oxalate (LEXAPRO), levocetirizine dihydrochloride (XYZAL) and levonorgestrel (MIRENA) taken unknown indication from unknown date. No other vaccine was taken in four weeks of time. Patient did not have COVID prior to vaccination and was not tested post vaccination for the same. On 26Jan2021 at 20:00 patient experienced dizziness, weakness, fast heartbeat, high blood pressure, injection site pain, low grade fever, fatigue, headache, muscle aches, chills and nausea. No treatment was taken as a result of events and outcome of all the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Hypertension
Clinical narrative: Nausea; Dizziness; Weakness; Fast heartbeat; High blood pressure; Injection site pain; Low grade fever; Fatigue; Headache; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 09:00 (Batch/Lot Number: EL3249) (at the age of 25-years-old) as single dose for covid-19 immunisation. Medical history included endometriosis, known allergies to most antibiotics, Guaifenesin, Venlafaxine, peanuts and eggplant. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 05Jan2021 09:00 (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Concomitant medication(s) in two weeks included escitalopram oxalate (LEXAPRO), levocetirizine dihydrochloride (XYZAL) and levonorgestrel (MIRENA) taken unknown indication from unknown date. No other vaccine was taken in four weeks of time. Patient did not have COVID prior to vaccination and was not tested post vaccination for the same. On 26Jan2021 at 20:00 patient experienced dizziness, weakness, fast heartbeat, high blood pressure, injection site pain, low grade fever, fatigue, headache, muscle aches, chills and nausea. No treatment was taken as a result of events and outcome of all the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Nausea; Dizziness; Weakness; Fast heartbeat; High blood pressure; Injection site pain; Low grade fever; Fatigue; Headache; Muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 09:00 (Batch/Lot Number: EL3249) (at the age of 25-years-old) as single dose for covid-19 immunisation. Medical history included endometriosis, known allergies to most antibiotics, Guaifenesin, Venlafaxine, peanuts and eggplant. The patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 05Jan2021 09:00 (Batch/Lot Number: EK9231) as single dose for covid-19 immunisation. Concomitant medication(s) in two weeks included escitalopram oxalate (LEXAPRO), levocetirizine dihydrochloride (XYZAL) and levonorgestrel (MIRENA) taken unknown indication from unknown date. No other vaccine was taken in four weeks of time. Patient did not have COVID prior to vaccination and was not tested post vaccination for the same. On 26Jan2021 at 20:00 patient experienced dizziness, weakness, fast heartbeat, high blood pressure, injection site pain, low grade fever, fatigue, headache, muscle aches, chills and nausea. No treatment was taken as a result of events and outcome of all the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Blood test, Inflammatory marker increased
Clinical narrative: pain in her shoulders and legs/the pain in her shoulders is bilateral; pain in her shoulders and legs; difficult for her to sleep at night; anytime she has to engage her muscles to move it hurts; her blood pressure was elevated but not at an alarming level; her inflammatory markers were elevated; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiry date not reported) via an unspecified route of administration as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing The patient's concomitant medications were not reported. On an unspecified date, patient started experiencing pain in her shoulders and legs that was making it difficult for her to sleep at night. She states that anytime she has to engage her muscles to move it hurts. She notices it mostly when she has been lying or sitting still for long periods of time and then tries to move. She also states that once she is moving around it doesn't bother her as much. She has a history of arthritic problems in the past but she has never experienced pain in her legs before now. She reports that she did not have any arm pain at the injection site and the pain in her shoulders is bilateral. Her husband stated that she did call and report these symptoms to Pfizer already but they would like to know if these symptoms could be related to the vaccine or if they could potentially be related to something else. The patient did see her PCP on Tuesday of this week for these symptoms and she noted that her blood pressure was elevated but not at an alarming level. On 26JAN2021, the patient underwent lab tests and procedures which included blood pressure measurement: elevated, blood test: inflammatory markers were elevated. Her blood pressure elevated but not at alarming level. The patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine since she has experienced these side effects. The outcome of events was unknown.   No follow up attempts possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain in extremity
