chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Back pain, Cough, Fatigue, Feeling hot
Clinical narrative: not being able to smell anything/Cannot smell anything; Sinus issues; Cough; Congestion; Feels hot; backache; fatgue; headache; This is a spontaneous report received from a contactable other health professional (who is also the patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm, on 15Dec2020, at single dose, for COVID-19 immunization. There was no medical history. The patient's concomitant medications were not reported. The patient reported that she got the COVID vaccine last Tuesday, on 15Dec2020. She is a psychologist and works close with patients all the time. She has had symptoms since last Wednesday (16Dec2020). She clarified that her symptoms were back ache shortly after the vaccine, fatigue, headache, sinus issues and cough. Then her backache went away. She also had congestion and felt hot on 16Dec2020. She had an appointment last Friday (18Dec2020) and they took her temperature, but she did not have a fever. And then since yesterday (20Dec2020), she cannot smell anything. She has a baby and cannot smell the dirty diapers. She cannot smell her perfume. She asked other people who received the vaccine if they experienced this, and they did not. She was wondering if this is the vaccine or does she possibly have some other infection or should she get tested for COVID or is it possible this is from the vaccine? The patient clarified that at first her back ache went away but it is still ongoing now. It has persisted at the same level as well as all of the other symptoms. The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Respiratory tract congestion, Sinus disorder
Clinical narrative: not being able to smell anything/Cannot smell anything; Sinus issues; Cough; Congestion; Feels hot; backache; fatgue; headache; This is a spontaneous report received from a contactable other health professional (who is also the patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm, on 15Dec2020, at single dose, for COVID-19 immunization. There was no medical history. The patient's concomitant medications were not reported. The patient reported that she got the COVID vaccine last Tuesday, on 15Dec2020. She is a psychologist and works close with patients all the time. She has had symptoms since last Wednesday (16Dec2020). She clarified that her symptoms were back ache shortly after the vaccine, fatigue, headache, sinus issues and cough. Then her backache went away. She also had congestion and felt hot on 16Dec2020. She had an appointment last Friday (18Dec2020) and they took her temperature, but she did not have a fever. And then since yesterday (20Dec2020), she cannot smell anything. She has a baby and cannot smell the dirty diapers. She cannot smell her perfume. She asked other people who received the vaccine if they experienced this, and they did not. She was wondering if this is the vaccine or does she possibly have some other infection or should she get tested for COVID or is it possible this is from the vaccine? The patient clarified that at first her back ache went away but it is still ongoing now. It has persisted at the same level as well as all of the other symptoms. The outcome of the events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: Sore arm at injection site and headache at bedtime.; Sore arm at injection site and headache at bedtime.; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced sore arm at injection site and headache at bedtime on 20Dec2020. Outcome of the event was recovered on unspecified date in Dec2020. No treatment received for the events. The events were assessed as non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: fever; body malaise; Body aches; muscles hurt; sharp eye pain/If she turns her eyes to the right or to the left; chills; This is a spontaneous report from a contactable consumer. A 24-year-old female patient (daughter) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at 18:00 on 17Dec2020 at single dose for COVID-19 immunization. Medical history included asthma and anxiety. Concomitant medication included sertraline hydrochloride (ZOLOFT) for anxiety. The patient experienced fever, body malaise, body aches, muscles hurt, sharp eye pain/if she turned her eyes to the right or to the left, and chills on 18Dec2020. At time of reporting, the outcome of events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash spreading started at the neck slowly progress to the entire neck, then the scalp, torso, legs and arms. Started within 4 hours over night then at 0830 am started getting worse.; This is a spontaneous report from a contactable nurse reporting for herself.  A 40-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included hyperlipidaemia, antiphospholipid syndrome and migraine. Concomitant medication included metronidazole benzoate (FLAGYL), butalbital, caffeine, paracetamol (FIORICET), iron (IRON) and multivitamin. The patient experienced rash spreading started at the neck slowly progress to the entire neck, then the scalp, torso, legs and arms on 20Dec2020 21:30 with outcome of not recovered.  On21Dec2020 at 08:30 am it started getting worse. The outcome of the events was not recovered. The patient took Benadryl as treatment for the events. The patient did not undergo COVID test and did not have COVID prior to vaccination.