chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Arm is swollen; Pain; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2 reported as COVID SHOT; unknown lot number and expiration date) at unknown age of vaccination via an unspecified route of administration in the arm on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife reported that her husband who had a COVID shot Friday in his arm. The patient's arm was swollen and he was having pain. She inquired what can he do for that. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pain, Paraesthesia
Clinical narrative: the lumpy, red area is not itchy, but it is tingling, and stings sometimes.; stings; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the right upper arm on 25Jan2021 at 11:30 at a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included Influenza vaccine in Dec2020 and Balance of Nature Fruits as supplement since Jan2021 - she started taking Whole Foods brand Balance of Nature Fruits pills and has been taking them off and on for the last couple weeks. On 27Jan2021, the patient had a lumpy, red area on the opposite shoulder from where she received the COVID-19 vaccine. She said she discovered the lumpy, red raised up bumps area on her left shoulder that morning. She said the lumpy, red area is on the back of her left shoulder, neck and hairline area. She said her husband said the lumpy, red area is a couple square inches in size. She said the lumpy, red area is not itchy, but it is tingling, and stings sometimes. She also asked if what she is experiencing is a side effect of the vaccine. The patient declined any treatment for the events saying she didn't know what to do. The event "lumpy, red area on the opposite shoulder from where she received the COVID-19 Vaccine/lumpy, red raised up bumps area on her left shoulder" had not resolved while the outcome of the rest of the events was unknown.   Information on the batch/lot number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Pt developed left lower lip paresthesia that radiated to L side of face.; Pt developed left lower lip paresthesia that radiated to L side of face.; This is a spontaneous report from a non-contactable pharmacist. A 75-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), intramuscular on 26Jan2021 at 10:00 at a single dose for covid-19 immunisation.  Medical history included transient ischaemic attack (TIA), stroke and chronic kidney disease (CKD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took gabapentin for facial nerve pain. The patient developed left lower lip paresthesia that radiated to the left (L) side of face on 26Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Dizziness, Fatigue
Clinical narrative: Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain
Clinical narrative: Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Sinus pain
Clinical narrative: Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Extrasystoles, Fatigue, Feeling abnormal, Nervousness
Clinical narrative: light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while laying down; weird/ didn't feel normal; get restless; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 20Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included having one thyroid and had a benign tumor removed from behind heart when she was young and birth control. Concomitant medication included benzalkonium chloride, sodium chloride (ALIVE) and desogestrel, ethinylestradiol (ISIBLOOM) for birth control. After taking the shot she got light headed as she was walking to her car on 20Jan2021 15:00. Didn't think nothing of it since she was nervous about taking the shot. Then once she got home, she got really tired. She only had one thyroid so the shot made me really sleepy and she had a few skipped heart beats while laying down. After she slept, she felt fine but weird then after being up for a few hours she would get restless again. She got light headed again the next day going to the grocery store then back restless. She didn't feel normal until this Tuesday, she was not feeling weird and she was not as tired as she had been since she took the shot. She had tried to get seen from her doctor but she was booked up. No treatment was received for the events. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Somnolence
Clinical narrative: light headed; nervous; really tired; made me really sleepy; i had a few skipped heart beats while laying down; weird/ didn't feel normal; get restless; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 20Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included having one thyroid and had a benign tumor removed from behind heart when she was young and birth control. Concomitant medication included benzalkonium chloride, sodium chloride (ALIVE) and desogestrel, ethinylestradiol (ISIBLOOM) for birth control. After taking the shot she got light headed as she was walking to her car on 20Jan2021 15:00. Didn't think nothing of it since she was nervous about taking the shot. Then once she got home, she got really tired. She only had one thyroid so the shot made me really sleepy and she had a few skipped heart beats while laying down. After she slept, she felt fine but weird then after being up for a few hours she would get restless again. She got light headed again the next day going to the grocery store then back restless. She didn't feel normal until this Tuesday, she was not feeling weird and she was not as tired as she had been since she took the shot. She had tried to get seen from her doctor but she was booked up. No treatment was received for the events. The facility where the vaccine was administered was in a Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Sinusitis