Clinical narrative: pain in her shoulders and legs/the pain in her shoulders is bilateral; pain in her shoulders and legs; difficult for her to sleep at night; anytime she has to engage her muscles to move it hurts; her blood pressure was elevated but not at an alarming level; her inflammatory markers were elevated; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiry date not reported) via an unspecified route of administration as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing The patient's concomitant medications were not reported. On an unspecified date, patient started experiencing pain in her shoulders and legs that was making it difficult for her to sleep at night. She states that anytime she has to engage her muscles to move it hurts. She notices it mostly when she has been lying or sitting still for long periods of time and then tries to move. She also states that once she is moving around it doesn't bother her as much. She has a history of arthritic problems in the past but she has never experienced pain in her legs before now. She reports that she did not have any arm pain at the injection site and the pain in her shoulders is bilateral. Her husband stated that she did call and report these symptoms to Pfizer already but they would like to know if these symptoms could be related to the vaccine or if they could potentially be related to something else. The patient did see her PCP on Tuesday of this week for these symptoms and she noted that her blood pressure was elevated but not at an alarming level. On 26JAN2021, the patient underwent lab tests and procedures which included blood pressure measurement: elevated, blood test: inflammatory markers were elevated. Her blood pressure elevated but not at alarming level. The patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine since she has experienced these side effects. The outcome of events was unknown.   No follow up attempts possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Red rash near injection site, slightly raised; Red rash near injection site, slightly raised; Red rash near injection site, slightly raised; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old non- pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm Left on 19Jan2021 09:45 as single dose for covid-19 immunisation. Patient was not tested for COVID before vaccination. Patient was not tested for COVID post vaccination. Patient did not took any other vaccine in 4 weeks. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Red rash near injection site, slightly raised. The outcome of the events was recovering. There was no treatment given to treat events.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling; received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling; This is a spontaneous report from a contactable consumer or other non hcp. A 26-years-old female patient received bnt162b2 (BNT162B2 solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication. The patient medical history and concomitant was not reported. On unknown date, the patient received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling with outcome of unknown. Clinical measures were taken, She has taken Benadryl for this but it has not gone down, and they are thinking whether she should get the second dose of the vaccine. Therapeutic measures were taken as a result of received the covid vaccine on Tuesday and experienced a sensitive allergic reaction consisting of facial swelling. Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.  \
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Photophobia, Pyrexia
Clinical narrative: She has a very bad headache/worst headache; fever; achiness; she cant even look at the bright lights on the screen; This is a spontaneous report from a contactable consumer (the patient). A 58 age (unit: not reported) female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 28Jan2021 11:00 as a 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, caller took Covid vaccine yesterday and now today she had a very bad headache. She was wondering when she can take some pain relievers. She declined PMI information. They told her at the vaccine site not to take any pain reliever. She had the vaccine at 11. She had the worst headache, fever, and achiness. When can she take something without losing effectiveness of the vaccine. She declined to write down the websites for further covid vaccine information stating that she cant even look at the bright lights on the screen. When queried for address caller states that she doesn't want to do any of this, she had a headache and already has been on hold for a long time. She just wants her question addressed. Caller declined safety report. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Disturbance in attention, Fatigue
Clinical narrative: Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumbled speech; Numbness; Tingling all over; Difficulty focusing; Body Aches; Fatigue, Tiredness; Foggy head; This is a spontaneous report from a contactable other hcp (Nurse). A 40-years-old female non pregnant patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0142), intramuscular, administered in Arm Left on 28Jan2021 at 08:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of bnt162b2 as first dose (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 08Jan2021 at 03:00 PM (Batch/Lot Number was EL0140) as first dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No allergies were found. Patient was not pregnant at the time of vaccination. Patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 28Jan2021 at 17:00 patient experienced severe chills, joint pain, severe headache, stomachache, cold feet/ cold hands, forgetfulness, mumbled speech, numbness, tingling all over of, difficulty focusing, body aches, fatigue, tiredness and foggy head. No treatment was received. The outcome of the events was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Memory impairment, Pain