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm following vaccination; This is a spontaneous report from a Pfizer sponsored program, Pfizer First Connect, received from a contactable consumer (patient). A female patient of an unspecified age received 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 20Dec2020 at a single dose for COVID-19 immunisation. Medical history included bone pain and arthritis (patient received a prescription of Prednisone today for bone pain and arthritis). The patient's concomitant medications were not reported. The patient reported receiving the first dose of the COVID-19 vaccine yesterday morning (20Dec2020). She mentioned experiencing a sore arm following vaccination. She then explained receiving a prescription of Prednisone today for bone pain and arthritis, after consulting with her foot doctor. She asked if she should she take this steroid treatment, and also asked if she should receive her second dose of the Shingle vaccine while being on the COVID-19 treatment. Outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia, heart rate remained higher than 100 bpm throughout the day at rest. Readings ranged from 110-117; This is a spontaneous report from a contactable Nurse. This 25-years-old female Nurse reported for herself (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 18Dec2020 01:00 PM at Right arm at single dose for covid-19 immunization. Medical history was allergy to ham. Concomitant drug was Omeprazole. No other vaccine in four weeks. Adverse event reported as Tachycardia, heart rate remained higher than 100 bpm throughout the day at rest (non-serious). Readings ranged from 110-117 on 19Dec2020 09:00 AM with outcome of Recovered. No treatment. No COVID prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts have been completed and no further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Feeling abnormal, Lethargy
Clinical narrative: dizziness; weakness; loss of balance; brain fog; lethargy; Dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder); Dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder); Dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder); This is a spontaneous report from a contactable nurse. This 41-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (Lot# EH9889) intramuscularly at left arm at single dose for COVID-19 ((PFIZER-BIONTECH COVID-19 VACCINE) immunisation on 17Dec2020. Relevant history was unknown. Relevant concomitant drug included multivitamin and ergocalciferol (VIT D).  No known allergies. No allergies to medications, food, or other products. Relevant medical history was none. After receiving first dose, the patient experienced dizziness, weakness, loss of balance, brain fog, lethargy on 18Dec2020, 07:00 AM. The dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder). No treatment was received. The patient resolved with sequel from the events. No covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were considered as non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; chills; fatigue; This is a spontaneous report from a non-contactable nurse. This nurse reported for a 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EK5730) Intramuscularly at Left arm at single dose for COVID-19 immunisation on 19Dec2020 (02:30 PM). Relevant history and concomitant drugs were unknown. The patient experienced had chills, fatigue, headache in the morning of  20Dec2020 at 7:00 am.  The patient received Tylenol as treatment and the outcome of events was resolved in unknown date of Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: amount of blood on his Band-Aid after the injection; This is a spontaneous report from a contactable pharmacist. A male patient unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on 20Dec2020. Relevant history and concomitant drugs were unknown. The patient had a significant (then rephrased to "small") amount of blood on his Band-Aid after the injection on 20Dec2020. Outcome of the event was unknown.    The information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: arm started to feel sore; injection site pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number E9899, expiry date Mar2021) intramuscular on left arm on 17Dec2020 at single dose for COVID-19 immunization. The patient has no prior vaccinations within 4 weeks. Medical history included and concomitant medications were none. The patient got the COVID vaccine on Thursday (17Dec2020), her arm was still really sore (17Dec2020). The patient asked on how long will this last and was referred to healthcare professional. Full EUA PI, discussed incidence of injection site pain. No information on duration after 1st dose. The patient received the Covid vaccine around 10:30 on Thursday morning and her arm started to feel sore Thursday evening. The patient clarified that the vaccine was administered around 10:30AM to 11:00AM. The patient was advised to follow up with healthcare professional. The patient did not receive treatment for the events. The outcome of the events arm started to feel sore and injection site pain was recovering. The reporter informed that the vaccination facility type was a hospital and was not administered at a military facility.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: fatigue; chills; arm soreness; This is a spontaneous report from a contactable pharmacist. This 34-year-old female pharmacist (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular on left arm on 18Dec2020 at 12:45 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. It was reported patient had no other vaccine in four weeks; she had oral contraceptive in two weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fatigue, chills, arm soreness on 18Dec2020 at 03:00 PM. No treatment was received. Outcome of events was recovered in Dec2020.