chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: some chills; fever; nausea; her right knee went out; she developed an ingrown toenail that was painful and she would not walk.; cough; ear hurting; stuffy nose; sore throat; just feeling sick; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (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 unspecified dates, after the first injection of the vaccine, the patient experienced some chills, fever, and nausea that went away. Later, she reports her right knee went out and she developed an ingrown toenail that was painful and she would not walk. She was able to get the ingrown toenail removed by a doctor and was prescribed cefalexin (CEPHALEXIN), taken 4 times a day. At the time of the report, the consumer was experiencing cough, ear hurting, stuffy nose, fever, chills, sore throat, and just feeling sick. The patient was uncertain if this was due to the vaccine, the cefalexin, or some other reason. The patient was scheduled to get the second dose. The patient recovered from nausea and ingrown toenail on unspecified dates while the outcome of the other events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dizziness, Pyrexia
Clinical narrative: she was unable to get an appointment for the 2nd shot due on 29Mar2021; dizziness; fever; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer(patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient experienced she was unable to get an appointment for the 2nd shot due on 29Mar2021 and patient experienced dizziness and fever that might have missed her 2nd shot. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Productive cough, Sinus disorder
Clinical narrative: sinus drainage has significantly increased; dealing with joint pain; coughing more phlegm; This is follow-up spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history includes had a severe case of COVID on an unspecified date in July2020 and was hospitalized. The patient concomitant medications were not reported. It was stated that, he had the usual effects the next day that lasted for a day in a half. On 20Mar2021, the patient experienced sinus drainage has significantly increased, coughing more phlegm, and dealing with joint pain it has almost been two weeks since the first dose. He did not had his second dose and figured he would ask the manufacture of the study. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Arm hurts; Chills; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 13:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced arm hurts and chills. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not  been tested for COVID-19.The clinical outcomes of the events arm hurts and chills were unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Sleepiness; Headache; Joint pain; Injection pain; High fever; Chills; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: ER8732; Expiration Date: 30Jun2021), via an unspecified route of administration on 27Mar2021 (at the age of 57-years-old) at dose 1, single for covid-19 immunization. The patient medical history were not reported. Patient take a number of medications. The patient experienced sleepiness, headache, joint pain, injection pain, high fever, chills on an unspecified date. Patient has been taking Tylenol and that helping for the events. The outcome of the events was unknown. The relationship between the vaccine and events was related.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepiness; Headache; Joint pain; Injection pain; High fever; Chills; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: ER8732; Expiration Date: 30Jun2021), via an unspecified route of administration on 27Mar2021 (at the age of 57-years-old) at dose 1, single for covid-19 immunization. The patient medical history were not reported. Patient take a number of medications. The patient experienced sleepiness, headache, joint pain, injection pain, high fever, chills on an unspecified date. Patient has been taking Tylenol and that helping for the events. The outcome of the events was unknown. The relationship between the vaccine and events was related.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: developed muscle and joint pains; developed muscle and joint pains; felt sore; sore on her arm; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 24Mar2021, Tuesday (at the age of 45-Years-old) (Batch/Lot number was not reported) as DOSE1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Mar2021, the patient experienced tiredness. she was tired a little the day after vaccination. She had tiredness on the 26Mar2021. That was fine by the 27Mar2021. On 26Mar2021, 2 days after vaccination, she experienced felt sore and had sore on her arm. She clarified the pain in her legs started on 30Mar2021 and not on 29Mar2021. On 30Mar2021, she developed muscle and joint pains. It was on and off. It was not unbearable, it was bearable. It may be a little bit better, it has moved from legs to kind of like just her quads or her thighs. It was reported that ever since she