Clinical narrative: Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumbled speech; Numbness; Tingling all over; Difficulty focusing; Body Aches; Fatigue, Tiredness; Foggy head; This is a spontaneous report from a contactable other hcp (Nurse). A 40-years-old female non pregnant patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0142), intramuscular, administered in Arm Left on 28Jan2021 at 08:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of bnt162b2 as first dose (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 08Jan2021 at 03:00 PM (Batch/Lot Number was EL0140) as first dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No allergies were found. Patient was not pregnant at the time of vaccination. Patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 28Jan2021 at 17:00 patient experienced severe chills, joint pain, severe headache, stomachache, cold feet/ cold hands, forgetfulness, mumbled speech, numbness, tingling all over of, difficulty focusing, body aches, fatigue, tiredness and foggy head. No treatment was received. The outcome of the events was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Speech disorder
Clinical narrative: Severe chills; Joint pain; Severe Headache; Stomach Ache; Cold feet/ Cold hands; Forgetfulness; Mumbled speech; Numbness; Tingling all over; Difficulty focusing; Body Aches; Fatigue, Tiredness; Foggy head; This is a spontaneous report from a contactable other hcp (Nurse). A 40-years-old female non pregnant patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0142), intramuscular, administered in Arm Left on 28Jan2021 at 08:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of bnt162b2 as first dose (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm right on 08Jan2021 at 03:00 PM (Batch/Lot Number was EL0140) as first dose single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No allergies were found. Patient was not pregnant at the time of vaccination. Patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 28Jan2021 at 17:00 patient experienced severe chills, joint pain, severe headache, stomachache, cold feet/ cold hands, forgetfulness, mumbled speech, numbness, tingling all over of, difficulty focusing, body aches, fatigue, tiredness and foggy head. No treatment was received. The outcome of the events was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Extremely dizzy, almost fell, after reaching up. This has never happened before; Extremely dizzy, almost fell, after reaching up. This has never happened before; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 28Jan2021 18:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included glucose tolerance impaired. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination.Patient did not have allergies to medications, food, or other products and no known allergies. The patient's concomitant medications were not reported. On 29Jan2021 08:45, the patient experienced Extremely dizzy, almost fell, after reaching up. This has never happened before. Treatment was not received for the adverse event. Outcome of the event was recovered on an unspecified date.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable nurse (patient). A 59-years-old female patient received second dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL0142; expiration: not reported), via an unspecified route of administration, administered in arm left on 27Jan2021 as single dose for covid-19 immunisation (at the age of 59 years and the patient was not pregnant at the time of vaccination) at hospital. Medical history included iron deficiency from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, sulfa allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN SR) taken for an unspecified indication, start and stop date were not reported; HCTZ (HCTZ) taken for an unspecified indication, start and stop date were not reported; pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported and hormone replacement therapy (HRT) (all medication within 2 weeks of vaccination). Previously, patient received BNT162B2, via an unspecified route of administration, administered in arm left on 06Jan2021 (Batch/Lot Number: EJ1685; expiration: not reported) as first dose, single for covid-19 immunisation (at the age of 59years). On 29Jan2021 04:30, 2nd day after 2nd dose the patient woke up extremely dizzy. Dizziness had lessened in intensity over last 6 hours but has not resolved. No treatment received for the adverse event. Outcome for event was not recovered.  Follow-up (15Apr2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: left arm swelling size is pretty close to a golf ball; elbow is swollen/left elbow swelling/knot on his elbow; This is a spontaneous report from a contactable Consumer. This male consumer (patient, reported for herself)  A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in Arm Left on 26Jan2021 10:45 as single for covid-19 immunisation.  