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm pain; low grade fever of 100; This is a spontaneous report from a contactable nurse.  A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscularly at the left arm on 20Dec2020 10:30 at a single dose for COVID-19 immunization at a hospital.  Medical history included migraine and asthma. Allergy with only certain nausea medications (unspecified). There were concomitant medications but were unspecified which the patient received within 2 weeks of vaccination. 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 and was not tested for it since the vaccination. On 20Dec2020, 22:00, after almost 12 hours, patient had a low grade fever of 100 (unit unspecified) and had an arm pain with no treatment while fever responded to acetaminophen (TYLENOL). The patient recovered from the events on an unknown date.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Extensive swelling of vaccinated limb, Headache, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Injection site was very painful and it's blowing and my whole arm was hurting; Injection site was very painful and it's blowing and my whole arm was hurting; I have swelling in my whole arm; Weakness; Muscle soreness; Headache; This is a spontaneous report from a contactable consumer (patient, nurse's assistant). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Friday 18Dec2020 at about 09:58 at 0.3 ml, single for covid-19 immunization. This was the first dose. None medical history. There were no concomitant medications. In 2020, the patient stated the injection site itself, was very painful and it's blowing and in fact her whole arm, the whole arm was hurting and she has swelling in her whole arm and also she had like muscle soreness and weakness. The only other thing she felt was like headache and that's it. The patient was given aspirin for treatment. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Injection site was very painful and it's blowing and my whole arm was hurting; Injection site was very painful and it's blowing and my whole arm was hurting; I have swelling in my whole arm; Weakness; Muscle soreness; Headache; This is a spontaneous report from a contactable consumer (patient, nurse's assistant). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Friday 18Dec2020 at about 09:58 at 0.3 ml, single for covid-19 immunization. This was the first dose. None medical history. There were no concomitant medications. In 2020, the patient stated the injection site itself, was very painful and it's blowing and in fact her whole arm, the whole arm was hurting and she has swelling in her whole arm and also she had like muscle soreness and weakness. The only other thing she felt was like headache and that's it. The patient was given aspirin for treatment. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: numbness and tingles in armed or pant in all my fingers; numbness and tingles in armed or pant in all my fingers; This is a spontaneous report from a contactable consumer.  A 44-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: Mar2021), via an unspecified route of administration on 18Dec2020 at 44-years-old at a single dose for COVID-19 immunization.  The patient's medical history was reported as none. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), misoprostol (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. On 19Dec2020, the patient experienced: "numbness and tingles in armed or pant in all my fingers."  The patient stated, ''I got my shot (COVID Vaccine) at work yesterday around 3 pm. Since 1 O 'clock this morning I have numbness and tingles in armed or pant in all my fingers, can won't go away.'' There was no treatment received. The patient reported that she worked in an emergency department as a technician. The patient underwent lab tests and procedures which included body weight: about 190   on an unspecified date.  The clinical outcome of the events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.  Rating 5/10 pain.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; Back pain radiating down to the L buttocks, down the L leg and ending at the ankle.; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on right arm on 19Dec2020 10:00 AM, single dose for COVID-19 immunization at 29-year-old. Medical history included: COVID-19 diagnosed prior to vaccination. No known allergies. Concomitant medications included: drospirenone, ethinylestradiol betadex clathrate (YAZ); ibuprofen; cetirizine hydrochloride (ZYRTEC); diphenhydramine hydrochloride (BENADRYL); melatonin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Dec2020, 10:00 AM, the patient experienced back pain radiating down to the L buttocks, down the L leg and ending at the ankle, rating 5/10 pain. No treatment received for the adverse events. Lab data included: COVID-19 (positive) diagnosed prior to vaccination; pain 5/10 on 20Dec2020. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia oral