started having muscle and joint pain in her legs and she was researching that and it seems like it was a common thing but she was concerned that it happened like 7 days later she was wondering if there was any information on that or if she was in the right place to ask about that. It was reported that she had just finished her period which she knows was a little bit gross but that just finished right before this, she does not know if that had anything to do with it, it does not seem that way though. At the time of this report, the outcome of event felt sore and sore on her arm was unknown, developed muscle and joint pains was recovering and tiredness recovered on 27Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Body temperature, Chills, Condition aggravated, Erythema
Clinical narrative: redness in her injection arm; body aches; chills; fever; oxygen level, it gets roll into 90, when I was sitting down; sore arm; headache; Gets worsened; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female 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 29Mar2021 as dose 1, single (at the age of 52-years-old) for COVID-19 immunization. Medical history included hypertension, high cholesterol, asthma, helps me breath, and high creatinine. It was reported that, the patient when probed about medical history stated, she was about to undergo some testing for Kidney, a physician found high creatinine level and so he got to go tested. Concomitant medications included metoprolol and hydrochlorothiazide, lisinopril; both taken for hypertension, Astra Statin and fenofibrate; both taken for high cholesterol, salbutamol sulfate (PROAIR HFA) taken for asthma, alprazolam taken for helps me breath; all start and stop dates were not reported. On 29Mar2021, the patient had a sore arm and little bit of headache for the first 2 days and then the patient started getting body aches, and it started getting worse. On 31Mar2021, the patient started to experience redness in her injection arm, body aches and chills and has a fever of 102 (degree) F. The patient on 31Mar2021, has experienced oxygen level on oximeter, it gets roll into 90, when she was sitting down. The patient had an increasingly bad reaction, had body chill and aches and It was reported that overnight it turned into fever and, it was low grade like around 100 and in past couple of hours it has gone up. The patient had taken Tylenol 1000mg. Upon reconfirmation patient stated, her oxygen level went down to 90, when she was sitting down relaxed, and never had it that low. The patient confirmed that all the events the patient was experiencing was since 31Mar2021. The patient also stated it gets worsened when asked whether still experiencing the problem. The patient confirmed taking Tylenol 1000mg about an hour, may be quite an hour bit. The patient underwent lab tests and procedures which included blood creatinine: high creatinine level on an unspecified date, body temperature: 102-degree F on 31Mar2021, body temperature: it was low grade like around 100 on 31Mar2021, oxygen saturation: 90, when she was sitting down relaxed, and never had it that low on 31Mar2021. Therapeutic measures were taken as a result of body aches, chills, fever, sore arm, and headache. The patient had recovered from the events headache and sore arm on 31Mar2021. The patient had not recovered from the other events at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oxygen saturation, Oxygen saturation decreased, Pain, Pain in extremity
Clinical narrative: redness in her injection arm; body aches; chills; fever; oxygen level, it gets roll into 90, when I was sitting down; sore arm; headache; Gets worsened; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female 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 29Mar2021 as dose 1, single (at the age of 52-years-old) for COVID-19 immunization. Medical history included hypertension, high cholesterol, asthma, helps me breath, and high creatinine. It was reported that, the patient when probed about medical history stated, she was about to undergo some testing for Kidney, a physician found high creatinine level and so he got to go tested. Concomitant medications included metoprolol and hydrochlorothiazide, lisinopril; both taken for hypertension, Astra Statin and fenofibrate; both taken for high cholesterol, salbutamol sulfate (PROAIR HFA) taken for asthma, alprazolam taken for helps me breath; all start and stop dates were not reported. On 29Mar2021, the patient had a sore arm and little bit of headache for the first 2 days and then the patient started getting body aches, and it started getting worse. On 31Mar2021, the patient started to experience redness in her injection arm, body aches and chills and has a fever of 102 (degree) F. The patient on 31Mar2021, has experienced oxygen level on oximeter, it gets roll into 90, when she was sitting down. The patient had an increasingly bad reaction, had body chill and aches and It was reported that overnight it turned into fever and, it was low grade like around 100 and in past