chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: shoulder and joint pain; stiffness in joints and shoulder; stiffness in joints and shoulder; This is a spontaneous report from a contactable other hcp.  A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231), via an unspecified route of administration on 11Jan2021 at single dose at left upper arm for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The first dose of the vaccine BNT162B2 was administered on 19Dec2020 at 42 years old.  Caller stated she received the 2nd dose yesterday of the covid vaccine and experienced shoulder and joint pain, and this morning she has stiffness in joints and shoulder. The patient reported that last night, her shoulder joint started hurting but it was mild. This morning, it is very painful. Caller was looking at where the medication was injected on her, and she thinks the product may have been injection too high on her arm, like it was directly under the acromion process, and she is concerned the product may have been injected directly into her shoulder joint, instead of into the muscle. She thinks that injection was given to her too high, it may went to the joint not the muscle. Caller confirmed that she had no other vaccines on the same day as her COVID vaccine. The outcome of the event shoulder and joint pain was unknown while not recovered for the other events.   Information on lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Overdose
Clinical narrative: shoulder and joint pain; stiffness in joints and shoulder; stiffness in joints and shoulder; This is a spontaneous report from a contactable other hcp.  A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231), via an unspecified route of administration on 11Jan2021 at single dose at left upper arm for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The first dose of the vaccine BNT162B2 was administered on 19Dec2020 at 42 years old.  Caller stated she received the 2nd dose yesterday of the covid vaccine and experienced shoulder and joint pain, and this morning she has stiffness in joints and shoulder. The patient reported that last night, her shoulder joint started hurting but it was mild. This morning, it is very painful. Caller was looking at where the medication was injected on her, and she thinks the product may have been injection too high on her arm, like it was directly under the acromion process, and she is concerned the product may have been injected directly into her shoulder joint, instead of into the muscle. She thinks that injection was given to her too high, it may went to the joint not the muscle. Caller confirmed that she had no other vaccines on the same day as her COVID vaccine. The outcome of the event shoulder and joint pain was unknown while not recovered for the other events.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: dose of the COVID vaccine she was just given on 11Jan2021 was given too high; She was experiencing shoulder and joint pain; She was experiencing shoulder and joint pain; This is a spontaneous report from a Pfizer sponsored call center, by a contactable consumer (patient).  This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left deltoid on 11Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was experiencing shoulder and joint pain  on an unspecified date in Jan2021 with outcome of unknown. The patient stated that she was concerned that dose of the COVID vaccine she was just given on 11Jan2021 was given too high, underneath the shoulder bone. She had questions on the efficacy of the product given.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Overdose
Clinical narrative: dose of the COVID vaccine she was just given on 11Jan2021 was given too high; She was experiencing shoulder and joint pain; She was experiencing shoulder and joint pain; This is a spontaneous report from a Pfizer sponsored call center, by a contactable consumer (patient).  This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left deltoid on 11Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was experiencing shoulder and joint pain  on an unspecified date in Jan2021 with outcome of unknown. The patient stated that she was concerned that dose of the COVID vaccine she was just given on 11Jan2021 was given too high, underneath the shoulder bone. She had questions on the efficacy of the product given.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Swelling, Ultrasound scan
Clinical narrative: office pocus revealed a 2.5 cm lymph node; 36 hours after second shot I developed marked swelling and pain in my left axilla./Swelling persists into day 3.; 36 hours after second shot I developed marked swelling and pain in my left axilla./Swelling persists into day 3.; This is a spontaneous report from a contactable physician reported for herself.   This 45-year-old female patient started the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL1284), via an unspecified route of administration at single dose on 09Jan2021 14:30  for covid-19 immunisation. Medical history included anxiety. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D [COLECALCIFEROL]), escitalopram oxalate (LEXAPRO). Previously the patient received the first dose of BNT162B2 (Lot # EK5730), in the left arm on 19Dec2020 02:15 PM for covid-19 immunisation. On 11Jan2021 02:30, the patient experienced that office POCUS revealed a 2.5 cm lymph node, 36 hours after second shot I developed marked swelling and pain in my left axilla. Swelling persists into day 3. The outcome of the events was recovering. The patient underwent lab tests and procedures which included ultrasound scan: 2.5 cm lymph node on 11Jan2021 (Office POCUS  revealed a 2.5 cm lymph node).   Therapeutic measures were taken as a result of the events included Naproxen. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Had pain underneath arm; Then whole lymph nodes were swollen up until her armpit; This is a spontaneous report from a contactable Other-HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Dec2020 at SINGLE DOSE for covid-19 vaccination. The patient's medical history and concomitant medications were not reported.  