Clinical narrative: dizzy; sinus infection; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number and expiry date unknown, via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first round of the vaccine and was dizzy on unspecified date. The patient informed that it was not like vertigo but similar. The patient informed that he did not know if it has something to do with what was going on or if it was a sinus infection. The patient informed that he went to bed dizzy. The patient informed that he was dizzy right now but not all the time. The outcome of the events was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Headache
Clinical narrative: headache; not eating; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included headache on 26Jan2021. There were no concomitant medications. The reporter stated that her husband (patient) received the first dose of the vaccine about two and one-half to three weeks ago and he had some aches and pain but it was not that bad. She reported that a day or two after the first dose he was achy and didn't feel like himself. Then on 26Jan2021, he got a major headache; he would sleep and wake up and sleep again trying to get rid of the headache. She gave him paracetamol (TYLENOL) 650 mg one by mouth and it didn't help. He got the second dose on 27Jan2021 between 07:00 and 09:00AM she was unsure of the arm. He came home and is sleeping now and had a headache on 27Jan2021. She was asking what can she give him for the headache. She also stated that he also was not eating on an unspecified date in Jan2021. She wanted more information on what to do for him. The events did not require a visit to the physician or ER. The outcome of the event headache was not recovered while the outcome of the event not eating was unknown.   Information about lot/batch number has been requested.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Lymph nodes hurting/burning pain on chest and breast area/ Her Lymph nodes are tender on the Left Side, it goes down the breast arm; This is a spontaneous report from a contactable consumer reporting for herself. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration (arm right) on 26Jan2021 at SINGLE DOSE for COVID-19 immunization, at 92 years old. Medical history lung cancer 12 years before from 2009, breast cancer on an unspecified date, and a lump already on the breast from the surgery and she usually get pain there from an unspecified date. She is a cancer survivor. She had surgery for breast cancer on same side, that's where the pain was. She also had a stroke and speech is slurry from an unspecified date. The patient asked to bear with her as she had a stroke in the past and her speech is slurry. She lost the COVID card, she did not even know they gave a card, until somebody told her that they had their card. She lives in a Senior citizen facility, and she does not remember any card. They just gave her information sheets. It was reported that the patient had the vaccine and she was having a lot of pain on the left side, however she got the vaccine on the right side. She had surgery for breast cancer on same side, that's where the pain was, however the vaccine was on the other arm. Patient stated that she thinks it was the lymph nodes, she does not know what to do about it, since she is a Cancer survivor. The patient requested the call handler to talk slow, she is 92 years old. She cannot call the doctor because he is retired and so she does not have a doctor. The patient expressed that its especially in the Lymph nodes, she read the papers that she got, she thought this is common. Her First Dose was on 26Jan2021, probably around 9:30AM or 10AM. The Lymph nodes began hurting on 26Jan2021, it was a burning pain on chest and breast area. She took a Vicodin and it went away and did not bother her for the rest of the day, but it was bothering her this morning and it woke her up. She has a lump already on the breast from the surgery and she usually get pain there, but this is not the same pain today. As of reporting time, it was different, it was a stronger pain, it goes down the breast arm. Her Lymph nodes are tender on the Left Side which is the same side she had surgery on in the past. She got the vaccine on the right arm. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, SARS-CoV-2 test, Trigeminal neuralgia, Vomiting
Clinical narrative: axillary lymphadenopathy x 2 weeks right side (same side as first injection).; nausea; vomiting; transitory trigeminal neuralgia - right sided; This is a spontaneous report from a contactable physician (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at the right arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. The patient has no medical history. The patient has no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included influenza vaccine (FLU) on 10Dec2020 at the left arm. The patient experienced axillary lymphadenopathy for 2 weeks right side (same side as first injection), nausea, vomiting, and transitory trigeminal neuralgia - right sided; all on 01Jan2021. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab (COVID PCR): negative on 19Jan2021. The patient recovered from the event axillary lymphadenopathy on 15Jan2021 and recovered on an unspecified date for the rest of the events.