couple of hours it has gone up. The patient had taken Tylenol 1000mg. Upon reconfirmation patient stated, her oxygen level went down to 90, when she was sitting down relaxed, and never had it that low. The patient confirmed that all the events the patient was experiencing was since 31Mar2021. The patient also stated it gets worsened when asked whether still experiencing the problem. The patient confirmed taking Tylenol 1000mg about an hour, may be quite an hour bit. The patient underwent lab tests and procedures which included blood creatinine: high creatinine level on an unspecified date, body temperature: 102-degree F on 31Mar2021, body temperature: it was low grade like around 100 on 31Mar2021, oxygen saturation: 90, when she was sitting down relaxed, and never had it that low on 31Mar2021. Therapeutic measures were taken as a result of body aches, chills, fever, sore arm, and headache. The patient had recovered from the events headache and sore arm on 31Mar2021. The patient had not recovered from the other events at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: redness in her injection arm; body aches; chills; fever; oxygen level, it gets roll into 90, when I was sitting down; sore arm; headache; Gets worsened; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female 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 29Mar2021 as dose 1, single (at the age of 52-years-old) for COVID-19 immunization. Medical history included hypertension, high cholesterol, asthma, helps me breath, and high creatinine. It was reported that, the patient when probed about medical history stated, she was about to undergo some testing for Kidney, a physician found high creatinine level and so he got to go tested. Concomitant medications included metoprolol and hydrochlorothiazide, lisinopril; both taken for hypertension, Astra Statin and fenofibrate; both taken for high cholesterol, salbutamol sulfate (PROAIR HFA) taken for asthma, alprazolam taken for helps me breath; all start and stop dates were not reported. On 29Mar2021, the patient had a sore arm and little bit of headache for the first 2 days and then the patient started getting body aches, and it started getting worse. On 31Mar2021, the patient started to experience redness in her injection arm, body aches and chills and has a fever of 102 (degree) F. The patient on 31Mar2021, has experienced oxygen level on oximeter, it gets roll into 90, when she was sitting down. The patient had an increasingly bad reaction, had body chill and aches and It was reported that overnight it turned into fever and, it was low grade like around 100 and in past couple of hours it has gone up. The patient had taken Tylenol 1000mg. Upon reconfirmation patient stated, her oxygen level went down to 90, when she was sitting down relaxed, and never had it that low. The patient confirmed that all the events the patient was experiencing was since 31Mar2021. The patient also stated it gets worsened when asked whether still experiencing the problem. The patient confirmed taking Tylenol 1000mg about an hour, may be quite an hour bit. The patient underwent lab tests and procedures which included blood creatinine: high creatinine level on an unspecified date, body temperature: 102-degree F on 31Mar2021, body temperature: it was low grade like around 100 on 31Mar2021, oxygen saturation: 90, when she was sitting down relaxed, and never had it that low on 31Mar2021. Therapeutic measures were taken as a result of body aches, chills, fever, sore arm, and headache. The patient had recovered from the events headache and sore arm on 31Mar2021. The patient had not recovered from the other events at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in my left arm; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 15:00, the patient experienced pain in her left arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in her left arm was recovered on 01Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: she has a small rash on her leg; feeling unwell; slight fever; swollen lymph nodes; terrible headache; so much tiredness / fatigue; chills; joint pain all over; muscle stiffness; been sleeping a lot; dizziness; weakness; flu like symptoms; pain at injection site; feeling warm; nauseous; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age 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 on 24Mar2021 as dose 1, single for covid-19 immunization. Patient medical history included depression and under medications (unspecified), migraine, autoimmune disorder and has compromised issues from an unknown date and unknown if ongoing. Patient had allergies [unspecified]. Concomitant medication included unspecified medication of depression. On 24Mar2021, the night after receiving the first shot of vaccine patient experienced flu like symptoms, pain at injection site, feeling warm, nauseous. Patient reported that 24 hours later on 25Mar2021, patient was feeling unwell, slight fever, has swollen lymph nodes, terrible headache, so much tiredness/fatigue, chills, joint pain all over, muscle stiffness, been sleeping a lot, dizziness, weakness for 3 days. Patient stated she has a small rash on her leg and doesn't know where it came from on an unspecified date. Patient wanted to know if that was okay for her to take Midol asking if that was a safe thing to be done after receiving the 1st dose and was concerned with the side effects and what she needs to be done prior to taking the 2nd dose. Outcome of the events flu like symptoms, pain at injection site, feeling warm, nauseous and rash on leg were unknown and the rest of the events was recovered on 28Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hypersomnia, Influenza like illness, Lymphadenopathy
