chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased, Palpitations, Paraesthesia
Clinical narrative: heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly; feeling feverish but no fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9262) via an unspecified route of administration administered in Arm Right on 25Jan2021 14:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure. The patient's concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) ongoing at 12.5 of unknow units once daily for blood pressure and tamsulosin. The patient underwent lab tests and procedures which included heart rate: little elevated. He checked his pulse and it was a little elevated. It was reported as the patient received the first dose of the pfizer covid 19 vaccine on Monday 25Jan2021 but did not have any symptoms until Thursday 28Jan2021. The patient reported feeling feverish but no fever, heart races a little, eyes are tingly and feels flushed. The patient wants to know if what he is experiencing normal. The patient wanted to know if the rumor is true that the second dose has more side effects. He has had no allergic reactions to medicine. He takes a blood pressure medicine, anti-anxiety medicine, and cholesterol medicine. Starting yesterday he started to feel feverish but had no fever. His eyes started to feel tingly, like a feverish feeling. This started after lunch time. He took a nap for like an hour, slept fine, and then the feeling was gone and he was okay. Today, he woke up this morning around 6:30 AM and was fine. It was not until later this morning around 11 AM when he started to feel the same way again. It was like his heart raced a little. He checked his pulse and it was a little elevated, but nothing crazy. He felt flushed. His eyes were tingly. It is like something does not feel right. He was calling to see if these were side effects. Feeling like his heart was racing has subsided. It was worse earlier. The feeling flushed is minor now. The eyes tingly has almost subsided, but still there. The patient experienced feeling feverish but no fever, eyes are tingly on 28Jan2021, heart races a little, feels flushed and checked his pulse and it was a little elevated on an unspecified date. The outcome of the events heart races a little and eyes are tingly and feels flushed was recovering, while the outcome of remaining events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: heart races a little; feels flushed; checked his pulse and it was a little elevated; eyes are tingly; feeling feverish but no fever; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EL9262) via an unspecified route of administration administered in Arm Right on 25Jan2021 14:00 (at the age of 51-years-old) as single dose for covid-19 immunisation. The patient's medical history included blood pressure. The patient's concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) ongoing at 12.5 of unknow units once daily for blood pressure and tamsulosin. The patient underwent lab tests and procedures which included heart rate: little elevated. He checked his pulse and it was a little elevated. It was reported as the patient received the first dose of the pfizer covid 19 vaccine on Monday 25Jan2021 but did not have any symptoms until Thursday 28Jan2021. The patient reported feeling feverish but no fever, heart races a little, eyes are tingly and feels flushed. The patient wants to know if what he is experiencing normal. The patient wanted to know if the rumor is true that the second dose has more side effects. He has had no allergic reactions to medicine. He takes a blood pressure medicine, anti-anxiety medicine, and cholesterol medicine. Starting yesterday he started to feel feverish but had no fever. His eyes started to feel tingly, like a feverish feeling. This started after lunch time. He took a nap for like an hour, slept fine, and then the feeling was gone and he was okay. Today, he woke up this morning around 6:30 AM and was fine. It was not until later this morning around 11 AM when he started to feel the same way again. It was like his heart raced a little. He checked his pulse and it was a little elevated, but nothing crazy. He felt flushed. His eyes were tingly. It is like something does not feel right. He was calling to see if these were side effects. Feeling like his heart was racing has subsided. It was worse earlier. The feeling flushed is minor now. The eyes tingly has almost subsided, but still there. The patient experienced feeling feverish but no fever, eyes are tingly on 28Jan2021, heart races a little, feels flushed and checked his pulse and it was a little elevated on an unspecified date. The outcome of the events heart races a little and eyes are tingly and feels flushed was recovering, while the outcome of remaining events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that on an unspecified age she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route administration on 26Jan2021 at single dose for COVID-19 immunization. The patient medical history included ongoing urinary tract infection, she said the UTI does not have anything to do with the vaccine.  She was having symptoms before she got it. The patient concomitant medications were not reported.  