chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Congestion; This is a spontaneous report from a nurse. An 88-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: Unknown), intramuscular on 20Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 on 30Dec2020 at the age of 88 years for COVID-19 immunization. The patient experienced congestion (pending clarification) on 21Jan2021 13:00. Treatment was not received for the adverse event. The vaccine was administered in a Nursing Home/Senior Living Facility. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.  Information on the Batch/Lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Muscular weakness
Clinical narrative: bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued; This is a spontaneous report from a contactable Nurse (the patient).  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685, expiration date unknown), intramuscularly in the left arm, on 28Dec2020 as a single dose for COVID-19 vaccination.  Medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 28Dec2020 the patient experienced fatigue. On 29Dec2020 the patient states that her feet were numb bilaterally and her hands felt weak. The patient did not seek any medical attention and no treatment of the events was reported. The clinical outcome of fatigue, numbness of feet and weakness of hands was recovered (reported as "resolved entirely on its own") on an unspecified date.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: palpitations; nauseous; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 29Dec2020 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included hypertension and obesity. The patient's concomitant medications were not reported. The patient previously took Dilaudid and experienced allergies. With first shot-immediately after (on 29Dec2020) had palpitations. Was nauseous times 24 hours on an unspecified date. The outcome of the events was unknown. The patient was not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site discomfort, Vaccination site pain, Vaccination site pruritus
Clinical narrative: my arm started to  hurt like someone was punching me in my arm/arm is very sore; had some itching/itching is in the upper and lower arm that she received the vaccine; lot of discomfort in her arm where she got the vaccine; injection site pain/she has had a lot of discomfort in her arm where she got the vaccine. She says it feels sore and hurts; lot of discomfort in her arm where she got the vaccine. She says it feels sore and hurts. She says for a while it was itching,; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 14Jan2021 09:30 at single dose (right arm) for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient reported that she received her 1st vaccine shot last Thursday, 14Jan2021. She initially had no problem, then a day or 2 later, her arm started to hurt like someone was punching me in my arm. She also had some itching in the upper and lower arm where she received the vaccine; the itching was worse, but now it was better. She also had a lot of discomfort in her arm where she got the vaccine. She says it felt sore and hurts and for a while it was itching, but it stopped itching, she has no rash, just her arm was very sore. Patient reported that she never got her vaccine card after she left the room where she was observed for 15 minutes, and when she asked, they said she won't get the card until after her second shot. She says that she saw on all of the directions for the vaccine it says to keep your card, but when she left the room they told her she won't get it until after her second shot. She confirmed she has only had her first dose. Patient reported that she had no other recent vaccinations or started no other new medications. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased interest, Fatigue
Clinical narrative: was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose.  She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills  was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown.   Information about batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose.  She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills  was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown.   Information about batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: was always in the bed not wanting to do anything; Weakness; tired; Chills; sore arm; Swollen arm; Joint pain; Muscle pain; she was severely sick for 11 days; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 0930 at a single dose on the right arm for COVID-19 immunization. Medical history included ongoing cholesterol problems from 2019 (manages without medication) and colitis. Concomitant medications were not reported. The patient previously took doxycycline from Aug2020 to 30Dec2020 for colitis. The patient experienced muscle pain, joint pain, sore arm and swollen arm on 31Dec2020. She experienced weakness, tired, chills on 01Jan2021, and was always in the bed not wanting to do anything on an unspecified date. The patient stated she was severely sick for 11 days and stated her covid and flu test came back negative. She said she could not work and was off work due to the side effects. She had to go to urgent care also. She wanted to know about taking the second dose.  She was scheduled to get her second dose on 22Jan2021. She was sick with the first dose. She was weak, tired, had chills and was always in bed not wanting to do anything. She asked if these events will come back with the second dose and if it is possible to not get the second dose. She also reported that her arm was sore. She had joint and muscle pain. She tried to fight it. The weakness and chills continued off and on. She returned to work on 12Jan2021. She went to the urgent care and has also went to see her physician. She had lab work done. She also had a rapid Covid and flu test, both of which were negative. Outcome of weakness and chills  was recovering; outcome of sore arm and swollen arm was recovered on 04Jan2021; outcome of joint pain and muscle pain was recovered on 12Jan2021; outcome of tired was not recovered; outcome of "she was severely sick for 11 days" was recovered on an unspecified date; outcome of "always in bed not wanting to do anything" was unknown.   