Clinical narrative: she has a small rash on her leg; feeling unwell; slight fever; swollen lymph nodes; terrible headache; so much tiredness / fatigue; chills; joint pain all over; muscle stiffness; been sleeping a lot; dizziness; weakness; flu like symptoms; pain at injection site; feeling warm; nauseous; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age 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 on 24Mar2021 as dose 1, single for covid-19 immunization. Patient medical history included depression and under medications (unspecified), migraine, autoimmune disorder and has compromised issues from an unknown date and unknown if ongoing. Patient had allergies [unspecified]. Concomitant medication included unspecified medication of depression. On 24Mar2021, the night after receiving the first shot of vaccine patient experienced flu like symptoms, pain at injection site, feeling warm, nauseous. Patient reported that 24 hours later on 25Mar2021, patient was feeling unwell, slight fever, has swollen lymph nodes, terrible headache, so much tiredness/fatigue, chills, joint pain all over, muscle stiffness, been sleeping a lot, dizziness, weakness for 3 days. Patient stated she has a small rash on her leg and doesn't know where it came from on an unspecified date. Patient wanted to know if that was okay for her to take Midol asking if that was a safe thing to be done after receiving the 1st dose and was concerned with the side effects and what she needs to be done prior to taking the 2nd dose. Outcome of the events flu like symptoms, pain at injection site, feeling warm, nauseous and rash on leg were unknown and the rest of the events was recovered on 28Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal stiffness, Nausea, Pyrexia, Rash
Clinical narrative: she has a small rash on her leg; feeling unwell; slight fever; swollen lymph nodes; terrible headache; so much tiredness / fatigue; chills; joint pain all over; muscle stiffness; been sleeping a lot; dizziness; weakness; flu like symptoms; pain at injection site; feeling warm; nauseous; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age 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 on 24Mar2021 as dose 1, single for covid-19 immunization. Patient medical history included depression and under medications (unspecified), migraine, autoimmune disorder and has compromised issues from an unknown date and unknown if ongoing. Patient had allergies [unspecified]. Concomitant medication included unspecified medication of depression. On 24Mar2021, the night after receiving the first shot of vaccine patient experienced flu like symptoms, pain at injection site, feeling warm, nauseous. Patient reported that 24 hours later on 25Mar2021, patient was feeling unwell, slight fever, has swollen lymph nodes, terrible headache, so much tiredness/fatigue, chills, joint pain all over, muscle stiffness, been sleeping a lot, dizziness, weakness for 3 days. Patient stated she has a small rash on her leg and doesn't know where it came from on an unspecified date. Patient wanted to know if that was okay for her to take Midol asking if that was a safe thing to be done after receiving the 1st dose and was concerned with the side effects and what she needs to be done prior to taking the 2nd dose. Outcome of the events flu like symptoms, pain at injection site, feeling warm, nauseous and rash on leg were unknown and the rest of the events was recovered on 28Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she has a small rash on her leg; feeling unwell; slight fever; swollen lymph nodes; terrible headache; so much tiredness / fatigue; chills; joint pain all over; muscle stiffness; been sleeping a lot; dizziness; weakness; flu like symptoms; pain at injection site; feeling warm; nauseous; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age 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 on 24Mar2021 as dose 1, single for covid-19 immunization. Patient medical history included depression and under medications (unspecified), migraine, autoimmune disorder and has compromised issues from an unknown date and unknown if ongoing. Patient had allergies [unspecified]. Concomitant medication included unspecified medication of depression. On 24Mar2021, the night after receiving the first shot of vaccine patient experienced flu like symptoms, pain at injection