Clinical narrative: lips tingling and "on fire"/tingling "8/10", "2/10"; lips tingling and "on fire"/tingling "8/10", "2/10"; This is a spontaneous report from a contactable other healthcare professional.  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 at single dose for COVID-19 immunization at hospital. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of Pfizer COVID-19 vaccine. After "10:00 minutes" of observation phase, patient complained Of (c/o) lips tingling and "on fire". Lips not swollen, denies short of breath (SOB), "skin WNLs", denies difficulty swallowing. The Medical Emergency Response Team (MERT) was called. Patient was assessed, stated tingling 8/10, no other symptoms. Patient was given bottle of water and was tolerating that fine. Allegra 60mg was ordered and administered at 8:52 A.M. Patient stated was at a 2/10, 10 minutes after getting the Allegra. Patient was drinking water without difficulties. Patient remained without further symptoms, lips still 2/10 with tingling. Outpatient lab work was ordered. Patient left at 10:00 A.M ambulatory to outpatient lab. MERT educated her to notify administrator of her symptoms prior to her second vaccine. The outcome of the event was reported as recovered (in Dec2020).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: severe dizziness; horrible nausea and vomiting; horrible nausea and vomiting; muscle soreness; headache; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female nurse received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route in left lower deltoid on 17Dec2020 10 am, single dose for COVID-19 immunization at 40-year-old. Medical history included: surgery and lipoma removed from upper deltoid in Nov2020. Family medical history included: Her mother had colorectal cancer at age 40. When the patient turned 40, she had colonoscopy earlier this year (2020) and it was negative. Concomitant medication included: levothyroxine 100ug daily from 2001. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had pretty severe muscle soreness Thursday night (17Dec2020) and the next two days. On 19Dec2020 it was not as severe. It was mild and it started to dissipate on 19Dec2020. The only thing she had been taking was acetaminophen 650mg that night for the muscle soreness. The patient awoke at 3:00 am on 20Dec2020 out of a dream with severe dizziness that turned into horrible nausea and vomiting. She had vomiting for a little while the third night (20Dec2020) into the fourth day. The patient (nurse) considered the muscle soreness and dizziness was non-serious and not medically significant. She didn't feel the need to go to the hospital because it did improve. After she threw up, the dizziness kind of went way. Even today (21Dec2020) she felt fine and no more nausea, but still felt kind of off and dizziness, lingering dizziness. It wasn't extreme dizziness but when texting she could feel, and it was hard to focus. She was not one hundred percent her normal self. She was not sure if it was related to the vaccine. She was eating and drinking normally. The night that she received the vaccine, she had one beer and one margarita at dinner. She did have alcoholic beverages, a beer and a margarita. It was nothing excessive with dinner. She was not overly drunk. She didn't know if alcohol could have contributed. She had never had that kind of reaction before from drinking. That was very odd. She just wouldn't drink any alcohol. She took acetaminophen for a headache (in Dec2020) that she was experiencing. She was pretty healthy. All of this was so new with the COVID vaccine. That night into this morning she started her menstrual period as well. She had never had any horrible side effects like migraines or cramping when getting her menstrual cycle. It could have been the alcohol or her period. No visit to emergency room or physician office. Action taken for BNT162B2 was not applicable. Outcome of the event muscle soreness was resolved on 19Dec2020; outcome of the event severe dizziness was resolving; outcome of the other events was unknown. Causality assessment between the event muscle soreness and the suspect product BNT162B2 per the patient was reported as related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe dizziness; horrible nausea and vomiting; horrible nausea and vomiting; muscle soreness; headache; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female nurse received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route in left lower deltoid on 17Dec2020 10 am, single dose for COVID-19 immunization at 40-year-old. Medical history included: surgery and lipoma removed from upper deltoid in Nov2020. Family medical history included: Her mother had colorectal cancer at age 40. When the patient turned 40, she had colonoscopy earlier this year (2020) and it was negative. Concomitant medication included: levothyroxine 100ug daily from 2001. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had pretty severe muscle soreness Thursday night (17Dec2020) and the next two days. On 19Dec2020 it was not as severe. It was mild and it started to dissipate on 19Dec2020. The only thing she had been taking was acetaminophen 650mg that night for the muscle soreness. The patient awoke at 3:00 am on 20Dec2020 out of a dream with severe dizziness that turned into horrible nausea and vomiting. She had vomiting for a little while the third night (20Dec2020) into the fourth day. The patient (nurse) considered the muscle soreness and dizziness was non-serious and not medically significant. She didn't feel the need to go to the hospital because it did improve. After she threw up, the dizziness kind of went way. Even today (21Dec2020) she felt fine and no more nausea, but still felt kind of off and dizziness, lingering dizziness. It wasn't extreme dizziness but when texting she could feel, and it was hard to focus. She was not one hundred percent