Information about batch/lot number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: his first was on 28Dec and his second was on 08Jan; antibody test shows no antibodies after taking two doses of the vaccine; This is a spontaneous report from a contactable physician. A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration from 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient received the first dose of BNT162B2 on 28Dec2020. Reporter stated he got the first dose of the COVID 19 vaccine on 28Dec2020 and second dose on 08Jan2021. He took an antibody test yesterday (20Jan2021) which showed no antibodies and wanted this explained to him. He is on ADVAIR and had a steroid shot on 04Jan2021. He wanted to know if there is any data on patients using ADVAIR. He also wanted to know if he should take the second dose again or what he should do. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: showed no antibodies on 20Jan2021. The outcome of the event 'antibody test shows no antibodies after taking two doses of the vaccine' was unknown.  Information on the batch number/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Nausea
Clinical narrative: feeling nauseous; stomach pain; stomach was burning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 20Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient initially asked if the nausea and stomach pain that she experienced after getting the first dose of the Covid vaccine is a normal side effect. The patient reported that she received the first dose of the Covid vaccine yesterday (20Jan2021) and a few hours after she started feeling nauseous. She added that during the night she felt her like her stomach was burning and felt even more nauseous. She felt nauseous at night and today (21Jan2021). The patient asked she can take Prevacid or Tums or Pepto bismol or if there's a contraindication like there is with taking Tylenol or Motrin. The patient reported having read that taking Tylenol or Motrin may interfere with the vaccine and she wants to know if an antacid will have the same effect. The patient does not want to go to her HCP (healthcare professional). She just does not want anything to affect the efficacy of the first dose. The other part is she knows that achiness or fever can be a side effect, but she did not indicate if she experienced that. The outcome of events was unknown. This case is non-serious.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Stress
Clinical narrative: numbness on the left side of her face; very stressed; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was having numbness on the left side of her face after receiving the first dose of the COVID-19 vaccine. She inquired about the symptoms in question and if Pfizer recommends receiving the second dose given her reaction to the first dose. She mentioned that she was very stressed about this symptom. The outcome of the events was unknown.   The following information on the batch/lot number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Chills, Dyspnoea, Erythema, Fatigue
Clinical narrative: oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) .  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30  at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No  COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't  received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day.  I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask.  I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems.   I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering.  Information on lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypersensitivity, Injection site pain, Oxygen saturation decreased
Clinical narrative: oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) .  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30  at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No  COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't  received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day.  I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask.  I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems.   I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering.  Information on lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Temperature intolerance
Clinical narrative: oxygen dropping to 89; causing me to have breathing problems; heavy breathing when I walked and wore the mask; sensitivity to the cold; had instances where I felt an unusually high chill on my chest and wavy feeling; fever rising as high as 100.4; had instances where I felt an unusually high chill on my chest and wavy feeling; was told that I looked red; Had soreness on site the night of the injection; headaches; tiredness; This is a spontaneous report from a contactable contactable consumer (patient) .  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm on 14Jan2021 14:30  at SINGLE DOSE for COVID-19 immunization.Medical history included Type one diabetes, obesity, high cholesterol.No  COVID prior vaccination . Facility where the most recent COVID-19 vaccine was other .The patient didn't  received any other vaccines within 4 weeks prior to the COVID vaccine. No Concomitant medications reported.Clincal course was reported as follows: on 14Jan2021 I had soreness on site the night of the injection, had headaches, tiredness, and was told that I looked red and was not myself beginning on the next day.  I have had sensitivity to the cold, which I never had before, and heavy breathing when I walked and wore the mask.  I had instances where I felt an unusually high chill on my chest and wavy feeling, causing me to have breathing problems.   I have had fever rising as high as 100.4, and oxygen dropping to 89. The events were reported as non-serious. The patient went to Emergency room/department or urgent care and was treated with Prednisone, inhaler and Tylenol.The patient had been tested for COVID post vaccination (Nasal Swab(20Jan2021) :unkonwn results).Outcome of the events was recovering.  Information on lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vomiting