site, feeling warm, nauseous. Patient reported that 24 hours later on 25Mar2021, patient was feeling unwell, slight fever, has swollen lymph nodes, terrible headache, so much tiredness/fatigue, chills, joint pain all over, muscle stiffness, been sleeping a lot, dizziness, weakness for 3 days. Patient stated she has a small rash on her leg and doesn't know where it came from on an unspecified date. Patient wanted to know if that was okay for her to take Midol asking if that was a safe thing to be done after receiving the 1st dose and was concerned with the side effects and what she needs to be done prior to taking the 2nd dose. Outcome of the events flu like symptoms, pain at injection site, feeling warm, nauseous and rash on leg were unknown and the rest of the events was recovered on 28Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vaccination site pain
Clinical narrative: Having dizzy spells and headache and pain in the injection area; Having dizzy spells and headache and pain in the injection area; Having dizzy spells and headache and pain in the injection area; This is a spontaneous report from a contactable consumer. A 44-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, schizoaffective disorder and narcolepsy. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included metformin (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN), oxybate sodium (XYREM), armodafinil (MANUFACTURER UNKNOWN), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), simvastatin (MANUFACTURER UNKNOWN), risperidone (MANUFACTURER UNKNOWN), agrimonia eupatoria (AGRIMONY), guaifenesin (MUCINEX), cetirizine (MANUFACTURER UNKNOWN), chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX), boron, chromium, copper, germanium, iodine, manganese, molybdenum, selenium, silicon, sitosterol, vanadium, vitamin d nos, zinc (SUPER BETA PROSTATE), probiotics and curcuma longa rhizome (TURMERIC); all for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 at 14:00, the patient was having dizzy spells and headache and pain in the injection area. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event having dizzy spells and headache and pain in the injection area was resolved with sequelae on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: Shot site, it's kind of puffed up; Rash from my shoulder to midway my arm after the shot; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205, Expiration date: Not reported), via an unspecified route of administration on 26Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 25Feb2021 as dose 1, single for COVID-19 immunization. After the second vaccination, the patient's shot site was kind of puffed up and rash from the shoulder to midway of the arm after the shot on 28Mar2021. It was reported that the patient took some diphenhydramine (BENADRYL) and wanted to know what should be taken for these events. The patient also wanted to know why they need all the event related information and informed that what need to be done from the patient's end. The outcome of the events was unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a rash at the injection site and described it as "itching real bad" and "very painful." The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: woke up with a very red face that has been red for 5 hours or so; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 31Mar2021 (at the age of 22 years) as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient woke up with a very red face that has been red for 5 hours or so on 01Apr2021 and it had not gone down. Her face never got red at all ever. She wanted to know if that was normal or should she be concerned. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dehydration, Dyspepsia, Fatigue
Clinical narrative: joint pain in her ankles, knuckles and back; joint pain in her ankles, knuckles and back; Joint pain; Aches/Body ache; Fever/Low grade fever; Dehydration; Indigestion/Heartburn; Fatigue/tired; Lip was twitching briefly; Sleeplessness; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection; Batch/Lot number: EN6208, Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Mar2021, patient experienced joint pain, aches/body ache, fever/low grade fever, dehydration, indigestion like heartburn, and fatigue/pretty tired for a week, sleeplessness, nauseous after receiving her vaccine dose. On Mar2021, patient lip was twitching briefly after receiving the vaccine dose, Patient stated that most of her symptoms went away 1 week after receiving the dose. On 28Mar2021, patient stated that her joint pain returned and describes it as mild and sporadic joint pain in her ankles, knuckles and back, like patient have not had to take any medicine or anything for it but patient do notice that she had some joint pain (was fine and then this past Sunday patient started feeling like joint pain). Patient was supposed to get her second dose of the vaccine 03Apr2021. Patient wanted to know if these side effects had been reported and wanted to know if Pfizer had data on individuals who had severe allergic reactions and did, they had them mostly after the first or the second dose. The outcome of joint pain in her ankles, knuckles and back was not recovered and recovered for rest of the events on Mar2021.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle twitching, Nausea, Pain, Pyrexia