The patient experienced urinary tract infection on an unspecified date. Caller received the covid vaccine on Tuesday where she had already started to feel slight symptoms of the UTI. Yesterday she called her doctor, this morning she took the urine tests and was prescribed Bactrim. She had taken 1 pill already when she realized. She called her doctor office where she was told it should be fine. Caller would like to know if she may take Bactrim, which was prescribed for a urinary tract infection, after taking the covid vaccine. Caller would like to know if it is true that one should not take alcohol up to 3 days prior to the covid vaccine. Upon Follow-up (29Jan2021): It was reported that received call from consumer regarding the Pfizer COVID vaccine patient had it on 26Jan2021 and came down with a UTI and her doctor gave her Bactrim, antibiotic, for the UTI. patient would like to know if she can take it or will it affect the immunity of the vaccine.  She said the UTI does not have anything to do with the vaccine. She was having symptoms before she got it. Patient received the treatment with Bactrim, antibiotic, for the UTI. The outcome of event was unknown.  Follow-up (29Jan2021): This is a spontaneous report from a contactable consumer. The new information included: clinical information added, Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Off label use, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other hcp from Pfizer-sponsored program. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 subcutaneous, administered in Arm on 28Jan2021 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. On 28Jan2021, it was reported that patient arm was squeezed, and second dose was administered in subcutaneous tissue instead of doing an intramuscular into the deltoid muscle and on a patient arm is even sore on an unknown date in 2021. The patient wanted to know about efficacy of the medication and if Pfizer recommends me to get another dose. Patient reported that a doctor meets up under the theme "Don't Grieve my Arm" as this subcutaneous administration was a "systemic problem". The outcome of the events was unknown.     Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Diarrhoea, Fatigue, Oxygen saturation
Clinical narrative: severe lower abdominal discomfort; very tender; hurts to press on; watery stools; bloating; fatigue; pulse ox of 94; This is a spontaneous report received from a contactable consumer. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiration date were unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, after administration, there was severe lower abdominal discomfort, very tender, hurts to press on, watery stools, bloating, fatigue, and a pulse ox of 94 in Jan2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pain, Tenderness
Clinical narrative: severe lower abdominal discomfort; very tender; hurts to press on; watery stools; bloating; fatigue; pulse ox of 94; This is a spontaneous report received from a contactable consumer. A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiration date were unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, after administration, there was severe lower abdominal discomfort, very tender, hurts to press on, watery stools, bloating, fatigue, and a pulse ox of 94 in Jan2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Feeling of body temperature change, Illness
Clinical narrative: fever; chills; throwing up; hot, cold; couldn't eat; nauseated; sick; her first dose was on 09Jan2021; received her second dose on 26Jan2021; her first dose was on 09Jan2021; received her second dose on 26Jan2021; This is a spontaneous report from a contactable consumer, the patient. A 67-Year-old female patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EL0140), via unspecified route of administration on 09Jan2021 and second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: EL3248), via unspecified route of administration in left arm on 26Jan2021 (Tuesday) at 09:20 as a single dose (at the age of 67-years) for COVID-19 immunization. Patient received the second dose 18 days after receiving the first dose. Medical history included ongoing diabetes type 2 (diagnosed about two years ago). The concomitant medications included liraglutide (VICTOZA) 1.8, via injection once daily (approximately 2 years ago and ongoing for diabetes type 2). Patient did not receive any other vaccines on the same day. Patient received her shot on 26Jan2021 at about 9:20AM and was sick by that evening. Tuesday night, patient started throwing up, all night and a little bit on Wednesday. Patient had chills, fever with hot and cold feeling, nausea and could not eat. Patient thought that today she felt good enough to eat, but she was so nauseated. On 29Jan2021, body temperature was normal, and fever resolved. Patient was still very nauseated, and the chills came and went. Outcome of the events chills, throwing up, hot and cold, couldn't eat and not felt well was unknown while of nausea was not recovered. Investigation Assessment: No.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Off label use, Pyrexia, Vomiting