Medical history included blood pressure high (Caller says it has been diagnosed for every bit of ten years) and two stents from Apr2020 to an unknown date. Concomitant medications included gabapentin taken for blood pressure high as 100mg once a day by mouth and a blood thinner. Patient says he has had no other vaccinations recently. He says that the Gabapentin is in a white bottle, but the LOT/EXP was covered by a pharmacy label. No further details provided about the other two medications patient mentioned that are not new medications.  Patient reported that he got his first dose of the Pfizer COVID-19 vaccine at 11:00AM on 26Jan2021. He says he has developed a swelling on his elbow, and called but no one answered. Patient says he didn't see his doctor about it yet, he woke up this morning and noticed it, today 29Jan2021. He says that it is just one elbow that is swelling, on the arm where he got the injection. Patient says he has his hand-written vaccine card, but they didn't write NDC/LOT/EXP on it. Patient clarifies that he probably got his shot injected around 10:45AM, because he had to wait until 11:00AM to leave. He says that the left arm swelling size is pretty close to a golf ball. Regarding Investigations, the patient reported that he had labs at the (Medical center name) before he got his COVID vaccine shot, which he also got there, but he hasn't got the results back yet. Investigation Assessment: Unknown. The patient reported that so far the swelling is not sore or anything, he just has a knot on his elbow. He says he would like to know if he should see a doctor if it gets worse, and find out if he should put a cold compress on the swelling. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer. This consumer (Caregiver) reported for a male patient (brother-in-law).  A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient he experienced fever and chills since Last night (28Jan2021) that lasted until today (29Jan2021). Reporter wanted to know whether it was normal to experience these side effects. The outcome of the events was unknown. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. No PQC involved.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Tinnitus
Clinical narrative: ear buzzing like a mini tornado or hurricane wind sound/ right ear sounded like it had a motor running in it. It was a loud humming in his ear; dry mouth; This is a spontaneous report from a contactable consumer (Patient).    A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 25Jan2021 as single dose for covid-19 immunisation. Medical history included excessive cerumen production and cerumen removal. The patient's concomitant medications were not reported. Caller stated he wanted to report side effects for the first dose of the Pfizer vaccine he got on the 25Jan2021, He said when he wakes up his "ear buzzing like a mini tornado or hurricane" wind sound. it usually goes away after few hours, it has been happening in the morning. On 26Jan2021, he also has dry mouth, had never experienced something like this before. Then, yesterday morning on 28Jan2021, at 3 am, his right ear sounded like it had a motor running in it. It was a loud humming in his ear. It eventually went away before he got up.This morning, he had the same thing at about 4-430 am. He turned over and his ear had like a mild roaring. It sounded like a motor running. It was like a rushing sound. It went away by this morning. He didn't have a prescribing doctor. The dry mouth wasn't a solid 12 hours.It comes at odd times. Patient understood mouth breathing could cause dry mouth, but he isn't breathing from his mouth. He is normal breathing. His mouth is dry and has to keep drinking water. Sometimes later on in the day it is randomly dry. He has never noticed anything like this in his entire life. When he rolled over in his sleep, he could hear a rushing in his right ear.He had wax in his ear before, and the nurse would pop a ball of wax out that was blocking his ear, but this noise isn't anything like that. Patient never had this noise before. In his 70 some years he has never had ear problems. The outcome of the event tinnitus was not recovered and dry mouth was recovering. Information about Lot/Batch number is requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable consumer (patient, self-reporting). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration dates were not reported), via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for covid-19 immunization. Medical history included autoimmune disorder (He says this issue is separate from the vaccine, a possible autoimmune disorder with symptoms that developed well before the vaccine). The patient's concomitant medications were not reported. The patient received the first dose of the vaccine a week ago today. He stated he has no concerns about side effects. He had some minor arm pain but that was not his concern. He was not taking any medications. However, he has been advised by a physician to take a high dose of prednisone, 15 mg for 3 days, to see if it resolves another issue he had. He says this issue is separate from the vaccine, a possible autoimmune disorder with symptoms that developed well before the vaccine. The caller asked if this would interfere with the efficacy of the vaccine. The caller asked would an antibody test reveal how much protection patient have. Outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.