her normal self. She was not sure if it was related to the vaccine. She was eating and drinking normally. The night that she received the vaccine, she had one beer and one margarita at dinner. She did have alcoholic beverages, a beer and a margarita. It was nothing excessive with dinner. She was not overly drunk. She didn't know if alcohol could have contributed. She had never had that kind of reaction before from drinking. That was very odd. She just wouldn't drink any alcohol. She took acetaminophen for a headache (in Dec2020) that she was experiencing. She was pretty healthy. All of this was so new with the COVID vaccine. That night into this morning she started her menstrual period as well. She had never had any horrible side effects like migraines or cramping when getting her menstrual cycle. It could have been the alcohol or her period. No visit to emergency room or physician office. Action taken for BNT162B2 was not applicable. Outcome of the event muscle soreness was resolved on 19Dec2020; outcome of the event severe dizziness was resolving; outcome of the other events was unknown. Causality assessment between the event muscle soreness and the suspect product BNT162B2 per the patient was reported as related.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Headache; body aches; chills; low grade fever 100 degrees Fahrenheit; Soreness to the right arm where vaccine was administered.; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm on 18Dec2020 03:00 PM, single dose for COVID-19 immunization at 60-year-old. Medical history included: COVID-19 diagnosed prior to vaccination. Concomitant medication was not reported. No other vaccine received within 4 weeks prior to the COVID vaccine. On 19Dec2020 12:00 PM, the patient had headache, body aches, chills and low-grade fever 100 degrees Fahrenheit. At the same time (19Dec2020 12:00 PM), the patient had soreness to the right arm where vaccine was administered. No treatment received for above adverse events. Lab data included: COVID-19 (positive) diagnosed prior to vaccination; 100 degrees Fahrenheit low-grade fever on 19Dec2020. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved in Dec2020. It was reported as non-serious.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Headache, Lip swelling
Clinical narrative: Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm at 08:30 AM.on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days and headache in Dec2020 (reported as 11Dec2020 at time 08:45 AM). All events were reported as non-serious. The patient self administered Benadryl. Acetaminophen and ibup (ibuprofen) as treatment. The outcome of events was resolved with sequel. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; Diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days, headache; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm at 08:30 AM.on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none, no known allergies. The patient's concomitant medications were not reported. The patient experienced diarrhea, dizziness, swollen tongue and lips. Sore joints for multiple days and headache in Dec2020 (reported as 11Dec2020 at time 08:45 AM). All events were reported as non-serious. The patient self administered Benadryl. Acetaminophen and ibup (ibuprofen) as treatment. The outcome of events was resolved with sequel. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: urticaria on inside of both arms; This is a spontaneous report from a contactable Physician. This physician reported for a female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunization. Medical history was urticaria. Physician stated that I have a female patient in good health with a history of urticaria. She got the vaccine and developed urticaria on inside of both arms - looking for information on whether this patient should receive the 2nd dose. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eye swelling, Eyelid disorder, Hypersensitivity, Pruritus
Clinical narrative: I woke up and my left eye is swollen and my face is kind of swollen; I woke up and my left eye is swollen and my face is kind of swollen; rash/ rash on and off on my back and on my arm and around my face; allergic symptoms; kind of like itchiness on my ears and my scalp and also like on and off on my back and also on both of my arms like my wrist area on both arms/All night I was up with scratching my face; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of followup information on 20Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician (patient). A 30-years-old female patient received first dose bnt162b2 (BNT162B2), intramuscular on 2020 at single dose for covid-19 immunisation. Medical history included On nose, had prior to getting the vaccine, was experiencing some kind of she got through the contact dermatitis rash like her arms and behind her ears and it was all over her neck (she thought it was related to mat because she was getting it on neck and ears taking medication for that it just allergy medication and it had gotten better). There were no concomitant medications. The physician reported she have been experiencing some allergic symptoms following it since Dec2020, she had itchiness, it was like a rash on and off on back and on arm and around face and itchiness on calp and face/ experiencing kind of like itchiness on ears and scalp and also like on and off on back and also on both of arms like wrist area on both arms and then in the morning like 20Dec2020, it was kind of all night she was up with scratching face,; In the morning 20Dec2020, she woke up with some mild facial swelling, noticed like eyes swollen and little bit droopy. The events were still going on, she just took medicine for it. It's kind of persistent. Physician stated, "I guess I can report the worsening of my symptoms that was in the morning of reporting date like 8 AM." Treatment included just took medicine, Prednisone, Benadryl and Zyrtec. Weight: About 103. The event outcome was not recovered.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Scratch, Swelling face