The patient experienced side effects after she got her 1st dose last 24Dec2020. On 26Dec2020, she had pain underneath arm and then whole lymph nodes were swollen up until her armpit 2 days after receiving the vaccine. Her 2nd dose is scheduled this Thursday and wants to know if she should get it. The outcome of the events was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Real fatigued; Muscle pain; Joint pain; 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) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had headache; was real fatigued; had muscle pain; and joint pain. The outcome of the events, 'headache', 'fatigued', 'muscle pain' and 'joint pain', was unknown. The patient was asking if the side effects will be worse after the second dose, and if she should get the second dose.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Fatigue, Pain, Rhinorrhoea, Swelling of eyelid
Clinical narrative: swelling of the eyelids; itching of the eyes; body aches; runny nose; generalized fatigue and tiredness; This is a spontaneous report from a contactable Nurse. This female Nurse reported for herself that:  A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 29Dec2020 for Covid-19 immunisation.  The patient medical history included high rheumatoid factors diagnosed in 2020 taking Plaquenil for over a year with occasional steroid use for bad flare ups. The concomitant medications included Plaquenil for over a year for high rheumatoid factors increased, steroids occasionally for bad flare ups.  On 29Dec2020 the patient experienced swelling of the eyelids, itching of the eyes, body aches, runny nose, generalized fatigue and tiredness that lasted about 2 weeks. She was feeling better, body aches, runny nose, and fatigue were resolved on 09Jan2021, but her eyes are still a little but itchy with her eyelids not as swollen anymore. The outcome of swelling of the eyelids, itching of the eyes was unknown, of body aches, runny nose, generalized fatigue and tiredness was recovered. She was asking if it would still be okay for her to take the 2nd dose after her experienced side effects. She was due for the 2nd dose on 19Jan2021  Information about Batch/Lot number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Headache, Muscular weakness, Musculoskeletal discomfort
Clinical narrative: lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer.  A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation.  Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin.  Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer.  A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation.  Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin.  Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other healthcare professional (hcp). This hcp reported the same events for 2 patients. This is the first of two reports.  A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on 21Dec2020 at a single dose on left deltoid for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient reported to have received the vaccine 3 weeks ago and was scheduled to receive the vaccine yesterday (11Jan2021) but tested positive last Saturday 09Jan2021. He mentioned that he had subsequent symptoms of COVID on 01Jan2021. He and his significant other (S/O) got tested last 05Jan2021. He got a negative result while his S/O got a positive result. He had symptoms throughout the week until he confirmed positive last Saturday. As of this report, he is still in quarantine and is experiencing residual congestion and tiredness. He asked when he should schedule to receive the vaccine. The patient underwent lab tests and procedures which included COVID-19 test: negative   on 05Jan2021, and then positive on 09Jan2021. The patient has not recovered from the events.; Sender's Comments: Based on the available information, a causal relationship between event positive "COVID-19 test with symptoms" (coded to coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021030850 same drug/events/reporter, different patients
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Night sweats, Pyrexia
Clinical narrative: Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; This is a spontaneous report from a contactable physician (patient). A 26-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), intramuscular (vaccine location: Left arm) on 11Jan2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. The patient's had no concomitant medications. There had been no other vaccine in four weeks. There were no other medications in two weeks. The patient had no prior covid vaccination. The patient experienced fever, chills, night sweats, fatigue, and headache on 11Jan2021 22:00. The patient has not been tested for covid post vaccination. No treatment was provided. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspepsia, Fatigue, Gastrooesophageal reflux disease, Malaise
Clinical narrative: having a bad taste in his mouth; terrible gastric reflux; heartburn; tired; sickly; This is a spontaneous report from a contactable consumer received via Medical Information Team.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported he felt tired and sickly. On 11Jan2021, he started having a bad taste in his mouth and terrible gastric reflux and heartburn. Medication did help the reflux, but "the bad taste was still in mouth". The patient outcome of " tired and sickly" was recovered on 11Jan2021, the outcome of gastric reflux and heartburn was recovering and the outcome of "the bad taste" was not recovered.  The information on the batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EK9231) , via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 16Dec2020 (lot no: EH9899) administered on left arm. Patient was not pregnant.  The patient has no COVID prior vaccination.  On 07Jan2021, patient stated "I had a sore arm at the injection site. I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2- 100.4 for majority of day and decreased to 99.6 that night. It only lasted the day after being vaccinated" The patient recovered on unspecified date from all of the events. The patient has not tested COVID on post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Headache, Night sweats, Pain