Clinical narrative: joint pain in her ankles, knuckles and back; joint pain in her ankles, knuckles and back; Joint pain; Aches/Body ache; Fever/Low grade fever; Dehydration; Indigestion/Heartburn; Fatigue/tired; Lip was twitching briefly; Sleeplessness; Nauseous; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection; Batch/Lot number: EN6208, Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on 13Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Mar2021, patient experienced joint pain, aches/body ache, fever/low grade fever, dehydration, indigestion like heartburn, and fatigue/pretty tired for a week, sleeplessness, nauseous after receiving her vaccine dose. On Mar2021, patient lip was twitching briefly after receiving the vaccine dose, Patient stated that most of her symptoms went away 1 week after receiving the dose. On 28Mar2021, patient stated that her joint pain returned and describes it as mild and sporadic joint pain in her ankles, knuckles and back, like patient have not had to take any medicine or anything for it but patient do notice that she had some joint pain (was fine and then this past Sunday patient started feeling like joint pain). Patient was supposed to get her second dose of the vaccine 03Apr2021. Patient wanted to know if these side effects had been reported and wanted to know if Pfizer had data on individuals who had severe allergic reactions and did, they had them mostly after the first or the second dose. The outcome of joint pain in her ankles, knuckles and back was not recovered and recovered for rest of the events on Mar2021.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Influenza like illness
Clinical narrative: headaches; flu like symptoms; joint soreness; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) on an unspecified date (at the age of 38-year-old) for covid-19 immunisation. On an unspecified date in 2021, the patient experienced headaches, flu like symptoms and joint soreness. They also wanted to know if it was okay to take tylenol or ibuprofen or will it interfere with antibody production. The event was reported a non serious. The outcome of all the events was unknown.   No follow-up attempts are possible; information about lot batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366793 same reporter/drug/AE with different patient
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Influenza like illness
Clinical narrative: headaches; flu like symptoms; joint soreness; This is a spontaneous report from a contactable consumer. A 38 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number was not reported,Expiry date was not reported), dose 2 via an unspecified route of administration on 31Mar2021 as DOSE 2,SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Previously patient took first dose of bnt162b2 via an unspecified route of administration on an unknown date for covid-19 immunization. The patient experienced headaches, flu like symptoms, joint soreness.The reporter wants to know can he take Tylenol as a treatment for the adverse event. The clinical outcome of the event was unknown.  No follow up attempts are possible, information about lot or batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360708 same reporter/drug/AE with different patient
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain
Clinical narrative: few aches and pains; joint pain; muscle pain; headaches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as age: 51; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced some symptoms, such as a few aches and pains on an unspecified date. The patient mentioned "joint pain, muscle pain and headaches" on an unspecified date. The outcome of the events was unknown. The patient was querying on how soon after the shot can he take other medications, such as Advil and Advair.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Nasopharyngitis
Clinical narrative: cold; sick; cough; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route on 14Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The second dose was scheduled on 03Apr2021.  The patient had cold on 29Mar2021, sick and cough on an unspecified date in Mar2021. The clinical course includes when she went to have her first covid vaccine there was a paper that asked if you are allergic to anything. Her sister said it said or are you sick. Caller states she has been sick for about 3 days and asks if it is safe to get the vaccine with a cold. She was going for her second vaccine on Saturday. Caller states the paper said have you done steroids in the last week or something like that but that can't remember what it said. Clarified with caller details and states that both her and her sister saw the paper and she thought she signed it. Caller states it was just a cold, she gets a cold about once a year. The patient took cough medicine and Alka-Seltzer Plus once. Caller also asked if it's okay to proceed with her 2nd dose of the vaccine even if she has colds. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gait disturbance, Pruritus