Clinical narrative: fever; chills; throwing up; hot, cold; couldn't eat; nauseated; sick; her first dose was on 09Jan2021; received her second dose on 26Jan2021; her first dose was on 09Jan2021; received her second dose on 26Jan2021; This is a spontaneous report from a contactable consumer, the patient. A 67-Year-old female patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EL0140), via unspecified route of administration on 09Jan2021 and second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: EL3248), via unspecified route of administration in left arm on 26Jan2021 (Tuesday) at 09:20 as a single dose (at the age of 67-years) for COVID-19 immunization. Patient received the second dose 18 days after receiving the first dose. Medical history included ongoing diabetes type 2 (diagnosed about two years ago). The concomitant medications included liraglutide (VICTOZA) 1.8, via injection once daily (approximately 2 years ago and ongoing for diabetes type 2). Patient did not receive any other vaccines on the same day. Patient received her shot on 26Jan2021 at about 9:20AM and was sick by that evening. Tuesday night, patient started throwing up, all night and a little bit on Wednesday. Patient had chills, fever with hot and cold feeling, nausea and could not eat. Patient thought that today she felt good enough to eat, but she was so nauseated. On 29Jan2021, body temperature was normal, and fever resolved. Patient was still very nauseated, and the chills came and went. Outcome of the events chills, throwing up, hot and cold, couldn't eat and not felt well was unknown while of nausea was not recovered. Investigation Assessment: No.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Urine output decreased
Clinical narrative: This is a spontaneous report received from a contactable nurse (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. Patient inquired that while administer her 1st shot, she was not asked about her weight, and on her 2nd shot (which she received on Wednesday, as reported) she was asked about it. Wondered why she was asked about her weight and if it has something to do with the amount of dose in every shot. Patient noticed that she did not see any alcohol wipes or wipes to clean the area. Patient did not get up during the night to urinate and in the morning she had very little urine. Outcome for the event was unknown.  Follow-up (19Apr2021): 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247) via an unspecified route of administration on 28Jan2021 at 12:00 in left arm as a single dose for COVID-19 immunization. The patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events, concomitant medications, other products and investigation assessment were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines included flu vaccine and tetanus vaccine which caused sore arm. It was reported that the patient received the COVID vaccine around noon at 12:00 on 28Jan2021 at work and had swelling and redness at the injection site the size of a golf ball. The site of injection was red, a little raised, and warm to touch. She asked if it was normal and was there anything she could look out for. She stated it had been really sore, but she did not look at it because she had long sleeves on. She first noticed it around 16:00 on 29Jan2021. There was no emergency room or physician office visit. Relevant tests were not reported. The outcome for the event vaccination site pain was unknown and for all other events was not recovered/not resolved.  Follow-up attempts are completed. No further information was expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Flatulence, Influenza like illness, Nasopharyngitis, Secretion discharge
Clinical narrative: started coughing; coughed up green mucus; it feels like he is getting a cold; almost like getting the flu symptoms; getting gas; he thinks he gained a little weight; This is a spontaneous report from a contactable consumer (patient).A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 15:00 (Batch/Lot Number: EL9265, expiration date unknown) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 29Jan2021, in the morning, the patient started coughing, green mucus, he spit it on the ground, so he knows it was green mucus and was asking if that was the part of the side effect of the vaccine as he had no mucus prior to the shot. He further stated that it was almost like getting the flu symptoms, when you start getting the flu and Just came up today after getting the vaccine and he felt like he was getting a cold. Also mentioned that he was getting gas and thought he had gained a little weight.The patient was not recovered from the event of cold and outcome of all other events was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: started coughing; coughed up green mucus; it feels like he is getting a cold; almost like getting the flu symptoms; getting gas; he thinks he gained a little weight; This is a spontaneous report from a contactable consumer (patient).A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 at 15:00 (Batch/Lot Number: EL9265, expiration date unknown) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 29Jan2021, in the morning, the patient started coughing, green mucus, he spit it on the ground, so he knows it was green mucus and was asking if that was the part of the side effect of the vaccine as he had no mucus prior to the shot. He further stated that it was almost like getting the flu symptoms, when you start getting the flu and Just came up today after getting the vaccine and he felt like he was getting a cold. Also mentioned that he was getting gas and thought he had gained a little weight.The patient was not recovered from the event of cold and outcome of all other events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) and Medical Information Team. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982, Expiration date: Unknown) on 21Jan2021 (at the age of 75-years-old) as 1st dose, single on left arm for COVID-19 immunization. The concomitant medications were not reported. The patient stated that years ago, she took a flu vaccine, and after she did not have the flu but had flu-like symptoms, that is probably the only thing that she had a reaction. The patient was not tested positive for Covid-19 prior to the first dose of vaccine.   On 24Jan2021, (after 3 days of  vaccination the patient experienced stomach cramps and diarrhea (till 26th Jan 2021), achiness and headache (till 27th Jan 2021) and also a little bit of chills. The patient receive treatment with Imodium 24-hour period it ended and stomach cramps has been resolved in 2 days. The patient also received treatment with Tylenol for achiness and headache and was resolved in 3 days. The patient askes could the presented events be a side effect from vaccine. The patient is concerned about the second dose of vaccine which was scheduled on 12Feb2021. The patient asked about her second dose if she should not get since, she experienced side effects. Action taken was not applicable. The outcome of the events stomach cramps and diarrhea was resolved on 26Jan2021 while outcome of the events achiness and headache was resolved on 27Jan2021. Outcome of the event also a little bit of chills was resolved on an unspecified date in   No follow-up attempts possible. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I am 9 weeks pregnant and I just elected to receive the Pfizer COVID vaccine. I got the first shot yesterday.; This is a spontaneous report from a contactable consumer (patient) reported to Pfizer. A female pregnant patient of an unspecified age received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The report received as, I am 9 weeks pregnant, and I just elected to receive the Pfizer COVID vaccine. I got the first shot yesterday. Knowing there is little data on this with pregnancy, I would like to assist with adding to your data if possible, to help other expectant mothers. Please let me know how I may assist. I'm registered to get my 2nd shot on 22Feb. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted the events off label use and drug use in unapproved population.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experienced a headache after the 1st shot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's husband) reported for a Female patient (wife). A patient on an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and medications were not reported.  On an unspecified date, the patient experienced a headache after the first shot. The reporter inquired whether the patient can take Tylenol or Advil. The outcome of event was unknown.  Information on Lot/Batch 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.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itchy red rash on neck; Itchy red rash on neck; This is a spontaneous report from a contactable other health professional. A 25-years-old female patient herself received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 15:15 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization.The patient's medical history included generalised anxiety disorder.The Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE) taken for an unspecified indication, start and stop date were not reported. The patient previously took clindamycin and experienced drug hypersensitivity. No treatment was received for the adverse events. The patient experienced itchy red rash on neck on 26Jan2021.12:00 AM. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Administration facility. The outcome of the events was not recovered.  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: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nausea; Headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received bnt162b2 (BNT162B2,Formulation: Solution for Injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for Covid-19 immunization. The patient experienced headache and nausea after 2 nd dose. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that patient asked could she take aspirin 30 minutes after getting vaccinated? Mentioned she was considering taking it due to a slight headache. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pain