Clinical narrative: she threw up; her legs hurt; so tired; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  She got the vaccine on 15Jan2021 and on an unspecified date in Jan2021 she threw up and her legs hurt, and it just keeps on going down the list. She also reports that she was feeling "so tired" on an unspecified date in Jan2021. She reported that it has almost been 7 days and she is still having side effects.  Information on the Lot/Batch number has been requested
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dysphonia, Gastrooesophageal reflux disease, Oesophageal pain
Clinical narrative: diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat; painful esophagus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 05:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient receive the vaccine Covid vaccine and had no problems. The next day on 16Jan2021, she had aches and pains but found them not unusual. 24 hours later that she had reflux on 17Jan2021. She had reflux all day on 17Jan20210 and took Gaviscon all day. Patient had very serious reflux Monday (18Jan2021) morning and took Prilosec. She also had a sore abdomen/ abdominal pain and took four Gaviscon that evening. She had diarrhea and stated that the same thing happened Tuesday (19Jan2021) but she was little better in the afternoon. She had no Gaviscon then. On Wednesday (20Jan2021), she very bad reflux all day, sore abdomen and diarrhea. Patient took Prilosec in the morning one hour before eating and took Gaviscon all night. Her voice was grabbly and she has sore a throat, painful esophagus and abdomen on Jan2021. She felt better the morning of 21Jan20221 and had Prilosec. She still has diarrhea and loose stool, and felt better after going to the bathroom. Her healthcare provider and the nurse stated to keep taking Prilosec. Patient wanted to know if this may be a side effect though not very prominent that is out there but not very common. Outcome of the event of diarrhea was not recovered while for the remaining events was unknown.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat; painful esophagus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 05:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient receive the vaccine Covid vaccine and had no problems. The next day on 16Jan2021, she had aches and pains but found them not unusual. 24 hours later that she had reflux on 17Jan2021. She had reflux all day on 17Jan20210 and took Gaviscon all day. Patient had very serious reflux Monday (18Jan2021) morning and took Prilosec. She also had a sore abdomen/ abdominal pain and took four Gaviscon that evening. She had diarrhea and stated that the same thing happened Tuesday (19Jan2021) but she was little better in the afternoon. She had no Gaviscon then. On Wednesday (20Jan2021), she very bad reflux all day, sore abdomen and diarrhea. Patient took Prilosec in the morning one hour before eating and took Gaviscon all night. Her voice was grabbly and she has sore a throat, painful esophagus and abdomen on Jan2021. She felt better the morning of 21Jan20221 and had Prilosec. She still has diarrhea and loose stool, and felt better after going to the bathroom. Her healthcare provider and the nurse stated to keep taking Prilosec. Patient wanted to know if this may be a side effect though not very prominent that is out there but not very common. Outcome of the event of diarrhea was not recovered while for the remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Herpes zoster
Clinical narrative: Blood pressure issues; Shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 08Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included allergy. The patient's concomitant medications were not reported. On 08Jan2021, following the first dose of vaccination, the patient had shingles and blood pressure issues (unknown results). The outcome of the events, 'singles' and 'blood pressure issues', was unknown.  Information about lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at the injection site; chills; low grade fever; This is a spontaneous report from a contactable other healthcare professional reporting for himself  A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3247, via an unspecified route of administration on 20Jan2021 at 11:45 (at the age of 59 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included gastroesophageal reflux disease, and heart disease, both from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication included Evolocumab (REPATHA) and omeprazole (OMEPRAZOLE DR). The patient did not receive any other vaccines within four weeks prior to the vaccination,  On 21Jan2021 at 01:00AM, the patient experienced soreness at the injection site, chills, and low grade fever. The patient did not receive treatment for the events. The clinical outcome of soreness at the injection site, chills, and low grade fever was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Fever; Chills; Muscle and joint pain; Muscle and joint pain; Headache; Dizziness; This is a spontaneous report from a non-contactable healthcare professional (patient). A non-pregnant 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261), via an unspecified route of administration in right arm, on 20Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included endometriosis, anxiety, and depression. The patient was taking unspecified concomitant medications. The patient previously took the first dose of BNT162B2 on 30Dec2020 at 01:30 PM for COVID-19 immunization (in left arm). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 20Jan2021 at 10:00 PM (22:00), the patient experienced fever, chills, muscle and joint pain, headache, and dizziness. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Muscle and joint pain; Muscle and joint pain; Headache; Dizziness; This is a spontaneous report from a non-contactable healthcare professional (patient). A non-pregnant 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261), via an unspecified route of administration in right arm, on 20Jan2021 at 08:30, at a single dose, for COVID-19 immunization. The patient's medical history included endometriosis, anxiety, and depression. The patient was taking unspecified concomitant medications. The patient previously took the first dose of BNT162B2 on 30Dec2020 at 01:30 PM for COVID-19 immunization (in left arm). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 20Jan2021 at 10:00 PM (22:00), the patient experienced fever, chills, muscle and joint pain, headache, and dizziness. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: body aches; felt very tired; lymph node in her left armpit swelled and was painful; lymph node in her left armpit swelled and was painful; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration on 15Jan2021 at 12:45 in the left arm at a single dose for COVID-19 immunization. The patient's medical history included COVID 19. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and tetracycline and which she had an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at 20:00, the patient started having body aches , felt very tired and the lymph node in her left armpit swelled and was painful. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body ached so badly that felt like a truck ran over; severe headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 20Jan2021 at 09:45 in the left arm at a single dose for COVID-19 immunization. The patient's medical history was reported as none. Concomitant medications included trazodone, escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN), and raloxifene hydrochloride (EVISTA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 20Jan2021 at 09:45, the patient's body ached so badly that felt like a truck ran over and had severe headache. The patient had a physician office visit but did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unknown route of administration on 15Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if diarrhea was a side effect of the vaccine and for the efficacy after one dose, if there was a certain percentage. The patient had received the vaccine on 15Jan2021. On the 17Jan2021 or 18Jan2021 she started having diarrhea that had been off and on. She was scheduled for the second vaccine on 05Feb2021. The clinical outcome of the diarrhea was reported as recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Lymphadenopathy, Pain in jaw
Clinical narrative: pain from the tongue going to the jaw and back; pain from the tongue going to the jaw and back; swelling in the lymph nodes; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of the vaccine at around 11.35 mins ago (21Jan2021) then she experienced pain from the tongue going to the jaw and back (pending clarification), and after that it still hurts a bit. She also mentioned some swelling in the lymph nodes (21Jan2021). The outcome of events was unknown. This case is non-serious.   Information about lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Full body aches; Joint inflammation; Headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302, Expiration Date: 30May2021), via an unspecified route of administration in left arm, on 20Jan2021 at 09:15, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899) on 30Dec2020 at 09:30 AM for COVID-19 immunization (left arm). The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a military base facility. On 20Jan2021 at 06:00 PM, the patient experienced fever, chills, full body aches, and joint inflammation. In Jan2021 (after the vaccine), the patient experienced headache and ibuprofen was received as treatment. No treatment was received for the other events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The outcome of "Headache" was unknown. The patient was recovering from the other events.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Dysuria
Clinical narrative: burning when he urinates; sharp pain where his navel is; pain in his stomach; This is a spontaneous report from a contactable consumer reporting for himself. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL1283), via an unspecified route of administration on 14Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included Parkinson's disease from an unknown date. The doctor told him to make an appointment with his Parkinson's doctor and tell him, maybe that has something do with it. There were no concomitant medications. The patient experienced burning when he urinates for 2 weeks, a sharp pain where his navel is, and pain in his stomach on Jan2021. He was wondering if it could be from the shot or if it is something else. He had an appointment with his doctor on Monday and he told him about it. The doctor gave him an antibiotic, Ciprofloxacin 500 mg that made him dizzy, he does not know if he will continue to take it but it helped the burning, the burning was not as bad. It was in a brown clear pharmacy bottle. The burning when he urinated is going away but the pain in his stomach comes and goes and it is right on his navel, it was described as a real hard pain. Patient would come back 03Feb2021 per vaccination card. Outcome of the event burning when he urinates was recovering while unknown for a sharp pain where his navel is, and pain in his stomach. The events were considered non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, SARS-CoV-2 test positive