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; his arm was a little sore; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date: unknown) at the vaccination age of 82-year-old intramuscularly in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 vaccination (COVID-19 immunization). The patient's medical history and concomitant medications were none. The patient did not received other vaccine within 4 weeks prior to vaccination. The wife reported that her husband got the first dose of the Covid-19 Vaccine on 25Jan2021 about 14:00 and did not have any reaction except his arm was a little sore on 25Jan2021 18:00. It is sore if he rubs the area, but has gotten better She said that last night, he developed diarrhea at about 22:30 26Jan2021. She inquired if this is a coincidence, he got the diarrhea or is it a side effect from the shot. She added that the diarrhea started about 36 hours after he got the first dose. He had the diarrhea at 22:30 26Jan2021, he had it again at 02:00 27Jan2021, and again at 07:00 27Jan2021 and he has not had it since. She said that her husband was saying he thinks it was getting better. She mentioned that after he received the vaccine, they waited for 15 minutes to make sure there was no reaction. She added that the vaccination facility type was health department drive through vaccination. The adverse events did not require emergency room or physician office visit. The outcome of the event was recovering.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Weight, Weight fluctuation
Clinical narrative: weight was 236-238 and bounces back and forth; Started getting real dizzy that comes and goes/ if she moves too fast that the dizziness comes and goes; Right arm is sore and not tender; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249 expiration date: May2021, via an unspecified route of administration on 26Jan2021 at a single dose in the right arm for COVID-19 immunization. Medical history included heart problem from Nov2019 and ongoing and angina pectoris. Concomitant medication included a lot of pills for her heart problem. She was on blood thinners, sugar pills, and uric acid because of the diuretics. The patient stated that she got her shot yesterday (26Jan2021) a little after 1. Later this morning (27Jan2021), that she started getting real dizzy that comes and goes. She was reading the list and dizziness was one of more serious side effects. She wanted to know what to do about it, it was one of things. She has another shot coming up on 16Jan (as reported). The patient further mentioned that her right arm was sore and not tender on 27Jan2021. If she moves too fast that the dizziness comes and goes. Her weight was 236-238 and bounces back and forth because she was on diuretics. The outcome of the events dizziness was not recovered, right arm was sore was recovering while for weight was 236-238 and bounces back and forth was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: With the first dose she felt the little warmth or gush of the medication going in; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at the upper left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. With the first dose she felt the little warmth or gush of the medication going in on 06Jan2021, not pain but she could feel it going in but with this second shot there was nothing and no blood. The outcome of the event was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Vaccination site pain
Clinical narrative: soreness at the injection site; Headache; elevated temperature (100.2 F); This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported), via an unspecified route of administration in left arm on 26Jan2021 08:30 at a single dose for covid-19 immunization.  Medical history was reported as none. There was no other vaccine administered to the patient in four weeks. No known allergies. Patient was not pregnant at time of vaccination.  The patient's concomitant medications were not reported.   On 27Jan2021 at 07:00, patient experienced soreness at the injection site, headache and elevated temperature (100.2 F). Outcome of the events was unknown. Patient was given the vaccine in a workplace clinic.  The patient has not tested with Covid since vaccination.    Information about Batch/Lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982), via an unspecified route of administration by injection once to left arm, upper part, on 26Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient experienced tingling on right side by cheek bone on 27Jan2021 and she did not have it yesterday, and the shot was on the left side, later clarified as the left arm. The outcome of the event was not recovered.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: achy / aches and pain; didn't feel like himself; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The reporter stated that her husband (patient) received the first dose of the vaccine about two and one-half to three weeks ago and he had some aches and pain but it was not that bad. She was unsure of the exact day or time and does not know which arm. She reported that a day or two after the first dose he was achy and didn't feel like himself. He didn't say much about it. Then yesterday 26Jan2021 he got a major headache after the second dose; he would sleep and wake up and sleep again trying to get rid of the headache. She gave him Tylenol 650mg one by mouth and it didn't help. Outcome of the events was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Sinus headache
Clinical narrative: Feels terrible now; Sinus headache; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient's husband) reported that 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) at a single dose, with route of administration and therapy date unspecified, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had felt "terrible now"; and had sinus headache. The outcome of the events, 'felt terrible' and 'sinus headache', was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph nodes around collarbone and neck; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3246 and expiration date unknown), via an unspecified route of administration on the left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), probiotics (PROBIOTICS) and multivitamin. The patient had no other vaccine in four weeks and was not diagnosed with COVID-19 prior to the vaccination. The patient experienced swollen lymph nodes around collarbone and neck on 20Jan2021. No treatment was administered for the event. The patient underwent lab tests and procedures which included nasal swab: negative on 04Jan2021. The event had not resolved. The event required a physician office visit.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms
Clinical narrative: For 24 hours I had muscle spasms down the middle of my back and in my neck; severe malaise; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1824; expiry date: unknown) via an unspecified route of administration in the right arm, on 20Jan2021 at 10:00, at a single dose, for Covid-19 immunization. Other medical history included depression, anxiety, and hypothyroidism. The patient had no known allergies. Concomitant medications included sertraline, prednicarbate (TOPIMAX), levothyroxine, and ethinylestradiol, norelgestromin (XULANE). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EI1284) in the right arm, on 26Dec2020 at 06:15 AM, for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 21Jan2021, at 12:00 AM, for 24 hours, the patient had muscle spasms down the middle of her back and in her neck, and severe malaise. The patient did not receive therapy for the events. Outcome of the events was recovered.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: 4 inch area of erythema around the injection site; 4 inch area of erythema around the injection site/There was no induration or hives, nothing other than pain due to injection; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. It was reported that the patient got the first shot and over 4 days developed a 4-inch area of erythema around the injection site. There was no induration or hives, nothing other than pain due to injection. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pain, Pyrexia
Clinical narrative: body aches; Low grade fever; swelling of upper lip/recurrent swelling of the upper lip; This is a spontaneous report from a contactable physician. A 54-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication included morniflumate (FLOMAX [MORNIFLUMATE]) for benign prostatic hyperplasia. It was also reported that patient was not on an ACE inhibitor. The physician reported that the patient received the second dose of the Pfizer COVID 19 vaccine two weeks ago today (unspecified date). Eleven to thirteen hours later, the patient had the typical symptoms including body aches and low grade fever. Patient also experienced swelling of the upper lip. All of these effects resolved within 24 hours and the patient had recovered completely. Then 14 days later, the patient had recurrent swelling of the upper lip again. It was stated that the events were not serious.  Outcome of the events 'body aches' and 'low grade fever' was recovered; outcome of the event 'swelling of upper lip/recurrent swelling of the upper lip' was not recovered.  Information on the lot/ batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching at her head, face and shoulders and the back; This is a spontaneous report from a contactable consumer (patient).  An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: EL9261), via an unspecified route of administration on the right arm on 26Jan2021 10:30 at SINGLE DOSE as COVID-19 immunization at the hospital.  Medical history heart attack, ongoing bone disorder (reported as bone), ongoing blood pressure abnormal (reported as blood pressure), ongoing  pain in leg, ongoing blood cholesterol abnormal (reported as cholesterol), ongoing allergy, and ongoing blood clots in leg. The patient was also allergic to sulfa. Ongoing concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) since 2011 (taking for 10 years) and for blood pressure, cetirizine hydrochloride (ZYRTEC) from unknown date (taking for long time) for allergy, losartan (LOSARTAN) since 2016 (taking for 5 years) for cholesterol, potassium (POTASSIUM) from unknown date (taking for long time) for pain in leg, metoprolol tartrate (LOPRESSOR) since 2011 (taking for 3 years) for blood pressure, omeprazole (PROTONIX) since 2011 (taking for 3 years) for blood clots in leg, fish oil (FISH OIL) from unknown date and indication, acetylsalicylic acid (ASPIRIN) since 2001 (taking for 20 years) for heart attack, colecalciferol (D3) since 2016 (taking for 5 year) for calcium supplementation reported as (calcium and body build up), and calcium (CALCIUM) from unknown date for bones. The patient first dose of the Pfizer COVID 19 vaccine on 26Jan2021 at 10:30AM in the right arm. She noticed about 9PM last night, she started itching at her head, face, shoulders and back. The itching only lasted for a little over an hour (26Jan2021 10:00 PM). She took some diphenhydramine (BENADRYL) and it helped, gave her some relief. She was fully recovered today 27Jan2021. She was scheduled for the next dose 16Feb2021.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dysstasia, Malaise