Clinical narrative: pain; low energy; mild headache; mild nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: E99261), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 (at the age 82-year-old) as SINGLE DOSE for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced mild headache and mild nausea on 02Feb2021, low energy on 03Feb2021, pain on an unspecified date. Reporter stated that "He is calling about the covid 19 vaccine. He had his first shot yesterday afternoon at 2. He slept great. He had a mild headache last night and mild nausea. This morning he got breakfast, and it wasn't excruciation but still felt pain, as well as the nausea, and his energy level was not normal. As far as the headache, would it be okay to take Tylenol, and for the nausea can he take Phenergan or Dramamine, its not extreme but just uncomfortable. His First Dose of the Covid Vaccine was on 02Feb2021 at 2PM or 2:05PM. The mild headache started last night the same day. The Nausea started last night was mild, on the same day also. The energy level being low started today 03Feb2021". Caller confirms that "after the onset of events he took 2 tylenol last night at 7. He had a little sinus problem and took 1 of coricidin hbp sinus over the counter medication last night. Taking both together made him anxious. Thats why he is calling to find out in the morning. He does not want to take things close together". Outcome of the event pain was unknown and other were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, patient stated that he received first dose of the Pfizer vaccine a few weeks ago and experienced headache. The outcome of the event was unknown.   Information on Lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Maternal exposure during pregnancy, Paraesthesia
Clinical narrative: is_pregnant: Yes/36 Weeks pregnant; Slight tingling/numbing sensation that started at my ear and affected the right side of my face; Slight tingling/numbing sensation that started at my ear and affected the right side of my face; headache; This is a spontaneous report from a contactable consumer or other non hcp. This is the maternal report. A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in Arm Right on 02Feb2021 14:30 (at the age of 31-year-old) (Batch/Lot Number: EM9810) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included slightly under-active thyroid from an unknown date and unknown if ongoing (Pregnant and slightly under-active thyroid). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. The patient did not diagnosed with COVID-19 Prior to vaccination and since the vaccination, has the patient been tested for COVID-19. Concomitant medication(s) included minerals NOS vitamins NOS (PRENATAL VITAMINS [MINERALS NOS; VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for thyroid start and stop date were not reported. The reporter stated that is pregnant: yes/36 Weeks pregnant on an unspecified date, slight tingling/numbing sensation that started at my ear and affected the right side of my face on 02Feb2021 14:30 and headache on 02Feb2021 14:30. The date of last menstrual period 22May2020. The mother reported she became pregnant while taking bnt162b2. The mother was 36 weeks pregnant at the onset of the event. The mother was due to deliver on Mar2021. The mother delivered the pregnancy. The patient did not receive any treatment for the events headache and slight tingling/numbing sensation that started at my ear and affected the right side of my face. The seriousness of the events was reported as non-serious. The outcome of the events is pregnant: Yes/36 weeks pregnant was reported as unknown. Headache and slight tingling/numbing sensation that started at my ear and affected the right side of my face was reported as recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: fever (103), nausea, body aches and headache after second vaccination which lasted for 48 hours.; fever (103), nausea, body aches and headache after second vaccination which lasted for 48 hours; fever (103), nausea, body aches and headache after second vaccination which lasted for 48 hours; fever (103), nausea, body aches and headache after second vaccination which lasted for 48 hours; This is a spontaneous report from a contactable consumer (Patient). A 47-year-old female patient received second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, formulation: solution for injection), via an unspecified route of administration on an unspecified date (at the age of 47 years) at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, patient reported fever (103), nausea, body aches and headache after second vaccination which lasted for 48 hours. Events took place after use of product. The clinical outcome of the events was resolved on an unspecified date.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Husband only developed headache after vaccine; This is a spontaneous report from a contactable consumer via medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated her husband only developed headache after vaccine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Paraesthesia