Clinical narrative: I woke up and my left eye is swollen and my face is kind of swollen; I woke up and my left eye is swollen and my face is kind of swollen; rash/ rash on and off on my back and on my arm and around my face; allergic symptoms; kind of like itchiness on my ears and my scalp and also like on and off on my back and also on both of my arms like my wrist area on both arms/All night I was up with scratching my face; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of followup information on 20Dec2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician (patient). A 30-years-old female patient received first dose bnt162b2 (BNT162B2), intramuscular on 2020 at single dose for covid-19 immunisation. Medical history included On nose, had prior to getting the vaccine, was experiencing some kind of she got through the contact dermatitis rash like her arms and behind her ears and it was all over her neck (she thought it was related to mat because she was getting it on neck and ears taking medication for that it just allergy medication and it had gotten better). There were no concomitant medications. The physician reported she have been experiencing some allergic symptoms following it since Dec2020, she had itchiness, it was like a rash on and off on back and on arm and around face and itchiness on calp and face/ experiencing kind of like itchiness on ears and scalp and also like on and off on back and also on both of arms like wrist area on both arms and then in the morning like 20Dec2020, it was kind of all night she was up with scratching face,; In the morning 20Dec2020, she woke up with some mild facial swelling, noticed like eyes swollen and little bit droopy. The events were still going on, she just took medicine for it. It's kind of persistent. Physician stated, "I guess I can report the worsening of my symptoms that was in the morning of reporting date like 8 AM." Treatment included just took medicine, Prednisone, Benadryl and Zyrtec. Weight: About 103. The event outcome was not recovered.  Information on lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular on the left arm on 18Dec2020 13:00 at a single dose for covid-19 immunization. The patient's medical history included hypertension (HTN) and elevated triglycerides. The patient was not pregnant. The patient have no allergies to medications, food, or other products. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included metoprolol and fenofibric acid. The patient experienced soreness at the injection site on 19Dec2020 05:00. No treatment was received for the adverse event. Outcome of the event was recovered on Dec2020.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Minor headache; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot no. and expiration date were unknown), via an unspecified route of administration on 18Dec2020 23:45 on the left arm at single dose for COVID-19 immunization. Medical history included heart stent. The patient had no known drug allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Dec2020 01:00 AM, the patient experienced minor headache and chills. No treatment received for the events. The events recovered on unspecified date in Dec2020.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: When they put the shot it's been hurting me ever since then; This is a spontaneous report from a contactable consumer.  A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for  COVID-19 immunization.  Medical history included diabetes and headache from an unknown date. Concomitant medication included metformin (MANUFACTURER UNKNOWN) for diabetes.  On an unspecified date, the patient reported that " when they put the shot it's been hurting me ever since then " with outcome of unknown. Details were as follows: Patient indicated that when he  got the shot, everything was good but when they put the shot it's been hurting ever since then. There were no lab tests, or treatment given for the event.  The outcome of " when they put the shot it's been hurting me ever since then " was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Lethargy, Pain
Clinical narrative: my arm hurt for 4 Hours later and peaked that evening; headache; tiredness; lethargic/pretty lethargic.; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). Contactable Physicians (one was patient) reported that a 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021) on 18Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. The caller is a MD. He had the vaccine on Friday. His arm hurt 4 hours later, and then peaked that evening. It was very painful. It hurt and was painful. By Sunday it was 95 % gone. Today (21Dec2020) the pain is completely gone. He received the vaccine Friday. He is supposed to get an MRI Wednesday morning. He will be getting Gadolinun. He wanted to know if there was any adverse reaction with that. Will this material interfere with the immune response of COVID vaccine? He is considering canceling his