Clinical narrative: Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so weak he couldn't stand up out of a chair; felt really bad; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; EL3247), via an unspecified route of administration in the left arm near the shoulder on 16Jan2021 at about 2-3:00 PM as a single dose for COVID-19 immunization (also reported as to protect himself; hopefully). The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines on the same day as BNT162B2 or even four weeks prior and had no problems with vaccines in the past. The patient experienced fever, chills, extreme weakness; so weak he couldn't stand up out of a chair, and felt really bad on 26Jan2021. He had a fever a little over 100 degrees, extreme weakness. He was so week he couldn't stand up out of a chair. He also had chills and just felt really bad. The patient thinks he was over it, he hoped. The events did not require any visit to the Emergency Room or Physician's office. Outcome of the events was recovering.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so weak he couldn't stand up out of a chair; felt really bad; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; EL3247), via an unspecified route of administration in the left arm near the shoulder on 16Jan2021 at about 2-3:00 PM as a single dose for COVID-19 immunization (also reported as to protect himself; hopefully). The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines on the same day as BNT162B2 or even four weeks prior and had no problems with vaccines in the past. The patient experienced fever, chills, extreme weakness; so weak he couldn't stand up out of a chair, and felt really bad on 26Jan2021. He had a fever a little over 100 degrees, extreme weakness. He was so week he couldn't stand up out of a chair. He also had chills and just felt really bad. The patient thinks he was over it, he hoped. The events did not require any visit to the Emergency Room or Physician's office. Outcome of the events was recovering.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Pain in extremity
Clinical narrative: had trouble with his stomach in the bowels while sleeping; arm sore; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that his arm was sore the first night (23Jan2021) and did not take anything for it. On Monday night (25Jan2021), he had trouble with stomach in bowels while sleeping. He wanted to know if this was an occurrence from the vaccine or if it was a random occurrence. In all things that he read, diarrhea like symptoms were not mentioned. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the right arm on 19Dec2020 08:45 at 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. The patient experienced sore arm, mild headache, and nausea after the first dose on an unspecified date with outcome of not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: arm pain/soreness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EK9231), intramuscular at the left upper arm on 05Jan2021 10:20 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 05Jan2021, the patient experienced arm pain/soreness she took some Tylenol, not that she needed too much. She recovered from the arm pain/soreness within a day or two days. It was not a big deal.  The patient weight was 157-158lbs on an unspecified date. The outcome of the event was recovered on Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Culture, Dysuria, Micturition urgency, Pollakiuria
Clinical narrative: mild discomfort to my urethra; UTI symptoms; Burning upon urination; pain upon urination; urgency; frequency; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL0140) solution for injection, via an unspecified route of administration in left arm on 28Dec2020 15:45 at a single dose for Covid-19 immunization. Medical history included Hashimoto's Thyroiditis. Patient was not pregnant. The patient's concomitant medications included levothyroxine, unspecified daily multivitamin, and collagen. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and had allergies. The patient experienced UTI symptoms, burning upon urination, pain upon urination, urgency, and frequency on 29Dec2020, and mild discomfort to her urethra on an unspecified date. The patient visited her physician. Patient received antibiotic - Keflex. The patient underwent lab tests which included culture: no bacterial growth on an unknown date, Covid-19 rapid swab: negative on an unknown date, and urine analysis: urine had leukocytes and blood present on an unknown date. Outcome of the event mild discomfort to my urethra was unknown while the rest was recovered.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number has been obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urethral disorder, Urinary tract infection, Urine analysis
Clinical narrative: mild discomfort to my urethra; UTI symptoms; Burning upon urination; pain upon urination; urgency; frequency; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL0140) solution for injection, via an unspecified route of administration in left arm on 28Dec2020 15:45 at a single dose for Covid-19 immunization. Medical history included Hashimoto's Thyroiditis. Patient was not pregnant. The patient's concomitant medications included levothyroxine, unspecified daily multivitamin, and collagen. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and had allergies. The patient experienced UTI symptoms, burning upon urination, pain upon urination, urgency, and frequency on 29Dec2020, and mild discomfort to her urethra on an unspecified date. The patient visited her physician. Patient received antibiotic - Keflex. The patient underwent lab tests which included culture: no bacterial growth on an unknown date, Covid-19 rapid swab: negative on an unknown date, and urine analysis: urine had leukocytes and blood present on an unknown date. Outcome of the event mild discomfort to my urethra was unknown while the rest was recovered.  No follow-up attempts are possible. No further information is expected. Information about lot/batch number has been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report from a contactable consumer. An 88-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 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 got his on 14Jan2021, and his arm was sore in Jan2021 but he did not have any redness, itchiness, or warmth. The outcome of the event was unknown.  Information on the lot/batch number has been requested.