Clinical narrative: Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold with chills/ Was shivering; Fever; Sweating all night; This is a spontaneous report from a contactable nurse. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 31Dec2020 10:02 at a SINGLE DOSE for covid-19 immunisation. Medical history included tuberculosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BCG vaccine. The patient received Pfizer COVID Vaccine on 31Dec2020. On 04Jan2021, the patient got a couple of symptoms and started with a mild headache, not sharp pain and she took Tylenol. After she showered when she came home from work, she got chills. She took a couple more Tylenol, but doesn't know when. When she went to bed, she sweated all night and still feel cold with chills and was sweating all night. She didn't really check temperature, but knew she had a fever. On 05Jan2021, she woke up and felt like someone had hit her from her head to toes and every joint was aching, terrible body aches and couldn't walk. She went to emergency room on 05Jan2021 and thought she may have been exposed a couple of days before. She was working with patients who had COVID. She had a rapid COVID test that was negative and came home and symptoms continued. Today was the first day she was feeling a little better. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of mild, headache, cold with chills, cold with chills/ was shivering, fever, sweating all night , couldn't walk, terrible body aches, every joint was aching. The outcome of the events was unknown.  Information was requested on Lot/ Batch number.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold with chills/ Was shivering; Fever; Sweating all night; This is a spontaneous report from a contactable nurse. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 31Dec2020 10:02 at a SINGLE DOSE for covid-19 immunisation. Medical history included tuberculosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BCG vaccine. The patient received Pfizer COVID Vaccine on 31Dec2020. On 04Jan2021, the patient got a couple of symptoms and started with a mild headache, not sharp pain and she took Tylenol. After she showered when she came home from work, she got chills. She took a couple more Tylenol, but doesn't know when. When she went to bed, she sweated all night and still feel cold with chills and was sweating all night. She didn't really check temperature, but knew she had a fever. On 05Jan2021, she woke up and felt like someone had hit her from her head to toes and every joint was aching, terrible body aches and couldn't walk. She went to emergency room on 05Jan2021 and thought she may have been exposed a couple of days before. She was working with patients who had COVID. She had a rapid COVID test that was negative and came home and symptoms continued. Today was the first day she was feeling a little better. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of mild, headache, cold with chills, cold with chills/ was shivering, fever, sweating all night , couldn't walk, terrible body aches, every joint was aching. The outcome of the events was unknown.  Information was requested on Lot/ Batch number.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Feeling abnormal, Memory impairment, Pyrexia
Clinical narrative: Tested positive with COVID/ diagnosed with Covid-19; Tested positive with COVID/ diagnosed with Covid-19; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in right deltoid on 04Jan2021 at a single dose for covid-19 prophylaxis in a hospital at the age of 52 years old. Medical history included ongoing type 2 diabetes mellitus diagnosed 13 years ago (unspecified date).  The patient's concomitant medications were not reported. The patient reported that he has worked with more COVID patients and is making exposure much manageable. He is not sure if the first dose of the COVID vaccine shot is helping him. The patient is a paramedic and got the first dose of the Covid-19 vaccine 8 days ago and yesterday was diagnosed with the COVID virus. He was tested positive with COVID. The patient wanted to know if it safe to get the second dose or does he have to wait. He said that he was diagnosed with Covid-19 about 20:00 last night 11Jan2021. He said that last night, 11Jan2021, he had a horrible fever. He felt so bad last night that he can't remember much about last night. He stated that the vaccine works. His medical director said that that evidence shows that even with 1 dose if you get the Covid virus, the effects are a lot less. He said that the effects of COVID that he is experiencing are very mild except when the fever spikes. He said that the fevers started early Friday evening (08Jan2021). He said that they started out mild and hit him pretty good on Sunday (11Jan2021). He said that the fever came on midday Sunday and midday yesterday at 15:00, it showed up with a vengeance. He went from normal to 100.3 in a matter of about 5 seconds. He stated that the fevers are off and on. He stated that when his back starts to hurt he knows he is running a fever. Outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive with COVID/ diagnosed with Covid-19; Tested positive with COVID/ diagnosed with Covid-19; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in right deltoid on 04Jan2021 at a single dose for covid-19 prophylaxis in a hospital at the age of 52 years old. Medical history included ongoing type 2 diabetes mellitus diagnosed 13 years ago (unspecified date).  