Clinical narrative: itching all over his body; stomach felt upset; can't walk around; This is a spontaneous report from a Regulatory Authority. contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itching all over his body after 10 days and advised to take Benadryl and until 2nd shot (18Feb2021). The patient was still taking Benadryl and when his stomach felt upset, bad and can't walk around and even can't sit so decided to stop taking that medicine but the itching didn't stop. The patient mentioned after he stopped taking the Benadryl his arms, behind ears, shoulder and his back was itching and it doesn't stay on one spot. Therapeutic measures were taken as a result of itching all over his body. The outcome of the event itching all over his body was not recovered. The outcome of the events stomach felt upset and can't walk around was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Have a small bump at the injection site; The area is pink and itches/she felt a knot there that is red and pink, she wants to itch at it, she thinks it might just be because of the person that gave her the dose; Sore arm; Small pink spot and got bigger and bigger with a large knot; it is about 4 in by 4 in; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 31Mar2021 (at the age of 55 years old) as dose 2, single for COVID-19 immunization. Medical history included: hypertension She has had this condition for 3 or 4 years and received lisinopril hctz for hypertension at the dose of 20mg/25mg once a day. Concomitant medication(s) included celecoxib (CELEBREX) taken for arthritis. The patient previously BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6208, Expiry date: 30Jun2021) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced pain in extremity. Got her second shot on 31Mar2021 and the first one, she initially said two weeks before and then after being told it was to be given 3 weeks apart, she said yes, it was probably 3 weeks. She has reported this to us before but just wanted to confirm that this was a side effect. She knows some people who got the Moderna shot and had worse side effects. The reporter was calling about the Pfizer COVID 19 shot. She says she got the 2nd shot yesterday (31Mar2021) and, she doesn't consider it a side effect, she had no problems except a sore arm which she had from the first one too. However, this afternoon she felt a knot there at the injection site that is red and pink. She wants to itch at it. She thinks it might just be because of the person that gave her the dose. She says she doesn't really think it is an event, she knows any time you get shots you can get a knot. She just wants to make sure it doesn't mess with getting all the vaccine she is supposed to get. She wants to talk to someone about that. She says she has no headache, no fever, nothing like that. Caller declines to fill out a report, she says she would rather just talk with a nurse or whatever to ask her question. The patient Had a reaction to her Pfizer covid 19 shot. She looked on the CDC website and they had it listed as Covid arm. After the first shot, it was just sore but after the second shot, it started out as a small pink spot and got bigger and bigger with a large knot; it is about 4 in by 4 inches, she had a knot. Over the weekend, it got bigger and was 3-4 inches by 3-4 inches. The patient did not receive any treatment for the events. The outcome of the events was unknown.  Follow up attempts are completed. No further information was expected.
Sex: F
Vaccine: PPV
Symptoms: Blister, Urticaria
Clinical narrative: break out in "huge welts" all over her body; painful sores; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date in 2009 (Batch/Lot number was not reported) as dose number unknown, single for immunisation. Medical history included allergies to Penicillin and Sulfa. The patient previously took and had an allergy to Z pack, Nitrofur, Macrodanton, Hydrochlorozide, Ciproflaxin, Viox, and Bextra. Concomitant medications were not reported. The caller was a 74-year-old female who stated that, 12 years ago (2009), she received a pneumonia shot that caused her to break out in "huge welts" all over her body. As a result of this, she stated that for the past 12 years, she has been getting "painful sores". The patient would like to know if, because of this, she would be able to receive the Pfizer BioNTech COVID-19 vaccine. She was concerned because she stated that one of the forms that she has to fill out before vaccination asks if she has ever been allergic to a different vaccination. She stated that she has spoken to several doctors and pharmacist regarding this and has gotten mixed answers on whether or not she should get the vaccination. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.