MRI. The caller confirmed the details provided by the transferring agent. He doesn't have a prescribing doctor. He was looking at his CDC vaccination record log. He was given 0.3cc. He received the injection, and the pain started 4 hours later. It peaked in the evening. It was the worst arm pain he has ever had from a shot. He couldn't elevate his arm from pain. It was interesting because there was very little heat at the injection site. The amount of arm pain was not proportionate to a local reaction. He did take Tylenol that night. He got up the next day, Saturday, and it was painful but a little less painful. Then on Sunday 20Dec2020, it was 95% essentially. He started to get lethargic that Friday at about 9-12 hours later. Then he had a headache about 11 hours later that lasted 5-10 minutes. He was surprised but it went away. Saturday, he was pretty lethargic. He felt more lethargic from the shingles shot. No details on the shingles shot provided by the caller. He said the tiredness may have been a placebo effect because everyone says you will get tired. He was fine yesterday and today. He is glad he got it. He has recovered completely from all side effects he had. He never had a fever. His question about the MRI was escalated by the Medical information associate.  Follow-up attempts have been completed and no further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm hurt for 4 Hours later and peaked that evening; headache; tiredness; lethargic/pretty lethargic.; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). Contactable Physicians (one was patient) reported that a 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021) on 18Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. The caller is a MD. He had the vaccine on Friday. His arm hurt 4 hours later, and then peaked that evening. It was very painful. It hurt and was painful. By Sunday it was 95 % gone. Today (21Dec2020) the pain is completely gone. He received the vaccine Friday. He is supposed to get an MRI Wednesday morning. He will be getting Gadolinun. He wanted to know if there was any adverse reaction with that. Will this material interfere with the immune response of COVID vaccine? He is considering canceling his MRI. The caller confirmed the details provided by the transferring agent. He doesn't have a prescribing doctor. He was looking at his CDC vaccination record log. He was given 0.3cc. He received the injection, and the pain started 4 hours later. It peaked in the evening. It was the worst arm pain he has ever had from a shot. He couldn't elevate his arm from pain. It was interesting because there was very little heat at the injection site. The amount of arm pain was not proportionate to a local reaction. He did take Tylenol that night. He got up the next day, Saturday, and it was painful but a little less painful. Then on Sunday 20Dec2020, it was 95% essentially. He started to get lethargic that Friday at about 9-12 hours later. Then he had a headache about 11 hours later that lasted 5-10 minutes. He was surprised but it went away. Saturday, he was pretty lethargic. He felt more lethargic from the shingles shot. No details on the shingles shot provided by the caller. He said the tiredness may have been a placebo effect because everyone says you will get tired. He was fine yesterday and today. He is glad he got it. He has recovered completely from all side effects he had. He never had a fever. His question about the MRI was escalated by the Medical information associate.  Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pain, Lacrimation increased, Pain, Pain in jaw
Clinical narrative: left eye was irritated; left eye was sensitive to light; left eye was painful weeping and red.; left eye was red; left eye weepy; entire left side was sore, achy, including her jaw and stuff; entire left side was sore, achy, including her jaw and stuff; This is a spontaneous report from a contactable consumer. A female patient of unspecified age (reported as 59 with no unit) received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine), via an unspecified route of administration on right arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was painless on 16Dec2020. On 17Dec2020, her entire left side was sore, achy, including her jaw and stuff, 18Dec2020 evening, her left eye was irritated, sensitive to light, painful weeping and red (left eye was painful, red, and weepy). She called her doctor on 19Dec2020 and he gave her some eye drops. On 20Dec2020, the eye drops seemed to irritate her eye more. She woke up in the morning and it was seeming to get better as she had been taking Excedrin. She was supposed to wait 6 hours between drops, then her eye again was sensitive to light and painful, so she took another Excedrin, which helped again. She was trying to see an eye specialist the day after the time of the report. She had asked around at work and nobody else had any issues. She was wondering if this was vaccine related. She wanted to get tested for COVID, not that she thought she had it now, but might be she had it before she got the vaccine. She had not even talked to her workplace about this or anything. They asked everyone the first day after, if there were any issues and to report them to HR/Employee Health. She had not done so yet, so she wanted to do that first. Outcome of the events left eye was irritated, sensitive to light, painful weeping and red, and left eye weepy was resolving, and of other events was unknown.  Lot/batch number has been requested.