The patient's concomitant medications were not reported. The patient reported that he has worked with more COVID patients and is making exposure much manageable. He is not sure if the first dose of the COVID vaccine shot is helping him. The patient is a paramedic and got the first dose of the Covid-19 vaccine 8 days ago and yesterday was diagnosed with the COVID virus. He was tested positive with COVID. The patient wanted to know if it safe to get the second dose or does he have to wait. He said that he was diagnosed with Covid-19 about 20:00 last night 11Jan2021. He said that last night, 11Jan2021, he had a horrible fever. He felt so bad last night that he can't remember much about last night. He stated that the vaccine works. His medical director said that that evidence shows that even with 1 dose if you get the Covid virus, the effects are a lot less. He said that the effects of COVID that he is experiencing are very mild except when the fever spikes. He said that the fevers started early Friday evening (08Jan2021). He said that they started out mild and hit him pretty good on Sunday (11Jan2021). He said that the fever came on midday Sunday and midday yesterday at 15:00, it showed up with a vengeance. He went from normal to 100.3 in a matter of about 5 seconds. He stated that the fevers are off and on. He stated that when his back starts to hurt he knows he is running a fever. Outcome of the events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt only a little bit; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient was 66 years old and went to the stadium name yesterday on 11Jan2021 and there were 1000's of people there. The patient got her first dose of the vaccine and they gave her an appointment card for the first of February. The patient was fine by the way, her arm hurt only a little bit in Jan2021. She went back to that vaccine assistant thing to make an appointment. It was a computerized system for making an appointment. It generates a QR code. But she was not sure that she had an appointment for her second dose. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching and redness on head, itching on arms and torso.; Itching and redness on head, itching on arms and torso.; This is a spontaneous report from a contactable Other HCP (patient).  A 50-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 09:00 at SINGLE DOSE at Left arm for COVID-19 vaccination. The patient was not pregnant. Medical history included hypertension.  Concomitant medication in two weeks included omeprazole (PRILOSEC [OMEPRAZOLE]), doxycycline and otc vitamins. The patient previously took oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET) and experienced drug allergies. On 12Jan2021 10:00, the patient experienced itching and redness on head, itching on arms and torso. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Motion sickness
Clinical narrative: Motion sickness, and fatigue started about 11am; Motion sickness, and fatigue started about 11am / slept for 3 hours woke to just severe fatigue; Headache started about 6 hours after, progressively worsening about 12hrs; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899), via an unspecified route of administration at single dose in the left arm on 11Jan2021 14:00 to for Covid-19 immunisation.  Medical history included was none. Concomitant medication included fluticasone propionate and multi vitamin. The patient experienced headache started about 6 hours after, progressively worsening about 12hrs on 11Jan2021 20:00, motion sickness, and fatigue started about 11am on 12Jan2021. Completely wiped out by noon and had to lay down could not work slept for 3 hours woke to just severe fatigue, slight headache no nausea. Therapeutic measures were taken as a result of headache included Advil but no help. No treatment received for the other events. The vaccine was administered at Workplace clinic. 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. The patient had not been tested for COVID-19 since the vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 antibody test
Clinical narrative: Near complete loss of taste and smell.; Near complete loss of taste and smell.; This is a spontaneous report from a contactable nurse (patient).  A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration at left arm on 08Jan2021 at 10:00 at single dose for COVID-19 immunization.  The patient medical history included anxiety and depression, both from an unknown date and unknown if ongoing.  The patient's concomitant medication included lamotrigine, fluoxetine, rheum rhaponticum root (ESTROVERA) and gabapentin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at right arm on 22Dec2020 at 10:00 at single dose for COVID-19 immunization. On 11Jan2021 at 14:30, the patient experienced near complete loss of taste and smell. The patient underwent lab tests and procedure which included SARS-COV-2 antibody test (Nasal swab): negative on 11Jan2021. The patient outcome of the events was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient), then received from a Pfizer-sponsored program (Pfizer First Connect). This consumer reported similar events for two patients. This is the first of two reports. A 72 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0142) on 05Jan2021, for COVID-19 immunization. Medical history and concomitant medications were none. On 08Jan2021 the patient was tested positive for COVID 19. Events outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026991 same reporter/drug/AE, different patient
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Skin odour abnormal, Viral test positive
Clinical narrative: increased body odor/still start to smell bad a few hours after showering, even when not sweating; COVID test result: Positive (08Jan2021); COVID test result: Positive (08Jan2021); This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 13:15 at a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications in two weeks included ascorbic acid (VIT C), ascorbic acid, biotin, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, pantothenic acid, potassium iodide, pyridoxine hydrochloride, retinol, sodium selenate, zinc sulfate (CENTRUM MULTIGUMMIES MEN). The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination; tested on 03Jan2021 with the results pending. On 08Jan2021, the patient has tested positive via nasal swab post vaccination. On 09Jan2021, the patient experienced increased body odor. The patient had resorted to showering twice a day, and still start to smell bad a few hours after showering, even when not sweating. No treatment was administered for the event "increased body odor/still start to smell bad a few hours after showering, even when not sweating". The event "increased body odor/still start to smell bad a few hours after showering, even when not sweating" had not resolved, while the outcome of the rest of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: patient received the first dose on her left deltoid (arm was a little sore on an unspecified date); This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient (reported as 30-40 years old) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left deltoid on 22Dec2020 at a single dose for an COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on her left deltoid (arm was a little sore on an unspecified date). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; sores and pain; This is a spontaneous report from a contactable Other-HCP (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 02Jan2021 at single dose for COVID-19 immunisation. The patient medical history included ongoing lupus erythematosus. Concomitant medication included belimumab (BENLYSTA), intravenous from an unspecified date (after the vaccine) at unspecified dosage for systemic lupus erythematosus. The patient experienced shingles, sores and pain on 06Jan2021 with outcome of unknown.  The action taken for belimumab was unknown. She would like to know if her first dose of the vaccine was still effective and if she should receive her second dose of the vaccine on 23Jan2021.  Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142; Expiration date was not reported) on 30Dec2020 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included asthma, gastroesophageal reflux disease (GERD) and allergy to sulfa drugs. Concomitant medication included omeprazole. On 06Jan2021 (20:00), the patient had hives. The hives was further reported to have occurred in two instances: first was 14 days after receiving the vaccine, and the second was 17 days after vaccination (pending clarification on event onset date). The patient did not receive any treatment for the reported event. The outcome of the event, hives, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142; Expiration date was not reported) on 30Dec2020 (09:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included asthma, gastroesophageal reflux disease (GERD) and allergy to sulfa drugs. Concomitant medication included omeprazole. On 06Jan2021 (20:00), the patient had hives. The hives was further reported to have occurred in two instances: first was 14 days after receiving the vaccine, and the second was 17 days after vaccination (pending clarification on event onset date). The patient did not receive any treatment for the reported event. The outcome of the event, hives, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Head discomfort, Headache
Clinical narrative: Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf.  A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm  on 30Dec2020 10:30 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.   Since 03Jan2021, the patient has been sick.  Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away.  Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is  afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00  The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit;  101.2 Fahrenheit  then up 102.7 Fahrenheit ; 101.5 Fahrenheit.  Sars-cov-2 test: positive   on 11Jan2021  .  Further information has been requested
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise, Ocular discomfort, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf.  A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm  on 30Dec2020 10:30 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.   Since 03Jan2021, the patient has been sick.  Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away.  Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is  afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00  The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit;  101.2 Fahrenheit  then up 102.7 Fahrenheit ; 101.5 Fahrenheit.  Sars-cov-2 test: positive   on 11Jan2021  .  Further information has been requested
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf.  A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm  on 30Dec2020 10:30 at single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.   Since 03Jan2021, the patient has been sick.  Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away.  Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is  afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00  The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit;  101.2 Fahrenheit  then up 102.7 Fahrenheit ; 101.5 Fahrenheit.  Sars-cov-2 test: positive   on 11Jan2021  .  Further information has been requested
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site redness, swelling, lump, itching; injection site redness, swelling, lump, itching; injection site redness, swelling, lump, itching; injection site redness, swelling, lump, itching; First dose of BNT162B2 on 22Dec2020 15:00 PM, second dose of BNT162B2 on 07Jan2021 08:00; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on right arm on 07Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included known allergies to adhesive. Concomitant medication included duloxetine, ethinylestradiol, levonorgestrel (AMETHYST), bupropion, tizanidine. There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had not COVID tested post vaccination. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies; tramadol and experienced allergies. The patient received the first dose of BNT162B2 on right arm on 22Dec2020 15:00 PM for COVID-19 immunization. The patient experienced injection site redness, swelling, lump, itching on 07Jan2021 22:00 with outcome of recovering. No treatment was received for the events (injection site redness, swelling, lump, itching). The patient also had first dose of BNT162B2 on 22Dec2020 15:00 PM, second dose of BNT162B2 on 07Jan2021 08:00.  Information on the lot/batch number has been requested.