Clinical narrative: Dizzy; Chills; My body is a little bit of tingly; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Jan2021 as unknown single dose (at the age of 71-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Vaccination facility type was reported as Institute. Patient received the COVID shot on 20Jan2021, she had been okay since then except starting today (28Jan2021), she was getting very dizzy, she woke up very dizzy this morning, and she was walking around holding onto things, she did not know if this is from COVID shot (COVID Vaccine) but when she does get allergic reaction to things it does take almost a week for her to get the reaction, so she kind of feel a little bit like she had the chills, her body is a little bit of tingly, and like she said she was pretty dizzy today. Patient was still experiencing chills. She further asked whether she should go to the hospital. Patient questioned whether we know about the reaction, is that right, then she will just call her own doctor for that, are people complaining about the reaction week later, or these reaction normally happen right after the shot. In response to further probing, patient stated, if she does not drop dead in meantime it is welcome to you. The outcome of the event chills was not recovered while for other events was unknown.  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: Rhinorrhoea
Clinical narrative: nose was running yesterday too; This is a spontaneous report from a contactable consumer (Patient). This consumer reported for a female patient (reporter's mother),who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Patient's age at vaccination was not mentioned. The patient's medical history and concomitant medication(s) was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date, the patient experienced runny nose (rhinorrhoea) after administration of BNT162B2 vaccine. The caller asked if a runny nose was a normal side effect of the vaccine. Information on treatment taken is unknown. Outcome of the event is unknown.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Computerised tomogram, Dysgeusia, Mammogram
Clinical narrative: Itching/her shoulder started to itch like crazy/ Was itching so bad like a mosquito bite; Has a little fever; Rash/rash is hot and has a temperature in it/Rash was a week later and was weird; Itching began 25Jan2021 at night at injection site; felt like an anxiety attack; Metal taste in mouth; Funny feeling in chest; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 19Jan2021 at 17:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received flu shot and experienced shoulder pain, she received first week in Oct2020 at one of the grocery stores, she doesn't remember doing that the last year or before. On 19Jan2021, the patient had metal taste in her mouth and a funny feeling in her chest that felt like an anxiety attack. The next day was fine. The patient was not anxious prior to COVID-19 Vaccine, lasted for a couple seconds and then was gone. It was minor and was not short of breath or anything.On 25Jan2021, the patient had rash and week later 26Jan2021, her shoulder started to itch like crazy. didn't look at it until the next day. Looked in mirror and noticed a rash. Has a little fever, rash was still there and can see the rash around where the point of the needle went in. The patient did not know if that was important.On 27Jan2021 took a picture of the rash and was still there. Feels there was a temperature in the rash, but it was not hurting. Stated the rash site has a fever in it. Rash looked unhappy but took a long time to look unhappy. On day of reporting, patient noticed the rash was hot and has a temperature in it. It was not big and red but was still there. Surprising that rash appeared a week later. The patient did not go through primary care to receive COVID-19 Vaccine. Lab test included mammogram, CAT scan, and testing done at the hospital. A week later rash was weird and was itching so bad like a mosquito bite and was scratching and rubbing it, didn't look in the mirror. The patient doesn't know if rash was there when it started itching. Next day was when she noticed the rash. Stated rashes can itch if they are the allergic type of reaction. Thought it was very strange. On 19Jan2021, the outcome of event anxiety attack, metal taste in her mouth and a funny feeling in her chest was recovered and outcome of other events was unknown.  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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Vaccination site pruritus
Clinical narrative: Itching/her shoulder started to itch like crazy/ Was itching so bad like a mosquito bite; Has a little fever; Rash/rash is hot and has a temperature in it/Rash was a week later and was weird; Itching began 25Jan2021 at night at injection site; felt like an anxiety attack; Metal taste in mouth; Funny feeling in chest; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 19Jan2021 at 17:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received flu shot and experienced shoulder pain, she received first week in Oct2020 at one of the grocery stores, she doesn't remember doing that the last year or before. On 19Jan2021, the patient had metal taste in her mouth and a funny feeling in her chest that felt like an anxiety attack. The next day was fine. The patient was not anxious prior to COVID-19 Vaccine, lasted for a couple seconds and then was gone. It was minor and was not short of breath or anything.On 25Jan2021, the patient had rash and week later 26Jan2021, her shoulder started to itch like crazy. didn't look at it until the