Clinical narrative: Covid test positive; Covid test positive; feeling bad/even worse; feel like sick; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumers (one of which is the patient) reported that a male patient of an unspecified age (reported as 45, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date then received the second dose on 19Jan2021 both via an unspecified route of administration at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's second shot was on Tuesday (19Jan2021). He was feeling really bad Tuesday afternoon, and on Wednesday (20Jan2021) even worse. He worked in a laboratory. He took a COVID test Wednesday at work, and within two minutes of testing himself it said positive. They also have PCR test. He was wondering if the vaccination can cause false positives. He feel like he's sick, like there was something going on. The patient wasn't hospitalized. He was already sitting at home in quarantine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tired; Arm hurt a bit; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 18Jan2021 at 14:30, at a single dose, for COVID-19 immunization; and ibuprofen (ADVIL; Strength: 200 mg, Lot Number: DC5474, Expiration Date: May2022), via an unspecified route of administration,  on 18Jan2021, at 400 mg, single, as premedication. The patient's medical history and concomitant medications were not reported. The patient's wife was told by a nurse to give ibuprofen before the patient's first shot. So, the patient's wife told the patient to take ibuprofen before the COVID-19 vaccine shot and he took two 200 mg ibuprofen before the vaccine. The patient's wife feels guilty because she doesn't know if the patient is protected or not. The patient's wife gave the patient two ibuprofen before the COVID-19 shot. On 18Jan2021, the patient felt a bit tired and his arm hurt a bit, but he was fine the next morning (19Jan2021). He only felt a little tired that day and the next day, he felt great. It was further reported that the patient's wife gets allergy shots from a nurse, and the nurse told her to take ibuprofen before the COVID-19 vaccine shot. The patient never takes ibuprofen and the patient's wife can't believe she told him to take it. She had a friend who said ibuprofen could minimize the effectiveness of the shot. So, she was asking if the patient should have another shot since he took ibuprofen before his vaccine. It was a very bad advice because the patient's wife just learnt she shouldn't have. The patient's wife wanted him to have a little reaction as she thinks the vaccine is not going to be effective; asked if the patient should take an additional shot. The patient is scheduled for the second dose of the COVID-19 vaccine on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable; and for ibuprofen was post-therapy. The patient recovered from the events on 19Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swelling, redness, and pain; Injection site swelling, redness, and pain; Injection site swelling, redness, and pain; Joint pain in arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247), via an unspecified route of administration on 19Jan2021 16:30 at a single dose on left arm for COVID-19 immunization. Medical history included Major Depressive Disorder, Generalized Anxiety Disorder, and COVID-19 on an unspecified date. Concomitant medication included fluoxetine, and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient experienced injection site swelling, redness, and pain, and joint pain in arm on 20Jan2021. No treatment received for the events. The outcome of the events was unknown. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Heart rate, Heart rate increased, Urine abnormality
Clinical narrative: Spike in temp; high heart rate; cloudy urine with a strong odor; cloudy urine with a strong odor; This is a spontaneous report from a contactable consumer (patient's parent). A 28-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL 1283) via an unspecified route of administration on the right arm on 19Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included traumatic brain injury in 2009, vegetative state and known allergies: sulfa. Concomitant medication included fluticasone, levetiracetam (KEPPRA), dextromethorphan hydrobromide (DELSYM), probiotics and miralact. On 20Jan2021 05:00 PM, the patient experienced spike in temp, high heart rate; not sure if this was related but cloudy urine with a strong odor. Took a sample to his primary care. Therapeutic measures were taken as a result of the events which included alternating acetaminophen and ibuprofen. The facility where the vaccine was administered was in an outdoor tent (other). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: Spike in temp; high heart rate; cloudy urine with a strong odor; cloudy urine with a strong odor; This is a spontaneous report from a contactable consumer (patient's parent). A 28-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL 1283) via an unspecified route of administration on the right arm on 19Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included traumatic brain injury in 2009, vegetative state and known allergies: sulfa. Concomitant medication included fluticasone, levetiracetam (KEPPRA), dextromethorphan hydrobromide (DELSYM), probiotics and miralact. On 20Jan2021 05:00 PM, the patient experienced spike in temp, high heart rate; not sure if this was related but cloudy urine with a strong odor. Took a sample to his primary care. Therapeutic measures were taken as a result of the events which included alternating acetaminophen and ibuprofen. The facility where the vaccine was administered was in an outdoor tent (other). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Sore and swollen lymph node in neck; Sore and swollen lymph node in neck; Tired; Arm I was injected is sore; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on 20Jan2021 (14:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient had no relevant medical history and concomitant medications. The patient was not pregnant at the time of vaccination. On 20Jan2021 (17:30), at night on the day of vaccination, the patient had sore and swollen lymph node in the neck; was tired; and the arm she was injected in was sore. The patient did not receive any treatment for the reported events. The outcome of the events, 'sore and swollen lymph node in the neck', 'tired' and 'arm she was injected in was sore', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.