next day. Looked in mirror and noticed a rash. Has a little fever, rash was still there and can see the rash around where the point of the needle went in. The patient did not know if that was important.On 27Jan2021 took a picture of the rash and was still there. Feels there was a temperature in the rash, but it was not hurting. Stated the rash site has a fever in it. Rash looked unhappy but took a long time to look unhappy. On day of reporting, patient noticed the rash was hot and has a temperature in it. It was not big and red but was still there. Surprising that rash appeared a week later. The patient did not go through primary care to receive COVID-19 Vaccine. Lab test included mammogram, CAT scan, and testing done at the hospital. A week later rash was weird and was itching so bad like a mosquito bite and was scratching and rubbing it, didn't look in the mirror. The patient doesn't know if rash was there when it started itching. Next day was when she noticed the rash. Stated rashes can itch if they are the allergic type of reaction. Thought it was very strange. On 19Jan2021, the outcome of event anxiety attack, metal taste in her mouth and a funny feeling in her chest was recovered and outcome of other events was unknown.  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: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A 88-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in arm left (upper muscle) in Jan2021 (25Jan2021 or 26Jan2021 after 20:00) (Batch/Lot number: unknown) (at the age of 88-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included pacemaker from 2010 and ongoing, congestive heart failure, cord wrapped around his neck (he was born with cord wrapped around his neck, what they called a blue baby), heart medicine, prediabetes (a couple of doctors thought he might have prediabetes but he does not think so) and he has something, not diverticulosis but something like that he does not remember. There was no family medical history relevant to adverse event. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for cardiac disorder from an unspecified start date and ongoing, and unknown product green capsule 190mg taken for cardiac disorder. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. On 28Jan2021, the patient experienced headache. This morning he woke with a slight headache; he took a shower, took his other heart medication and Bystolic; headache was fine for a while; then it started up after lunch; now it is not a raging headache; but it starts in the back of the head right behind his left ear up to the top of, crown of his head. The patient was not sure about the vaccine administration date, 25Jan2021 or 26Jan2021, but his second dose was scheduled for 16Feb2021. He wondered if he can take some Tylenol or something for the headache. The adverse event did not require a visit to emergency room or physician office. The patient was not hospitalized. Outcome of the event was unknown.  Information on 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Headache, Influenza like illness, Pain, Physical examination
Clinical narrative: Headache; Body ache; Flu like symptoms; I was in the bed for like 2 days; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at an unknown dose as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included multivitamin and other unspecified medications. It was stated that the patient got the Pfizer vaccine exactly a week ago, the first dose and was wondering, I know it says the symptoms last for 48 hours but patient on 22Jan2021 had a headache and body ache still and patient was concerned if she should get the second vaccine because patient have flu like symptoms in 2021 and was in the bed for like 2 days and then it got better on an unknown date in 2021. The patient had Lab test few weeks ago included physical lab work with unknown results but that was before the vaccine that was the 8th of January. Therapeutic measures received for events headache, body ache and flu like symptoms included Tylenol, Ibuprofen. The outcome of events headache, pain was not recovered and outcome of other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Toothache
Clinical narrative: toothache; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9263) via an unspecified route of administration on 27Jan2021 as 1st dose single (at the age of 65-years-old) for COVID-19 immunization. Patient medical history included an ongoing toothache. The concomitant medications included ibuprofen taken at dose in-between 400-600 mg 3 times a day for toothache. Patient reported that he took Ibuprofen for his toothache before and after vaccination. Patient said that he received his first shot yesterday (28Jan2021) and he has been bothered with a toothache the last couple days and will be bothered with it for a day or two until he can get the tooth extracted. He says he read that it was not recommended to take Ibuprofen prior to vaccination and after vaccination, which he did, so he would like to know what is the situation. He said he did not had any problems. The outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Fever ranging between 99.6-100.6 (lasting 1 weeks) cough, runny nose/congestion (lasting 1week +)